chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Illness, Rhinorrhoea, Skin exfoliation
Clinical narrative: nose kept running like a faucet; skin peeled off under her feet; very sick for 3 days; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient's Mother) reported for a 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced nose kept running like a faucet, skin peeled off under her feet, very sick for 3 days. It was reported that daughter just took both doses of the Pfizer-BioNTech COVID-19 Vaccine, a young girl with no medical issues. After the first dose, Daughter experienced severe reactions. After the second dose, Daughter had "running nose, like a cold", "skin on feet peeled" but she didn't get sick. Caller asked if these are possible side effects. The outcomes of events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound scan
Clinical narrative: blood clots; This is a spontaneous report from a contactable consumer (the patient).   A 55-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 26Jun2021 14:00 (Batch/Lot Number: EW0196) as single dose for covid-19 immunisation  .  Medical history included diabetes mellitus.  There were no concomitant medications. On 05Jun2021 the patient received the first dose of BNT162B2 vaccine (lot # EW0191). The patient experienced blood clots  (medically significant) on 03Jul2021 08:00 with outcome of recovering.  The patient underwent lab tests and procedures which included ultrasound scan: unknown results.   Therapeutic measures were taken as a result of the event including Emergency room/department or urgent care visit and treatment with  Eliquis, IV antibiotics & IVF. The patient was not pregnant at the time of the visit. Course of the event: After second COVID-19 vaccine developed blood clots to right elbow, right leg upper posterior and anterior, left leg upper anterior.  Follow up information has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Insomnia, Palpitations, Tachycardia
Clinical narrative: tachycardia; Not been able to sleep; Heart beating more than normal; Heart racing all the time; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration administered in arm left on 02Sep2021 at 12:00 AM(Lot Number: 1021) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history was none. The patient was not pregnant and was not pregnant at time of vaccination. Previously the patient received an unspecified vaccine in 2021 (other vaccine in four weeks) at 31 years for immunisation with no adverse effect. Concomitant medication included an unspecified Pfizer vaccine (lot# fc3181) received on 02Sep2021 (same date of bnt162b2). The patient experienced tachycardia (caused hospitalization) on 03Sep2021 13:00 with outcome of not recovered, not been able to sleep (caused hospitalization) on 03Sep2021 13:00 with outcome of not recovered, heart beating more than normal (caused hospitalization) on 03Sep2021 13:00 with outcome of not recovered, heart racing all the time (caused hospitalization) on 03Sep2021 13:00 with outcome of not recovered.    No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Extra dose administered, Off label use, SARS-CoV-2 antibody test
Clinical narrative: Patient had third Pfizer/BioNtech vaccine within the past 2 weeks.; Patient had third Pfizer/BioNtech vaccine within the past 2 weeks.; Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer.   A 72-year-old male patient received three doses of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date, at the age of 72-years-old,  (Batchs/Lot numbers was not reported) as single dose for covid-19 immunisation. Medical history included chronic kidney disease and renal transplant from an unknown date. The patient received other unspecified medications. The patient tested positive for covid via Nasal Swab on 07Sep2021. The patient received Monoclonal Antibody Infusion as treatment for the event. No covid prior vaccination and no covid tested post vaccination. The outcome of the event was not recovered.  The lot number for the vaccine, bnt162b2 was not provided and will be requested during follow up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient received both doses of Pfizer/BioNtech vaccine in February 2021 and now tested positive for COVID 19; Patient received both doses of Pfizer/BioNtech vaccine in February 2021 and now tested positive for COVID 19; This is a spontaneous report from a contactable consumer.   A 73-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) and  dose 1 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) both as single dose for covid-19 immunisation (Age at vaccination 73 years) .  Medical history included diabetes mellitus.  Concomitant medications were not reported.  The patient was not pregnant at the time of vaccination. The  patient received both doses of pfizer/biontech vaccine in February 2021 and now tested positive for covid 19  (medically significant) on 07Sep2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive   on 07Sep2021  .  Therapeutic measures were taken as a result of the reported events including Monoclonal Antibody Infusion. The patient visited a Physician office as a result of the events.  Information about Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: skin rash in full bloom; itching; This is a spontaneous report from a contactable consumer (Patient) via Regulatory Authority. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 31Mar2021 as single for covid-19 immunisation. Medical history included penicillin allergy. The patient's concomitant medications were not reported. She stated it has been more than the recommended time since she had her first dose, that it has been about 5 months since her first dose on 31Mar2021. She asks if she can get the second dose now? She stated she had an allergic reaction to an antibiotic, Clindamycin, that she took for a dental procedure right at the time for her second dose and the doctor said don't go for the vaccine because she had a skin rash in full bloom. She stated her doctor gave her a steroid shot that lasted for 2 months in her system to get rid of the allergic reaction, so she was told not go get the vaccine until the steroids were out of her system. She stated she wanted to make sure it's ok to have the second shot this far out because she read in other countries they have had success with people taking the second dose several months after the first dose. She stated she had an allergic reaction 4 weeks after the first vaccine and they don't believe it had to do with the vaccine, she feels it was strictly related to the antibiotic she was taking. She stated she took the antibiotic twice within 6 weeks. She stated it was a pretty bad reaction and it took a long time to get back to normal because of the steroid shot she had never taken before. She stated she was allergic to penicillin so when she got the shot they showed her the ingredients and it's nothing she's had a reaction to. She stated she was taking 300mg of Clindamycin 3 times a day for 10 days. She stated she started it on 08Mar2021 and then again on 05Apr2021. She stated one was for a dental tooth infection and the other was in preparation for a dental implant procedure. She stated that on 31Mar2021 she then had her first dose of the Pfizer Covid-19 vaccine. She stated the rash and itching didn't show up until the second course of antibiotics, the end of that about 18 days after the vaccine. She stated they said because there was no way to determine if it was related to the vaccine because there was not enough allergy testing available for that, but that they're pretty confident it's coming from the Clindamycin. Reporter considered events as non-serious. Therapeutic measures were taken as a result of skin rash in full bloom, itching. The outcome of events was unknown.  Follow-up activities closed. Batch/lot number not available for vaccine BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: two friends had a stroke after getting the COVID-19; This is a spontaneous report from a contactable consumer received from a Pfizer sponsored Program. This is the first of two reports. A female patient of unspecified age received a dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported that two friends had a stroke after getting the COVID-19 vaccine on an unspecified date with outcome of unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101170640 same reporter, product and AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for 2 patients. This is the first of two reports.   A 13-year-old patient of an unspecified gender received the first dose of BNT162B2 (BNT162B2, Manufacturer Pfizer-BioNTech) via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient became COVID-19 positive two weeks after first dose. The patient showed minimal symptoms. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unspecified date 2 weeks after vaccination. Clinical outcome was unknown at time of this report.   The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and COVID-19 cannot be totally excluded .,Linked Report(s) : US-PFIZER INC-202101172409 same reporter, product and AE, different patient
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Heart rate
Clinical narrative: Chest pain; This is a spontaneous report from a contactable consumer (parent; patient's father). A 14-year-old male patient (son) received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the right arm on 19Jul2021 18:00 (batch/lot number: FA6780 and expiration date: 01Sep2021) at the age of 14 years old, as DOSE 2, SINGLE for COVID-19 immunization. The Vaccination Facility Type where patient received the vaccine dose was reported as a grocery store. The patient had no medical and family history relevant to the reported adverse event. When the family first moved here, the patient had to take a lot of vaccinations, and he didn't have any reaction to any of them. There were no concomitant medications. There were no prior vaccinations within 4 weeks, and no additional vaccines were administered on same date of the Pfizer suspect. The patient previously received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the right arm on 28Jun2021 (batch/lot number: EW0196 and expiration date: 30Sep2021) at the age of 14 years old, as DOSE 2, SINGLE for COVID-19 immunization. On 19Jul2021, the patient experienced chest pain. It was reported that the patient was alright for a while, and then he noticed chest pain in the middle of the night the same day of the second dose. They took his son to a clinic, and they just tried to read the heartbeat, and they couldn't quite read it; so, they sent him to the emergency room. They waited patiently for four or five hours next to the Exit in the Emergency room; and his son just got better. At the emergency room they read his heartbeat and that was that. Patient was sent home. No investigation assessments were performed. The patient's father further reported that they have a couple of emergency room bills and when he called them, they told him to call someone else to get reimbursement. The patient's father asked for information about how to seek reimbursement. He thought they could just file for it, but they were told since it is COVID related he should call. The father added, they got the bill after they got home; they were visiting another country; he called the bill office and said this was COVID related and they told him to call someone in (place name) but this was the first number he found to call. When asked to report, the father stated no, at this point everything was fine, then decided to report anyway. The patient recovered from the event chest pain on 19Jul2021.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Off label use, Peripheral swelling, Product use issue
Clinical narrative: The day after vaccine my arm was red, swollen, rashy; The day after vaccine my arm was red, swollen, rashy; I had a headache/nausea and vomited; I had a headache/nausea and vomited; I had a headache/nausea and vomited; Yesterday injection site started swelling and getting really red, hot & itchy; I have about a golf ball size knot; Yesterday injection site started swelling and getting really red, hot & itchy; I'm breastfeeding and have MTHFR gene mutation; I'm breastfeeding and have MTHFR gene mutation; Yesterday injection site started swelling and getting really red, hot & itchy; Yesterday injection site started swelling and getting really red, hot & itchy; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported similar events for mother and baby. This is a mother report. A 33-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3181), dose 1 via an unspecified route of administration, administered in Arm Left on 30Aug2021 at 12:00 (at the age of 33-years-old) as dose 1, single for covid-19 immunisation. Medical history included MTHFR gene mutation, anaemia, Latex: Allergies, Latex: adhesive allergy and sensitivity to anesthesia. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient received no other vaccine in four weeks. On 01Sep2021, the patient experienced the day after vaccine my arm was red, swollen, rashy, i had a headache/nausea and vomited, yesterday injection site started swelling and getting really red, hot & itchy, i have about a golf ball size knot, itchy, i'm breastfeeding and have mthfr gene mutation. Treatment was provided for the events. It was reported that the day after vaccine her arm was red, swollen, rashy and she had a headache/nausea and vomited. Then for 6 days she was fine. Yesterday injection site started swelling and getting really red, hot & itchy. She had about a golf ball size knot, it's visibly swollen from all angles and is so hot and itchy She believed she got into poison ivy. She had taken Benadryl, Zyrtec, used topical Benadryl, hydrocortisone and calamine with no relief. She also had a lingering headache today. She was breastfeeding. So was advised to double her aspirin for 90 days. The patient was not COVID prior vaccination and did not test for COVID post vaccination. Outcome of the events swollen arm, rash, I have about a golf ball size knot and injection site started swelling and getting really red, hot & itchy were not recovered and that of headache, nausea and vomiting was recovered on ??-???-2021.  Follow-up (10Sep2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101171059 child case
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: The day after vaccine my arm was red, swollen, rashy; The day after vaccine my arm was red, swollen, rashy; I had a headache/nausea and vomited; I had a headache/nausea and vomited; I had a headache/nausea and vomited; Yesterday injection site started swelling and getting really red, hot & itchy; I have about a golf ball size knot; Yesterday injection site started swelling and getting really red, hot & itchy; I'm breastfeeding and have MTHFR gene mutation; I'm breastfeeding and have MTHFR gene mutation; Yesterday injection site started swelling and getting really red, hot & itchy; Yesterday injection site started swelling and getting really red, hot & itchy; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported similar events for mother and baby. This is a mother report. A 33-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3181), dose 1 via an unspecified route of administration, administered in Arm Left on 30Aug2021 at 12:00 (at the age of 33-years-old) as dose 1, single for covid-19 immunisation. Medical history included MTHFR gene mutation, anaemia, Latex: Allergies, Latex: adhesive allergy and sensitivity to anesthesia. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient received no other vaccine in four weeks. On 01Sep2021, the patient experienced the day after vaccine my arm was red, swollen, rashy, i had a headache/nausea and vomited, yesterday injection site started swelling and getting really red, hot & itchy, i have about a golf ball size knot, itchy, i'm breastfeeding and have mthfr gene mutation. Treatment was provided for the events. It was reported that the day after vaccine her arm was red, swollen, rashy and she had a headache/nausea and vomited. Then for 6 days she was fine. Yesterday injection site started swelling and getting really red, hot & itchy. She had about a golf ball size knot, it's visibly swollen from all angles and is so hot and itchy She believed she got into poison ivy. She had taken Benadryl, Zyrtec, used topical Benadryl, hydrocortisone and calamine with no relief. She also had a lingering headache today. She was breastfeeding. So was advised to double her aspirin for 90 days. The patient was not COVID prior vaccination and did not test for COVID post vaccination. Outcome of the events swollen arm, rash, I have about a golf ball size knot and injection site started swelling and getting really red, hot & itchy were not recovered and that of headache, nausea and vomiting was recovered on ??-???-2021.  Follow-up (10Sep2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101171059 child case
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth, Vomiting
Clinical narrative: The day after vaccine my arm was red, swollen, rashy; The day after vaccine my arm was red, swollen, rashy; I had a headache/nausea and vomited; I had a headache/nausea and vomited; I had a headache/nausea and vomited; Yesterday injection site started swelling and getting really red, hot & itchy; I have about a golf ball size knot; Yesterday injection site started swelling and getting really red, hot & itchy; I'm breastfeeding and have MTHFR gene mutation; I'm breastfeeding and have MTHFR gene mutation; Yesterday injection site started swelling and getting really red, hot & itchy; Yesterday injection site started swelling and getting really red, hot & itchy; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported similar events for mother and baby. This is a mother report. A 33-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3181), dose 1 via an unspecified route of administration, administered in Arm Left on 30Aug2021 at 12:00 (at the age of 33-years-old) as dose 1, single for covid-19 immunisation. Medical history included MTHFR gene mutation, anaemia, Latex: Allergies, Latex: adhesive allergy and sensitivity to anesthesia. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient received no other vaccine in four weeks. On 01Sep2021, the patient experienced the day after vaccine my arm was red, swollen, rashy, i had a headache/nausea and vomited, yesterday injection site started swelling and getting really red, hot & itchy, i have about a golf ball size knot, itchy, i'm breastfeeding and have mthfr gene mutation. Treatment was provided for the events. It was reported that the day after vaccine her arm was red, swollen, rashy and she had a headache/nausea and vomited. Then for 6 days she was fine. Yesterday injection site started swelling and getting really red, hot & itchy. She had about a golf ball size knot, it's visibly swollen from all angles and is so hot and itchy She believed she got into poison ivy. She had taken Benadryl, Zyrtec, used topical Benadryl, hydrocortisone and calamine with no relief. She also had a lingering headache today. She was breastfeeding. So was advised to double her aspirin for 90 days. The patient was not COVID prior vaccination and did not test for COVID post vaccination. Outcome of the events swollen arm, rash, I have about a golf ball size knot and injection site started swelling and getting really red, hot & itchy were not recovered and that of headache, nausea and vomiting was recovered on ??-???-2021.  Follow-up (10Sep2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101171059 child case
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This is a spontaneous report from a contactable consumer reporting for the daughter.   A 15-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 03Sep2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient experienced allergic reaction  (medically significant) on Sep2021 with outcome of unknown.  Therapeutic measures were taken as a result of the reported event including Benadryl.  Information about Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: Patient reported hearing loss after vaccination, that has persisted and not resolved; This is a spontaneous report from a contactable consumer (Pfizer employee) received regulatory authority.  A female patient of an unspecified age received a dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported hearing loss after vaccination, that has persisted on an unspecified date with outcome of not recovered. The event required doctor or other healthcare professional office/clinic visit.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke after getting the COVID-19; This is a spontaneous report from a contactable consumer received from Regulatory Authority. A female patient of unspecified age received a dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient had a stroke after getting the COVID-19 vaccine on an unspecified date with outcome of unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101169478 same reporter, product and AE, different patient
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Injection site pruritus, Vaccination site mass, Vaccination site swelling
Clinical narrative: Painful eyes; golf ball sized lump under injection site with swelling and itchiness; golf ball sized lump under injection site with swelling and itchiness; golf ball sized lump under injection site with swelling and itchiness; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration in left arm on 05Sep2021 14:30 as dose 1, single for COVID-19 immunization (at the age of 23-year-old, non-pregnant). The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included depression and anxiety, known allergies to Penicillin, black beans, agave, everything bagel seasoning and patient had covid prior vaccination from an unknown date and unknown if ongoing. Covid was not tested post vaccination. Concomitant medication(s) (within 2 weeks of vaccination) included sertraline hydrochloride (ZOLOFT). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced painful eyes, golf ball sized lump under injection site with swelling and itchiness on 05Sep2021 15:45. Reported seriousness for the events was non-serious. The patient did not receive treatment for the event. The outcome of the events was not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from contactable pharmacist. This pharmacist reported similar events for 2 patients. This is the 2nd of 2 reports. A 16-year-old patient of an unspecified gender received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced COVID-19 (medically significant) on an unspecified date 2 weeks after vaccination with outcome of unknown. The patient showed minimal symptoms. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unspecified date 2 weeks after vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events drug ineffective and Covid 19 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202101169498 Same reporter/product/event, different patient
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Enlarged uvula, Tachycardia
Clinical narrative: Swelling of uvula (required emergency treatment); tachycardia (required medical treatment).; This is a spontaneous report from a contactable consumer (Patient) reported that: A 55- years-old Female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8729 and expiration date: Not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 06Apr2021 10:45 as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 55 years). The patient Medical history was none. The concomitant medications were not reported. The patient historical Vaccine include PFIZER-BIONTECH COVID-19 VACCINE (1st dose via right arm) (Batch/Lot Number: ER2613) for covid-19 immunization on unspecified date in Mar2021 at 10:00 AM. The patient is not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There were no allergies reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in two weeks. The patient experienced Swelling of uvula (required emergency treatment) and tachycardia (required medical treatment) on 06Apr2021 at01:00 AM. The seriousness criteria are medically significant. The events result in emergency room/department or urgent care. The patient is treated with IV Benadryl and epinephrine nebulizer. The event outcome was recovered on unspecified date in Apr2021.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Blood pressure measurement, Ear discomfort, Heart rate, Hyperacusis
Clinical narrative: Ear ringing; ear fullness; sensitivity to sounds; This is a spontaneous report from a contactable consumer (patient).     A 57-year-old female, no-pregnancy patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm on 15Mar2021 11:00 at the age of 57-year-old, (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. Medical history included tobacco user (Former smoker), breast cancer. Concomitant medication included tamoxifen taken for breast cancer from 2013 and ongoing. The patient previously took cefatrizine propyleneglycolate (CEFTIN) and experienced urticaria.  The patient experienced ear ringing on 08Apr2021 with outcome of not recovered, the patient received steroid for this event with no effect. Following 1st vaccine, the patient also noted ear fullness, sensitivity to sounds day prior to 2nd vaccine, both on unknown date in 2021 with outcome of unknown. The patient underwent lab test which included audiogram: right:15, left: 15 on 2021, blood pressure measurement: 105/74mm[hg] on 2021, heart rate: 78 bpm on 2021, tympanometry: right: 20,left:15 on 2021, tympanometry: right: 1.4,left:1.2 on 2021.   The event ear ringing was assessed as serious, for disability and as important medical event.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Tympanometry
Clinical narrative: Ear ringing; ear fullness; sensitivity to sounds; This is a spontaneous report from a contactable consumer (patient).     A 57-year-old female, no-pregnancy patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm on 15Mar2021 11:00 at the age of 57-year-old, (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. Medical history included tobacco user (Former smoker), breast cancer. Concomitant medication included tamoxifen taken for breast cancer from 2013 and ongoing. The patient previously took cefatrizine propyleneglycolate (CEFTIN) and experienced urticaria.  The patient experienced ear ringing on 08Apr2021 with outcome of not recovered, the patient received steroid for this event with no effect. Following 1st vaccine, the patient also noted ear fullness, sensitivity to sounds day prior to 2nd vaccine, both on unknown date in 2021 with outcome of unknown. The patient underwent lab test which included audiogram: right:15, left: 15 on 2021, blood pressure measurement: 105/74mm[hg] on 2021, heart rate: 78 bpm on 2021, tympanometry: right: 20,left:15 on 2021, tympanometry: right: 1.4,left:1.2 on 2021.   The event ear ringing was assessed as serious, for disability and as important medical event.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Premature baby
Clinical narrative: Premature live birth 29 weeks; Maternal exposure during pregnancy first  trimester; This is a spontaneous report from a nurse (mother).   This other hcp reported information for both mother and fetus/baby.  This is a fetus/baby report.  A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 transplacental on 24Jan2021 (Batch/Lot number EL3247) and  dose 1 transplacental on 03Jan2021 (Batch/Lot EK9231) both as single dose  for covid-19 immunisation  .  The patient medical history was not reported. Concomitant medications included multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]) taken for prenatal care from 01Dec2020 to 01Aug2021; folic acid (FOLATE) taken for prenatal care from 01Dec2020 to 01Aug2021; acetaminophen (ACETAMINOPHEN) taken for pain, start and stop date were not reported; multivitamins (MULTIVITAMINS [VITAMINS NOS]) taken for prenatal care from an unspecified start date and ongoing.  The patient experienced maternal exposure during pregnancy first  trimester  (hospitalization, medically significant) on 03Jan2021 with outcome of unknown , premature live birth 29 weeks  (hospitalization, medically significant) on 03Jun2021 with outcome of unknown.    The mother LMP was on 12Nov2020 and received the first dose of BNT162B2 on 03Jan2021 and the second dose on 24Jan2021. The mother delivered the baby via cesarean sectio. The baby weight at birth was 1200gr; and the APGAR score was 5 at the first minute and 8 at five minutes; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Maternal exposure during pregnancy, first trimester and Premature birth  cannot be totally excluded. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Proctalgia, Rash, Rectal haemorrhage
Clinical narrative: Injection site pain; Rash both legs; Rectal bleeding; Rectal pain; Feeling abnormal; Skin disorder; Skin discoloration; Pain localised; This is a solicited report from a contactable consumer (patient) via a non-Pfizer sponsored program. A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number was not reported), intramuscularly on 20Aug2021 (at the age of 14-years-old) as dose 2, single for COVID-19 immunization; and adalimumab (HUMIRA), subcutaneously from 26May2021 (lot number was not reported) to an unspecified date at 80 mg (day 1, loading dose), and subcutaneously from 23Jun2021 (lot number was not reported) and ongoing at 40 mg (40 mg, 1 in 14) for pediatric Crohn's disease. Medical history included eczema. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was not reported) intramuscularly on an unspecified date as dose 1, single for COVID-19 immunization, and experienced bloody stool, Crohn's, dizziness, oral intake reduced, difficulty sleeping, fear, activities of daily living impaired, feeling sad, wound secretion, and cyst. In Aug2021, the patient experienced rectal bleeding, injection site pain, rash both legs, and rectal pain. On an unspecified date in 2021, the patient experienced feeling abnormal, skin disorder, skin discoloration, and pain localized. The action taken in response to the events for adalimumab was dose not changed. The outcome of events rectal bleeding, Rectal pain was recovered in Aug2021 while the event pain localised was recovered on an unspecified date in 2021. The outcome of the remaining events was unknown.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of the report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information, the causal association between the events rectal hemorrhage, feeling abnormal, vaccination site pain, rash, skin disorder, skin discolouration, pain and proctalgia and the suspect drug cannot be excluded. The case will be reassessed once new 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration, Skin disorder, Vaccination site pain
Clinical narrative: Injection site pain; Rash both legs; Rectal bleeding; Rectal pain; Feeling abnormal; Skin disorder; Skin discoloration; Pain localised; This is a solicited report from a contactable consumer (patient) via a non-Pfizer sponsored program. A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number was not reported), intramuscularly on 20Aug2021 (at the age of 14-years-old) as dose 2, single for COVID-19 immunization; and adalimumab (HUMIRA), subcutaneously from 26May2021 (lot number was not reported) to an unspecified date at 80 mg (day 1, loading dose), and subcutaneously from 23Jun2021 (lot number was not reported) and ongoing at 40 mg (40 mg, 1 in 14) for pediatric Crohn's disease. Medical history included eczema. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was not reported) intramuscularly on an unspecified date as dose 1, single for COVID-19 immunization, and experienced bloody stool, Crohn's, dizziness, oral intake reduced, difficulty sleeping, fear, activities of daily living impaired, feeling sad, wound secretion, and cyst. In Aug2021, the patient experienced rectal bleeding, injection site pain, rash both legs, and rectal pain. On an unspecified date in 2021, the patient experienced feeling abnormal, skin disorder, skin discoloration, and pain localized. The action taken in response to the events for adalimumab was dose not changed. The outcome of events rectal bleeding, Rectal pain was recovered in Aug2021 while the event pain localised was recovered on an unspecified date in 2021. The outcome of the remaining events was unknown.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of the report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information, the causal association between the events rectal hemorrhage, feeling abnormal, vaccination site pain, rash, skin disorder, skin discolouration, pain and proctalgia and the suspect drug cannot be excluded. The case will be reassessed once new 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: tingling and numbness on the left side of her body; tingling and numbness on the left side of her body; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient's husband). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on May2021 as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tingling and numbness on the left side of her body. It was reported that, "The reason for calling that because my wife she have the shot since May but I called my primary doctor and he is not picking up the phone and I have the pamphlet with me and there is number so I find the number and I am calling you so basically my wife she is being about looking at side effects I guess with tingling and numbness on the left side of her body." The outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Candida infection, Laboratory test, Oral candidiasis, Oropharyngeal pain, Pain
Clinical narrative: thrush; oral thrush; body aches; tongue is still brown and white and it's pretty thick; tongue is still brown and white and it's pretty thick; sore throat; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of BNT162B2 (Comirnaty COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8731), via an unspecified route of administration on 12Apr2021 (age at the time of vaccination 64-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (Comirnaty COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration on 22Mar2021 (age at the time of vaccination 64-years-old), as a single dose for COVID-19 immunization. On an unspecified date May2021, the patient experienced Sore throat; and on an unspecified date thrush, oral thrush, body aches, tongue is still brown and white and it's pretty thick. On an unspecified date, the patient underwent lab tests and procedures which included laboratory test: Unknown, this time she had other side effects with it, so she thought that she had COVID, and she had a test done. Patient stated, she has gone to the doctor and they gave her a mouth rinse and she has been taking Tylenol for the body aches and that sort of thing, but she doesn't know if that has anything to do with the COVID vaccine or if she should just look elsewhere. The outcome of the event Sore throat was recovered on an unspecified date 2021; and others event was unknown.  Follow-up (09Sep2021): This is a follow-up spontaneous report from a contactable consumer. This 64-year-old female consumer (patient) reported that which included: weight of the patient, adverse events, and outcome was updated in narrative.  Follow-up (14Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discolouration, Tongue disorder
Clinical narrative: thrush; oral thrush; body aches; tongue is still brown and white and it's pretty thick; tongue is still brown and white and it's pretty thick; sore throat; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of BNT162B2 (Comirnaty COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8731), via an unspecified route of administration on 12Apr2021 (age at the time of vaccination 64-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (Comirnaty COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration on 22Mar2021 (age at the time of vaccination 64-years-old), as a single dose for COVID-19 immunization. On an unspecified date May2021, the patient experienced Sore throat; and on an unspecified date thrush, oral thrush, body aches, tongue is still brown and white and it's pretty thick. On an unspecified date, the patient underwent lab tests and procedures which included laboratory test: Unknown, this time she had other side effects with it, so she thought that she had COVID, and she had a test done. Patient stated, she has gone to the doctor and they gave her a mouth rinse and she has been taking Tylenol for the body aches and that sort of thing, but she doesn't know if that has anything to do with the COVID vaccine or if she should just look elsewhere. The outcome of the event Sore throat was recovered on an unspecified date 2021; and others event was unknown.  Follow-up (09Sep2021): This is a follow-up spontaneous report from a contactable consumer. This 64-year-old female consumer (patient) reported that which included: weight of the patient, adverse events, and outcome was updated in narrative.  Follow-up (14Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, SARS-CoV-2 antibody test
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0182), via an unspecified route of administration in left arm on 12May2021 (at the age of 56 years old) as single for covid-19 immunisation. Medical history included chronic atrophic gastritis, prediabetes, gluten sensitivities. The patient had known allergies to shellfish, Bentyl, sulfa meds. There were no concomitant medications. The patient did not receive other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0171), via an unspecified route of administration in left arm on 21Apr2021 (at the age of 56 years old) for covid-19 immunisation. On 15Jun2021 patient experienced shingles. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 25Jul2021. The event resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Therapeutic measures were taken as a result of shingles with gabapentin and Tylenol with codeine. The outcome of event was recovered with sequelae on an unspecified date in 2021.