chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Diarrhoea, Drug ineffective, Exposure to communicable disease
Clinical narrative: COVID-19; COVID-19; Exposure to communicable disease; Fluid in middle ear; Diarrhea; Vertigo; Back pain; Gastric infection; dose 2  subcutaneous, administration; Flu like symptoms; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4153593-00.  A 85 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 16Apr2021 (Batch/Lot number: unknown) at the age of 85 years as dose 1, single and subcutaneous, administration date 07May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19"; EXPOSURE TO COMMUNICABLE DISEASE (non-serious), outcome "recovered" (2021), described as "Exposure to communicable disease"; MIDDLE EAR EFFUSION (non-serious), outcome "unknown", described as "Fluid in middle ear"; DIARRHOEA (non-serious), outcome "recovering", described as "Diarrhea"; VERTIGO (non-serious), outcome "recovering", described as "Vertigo"; BACK PAIN (non-serious), outcome "not recovered", described as "Back pain"; INFLUENZA LIKE ILLNESS (non-serious) with onset May2021, outcome "recovered" (2021), described as "Flu like symptoms"; GASTRIC INFECTION (non-serious), outcome "recovered" (2021), described as "Gastric infection"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 07May2021, outcome "unknown", described as "dose 2  subcutaneous, administration". The action taken for adalimumab was unknown. Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of VERTIGO, EXTRA FLUID IN EAR, DIARRHEA, COVID TWICE, BACK PAIN, FLU LIKE REACTION, CAUGHT A BUG FROM GRANDCHILDREN/IT WAS STOMACH VIRUS unknown onset and CAUGHT A BUG FROM GRANDCHILDREN/IT WAS STOMACH VIRUS unknown onset was not provided. reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available in narrative the reported  events of  VERTIGO, EXTRA FLUID IN EAR, EXPOSURE TO COMMUNICABLE DISEASE  ,DIARRHEA, LOE, BACK PAIN, FLU LIKE REACTION, assessed as related to suspected vaccine BNT162B2. However the event of gastric infection is assessed as unrelated to suspected vaccine.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Gastric infection, Incorrect route of product administration, Influenza like illness, Middle ear effusion, Vertigo
Clinical narrative: COVID-19; COVID-19; Exposure to communicable disease; Fluid in middle ear; Diarrhea; Vertigo; Back pain; Gastric infection; dose 2  subcutaneous, administration; Flu like symptoms; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4153593-00.  A 85 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 16Apr2021 (Batch/Lot number: unknown) at the age of 85 years as dose 1, single and subcutaneous, administration date 07May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19"; EXPOSURE TO COMMUNICABLE DISEASE (non-serious), outcome "recovered" (2021), described as "Exposure to communicable disease"; MIDDLE EAR EFFUSION (non-serious), outcome "unknown", described as "Fluid in middle ear"; DIARRHOEA (non-serious), outcome "recovering", described as "Diarrhea"; VERTIGO (non-serious), outcome "recovering", described as "Vertigo"; BACK PAIN (non-serious), outcome "not recovered", described as "Back pain"; INFLUENZA LIKE ILLNESS (non-serious) with onset May2021, outcome "recovered" (2021), described as "Flu like symptoms"; GASTRIC INFECTION (non-serious), outcome "recovered" (2021), described as "Gastric infection"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 07May2021, outcome "unknown", described as "dose 2  subcutaneous, administration". The action taken for adalimumab was unknown. Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of VERTIGO, EXTRA FLUID IN EAR, DIARRHEA, COVID TWICE, BACK PAIN, FLU LIKE REACTION, CAUGHT A BUG FROM GRANDCHILDREN/IT WAS STOMACH VIRUS unknown onset and CAUGHT A BUG FROM GRANDCHILDREN/IT WAS STOMACH VIRUS unknown onset was not provided. reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available in narrative the reported  events of  VERTIGO, EXTRA FLUID IN EAR, EXPOSURE TO COMMUNICABLE DISEASE  ,DIARRHEA, LOE, BACK PAIN, FLU LIKE REACTION, assessed as related to suspected vaccine BNT162B2. However the event of gastric infection is assessed as unrelated to suspected vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Heart rate, Heart rate increased, Muscle twitching, Pain in extremity
Clinical narrative: Muscle twitching and my left side mostly below my knee, calf and foot; I am still having problems with muscle twitching; Ocular migraine; Rapid heartbeat; The COVID rash in my shoulder to elbow; Sore arm and the COVID rash in my shoulder to elbow; The COVID rash in my shoulder to elbow; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 02Mar2021 (Lot number: EN6202) as dose 2, single and administration date 08Feb2021 (Lot number: EL3249) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), RASH (non-serious) all with onset 02Mar2021, outcome "unknown" and all described as "The COVID rash in my shoulder to elbow"; DRUG INEFFECTIVE (medically significant) with onset 02Mar2021, outcome "unknown", described as "Sore arm and the COVID rash in my shoulder to elbow"; PAIN IN EXTREMITY (non-serious) with onset 02Mar2021, outcome "unknown", described as "Sore arm"; MUSCLE TWITCHING (non-serious) with onset 06Mar2021, outcome "not recovered", described as "Muscle twitching and my left side mostly below my knee, calf and foot; I am still having problems with muscle twitching"; RETINAL MIGRAINE (non-serious) with onset 03Mar2021, outcome "unknown", described as "Ocular migraine"; HEART RATE INCREASED (non-serious) with onset 03Mar2021, outcome "unknown", described as "Rapid heartbeat". The patient underwent the following laboratory tests and procedures: heart rate: (03Mar2021) rapid, notes: Rapid heartbeat.  Clinical course: Patient had second COVID shot on 02Mar2021, on the day of course patient had the sore arm and the COVID rash in shoulder to elbow. The second day patient had the first ocular margarine of life and rapid heartbeat and patient reported both of those things. And then about 4 days later patient start getting muscle twitching and left side mostly below knee, calf and foot but patient didn't report it because patient hadn't heard for first time. And now patient looking online because patient still having problems with muscle twitching, and patient see a lot of people saying that it was right after there COVID shot. Patient concerned about the omicron variant and would very much like to get the booster but afraid to with all the bad reactions have had. So, patient wanted to talk to somebody who could give me some advice on that. Patient was suggested to contact to the Physician or the Pharmacist in case of emergency.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Retinal migraine, Suspected COVID-19
Clinical narrative: Muscle twitching and my left side mostly below my knee, calf and foot; I am still having problems with muscle twitching; Ocular migraine; Rapid heartbeat; The COVID rash in my shoulder to elbow; Sore arm and the COVID rash in my shoulder to elbow; The COVID rash in my shoulder to elbow; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 02Mar2021 (Lot number: EN6202) as dose 2, single and administration date 08Feb2021 (Lot number: EL3249) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), RASH (non-serious) all with onset 02Mar2021, outcome "unknown" and all described as "The COVID rash in my shoulder to elbow"; DRUG INEFFECTIVE (medically significant) with onset 02Mar2021, outcome "unknown", described as "Sore arm and the COVID rash in my shoulder to elbow"; PAIN IN EXTREMITY (non-serious) with onset 02Mar2021, outcome "unknown", described as "Sore arm"; MUSCLE TWITCHING (non-serious) with onset 06Mar2021, outcome "not recovered", described as "Muscle twitching and my left side mostly below my knee, calf and foot; I am still having problems with muscle twitching"; RETINAL MIGRAINE (non-serious) with onset 03Mar2021, outcome "unknown", described as "Ocular migraine"; HEART RATE INCREASED (non-serious) with onset 03Mar2021, outcome "unknown", described as "Rapid heartbeat". The patient underwent the following laboratory tests and procedures: heart rate: (03Mar2021) rapid, notes: Rapid heartbeat.  Clinical course: Patient had second COVID shot on 02Mar2021, on the day of course patient had the sore arm and the COVID rash in shoulder to elbow. The second day patient had the first ocular margarine of life and rapid heartbeat and patient reported both of those things. And then about 4 days later patient start getting muscle twitching and left side mostly below knee, calf and foot but patient didn't report it because patient hadn't heard for first time. And now patient looking online because patient still having problems with muscle twitching, and patient see a lot of people saying that it was right after there COVID shot. Patient concerned about the omicron variant and would very much like to get the booster but afraid to with all the bad reactions have had. So, patient wanted to talk to somebody who could give me some advice on that. Patient was suggested to contact to the Physician or the Pharmacist in case of emergency.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (she had a sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 028A21A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, LOSARTAN and BUPROPION HYDROCHLORIDE (BUP) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (she had a sore arm). At the time of the report, PAIN IN EXTREMITY (she had a sore arm) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2021-433166, MOD-2021-433313 (Patient Link).
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Hypoaesthesia, Influenza like illness
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a 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 influenza-like symptoms, chills, burning sensation and numbness. On an unknown date, the outcome of the influenza-like symptoms and chills were recovered/resolved and the outcome of the burning sensation and numbness were not recovered/not resolved. The reporter considered the influenza-like symptoms, chills, burning sensation and numbness to be related to Shingles vaccine. Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The reporter stated that, the 2nd shot gave him/her intense chills, flu like symptoms for 5 days. Followed by intense burning inside all over body and then lost feeling in feet and arms. The reporter stated that, it had been 3 years of countless doctors and medicines. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Eye contusion, Herpes zoster, Herpes zoster oticus, Vaccination failure
Clinical narrative: Shingles, had both shingles shot/ suspected vaccination failure; shingles, had surgery, scar on side of head, went to ear; Shingles went to ear; eye looked like somebody had punched me; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included surgery (head surgery). Concurrent medical conditions included scar (scar on the side of head where the patient had the surgery).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, herpes zoster oticus (serious criteria GSK medically significant) and black eye. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure, herpes zoster oticus and black eye were unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, herpes zoster oticus and black eye to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she was getting over shingles now and had a scar on the side of head where he/she had the surgery, that was where shingles started then went to ear. The next day, the patient's eye looked like somebody had punched him/her. The patient immediately went to the eye doctor and the doctor asked if patient had received the Shingles shot, to which the patient replied that he/she had both the shots.  The doctor checked the patient's eye and it wasn't in eye but he said, the patient had shingles.  The patient was still taking the anti viral, the doctor had prescribed. The patient stated that, before he/she knew what he/she had, the patient thought he/she was going to scratch the head off.  The patient would get the simple Super B complex, and was asking where to purchase this. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding the laboratory test confirming shingles and time to onset for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure/still get mild cases; still get mild cases; very painful; nerve damage in both feet; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and nerve damage. On an unknown date, the outcome of the vaccination failure, pain and nerve damage were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and nerve damage to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received shot and still get mild cases of shingles once in a while. The patient stated that shingles were very painful and had nerve damage in both feet.  The patient stated that had that for years but not cure. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: It makes your arm hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 60-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The patient received 1st dose of Shingles vaccine, at the age of 60. After vaccination the patient had pain in arm. The patient stated that, it was better than suffering with shingles. This case is linked with case US2021AMR264878, reported for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR264878:Same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a neonate patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis. On 24th December 2021, the patient received Influenza vaccine Quadrivalent 2021-2022 season. On 24th December 2021, unknown after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that, a medication error occurred, an adult Flu vaccine of GlaxoSmithKline was given to a newborn (patient), which led to inappropriate age at vaccine administration. The reporter would like to know if there was any possible side effects or reaction they should watch out for.  The reporter asked to contact and ask to speak to any nurses available on the shift.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 1st dose in 8/23/2021 / second dose  was administered 9/10/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number 4J2SP, expiry date 14th November 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23rd August 2018).   On 10th September 2021, the patient received the 2nd dose of Shingrix. On 10th September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Administered expired dose; Adult expired dose to pediatric patient; Adult expired dose to pediatric patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received HBV (Engerix B adult) (batch number L9539, expiry date 7th December 2021) for prophylaxis.   On 23rd December 2021, the patient received Engerix B adult. On 23rd December 2021, unknown after receiving Engerix B adult, the patient experienced expired vaccine used, overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used, overdose and inappropriate age at vaccine administration were unknown.  Additional details were reported as follows:                 The clinical coordinator administered an expired adult dose of Engerix-B to a pediatric patient, which led to overdose, inappropriate age at vaccine administered and expired vaccine administered. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021262290:Same reporter, deleted case
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose August 2019, 2nd dose in June-July 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received in August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The age at vaccination was not reported. As patient received 2nd dose of Shingrix either June or July of 2021 later than the recommended interval which led to drug dose administration interval too long. No symptoms reported. The health care professional did not have the patient's date of birth or exact dates of vaccination. The HCP did not have the lot for the 2nd dose as it was not given at that pharmacy. The reporter consented to follow up.
Age: 83.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired dose of Engerix-B was administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 83-year-old female patient who received HBV (Engerix B) (batch number 54A32, expiry date 12th November 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th December 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 28th December 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   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 patient received an expired dose of Engerix-B, which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Has not received a second dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received Shingrix a couple of years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The reporter was patient's neighbor. The age at vaccination was not applicable.  The patient only received one dose of shingrix and had not received a 2nd dose till the time of reporting, which led to incomplete course of vaccination. The reporter did not feel comfortable providing patient's information.  The reporter did not provide the date of birth, initials, lot/exp date, route/date of administration, and consent to follow-up with HCP.  However, the patient received the vaccine at the same Pharmacy that the reporter went to. The reporter consented to follow up. This case was 1 of 3 case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021264519:Same reporter. US-GLAXOSMITHKLINE-US2021261510:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: Nerve pain; Shingles after receiving first dose; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 82-year-old male patient who received Herpes zoster (Shingrix) (batch number 9472F, expiry date 14th October 2022) for prophylaxis.   The patient's past medical history included lymphoma (patient was diagnosed with lymphoma prior to starting the series).   On 27th May 2021, the patient received the 1st dose of Shingrix. In June 2021, 1 month after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced nerve pain. The patient was treated with gabapentin and acyclovir. On an unknown date, the outcome of the shingles and nerve pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles and nerve pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that, the patient who received the first dose of Shingrix 6 months ago, had lymphoma and exhibited shingles about a month after receiving the first dose.  On an unknown date, less than 9 months after receiving Shingrix the patient experienced nerve pain The patient was treated with Gabapentin and Acyclovir.  The patient was still being treated with Gabapentin for the nerve pain. The reporter consented to follow up.
Age: 28.0
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 28 year old was administrated Bexsero; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 28-year-old male patient who received Men B NVS (Bexsero) (batch number abxa95aa, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st November 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st November 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   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 pharmacist reported that the 28 year old patient was administrated a dose of Bexsero, which led to inappropriate age at vaccine administration. No further events were reported.  The reporter consented to follow-up.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Myocardial infarction
Clinical narrative: HEART ATTACK; DEATH; This spontaneous report received from a consumer concerned a 64 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, dose number in series was 1, 01 total, administered on 24-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient had a heart attack which was diagnosed by his primary care physician (PCP). On 29-MAR-2021, as per death certificate, the patient died from obesity, hypertension (HTN) and diabetes. Reportedly, he was driving at the time he passed away (dose number in series was 1). Autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of death was fatal and the outcome of heart attack was not reported. This report was serious (Death, and Other Medically Important Condition).  .; Sender's Comments: V0: 20211258857-Covid-19 vaccine ad26.cov2.s- Death, Heart attack. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: OBESITY; HYPERTENSION (HTN); DIABETES
Sex: U
Vaccine: COVID19
Symptoms: Death, Injury
Clinical narrative: DIED; CATASTROPHIC INJURY; This spontaneous report received from a consumer via a company representative concerned multiple (48 patients) of unspecified race and ethnic origin. No past medical history or concurrent conditions were reported.  The patients received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total was administered for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  It was reported by the reporter that, "I personally know of 48 people who have either died from the experimental drug or who have suffered catastrophic injury from the experimental drug". On an unspecified date, the patients died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patients died of death on an unspecified date, and the outcome of catastrophic injury was not reported.  This report was serious (Death).  This case, from the same reporter is linked to 20211260743, 20211261168 and 20211261664.; Sender's Comments: V0:20211260953-COVID-19 VACCINE AD26.COV2.S-Died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a patient concerned a multiple adult patients (ages 18-39 year) of unspecified sex, race and ethnicity.  No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total, for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patients experienced blood clot. It was reported that, "so 7 per million blood clot with JNJ ages 18-39". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20211264065 -COVID-19 VACCINE AD26.COV2.S- Blood Clot. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, dose number in series 1, 1 total, for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient died (Dose number in series 1). It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date, the patient died from unknown cause of death. This report was serious (Death).; Sender's Comments: V0: 20211264458-COVID-19 VACCINE AD26.COV2.S-Died. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: pain all over her stomach; nausea; Patient threw up for 2 days in a row.; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (pain all over her stomach), NAUSEA (nausea) and VOMITING (Patient threw up for 2 days in a row.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced ABDOMINAL PAIN UPPER (pain all over her stomach), NAUSEA (nausea) and VOMITING (Patient threw up for 2 days in a row.). At the time of the report, ABDOMINAL PAIN UPPER (pain all over her stomach), NAUSEA (nausea) and VOMITING (Patient threw up for 2 days in a row.) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-433382, MOD-2021-433458 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: now experiencing hair loss even more this morning, whole braid came out/having with my hair loss/ Now I am Balded from left, middle, and on the right side of my head; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (now experiencing hair loss even more this morning, whole braid came out/having with my hair loss/ Now I am Balded from left, middle, and on the right side of my head) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Nose swipe) on 05-Jun-2021. Concurrent medical conditions included Rheumatoid arthritis since 06-Aug-2021, Pre-diabetic since 12-Sep-2015, Allergic reaction to drug (Steglatro), Allergic reaction to drug (Hydroxychloroquine), Allergic reaction to drug (Fenofibrate) and Blood pressure high since 12-Sep-2015. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ) from 12-Sep-2015 to an unknown date for Blood pressure high, AMITRIPTYLINE from 15-Sep-2016 to an unknown date for Hypertension, PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, METFORMIN from 12-Sep-2015 to an unknown date for Pre-diabetic, LEFLUNOMIDE from 06-Aug-2021 to an unknown date for Rheumatoid arthritis, COLECALCIFEROL (VITAMIN D3), CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), BIOTIN and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 13-Dec-2021 at 1:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2021, the patient experienced ALOPECIA (now experiencing hair loss even more this morning, whole braid came out/having with my hair loss/ Now I am Balded from left, middle, and on the right side of my head). At the time of the report, ALOPECIA (now experiencing hair loss even more this morning, whole braid came out/having with my hair loss/ Now I am Balded from left, middle, and on the right side of my head) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient experiencing hair loss. She started noticing it a couple of days ago and even more in the morning on the day of reporting. Her natural hair was braided. Her whole braid came out.  No treatment information details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2021: Significant Follow Up received updated Patient demographic information and History conditions, Concomitant medication dose details, Anatomical location, AE onset date Updated.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Pruritus, Skin burning sensation, Urticaria
Clinical narrative: 18-20 hours later my skin start itching; burning again; I have achy joint on wrist; I have non-stop hives everyday (all over the body, especially where I scratched, down my feet and wrist); This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (18-20 hours later my skin start itching), SKIN BURNING SENSATION (burning again), URTICARIA (I have non-stop hives everyday (all over the body, especially where I scratched, down my feet and wrist)) and ARTHRALGIA (I have achy joint on wrist) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 046821A and 047AZ1A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (I have non-stop hives everyday (all over the body, especially where I scratched, down my feet and wrist)). On an unknown date, the patient experienced PRURITUS (18-20 hours later my skin start itching), SKIN BURNING SENSATION (burning again) and ARTHRALGIA (I have achy joint on wrist). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (18-20 hours later my skin start itching), SKIN BURNING SENSATION (burning again) and ARTHRALGIA (I have achy joint on wrist) outcome was unknown and URTICARIA (I have non-stop hives everyday (all over the body, especially where I scratched, down my feet and wrist)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative (Negative) negative to all bloodwork.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient takes antihistamine (Zyrtec) everyday. Patient had been to doctor's office twice and this is the first time patient had hives.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Influenza like illness, Pain, Pyrexia
Clinical narrative: feeling sick after second dose; achy after second dose; flu-like symptoms after second dose; tired after second dose; fever after second dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feeling sick after second dose), PAIN (achy after second dose), INFLUENZA LIKE ILLNESS (flu-like symptoms after second dose), FATIGUE (tired after second dose) and PYREXIA (fever after second dose) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 026C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (feeling sick after second dose), PAIN (achy after second dose), INFLUENZA LIKE ILLNESS (flu-like symptoms after second dose), FATIGUE (tired after second dose) and PYREXIA (fever after second dose). At the time of the report, ILLNESS (feeling sick after second dose), PAIN (achy after second dose), INFLUENZA LIKE ILLNESS (flu-like symptoms after second dose), FATIGUE (tired after second dose) and PYREXIA (fever after second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 antibody test: positive (Positive) COVID in Oct 2020.         Concomitant medication was not provided.  Treatment information was not provided.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: feeling sick after second dose; achy after second dose; flu-like symptoms after second dose; tired after second dose; fever after second dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feeling sick after second dose), PAIN (achy after second dose), INFLUENZA LIKE ILLNESS (flu-like symptoms after second dose), FATIGUE (tired after second dose) and PYREXIA (fever after second dose) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 026C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (feeling sick after second dose), PAIN (achy after second dose), INFLUENZA LIKE ILLNESS (flu-like symptoms after second dose), FATIGUE (tired after second dose) and PYREXIA (fever after second dose). At the time of the report, ILLNESS (feeling sick after second dose), PAIN (achy after second dose), INFLUENZA LIKE ILLNESS (flu-like symptoms after second dose), FATIGUE (tired after second dose) and PYREXIA (fever after second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 antibody test: positive (Positive) COVID in Oct 2020.         Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Flared up drastically psoriasis after their 1st, 2nd, & booster doses; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Flared up drastically psoriasis after their 1st, 2nd, & booster doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (Flared up drastically psoriasis after their 1st, 2nd, & booster doses). At the time of the report, PSORIASIS (Flared up drastically psoriasis after their 1st, 2nd, & booster doses) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.    This case was linked to MOD-2021-432405, MOD-2021-432423 (Patient Link).   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: booster shot that turned out to be out of date; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster shot that turned out to be out of date) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A, 037K20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (booster shot that turned out to be out of date). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (booster shot that turned out to be out of date) had resolved.            No concomitant medications were reported.   It was reported that the booster dose was expired in Oct-2021.  No treatment details were reported.   This case was linked to  (Patient Link).