chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Illness, Pyrexia
Clinical narrative: Had a terrible reaction. Fever; Chills; Headache; Sick; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix.   On 19th October 2020, the patient received the 2nd dose of Shingrix. On 19th October 2020, less than a day after receiving Shingrix, the patient experienced fever, chills, headache and sickness. On an unknown date, the outcome of the fever, chills, headache and sickness were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, headache and sickness to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient was sick.  She experienced fever, chills and headache.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Muscle spasms
Clinical narrative: Flu like symptoms; Muscle spasms (neck); This case was reported by a consumer and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms and cervical spasm. On an unknown date, the outcome of the influenza-like symptoms and cervical spasm were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and cervical spasm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu like symptoms and muscle spasms (neck). Symptoms resolved within 3 days after injection.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Pain in extremity, Pyrexia
Clinical narrative: sore arm; fever of 101'F; Second dose of Shingrix today / First dose being on 27-AUG-2020; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 2ZN2D, expiry date unknown) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 9th October 2020, the patient received the 2nd dose of Shingrix. On 9th October 2020, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were reported as follows: On 27th August 2020, the patient received the 1st dose of Shingrix. On the date of reporting, the patient received 2nd dose of Shingrix early than the recommended schedule, which led to shortening of vaccination schedule. The reporter consented to follow up.   Follow up information was received from the physician on 20th October 2020: The patient's demographic details were updated. The patient arrived for flu shot at the time of reporting. On 9th October 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, fever. The patient was treated with ibuprofen (Advil).  The outcome of the pain in arm and fever were resolved.  It was unknown if the reporter considered the pain in arm and fever to be related to Shingrix. The VAERS details were updated. The physician misread last shingrix as 27th June 2020 instead of 27th August 2020. The vaccine was administered in an appropriate fashion with no issue.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness
Clinical narrative: it knocked her out for a day.; This case was reported by a consumer via call center representative and described the occurrence of loss of consciousness in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced loss of consciousness (serious criteria GSK medically significant). On an unknown date, the outcome of the loss of consciousness was recovered/resolved.   It was unknown if the reporter considered the loss of consciousness to be related to Shingrix.  Additional case details were reported as follows: The reporter was patient's friend. The patient received a dose of Shingrix and reported it knocked her out for a day. The reporter did not have any additional information to provide about the event or the patient. The reporter did not consent to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Arm is sore near site of injection; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 9974P, expiry date unknown) for prophylaxis.   On 19th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 19th September 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 69 or 70 years. The patient received Shingrix in right deltoid and her arm was very sore till the time of reporting. The arm was sore near site of injection, it was not red nor swollen. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives; This case was reported by a physician via call center representative and described the occurrence of hives in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 7th September 2020, unknown after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Physician reported that the patient had a reaction after receipt of Shingrix at a pharmacy. The patient developed hives. Physician stated that the patient received vaccine at a pharmacy not his office.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue
Clinical narrative: had no energy / were not able to do anything after receiving their first dose of Shingrix; felt like plug was pulled; This case was reported by a pharmacist via call center representative and described the occurrence of loss of energy in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced loss of energy and tiredness. On an unknown date, the outcome of the loss of energy and tiredness were recovered/resolved.   It was unknown if the reporter considered the loss of energy and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and felt like the plug was pulled, had no energy and felt like they were not able to do anything. The symptoms started the day of or the day after vaccination and lasted 3 to 7 days. The reporter consented to follow up. No further details were available. This case linked with US2020209416, US2020209434 and US2020209436, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020209416:same reporter US-GLAXOSMITHKLINE-US2020209434:same reporter US-GLAXOSMITHKLINE-US2020209436:same reporter
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram normal, Headache, SARS-CoV-2 test negative, Tremor
Clinical narrative: get shakes; giant headache / thought that her head was going to explode / headache was concentrated above her right ear; This case was reported by a consumer via call center representative and described the occurrence of headache in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2020, the patient received the 1st dose of Shingrix. On 30th September 2020, less than a day after receiving Shingrix, the patient experienced headache and tremor. The patient was treated with antimigraine preparations (Migraine Cocktail (Nos)). On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the tremor was unknown.   It was unknown if the reporter considered the headache and tremor to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix on 30th September 2020 and around 6 pm that day she started to get shakes and a giant headache. The patient thought that her head was going to explode and the headache lasted for 13 days. The patient was referred to the emergency room by her physician and they administered a COVID test and CT scan which was normal. They administered the patient a headache cocktail through  intravenous and it had no effect on the headache until she reached day 13. The headache was concentrated above her right ear. The reporter consented to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: developed Guillain-barre syndrome after receiving a flu shot; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not provided. The reporter stated that the patient experienced Guillain-barre syndrome after receiving a flu shot. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: experienced cellulitis after Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown.   It was unknown if the reporter considered the cellulitis to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The pharmacist reported  that patient experienced cellulitis after Shingrix. The reporter did not consent to follow-up
Age: 59.0
Sex: F
Vaccine: FLUR3, VARZOS
Symptoms: Herpes zoster, Rash, Skin ulcer
Clinical narrative: looked like shingles; rashes; sores; This case was reported by a pharmacist via call center representative and described the occurrence of possible shingles in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number MT7C9, expiry date 15th April 2022) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUBLOK) for prophylaxis.   On 10th October 2020, the patient received the 1st dose of Shingrix (intramuscular) and FLUBLOK. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles, rash and skin ulcer. On an unknown date, the outcome of the shingles, rash and skin ulcer were not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash and skin ulcer to be related to Shingrix.  Additional details were provided as follows: The patient Shingrix vaccine in the right deltoid intramuscularly and that same day the patient got the Flublok vaccine also and within 1 to 2 days had rashes and sores which looked like shingles on the left side of the body.  The reporter continues to experience rash and sores. The reporter consented to follow up.
Sex: U
Vaccine: MENB
Symptoms: Myalgia, Pyrexia, Skin reaction
Clinical narrative: fever; myalgia; skin reaction; This case was reported by a physician via call center representative and described the occurrence of fever in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, less than a day after receiving Bexsero, the patient experienced fever, myalgia and skin reaction. On an unknown date, the outcome of the fever, myalgia and skin reaction were unknown.   It was unknown if the reporter considered the fever, myalgia and skin reaction to be related to Bexsero.  Additional details were as follows: The age at vaccination was not reported. No patient's identifiers provided. no lot number nor expiration date provided. Physician reported that one patient experienced fever, myalgia and a skin reaction within hours after receiving the first dose of Bexsero. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020211101:same reporter
Sex: F
Vaccine: MENB
Symptoms: Mobility decreased
Clinical narrative: could not move her left arm; This case was reported by a physician via call center representative and described the occurrence of mobility decreased in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced mobility decreased. On an unknown date, the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the mobility decreased to be related to Bexsero.  Additional details were as follows: The age at vaccination was not reported. No patient's identifiers provided. no lot number nor expiration date provided. Physician reported that the female patient received the 1st dose of bexsero and after that patient couldn´t move her left arm for days but she recovered. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020211099:same reporter
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: On the left arm had hives; This case was reported by a nurse via call center representative and described the occurrence of hives in a 10-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 7N43B, expiry date 30th June 2021) for prophylaxis.   On 21st October 2020, the patient received the 1st dose of FluLaval Tetra 2020-2021 season. On 22nd October 2020, 1 days after receiving FluLaval Tetra 2020-2021 season, the patient experienced hives. On 22nd October 2020, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to FluLaval Tetra 2020-2021 season.  Additional details were reported as follows: The reporter stated that the Flulaval QIV was administrated to a female patient on the left arm had hives one days after receiving the vaccine. The reporter consented to follow up. This case has been linked with cases US2020211161 and US2020211159, reported for same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020211161:same reporter US-GLAXOSMITHKLINE-US2020211159:same reporter
Sex: M
Vaccine: FLUX
Symptoms: Death
Clinical narrative: flu shot killed patient; Initial information received on 13-Oct-2020 regarding an unsolicited valid serious social media case received from a consumer or non-healthcare professional via social media.  This case involves a male patient who died after he received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient died (death) unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was not reported if any laboratory tests were performed before he died.  It was not reported if the patient received any corrective treatment before he died.  The patient died on an unknown date. It was unknown if an autopsy was done and cause of death was not reported.  Information on the batch number was requested.; Sender's Comments: This poorly documented social media case concerns an elderly patient who died after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset was unknown. Also, patient's medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Death NOS
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Rotator cuff syndrome
Clinical narrative: Received the flu shot on 10/7.  The shot itself hurt much more than a normal flu shot I've had in the past.  For the next 5 days, I was not able to raise my arm beyond shoulder height without significant pain.  On 10/12 I noticed my shoulder felt a bit better but since then, the pain has not changed and even though I have full range of motion, it hurts at any movement above 90 degrees and any front and back motion. Went to my PCP on 10/19 due to the sustained pain.  My PCP diagnosed with me rotator cuff tendonitis and prescribed an anti-inflammatory medication to take for 14 days.  She also suggested Physical Therapy.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction, Asthenia, Blood test normal, Dysstasia
Clinical narrative: The patient felt weak. They couldn't stand up and went to the ER. The ER didn't find anything abnormal is the blood work and feel that it is a reaction to the Shingrix vaccine.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: very heavy shivers; fever; achiness
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: fever, malaise lasting 24 hours
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Flank pain, Headache, Injection site pain, Pain, Pain in extremity
Clinical narrative: As soon as I left the pharmacy, I had pain shooting on my left side, on the side of the injection,  at my waist and down my arm and leg.  My bottom lip was tingly too.  These symptoms subsided with in a half hour, which is why I did not seek medical help.   Then the intense headache started.  The headache continued for 24 hours.  The injection site soreness finally subsided yesterday, 10/25.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral
Clinical narrative: As soon as I left the pharmacy, I had pain shooting on my left side, on the side of the injection,  at my waist and down my arm and leg.  My bottom lip was tingly too.  These symptoms subsided with in a half hour, which is why I did not seek medical help.   Then the intense headache started.  The headache continued for 24 hours.  The injection site soreness finally subsided yesterday, 10/25.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient reported upper arm swelling of around 5 and 1/2 inches which started the next day and lasted until 3 days later.  Patient was given Benadryl, ice, and hydrocortisone cream, which didn't help until symptoms resolved at the 3 day mark.
Age: 11.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Sore right arm on 10/22/2020 at 12pm. Swollen right arm at 7:00am on 10/23/2020. At 7:45pm on 10/23/2020 right arm twice the size of left arm, warm to the touch, hard and painful to slightest touch, redness to site about baseball size. Applied ice pack and gave 2 Tylenol. Spoke with on call pediatrician and was advised to go to the Emergency room to have it looked at. Went to ER around 9pm, was seen, given some medications to help and sent home with a script of prednisone and benadryl.
Age: 11.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Tenderness
Clinical narrative: Sore right arm on 10/22/2020 at 12pm. Swollen right arm at 7:00am on 10/23/2020. At 7:45pm on 10/23/2020 right arm twice the size of left arm, warm to the touch, hard and painful to slightest touch, redness to site about baseball size. Applied ice pack and gave 2 Tylenol. Spoke with on call pediatrician and was advised to go to the Emergency room to have it looked at. Went to ER around 9pm, was seen, given some medications to help and sent home with a script of prednisone and benadryl.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Palpitations, Ventricular extrasystoles
Clinical narrative: I think it was a couple days after receiving it, I started getting heart palpitations, then they got more intense.  It felt like there was a cell phone in my shirt, chest pocket constantly going off on vibrate mode.  Some time later, I went to the Doctor and they told me I had PVC (preventricular heart contractions).  I also had chest pains.  It took many months for it to go away.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Urticaria
Clinical narrative: Patient reports in painful full body hives, saw her PCP. PCP name is unknown.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Pain and redness at injection site (within 12 hrs of administration Extreme myalgia, fatigue, fever (began within 18 hrs of administration and lasted 24 hours)
Sex: U
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: hearing loss; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 25-MAY-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event hearing loss was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, hearing loss was determined to be medically significant.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: multiple outbreaks of herpes zoster and post herpetic neuralgia; multiple outbreaks of herpes zoster and post herpetic neuralgia; pt under the age of 60 received zoster vaccine live (ZOSTAVAX) before March 2011; Information has been received from a lawyer, regarding a case in litigation, and refers to an adult patient (pt) of unknown gender and age at the time of the events, who was approx. 50 years old at the time of vaccination. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On 17-OCT-2008, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) at a local drugstore for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by a healthcare provider for the following injuries resulting from the pt's use of zoster vaccine live (ZOSTAVAX): multiple outbreaks of herpes zoster and post herpetic neuralgia. The outcome of the events was not provided. The reporter considered the events of multiple outbreaks of herpes zoster and post herpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: other zoster related injuries; shingles; varicella type rash; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 70-year-old patient of unknown gender. Medical history, concurrent conditions and concomitant medications were not provided.  On or about 16-APR-2013, the patient was administered the zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration and lot # were not provided), by a healthcare provider, for the long-term prevention of shingles and zoster-related conditions. On unknown dates, the patient was treated for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles, varicella type rash and other zoster related injuries. The patient claimed damages as a result of: injury to themselves, loss of consortium and  loss of services. The outcome of the events was not provided.  The lawyer felt the events were related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: FLU3, PPV
Symptoms: Necrotising fasciitis
Clinical narrative: Necrotizing fasciitis in the right shoulder; This spontaneous report was received from an other health professional and refers to a 52-year-old male patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 27-JAN-2009, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (exact dose, dose #, anatomical location, route of administration, lot # and expiration date were not provided) and a dose of influenza virus sag 3v vaccine inactivated (FLUVIRIN) injection, lot # 881292P, administered intramuscularly as immunization (expiration date, exact dose, dose # and anatomical location).  On 28-JAN-2009, patient experienced necrotizing fasciitis in the right shoulder. The event caused hospitalization since an unknown date. The outcome of the event was reported as not resolved.  The causality assessment between suspect vaccines and the events was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Ageusia, Anosmia, Fatigue, Nausea, SARS-CoV-2 test negative
Clinical narrative: broken out in hives on the right outside calf and left inside calf/both of my forearms were also broken out in hives; feeling tired; nauseated; couldn't taste/no smell or taste; no smell; This case was reported by a consumer and described the occurrence of hives in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th September 2020, the patient received the 1st dose of Shingrix. On 28th September 2020, 3 days after receiving Shingrix, the patient experienced hives, tiredness, nausea, taste loss and loss of smell. Shingrix was discontinued. On an unknown date, the outcome of the hives, tiredness and nausea were unknown and the outcome of the taste loss and loss of smell were not recovered/not resolved.   The reporter considered the hives, tiredness, nausea, taste loss and loss of smell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 50 or 51 years. On 28th September 2020, the patientI was feeling tired and nauseated and noticed that she was broken out in hives on the right outside calf and left inside calf. After eating soup for dinner, the patient realized she could not taste everything she was eating.  The patient immediately panicked and thought she had COVID. The patient got tested on 30th September 2020 and results were negative on 3rd October 2020. By that time both of the patient's forearms were also broken out in hives. Since the patient got tested negative for COVID, a nurse told the patient that all of her side effects were more than likely from Shingrix vaccine. The patient showed the pharmacist and she said not to get the second vaccine. The patient wanted to see if anyone else had reported the no smell or taste, it had been almost three weeks and the patient still could not. The patient looked over the list of drugs that might interact on website, but she did not take any that were listed.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: broken out in hives on the right outside calf and left inside calf/both of my forearms were also broken out in hives; feeling tired; nauseated; couldn't taste/no smell or taste; no smell; This case was reported by a consumer and described the occurrence of hives in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th September 2020, the patient received the 1st dose of Shingrix. On 28th September 2020, 3 days after receiving Shingrix, the patient experienced hives, tiredness, nausea, taste loss and loss of smell. Shingrix was discontinued. On an unknown date, the outcome of the hives, tiredness and nausea were unknown and the outcome of the taste loss and loss of smell were not recovered/not resolved.   The reporter considered the hives, tiredness, nausea, taste loss and loss of smell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 50 or 51 years. On 28th September 2020, the patientI was feeling tired and nauseated and noticed that she was broken out in hives on the right outside calf and left inside calf. After eating soup for dinner, the patient realized she could not taste everything she was eating.  The patient immediately panicked and thought she had COVID. The patient got tested on 30th September 2020 and results were negative on 3rd October 2020. By that time both of the patient's forearms were also broken out in hives. Since the patient got tested negative for COVID, a nurse told the patient that all of her side effects were more than likely from Shingrix vaccine. The patient showed the pharmacist and she said not to get the second vaccine. The patient wanted to see if anyone else had reported the no smell or taste, it had been almost three weeks and the patient still could not. The patient looked over the list of drugs that might interact on website, but she did not take any that were listed.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Shingle vaccine hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had pain.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm pain; This case was reported by a physician via sales rep and described the occurrence of pain in arm in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received Shingrix and had arm pain. The vaccine had not administered Shingrix in office yet but had heard this complaint from patients after she has referred them to a local pharmacy.  Approximately 20 minutes after the Virtual Engagement the reporter called the Office Manager due to audio issues with internet to collect more details and thinks this had happened 10 times in the past 18 months and also volunteered that thinks these patient complaints occurred when the patient was back in their office weeks or months after the patients had received their Shingrix at a local pharmacy, and  could not recollect any patients saying they opted out of a 2nd dose of Shingrix due to the arm pain.  The office did not recollect any individual patients and were speaking in general terms.
Sex: M
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Injection site extravasation, Tenderness, Underdose
Clinical narrative: Tenderness; More than half solution leaked; Leaked out of arm; This case was reported by a physician via call center representative and described the occurrence of accidental underdose in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2020, the patient received the 1st dose of Shingrix. On 10th October 2020, unknown after receiving Shingrix, the patient experienced accidental underdose and exposure via skin contact. On 11th October 2020, the patient experienced tenderness. On an unknown date, the outcome of the accidental underdose, exposure via skin contact and tenderness were unknown.   It was unknown if the reporter considered the tenderness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The physician reported that while giving 1st Shingrix more than half solution leaked out of arm, which led to accidental underdose and exposure via skin contact. The patient had some tenderness next day of vaccination. The reporter consented to follow up. This case has been linked with the case US2020206895, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020206895:same reporter, different patient
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: tremendous arm pain; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The physician states the patient had received Shingrix and reported tremendous arm pain. No further details provided. The reporter consented to follow up. This case has been linked to US2020206890, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020206890:same reporter, different patient
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Night sweats, Pruritus, Urticaria
Clinical narrative: itchy all over the body except face; hives; face is slightly red; night sweats; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2020, the patient received the 1st dose of Shingrix. On 17th October 2020, 5 days after receiving Shingrix, the patient experienced night sweat. On 19th October 2020, the patient experienced pruritus, hives and erythema. On an unknown date, the outcome of the pruritus, hives, night sweat and erythema were unknown.   It was unknown if the reporter considered the pruritus, hives, night sweat and erythema to be related to Shingrix.  Additional details were provided as follows: The case was reported by the husband of the patient. The patient received Shingrix and had night sweats and no fever.  7 days after the patient had pruritus, hives and erythema. At the time of reporting the patient had hives which are itchy all over the body except face. The face was slightly red. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: 1st dose on 2/3/2020.  She has not received the 2nd dose yet.; shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 3rd February 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 16th April 2020, 73 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient was diagnosed with Shingles 73 days after receiving the 1st dose of Shingrix. The patient did not received 2nd dose till the time of reporting which led to incomplete course of vaccination. No other information was provided. The reporter consented to follow up.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome; Initial information was received on 15-Oct-2020 regarding an unsolicited valid serious social media case from the consumer (patient's wife).   This case involves a male patient (age was not reported) who had Guillain Barre syndrome, while he received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed serious Guillain Barre syndrome, (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. Reporter stated that use of vaccine make person ill for several years to the point that the person wish, he/she could die to stop the constant suffering. It didn't save her husband's life, it almost killed him.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.; Sender's Comments: This poorly documented case concerns a patient of unknown age who developed Guillain Barre syndrome, after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Also, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Pneumonia, Vaccine positive rechallenge
Clinical narrative: pneumonia; Initial information received on 16-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional  via social media .  This case involves patient of unknown demographics who had pneumonia, after receiving INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  The patient's past vaccinations included flu shot every year and have had pneumonia.  Family history was not provided.  At the time of the event, the patient had ongoing COPD (Chronic obstructive pulmonary disease).  Concomitant medications included oxygen or concentrator.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer ,lot number and expiration date not reported) and  a dose of suspect PNEUMOCOCCAL VACCINE (not produced by Sanofi Pasteur ,lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date , the patient developed a serious pneumonia shortly after (exact latency unknown) following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE. This event was assessed as medically significant.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the event pneumonia.  Information on the batch number was requested.; Sender's Comments: This case involves patient who had pneumonia, shortly after the vaccination with INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE. The time to onset is compatible. The patient has ongoing condition of COPD (Chronic obstructive pulmonary disease) and the lab tests were not reported. Based upon the reported information, the role of the vaccine cannot be assessed separately from the pre-existing pathology.
Sex: M
Vaccine: FLUX
Symptoms: Death, Immediate post-injection reaction
Clinical narrative: patient died right after receiving the vaccine; Initial information regarding an unsolicited valid serious case was received from a consumer/non-health care professional via agency (Reference number- 00324247) and transmitted to Sanofi on 20-Oct-2020.  This case is linked to case 2020SA297516 and 2020SA298004 (same reporter).  This case involves male patient (demographics unknown) who died right after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient died right after receiving the INFLUENZA VACCINE. The event of death was also assessed as medically significant.  The reporter asked about side effects, efficacy, and the difference between fluzone quadrivalent and fluzone high-dose quadrivalent. Also stated her friend (only described as 87 years old) was convinced that a flu vaccine killed her parents because they died right after receiving them.   No laboratory data was provided.   It was not reported if the patient received any corrective treatment before death.  It was unknown if an autopsy was done and the cause of death was not reported.  Information on lot number was requested for this case.; Sender's Comments: This case concerns a male patient who died right after receiving the INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is compatible. Additional information regarding medical history, condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other etiologies and detailed autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: Death NOS
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Asthenia, Chills
Clinical narrative: received FLUID, then experienced chills, weakness, and was concerned because she had never had this feeling before
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever 103.5
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Dyspepsia, Loss of consciousness, Swelling, Urticaria
Clinical narrative: 10/8C/O indigestion in evening, woke up  next day, 10/9, with same symptoms.  Hives all over body, swollen. Passed out in shower, in & out of consciousness.  911 called, given Epi pen shot - no result, given 2nd Epi pen shot - transferred to Hospital.  Hospitalized from 10/9-10/13, received IV steroids and Benadryl and Nebulizer treatments.  Experienced 2 more anaphylactic reactions while in the hospital, 2 more Epi pens administered.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: At ~24 hours post immunization, child developed large local reaction with significant swelling and pain.  Circumference at that time ~6-8 inches.  To emergency department, recommended local care and benadryl.  By 48 hours post immunization, right thigh circumference noticeably larger than left, erythema/swelling area at least 12 inches in diameter.  To emergency department again, Rx w/ oral antibiotic in case of bacterial cellulitis.  By ~60 hours post immunization, pain and warmth improved and less brightly erythematous, but erythema now ~15x15 inches and ~3/4 circumference of right thigh.  Full range of motion, good distal circulation and sensation.  Recommended ongoing local care with cool packs, acetaminophen as needed for discomfort.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient describes a bright red, hot circle on the upper deltoid near the administration site about the size of a baseball (3-4 inches in diameter).
Age: 66.0
Sex: M
Vaccine: FLUC4
Symptoms: Aphasia, Dyspnoea, Swollen tongue, Urticaria
Clinical narrative: Awakened on 10/22 at 10 am, 18 hours post vaccination with hives on arms and legs. No airway involvement. Took Benadryl. Progressed over next 3 days to chest, trunk. On 10/24, c/o swelling of the tongue and difficulty speaking; no c/o difficulty breathing. States this followed eating vanilla ice cream. Went to ER and was assessed with no known cause determined. Denied any reaction in past, nothing new in diet, detergent, the usual things. No known allergies to meds or foods.  Improved with Benadryl and then reappeared today but much less/lighter/ no itching
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: itching and hives begin 24-30 hours post administration of vaccine, lip swelling 10/16/20, began taking Benedryl PO 10/15/20. Has continued with daily Zertec. Itching and hives are generalized over entire body. Itching seems a little better 10/25 and 10/26, hives are continuing.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Headache, Myalgia
Clinical narrative: Chills muscle aches headache low energy
Age: 71.0
Sex: M
Vaccine: FLUA3, FLUA4
Symptoms: Swelling face
Clinical narrative: Vaccination was for the Flu (Fluad (65+) PFS 2020-21 INJ 0.5 ml   Serial # unknown  Swelling of the right side of the face.  Slight swelling still present after 72 hours.
Age: 71.0
Sex: M
Vaccine: FLUA3, FLUA4
Symptoms: Angioedema
Clinical narrative: Vaccination was for the Flu (Fluad (65+) PFS 2020-21 INJ 0.5 ml   Serial # unknown  Swelling of the right side of the face.  Slight swelling still present after 72 hours.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Immune thrombocytopenia, Immunoglobulin therapy, Platelet count decreased
Clinical narrative: Developed ITP . Blood test 1 week after vaccine
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Chills, nauseous, low grade fever over night. Symptoms lasted for 10 hours.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration error given to child less that age vaccine is licensed for.