chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Anxiety, Confusional state, Diarrhoea, Fatigue
Clinical narrative: Confusion, anxiety,  4 to 5 days.  Went back in time with things that happened years ago,  brain fog. Abdominal gut pain , diarrhea.  Exhaustion lasting 2 weeks.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gastrointestinal pain
Clinical narrative: Confusion, anxiety,  4 to 5 days.  Went back in time with things that happened years ago,  brain fog. Abdominal gut pain , diarrhea.  Exhaustion lasting 2 weeks.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Exposure to SARS-CoV-2, Swelling
Clinical narrative: recieved first dose and was diagnosed with covid; recieved first dose and was diagnosed with covid/Started showing symptoms; I had COVID/; experienced swelling; on 25Jan I exposed to someone who had COVID; This is a spontaneous report from a contactable consumer a male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL0142) via an unspecified route of administration on 28Jan2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was diagnosed with COVID-19 infection on an unspecified date, started showing symptoms; had COVID-19 infection, on 25jan i exposed to someone who had covid ( COVID-19 infection  on 25Jan2021 with outcome of recovered, experienced swelling (swelling) (non-serious) on an unspecified date with outcome of recovered. Description of Product Complaint: The consumer stated that he was calling to see if he can get some guidance on whether he should get his second dose or not. Here is the reason why, on 25Jan he was exposed to someone who had COVID. He didn't know that at the time. On 28Jan he got first dose of the vaccine. On 29Jan he started showing symptoms. On 30Jan he was in emergency room and had the antibody infusion treatment. He was recovered and due for his second dose on 18th but given the facts that he had COVID and had antibody treatment makes him want to know if he should still be getting the second dose. Pharmacy says one thing and his doctor says another so he was wondering what Pfizer says. Therapeutic measures were taken. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Syncope
Clinical narrative: Site: Swelling at Injection Site-Mild, Systemic: Patient fell off and fainted for 1 minute-Mild, Additional Details: EMT came and checked on her vitals. Everything was normal. Pt left and drove home safety
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: few chills; sore arm-left arm at site; This is a spontaneous report from a contactable consumer (patient, self -reported). A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL8982 and expiry date was not provided), via an unspecified route of administration in arm left, on 04Feb2021, at 11:00 AM, as single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 14Jan2021 and experienced both cheeks were very rosy red. It was reported that patient received second dose of vaccine on 04Feb2021 at 11:00 AM. Later that day in evening, patient had a sore arm-left arm at site. Next morning (05Feb2021), patient had a few chills, no fever. By Friday after noon (05Feb2021) arm was not sore and no chills. Patient felt good and did not really have any bad reaction. Outcome of the events was recovered on 05Feb2021.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: arm swelled; hot at injection site; This is a spontaneous report received from a contactable consumer reported that:  A 78-years-old female patient received bnt162b2 (BNT162B2; solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 03Feb2021 17:30 (Batch/Lot Number: EL1283) as single dose and on 13Jan21 receveid BNT162b2 (Lot#EL0142)as single dose for covid-19 immunisation. The patient medical history was unknown. The patient's concomitant medications were unknown. On an unspecified date, the patient experienced arm swelled, hot at injection site. After 2nd day, occurred after 4th day. number of previous doses was 2nd shot. Outcome of the events were unknown.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus
Clinical narrative: He reported that he had puffiness around his lips and he was itching like crazy; itchiness; This is a spontaneous report from a contactable consumer or other non hcp. A 79-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 04Feb2021 (Batch/Lot Number: EN4809) as SINGLE DOSE for covid-19 immunisation. Medical history included surgery (three or four years ago) and gastrooesophageal reflux disease. Concomitant medication(s) included metformin; metoprolol; acetylsalicylic acid (BABY ASPIRIN); amlodipine; rosuvastatin; ezetimibe; famotidine (PEPCID [FAMOTIDINE]) for gastrooesophageal reflux disease; irbesartan and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient reported, he received his first shot of the Pfizer BioNTech COVID-19 vaccine on 04Feb2021 and is scheduled to receive his second on 22Feb2021. States that after his first dose, he experienced puffiness around his lip and itching like crazy with scratching his forehead, scalp, and shoulder. He hasn't experienced these symptoms for the last 4-5 days and reports it wasn't nasty. It doesn't last long. It has been tolerable. He remembers when he got the Shingles shot he had some itchiness. At the end of this week, he has to get the second shot. The outcome of event Lip swelling was recovered and for itchiness it was unknown on 06Feb2021.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive for COVID infection 3 days after receiving my vaccine; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine: Formulation: solution for injection) via an unspecified route of administration on 03Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. An unspecified date the patient received antibodies infusion for an unspecified underlying condition, the patient had in quarantine and back to normal, after 3 days of vaccination the patient reported COVID positive infection. The outcome of the events was unknown.  Information of lot/batch number has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Pain
Clinical narrative: injection site soreness; fairly severe chills; body aches; headache; This is a spontaneous report from a contactable consumer. A 48-Year-old male consumer (patient) reported that for herself that: he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL3247), via an unspecified route of administration on 17-FEB-2021 10:00 AM at single dose in left arm for covid-19 immunization. The patient's medical history included Factor V Leiden blood clotting disorder or mutation. Historical vaccine included BNT162B2 for covid-19 immunization (lot number: EL3247, administration date: 27Jan2021, administration time: 11:00 AM, vaccine location: Right arm and dose number: 1). Concomitant medications included eliquis (APIXABAN). On 18-FEB-2021 at 12:00, the patient experienced approximately 14hours post 2nd vaccination, injection site soreness, fairly severe chills, body aches and headache. Chills lasted 4- 5hours then subsided. Body aches and headache continue 26hours post vaccination. The patient took OTC pain reliever help to alleviate symptoms. The outcome of the events was recovering.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Vaccination site pain
Clinical narrative: Developed sroeness at injection site; nocturnal nasal congestion; This is a spontaneous report from a contactable pharmacist. A 64-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot #;EL3247), dose 1 via an unspecified route of administration, administered in Arm Right on 17Feb2021 11:45 as SINGLE DOSE for covid-19 immunisation. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing, vasomotor rhinitis from an unknown date and unknown if ongoing, benign prostatic hyperplasia from an unknown date and unknown if ongoing, dry eye from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 17Feb2021 18:30, the patient experienced developed sroeness at injection site, nocturnal nasal congestion. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of developed sroeness at injection site (vaccination site pain), nocturnal nasal congestion (nasal congestion). The outcome of the event was recovering.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Pain
Clinical narrative: Headache; generalized body aches; pain in left arm injection site; severe fatigue; chills; mild fever; dizziness; This is a spontaneous report from a contactable consumer (patient). A 30-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL3247, Expiration Date: unknown), via an unspecified route of administration in left arm on 17Feb2021 at 03:15 as a single dose for covid-19 immunization. Medical history included ongoing OCD and depression. Concomitant medications included escitalopram (ESCITALOPRAM) 10 mg once daily, Multivitamin. The patient known allergies: Erythromycin and Azithromycin. Historical vaccines included first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3247) via Left arm for covid-19 immunization on 27Jan2021. The patient experienced headache, generalized body aches, pain in left arm injection site, severe fatigue, chills, mild fever, dizziness on 18Feb2021 at 05:00 AM. Patient has been tested for COVID-19 with test type: nasal swab on 05Jan2020 with result negative. No other vaccine in four weeks. Patient covid tested post vaccination yes. No covid prior vaccination. No treatment received for the event. The outcome of the events was not recovered.  No follow up attempts are needed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Vaccination site pain
Clinical narrative: Headache; generalized body aches; pain in left arm injection site; severe fatigue; chills; mild fever; dizziness; This is a spontaneous report from a contactable consumer (patient). A 30-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL3247, Expiration Date: unknown), via an unspecified route of administration in left arm on 17Feb2021 at 03:15 as a single dose for covid-19 immunization. Medical history included ongoing OCD and depression. Concomitant medications included escitalopram (ESCITALOPRAM) 10 mg once daily, Multivitamin. The patient known allergies: Erythromycin and Azithromycin. Historical vaccines included first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3247) via Left arm for covid-19 immunization on 27Jan2021. The patient experienced headache, generalized body aches, pain in left arm injection site, severe fatigue, chills, mild fever, dizziness on 18Feb2021 at 05:00 AM. Patient has been tested for COVID-19 with test type: nasal swab on 05Jan2020 with result negative. No other vaccine in four weeks. Patient covid tested post vaccination yes. No covid prior vaccination. No treatment received for the event. The outcome of the events was not recovered.  No follow up attempts are needed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received the first dose of the Pfizer covid vaccine and subsequently tested positive for covid; received the first dose of the Pfizer covid vaccine and subsequently tested positive for covid; This is a spontaneous report from contactable consumer (patient's wife).  A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer covid vaccine and subsequently tested positive for covid. The patient experienced received the first dose of the Pfizer covid vaccine and subsequently tested positive for covid on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The event was assessed as medically significant. Outcome of the event was unknown.  Information on the lot batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Dyspnoea, Dysstasia, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received first dose of BNT162B2 (COMIRNATY, Formulation: solution for injection, Lot Number: EM9809), dose 1 via an unspecified route of administration, administer in arm left on 16Feb2021 14:15 as single dose for covid-19 immunisation. The medical history not reported. known allergy to Wheat. Concomitant medications included Vitamin D, Biotin, Alpha Lipoic Acid, MSM (methylsulfonylmethane), Vit B12 (cyanocobalamin). On 16Feb2021 20:00 approximately 6 hours post injection she became extremely tired, having difficulty sitting or standing upright and having to make an effort to speak clearly her speech was slowed, she had lay down and went to sleep about 1 1/2 hours later she woke up, feeling much more normal then she went back to sleep and slept through the night. The next morning on 17Feb2021 she went pole walk in her hilly neighborhood, she removed her mask to breathe better and was audibly wheezing no pain and no inability to walk at her usual, rapid pace. she had some tiredness that day but not to the degree of the day before. There was no wheezing on 18Feb2021, and no tiredness so far. No other vaccine in four weeks. No COVID-19 prior vaccination and No COVID-19 tested post vaccination. Patient did not receive any treatment.  The outcome of the events was recovered on 18Feb2021.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Flatulence, Gastrooesophageal reflux disease
Clinical narrative: acid reflex; Gas; This is a spontaneous report from a contactable 74-year-old male consumer (patient) reported for himself that she received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 17Feb2021, 09:00AM, at single dose in left arm for covid-19 immunization. The patient's medical history included liver receipient. Concomitant medications included tacrolimus (PROGRAF), omeprazole, sodium citrate and latanoprost. On 17Feb2021 13:00, the patient experienced acid reflex and gas. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered.  Information on the Batch/Lot number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 10Feb2021 at single dose for covid-19 immunisation administered at Hospital. The patient medical history and concomitant medications were not reported. The patient reported, he was vaccinated on 10 Feb 2021 and tested positive via a Rapid Antigen test yesterday, 17 Feb 2021. Confirmed as tested positive for COVID. He stated patient is in between the two doses. 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. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Covid-19 positive; This is a spontaneous report from a Pfizer-sponsored program. A contactable unspecified age of female consumer reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 06Feb2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 11Feb2021, the patient experienced covid-19 positive. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; Nausea; This is a spontaneous report from a contactable consumer (patient). A 66-year-old (non pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: Unknown, Expiry Date: Unknown,) via an unspecified route of administration on 16Feb2021 12:30 PM at single dose for COVID-19 immunisation. Patient did not take any other vaccine in four weeks. Patient's medical history included breast cancer and allergies to adhesive. The patient's concomitant medications were not reported. On 17Feb2021, the patient experienced headache, nausea. There was no covid prior vaccination and no covid tested post vaccination. Patient did not receive any treatment. The outcome of event was recovered on an unspecified date.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Chills, Fatigue
Clinical narrative: backache/back pain; chills; shoulder and stomach ache/joint pain; shoulder and stomach ache; Pain in arm; tired; Headache; muscle pain; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Feb2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that experiencing side effects such as backache, chills, shoulder and stomach ache on an unspecified date in Feb2021. Pain in arm, tired, Headache. muscle and joint pain and chills and back pain on an unspecified date in Feb2021. The outcome of the events was reported as unknown.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity
Clinical narrative: backache/back pain; chills; shoulder and stomach ache/joint pain; shoulder and stomach ache; Pain in arm; tired; Headache; muscle pain; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Feb2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that experiencing side effects such as backache, chills, shoulder and stomach ache on an unspecified date in Feb2021. Pain in arm, tired, Headache. muscle and joint pain and chills and back pain on an unspecified date in Feb2021. The outcome of the events was reported as unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: slight headache; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced slight headache. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in the arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient) reported that female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiry date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. Patient received Pfizer Covid-19 vaccine 2nd dose and experienced pain in the arm on an unspecified date. Wanted to know if she can take Ibuprofen after the shot. The outcome of the event was unknown.  Information about the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: doctor received both doses of Pfizer's COVID vaccine and resulted in zero antibodies after taking an antibody test.; This is a spontaneous report from a contactable pharmacist via medical information team. A 64-year-old male patient (doctor) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration on unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The reporter stated that doctor received both doses of Pfizer's COVID vaccine and resulted in zero antibodies after taking an antibody test. The outcome of event was unknown.  Information about lot/ batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19, Formulation: Solution for injection, Batch/Lot Number: unknown; Expiration Date: unknown) via an unspecified route of administration on an unspecified date as a SINGLE DOSE for COVID-19 immunization. The patient medical history was and concomitant medications were not reported. The patient experienced just chills for a little bit the night on an unspecified date. The outcome of the event was unknown. Information about lot/ batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Vaccination site pain
Clinical narrative: After 2nd shot my arm was very painful; reddish oval continued to grow larger each day, till it is now (2/19) around 6 inches inlength; This is a spontaneous report from a contactable consumer(patient). A 73-year-old female (non-pregnant) patient received second dose of BNT162B2 (Solution for injection, Lot number: EL9264, Expiration date: unknown), in left arm on 15Feb2021at 01:45 PM at single dose for COVID-19 immunization. The patient historical vaccine included first dose BNT162B2 (lot number: EN5318) left arm on 25Jan2021, 03:30 PM at single Covid-19 immunization. The patient medical history included bullous Pemphigoid in remission. Concomitant medication included in two weeks Generic Prozac & Lipitor, Fish Oil, Biotin, Iron. Patient was having known allergies to titanium, dark dye, some chemicals found in cosmetics. 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. After second shot Patient experienced her arm was very painful in morning after there was a small, hot reddish oval that was painful, that hot, reddish oval continued to grow larger each day, till it is now (2/19) around 6 inches in length on 16Feb2021 at 12:00 AM. The part near the injection site is much less red but the rest of the oval is still reddish. It's still hot & sore to touch but it was not as painful as it was through Wednesday. The outcome of the event was not recovered.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Experienced 1-2 hives on my body every day; This is a spontaneous report from a contactable Nurse. This 23-year-old non-pregnant female Nurse reported that she had received first dose of COVID 19 received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number EK5730), dose 1 via an unspecified route at Left arm administration on 29Dec2020 as single dose for COVID-19 immunization and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number EL1283) on 19Jan2021. Patient medical history reported as GERD and seasonal allergies. Patient concomitant medications included as Allegra, Zyrtec, Accutane, Flonase, Minastrin. Patient had not received other vaccine in four weeks. Patient stated that two weeks after her first dose, on 10Jan2021 she experienced 1-2 hives on her body every day. she worked for an allergist who thought it may be an immune response and recommended her still receive her second dose. 3 days after her second dose, her hives increased severely. The patient had full body hives that are extremely itchy that had not yet resolved and it had been over 4 weeks since her final dose. Her injection site got super red and itchy the day after her second injection, that lasted several days as well. The full body itchiness was unbearable and does not resolved with multiple antihistamines being taken. She had several pictures of the hives that she was willing to share if someone contacted her. Outcome of the event was not recovered.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9ZUZ, Expiration date: UNKNOWN), an unspecified route of administration in arm left on 05Feb2021 at 20:30 as a single dose for COVID-19 immunization. Medical history included chronic kidney disease, borderline high cholesterol, osteoporosis from an unknown date and unknown if ongoing. The patient had no allergies. The patient's concomitant medications were not reported. The patient did not received any other vaccine within 4 weeks and not received any other medication within 2 weeks. The patient was not tested prior to COVID-19 vaccination and not tested for COVID-19 after vaccination. The patient experienced neck started to feel tight on 05Feb2021 at 20:30. The patient has said that that about 25 minutes after shot left side of my neck started to feel tight. I could talk and swallow and after about 10-15 minutes feeling went away. The patient did not receive treatment for the event. The outcome of the event was recovered on an unspecified date 2021. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Muscle soreness; Fever; This is a spontaneous report received from a contactable consumer (Patient) as part of Pfizer-sponsored program COVAX  Support. A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration on 10Feb2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced muscle soreness and fever. Caller asking if he will experience the same reactions after the second dose. The outcome of the events were unknown.  Information about batch/lot number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: Blood pressure was unusually high/BP is elevated/ but it has been as high as 178/95; This is a spontaneous report from a contactable female consumer, the patient via Pfizer-sponsored program. A 67-year-old female patient (not pregnant) received the first dose of (Pfizer COVID-19 Vaccine, solution for injection, lot number: unknown) via an unspecified route of administration on 12Mar2021 (Friday) on left arm as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included hypertension. Patient had no allergies. Patient received Prescribed: Lisinopril 40 mg; Clonidine .0225 mg; Hctz 25 mg; Pravastatin 5 mg in two weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient noted that the evening of and the next two days after the vaccine (12Feb2021 at 05:15 PM) my BP is elevated. It's usually within normal range (125/82), but it has been as high as 178/95. Inquiring if that is a side effect. Relayed PMI number and transferred to unit queue due to high call volume. Will fax to company. No treatment was received for the events. Outcome of the event was Recovered.  Information on Lot /Batch Number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Tooth infection
Clinical narrative: rescheduling of appointments; tooth that is infected; This is a spontaneous report from contactable consumer the patient from Pfizer-sponsored program. A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9261, Expiration Date: 31May2021) via an unspecified route of administration on 04Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced infected implant during receiving her first dose tooth that is infected, second dose was schedule on 01Mar2021, which is a little more than 3 weeks and also schedule for oral surgery on 02Mar2021. The patient enquired if she the shot on 01Mar2021 would that still be okay. (rescheduling of appointments). The event considered non serious. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms/ cough, shortness of breath; positive COVID-19 test with symptoms/ cough, shortness of breath; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number; unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that after the 2nd dose have been tested positive for Covid-19. experienced cough, shortness of breath and took prednisone. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021191276 same reporter and drug, similar event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I got infected with COVID-19; This is a spontaneous report from the Pfizer. A contactable consumer (patient) reported that a patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 03Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that I have my first dose COVID-19 vaccine on 03Feb2021. I got infected with COVID-19 on 05Feb2021. My symptoms are mild. I would like to know if can still get my second vaccine that is scheduled for 24Feb2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: left arm, shoulder and neck pain; left arm, shoulder and neck pain; left arm, shoulder and neck pain; Tingling in left arm; tiredness an fatigue; This is a spontaneous report from a contactable consumer reported for a female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/batch number: Unknown, Expiration date: Unknown) via an un-specified route of administration, as single dose for covid-19 immunisation on an unspecified date. The patient medical history and concomitant medication was not reported. On an unspecified date, the patient experienced left arm, shoulder and neck pain tingling in left arm A little bit of tiredness a fatigue. The event considered non serious. The outcome of the events was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration, at the age of 55 years, on 15Feb2021 at a SINGLE DOSE for covid-19 immunization and tofacitinib citrate (XELJANZ XR), oral from 29Dec2020 (Batch/Lot number was not reported) to an unspecified date, at 11 mg, daily for rheumatoid arthritis. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient reported having headache after taking Covid vaccine. The outcome of the event was unknown.  Information about the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid; This is a spontaneous report from a sponsored program. A contactable nurse reported that a patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date in Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The nurse reported, the patient had first vaccine a week and a half ago and then they tested positive for Covid. Now, took another test and are now negative for Covid, but are also without antibodies. The outcome of event was resolved.  Information on the Batch/Lot number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Influenza like illness, Myalgia
Clinical narrative: flu like; lots of muscle pain in biceps, calfs, thighs; light headed; Dizzy; This is a spontaneous from a contactable consumer (patient) A 70-year-old male patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, on arm right on 08Feb21 as a single dose for Covid-19 immunization. The patient historic vaccine included first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EK9231), 11 hh:30 mm (24 hour clock) via an unspecified route of administration, on 08Jan21 at single dose for Covid-19 immunization .Ongoing concomitant medication included Crestor 5 mg 3 days WK Date Started 2008,Amitriptyline 10 mg 7 days WK Date Started 2005,Fluticasone propionate 7 days WK Date Started 2010, Amlodipine Besylate 215 mg 7 Days WK Date Started 2010.Patient experienced after second day of vaccination Flu Like with lots of muscles pain in bicps, Calfs, thighs, on day three most of event recovering. Still a little, light headed/ dizzy, Day 4 all but gone little left but seems it'll go soon. Vaccination Facility Type: Hospital  The outcome of event was Recovering.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Fatigue, Injection site pain
Clinical narrative: sore in the site for at day; explosive diarrea, liquid; Fatigue; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot number and Expiry date were not reported) via an unspecified route of administration on 09Feb2021 at single dose for covid-19 immunisation. Medical history included gastrobypass in 2004, after that I have to be and take care of not grease in my food cause I got as secondary diarrea. The patient's concomitant medications were not reported. The patient experienced sore in the site for at day, diarrhea and fatigue. Customer verbatim: The first vaccine fine small sore in the site for at day, after one day the pm I was very fatigue. second dossis since I got the vaccine even with a band diet everyday worse today in one hour it is the worse, explosive diarrea, liquid, patient cannot hold it. Patient had accidents and have to wear diapers please. Yesterday the only bad thing it was holiday and patient had a small coffee size but full of Nutella, It was for information. Was this an effect for us gastric bypass. Please be aware. The outcome of the events was unknown.  Information about lot/ batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Diarrhoea
Clinical narrative: sore in the site for at day; explosive diarrea, liquid; Fatigue; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot number and Expiry date were not reported) via an unspecified route of administration on 09Feb2021 at single dose for covid-19 immunisation. Medical history included gastrobypass in 2004, after that I have to be and take care of not grease in my food cause I got as secondary diarrea. The patient's concomitant medications were not reported. The patient experienced sore in the site for at day, diarrhea and fatigue. Customer verbatim: The first vaccine fine small sore in the site for at day, after one day the pm I was very fatigue. second dossis since I got the vaccine even with a band diet everyday worse today in one hour it is the worse, explosive diarrea, liquid, patient cannot hold it. Patient had accidents and have to wear diapers please. Yesterday the only bad thing it was holiday and patient had a small coffee size but full of Nutella, It was for information. Was this an effect for us gastric bypass. Please be aware. The outcome of the events was unknown.  Information about lot/ batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anal incontinence, Diarrhoea
Clinical narrative: sore in the site for at day; explosive diarrea, liquid; Fatigue; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot number and Expiry date were not reported) via an unspecified route of administration on 09Feb2021 at single dose for covid-19 immunisation. Medical history included gastrobypass in 2004, after that I have to be and take care of not grease in my food cause I got as secondary diarrea. The patient's concomitant medications were not reported. The patient experienced sore in the site for at day, diarrhea and fatigue. Customer verbatim: The first vaccine fine small sore in the site for at day, after one day the pm I was very fatigue. second dossis since I got the vaccine even with a band diet everyday worse today in one hour it is the worse, explosive diarrea, liquid, patient cannot hold it. Patient had accidents and have to wear diapers please. Yesterday the only bad thing it was holiday and patient had a small coffee size but full of Nutella, It was for information. Was this an effect for us gastric bypass. Please be aware. The outcome of the events was unknown.  Information about lot/ batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: sore in the site for at day; explosive diarrea, liquid; Fatigue; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot number and Expiry date were not reported) via an unspecified route of administration on 09Feb2021 at single dose for covid-19 immunisation. Medical history included gastrobypass in 2004, after that I have to be and take care of not grease in my food cause I got as secondary diarrea. The patient's concomitant medications were not reported. The patient experienced sore in the site for at day, diarrhea and fatigue. Customer verbatim: The first vaccine fine small sore in the site for at day, after one day the pm I was very fatigue. second dossis since I got the vaccine even with a band diet everyday worse today in one hour it is the worse, explosive diarrea, liquid, patient cannot hold it. Patient had accidents and have to wear diapers please. Yesterday the only bad thing it was holiday and patient had a small coffee size but full of Nutella, It was for information. Was this an effect for us gastric bypass. Please be aware. The outcome of the events was unknown.  Information about lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: tested positive on 21 Feb 2021; tested positive on 21 Feb 2021; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 1 via an unspecified route of administration on 01Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tested positive on 21Feb2021 on 21Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive: negative on 19Feb2021, sars-cov-2 test positive: positive on 21Feb2021. The event was assessed as medically significant. Outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Nasopharyngitis
Clinical narrative: Cold; Felt drugged; Tired; Chills; This is a spontaneous report from a contactable consumer (Patient) reporting on herself. A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 09Feb2021 as single dose for COVID-19 IMMUNIZATION. Patient medical history and concomitant medications were not reported. On 09Feb2021, the patient experienced tired, chills.Clinical course of the events includes: On 10Feb2021, the patient states the next day in the afternoon she got a little tired and cold, she laid down for a while, had dinner at 6, had a bowl of chili and got really, really tired, states she was so tired she could not even put her dish on counter, states she felt drugged is the only way she can describe it.The patient states that she got in bed and she got the chills, they lasted for hours, the next day towards the evening got chills again and that lasted about 3 hours and they were gone by 11Feb2021. Patient was in the car and does not have card with her at this time and could not provide much details about product. The outcome for the events was reported to be recovered on 11Feb2021.   Information on batch/lot number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Lymph node pain
Clinical narrative: lymph nodes left arm pit very sore; Soreness at injection site; Chills; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non pregnant female patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: unknown), via an unspecified route of administration on 12Feb2021, 10:45 AM at arm left as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.no other vaccine was administered in 4 weeks. The patient was on birth control. On 13 Feb 2021, at 05:00Am the patient experienced Soreness at injection site Chills and No fever. on 14 Feb 2021, she had lymph nodes left arm pit and it was very sore. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: headache; chest pain; I received my 1st dose 29Jan. I tested positive 07Feb; This is a spontaneous report from a contactable unspecified age female Consumer communicated to a Pfizer colleague that the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that she lives with her boyfriend and her16-year-old daughter. While she did quarantine after diagnosis, she spent a lot of time with her boyfriend prior to her diagnosis. He tested negative when they should have been positive. The patient's daughter also was with her, in very close quarters for several hours (a car for well over 3 hours) and her daughter also tested negative. The patient was 6 days post diagnosis and felt almost normal again. The patient chest pain and headache on an unknown date. On 07Feb2021, she tested positive.  The outcome of the events was unknown.  Information on the lot/batch number has been requested.