chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Eye swelling, Fatigue, Feeling abnormal, Flank pain
Clinical narrative: Red swollen/itchy eyes- first symptom started before I left the clinic. Brain fog, pain in lower right side, throwing up, dizziness- all these symptoms began within an hour after receiving the vaccine. Went to bed, woke up at 1 in the morning with a feeling like I was shaking so badly that I couldn't fully expand my lungs to breathe, extreme dizziness, and a weak, fluttery heartbeat. Went back to bed, awoke with a pounding headache, dizziness still present but not as extreme, very nauseous, had strange heartbeat episodes throughout the day, coughing, dizziness subsided about 24 hours after vaccination, headache lessened but took longer to mostly go away, one more shaking incident happened at 9:30 am 8/13 lasted about fifteen minutes but without the breathing issues and dizziness,48 hours after vaccination heartbeat episodes have stopped and most issues are gone expect for fatigue, nausea, and the sore arm.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Nervousness, Ocular hyperaemia, Pain in extremity
Clinical narrative: Red swollen/itchy eyes- first symptom started before I left the clinic. Brain fog, pain in lower right side, throwing up, dizziness- all these symptoms began within an hour after receiving the vaccine. Went to bed, woke up at 1 in the morning with a feeling like I was shaking so badly that I couldn't fully expand my lungs to breathe, extreme dizziness, and a weak, fluttery heartbeat. Went back to bed, awoke with a pounding headache, dizziness still present but not as extreme, very nauseous, had strange heartbeat episodes throughout the day, coughing, dizziness subsided about 24 hours after vaccination, headache lessened but took longer to mostly go away, one more shaking incident happened at 9:30 am 8/13 lasted about fifteen minutes but without the breathing issues and dizziness,48 hours after vaccination heartbeat episodes have stopped and most issues are gone expect for fatigue, nausea, and the sore arm.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Red swollen/itchy eyes- first symptom started before I left the clinic. Brain fog, pain in lower right side, throwing up, dizziness- all these symptoms began within an hour after receiving the vaccine. Went to bed, woke up at 1 in the morning with a feeling like I was shaking so badly that I couldn't fully expand my lungs to breathe, extreme dizziness, and a weak, fluttery heartbeat. Went back to bed, awoke with a pounding headache, dizziness still present but not as extreme, very nauseous, had strange heartbeat episodes throughout the day, coughing, dizziness subsided about 24 hours after vaccination, headache lessened but took longer to mostly go away, one more shaking incident happened at 9:30 am 8/13 lasted about fifteen minutes but without the breathing issues and dizziness,48 hours after vaccination heartbeat episodes have stopped and most issues are gone expect for fatigue, nausea, and the sore arm.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dizziness, Dry mouth, Fatigue, Headache
Clinical narrative: Received 1st shot, experienced headache, dizziness, fatigue, dry mouth, and knee joint pain in my left knee. Headache, Dizziness, fatigue, and dry mouth went away after a couple days but knee joint pain persists. It is now painful to place my weight on my left knee. Received 2nd dose today also mild headache, experienced shakiness and loss of balance, and dry mouth but expecting those symptoms to subside after a few days. Knee pain persists.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Tremor, Weight bearing difficulty
Clinical narrative: Received 1st shot, experienced headache, dizziness, fatigue, dry mouth, and knee joint pain in my left knee. Headache, Dizziness, fatigue, and dry mouth went away after a couple days but knee joint pain persists. It is now painful to place my weight on my left knee. Received 2nd dose today also mild headache, experienced shakiness and loss of balance, and dry mouth but expecting those symptoms to subside after a few days. Knee pain persists.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: Extreme soreness at injection site, headache
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Feeling cold, Flushing, Rash
Clinical narrative: Flush feeling and rash started on chest and moved to top of head, Blood pressure 180/110, heart rate 120's. Trouble swallowing and icy cold feeling in right axillary. Swallowing issues lasted almost an entire week. Received Benadryl, steroid, and Pepcid in ER.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Attention deficit hyperactivity disorder, Confusional state, Dyspnoea, Panic attack
Clinical narrative: Anxiety, panic attacks, difficulty breathing, tension in neck and head, confusion, attention difficulty
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Tension
Clinical narrative: Anxiety, panic attacks, difficulty breathing, tension in neck and head, confusion, attention difficulty
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: HIGH FREQUENCY RINGING IN EARS (OR IN HEAD), IT HAS BEEN 24 HR A DAY, EVERY SINGLE DAY SINCE LAST DOSE OF VACCINE
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 08/5/21: Usual symptoms of low grade fever, generalized weakness, soreness in arm of injection 08/06/21: Arrived at work (7PM to 7AM). Around 0300 AM noticed itching, redness, swollen, and extremely painful at and around the injection site. Upper arm was swollen and warm to touch. 08/07/21: After leaving work went to Urgent Care and saw medical professional for allergic reaction. Stated that it appeared warm, red, swollen and possible cellulitis. Was given IM injection of Rocephine and Solumedrol. Also given doxycycline 100 mg x 20 pills and fluconazole 150 mg x 2. Was instructed to us ice packs and was given excuse to return to work on 08/10/21.      Notified supervisor of work provisions. 08/10/21: Visit with primary physician to follow up on reaction to Covid 19 vaccine and increase in leg weakness and small tremor development. Was given Dexamethasone 2 mg tablets with 10 tablets to suppress my overactive immune symptoms. Noted leg weakness and overall general weakness. Also measured the area of injection and swelling and redness and heat noticed. Requested use ice packs for pain. Was given a notice for work absence and to return 08/17/21. 08/12/21: Notified employee health of reaction and filled out paper work for Workmen's Compensation. Was sent to Occupational Health for evaluation for Workmen's Compensation. Saw provider NP. Noted the area was still warm to touch with redness. Requested use warm packs for comfort. Was given notice to return to work 08/13/21 to unrestricted duties. Have Follow up appointed Monday 08/16/21 with medical profession and primary physician
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Muscular weakness, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: 08/5/21: Usual symptoms of low grade fever, generalized weakness, soreness in arm of injection 08/06/21: Arrived at work (7PM to 7AM). Around 0300 AM noticed itching, redness, swollen, and extremely painful at and around the injection site. Upper arm was swollen and warm to touch. 08/07/21: After leaving work went to Urgent Care and saw medical professional for allergic reaction. Stated that it appeared warm, red, swollen and possible cellulitis. Was given IM injection of Rocephine and Solumedrol. Also given doxycycline 100 mg x 20 pills and fluconazole 150 mg x 2. Was instructed to us ice packs and was given excuse to return to work on 08/10/21.      Notified supervisor of work provisions. 08/10/21: Visit with primary physician to follow up on reaction to Covid 19 vaccine and increase in leg weakness and small tremor development. Was given Dexamethasone 2 mg tablets with 10 tablets to suppress my overactive immune symptoms. Noted leg weakness and overall general weakness. Also measured the area of injection and swelling and redness and heat noticed. Requested use ice packs for pain. Was given a notice for work absence and to return 08/17/21. 08/12/21: Notified employee health of reaction and filled out paper work for Workmen's Compensation. Was sent to Occupational Health for evaluation for Workmen's Compensation. Saw provider NP. Noted the area was still warm to touch with redness. Requested use warm packs for comfort. Was given notice to return to work 08/13/21 to unrestricted duties. Have Follow up appointed Monday 08/16/21 with medical profession and primary physician
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Tremor
Clinical narrative: 08/5/21: Usual symptoms of low grade fever, generalized weakness, soreness in arm of injection 08/06/21: Arrived at work (7PM to 7AM). Around 0300 AM noticed itching, redness, swollen, and extremely painful at and around the injection site. Upper arm was swollen and warm to touch. 08/07/21: After leaving work went to Urgent Care and saw medical professional for allergic reaction. Stated that it appeared warm, red, swollen and possible cellulitis. Was given IM injection of Rocephine and Solumedrol. Also given doxycycline 100 mg x 20 pills and fluconazole 150 mg x 2. Was instructed to us ice packs and was given excuse to return to work on 08/10/21.      Notified supervisor of work provisions. 08/10/21: Visit with primary physician to follow up on reaction to Covid 19 vaccine and increase in leg weakness and small tremor development. Was given Dexamethasone 2 mg tablets with 10 tablets to suppress my overactive immune symptoms. Noted leg weakness and overall general weakness. Also measured the area of injection and swelling and redness and heat noticed. Requested use ice packs for pain. Was given a notice for work absence and to return 08/17/21. 08/12/21: Notified employee health of reaction and filled out paper work for Workmen's Compensation. Was sent to Occupational Health for evaluation for Workmen's Compensation. Saw provider NP. Noted the area was still warm to touch with redness. Requested use warm packs for comfort. Was given notice to return to work 08/13/21 to unrestricted duties. Have Follow up appointed Monday 08/16/21 with medical profession and primary physician
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Pain in extremity
Clinical narrative: Sweating in night; Having painful arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating in night), PAIN IN EXTREMITY (Having painful arm) and FATIGUE (Fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating in night), PAIN IN EXTREMITY (Having painful arm) and FATIGUE (Fatigue). At the time of the report, HYPERHIDROSIS (Sweating in night), PAIN IN EXTREMITY (Having painful arm) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that all symptoms went away in couple of days.  Concomitant medications were not reported.  No treatment details were provided   This case was linked to MOD-2021-074734 (Patient Link).
Sex: U
Vaccine: HPV9, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Patient was administered Improperly stored GARDASIL 9; This spontaneous report was received from a registered nurse and refers a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 07-AUG-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # 1687292 was confirmed to be valid, expiration date 25-AUG-2022, (dose, route and site of administration were not reported) for prophylaxis. The administered dose was exposed to the temperature of 1.53 degrees Celsius (C) for 30 minutes. The previous temperature excursions were reported as 1.29 C for 45 minutes, 1.43 C for 45 minutes and 1.38 C for 45 minutes. No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Wasn't able to get second dose/ NOBODY had it; This case was reported by a consumer via interactive digital media and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about 2 years ago from  the date of reporting on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that, did not receive 2nd dose of Shingrix as nobody had it, which led to product supply issue. The reporter stated that, it had been almost 2 years and doctor said that could just get 2nd dose but did not need to start over.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose in January 2021, can i still get dose #2?; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 22nd January 2021).   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 was the patient. 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. The reporter wanted to know if could still get 2nd dose of Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain, Pain, Rash, Skin weeping
Clinical narrative: suspected vaccination failure; My Mom had shingles; Shot was mildly painful; Covered with oozing rashes / couldn't even wear a light shirt; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and rash. On an unknown date, the outcome of the vaccination failure, shingles, pain and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine.  Additional details provided were as follows: Age at vaccination was not reported. The reporter was the patient's daughter/son. The patient received the Shingles shot which was midly painful and experienced Shingles.The patient was covered with oozing rashes front and back and could not even wear a light shirt but put a towel in the elastic waistband of her slacks. The reporter visited the patient daily to make sure that she had at least one or two meals. Follow-up was not possible as no contact details available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: suspected vaccination failure; My Mom had shingles; Shot was mildly painful; Covered with oozing rashes / couldn't even wear a light shirt; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and rash. On an unknown date, the outcome of the vaccination failure, shingles, pain and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine.  Additional details provided were as follows: Age at vaccination was not reported. The reporter was the patient's daughter/son. The patient received the Shingles shot which was midly painful and experienced Shingles.The patient was covered with oozing rashes front and back and could not even wear a light shirt but put a towel in the elastic waistband of her slacks. The reporter visited the patient daily to make sure that she had at least one or two meals. Follow-up was not possible as no contact details available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose/04-Jan-2019/not received dose two.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th January 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 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with cases US2021168350, US2020079556, US2019096333, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168350:Same reporter US-GLAXOSMITHKLINE-US2020079556:Same reporter US-GLAXOSMITHKLINE-US2019096333:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose/3 years ago, never received the 2nd dose; This case was reported by a pharmacist 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 (1st dose received 3 years ago on an unknown date).   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 pro vided as follows: 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 vaccine details were available. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose/8 months ago.; This case was reported by a pharmacist 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 (1st dose received 8 months 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 provided as follows: 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. The reporter consented to follow up. This case was linked with case US2021168360, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168360:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose / on 14Aug2019 and has not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 14th 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 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 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. The VAERS details were reported for 1st dose of Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via eye contact
Clinical narrative: accidentally get Shringrix in her eye; accidentally get Shringrix in her eye; This case was reported by a nurse via call center representative and described the occurrence of accidental occupational exposure to product in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced accidental occupational exposure to product and exposure via eye contact. On an unknown date, the outcome of the accidental occupational exposure to product and exposure via eye contact were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that their colleague accidentally exposed to Shringrix in her eye, which led to accidental occupational exposure to product and exposure via eye contact. The patient used the eye wash station. The reporter enquired if there was any other recommendations. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose given 08/2019. Second dose not yet given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (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 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 2nd dose of Shingrix, which led to incomplete course of vaccination. The pharmacist did not wish to disclose adverse event information. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Rash
Clinical narrative: received the 1st dose / developed shingles 3 weeks later; rash on abdomen to her back; 1st dose of Shingrix on 30Mar2019 / is late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 4X733, expiry date 8th March 2020) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 30th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 weeks after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, rash and incomplete course of vaccination. On an unknown date, the outcome of the shingles, rash and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details provided were as follows: The age at vaccination for 1st dose was not provided but it could be 79 or 80 years and it was not applicable for this report. The patient received the 1st dose of Shingrix and experienced shingles 3 weeks later, no pain but rash was on abdomen to her back. The patient was late for the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Injection site swelling, Myalgia
Clinical narrative: swelling at injection site; muscle pain; fever; headache; shivering; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th August 2021, the patient received the 1st dose of Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced injection site swelling, muscle pain, headache, shivering and upset stomach. On an unknown date, the patient experienced fever. On an unknown date, the outcome of the injection site swelling, muscle pain, fever, headache, shivering and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, muscle pain, fever, headache, shivering and upset stomach to be related to Shingrix.  Additional case details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got her 1st Shingrix shot on Sunday.  The patient developed swelling at injection site, muscle pain, headache, shivering, upset stomach and fever, which had not resolved. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: swelling at injection site; muscle pain; fever; headache; shivering; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th August 2021, the patient received the 1st dose of Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced injection site swelling, muscle pain, headache, shivering and upset stomach. On an unknown date, the patient experienced fever. On an unknown date, the outcome of the injection site swelling, muscle pain, fever, headache, shivering and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, muscle pain, fever, headache, shivering and upset stomach to be related to Shingrix.  Additional case details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got her 1st Shingrix shot on Sunday.  The patient developed swelling at injection site, muscle pain, headache, shivering, upset stomach and fever, which had not resolved. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Shingrix vaccines were placed in the freezer; This case was reported by a nurse via call center representative and described the occurrence of intercepted product storage error in an unspecified number of patients who received Herpes zoster (Shingrix) (batch number L4RD3, expiry date 8th October 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Nurse reported that Shingrix vaccines was exposed to a minimum temperature of minus 8.1 degree Fahrenheit since 28th July, 2021, which led to intercepted product storage error. The nurse realized they had made a mistake, and that the PI said that the vaccines should not be placed in the freezer. Vaccines was not given to patients, the health care professional  wanted to know if they were still viable or not. No further details was provided at the time of the call. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19; This spontaneous report received from a company representative on behalf of a health care professional concerned a male patient of unspecified age, race and ethnicity. 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 admin not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date after vaccination, the patient experienced suspected covid-19 (suspected clinical vaccination failure). On an unspecified date in AUG-2021 (same week of this report), the patient was hospitalized and was intubated. The duration of hospitalization was not specified. On an unspecified date in AUG-2021 (same week of this report), the patient died of covid-19. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of suspected clinical vaccination failure and suspected covid-19 on AUG-2021. This report was serious (Death, and Hospitalization Caused / Prolonged). This case was associated with the Product Quality Complaint number 90000188817.; Sender's Comments: V0: 20210815127- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected COVID-19. 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).  20210815127- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.; Reported Cause(s) of Death: COVID-19
Sex: U
Vaccine: COVID19
Symptoms: Medication error, Pyrexia, Tachycardia
Clinical narrative: TACHYCARDIA; MEDICATION ERROR; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. Concomitant medications included bnt 162 for prophylactic vaccination. On 06-AUG-2021, the patient experienced tachycardia. On 06-AUG-2021, the patient experienced medication error. On 06-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tachycardia, and fever, and the outcome of medication error was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 admin not reported, batch number: UNKNOWN) dose was not reported, administered on 29-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 01-JUL-2021, the patient experienced covid-19 infection. Laboratory data included: SARS-CoV-2 test (NR: not provided) positive. On 16-JUL-2021, Laboratory data included: SARS-CoV-2 test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 infection on 16-JUL-2021. This report was non-serious.; Sender's Comments: V0-Medical Assessment comment is not required as per standard procedures, as the case was assessed as non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Exercise tolerance decreased, Hyperhidrosis, Hypoaesthesia, Illness
Clinical narrative: SWEATING; SICKNESS; NOT ABLE TO DO EXERCISE FOR WEEK; ANXIETY; FEET AND TOES WERE NUMB; NUMBNESS IN CALVES; SORE ARM; NOT FEELING WELL; FEVER; This spontaneous report received from a parent concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient was usually very healthy and did not take any medication. 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 03-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.   On 03-AUG-2021, the patient experienced sweating. On 03-AUG-2021, the patient experienced sickness. On 03-AUG-2021, the patient experienced not able to do exercise for week. On 03-AUG-2021, the patient experienced anxiety. On 03-AUG-2021, the patient experienced feet and toes were numb. On 03-AUG-2021, the patient experienced numbness in calves. On 03-AUG-2021, the patient experienced sore arm. On 03-AUG-2021, the patient experienced not feeling well. On 03-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, and numbness in calves on 05-AUG-2021, had not recovered from sore arm, not able to do exercise for week, and feet and toes were numb, and the outcome of fever, not feeling well, sickness and anxiety was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: SWEATING; SICKNESS; NOT ABLE TO DO EXERCISE FOR WEEK; ANXIETY; FEET AND TOES WERE NUMB; NUMBNESS IN CALVES; SORE ARM; NOT FEELING WELL; FEVER; This spontaneous report received from a parent concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient was usually very healthy and did not take any medication. 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 03-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.   On 03-AUG-2021, the patient experienced sweating. On 03-AUG-2021, the patient experienced sickness. On 03-AUG-2021, the patient experienced not able to do exercise for week. On 03-AUG-2021, the patient experienced anxiety. On 03-AUG-2021, the patient experienced feet and toes were numb. On 03-AUG-2021, the patient experienced numbness in calves. On 03-AUG-2021, the patient experienced sore arm. On 03-AUG-2021, the patient experienced not feeling well. On 03-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, and numbness in calves on 05-AUG-2021, had not recovered from sore arm, not able to do exercise for week, and feet and toes were numb, and the outcome of fever, not feeling well, sickness and anxiety was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a female of unspecified age. 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 admin not reported, batch number: unknown) dose was not reported, 1 total, start therapy date was 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. The reporter called to report about female who she knew was vaccinated with Janssen COVID-19 vaccine and was sick with COVID after being vaccinated (suspected clinical vaccination failure, and suspected COVID-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected COVID-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210821314- Covid-19 vaccine ad26.cov2. s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a male of unspecified age. 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 admin not reported, batch number: 1898089, expiry: 04-AUG-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF A FILLED  SYRINGE THAT WAS STORED IN  REFRIGERATOR FOR 12-18 HOURS; ADMINISTRATION OF A FILLED  SYRINGE THAT WAS STORED IN  REFRIGERATOR FOR 12-18 HOURS; This spontaneous report received from a pharmacist concerned a 65 year old female. The patient's weight was 210 pounds, and height was 67 inches. The patient's concurrent conditions included: asthma, arthritis, alcohol user and smoker and other pre-existing medical conditions included: The patient is taking pro-air inhaler for unknown indication. The patient was previously experienced hives and skin rash when treated with ciprofloxacin for drug used for unknown indication, and drug dependence when treated with aripiprazole, colchicine, fluticasone propionate, escitalopram oxalate, naproxen, omeprazole, paracetamol and diclofenac for drug used for unknown indication, drug dependence when treated with gabapentin and oxybutynin.  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-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 11-AUG-2021, the patient experienced administration of a filled syringe that was stored in refrigerator for 12-18 hours. On 11-AUG-2021, the patient experienced administration of a filled syringe that was stored in refrigerator for 12-18 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of a filled syringe that was stored in refrigerator for 12-18 hours and administration of a filled syringe that was stored in refrigerator for 12-18 hours was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: TERRIBLE PAIN; FEVER; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. 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 30-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 30-JUL-2021, the patient experienced terrible pain. On 30-JUL-2021, the patient experienced fever. On 30-JUL-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, fatigue and terrible pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: SLEEPINESS; SORE ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced sleepiness, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepiness, and sore arm. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, SARS-CoV-2 test, Sensory disturbance
Clinical narrative: HIT LIKE A TON OF BRICKS; ACHY FEELING; SCRATCH IN THROAT; COLD CHILLS; TIREDNESS AND FATIGUE; This spontaneous report received from a patient concerned a 42 year old male. 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 admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, administered on 10-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-AUG-2021, the patient experienced hit like a ton of bricks. On 11-AUG-2021, the patient experienced achy feeling. On 11-AUG-2021, the patient experienced scratch in throat. On 11-AUG-2021, the patient experienced cold chills. On 11-AUG-2021, the patient experienced tiredness and fatigue. Laboratory data included: SARS-CoV-2 test (NR: not provided) Negative. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hit like a ton of bricks, tiredness and fatigue, achy feeling, cold chills, and scratch in throat. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: HIT LIKE A TON OF BRICKS; ACHY FEELING; SCRATCH IN THROAT; COLD CHILLS; TIREDNESS AND FATIGUE; This spontaneous report received from a patient concerned a 42 year old male. 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 admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, administered on 10-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-AUG-2021, the patient experienced hit like a ton of bricks. On 11-AUG-2021, the patient experienced achy feeling. On 11-AUG-2021, the patient experienced scratch in throat. On 11-AUG-2021, the patient experienced cold chills. On 11-AUG-2021, the patient experienced tiredness and fatigue. Laboratory data included: SARS-CoV-2 test (NR: not provided) Negative. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hit like a ton of bricks, tiredness and fatigue, achy feeling, cold chills, and scratch in throat. This report was non-serious.