chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Chills, Gait disturbance, Headache, Pollakiuria
Clinical narrative: Symptoms started about 8pm ShAking chills, headache in temple region and top-of-head, frequent urination (approx. Q. 15-20 minutes, and loss of balance, and unsteady gait. Symptoms lasted from 8pm - approx. 7AM - fell asleep from 7AM - 11AM next morning. When I awoke, I felt better, except a little fuzzy headed.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Symptoms started about 8pm ShAking chills, headache in temple region and top-of-head, frequent urination (approx. Q. 15-20 minutes, and loss of balance, and unsteady gait. Symptoms lasted from 8pm - approx. 7AM - fell asleep from 7AM - 11AM next morning. When I awoke, I felt better, except a little fuzzy headed.
Age: 69.0
Sex: U
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pt informed us on 11/3/20 that her Left arm has been soRE for over a month. She says there is no redness or swelling at the site of injection. But her arm is still soRE.
Age: 89.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and tenderness around injection site starting the night after receiving vaccine
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site cellulitis, Injection site pruritus, Injection site swelling
Clinical narrative: Menveo given on 8/26/20 Left upper arm patient woke up 8/27/20 with swelling of Left upper arm with Itching. no pain or fever. 5cm area of (L) upper arm. Dx. Cellulitis Tx Clindamycin & Prednisone
Sex: U
Vaccine: FLU4
Symptoms: Vitreous floaters
Clinical narrative: Patient came back at 12:50PM same day + complaint That he is feeling brown spot Floating in front of his right eye. No pain/itching/redness. That was the Ist time he received the Flu shot  Adviced patient to wash his eye + rest. If symptoms didn't resolve. Then call us + see eye doctor.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Pain, Peripheral swelling, Pharyngeal swelling, Pyrexia
Clinical narrative: 12 hours vaccination, pt reported experience a throat, hand/feet swelling, SOB, body aches, fever 100.6F
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: vaccine undergoes temperature excursion of negative 0.1 degrees C for 5 hours and 51 minutes then, negative 2.6 degrees C for 10 hours and 54 minutes and then positive 1.1 degrees C for 2 hours and 1 minute/no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via RA (Reference number- 00307411) and transmitted to Sanofi on 08-Oct-2020.  This case is linked to cases 2020SA283022, 2020SA283023 and 2020SA281884 (same reporter).  This case involves male patient (of an unknown age) who dose of 0.7 ml suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ516AB, expiry date: 30-Jun-2021) via intramuscular route at an unknown administration site for prophylactic vaccination on 08-Oct-2020, which undergoes to the temperature excursion of  negative 0.1 degrees C for 5 hours and 51 minutes then, negative 2.6 degrees Celsius (C) for 10 hours and 54 minutes and then positive 1.1 degrees C for 2 hours and 1 minute (product storage error).  Medical history, concomitant medications, past medical treatment(s), vaccination(s) and family history were not provided.  It was a case of an actual medication error due to product storage error temperature too low.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: I had shingles in December of 2019 in my left arm and shoulder.  Within days of the shot  in JulyI developed shingle like pain in the right arm(where I received the shot) and shoulder as bad as the pain I had with shingles.  Severe pain lasted for a month and I still have recurrent pain on and off after three months.  I know what shingles pain feels like and this pain has lasted longer than original shingles. Tylenol didn't touch the original pain.  I had to use CBD and THC.  The pain actually threw my heart rate off and raised my blood pressure
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure increased, Heart rate abnormal, Injection site pain
Clinical narrative: I had shingles in December of 2019 in my left arm and shoulder.  Within days of the shot  in JulyI developed shingle like pain in the right arm(where I received the shot) and shoulder as bad as the pain I had with shingles.  Severe pain lasted for a month and I still have recurrent pain on and off after three months.  I know what shingles pain feels like and this pain has lasted longer than original shingles. Tylenol didn't touch the original pain.  I had to use CBD and THC.  The pain actually threw my heart rate off and raised my blood pressure
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Extreme pain around the Torso, eventually blistering in several areas.  The pain still exists today 2 months after the shot.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdomen scan normal, Abdominal X-ray, Blister, Pain, X-ray normal
Clinical narrative: Extreme pain around the Torso, eventually blistering in several areas.  The pain still exists today 2 months after the shot.
Age: 71.0
Sex: M
Vaccine: FLUA3, FLUA4
Symptoms: Swelling face
Clinical narrative: Patient called pharmacy on 11/12/2020, reporting that he had experience angioedema on the right side of his face the night of the day he received his flu shot. The edema lasted for approximately 48 hours, and have cleared up without need for ER or doctor visit.
Age: 71.0
Sex: M
Vaccine: FLUA3, FLUA4
Symptoms: Angioedema
Clinical narrative: Patient called pharmacy on 11/12/2020, reporting that he had experience angioedema on the right side of his face the night of the day he received his flu shot. The edema lasted for approximately 48 hours, and have cleared up without need for ER or doctor visit.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Blindness, Dizziness, Fall, Feeling abnormal, Gait inability
Clinical narrative: Had shot 11/12/2020.  Woke up at 4:00 am  11/13/2020.  I tried to get up and fell back into the bed.  My head was spinning, I couldn?t see and I couldn?t move??.  I tried reaching my phone but I couldn?t because it felt like I was going to throw up!  It felt like someone was pushing me holding me down and my limbs felt like jelly and I was very dizzy and couldn?t see.  I laid there terrified but couldn?t even call 911.  I panicked and after a period of time fell back  to sleep,  I then woke up at 7:00 am still unable to walk.  I had to use the bathroom so I forced myself up and held on to the bed, doors and walks finding my way to the bathroom.  I was terribly nauseated too.  That day I couldn?t even watch tv because I felt so nauseous and dizzy.  The following day 11/14/2020 and 11/15/2020 I was still nauseous.  Today 11/16/2020 I felt a little better but not perfect yet.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Nausea, Panic reaction, Rubber sensitivity, Vertigo
Clinical narrative: Had shot 11/12/2020.  Woke up at 4:00 am  11/13/2020.  I tried to get up and fell back into the bed.  My head was spinning, I couldn?t see and I couldn?t move??.  I tried reaching my phone but I couldn?t because it felt like I was going to throw up!  It felt like someone was pushing me holding me down and my limbs felt like jelly and I was very dizzy and couldn?t see.  I laid there terrified but couldn?t even call 911.  I panicked and after a period of time fell back  to sleep,  I then woke up at 7:00 am still unable to walk.  I had to use the bathroom so I forced myself up and held on to the bed, doors and walks finding my way to the bathroom.  I was terribly nauseated too.  That day I couldn?t even watch tv because I felt so nauseous and dizzy.  The following day 11/14/2020 and 11/15/2020 I was still nauseous.  Today 11/16/2020 I felt a little better but not perfect yet.
Age: 63.0
Sex: F
Vaccine: FLU4, HEP, HEPA, HIBV, IPV, PPV
Symptoms: Arthralgia, Candida infection, Chills, Delirium, Peripheral swelling
Clinical narrative: Patient called in two days after the receiving vaccinations to report  that on the night of vaccinations she experienced: lower spine pain, vomiting, rigors, swollen tights, delirium, pain in the hip, welt on thigh,  she could "feel it in her bone marrow", thrush and a 103 fever. Patient reported she did not seek emergency treatment the day of or the following  two days, declined to seek treatment after staff recommendation. On the third day after vaccinations patient reported that the welt on thigh had become as large as her palm, patient refused to seek treatment against staff recommendations.
Age: 63.0
Sex: F
Vaccine: FLU4, HEP, HEPA, HIBV, IPV, PPV
Symptoms: Pyrexia, Spinal pain, Urticaria, Vomiting
Clinical narrative: Patient called in two days after the receiving vaccinations to report  that on the night of vaccinations she experienced: lower spine pain, vomiting, rigors, swollen tights, delirium, pain in the hip, welt on thigh,  she could "feel it in her bone marrow", thrush and a 103 fever. Patient reported she did not seek emergency treatment the day of or the following  two days, declined to seek treatment after staff recommendation. On the third day after vaccinations patient reported that the welt on thigh had become as large as her palm, patient refused to seek treatment against staff recommendations.
Age: 43.0
Sex: M
Vaccine: MMR
Symptoms: Hypoaesthesia, Limb discomfort, Pain in extremity
Clinical narrative: After about one and a half months after the vaccine booster. I developed tremendous pain in and pressure in both arms. As if both arms were being squeezed by a blood pressure cuff from my hands to the shoulder. The pain and pressure would hit both arms simultaneously and last for hours. Then tapper off, then come back. This lasted for months when I also felt my hands starting to go numb as this was taking place. This lasted for over a year when it began to slowly subside. The issue lasted total about 2 years.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Flank pain, Musculoskeletal chest pain, Pain in extremity
Clinical narrative: Right arm pain that radiates to right axilla and right flank / lateral chest wall
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Muscular weakness, Pain in extremity, Pyrexia
Clinical narrative: muscle weakness; pain in her extremities; fever; This spontaneous report was received from a health care business professional referring to a 16 years old female patient. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were unknown.  In 2018 (reported as 2 years ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, strength, batch/lot# and expiration date were unknown) for prophylaxis.  In 2018 (reported as 2 years ago) after the first dose, the patient experienced muscle weakness, pain in her extremities, and fever lasting several days. The patient had no prior medical conditions and it was unknown if she sought medical attention for symptoms experienced. It was unknown if any treatment was given to the patient. It was unknown if any lab diagnostic/study was performed. The outcome of the event was unknown. The causality assessment was not provided.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: HCP called to report a temperature excursion (see case# 01766674) and reported that ROTATEQ was administered to 2 patients on l0/26/2020 after a temperature excursion and prior to having vaccines evaluated; This spontaneous report as received from a health professional referring to a patient of unknown age and gender.  Information about concurrent condition, concomitant medication, drug reactions/allergies and pertinent medical history was not provided.  On 26-OCT-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1684163, which has been verified to be valid, expiration date reported and validated as 26-JUN-2021) orally for prophylaxis (formulation, strength, dose and frequency were not reported).  The vaccine was administered after a temperature excursion (below 36 degrees Fahrenheit/2 degree Celsius (0.9 degree Celsius to 1.9 degree Celsius) for 10 hours; above 47 degrees Fahrenheit/9 degree Celsius (9.1 degree Celsius) for 30 minutes) and prior to having vaccines evaluated. There was no previous temperature excursion reported. The call was not because of a data logger.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA010875:
Age: 27.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event reported; A nurse called to report that a expired VAQTA was administered to a patient on 27-OCT-2020; This spontaneous report was received from a licensed practical nurse concerning a 27-year-old male patient. The patient's concurrent conditions, medical history, historical drug and concomitant therapies were not provided.  On 27-OCT-2020, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) 1 dosage form (location and route of administration were not provided) lot number S030588 and expiration date 20-OCT-2020 for prophylaxis. No adverse events were reported.  Lot No. S030588 has been verified to be a valid lot number for Hepatitis A Vaccine, Inactivated (VAQTA), expiration date reported as 21-OCT-2020, but upon internal validation established as 20-OCT-2020.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: a patient received MMRII and VARIVAX after they had been stored outside of the recommended storage range; This spontaneous report as received from  a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, current condition, previous drug reaction or allergy, and concomitant medication were not reported.  On 23-SEP-2020, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 1 dose (strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number was reported as s020961,  but upon internal validation established as S020961, expiration date reported and validated as 07-JUL-2021) and varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose (strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number reported as t010310,  but upon internal validation established as T010310, expiration date reported and validated as 24-MAR-2022) for prophylaxis (Improper storage of product in use). The vaccine was exposed to the following temperature excursions: 19.32 degrees for 7 hours and 45 minutes. There was no previous temperature excursion. Data logger was not involved.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Injection site pain
Clinical narrative: pain at the injection site and tenderness that spread to her armpit; pain at the injection site and tenderness that spread to her armpit; pain at the injection site and tenderness that spread to her armpit; This spontaneous report was received from a pharmacist and refers to a 67-year-old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 05-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, intramuscularly, lot # T024669 with expiration date on 21-MAR-2020 (dose and anatomical localization were unknown) as it was recommended for the patient's age.  On 05-NOV-2020, after the injection, the patient started to experience pain and tenderness at the injection site, that spread to her armpit.  The patient did not sought medical attention and did not receive any treatment for the events. The outcome of the events was reported as not recovered.       The casual relationship between the events and suspect therapy was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; 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 29-MAY-2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. At the time of patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was an effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced patient to be vaccinated. Alternatively, on or about 29-MAY-2010, the patient's healthcare providers, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis, and believed that it did not carry any significant risks of adverse effects. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles. 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 event was unknown. The event was considered related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; shingles / painful and severe blisters across her back and torso; Information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or around 05-FEB-2009, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered painful and severe blisters across her back and torso. The pt was diagnosed with shingles and postherpetic neuralgia as a result of the suspect vaccine. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the 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, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events of shingles and postherpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).  The events of shingles and postherpetic neuralgia were considered to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: zoster-related eye injuries; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) by a healthcare provider at a physician's medical office for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at a physician's medical office for zoster-related eye injuries. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would 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 would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event of zoster-related eye injuries to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm is still swollen; Arm / Very red; Arm / hot; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced swelling arm, erythema of extremities and skin warm. On an unknown date, the outcome of the swelling arm, erythema of extremities and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, erythema of extremities and skin warm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported but was captured as an adult as per vaccine indication. The patient was vaccinated with !st dose of Shingrix on last thursday from reporting day. The patient experienced swollen and very red and hot till the reporting day. No further details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: My arm is sore; Headache for 2 days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2020, the patient received the 1st dose of Shingrix. On 8th November 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and headache. On an unknown date, the outcome of the pain in arm and headache were recovered/resolved.   It was unknown if the reporter considered the pain in arm and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix an experienced arm sore and headache was recovered in 2 days. The information regarding consent to follow up was not reported. No further information was available
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Malaise, Product storage error
Clinical narrative: don´t feel well today; kept at room temperature / was only administered an hour after the preparation; 1st: Saturday (7NOV) / 2nd: Monday (9NOV); This case was reported by a consumer via licensee and described the occurrence of malaise in a female patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included rabies vaccine needle device (Rabavert Needle Device) injection needle for prophylaxis and rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Rabies NVS (RabAvert).   On 9th November 2020, the patient received the 2nd dose of RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device. On 9th November 2020, unknown after receiving RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device, the patient experienced product storage error and drug dose administration interval too short. On 10th November 2020, the patient experienced malaise. On an unknown date, the outcome of the malaise, product storage error and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the malaise to be related to RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. On 9th November 2020, the patient received the RabAvert. On 10th November 2020, the patient experienced not feeling well. The vaccine was prepared, kept at room temperature and was only administered an hour after the preparation, which led to shortening of the vaccination schedule, product storage error.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: itching problems; This case was reported by a consumer via other manufacturer and described the occurrence of pruritus in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included depression, anxiety, migraine and hyperacidity. Concomitant products included famotidine, vortioxetine hydrobromide (Trintellix), topiramate and alprazolam (Alprazolam Er).   In August 2018, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after starting famotidine, 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 information was provided as follows: The age at vaccination was not reported. On an unknown date, after receiving Shingrix shot, the patient had a landslide of health problems and the itching started then. The patient had an extreme reaction to Shingrix and had these itching problems. The reporter consented to follow up.
Sex: M
Vaccine: MEN
Symptoms: Autism spectrum disorder, Deafness, Meningitis, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Got meringite and is now completly deaf; Autistic; now completly deaf; This case was reported by a consumer via interactive digital media and described the occurrence of  suspected vaccination failure in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), meningitis (serious criteria GSK medically significant), autistic disorder (serious criteria GSK medically significant) and deafness (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure, meningitis, autistic disorder and deafness were unknown.   It was unknown if the reporter considered the vaccination failure, meningitis, autistic disorder and deafness to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter knew somebody who was vaccinated got meningitis and was now completely deaf. The reporter stated that he or she was talking about vaccinated and plus been deaf and he was autistic too at  the time of reporting. The reported said, open your eyes people, they did not want us healthy. This case was considered as suspected vaccination failure as details regarding vaccination schedule, type of meningitis, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: Sore arm/hurt more than any other vaccination; Malaise; This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm and malaise. On an unknown date, the outcome of the pain in arm and malaise were unknown.   It was unknown if the reporter considered the pain in arm and malaise to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient had experienced a sore arm following Shingrix that hurted more than any other previous vaccination. The patient also felt malaise, but also had a flu vaccination, so wasn't sure which to attribute it to. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR225520:Same reporter, same patient
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Ageusia, Chills, Headache, Insomnia, Nausea
Clinical narrative: loss of taste and can not taste certain foods / 50% less taste; trouble sleeping; nausea; headache; chills; fever; This case was reported by a consumer via call center representative and described the occurrence of difficulty sleeping in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 24th October 2020, less than a day after receiving Shingrix, the patient experienced difficulty sleeping, nausea, headache, chills and fever. On an unknown date, the patient experienced taste loss. On an unknown date, the outcome of the difficulty sleeping, nausea, headache, chills and fever were recovered/resolved and the outcome of the taste loss was not recovered/not resolved.   It was unknown if the reporter considered the difficulty sleeping, nausea, headache, chills, fever and taste loss to be related to Shingrix.  Additional details were provided as follows: Within 6 hours of receiving the vaccine the patient had fever, chills, headache, nausea and trouble sleeping and these events lasted about 2 and half days and then resolved.  Few days after receiving the second dose she had a loss of taste and could not taste certain foods and reported that she had 50 percent less taste and this was still ongoing at the time of reporting. The patient did not have lot number or expiration date information to provide.  The reporter did not consent to follow-up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: loss of taste and can not taste certain foods / 50% less taste; trouble sleeping; nausea; headache; chills; fever; This case was reported by a consumer via call center representative and described the occurrence of difficulty sleeping in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 24th October 2020, less than a day after receiving Shingrix, the patient experienced difficulty sleeping, nausea, headache, chills and fever. On an unknown date, the patient experienced taste loss. On an unknown date, the outcome of the difficulty sleeping, nausea, headache, chills and fever were recovered/resolved and the outcome of the taste loss was not recovered/not resolved.   It was unknown if the reporter considered the difficulty sleeping, nausea, headache, chills, fever and taste loss to be related to Shingrix.  Additional details were provided as follows: Within 6 hours of receiving the vaccine the patient had fever, chills, headache, nausea and trouble sleeping and these events lasted about 2 and half days and then resolved.  Few days after receiving the second dose she had a loss of taste and could not taste certain foods and reported that she had 50 percent less taste and this was still ongoing at the time of reporting. The patient did not have lot number or expiration date information to provide.  The reporter did not consent to follow-up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fatigue, Injection site pain, Myalgia
Clinical narrative: low back pain; chills; had a fever; had injection site pain; tired; feeling achy; muscle aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th November 2020, immediately after receiving Shingrix, the patient experienced injection site pain, fatigue, general body pain and myalgia. On 7th November 2020, the patient experienced fever and chills. On 8th November 2020, the patient experienced back pain. On 7th November 2020, the outcome of the fatigue, general body pain, myalgia and chills were recovered/resolved. On an unknown date, the outcome of the injection site pain, fever and back pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fatigue, general body pain, myalgia, fever, back pain and chills to be related to Shingrix.  Additional details were provided as follows: The patient immediately had injection site pain that continues till the time of reporting. On 7th November 2020, within two hours of receiving the vaccine he started feeling achy, tired and having muscle aches which were resolved. Also he had fever that had been intermittent and ongoing and he had chills that night which resolved that night itself. On 8th November 2020, he started having low back pain that continues till the time of reporting. No further information was available. The reporter did not consent to follow-up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: low back pain; chills; had a fever; had injection site pain; tired; feeling achy; muscle aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th November 2020, immediately after receiving Shingrix, the patient experienced injection site pain, fatigue, general body pain and myalgia. On 7th November 2020, the patient experienced fever and chills. On 8th November 2020, the patient experienced back pain. On 7th November 2020, the outcome of the fatigue, general body pain, myalgia and chills were recovered/resolved. On an unknown date, the outcome of the injection site pain, fever and back pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fatigue, general body pain, myalgia, fever, back pain and chills to be related to Shingrix.  Additional details were provided as follows: The patient immediately had injection site pain that continues till the time of reporting. On 7th November 2020, within two hours of receiving the vaccine he started feeling achy, tired and having muscle aches which were resolved. Also he had fever that had been intermittent and ongoing and he had chills that night which resolved that night itself. On 8th November 2020, he started having low back pain that continues till the time of reporting. No further information was available. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: felt tired; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than 2 weeks after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The patient received the 1st dose of Shingrix and felt tired which was resolved in 24 hours. The reporter did not consented to follow up. No further information was available.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysarthria, Eyelid function disorder, Facial paralysis
Clinical narrative: Bell's Palsy /  Can't smile / Can't wink/blink his left eye; He isn't pronouncing his words clearly; can't wink/blink his left eye; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 23rd Mrach 2020 on unknown deltiod via intramuscular route).   On 26th May 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 5th November 2020, 163 days after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). In November 2020, the patient experienced dysarthria and eyelid function disorder. The patient was treated with prednisone. On an unknown date, the outcome of the bell's palsy was not recovered/not resolved and the outcome of the dysarthria and eyelid function disorder were unknown.   The reporter considered the bell's palsy, dysarthria and eyelid function disorder to be related to Shingrix.  Additional details were reported as follows: The patient reported the case by himself. The patient received 2nd dose of Shingrix on deltoid muscle at MD office. The patient began to noticing symptoms involving the left side of his case on 5th November 2020. On 9th November 2020, the patient went to the physician's office and was diagnosed with the Bell's Palsy. The patient was prescribed Prednisone 60 milligram daily for 7 days. The patient's condition was not improving it was about the same. The patient's wife said that she thought it look like the patient face was improving. The patient stated that he could not smile or wink or blink his left eye. The patient could only close his left eye if he closes both eyes. The reporter believed his bell's palsy was side effect of Shingrix. At the time of call, the physician mentioned that if he had trouble understanding of patient or he was not pronouncing his words clearly it was because of the Bell's palsy. The reporter consented to follow up.
Age: 81.0
Sex: M
Vaccine: FLU4, HIBV, IPV, TYP, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: ActHIB(unopened), Fluzone High Dose(unopened), Thyphim(unopened), Ipol(Opened and unopened)  and Tubersol(unopened) reached Lowest temperature was -17C degrees for 63 hour and  45 minutes, did not know the cause of the excursion with o adverse event; Initial information regarding this unsolicited valid non-serious case via the agency (reference number: 00316317) received from a nurse and transmitted to Sanofi 14-Oct-2020.  This case was linked to cases 2020SA288422, 2020SA288477, 2020SA290000 and 2020SA290005.  This case involved 89 years old male patient who was administered with a 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot: UJ450AA, expiry date: 30-Jun-2021), on 07-Oct-2020, via unknown route in right deltoid for prophylactic vaccination, which had a temperature excursion along with the vaccines TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM], IPV (VERO) [IPOL], HIB (PRP/T) VACCINE [ACT-HIB] and TUBERCULIN TEST [TUBERSOL] (lot number and expiry date not reported for all), at lowest temperature was -17C degrees for 63 hour and  45 minutes.  It was reported that 6- patients received vaccines that were not suitable for use post a temperature excursion. 5 received Fluzone Quadrivalent High Dose and 1 received Act-HIB.  Relevant medical history, past medical treatment, vaccination details and family history were not provided.   No adverse event was reported at the time of reporting.  It was a case of actual medical error due to product storage error temperature too low.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 39.0
Sex: M
Vaccine: FLUR4
Symptoms: Arthralgia, Injection site injury
Clinical narrative: NOTIFIED BY PATIENTS WIFE AS FOLLOWS... "PHARMACIST, THIS IS (WIFE). I WANTED TO LET YOU KNOW (PATIENT) HAS TO GO TO THE DOCTOR FOR HIS SHOULDER PAIN AFTER RECEIVING A FLU SHOT GIVEN BY (PHARMACIST) THE OTHER DAY. YOU WERENT THERE SO HE GAVE IT. (PATIENT) EVEN SAID THAT HE THOUGHT SOMETHING WASNT RIGHT BECAUSE (PHARMACIST) HAD TO LEAN FORWARD TO PUT SHOT IN FURTHER. HE SAID IT WAS GIVEN AT THE VERY TOP OF HIS SHOULDER AND THE NEEDLE WOULDNT GO IN FURTHER. IVE EVEN TALKED TO OTHER PEOPLE WHO GOT THEIR SHOTS BY HIM AND THEY SAY THERE IS SOMETHING WRONG WITH HIS TECHNIQUE. EVERYONE KNOW HOW YOU GIVE SHOTS AND HE IS NOT DOING SOMTHING RIGHT. MAYBE YOU SHOULD TAKE A LOOK." --- ALSO AFTER TALKING TO WIFE MORE, PATIENT WENT TO PRIMARY DOCTOR FOR SHOT ADMINISTERED 10/22/2020. WAS REFERRED OUT TO BONE AND JOINT SPECIALIST AND WILL HAVE A SCAN OF SHOULDER. PER WIFE, DOCTOR STATES THERE HAS BEEN INJURY FROM ADMINISTRATION OF THE VACCINE. PATIENT ALSO BETWEEN DR AND SPECIALIST APPT WENT TO URGENT CARE AND RECEVIED A PRESCRIPTION AND STEROID INJECTION.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Muscular weakness, X-ray normal
Clinical narrative: Difficulty with range of motion, weakness in right arm, pain to injection site. All symptoms began the night of the injection and have not gone away. She was seen by her provider on 11/16/2020, X-rays ordered. Physical therapy referral was made, diclofenac prescribed.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Severe arm pain at site of injection; Fever; Chills
Age: 76.0
Sex: M
Vaccine: FLUC4, FLUA4
Symptoms: Swelling face, Tongue disorder, Vaccine positive rechallenge
Clinical narrative: Pt presented in our ER on 11/16 with chief complaint of facial swelling and tongue thickening, had a flu vaccine on 11/12/20. Same type of co after last flu vaccine 10/11/2018. Was admitted that time overnight as observation, felt it was allergy to Lisinopril  REceived Benadryl, solu-medrol, claritin, and pepcid in our ER and discharged home
Age: 76.0
Sex: M
Vaccine: FLUC4, FLUA4
Symptoms: Swelling face, Tongue disorder
Clinical narrative: Pt presented in our ER on 11/16 with chief complaint of facial swelling and tongue thickening, had a flu vaccine on 11/12/20. Same type of co after last flu vaccine 10/11/2018. Was admitted that time overnight as observation, felt it was allergy to Lisinopril  REceived Benadryl, solu-medrol, claritin, and pepcid in our ER and discharged home
Age: 72.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Mobility decreased, Tenderness
Clinical narrative: PATIENT RECEIVED PNEUMOVAX 23 IMMUNIZATION ON 11/13/20 IN HIS RIGHT ARM AND BY THAT EVENING PATIENT WAS HAVING PAIN IN SHOULDER AND TROUBLE MOVING IT. HE REPORTED TO PHARMACY ON 11/16/20 AND PATIENT SAID PAIN WAS BETTER AND HE COULD MOVE IT A EASIER. REPORTED PAIN IN SHOULDER AND TENDERNESS. COULD BEND ARM BUT PAINFUL TO LIFT AT HIS SHOULDER. THERE WAS NO EVIDENCE OF REDNESS, SWELLING, OR WARMNESS. PATIENT SAID HE NEVER HAD ANY OF THOSE SIGNS AFTER IMMUNIZATION EITHER.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Insomnia
Clinical narrative: Patient said she became very hot and unable to sleep until roughly 4am. She called the pharmacy at 8am and said she was feeling better and asked if she could take advil due to headache from lack of sleep.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Eye pain, Feeling cold, Ocular discomfort
Clinical narrative: Shivers, incredible bone chilling cold that lasted for an hour before I went to sleep.  Couldn?t warm up.  Woke in the morning with pressure sensation soreness, in both eyes.  Took Motrin 800 and the rest of the following day was fine. No negative reactions since.
Age: 36.0
Sex: F
Vaccine: FLUR4
Symptoms: Myalgia, Pain, Wrong product administered
Clinical narrative: Patient is pregnant and is currently 39 weeks, was 37 at the time of immunization. Patient received flublock instead of tdap and states she had flulike symptoms after receiving the immunization. Normal side effects from receiving the flu shot, body aches, and muscle aches.
Age: 83.0
Sex: F
Vaccine: FLUC4
Symptoms: Deafness unilateral, Hypoacusis
Clinical narrative: Patient lost her hearing in one ear completely and some in the other ear about 5-6 hours after vaccine administration.
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Exposure during pregnancy
Clinical narrative: The patient is a healthy 27 yo female who received anthrax #1 10/27/20 (lot # 300070A) while 23 weeks pregnant . No specific AE other than inappropriate administration. Provider visits for education and counseling.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: I was requested by the physician to administer a flu vaccine per patient request. After administering it the patient stated they may have already had one but "figured why not."
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Limb discomfort, Loss of consciousness
Clinical narrative: patient received vaccine after vaccine given felt pressure in the leg and 2 minutes later patient passed out for 10 seconds came too . given Gatorade and nutrigrain  bar . patient felt fine after coming too waited in office for 45 minutes and then was to leave with mom.