chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Abdominal pain, Back pain, Chest pain, Dyspnoea
Clinical narrative: I was fully vaccinated and I have become positive for Covid 19; I was fully vaccinated and I have become positive for Covid 19; Wish I could get antibody infusion. I feel pretty awful.; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that:  A patient (age and gender unspecified) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on unspecified date as dose 2, and dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. It was reported that the patient was fully vaccinated and become positive for Covid-19. On an unspecified date, the patient  become positive for Covid 19. The patient wish that they get antibody infusion and also feel pretty awful. The outcome of events was unknown.  No Follow-up attempts are possible. No information is expected further.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Nausea, SARS-CoV-2 test
Clinical narrative: I was fully vaccinated and I have become positive for Covid 19; I was fully vaccinated and I have become positive for Covid 19; Wish I could get antibody infusion. I feel pretty awful.; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that:  A patient (age and gender unspecified) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on unspecified date as dose 2, and dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. It was reported that the patient was fully vaccinated and become positive for Covid-19. On an unspecified date, the patient  become positive for Covid 19. The patient wish that they get antibody infusion and also feel pretty awful. The outcome of events was unknown.  No Follow-up attempts are possible. No information is expected further.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Rash morbilliform, Rash pruritic
Clinical narrative: Noticed a swollen lymph node that is tender in the lower curve of my neck today that is tender.; Noticed a swollen lymph node that is tender in the lower curve of my neck today that is tender.; It's on my neck, arms and legs. Red, raised, itchy bumps.; Measles type rash started this morning; This is a spontaneous report from a contactable Consumer. This consumer(patient) reported that, A 49-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 02Sep2021 19:30 (Batch/Lot Number: FC318Z) as DOSE 2, SINGLE for covid-19 immunisation (age at vaccination 49-years-old). The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right On 26Jul2021(07:00 PM) (Batch/Lot Number: FA7484) as DOSE 1, SINGLE for covid-19 immunisation (age at vaccination 49-years-old) and not received any other vaccine within 4 weeks. Medical history included Controlled high blood pressure and if covid prior vaccination: Yes, from an unknown date and unknown if ongoing. Concomitant medication included metoprolol tartrate (METOPROLOL XL) 25mg, acetylsalicylic acid (ASPIRIN (E.C.)) and boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN) taken within 2 weeks of vaccination. Patient was not pregnant at time of vaccination. The patient Noticed a swollen lymph node that is tender in the lower curve of my neck today that is tender on 07Sep2021(10:00 AM) and Measles type rash started this morning and has progressively gotten worse today. It's on my neck, arms, and legs. Red, raised, itchy bumps on 07Sep2021(06:00 AM). For treatment, she did not take nothing and not been tested covid post vaccination. Outcome of the events was not recovered.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Extra dose administered, Illness, Off label use
Clinical narrative: flashes in the right eye like lightening flashes; he got sick; congestion; developed terrible cough; shortness of breath on exertion; heart palpitations; blurred vision; he was administered the Pfizer COVID vaccine booster shot on 31Aug2021; he was administered the Pfizer COVID vaccine booster shot on 31Aug2021; This is a spontaneous report from a Pfizer-sponsored program  Support. A contactable male consumer (patient) and physician. A 78-year-old male patient received comirnaty (BNT162B2, solution for injection, Lot Number: FC3180; Expiration Date: 31Oct2021:  number: unknown) dose 3 (booster dose) via an unspecified route of administration, administered in the right arm on 31Aug2021 (at the age of 78 years old) as dose 3, single for COVID-19 immunisation at pharmacy. Vaccine was not administered at military facility. Medical history included hypertension (his mother had high blood pressure and passed from age in a home), arteriosclerosis from 1950 to an unknown date (father died when patient was real young from what they used to call hardening of the arteries back in the 1950s), cancer surgery (he is being treated for cancer, onset date of cancer is unknown, 3 years ago maybe). Historical vaccine includes BNT162B2 (Moderna Covid-19 Vaccine, Lot number: 027L2GA) dose 1 on 22Jan2021, administered in right shoulder as dose 1 single and dose 2 BNT162B2 (Moderna Covid-19 Vaccine, Lot number: 02UM20A) dose 2 on 24Feb2021, administered in right shoulder as dose 2 single for COVID-19 immunisation. Historical vaccine also included flu shot (patient takes every year). Concomitant medication was not reported. No PQC was present. Investigation assessment was not provided. On Sep2021 the patient experienced congestion, he was administered the pfizer covid vaccine booster shot on 31aug2021, developed terrible cough, shortness of breath on exertion, heart palpitations, blurred vision, flashes in the right eye like lightning flashes, he got sick. Patient had not visit to emergency/physician room. The clinical outcome of the events congestion developed terrible cough, shortness of breath on exertion, heart palpitations was reported as not recovered and clinical outcome of the events he was administered the pfizer covid vaccine booster shot on 31aug2021, blurred vision, flashes in the right eye like lightning flashes, he got sick was reported as unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Photopsia, Pulmonary congestion, Vision blurred
Clinical narrative: flashes in the right eye like lightening flashes; he got sick; congestion; developed terrible cough; shortness of breath on exertion; heart palpitations; blurred vision; he was administered the Pfizer COVID vaccine booster shot on 31Aug2021; he was administered the Pfizer COVID vaccine booster shot on 31Aug2021; This is a spontaneous report from a Pfizer-sponsored program  Support. A contactable male consumer (patient) and physician. A 78-year-old male patient received comirnaty (BNT162B2, solution for injection, Lot Number: FC3180; Expiration Date: 31Oct2021:  number: unknown) dose 3 (booster dose) via an unspecified route of administration, administered in the right arm on 31Aug2021 (at the age of 78 years old) as dose 3, single for COVID-19 immunisation at pharmacy. Vaccine was not administered at military facility. Medical history included hypertension (his mother had high blood pressure and passed from age in a home), arteriosclerosis from 1950 to an unknown date (father died when patient was real young from what they used to call hardening of the arteries back in the 1950s), cancer surgery (he is being treated for cancer, onset date of cancer is unknown, 3 years ago maybe). Historical vaccine includes BNT162B2 (Moderna Covid-19 Vaccine, Lot number: 027L2GA) dose 1 on 22Jan2021, administered in right shoulder as dose 1 single and dose 2 BNT162B2 (Moderna Covid-19 Vaccine, Lot number: 02UM20A) dose 2 on 24Feb2021, administered in right shoulder as dose 2 single for COVID-19 immunisation. Historical vaccine also included flu shot (patient takes every year). Concomitant medication was not reported. No PQC was present. Investigation assessment was not provided. On Sep2021 the patient experienced congestion, he was administered the pfizer covid vaccine booster shot on 31aug2021, developed terrible cough, shortness of breath on exertion, heart palpitations, blurred vision, flashes in the right eye like lightning flashes, he got sick. Patient had not visit to emergency/physician room. The clinical outcome of the events congestion developed terrible cough, shortness of breath on exertion, heart palpitations was reported as not recovered and clinical outcome of the events he was administered the pfizer covid vaccine booster shot on 31aug2021, blurred vision, flashes in the right eye like lightning flashes, he got sick was reported as unknown.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report received from a non-contactable consumer (parent)via medical information team. A female patient of unspecified age received BNT162B2 (COMIRNATY, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on 01Aug2021, at dose 1, single for covid-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced diarrhea on an unspecified date in Aug2021. The outcome of the event was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: she is in critical condition from high blood pressure; This is a spontaneous report from a non-contactable consumer (patient's son) Pfizer sponsored program. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection; Lot Number: not reported, expiration date: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on an unspecified date as SINGLE for covid-19 immunization. Reporter stated, on an unspecified date, she is in critical condition from high blood pressure. Reporter also stated patient received both doses of the Pfizer Covid-19 vaccine. She now needs to be admitted to the hospital because she is in critical condition from high blood pressure. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Myalgia, Paraesthesia
Clinical narrative: tingling feeling in her calves and ankles; headache; muscle pain in her legs from her thighs down to her ankles; Getting out of bed hurts, it's debilitating; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 61-year-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 for COVID-19 immunization. On an unspecified date in Aug2021, the patient experienced tingling feeling in her calves and ankles, headache, muscle pain in her legs from her thighs down to her ankles, getting out of bed hurts, it's debilitating. Patient is a 61 y/o female. Patient reports receiving her second Comirnaty vaccine on 11Aug2021. Patient had a mild headache following the vaccine and approximately 1 week after the vaccine dose patient began to experience muscle pain in her legs from her thighs down to her ankles and a tingling feeling in her calves and ankles. Patient reports that the pain and tingling move around and is debilitating to the point where she wants to cry. Patient reports feeling these sensations 70% in her legs and 30% in her hands. Getting out of bed hurts, it's debilitating, my life is devastated. It's been going on for weeks now. Patient wants to know if we have information on this side effect and will it ever go away. Outcome of the events tingling feeling in her calves and ankles, muscle pain in her legs from her thighs down to her ankles, getting out of bed hurts, it's debilitating was not recovered and headache was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Body temperature increased, Diarrhoea, Lymphadenopathy
Clinical narrative: diarrhea; stomach cramping; sore throat; running a temperature; lymph node in right arm same side as shot is swollen the size of goose egg; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: FD8448, Expiration date: 31Oct2021) via an unspecified route of administration, administered in arm right on 04Sep2021 13:00 (age at vaccination: 46-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included both herself and her husband had a pretty heavy case of covid-19 in Mar2020. Relevant medical history and concomitant medications included none. On 04Sep2021, the patient had experienced running a temperature, lymph node in right arm same side as shot was swollen to the size of goose egg, diarrhea, stomach cramping and sore throat. The patient underwent lab tests and procedures which included sars-cov-2 test: covid-19 in Mar2020; body temperature: 99.8 on 04Sep2021, and on unknown date in 2021 it was 101.3-101.8. Therapeutic measures were taken as a result of running a temperature, lymph node in right arm same side as shot was swollen to the size of goose egg, diarrhea, stomach cramping, sore throat and included Tylenol and Imodium. The outcome of the event running a temperature was recovering and other events was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: diarrhea; stomach cramping; sore throat; running a temperature; lymph node in right arm same side as shot is swollen the size of goose egg; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: FD8448, Expiration date: 31Oct2021) via an unspecified route of administration, administered in arm right on 04Sep2021 13:00 (age at vaccination: 46-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included both herself and her husband had a pretty heavy case of covid-19 in Mar2020. Relevant medical history and concomitant medications included none. On 04Sep2021, the patient had experienced running a temperature, lymph node in right arm same side as shot was swollen to the size of goose egg, diarrhea, stomach cramping and sore throat. The patient underwent lab tests and procedures which included sars-cov-2 test: covid-19 in Mar2020; body temperature: 99.8 on 04Sep2021, and on unknown date in 2021 it was 101.3-101.8. Therapeutic measures were taken as a result of running a temperature, lymph node in right arm same side as shot was swollen to the size of goose egg, diarrhea, stomach cramping, sore throat and included Tylenol and Imodium. The outcome of the event running a temperature was recovering and other events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Extrasystoles, Lung disorder, Peripheral swelling, Scleroderma
Clinical narrative: They think I may have Scleroderma; heart skipped beats less; swelling in my legs; my heart and lungs affected; My skin was thick and tight; my heart and lungs affected; This is a spontaneous report received from a contactable consumer or other non hcp. A patient of unspecified age and gender received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on Aug2021 as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced may have scleroderma on 2021, heart skipped beats less, swelling in my legs,heart and lungs affected, my skin was thick and tight on 2021.The outcome of the events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Skin tightness
Clinical narrative: They think I may have Scleroderma; heart skipped beats less; swelling in my legs; my heart and lungs affected; My skin was thick and tight; my heart and lungs affected; This is a spontaneous report received from a contactable consumer or other non hcp. A patient of unspecified age and gender received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on Aug2021 as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced may have scleroderma on 2021, heart skipped beats less, swelling in my legs,heart and lungs affected, my skin was thick and tight on 2021.The outcome of the events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient tested positive for COVID on 05Sep2021; Patient tested positive for COVID on 05Sep2021; This is a spontaneous report from a contactable other healthcare professional. A 12-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0175) via intramuscular on 15May2021 (12-year-old at the time of vaccination) as dose 1, single, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0175) via intramuscular on 05Jun2021 (12-year-old at the time of vaccination) as dose 2, single for covid-19 immunization. Medical history included the patient was infected with COVID 19 in December 2020 and unknown if ongoing. The patient's concomitant medications were not reported. The patient was fully vaccinated. The patient had covid prior to vaccination. The patient was tested since vaccination. On 05Sep2021, the patient was tested positive for COVID. The patient underwent lab tests and procedures which included COVID test positive on 05Sep2021. The outcome of the events were recovering.  No follow-up attempts are possible. No further information is expected. Based on plausible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported events  The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received BNT162B2 and it was longer than 7 days after their 2nd dose that they contracted COVID-19/Patient was vaccinated and contracted COVID-19; Received BNT162B2 and it was longer than 7 days after their 2nd dose that they contracted COVID-19/Patient was vaccinated and contracted COVID-19; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), on an unspecified date (lot number was not reported) as dose 1, single; then on an unspecified date (lot number was not reported) as dose 2, single - both via an unspecified route of administration for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received BNT162B2 and it was longer than 7 days after their 2nd dose that they contracted COVID-19 on an unspecified date. The patient was vaccinated and contracted COVID-19 who died with it and they were young. The patient underwent COVID-19 RT-PCR test: contracted COVID, positive on an unspecified date. The patient died due to COVID-19 and drug ineffective. It was unknown if an autopsy was performed or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Drug ineffective; COVID-19
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Myalgia, Pain in extremity
Clinical narrative: muscles and joints in her left arm hurt; numbness in her fingers; muscles and joints in her left arm hurt; muscles and joints in her left arm hurt; This is a spontaneous report from a contactable nurse. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown), via an unspecified route of administration on 03Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that on an unspecified date in Sep2021, patient experienced muscle and joint pain along with numbness in her fingers that feels off because of the muscles and joints in her left arm was hurt. The outcome of the event was unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Herpes zoster, Off label use, SARS-CoV-2 test
Clinical narrative: Shingles left shoulder and posterior neck; the Pfizer booster (#3); the Pfizer booster (#3); This is a spontaneous report from a contactable physician. A 56-years-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: AF7485) (age at the time of vaccination was 56 years and non-pregnant at the time of vaccination) via an intramuscular route of administration on 30Aug2021 at 10:30 in right arm as dose 3, single for COVID-19 immunisation. The patient medical history included psoriatic arthropathy and psoriatic arthritis. Concomitant medications included Celebrex and Humira. The patient had known allergies with Climdamycin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination were Steriod and Humira. No COVID prior vaccination. COVID tested positive post vaccination. The patient previosuly received 1st and 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unknown route of administration on an unknown date as dose 1, single and dose 2, single for COVID-19 immunisation. On 01Sep2021 22:00, the patient experienced shingles left shoulder and on posterior neck and on 30Aug2021 10:30 the pfizer booster (3) was taken. The event shingles left shoulder and posterior neck resulted in Doctor or other healthcare professional office/clinic visitx. The patient underwent lab tests and procedures which included sars-cov-2 test: nasal swab on Jul2021, Covid test post vaccination: Covid test type post vaccination: Nasal Swab, Covid test date: Jul2021 Covid test result: Negative. Treatment was received for the event shingles left shoulder and posterior neck (Valtrex 1gm every 8 hours for 7 days). The outcome of event shingles left shoulder and on posterior neck was not recovered.  Follow-up attempts are completed. No further information was expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling hot, Hyperhidrosis, Malaise, Nausea
Clinical narrative: didn't feel good; woke up itching really bad; raise her right arm which hurt; Nausea; Sweating; felt hot but didn't have  a fever; Diarrhea; This is a spontaneous report from a contactable other hcp. A 54-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 02Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included fatty liver disease and hypothyroid from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The caller is calling about the Pfizer covid vaccine. The caller tried to get on VSAFE and wanted to report her side effects but was unable to. On 03Sep2021 the caller has experienced the sweating and things like that. The caller started itching and having whelps come up. The caller has taken Benadryl and its helped, but she still has it. It feels like it's not bad like it was before the Benadryl, but the caller feels like a sensation like she wants to scratch. The caller woke up the second night with this itching. Friday morning the caller had sweating, and she felt hot but didn't have a fever, had diarrhea and didn't feel good. Saturday the caller woke up and went to raise her right arm which hurt to lift it, but she got her shot in the left arm and she had nausea. Sunday the caller was better. Monday morning the caller woke up itching bad and took Benadryl. Then last night this happened again early in the morning, she woke-up itching. The outcome of the event raise her right arm which hurt, woke up itching really bad was not recovered and outcome of the event didn't feel good was unknown and outcome for other events was recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: didn't feel good; woke up itching really bad; raise her right arm which hurt; Nausea; Sweating; felt hot but didn't have  a fever; Diarrhea; This is a spontaneous report from a contactable other hcp. A 54-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 02Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included fatty liver disease and hypothyroid from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The caller is calling about the Pfizer covid vaccine. The caller tried to get on VSAFE and wanted to report her side effects but was unable to. On 03Sep2021 the caller has experienced the sweating and things like that. The caller started itching and having whelps come up. The caller has taken Benadryl and its helped, but she still has it. It feels like it's not bad like it was before the Benadryl, but the caller feels like a sensation like she wants to scratch. The caller woke up the second night with this itching. Friday morning the caller had sweating, and she felt hot but didn't have a fever, had diarrhea and didn't feel good. Saturday the caller woke up and went to raise her right arm which hurt to lift it, but she got her shot in the left arm and she had nausea. Sunday the caller was better. Monday morning the caller woke up itching bad and took Benadryl. Then last night this happened again early in the morning, she woke-up itching. The outcome of the event raise her right arm which hurt, woke up itching really bad was not recovered and outcome of the event didn't feel good was unknown and outcome for other events was recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood disorder
Clinical narrative: This is a spontaneous report from Pfizer sponsored program COVAX US Support. A contactable pharmacist reported for a female patient. A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number, Expiry Date, NDC number: Unknown) as dose 2, single and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number, Expiry Date, NDC number: Unknown) as dose 1, single both taken for COVID-19 immunization. Medical history included blood transfusion 23 days ago from an unknown date and unknown if ongoing and concomitant medications were not reported. The reporter called regarding administering the 3rd dose of the Pfizer COVID vaccine to a patient that had a blood transfusion 23 days ago (on an unspecified date) and asked for recommendations for this patient regarding receiving the 3rd dose or booster of the Pfizer Covid vaccine and had no lots, expiry dates or NDC numbers to provide for the patient's Pfizer COVID vaccine but stated the blood transfusion was after the 1st and 2nd dose of the patient's Pfizer COVID vaccine. The event outcome was unknown. The lot number for the vaccine, (BNT162B2), was not provided and would be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Dizziness, Dyspnoea, Headache
Clinical narrative: she felt that her legs felt weak; dizziness and weakness; headache went to her right side. Had chest pain; dizziness and weakness; hard time taking inhaler as she had a hard time breathing; Had chest pain, left side above her breast; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). This is a report received from Pfizer sponsored program. A female patient of unspecified age received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiry date was not reported), dose 1 via an unspecified route of administration, administered on 01Sep2021 as dose 1, single for covid-19 immunisation. The patient medical history included loss of smell and other Covid symptoms started couple of months ago (patient thought she had Covid) and she was tested negative but still patient felt she had Covid. The concomitant medications were not reported. On an unspecified date in Sep2021, the patient experienced dizziness and weakness on 2nd day after vaccine. and 3rd day after getting the first dose of the vaccine. On 04Sep2021, she felt that her legs felt weak (On her 4th day from vaccination). On an unspecified date in Sep2021, the patient also experienced a hard time taking inhaler as she had a hard time breathing and headache went to her right side and had chest pain, left side above her breast. Asking if she could take the second dose after all these. The patient was able to speak to her doctor at the time of events. The patient got her first dose of the vaccine on 01Sep2021 and was wondering if we have info on how soon can she expect antibodies as she has only gotten her first dose 7 days from today. Asking how soon after her first dose can she take an antibody test and that if she would have some level of protection after her first dose of the vaccine. The patient lab test was included as Covid test: negative on an unspecified date. The clinical outcome of the events was unknown at the time of the report.  information about lo/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, SARS-CoV-2 test
Clinical narrative: she felt that her legs felt weak; dizziness and weakness; headache went to her right side. Had chest pain; dizziness and weakness; hard time taking inhaler as she had a hard time breathing; Had chest pain, left side above her breast; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). This is a report received from Pfizer sponsored program. A female patient of unspecified age received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiry date was not reported), dose 1 via an unspecified route of administration, administered on 01Sep2021 as dose 1, single for covid-19 immunisation. The patient medical history included loss of smell and other Covid symptoms started couple of months ago (patient thought she had Covid) and she was tested negative but still patient felt she had Covid. The concomitant medications were not reported. On an unspecified date in Sep2021, the patient experienced dizziness and weakness on 2nd day after vaccine. and 3rd day after getting the first dose of the vaccine. On 04Sep2021, she felt that her legs felt weak (On her 4th day from vaccination). On an unspecified date in Sep2021, the patient also experienced a hard time taking inhaler as she had a hard time breathing and headache went to her right side and had chest pain, left side above her breast. Asking if she could take the second dose after all these. The patient was able to speak to her doctor at the time of events. The patient got her first dose of the vaccine on 01Sep2021 and was wondering if we have info on how soon can she expect antibodies as she has only gotten her first dose 7 days from today. Asking how soon after her first dose can she take an antibody test and that if she would have some level of protection after her first dose of the vaccine. The patient lab test was included as Covid test: negative on an unspecified date. The clinical outcome of the events was unknown at the time of the report.  information about lo/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Polymerase chain reaction, Sneezing, Vaccination failure
Clinical narrative: Tested positive with PCR test; Tested positive with PCR test; sneezing; slight headache; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EP6995) via intramuscular, administered in Arm Right on 30Mar2021 at 14:00 (at the age of 48-year-old) as dose 2, single and dose 1, bnt162b2 (BNT162B2, Solution for injection, Lot Number:EL3247) via intramuscular, administered in Arm Right on 09Mar2021 at 14:45 (at the age of 47-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included Hashimoto Disease (thyroid) and  the patient was allergic to dairy, wheat, egg white, soy, corn. Concomitant medication included levothyroxine sodium (LEVOXYL) taken for an unspecified indication. Prior to vaccination the patient was not diagnosed with COVID-19. Patient stated that he tested positive with PCR test taken on 05Sep2021,no symptoms other than some sneezing, slight headache evening of 05Sep. Since the vaccination in 2021, the patient been tested for COVID-19. The patient underwent lab tests and procedures which included polymerase chain reaction: positive on 05Sep2021(Nasal Swab). The outcome of the event events was recovered on unknown date in Sep2021.  Follow-Up (10Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Skin exfoliation
Clinical narrative: "running nose, like a cold"; "skin on feet peeled"; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (Mother) reported for a 44-year-old female patient (Daughter) that:  A 44-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. Medical history included latex allergy, and allergy to avocado, bananas over 20 years ago she was also diagnosed, figs, 2 anaphylactic shocks so she knows how to manage. The patient concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, 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 and experienced nose kept running like a faucet, skin peeled off under her feet, very sick, After the first dose, Daughter had severe reactions: nose kept running like a faucet, skin peeled off under her feet, and was very sick for 3 days. The patient previously took flu shot, every year with no problem. On an unspecified date, the patient experienced "running nose, like a cold", "skin on feet peeled". Caller mentioned she has some food allergies, and the allergist cautioned her about polyethylene glycol (PEG). Caller has an appointment on Monday. She also takes Zyrtec everyday and has no reaction to it. Caller asked if there was another ingredient that people are allergic. The clinical outcome of events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products, Off label use, Pain in extremity, Throat irritation
Clinical narrative: throw up; had a little tickle in the back of my throat; Her left arm was also sore; They both had the first 2 shots with Moderna. She and her husband took the Pfizer-BioNTech COVID-19 Vaccine booster shot 2 weeks ago; They both had the first 2 shots with Moderna. She and her husband took the Pfizer-BioNTech COVID-19 Vaccine booster shot 2 weeks ago; They both had the first 2 shots with Moderna. She and her husband took the Pfizer-BioNTech COVID-19 Vaccine booster shot 2 weeks ago; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 77-years-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date in Aug2021 (age at vaccination was unknown) as dose 3, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first and second dose of COVID-19 vaccine MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single and dose 2, single for COVID-19 immunization. The patient and her husband took the Pfizer-BioNTech COVID-19 Vaccine booster shot 2 weeks ago, last Sunday. It would have been 14 days on 06Sep2021. They both had the first 2 shots with Moderna. She asked if Pfizer was making a study about mixed doses and their side effect. She said that they could be a subject. The patient didn't know if that was related to Pfizer. It didn't happen until last Saturday. On an unspecified date in Aug2021, the patient did throw up and had a little tickle in the back of her throat. She said that she was going to take a COVID test to double check. Her left arm was also sore but she wasn't sure if it was from old age. It was a little sore all week. She also had some medications and not sure if those might have caused it. She noted that it was deep in the muffle, from her shoulder to elbow. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: throw up; had a little tickle in the back of my throat; Her left arm was also sore; They both had the first 2 shots with Moderna. She and her husband took the Pfizer-BioNTech COVID-19 Vaccine booster shot 2 weeks ago; They both had the first 2 shots with Moderna. She and her husband took the Pfizer-BioNTech COVID-19 Vaccine booster shot 2 weeks ago; They both had the first 2 shots with Moderna. She and her husband took the Pfizer-BioNTech COVID-19 Vaccine booster shot 2 weeks ago; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 77-years-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date in Aug2021 (age at vaccination was unknown) as dose 3, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first and second dose of COVID-19 vaccine MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single and dose 2, single for COVID-19 immunization. The patient and her husband took the Pfizer-BioNTech COVID-19 Vaccine booster shot 2 weeks ago, last Sunday. It would have been 14 days on 06Sep2021. They both had the first 2 shots with Moderna. She asked if Pfizer was making a study about mixed doses and their side effect. She said that they could be a subject. The patient didn't know if that was related to Pfizer. It didn't happen until last Saturday. On an unspecified date in Aug2021, the patient did throw up and had a little tickle in the back of her throat. She said that she was going to take a COVID test to double check. Her left arm was also sore but she wasn't sure if it was from old age. It was a little sore all week. She also had some medications and not sure if those might have caused it. She noted that it was deep in the muffle, from her shoulder to elbow. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Extra dose administered, Feeling hot
Clinical narrative: who was inadvertently given a 3rd dose of the COMIRNATY vaccine yesterday afternoon; who was inadvertently given a 3rd dose of the COMIRNATY vaccine yesterday afternoon; experienced having a hard time breathing further described as congested; experienced having a hard time breathing further described as congested; throws up; tingling of hands (needle like); fever; chills; felt hot; This is a spontaneous report from a contactable consumer. A 25-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 06Sep2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historic vaccine included first and second dose of BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. On an unspecified date in Sep2021, the patient experienced having a hard time breathing further described as congested, throws up, tingling of hands, fever, chills, felt hot, on 06Sep2021, who was inadvertently given a 3rd dose of the comirnaty vaccine yesterday afternoon. Caller called for his wife about the Pfizer Covid vaccine, She was inadvertently given a 3rd dose of the COMIRNATY vaccine yesterday afternoon (06Sep2021) by a local pharmacy even though patient did not fall into the category of being immunocompromised. Caller mentioned that the Pharmacy tech gave the 3rd dose to her wife with the premise of her mother being immunocompromised and that she could have been potentially exposed to her. Also, another information was given that the dose given to her wife was a dose supposed to be disposed because it was an extra one and thus offering it to her wife so that dose will not be put to waste. They gave her the vaccine anyway because of the patient's mother; states the patient's mother was not able to get the 3rd dose of the Pfizer Covid vaccine and that was the reason they gave the patient her 3rd dose and he wanted to know if this is what is recommended and she was also having side effects. Stated the patient was having a hard time breathing and threw up this morning and her hands are getting tingly and she had got a little bit of fever 100.2 degrees as of 20 minutes ago; states the patient was taking Ibuprofen and nothing seems to be better regarding her side effects and she had to be driven home and could not drive herself home. The patient underwent lab tests and procedures which included body temperature: 100.2 degrees. Therapeutic measures were taken as a result of adverse events. The outcome of events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.