chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Injection site bruising, Injection site pain, Injection site pruritus
Clinical narrative: The next morning my eyes were sensitive to light and then I became more exhausted by the hour. Full body Aches set in, foggy head, headache. By around two I began running a light fever. By about 3 pm I felt overall horrible. By four-five I became incredibly nauseated and began vomiting about an hour later. I kept vomiting throughout the night until it was only acidic bile left. During this time I was burning up if I had even a sheet on my skin, but freezing if I didn?t. I was sweating late into the night.  Vomiting stopped around 3 am.   The next two days I managed rice, bananas and teaspoons of water but was always nauseated. Fever was gone, but headache and exhaustion remained.  Daily nausea finally began to wane and was replaced by heartburn and gross feeling in my throat for about two days. About a week and half after the shot I finally regained my energy and had no stomach issues. Two weeks after injection today- The injection site still is bruised and burns/itches from time to time lightly.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain, Photophobia, Pyrexia
Clinical narrative: The next morning my eyes were sensitive to light and then I became more exhausted by the hour. Full body Aches set in, foggy head, headache. By around two I began running a light fever. By about 3 pm I felt overall horrible. By four-five I became incredibly nauseated and began vomiting about an hour later. I kept vomiting throughout the night until it was only acidic bile left. During this time I was burning up if I had even a sheet on my skin, but freezing if I didn?t. I was sweating late into the night.  Vomiting stopped around 3 am.   The next two days I managed rice, bananas and teaspoons of water but was always nauseated. Fever was gone, but headache and exhaustion remained.  Daily nausea finally began to wane and was replaced by heartburn and gross feeling in my throat for about two days. About a week and half after the shot I finally regained my energy and had no stomach issues. Two weeks after injection today- The injection site still is bruised and burns/itches from time to time lightly.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: The next morning my eyes were sensitive to light and then I became more exhausted by the hour. Full body Aches set in, foggy head, headache. By around two I began running a light fever. By about 3 pm I felt overall horrible. By four-five I became incredibly nauseated and began vomiting about an hour later. I kept vomiting throughout the night until it was only acidic bile left. During this time I was burning up if I had even a sheet on my skin, but freezing if I didn?t. I was sweating late into the night.  Vomiting stopped around 3 am.   The next two days I managed rice, bananas and teaspoons of water but was always nauseated. Fever was gone, but headache and exhaustion remained.  Daily nausea finally began to wane and was replaced by heartburn and gross feeling in my throat for about two days. About a week and half after the shot I finally regained my energy and had no stomach issues. Two weeks after injection today- The injection site still is bruised and burns/itches from time to time lightly.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site pain
Clinical narrative: Raised pink patch approx 3x2? at injection site. Burning sensation. Lasted 5 days, but burning sensation stopped after 2 days.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: her uncle received an unknown shingles vaccination about a year ago and developed shingles; This spontaneous report was received from a consumer referring to a 92-year-old male patient. The patient's pertinent medical history, concomitant drugs and drug allergies were reported unknown. His historical vaccine included unspecified skin condition shingles vaccine in 2016.   In 2020, the patient was vaccinated with the first dose of zoster vaccine live (ZOSTAVAX) (dose, strength, frequency, route, lot number and expiration date were not reported) for prophylaxis.   In 2020, he got shingles after the first shot of zoster vaccine live (ZOSTAVAX). The action taken with zoster vaccine live (ZOSTAVAX) was not applicable. It was unknown if the patient sought medical attention and if he received any treatments. The outcome of shingles was not provided.   The causality assessment between shingles and zoster vaccine live (ZOSTAVAX) was not provided.
Sex: F
Vaccine: MMR
Symptoms: Adverse event
Clinical narrative: adverse event/side effects; This spontaneous report was received from a female patient of unknown age referring to herself. Her pertinent medical history, concomitant medications and drug reactions or allergies were unknown.  On an unknown date (reported as when being "much younger"), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, anatomical location, route of administration, lot # and expiration date were not reported) as prophylaxis. The patient reported having experienced adverse event/side effects on an unknown date but could not recall the side effects. The patient reported that her parents did not know how to report the side effects to the company. The outcome of the event was unknown.  The relatedness between the suspect therapy and the event was not provided.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No other information given at this time.; Medical assistant calls to report a temperature excursion/ The products were administered; This spontaneous report as received from a medical assistant, concerning a 12 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 07-JAN-2021, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S029457 with expiration date 19-SEP-2021 (dose, frequency, route and anatomical location were not provided) for prophylaxis. The excursion date was on 25-NOV-2020 with a temperature of 47.4 and duration of 1 hour and 20 minutes. No other information given at this time.  This is one of 25 reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA005178:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; an expired dose ofM-M-R II was inadvertently administered to a patient today; This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 14-APR-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S006051 with expiration date on 27-FEB-2021, therapy type: rHA (exact dose, route of administration were unknown) for prophylaxis. No adverse events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Broke out in rash under her breast / Rash Resolved; This case was reported by a physician via sales rep and described the occurrence of rash in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the physician for her mother. The age at vaccination was not reported. The patient received shingles vaccine last year and broke out in rash under her breast. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: accidentally gave just the adjuvant suspension. Did not mix.; accidentally gave just the adjuvant suspension. Did not mix.; This case was reported by a pharmacist and described the occurrence of inappropriate preparation of medication in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 16th September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. Medical associate accidentally gave just the adjuvant suspension to the patient and did not mix it with powder part, which led to inappropriate preparation of medication and inappropriate dose of vaccine administration. The reporter consent to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: A long time she fainted after a flu shot.; This case was reported by a consumer via licensee and described the occurrence of faint in a 52-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included post-traumatic stress disorder and sleep apnea. Concurrent medical conditions included epilepsy.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced faint (serious criteria GSK medically significant). On an unknown date, the outcome of the faint was unknown.   It was unknown if the reporter considered the faint to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, a long time she was fainted after the flu shot. No further information was available.
Sex: M
Vaccine: MEN
Symptoms: Gait inability, Myelitis transverse, Paralysis, Seizure
Clinical narrative: almost dies becomes paralyzed for over one year; seizures; has to live with Transverse myelitis for the rest of their life; has to relearn to walk again; This case was reported by a consumer via  interactive digital media and described the occurrence of paralysis 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 paralysis (serious criteria GSK medically significant and life threatening), seizure (serious criteria GSK medically significant), myelitis transverse (serious criteria GSK medically significant) and unable to walk. On an unknown date, the outcome of the paralysis and unable to walk were unknown and the outcome of the seizure and myelitis transverse were not recovered/not resolved.   The reporter considered the paralysis, seizure, myelitis transverse and unable to walk to be related to Meningococcal B vaccine.  Additional details were provided as follows: The reporter was patient's wife. The age at vaccination was not reported. The reporter said it was hard to forget that the patient was perfectly healthy before the vaccine got the said life saving vaccine and almost died and became paralyzed for over one year and had to relearn to walk again. The patient had seizures and had to live with transverse myelitis for the rest of their life.  Also the patient would not be allowed anymore vaccines because they could kill him and patient's kids can't have them either because of the patient's reaction.  The reporter commented one size does not fit all and guess you may have forgotten that.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: received 4 doses of Shingrix /second dose given 14Apr2021; received 4 doses of Shingrix / first dose in second series was given 14Nov2020; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 28th August 2019) and Shingrix (2n dose received on 24th January 2020).   On 14th April 2021, the patient received the 4th dose of Shingrix. On 14th November 2020, the patient received the 3rd dose of Shingrix. On 14th November 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced extra dose administered. On 14th April 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.  Additional details were reported as follows: The patient received 3rd and 4th dose of Shingrix, which led to extra dose administered. The reporter consented to follow up via email. No other information provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received the first dose of Shingrix a year ago and has not received the second dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received a year before 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 age at vaccination was not applicable for this report. The age group was not reported but it was selected as an adult as per vaccine indication. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: given a 3rd dose of Havrix on 16Mar2021; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 12-year-old female patient who received HAV (Havrix) (batch number B23EA, expiry date 15th May 2022) for prophylaxis.   Previously administered products included Havrix (received 1st dose on an unknown date) and Havrix (received 2n dose on an unknown date).   On 16th March 2021, the patient received the 3rd dose of Havrix. On 16th March 2021, unknown after receiving Havrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional details was reported as follows: The patient was accidentally given 3rd dose of Havrix, which led to extra dose administered. No symptoms were reported. The reporter consented to follow up. This case is linked with case US2021085461, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021085461:same reporter
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Accidental overdose, Extra dose administered
Clinical narrative: given a 3rd dose of Havrix on 16Mar2021; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 10-year-old female patient who received HAV (Havrix) (batch number B23EA, expiry date 15th May 2022) for prophylaxis.   Previously administered products included Havrix (received 1st dose on an unknown date) and Havrix (received 2nd dose on an unknown date).   On 16th March 2021, the patient received the 3rd dose of Havrix. On 16th March 2021, unknown after receiving Havrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details was reported as follows: The patient was accidentally given 3rd dose of Havrix, which led to extra dose administered. No symptoms were reported. The reporter consented to follow up. This case is linked with case US2021085460, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021085460:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the first dose / in August 2020/ had not received dose two of Shingrix; This case was reported by a physician and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2020). Concomitant products included TOZINAMERAN (PFIZER COVID-19 VACCINE (BNT162B2)).   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 provided as follows: The age at vaccination was not applicable to this report. A patient roughly in his late sixties, received the first dose of Shingrix. In this patient, COVID vaccination was prioritized, the last dose of Pfizer´s vaccine was administered a week before this report.  The patient had not received the 2nd dose of Shingrix, which led to incomplete course of vaccination  No further information reported. Reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2018069003:same reporter
Sex: U
Vaccine: HEPA
Symptoms: Allergy test, Off label use
Clinical narrative: Havrix being used for skin allergy testing / prior to administration of COVID vaccines; This case was reported by a pharmacist via call center representative and described the occurrence of off label use in an unspecified number of patients who received HAV (Havrix 1440 adult) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th April 2021, the patient received Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 15th April 2021, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced off label use. On an unknown date, the outcome of the off label use 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 age at vaccination was not applicable for this report. Pharmacist reported that Havrix being used for skin allergy testing on adults prior to administration of COVID vaccines, which led to off label use.  Testing was done for polysorbate 20 allergies in adult patients.  No further information reported. Reporter consented to follow up
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: dose one of Shingrix in Spring 2019 / not yet had dose 2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in spring 2019).   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 provided as follows: The reporter reported for himself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No address available at time of the report. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st Shingrix in May 2018 / 2nd dose on February 3, 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 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in May 2018).   On 3rd February 2021, the patient received the 2nd dose of Shingrix. On 3rd February 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 2nd dose of Shingrix later than recommended schedule, which led to lengthening of the vaccination schedule. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received her first Shingrix shot on 22 OCT 2019 / has not received her second shot yet.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 22nd October 2019).   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 provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive the 2nd dose of vaccination, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Paraesthesia, Swelling
Clinical narrative: TINGLING OF THE LEFT LEG; SWELLING; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit usage of drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced soreness at injection site. On 12-APR-2021, the subject experienced tingling of the left leg. On 12-APR-2021, the subject experienced swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling of the left leg, and swelling, and the outcome of soreness at injection site was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Pain in extremity
Clinical narrative: UNABLE TO MOVE ARM; SORE ARM GETTING WORSE AND WORSE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety, alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. Concomitant medications included fluoxetine for anxiety.  On 13-MAR-2021, the subject experienced sore arm getting worse and worse. On an unspecified date, the subject experienced unable to move arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm getting worse and worse, and the outcome of unable to move arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Diarrhoea, Feeling abnormal
Clinical narrative: INJECTION SITE LUMP\KNOT; VOMITING; DIARRHEA; CHEST PAIN/SORENESS; FELT BAD; COLD; PAIN IN ARM; FLU-LIKE SYMPTOMS; BODYACHE; CHILLS; This spontaneous report received from a consumer concerned a 30 year old female. The patient's weight was 125 pounds, and height was not reported.  The patient's concurrent conditions included supraventricular tachycardia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced flu-like symptoms. On 10-APR-2021, the subject experienced bodyache. On 10-APR-2021, the subject experienced felt bad. On 10-APR-2021, the subject experienced cold. On 10-APR-2021, the subject experienced pain in arm. On 11-APR-2021, the subject experienced vomiting. On 11-APR-2021, the subject experienced diarrhea. On 11-APR-2021, the subject experienced chest pain/soreness. Laboratory data included: Body temperature (NR: not provided) 80 F. On an unspecified date, the subject experienced injection site lump\knot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and diarrhea, had not recovered from injection site lump\knot, and the outcome of chills, flu-like symptoms, bodyache, pain in arm, chest pain/soreness, cold and felt bad was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site mass, Nasopharyngitis, Pain, Pain in extremity
Clinical narrative: INJECTION SITE LUMP\KNOT; VOMITING; DIARRHEA; CHEST PAIN/SORENESS; FELT BAD; COLD; PAIN IN ARM; FLU-LIKE SYMPTOMS; BODYACHE; CHILLS; This spontaneous report received from a consumer concerned a 30 year old female. The patient's weight was 125 pounds, and height was not reported.  The patient's concurrent conditions included supraventricular tachycardia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced flu-like symptoms. On 10-APR-2021, the subject experienced bodyache. On 10-APR-2021, the subject experienced felt bad. On 10-APR-2021, the subject experienced cold. On 10-APR-2021, the subject experienced pain in arm. On 11-APR-2021, the subject experienced vomiting. On 11-APR-2021, the subject experienced diarrhea. On 11-APR-2021, the subject experienced chest pain/soreness. Laboratory data included: Body temperature (NR: not provided) 80 F. On an unspecified date, the subject experienced injection site lump\knot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and diarrhea, had not recovered from injection site lump\knot, and the outcome of chills, flu-like symptoms, bodyache, pain in arm, chest pain/soreness, cold and felt bad was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: INJECTION SITE LUMP\KNOT; VOMITING; DIARRHEA; CHEST PAIN/SORENESS; FELT BAD; COLD; PAIN IN ARM; FLU-LIKE SYMPTOMS; BODYACHE; CHILLS; This spontaneous report received from a consumer concerned a 30 year old female. The patient's weight was 125 pounds, and height was not reported.  The patient's concurrent conditions included supraventricular tachycardia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced flu-like symptoms. On 10-APR-2021, the subject experienced bodyache. On 10-APR-2021, the subject experienced felt bad. On 10-APR-2021, the subject experienced cold. On 10-APR-2021, the subject experienced pain in arm. On 11-APR-2021, the subject experienced vomiting. On 11-APR-2021, the subject experienced diarrhea. On 11-APR-2021, the subject experienced chest pain/soreness. Laboratory data included: Body temperature (NR: not provided) 80 F. On an unspecified date, the subject experienced injection site lump\knot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and diarrhea, had not recovered from injection site lump\knot, and the outcome of chills, flu-like symptoms, bodyache, pain in arm, chest pain/soreness, cold and felt bad was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: RASH ON ANKLES, FEET AND LOWER LEGS; HIVES ON ANKLES,FEET AND LOWER LEGS; This spontaneous report received from a patient concerned a female of unspecified age. 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 admin not reported, batch number: Unknown) dose, start therapy date were not reported 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 subject experienced rash on ankles, feet and lower legs, and hives on ankles, feet and lower legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives on ankles,feet and lower legs, and rash on ankles, feet and lower legs. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lip blister, Lip discolouration, Lip pain, Lip swelling
Clinical narrative: LIP SWOLLEN; LIP BLISTERED; LIP SORENESS AND  SENSITIVITY; LIP DISCOLORATION; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included swelling of full face, and swelling of neck, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced lip swollen. On 30-MAR-2021, the subject experienced lip blistered. On 30-MAR-2021, the subject experienced lip soreness and sensitivity. On 30-MAR-2021, the subject experienced lip discoloration. Treatment medications (dates unspecified) included: menthol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lip swollen, lip blistered, lip soreness and sensitivity, and lip discoloration. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dizziness, Pain, Pyrexia
Clinical narrative: BODY ACHES; LIGHT HEADEDNESS; STOMACH ACHE; CHILLS; LOW GRADE FEVER; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no medication allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced body aches, light headedness, stomach ache, chills, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever, chills, body aches, light headedness and stomach ache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PAIN IN ARM; This spontaneous report received from a consumer concerned a male of unspecified age. 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 admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for the case. No concomitant medications were reported.  On an unspecified date, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain in arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Oropharyngeal pain, Pain
Clinical narrative: SORE THROAT; FELT LITTLE SLOWER THAN NORMAL; BODY ACHES; This spontaneous report received from a patient concerned a female of unspecified age. 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 admin not reported, batch number: Unk) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced felt little slower than normal. On 14-APR-2021, the subject experienced sore throat. Laboratory data included: Body temperature (NR: not provided) 99.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt little slower than normal on 07-APR-2021, had not recovered from body aches, and the outcome of sore throat was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age. 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 admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced tight chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tight chest was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vomiting
Clinical narrative: Fever,vomit,chills,headache
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Taste disorder
Clinical narrative: Altered sense of taste to foods some worse than others  .  Taste of some foods so bad causing gagging and unable to swallow the food.   This lasted for 4 weeks and slowly improved over time .  Sense of smell not affected..  lost weight as not able to eat much
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a health care professional concerned a 54 year old male. The patient's height, and weight were not reported. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced body aches. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, and headache on 26-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210429909.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Blood test, Chest X-ray, Chest pain
Clinical narrative: On day 6 (4/12) I experience the following: Coughing, Aches all over, breathing issues and chest pain, hot flashes (NO fever), light headed, foggy head/concentration issues, fatigue, diarrhea, upset stomach/cramps, headache On day 11 (4/17) I experience EXTREME fatigue, headache and foggy head. Slept for over 12 consecutive hours. Aches persisted since day 1 (cleared up on day 12).  Cough ing and breathing issues and chest pain when coughing have persisted since day 3 and have not cleared up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Dizziness, Dyspnoea, Fatigue
Clinical narrative: On day 6 (4/12) I experience the following: Coughing, Aches all over, breathing issues and chest pain, hot flashes (NO fever), light headed, foggy head/concentration issues, fatigue, diarrhea, upset stomach/cramps, headache On day 11 (4/17) I experience EXTREME fatigue, headache and foggy head. Slept for over 12 consecutive hours. Aches persisted since day 1 (cleared up on day 12).  Cough ing and breathing issues and chest pain when coughing have persisted since day 3 and have not cleared up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hot flush, Pain
Clinical narrative: On day 6 (4/12) I experience the following: Coughing, Aches all over, breathing issues and chest pain, hot flashes (NO fever), light headed, foggy head/concentration issues, fatigue, diarrhea, upset stomach/cramps, headache On day 11 (4/17) I experience EXTREME fatigue, headache and foggy head. Slept for over 12 consecutive hours. Aches persisted since day 1 (cleared up on day 12).  Cough ing and breathing issues and chest pain when coughing have persisted since day 3 and have not cleared up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities, Musculoskeletal stiffness
Clinical narrative: Since my 2nd  pfizer covid vaccine, Ive had joint pain and stiffness in my left shoulder where administered. I expected it to lessen over the weeks but it is slowly becoming worse,  The pain makes it difficult to do daily activities some days and causes me to take ibuprofen every day which does help temporarily.  I've waited to report this because its not a severe or life threatening  reaction, and I wanted to see if it got better.  Please advise if I should be concerned about this.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: developed shingles around 8/9 days after vaccination. shingles on right lower back. currently still have.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope
Clinical narrative: THE PATIENT WAS SEATED IN THE LOBBY AFTER HIS IMMUNIZATION.  HE THEN  SAW A PATIENT FAINTED AND IMMEDIATELY PASSED OUT ALSO. PARAMEDICAS WERE CALLED AND AFTER EXAMINATION THEY TOOK HIM TO THE HOSPITAL
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: Feeling inner ear pressure/ feeling clogged, which is now ringing in both my ears.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Paraesthesia, Pruritus, Rash erythematous
Clinical narrative: Around 11:10 am, my neck became itchy and then began tingling. I looked in the mirror and my neck and face were flushed. Within the next few moments, I then felt warm sensations on my arms and legs, and upon looking at them, I noticed red rashes around my elbows and knees. After about 2 hours, the rashes had gone away on their own.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling hot, Paraesthesia, Pruritus, Rash erythematous
Clinical narrative: Around 11:10 am, my neck became itchy and then began tingling. I looked in the mirror and my neck and face were flushed. Within the next few moments, I then felt warm sensations on my arms and legs, and upon looking at them, I noticed red rashes around my elbows and knees. After about 2 hours, the rashes had gone away on their own.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Cellulitis from 2nd injection
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Rheumatoid arthritis
Clinical narrative: Both of my little fingers started cramping and my hands look like I have broken little fingers or rheumatoid arthritis. I don't have RA.  Also my right big toe area and down into my middle of my right foot started cramping.  I received the vaccine at 2:16pm today and this started t 5:03 pm. I drank about 6 ounces of powerade and took 1/2 tablet of potassium.  I thought the magnesium in the powerade and maybe the potassium would help reduce the cramping. Also, massaged the 3 areas and reduced the cramping. It came back around 6 pm and it's now 7 pm and it feels like I could set it off to cramp if I move wrong by accident.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: BRUISE ON LEFT ARM; This spontaneous report received from a patient concerned a 49 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 admin not reported, batch number: Unknown) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 15-APR-2021, the subject experienced bruise on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruise on left arm. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anal incontinence, Arthralgia, Asthenia, Axillary pain
Clinical narrative: On Saturday, 11 hours (10:30pm) after the injection my arm was extremely sore. There was a sharp pain in my underarm whenever I tried to move it. On Sunday morning, 19 hours  (6:21am) after my injection I experienced severe stomach cramps they woke me up out of my sleep. These stomach pains were constant ranging from a pain of 6 to 9.  I threw up three times. Each time I vomited was preceded by stomachaches that reach up to a 9. Each time was hours apart. I was extremely hot so I needed the turn the AC on and I slept in front of a fan. Sometimes I put on a cool rag on my face. At night around 8pm. I started having diarrhea.  Whenever I had to go I would have severe stomachaches at a 9. Sometimes I would have to vomit while have an episode of diarrhea. During the day I had back, and hip pain that made me constantly toss from one side to the other to get comfortable. Day 2 (Monday), the cramps lessoned they ranged from a 2-4 on average. They were not as constant. I was still hot but not like on day one. I kept the house cold but I could sleep without the additional fan. I no longer had explosive diarrhea however I did have to wear a pad. I continued to leak. Which is something I've never experienced before. Day 2 I still had very low energy. Day 3. I feel a lot better. I have occasional cramps and still occasional leaking. My energy is better but still lower than my usual.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Feeling hot, Pain in extremity, Sleep disorder
Clinical narrative: On Saturday, 11 hours (10:30pm) after the injection my arm was extremely sore. There was a sharp pain in my underarm whenever I tried to move it. On Sunday morning, 19 hours  (6:21am) after my injection I experienced severe stomach cramps they woke me up out of my sleep. These stomach pains were constant ranging from a pain of 6 to 9.  I threw up three times. Each time I vomited was preceded by stomachaches that reach up to a 9. Each time was hours apart. I was extremely hot so I needed the turn the AC on and I slept in front of a fan. Sometimes I put on a cool rag on my face. At night around 8pm. I started having diarrhea.  Whenever I had to go I would have severe stomachaches at a 9. Sometimes I would have to vomit while have an episode of diarrhea. During the day I had back, and hip pain that made me constantly toss from one side to the other to get comfortable. Day 2 (Monday), the cramps lessoned they ranged from a 2-4 on average. They were not as constant. I was still hot but not like on day one. I kept the house cold but I could sleep without the additional fan. I no longer had explosive diarrhea however I did have to wear a pad. I continued to leak. Which is something I've never experienced before. Day 2 I still had very low energy. Day 3. I feel a lot better. I have occasional cramps and still occasional leaking. My energy is better but still lower than my usual.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: On Saturday, 11 hours (10:30pm) after the injection my arm was extremely sore. There was a sharp pain in my underarm whenever I tried to move it. On Sunday morning, 19 hours  (6:21am) after my injection I experienced severe stomach cramps they woke me up out of my sleep. These stomach pains were constant ranging from a pain of 6 to 9.  I threw up three times. Each time I vomited was preceded by stomachaches that reach up to a 9. Each time was hours apart. I was extremely hot so I needed the turn the AC on and I slept in front of a fan. Sometimes I put on a cool rag on my face. At night around 8pm. I started having diarrhea.  Whenever I had to go I would have severe stomachaches at a 9. Sometimes I would have to vomit while have an episode of diarrhea. During the day I had back, and hip pain that made me constantly toss from one side to the other to get comfortable. Day 2 (Monday), the cramps lessoned they ranged from a 2-4 on average. They were not as constant. I was still hot but not like on day one. I kept the house cold but I could sleep without the additional fan. I no longer had explosive diarrhea however I did have to wear a pad. I continued to leak. Which is something I've never experienced before. Day 2 I still had very low energy. Day 3. I feel a lot better. I have occasional cramps and still occasional leaking. My energy is better but still lower than my usual.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, Catheterisation cardiac normal, Chest pain, Echocardiogram normal, Electrocardiogram abnormal
Clinical narrative: Young healthy patient presented with chest pain starting 3 days after vaccine. Profoundly abnormal EKG and marked troponin elevation. Workup consistent with acute myocarditis of unclear etiology.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Red blood cell sedimentation rate normal, Troponin increased
Clinical narrative: Young healthy patient presented with chest pain starting 3 days after vaccine. Profoundly abnormal EKG and marked troponin elevation. Workup consistent with acute myocarditis of unclear etiology.