chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Ischaemic stroke, Nausea, Vertigo, Vomiting
Clinical narrative: acute ischemic stroke; nausea/emesis; nausea/emesis; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age.The pt's medical history, concurrent conditions and concomitant medications were not provided. In or around 26-SEP-2017, pt was inoculated with zoster vaccine live(ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live(ZOSTAVAX), pt suffered an abrupt onset of vertigo, vision loss and nausea/emesis. Pt was hospitalized and diagnosed with an acute ischemic stroke. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Upon internal review, acute ischemic stroke was determined to be medically significant. All events considered as disability by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Optic neuritis
Clinical narrative: Optic Neuritis; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age.The pt's medical history, concurrent conditions and concomitant medications were not provided. On or around 18-SEP-2017, pt was inoculated with zoster vaccine live(ZOSTAVAX)for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live(ZOSTAVAX), pt suffered from Optic Neuritis. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   Upon internal review, optic neuritis was determined to be medically significant. Optic neuritis was considered as disability by the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect; patient ws inadvertenly administeres a dose of VARIVAX, that had been improperly sored; This spontaneous report was received from the immunization coordinator concerning to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On 04-DEC-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number S020464 with expiration date on 02-JUL-2021 (dosage schedule, route and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with a properly stored diluent.  Administered doses of vaccine experienced temperature excursion of -2.1 degrees Celsius (C)  for 4 hours and 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional event; improperly stored varivax; This spontaneous report as received from an immunization coordinator refers to a patient of unknown age and gender.   The patient's medical history and concurrent condition were not reported. The patient's pertinent medical history and drug reactions/allergies were not reported. On 04-DEC-2019, the patient was inadvertently administered with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S020464, 02-JUL-2021) for prophylaxis.      The concomitant medication included sterile diluent which was reported to be stored properly. It was reported that the vaccine was exposed to a temperature of -2.1 Celsius for a time frame of 4 hours 30 minutes. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report. No additional adverse effect.  The outcome of product storage error and no adverse event was unknown.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse symptoms; First dose received in november 2018 and second dose in december 8 2019; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, allergies/drug reactions and concomitant medications were not reported. On an unknown date in November 2018, the patient was vaccinated with first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 08-DEC-2019, the patient received second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (Inappropriate schedule of product administration). No adverse symptoms reported. No product quality complaint was involved.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; pateint received an expired dose of M-M-R-II; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 09-DEC-2019, the patient was vaccinated with an expired dose (expired product administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection recombinant human albumin (rHA), lot # N032749 and expiry date 20-NOV-2019, at a dose of 1 dosage form for prophylaxis, (strength, route and anatomical location were not reported). No adverse effects were reported. No PQC was reported. The outcome of expired product administered was unknown.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effect; Patient received second dose of GARDASIL 9 outside of prescribing information; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.       On 06-APR-2019 and 24-MAY-2019, the patient was subsequently vaccinated with first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (lot # and expiry date was not reported) for prophylaxis. On 24-MAY-2019, the patient received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) outside of prescribing information (inappropriate schedule of product administration). It was reported that the patient had not yet received the third dose. There was no adverse event reported.
Sex: U
Vaccine: VARZOS
Symptoms: Blood glucose increased, Condition aggravated, Herpes zoster, Pain
Clinical narrative: Shingles in the groin area; pain; glucose has been running high; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 80-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles at age of 26). Concurrent medical conditions included insulin dependent diabetic and diabetic neuropathy.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced shingles, pain and glucose increased. On an unknown date, the outcome of the shingles, pain and glucose increased were unknown.   It was unknown if the reporter considered the shingles, pain and glucose increased to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient had Shingrix and glucose has been running high ever since and had a severe case in the groin area and was extremely painful. The patient had steroid type reaction and patient asked how prevalent is this type reaction. The monograph did not list as an avr. The patient was glad that had diabetic neuropathy to deaden the pain.      Lab Comments: The patient had diabetic neuropathy to deaden the pain
Sex: U
Vaccine: VARZOS
Symptoms: Dermatitis contact, Rash pruritic
Clinical narrative: itch\ bumps" start breaking out on my face; Poison ivy; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. In November 2019, 2 weeks after receiving Shingrix, the patient experienced itchy rash and poison ivy rash. The patient was treated with methylprednisolone (Methylprednisone Dose Pack) and prednisone. On an unknown date, the outcome of the itchy rash and poison ivy rash were unknown.   It was unknown if the reporter considered the itchy rash and poison ivy rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient received 1st dose of Shingrix about 4 weeks before the time of reporting. The patient developed bumps that started breaking out her face about 2 weeks before the time of reporting. At first, she thought she had poison Ivy and the physician gave her Methylprednisone but with no change.  The patient got shot one week before and a new prescripation of plain prednisone but new bumps appear everyday.  The bumps were itch a little but other than that they were just ugly.  The patient was enquiring, if the shot could cause them. The patient was scheduled for the follow up shot in about 2 weeks.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction, Headache, Insomnia
Clinical narrative: Blinding head ache; Slept two hours last night; All the symptoms listed on the website; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th November 2019, the patient received Shingrix. On 26th November 2019, less than a day after receiving Shingrix, the patient experienced adverse reaction and sleep decreased. On 27th November 2019, the patient experienced headache. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the adverse reaction, headache and sleep decreased were unknown.   It was unknown if the reporter considered the adverse reaction, headache and sleep decreased to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per the vaccine indication. The patient had all the symptoms listed on the website.  The patient slept two hours the previous night. One day after receiving Shingrix, the patient had blinding headache. It was reported that Tylenol did not help at all.
Sex: F
Vaccine: HEP, TDAP, VARZOS
Symptoms: Dyspnoea, Headache, Nasal congestion, Sinusitis
Clinical narrative: Stuffy nose; Can barely breathe; Headaches; Sinus infection; This case was reported by a consumer via patient support programs and described the occurrence of sinus infection in a 51-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Advair HFA (received 10 years before from the time of reporting, refer linked case US2019AMR214034) and Ventolin HFA (received 10 years ago from the time of reporting, refer linked case US2019AMR214034).   On an unknown date, the patient received Boostrix .5 ml, Engerix B and Shingrix .5 ml. On an unknown date, less than 2 years after receiving Boostrix, Engerix B and Shingrix, the patient experienced sinus infection, nasal stuffiness, difficulty breathing and headache. On an unknown date, the outcome of the sinus infection was recovered/resolved and the outcome of the nasal stuffiness, difficulty breathing and headache were unknown.   It was unknown if the reporter considered the sinus infection, nasal stuffiness, difficulty breathing and headache to be related to Boostrix, Engerix B and Shingrix.  Additional case details were reported as follows: The reporter who is a consumer was reporting a case for herself The age at vaccination was not reported, however the patient could be 49 or 50 years old. In 2018, the patient received Boostrix, Engerix-B and Shingrix. The patient had a sinus infection for about a week.  Her symptoms from the sinus infection included a stuffy nose, she could barely breathe and she had headaches.  No more information was given. The reporter consented to follow up.
Sex: M
Vaccine: DTP
Symptoms: Autism spectrum disorder, Seizure
Clinical narrative: Seizures; Autism; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a male patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis.   On an unknown date, the patient received DTP vaccine. On an unknown date, unknown after receiving DTP vaccine, the patient experienced seizure (serious criteria GSK medically significant) and autism (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure and autism were unknown.   It was unknown if the reporter considered the seizure and autism to be related to DTP vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter was patient's mother. The reporter trying to informed how the DTP vaccine injured every member of her family. The patient experienced autism and seizure. The follow up was not required. This is 1 of the 4 linked cases reported by the same reporter.
Sex: F
Vaccine: DTP
Symptoms: Thyroid disorder
Clinical narrative: Early thyroid problems; This case was reported by a consumer via interactive digital media and described the occurrence of thyroid disorder in a female patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis.   On an unknown date, the patient received DTP vaccine. On an unknown date, unknown after receiving DTP vaccine, the patient experienced thyroid disorder. On an unknown date, the outcome of the thyroid disorder was unknown.   It was unknown if the reporter considered the thyroid disorder to be related to DTP vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter was patient's mother. The reporter trying to informed how the DTP vaccine injured every member of her family. The patient experienced thyroid problems. The follow up was not required. This is 1 of the 4 linked cases reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise
Clinical narrative: sick in bed; This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient reported about being sick in bed for 5 days after receiving the shingles shot. The patient intentionally disconnected the call abruptly. Since the limited information was provided and therefore was unable to clarify details about the 2nd shingles shot. This is one of the 6 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: sick in bed; This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient reported about being sick in bed for 5 days after receiving the shingles shot. The patient intentionally disconnected the call abruptly. Since the limited information was provided and therefore was unable to clarify details about the 2nd shingles shot. This is one of the 6 cases, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Malaise
Clinical narrative: horrible reaction to second shingles shot; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not provided but age group was taken as per suspect indication. The reporter knows patient that had horrible reaction to second shingles shot.  The reporter provided limited information. It was unable to clarify second shingles shot. This was 1of the 6 case reported by same reporter for different patient.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: horrible reaction to second shingles shot; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not provided but age group was taken as per suspect indication. The reporter knows patient that had horrible reaction to second shingles shot.  The reporter provided limited information. It was unable to clarify second shingles shot. This was 1of the 6 case reported by same reporter for different patient.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Eczema, Feeling hot, Headache, Herpes zoster
Clinical narrative: possible shingles rash; unusual pain on right side of her neck; pain extended to her head and skull; Eczema rash; right side of her skull the rash is not fluid-filled, it is raised and hardened; Localized swelling at the injection site; Flu-like symptoms; Feeling warm or feeling febrile; Generalized aching/ rash hurts; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included eczema (had been flaring up for a couple of months.).   On 21st November 2019, the patient received the 1st dose of Shingrix. On 21st November 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling, flu-like symptoms, feeling of warmth and generalized aching. On 24th November 2019, the patient experienced shingles, neck pain, headache, eczematous rash and rash. The patient was treated with ibuprofen (Advil). On 23rd November 2019, the outcome of the injection site swelling, flu-like symptoms, feeling of warmth and generalized aching were recovered/resolved. On an unknown date, the outcome of the shingles, neck pain, headache, eczematous rash and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles, injection site swelling, flu-like symptoms, feeling of warmth, generalized aching, neck pain, headache, eczematous rash and rash to be related to Shingrix.   Additional case details were reported as follows: The patient was a retired nurse and she reported the case for herself. In the evening of vaccination, the patient noticed localized swelling at the injection site. She also reported flu-like symptoms and described as having generalized aching and felt warm or febrile although she did not check her temperature.  The patient took Advil and swelling and flu-like symptoms approximately lated for 48 hours or 1 to 2 days.  On Sunday, 3 days after Shingrix vaccination, the patient felt an unusual pain on right side of her neck that extended to her head and skull. She was unsure if it was an eczema rash or possible shingles rash. She further stated that, on the right side of her skull the rash was not fluid-filled, it was raised and hardened but it did not itch like regular eczema, rather the rash hurt.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site swelling, Neck pain, Pain, Rash
Clinical narrative: possible shingles rash; unusual pain on right side of her neck; pain extended to her head and skull; Eczema rash; right side of her skull the rash is not fluid-filled, it is raised and hardened; Localized swelling at the injection site; Flu-like symptoms; Feeling warm or feeling febrile; Generalized aching/ rash hurts; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included eczema (had been flaring up for a couple of months.).   On 21st November 2019, the patient received the 1st dose of Shingrix. On 21st November 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling, flu-like symptoms, feeling of warmth and generalized aching. On 24th November 2019, the patient experienced shingles, neck pain, headache, eczematous rash and rash. The patient was treated with ibuprofen (Advil). On 23rd November 2019, the outcome of the injection site swelling, flu-like symptoms, feeling of warmth and generalized aching were recovered/resolved. On an unknown date, the outcome of the shingles, neck pain, headache, eczematous rash and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles, injection site swelling, flu-like symptoms, feeling of warmth, generalized aching, neck pain, headache, eczematous rash and rash to be related to Shingrix.   Additional case details were reported as follows: The patient was a retired nurse and she reported the case for herself. In the evening of vaccination, the patient noticed localized swelling at the injection site. She also reported flu-like symptoms and described as having generalized aching and felt warm or febrile although she did not check her temperature.  The patient took Advil and swelling and flu-like symptoms approximately lated for 48 hours or 1 to 2 days.  On Sunday, 3 days after Shingrix vaccination, the patient felt an unusual pain on right side of her neck that extended to her head and skull. She was unsure if it was an eczema rash or possible shingles rash. She further stated that, on the right side of her skull the rash was not fluid-filled, it was raised and hardened but it did not itch like regular eczema, rather the rash hurt.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Vaccine positive rechallenge
Clinical narrative: shivering; headache; fatigue; This case was reported by a consumer via call center representative and described the occurrence of shivering in an unspecified number of  patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of chills (1st dose received on an unknown date, refer linked case US2019AMR216742).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shivering, headache and fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the shivering, headache and fatigue were unknown.   It was unknown if the reporter considered the shivering, headache and fatigue to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. Several unknown patients had shivering, headache, and fatigue which was described as stronger than those experienced with 1st dose of Shingrix.  The reporter did not consent to follow-up. The reporter did not wish to participate in a safety report, she just gave a general statement about her friend's experience with Shingrix.  There were no other details.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Lymphadenopathy, Lymphoedema, Pain
Clinical narrative: swelling in the arm pit/swelling into the rib cage/described as lymphedema; Swollen lymph nodes; Headache; achy; This case was reported by a other health professional via call center representative and described the occurrence of lymphedema in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number M57C5, expiry date 9th April 2022) for prophylaxis.   On 23rd November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 24th November 2019, 1 days after receiving Shingrix, the patient experienced lymphedema, lymphadenopathy cervical, headache and general body pain. The patient was treated with cephalexin (Keflex). On an unknown date, the outcome of the lymphedema, lymphadenopathy cervical, headache and general body pain were recovering/resolving.   It was unknown if the reporter considered the lymphedema, lymphadenopathy cervical, headache and general body pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had swelling in the arm pit and into the rib cage described as lymphedema, along with swollen lymph nodes in the neck and a headache. The reporter consented to follow up.  At the time of reporting the events have improved. Provided by second line agent who MI was transferred The patient also felt achy. It progressed to a marble sized lump in the arm pit. The swelling continued down to rib cage. He went to his PCP and was prescribed Keflex.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Itchy feeling in the middle of her back; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number E3Z7E, expiry date 18th May 2021) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, couple of days after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was recovered/resolved.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows: The patient experienced an itchy feeling in the middle of her back a couple days after getting Shingrix.  The itchy feeling has nowresolved.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Adverse reaction after firs dose of Shingrix.; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided. The patient developed an adverse reaction after the administration of the first dose of Shingrix and she mentioned it as an allergic reaction. The physician asked if the patient should receive the second dose. The follow up consent was granted.
Age: 4.0
Sex: F
Vaccine: FLU4, MMRV
Symptoms: Erythema, Local reaction, Pain, Skin discolouration, Skin warm
Clinical narrative: Local reaction,  initially 7X5 Cm erythematous, warm reaction, extended to 15X11cm  of erythema 3 days after vaccine with central purplish discoloration, minimal pain
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3
Symptoms: Gait disturbance, Injection site pain, Injection site swelling
Clinical narrative: L thigh swelling and pain at injection site (both immunizations) and refusal to walk
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Impaired work ability, Somnolence
Clinical narrative: fatigue;  could not work more than 2 hours the next day;  had trouble staying awake driving home;  had to continuously pinch myself to stay awake while driving.    Went to a "urgent care"  (walk-in) doctor facility to have a doctor see if I had  something seriously wrong with me  later that day. shivering;  it was 78 degrees in the lab where I worked the 2 hours that morning, and I was shivering the whole time.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: Redness and pain and swelling and itching spreading over upper arm over hours, starting about an hour after injection, with a mild fatigue and chills for the first few hours, improving by next morning with icing and naproxen
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus
Clinical narrative: Redness and pain and swelling and itching spreading over upper arm over hours, starting about an hour after injection, with a mild fatigue and chills for the first few hours, improving by next morning with icing and naproxen
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: pt presented with erythema and edema from LEFT shoulder down to LEFT elbow,
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: sore arm immediately after vaccination, arm continues to be sore 2 months later
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional event; second dose of gardasil 9 3 years later; This spontaneous report was received from a nurse referring to a currently approximately 17 year old female patient. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2016, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, anatomical location, lot # and expiration date were unknown) for prophylaxis at the age of 14. On an unknown date in August 2019 (reported as three years after the first dose), the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration and anatomical location were unknown) with lot # R009614 and expiration date 30-NOV-2020 for prophylaxis (inappropriate schedule of product administration). There were no additional adverse event. The outcome of the event of inappropriate schedule of product administration and no adverse event was unknown. There was no product quality complaint associated with the case.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Pain, Paraesthesia, Pharyngeal swelling
Clinical narrative: tingling in the arm; achy; fullness in her throat; This case was reported by a physician via sales rep and described the occurrence of tingling of extremity in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENACTRA for prophylaxis.   In November 2019, the patient received Bexsero and MENACTRA. In November 2019, less than a day after receiving Bexsero, the patient experienced tingling of extremity, pain and throat swelling. The patient was treated with steroids nos (Steroid Pack (Nos)). On an unknown date, the outcome of the tingling of extremity, pain and throat swelling were unknown.   It was unknown if the reporter considered the tingling of extremity, pain and throat swelling to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero and Menactra and within hours patient experienced tingling in the arm that Menactra was administered.  The patient was also achy and she had fullness in her throat.  The patient visited and was given a steroid pack.  The physician also tested the patient for mono.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Musculoskeletal disorder, Pain, Tenderness
Clinical narrative: Painful injection, arm trembling just after injection. Ongoing pain and tenderness for one month. Unable to use arm with ADLs with loss of ROM
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Painful injection, arm trembling just after injection. Ongoing pain and tenderness for one month. Unable to use arm with ADLs with loss of ROM
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Corrective lens user, Cranial nerve disorder, Strabismus
Clinical narrative: Ocular Palsies ( Third Cranial Nerve Palsy - Strabismus) Misalignment of the left eye, weakness of cranial nerves. LE started drifting inward, not working with the other eye. Worsened over time. Palsy refers to paralysis, number one cause of Ocular Palsies is pressure on the Cranial Nerve, which likely came from Encephalitis (inflammation of the brain) which is another known and listed vaccine side affect (adverse event). Adverse event caused permanent damage, needs surgery to correct it. Has been in glasses since diagnosis. Will need to do a thorough detox to remove the heavy metals and toxins from her body that caused the Encephalitis which caused the Ocular Palsies.
Age: 45.0
Sex: M
Vaccine: JEV1
Symptoms: C-reactive protein increased, Hyperhidrosis, Malaise, Myalgia, Night sweats
Clinical narrative: Fever, drenching nightsweats, malaise, myalgias.  Started a few days after vaccine, but persisted for over 6 weeks with objectively documented fevers up to 102F
Age: 45.0
Sex: M
Vaccine: JEV1
Symptoms: Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Fever, drenching nightsweats, malaise, myalgias.  Started a few days after vaccine, but persisted for over 6 weeks with objectively documented fevers up to 102F
Age: 48.0
Sex: M
Vaccine: FLUC4
Symptoms: Musculoskeletal pain
Clinical narrative: Sore shoulder for 2 months
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Injection site reaction, Joint range of motion decreased, Pain in extremity, Radiculitis brachial
Clinical narrative: Pt was seen 11-20-19 by employee for left arm pain, 2 weeks after the injection. she was diagnosed with injection site reaction and was treated with steroids. symptoms persisted. she returned to clinic and was seen by me 12-9-19 for continued pain in the left arm with severely limited ROM. I diagnosed with with brachial neuritis, treated her with NSAIDs and PT.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Arm pain at the site of injection
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site induration, Injection site mass, Injection site swelling, Insomnia, Musculoskeletal stiffness
Clinical narrative: Stiffness throughout body Stopped sleeping for more then an hour at a time Hard, swollen lump from injection sights(lasted months)
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Patient reported pain in shoulder and difficulty lifting left arm
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; EXPIRED VACCINE ADMINISTERED; This spontaneous report was received from a medical assistant refers to a 53 year old female patient. The patient's medical history, historical drugs, drug allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) (lot # R030120 and expiration date 15-NOV-2019) (strength, dose and frequency was not reported) for prophylaxis. On 06-DEC-2019, the patient was administered an expired hepatitis a vaccine, inactivated(VAQTA). No additional adverse event reported. Product quality complaint was not involved in the case.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO ADVERSE SYMPTOMS; another dose of M-M-R was inadvertently administered; unspecified patient was administered a dose of MMR II; This spontaneous report was received from a physician refers to an adult patient (age reported in 20s or 30s) of unknown age and gender. The patient's pertinent medical history, drug reactions/ allergies, concurrent conditions were not reported. The patient's concomitant therapy included sterile diluent. On 03-DEC-2019, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  (strength, dosage, route, lot number and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). On 09-DEC-2019, the patient was inadvertently vaccinated with another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (inappropriate schedule of product administration). No adverse events were reported.  No product quality complaint was reported. The outcome of inappropriate schedule of product administration, product administered to patient of inappropriate age and no adverse event were  unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Fatigue
Clinical narrative: Bedridden; fatigue / bad reaction; This case was reported by a nurse via sales rep and described the occurrence of fatigue in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue and bedridden. On an unknown date, the outcome of the fatigue was recovered/resolved and the outcome of the bedridden was unknown.   The reporter considered the fatigue and bedridden to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had severe fatigue lasting a month after the second dose of Shingrix, leaving her bed ridden. The patient and staff felt it was due to the second dose of Shingrix. The reporter enquired whether a patient who had bad reaction to Shingrix could then get the flu vaccine at a later visit or not. No other shots were receive. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Migraine
Clinical narrative: i get migraines so; This case was reported by a consumer via call center representative and described the occurrence of migraine in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced migraine. On an unknown date, the outcome of the migraine was unknown.   It was unknown if the reporter considered the migraine to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient after receiving Shingrix had experienced migraines and patient was trying to detirmin if it is a migraine or reaction. The patient was told majority of people get some or side effects. The patient asked how soon do most see the symptoms reactions.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: Side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that after vaccination had all the potential side effects. The reporter asked how long the side effects were last. .
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: bump in vaccination arm/ bump where the vaccination was; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling 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 month after receiving Shingrix, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix a month ago from  the date of reporting and experienced bump at the injection site. The patient stated that, was reluctant to get the follow up vaccine, but the bump has not diminished in the month since the initial vaccination.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Itching on my head and back; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows:  It was reported that the patient had shingles shot on last friday and the patient experienced itching on head and back.
Sex: U
Vaccine: VARZOS
Symptoms: Sinusitis
Clinical narrative: get the first shingrix shot and an an unknown time later developed sinusitis; This case was reported by a consumer via call center representative and described the occurrence of sinusitis 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, unknown after receiving Shingrix, the patient experienced sinusitis. On an unknown date, the outcome of the sinusitis was recovering/resolving.   The reporter considered the sinusitis to be unrelated to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient did get the first shingrix shot and an unknown time later developed sinusitis.  The patient inquired, if the patient could get 2nd Shingles shot as the patient was recovering from sinusitis. The patient had been advised to speak with the patient's health care provider regarding use of Shingrix if a patient who has sinusitis. The patient did not seem to be indicating that Shingrix caused the sinusitis.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pain in arm; This case was reported by a consumer via other manufacturer 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 at an unknown dose. On an unknown date, 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 recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. A year before the time of reporting, the patient received a dose of Shingrix. Within a few hours after being administered the Shingrix, she experienced a sore arm for about 5 or 6 days. The patient when touched her arm around the injection site she would feel the soreness even more. The patient declined to provide physician demographics. No additional adverse event information was given. This case has been linked to US2019AMR222431, reported by the same reporter.