chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 15-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 15-Apr-2022) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 15-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 15-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the pharmacist thought that the expiry date of the vaccine was Jun-2022, However the vaccine expired on 01-Apr-2022. On 04-Apr-2022, the vial was initially stored in the refrigerator. Reportedly, the vial didn't undergo any temperature excursions.  No treatment information was reported.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 04-Apr-2022 and on 19-Apr-2022 administrated to patient; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 04-Apr-2022 and on 19-Apr-2022 administrated to patient) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 04-Apr-2022 and on 19-Apr-2022 administrated to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 04-Apr-2022 and on 19-Apr-2022 administrated to patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that pharmacist thought that the vaccine was expired in Jun-2022, however it was expired on 01-Apr-2022.  No treatment information was reported.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Blood glucose normal, Metabolic function test, Metabolic function test normal, Seizure, Ultrasound head normal
Clinical narrative: Generalized convulsive seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 4-month-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 2, single (Lot number: EX1979, Expiration Date: 31Dec2023) for immunisation; diphtheria vaccine toxoid, hepatitis B vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (VAXELIS), as dose 2, single (Lot number: U7125AA, Expiration Date: 15Jul2024) for immunisation; rotavirus vaccine live reassort oral 5v (ROTATEQ), as dose 2, single (Lot number: 1742434, Expiration Date: 16Mar2023) for immunisation. The patient's relevant medical history included: "Ventricular septal defect" (unspecified if ongoing), notes: 'not' receiving any treatment or medication for such. The patient's concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "Generalized convulsive seizure". The event "generalized convulsive seizure" required emergency room visit. The patient underwent the following laboratory tests and procedures: Ultrasound head: normal; Metabolic function test: normal; Blood glucose: normal.  Follow-up (28Apr2022): Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66-year-old male patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 03Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 22Nov2021 as dose 3, (booster) single (Batch/Lot number: unknown) at the age of 66 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: High BP (moderate). Concomitant medication(s) medication in 2weeks included: AMLODIPINE, start date: 01Jan2017, OLMESARTAN, start date: 01Jan2017; GLUCOSAMINE 1500mg & CHONDORITIN 1200 mg, start date: 01Jan2017; FLAX SEED OIL 1000 mg, start date: 01Jan2017; KLOR-CON 10 meq, start date: 01Jan2017; CHLORTHALIDONE 25mg start date: 01Jan2018; PANTOPRAZOLE, start date: 01Feb2022; VITAMIN D3, start date: 01Jan2020; ZINC, start date: 01Jan2021; Alive Multi Vitamin 200 mg, start date=01Jan2017, COENZYME Q10 [UBIDECARENONE], start date: 01Jan2017; ASPIRIN 81, start date: 01Jan2017; BENZONATATE 100mg, start date: 08Apr2022, stop date: 27Apr2022; ADVIL [IBUPROFEN] 200mg, brand= Advil, taken for sinusitis, hypersensitivity, start date: 09Apr2022; TURMERIC CURCUMIN taken for sinusitis, hypersensitivity, start date: 01Jan2017. Past drug history included: Vioxx, reaction(s): "Drug allergy"; Caffeine, reaction(s): "Drug allergy". The following information was reported: COVID-19 (medically significant) with onset 14Apr2022, outcome "unknown", described as "Had several home and Rapid tests - still positive"; DRUG INEFFECTIVE (medically significant) with onset Apr2022, outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown result, notes: Took PCR test today. Awaiting results; Negative, notes: Tested negative on Rapid and PCR test; positive, notes: several home and Rapid tests - still positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Anti viral details, product= COVID-19 Treatment, brand=Pfizer Paxlovid, treatment start date=08Apr2022, treatment stop date=12Apr2022, indication=Treatment of COVID-19. Adverse event: Took Paxlovid as directed by (name) Clinic Nurse Practitioner (after also consulting with my primary care Doctor), For five days as directed. Felt better on 5th day. Tested negative on Rapid and PCR test. Then had relapse with similar symptoms for next two weeks. Had several home and Rapid tests - still positive as of this week. Took PCR test today. Awaiting results. Adverse event start date: 14Apr2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: First negative tests were 19Apr & 20Apr; First negative tests were 19Apr & 20Apr; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sinusitis" (unspecified if ongoing), notes: Other medical history: Sinusitis; "known allergies kiwi" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Apr2022, outcome "unknown" and all described as "First negative tests were 19Apr & 20Apr". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Negative, notes: First negative tests were 19Apr & 20Apr; (20Apr2022) Negative, notes: First negative tests were 19Apr & 20Apr. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: About 5 days after finishing the treatment course of pills I felt like I was sick again. Headache back, Slightly dizzy at times, very congested, Tired, appetite off. I repeated a Covid Home test today and it is negative. First negative tests were 19Apr & 20Apr. Adverse event start on 23Apr2022,09:00 am, patient was recovering from AE, If treatment ae: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid symptoms returned; Covid symptoms returned; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 at 18:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Mar2021 at 09:00 as dose 2, single (Batch/Lot number: unknown) and on 25Sep2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "High blood pressure" (ongoing); "High Cholesterol" (ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 01Jun2019; ATORVASTATIN, start date: 01Jun2012; METFORMIN, start date: 01Jun2019; JANUMET, start date: 01Jun2012; ASPIRIN 81, start date: 01Jun2012. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 19Apr2022 at 05:00, outcome "recovering" and all described as "Covid symptoms returned". Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  Clinical information: No known allergies reported. Adverse event details was reported as 6 days after completing Paxlovid treatment and feeling much better covid symptoms returned.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive on 08Apr2022; tested positive on 08Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 at 12:00 as dose 1, single (Lot number: EN6199), in left arm, on 26Mar2021 at 12:00 as dose 2, single (Lot number: ER8732), in left arm and on 10Dec2021 at 13:00 as dose 3 (booster), single (Lot number: FE3590) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "interstitial cystitis" (unspecified if ongoing). Concomitant medication(s) included: AMITRIPTYLINE HCL.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Apr2022, outcome "unknown" and all described as "tested positive on 08Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2022) Positive, notes: having tested positive on 08Apr2022; (19Apr2022) Negative, notes: testing negative eleven days after my first positive test; (27Apr2022) Positive, notes: I tested positive again for Covid on 27Apr2022. Therapeutic measures were taken as a result of covid-19. Clinical course: Anti-viral details: product: Covid 19 Treatment, treatment start date was 08Apr2022 and treatment stop date was 13Apr2022; indication included treatment of Covid 19. Other medication in 2weeks included Amitriptyline HCL 25 mg. The patient had no known allergies. Adverse event: The patient tested positive again for Covid on 27Apr2022, after having tested positive on 08Apr2022, and taking a full dose treatment of Paxlovid, and testing negative eleven days after my first positive test. The patient do not have Covid symptoms now, but the patient tested because her husband also had Covid return a few days ago (he had symptoms again) after taking a full dose of Paxlovid and recovering from Covid. The patient read on the news that in "rare" cases this has happened. It is interesting that it happened to both to her husband and herself. They got original Covid cases about three or four days apart. Adverse event start date: 27Apr2022, start time 01:00 PM. No ae treatment ae.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid 19/ home test positive; Covid 19/ home test positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: ER2613), on 11Apr2021 as dose 2, single (Lot number: EW0161) and on 08Sep2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history included: "Lymphoma" (unspecified if ongoing). The patient had no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid 19/ home test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Covid-19 Treatment-Paxlovid; (21Apr2022) Positive, notes: I began feeling quite congested and took a home test showing me positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: By 13Apr I was feeling better. By 18Apr I felt most symptoms were gone. On 21Apr I began feeling quite congested and took a home test showing me positive. Contacted my GP. 22Apr symptoms lessoned. Since have had a snotty, runny nose and a very sporadic dry.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got covid and she was vaccinated; got covid and she was vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (173415). The reporter is the parent.  A 19-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got covid and she was vaccinated".  Event Description: I am not thrilled about the vaccine even though I've had both doses of Pfizer vaccine. Then my 19-year-old daughter got covid and she was vaccinated, so I guess I considered that one of the rare breakthrough cases and then I got covid. Also had very little symptoms, but it seems like now it wasn't just rare breakthrough cases, it was everybody's getting covid whether you're vaccinated or not."  ADDITIONAL CASE INFORMATION: Other medications (Including over-the-counter medications, nutritional and herbal supplements, etc. was Unknown. Family History was Unknown. Social History (Including occupational history, use of alcohol, tobacco, or recreational drugs was Unknown. Other relevant information, use this space to include any additional information that may be relevant, including any additional Events or Suspect Products Unwas known  No follow-up attempts are possible, batch or lot number is not available. No further information is expected
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Had covid and took Plaxovid right away; Had covid and took Plaxovid right away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: El9264), in right arm, on 26Feb2021 as dose 2, single (Lot number: En6203), in right arm and on 06Oct2021 as dose 3 (booster), single (Lot number: 301558A) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Mar2022, outcome "unknown" and all described as "Had covid and took Plaxovid right away". Therapeutic measures were taken as a result of covid-19. Clinical course: No known allergies. 8 (maybe fewer) days after taking Plaxovid my covid symptoms got worse: Had covid and took Plaxovid right away: had fever for two days and then steadily got better. Then a few days after finishing Plaxovid I had a fever for 2.5 days and developed new symptoms. Felt worse the second time. Fever cough and shortness of breath. I still have the cough sometimes abs shortness of breath daily, though improving. If patient recovered: Recovered with lasting effects.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID relapse with positive home test; COVID relapse with positive home test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 at 13:15 as dose 4 (booster), single (Lot number: FK9896) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Parkinson's Disease" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Apr2022 at 12:00, outcome "not recovered" and all described as "COVID relapse with positive home test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2022) positive, notes: COVID relapse after Paxlovid treatment, after symptoms disappeared after negative home test. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Additional information: Patient took no other medications in two weeks. No anti viral details were provided. COVID relapse with positive home test, after Paxlovid treatment, after symptoms disappeared and after negative home test
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: after booster (3rd shot) my hair started falling out. The shedding hair is beyond excessive. Literally handfulls of hair lost daily.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Nov2021 at 18:15 as dose 3 (booster), single (Lot number: 33026BD) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Allergy of pepper" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 2, Dose brand unknown: False, Dose lot number: EW0171, Dose administration time: 03:45PM, Dose vaccine location: Right arm), administration date: 28Apr2021, when the patient was 64-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, Dose brand unknown: False, Dose lot number: EP7533, Dose administration time: 04:00PM, Prev dose vaccine location: Right arm), administration date: 31Mar2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 10Jan2022, outcome "not recovered", described as "after booster (3rd shot) my hair started falling out. The shedding hair is beyond excessive. Literally handfulls of hair lost daily.". Therapeutic measures were not taken as a result of alopecia. Additional information: The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Tested Positive for COVID-19; Tested Positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 18Jun2021 as dose 1, single (Lot number: EW0180), on 09Jul2021 as dose 2, single (Lot number: EW0196), in left arm and on 12Jan2022 as dose 3 (booster) , single (Lot number: FJ1614) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic Lyme Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 27Apr2022, outcome "unknown", VACCINATION FAILURE (medically significant) with onset 27Apr2022, outcome "recovering" and all described as "Tested Positive for COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19: (27Apr2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19, vaccination failure.  Clinical course: No Covid prior to vaccination. No other vaccine in four weeks. No other medication in two weeks. No known allergies.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). A 13-year-old (non-pregnant) female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: FC3183) and as dose 2, single (Lot number: 301308A) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 24Apr2022, outcome "recovered", COVID-19 (medically significant) with onset 24Apr2022, 6 months 29 days after the suspect product(s) administration, outcome "recovered" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Apr2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Additional information: The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have COVID-19 nor any symptoms associated with COVID-19 prior vaccination.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: Pain; Rash all over body (both arms and her chest)/developed a rash, which started on the arm opposite of the injection arm, it spread down that arm, across chest, under breasts and to the other arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team.  A 57-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (booster); unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown"; RASH (non-serious), outcome "unknown", described as "Rash all over her body (both arms and her chest)/developed a rash, which started on the arm opposite of the injection arm, it spread down that arm, across her chest, under her breasts and to the other arm". The events "rash all over her body (both arms and her chest)/developed a rash, which started on the arm opposite of the injection arm, it spread down that arm, across her chest, under her breasts and to the other arm" required physician office visit.  Additional information: The reporter was calling on behalf of his girlfriend (patient) and stated that they both received the second booster. Received the 2nd booster dose of the Pfizer-BioNTech Covid 19 Vaccine and has a rash all over her body (both arms and her chest) ever since she received the vaccine. He stated that her girlfriend was in pain. Within 24 hours, the patient developed a rash, which started on the arm opposite of the injection arm, it spread down that arm, across her chest, under her breasts and to the other arm. She has seen several doctors and they were only discussing this as a treatment. The doctors did have concerns about prescribing Prednisone, and that it might prevent the effectiveness of the vaccine. The reported wanted detailed information, in order to relief the pain that patient was having due to the vaccine. Reporter also wanted to know if the efficacy of the vaccine could be affected if her girlfriend takes Prednisone as a treatment for rashes. The patient has not taken Prednisone yet, has not been prescribed, or has not got a prescription for Prednisone. Other Conditions and investigation were not provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise
Clinical narrative: had an adult covid shot it was so awful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "had an adult covid shot it was so awful". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported no product. Was not present.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Hypothyroidism, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: his thyroid is not producing enough hormone, so he is hypothyroid; experienced pain under left armpit; pain on the glands in his throat.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Caller stated that on his 1st dose, he experienced tiredness.), for COVID-19 immunization, reaction(s): "Tiredness"; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: AXILLARY PAIN (non-serious) with onset 2021, outcome "unknown", described as "experienced pain under left armpit"; HYPOTHYROIDISM (medically significant) with onset 2021, outcome "unknown", described as "his thyroid is not producing enough hormone, so he is hypothyroid"; OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "pain on the glands in his throat.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive.  Clinical course: Caller verified the information provided by the transferring agent. States his 3rd shot was in Oct2021, and he got Covid 19 on New Years weekend. He has been having lingering symptoms, one of which being his thyroid is not producing enough hormone, so he is hypothyroid. He is hoping that maybe the 4th shot will help that improve. Declined to complete the report. States that he is thinking about getting the 4th shot this weekend, but wants to make sure it won't make his thyroid issue worse. Requests to be transferred.    Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: his thyroid is not producing enough hormone, so he is hypothyroid; experienced pain under left armpit; pain on the glands in his throat.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Caller stated that on his 1st dose, he experienced tiredness.), for COVID-19 immunization, reaction(s): "Tiredness"; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: AXILLARY PAIN (non-serious) with onset 2021, outcome "unknown", described as "experienced pain under left armpit"; HYPOTHYROIDISM (medically significant) with onset 2021, outcome "unknown", described as "his thyroid is not producing enough hormone, so he is hypothyroid"; OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "pain on the glands in his throat.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive.  Clinical course: Caller verified the information provided by the transferring agent. States his 3rd shot was in Oct2021, and he got Covid 19 on New Years weekend. He has been having lingering symptoms, one of which being his thyroid is not producing enough hormone, so he is hypothyroid. He is hoping that maybe the 4th shot will help that improve. Declined to complete the report. States that he is thinking about getting the 4th shot this weekend, but wants to make sure it won't make his thyroid issue worse. Requests to be transferred.    Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for Covid-19 immunization.  The following information was reported: VERTIGO (non-serious), outcome "unknown".  Additional information: Caller stated she just got the 4th dose of the Pfizer Covid 19 vaccine the other day went to bed and woke up the next morning experiencing vertigo for a week now. Caller was asking if this was normal.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Dose Number: 3, testing positive for COVID; Dose Number: 3, testing positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Artichokes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Dose Number: 3, testing positive for COVID". The patient underwent the following laboratory tests and procedures: SARS CoV-2 test: Positive, notes: Within testing positive for COVID, after 4 days I tested negative 3 times in a week. 12 days after initial diagnosis I was sick for 5 days and kept testing positive; Negative, notes: Within testing positive for COVID, after 4 days I tested negative 3 times in a week. 12 days after initial diagnosis I was sick for 5 days and kept testing positive; Positive, notes: Within testing positive for COVID, after 4 days I tested negative 3 times in a week. 12 days after initial diagnosis I was sick for 5 days and kept testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included no other medication in 2weeks. Patient felt great after day 2 of taking Paxlovid. Within testing positive for COVID, after 4 days patient tested negative 3 times in a week. 12 days after initial diagnosis patient was sick for 5 days and kept testing positive. Felt sicker than patient did when first positive and taking Paxlovid. My husband had similar experience.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound effect from Paxlovid. Finished course, recovered and tested negative for 4 days in a row, then symptoms returned and tested positive for 7 days.; Rebound effect from Paxlovid. Finished course, recovered and tested negative for 4 days in a row, then symptoms returned and tested positive for 7 days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC, start date: 01Apr2022. Past drug history included: Aspirin, reaction(s): "Known allergies: aspirin"; Ibuprofen, reaction(s): "Known allergies: ibuprofen". Vaccination history included: moderna (vaccine brand=Other,, vaccine brand other=Moderna,, vaccine brand unknown=False,, vaccine administration date=07Nov2021, vaccine lot unknown=True,, vaccine lot unknown reason=Not available/provided to reporter at the time of report completion,, vaccine dose number=3,, vaccine dose number unknown=False, vaccine location=Right arm), administration date: 07Nov2021, when the patient was 46-year-old, for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Apr2022 at 09:00, outcome "recovered" (26Apr2022) and all described as "Rebound effect from Paxlovid. Finished course, recovered and tested negative for 4 days in a row, then symptoms returned and tested positive for 7 days.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Finished course, recovered and tested negative for 4 days in a row, then symptoms returned and tested positive for 7 days; Positive, notes: Finished course, recovered and tested negative for 4 days in a row, then symptoms returned and tested positive for 7 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid Arthritis flare up in hands and knees; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4371883-00.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 61 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 vaccination. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "Rheumatoid Arthritis flare up in hands and knees". The action taken for adalimumab was unknown.  The reporter considered "rheumatoid arthritis flare up in hands and knees" not related to BNT162b2.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for Humira (Adalimumab):  The reporter's causality for the event(s) of Rheumatoid Arthritis flare up in hands and knees was not provided.  Seq.No.: 1  Drug: Humira (Solution for injection in pre-filled pen) (Adalimumab) Causality  1) Rheumatoid arthritis flare up (Rheumatoid arthritis)   Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  Seq.No.: 2  Drug: Pfizer BioNtech Covid-19 Vaccine (Tozinameran) (Tozinameran) Unknown, unknown Causality 1) Rheumatoid arthritis flare up (Rheumatoid arthritis)   Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not related Dechallenge: N/A    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event rheumatoid arthritis flare up in hands and knees and the use of suspect product BNT162B2 cannot be fully excluded. The case will be reassessed once further information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive PCR with symptoms; Positive PCR with symptoms; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 at 13:00 as dose 1, single (Lot number: EK9231), in left arm and on 22Jan2021 at 13:00 as dose 2, single (Lot number: EL3249) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Menieure's" (unspecified if ongoing). The patient did not have any known allergies. Concomitant medication(s) or other medications the patient received within 2 weeks included: BETAHISTINE, start date: 13Apr2022, stop date: 15Apr2022; ROPINIROLE, start date: 13Apr2022, stop date: 15Apr2022; TRIAMTERENE/HCTZ, start date: 13Apr2022, stop date: 15Apr2022; MUCINEX, start date: 13Apr2022, stop date: 15Apr2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "not recovered" and all described as "Positive PCR with symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: Positive PCR with symptoms; (18Apr2022) Negative, notes: Salivary PCR; (25Apr2022) Positive, notes: Salivary PCR; (22Apr2022) Negative, notes: Rapid antigen, Salivary PCR; (25Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid. The adverse event was treated with Paxlovid from 13Apr2022 to 17Apr2022 after positive PCR with symptoms. Negative salivary PCR was on 18Apr2022. Negative rapid antigen was on 22Apr2022. The symptoms returned on 24Apr2022. Positive salivary PCR and rapid antigen test was on 25Apr2022. The patient remained symptomatic. The device date was reported as 28Apr2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: First dose:J&J and second dose: Pfizer vaccine; First dose:J&J and second dose: Pfizer vaccine; I tested positive with symptoms on a rapid test on the evening of April 12; I tested positive with symptoms on a rapid test on the evening of April 12; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), in Jul2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 05Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PHENYLEPHRINE. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 22Apr2022, outcome "unknown" and all described as "First dose:J&J and second dose: Pfizer vaccine"; DRUG INEFFECTIVE (medically significant) with onset 22Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 22Apr2022, outcome "recovering" and all described as "I tested positive with symptoms on a rapid test on the evening of April 12". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) positive; (20Apr2022) negative; (28Apr2022) positive. Therapeutic measures were not taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: First dose:J&J and second dose: Pfizer vaccine; First dose:J&J and second dose: Pfizer vaccine; I tested positive with symptoms on a rapid test on the evening of April 12; I tested positive with symptoms on a rapid test on the evening of April 12; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), in Jul2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 05Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PHENYLEPHRINE. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 22Apr2022, outcome "unknown" and all described as "First dose:J&J and second dose: Pfizer vaccine"; DRUG INEFFECTIVE (medically significant) with onset 22Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 22Apr2022, outcome "recovering" and all described as "I tested positive with symptoms on a rapid test on the evening of April 12". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) positive; (20Apr2022) negative; (28Apr2022) positive. Therapeutic measures were not taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.