chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: body aches after taking  the first dose; had fever; This is a spontaneous report received from a non-contactable consumer or other non hcp. A patient of unspecified age and gender received 1st dose of bnt162b2 (Pfizer's COVID-19 vaccine,Batch/Lot Number: EL9269), via an unspecified route of administration on an unspecified date as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced body aches after taking the first dose and had fever on an unspecified date.  No follow-up attempts are possible. No further Information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia
Clinical narrative: She said her husband had experienced Fever; Chills; Diarrhea; This is a spontaneous report from a sponsored program Support. A contactable consumer (wife) reported for a male patient (husband).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The caller was calling on behalf of her husband. She said her husband had experienced fever, chills and diarrhea on an unspecified date, after receiving the first shot of Covid-19 Vaccine. She was asking 2 weeks after receiving the first shot side effects occur. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected. Information about lot/batch number requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Severe headache; fever; tiredness; This is a spontaneous report from a contactable other health care professional (reported for himself). A 38-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL3247/Batch number was not reported), dose 2 intramuscular, administered in arm right on 16Feb2021 at 15:00 (at the age of 38-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has no reported allergies. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 intramuscular, administered in arm right on 28Jan2021 at 15:00 (at the age of 38-years-old) as dose 1, single for covid-19 immunisation. On 17Feb2021 at 07:00, the patient experienced severe headache, fever and tiredness. No treatment was given for the events. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Epistaxis, Fatigue, Nausea
Clinical narrative: a small nosebleed; Felt very fatigued for the following 2 days(stayed home); experienced mild nausea; dizziness; This is a spontaneous report from a contactable other healthcare professional (Patient). A 27-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, on 16Feb2021 at 10:00 (at the age of 27-year-old), as dose 2, single in left arm for COVID-19 immunization at Workplace clinic. The patient's medical history was not reported. Patient had no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, on 25Jan2021 at 11:15 AM (at the age of 27-year-old), as single dose in left arm for COVID-19 immunization. Concomitant medications in two weeks were reported as daily multivitamin, ibuprofen; taken for unspecified indications, start and stop dates were not reported. Patient did not receive any other vaccine in four weeks after COVID vaccination. On 16Feb2021 at 12:00 PM, 2 hours after second dose of vaccine, the patient felt very fatigued for the following 2 days (stayed home), experienced mild nausea and dizziness. On 17Feb2021 morning, on second day after dose 2, the patient experienced a small nosebleed. Patient still felt fatigued on day 3, although much better. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Rash pruritic
Clinical narrative: She developed a dry, itchy rash on her shins; She developed a dry, itchy rash on her shins; This is a spontaneous report from a contactable other hcp. A 77-year-old female non pregnant patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 intramuscular on 08Feb2021 (at the age of 77-year-old) (Batch/Lot Number: EN5318) as dose 1, single for covid-19 immunisation. Medical history arthritis and hyperlipidemia from an unknown date and unknown if ongoing. The patient previously experienced known allergies: Iodine Dye. The patient's concomitant medications were not reported. The patient experienced a dry, itchy rash on her skin 4 days after the vaccination (12Feb2021). She think it was because it had been cold and dry out, but she was remarkably insistent that it was a vaccine effect. The patient received treatment for the events. The treatment medication was topical steroids. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Influenza like illness, Pain
Clinical narrative: experience felt like the flu; Slight headache; low grade fever; chills; She reports a fever of 101°F; feeling achy all over; This is a spontaneous report from a contactable consumer or other non-Hcp. A 80-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation; Solution for injection, Lot Number: EL9263 Expiry date: Unknown) via an unspecified route of administration, administered in Deltoid Left on 25Jan2021 at 13:15 as dose 1, single for COVID-19 immunisation. The patient medical history included bronchitis from an unknown date and unknown if ongoing She reported a long time ago, she would get Bronchitis, but not for a long time now. The patient's concomitant medications were not reported. On 16Feb2021 at 00:15 the patient experienced a fever of 101°f, feeling achy all over, chills, on 18Feb2021 patient experienced low grade fever, experience felt like the flu, slight headache, The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on 16Feb2021, body temperature was 99 Fahrenheit on 18Feb2021. The outcome of events pain, influenza like illness and chills was unknown, outcome of pyrexia was not recovered.  Patient's Medical History (including any illness at time of vaccination) Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: None. She reported a long time ago she would get Bronchitis, but not for a long time now.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: experience felt like the flu; Slight headache; low grade fever; chills; She reports a fever of 101°F; feeling achy all over; This is a spontaneous report from a contactable consumer or other non-Hcp. A 80-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation; Solution for injection, Lot Number: EL9263 Expiry date: Unknown) via an unspecified route of administration, administered in Deltoid Left on 25Jan2021 at 13:15 as dose 1, single for COVID-19 immunisation. The patient medical history included bronchitis from an unknown date and unknown if ongoing She reported a long time ago, she would get Bronchitis, but not for a long time now. The patient's concomitant medications were not reported. On 16Feb2021 at 00:15 the patient experienced a fever of 101°f, feeling achy all over, chills, on 18Feb2021 patient experienced low grade fever, experience felt like the flu, slight headache, The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on 16Feb2021, body temperature was 99 Fahrenheit on 18Feb2021. The outcome of events pain, influenza like illness and chills was unknown, outcome of pyrexia was not recovered.  Patient's Medical History (including any illness at time of vaccination) Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: None. She reported a long time ago she would get Bronchitis, but not for a long time now.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Inappropriate schedule of product administration, Off label use
Clinical narrative: Caller's daughter had her appointment for the second dose of the Pfizer covid vaccine cancelled twice and it has almost been a month and a half since her first dose.; Caller's daughter had her appointment for the second dose of the Pfizer covid vaccine cancelled twice and it has almost been a month and a half since her first dose.; flushing; This is a spontaneous report from a contactable consumer. A female patient (consumer's daughter) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified age, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller's daughter had her appointment for the second dose of the Pfizer covid vaccine cancelled twice and it has almost been a month and a half since her first dose. Caller wanted to know how long the second dose of the vaccine may be given for it to be considered effective and asked do you have any information on the effectiveness of the vaccine if only one dose was received. Caller mentioned that she experienced some flushing after receiving the first dose on an unspecified date and wanted to know if this has been reported prior. She stated that this has been the third person she was transferred to, potential duplicate AE report filed and asked was it okay to get the vaccine if you have a cold. Outcome of the events was unknown.  Information about lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: had headache for 2 hrs; This is a spontaneous report from a contactable Consumer. This 59-Year-old male Consumer reported in response to Non-HCP letter sent in a cross-reference case which included that: A 59-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 59-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 3Dec2020 as single dose for covid-19 immunisation and experienced the events Feeling tired, Headache, Nauseous and had the chill. Patient reported that I was feeling tired & had the chill for three after first shot. Second shot had headache for 2 hrs. The outcome of the event was reported as recovered on an unspecified date.  Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Tenderness
Clinical narrative: Swelling under left armpit; Tenderness; This is a spontaneous report from a non-contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247) via an unspecified route, administered in Left Arm on 16Feb2021 at 13:15 (44-year-old at vaccination) as a Dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Facility type vaccine was reported as Workplace clinic. The patient had not received any other vaccine within 4 weeks prior to vaccination. The patient was not diagnosed with Covid prior vaccination.  The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247) via an unspecified route, administered in Left Arm on 26Jan2021 at 13:00 (44-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. On 17Feb2021 at 17:00, the patient had experienced Swelling under left armpit with some tenderness. The patient was not tested for Covid post vaccination. No treatment received for resulted events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder, Swelling face, Swollen tongue
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiration date: not reported), via an unspecified route of administration, on Feb 16, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The caller stated she received her first COVID-19 vaccine from Pfizer and did not have allergic reaction the first 15 minutes afterwards. However, after 24 hours, on an unspecified date, patient experienced swelling of tongue and face and had bumps on chin, with outcome of unknown. She asked whether she could take the second dose of the Moderna vaccine. Information on the batch/lot number requested. Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Influenza like illness, Pyrexia
Clinical narrative: Flu-like symptoms; Chills; mild fever; achy joints; This is a spontaneous report from a contactable consumer (Patient). A 51-years-old male patient received BNT162B2 (COMIRNATY; Formulation: Solution for injection, Batch/Lot Number: EL3248), via an unspecified route of administration, administered in Arm Left on 12Feb2021 08:00 (at the age of 51-years-old) as dose 2, single for COVID-19 immunization. Medical history was reported as none. No other vaccine was given in four weeks. No known allergies were reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Historical vaccine included BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EL3248), via an unspecified route of administration, administered in arm left on 22Jan2021 08:00 (at the age of 51-years-old) as single for COVID-19 immunization. There were no concomitant medications was given in two weeks. On 13Feb2021 02:00 the patient experienced flu-like symptoms, chills, mild fever and achy joints. Patient did not receive any treatment for events. The outcome of the events was recovered on an unspecified date and month of 2021.  Follow-up (25Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation for Pfizer receipt date. Response received and awareness date was confirmed as 13Feb2021 the day after the vaccine was administered.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hypersomnia, Injected limb mobility decreased, Lymph node pain
Clinical narrative: Eye and face twitching on left side of face occurred 6 days after the vaccine; Severe pain and swelling in lymph nodes; Severe pain and swelling in lymph nodes; Limited mobility of left arm that lasted for more than 5 days; Tenderness still occurs; Friday night to Saturday with chills; fever; muscle ache; slept for almost 19 hours straight; This is a spontaneous report from a contactable other health care professional (patient). A 47-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 at 10:30 hours (Batch/Lot Number: EN5318; Expiration Date: May2021) as DOSE 2, SINGLE (at the age of 47-years-old) for COVID-19 immunisation. The patient's medical history included migraine from an unknown date and unknown if ongoing. The patient had known allergies with penicillins, sulfa drugs, doxycycline, tetracycline, cephalosporins, latex, adhesive, and iodine from an unknown date and unknown if ongoing. Concomitant medications included naproxen sodium; and fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA D). The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 at 09:45 AM (Batch/Lot Number: EL3248; Expiration Date: 30Apr2021) as DOSE 1, SINGLE for COVID-19 immunisation. On 12Feb2021 at 11:30, the patient experienced severe pain and swelling in lymph nodes in left armpit within 1 hour of receiving the vaccine, limited mobility of left arm that lasted for more than 5 days, tenderness still occurs, slept for almost 19 hours straight Friday night to Saturday with chills, fever and muscle ache. On 18Feb2021, the patient experienced eye and face twitching on left side of face, occurred 6 days after the vaccine. The patient underwent lab tests and procedures which included body temperature: fever on 12Feb2021. The patient did not receive treatment for the adverse events. The patient did not have COVID prior vaccination and did not get COVID tested post vaccination. The patient did not have any other vaccine in four weeks. The patient was recovering from the adverse events.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Muscle twitching, Myalgia, Pyrexia, Tenderness
Clinical narrative: Eye and face twitching on left side of face occurred 6 days after the vaccine; Severe pain and swelling in lymph nodes; Severe pain and swelling in lymph nodes; Limited mobility of left arm that lasted for more than 5 days; Tenderness still occurs; Friday night to Saturday with chills; fever; muscle ache; slept for almost 19 hours straight; This is a spontaneous report from a contactable other health care professional (patient). A 47-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 at 10:30 hours (Batch/Lot Number: EN5318; Expiration Date: May2021) as DOSE 2, SINGLE (at the age of 47-years-old) for COVID-19 immunisation. The patient's medical history included migraine from an unknown date and unknown if ongoing. The patient had known allergies with penicillins, sulfa drugs, doxycycline, tetracycline, cephalosporins, latex, adhesive, and iodine from an unknown date and unknown if ongoing. Concomitant medications included naproxen sodium; and fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA D). The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 at 09:45 AM (Batch/Lot Number: EL3248; Expiration Date: 30Apr2021) as DOSE 1, SINGLE for COVID-19 immunisation. On 12Feb2021 at 11:30, the patient experienced severe pain and swelling in lymph nodes in left armpit within 1 hour of receiving the vaccine, limited mobility of left arm that lasted for more than 5 days, tenderness still occurs, slept for almost 19 hours straight Friday night to Saturday with chills, fever and muscle ache. On 18Feb2021, the patient experienced eye and face twitching on left side of face, occurred 6 days after the vaccine. The patient underwent lab tests and procedures which included body temperature: fever on 12Feb2021. The patient did not receive treatment for the adverse events. The patient did not have COVID prior vaccination and did not get COVID tested post vaccination. The patient did not have any other vaccine in four weeks. The patient was recovering from the adverse events.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Neuralgia
Clinical narrative: intense nerve pain; Headache; Chills; joint pain; This is a spontaneous report from a non-contactable other hcp (Patient). A 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EL9264) via an unspecified route of administration (Age at vaccination 18-year) in Left Arm on 16Feb2021 at 01:30 PM as dose 2, single for COVID-19 immunization. Medical history included Walnuts allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (lot number: EL9261) administered in left arm as single dose on 26Jan2021 at 01:00 PM for COVID-19 immunization. The patient received no other vaccine in four weeks. No COVID prior vaccination was reported. The patient not tested COVID post vaccination. On 16Feb2021 at 02:00 AM the patient experienced intense nerve pain, headache, chills, joint pain. It was reported by the patient that "she experienced intense nerve pain and joint pain all over her body. This lasted approximately 18 hours. She did not have a fever. She also experienced a constant headache and chills." The patient received no treatment for the adverse events. The clinical outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Full blood count, Metabolic function test, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: heart burn; This is a spontaneous report from a contactable nurse (patient). A 29-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was unknown), via intramuscular in arm right on 18Dec2020 at 10:30 AM (at the age of 29-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history was not reported. The patient with known allergies were reported as none. The patient's concomitant medications included metformin, levothyroxine sodium, loratadine (CLARITIN [LORATADINE]), all were taken for an unspecified indication. It was reported that, the patient was not pregnant at time of vaccination. No covid prior vaccination and covid tested post vaccination was reported as yes. On an unspecified date, at 2 weeks post first vaccine, the patient experienced heart burn for about a week, not a huge deal. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the event included was the patient went to her PCP where additional labs were drawn CBC, CMP, covid antibodies and covid test. On 09Feb2021, the patient underwent lab tests and procedures which included CBC, CMP, covid antibodies, covid test, all were resulted as unknown result and nasal swab, resulted as negative. The outcome of the event was recovering.  Follow-up attempts completed. No further information expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Vaccination site pain
Clinical narrative: Injection site pain; leg muscle soreness; This is a spontaneous report from a contactable Other-HCP. A 41-years-old female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot number Ek5730), via an intramuscular route of administration on 18Dec2020 at 07:35(at the age of 41-years-old) into Arm Left as a single dose for COVID-19 immunisation at hospital. Medical history included asthma from 09Jan1981 and ongoing, polycystic ovaries from 15Aug2016 and ongoing, Allergies from an unknown date and unknown if ongoing, High Blood pressure from an unknown date and unknown if ongoing. Concomitant medication(s) included mometasone furoate (MOMETASONE FUROATE) taken for Allergies from 15Jul2010 to an unspecified stop date; cetirizine hydrochloride taken for Allergies from 30Aug2013 to an unspecified stop date; lisinopril taken for High Blood pressure from 15Jul2016 to an unspecified stop date. On an unspecified date, the patient experienced Injection site pain,8-10 hours after injection leg muscle soreness. Treatment included Magnesium 400mg, Electrolyte water, Ibuprofen for the events. No culture was performed. The events did not require visits to the emergency room or the physician's office. The patient received acetaminophen 400 mg (2x200 mg) by mouth on 08Jan2021 for fever,30 hours after injection fever over 100.3. The patient underwent lab tests and procedures which included body temperature: 99.0-101.6 on an unknown date, body temperature: fever over 100.3 on 08Jan2021.The outcome of the events was recovered.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Dyspnoea, Electrocardiogram, Headache
Clinical narrative: When I first got the shot in my left arm, it was sore; I had a bad taste in my mouth; headaches; short of breath; there is lead in my legs/legs are real heavy; I have pressure on center of my chest.; This is a spontaneous case from a contactable consumer (patient) reported for herself. A 74-years-old female patient received first 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 in left arm on 10Feb2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was having side effects, she saw her doctor yesterday, had blood work, EKG (Electrocardiogram), x-ray which showed no findings yet on an unspecified date, she hadn't heard anything back yet. They had ice there, they may not even be opened today. When she first got the shot in her left arm, it was sore and she had a bad taste in her mouth on an unspecified date. Last week she started getting headaches off and on, the worst symptom she had been short of breath, she felt like there was lead in her legs, like it was hard to walk up the steps, her legs were real heavy on an unspecified date. She was wondering if these were side effects that others have had. She was still experiencing, shortness of breath and heaviness in legs. Slight headaches off and on. She had pressure on center of her chest on an unspecified date. She had it for a week. The patient didn't know if she should get 2nd dose. The outcome of the events pain in extremity, taste disorder and chest discomfort was unknown. The outcome of the event headache was resolving. The outcome of the events dyspnoea and limb discomfort was not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Taste disorder, X-ray
Clinical narrative: When I first got the shot in my left arm, it was sore; I had a bad taste in my mouth; headaches; short of breath; there is lead in my legs/legs are real heavy; I have pressure on center of my chest.; This is a spontaneous case from a contactable consumer (patient) reported for herself. A 74-years-old female patient received first 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 in left arm on 10Feb2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was having side effects, she saw her doctor yesterday, had blood work, EKG (Electrocardiogram), x-ray which showed no findings yet on an unspecified date, she hadn't heard anything back yet. They had ice there, they may not even be opened today. When she first got the shot in her left arm, it was sore and she had a bad taste in her mouth on an unspecified date. Last week she started getting headaches off and on, the worst symptom she had been short of breath, she felt like there was lead in her legs, like it was hard to walk up the steps, her legs were real heavy on an unspecified date. She was wondering if these were side effects that others have had. She was still experiencing, shortness of breath and heaviness in legs. Slight headaches off and on. She had pressure on center of her chest on an unspecified date. She had it for a week. The patient didn't know if she should get 2nd dose. The outcome of the events pain in extremity, taste disorder and chest discomfort was unknown. The outcome of the event headache was resolving. The outcome of the events dyspnoea and limb discomfort was not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: had bad chills for 15 min; This is a spontaneous report from a contactable consumer (patient's wife) via Pfizer Sales Representative. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bad chills on an unspecified date. The outcome of the event was recovered on an unspecified date (with the reported duration of 15 minutes).  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness
Clinical narrative: got light headed; Had stomach discomfort; This is a spontaneous report from a non-contactable other hcp (patient) received via a representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, Expiration date were not reported), via an unspecified route of administration on an unspecified date, as dose number unknown , single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced got light headed and had stomach discomfort on an unspecified date and only lasted for 12 hours. The outcome of events was recovered on an unspecified date.  No follow-up attempts are possible; information on lot /batch number could not be obtained. No further Information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: she had a low grade fever after the first dose of Pfizer vaccine; This is a spontaneous report from a contactable consumer and pharmacist reported that. 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 an unspecified date (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced she had a low-grade fever after the first dose of pfizer vaccine on an unspecified date. The event outcome was Unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: headache; nausea; fever; arm hurts a lot; feel very bad; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced headache, nausea, fever, arm hurts a lot, feel very bad. Patient received yesterday the COVID-19 vaccine (Pfizer-BioNTech). Today patient woke up with a headache, nausea, fever, and patient arm hurts a lot. Patient couldn't go to work, patient feel very bad. What medicine can patient take. Patient is 65-years old, recently received her first dose. Agreed to be contacted by the Safety Department, declined to file a report on www.pfizersafetyreporting.com. Consumer already contacted her Doctor and is waiting for a response. She is welcomed to call for future medical questions related to the COVID-19 vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (03Apr2021): Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Injection site pain, Lymphadenopathy, Pain
Clinical narrative: fever; fatigue; aches; injection site soreness; reddened rash around abdominal /chest area with very intense itching; swollen lymph node esp to left axilla area; reddened rash around abdominal /chest area with very intense itching; This is a spontaneous report from a contactable nurse reported for herself. This 58-year-old non-pregnant female patient received bnt162b2 (COVID 19 VACCINE, Solution for injection, lot number: EL9262), intramuscular on left arm on 26Jan2021 06: 00 (at the age of 58-year-old) at dose 2, single for COVID-19 immunisation. Medical history included allergy to eggs, chicken, seafoods, dust. Concomitant medications were not reported. The historic vaccine included bnt162b2 (COVID 19 VACCINE, lot number: EJ1685), intramuscular on left arm on 05Jan2021 at dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. The patient had no covid prior to the vaccination. The patient had not been tested positive for covid post vaccination. It was reported that aside from expected side effects of fever (lasted 4 days with temps ranging from 102F-103F, fatigue, body aches; soreness of injection site; I had developed reddened rash around abdominal /chest area with very intense itching. Also noted swollen lymph node esp to left axilla area; all on 27Jan2021 at 05:00 PM. The patient received treatment for reported events as Benadryl orally, hydrocortisone topical ointment. Outcome of the events was recovered on an unknown date in 2021.  Follow-up attempts completed. No further information expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash erythematous
Clinical narrative: fever; fatigue; aches; injection site soreness; reddened rash around abdominal /chest area with very intense itching; swollen lymph node esp to left axilla area; reddened rash around abdominal /chest area with very intense itching; This is a spontaneous report from a contactable nurse reported for herself. This 58-year-old non-pregnant female patient received bnt162b2 (COVID 19 VACCINE, Solution for injection, lot number: EL9262), intramuscular on left arm on 26Jan2021 06: 00 (at the age of 58-year-old) at dose 2, single for COVID-19 immunisation. Medical history included allergy to eggs, chicken, seafoods, dust. Concomitant medications were not reported. The historic vaccine included bnt162b2 (COVID 19 VACCINE, lot number: EJ1685), intramuscular on left arm on 05Jan2021 at dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. The patient had no covid prior to the vaccination. The patient had not been tested positive for covid post vaccination. It was reported that aside from expected side effects of fever (lasted 4 days with temps ranging from 102F-103F, fatigue, body aches; soreness of injection site; I had developed reddened rash around abdominal /chest area with very intense itching. Also noted swollen lymph node esp to left axilla area; all on 27Jan2021 at 05:00 PM. The patient received treatment for reported events as Benadryl orally, hydrocortisone topical ointment. Outcome of the events was recovered on an unknown date in 2021.  Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure decreased, Blood pressure measurement, Body temperature, Fall
Clinical narrative: Fever of 101d for 2 -3 days.; drop in blood pressure resulting in fall in in bathroom; Arm ache; weak low energy; drop in blood pressure resulting in fall in in bathroom; This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 12Feb2021 14:00 as DOSE 1, SINGLE for covid-19 immunisation (Age at vaccination 75 years). Medical history included cardiac disorder, implantable defibrillator insertion/ pacemaker. No other vaccine in four weeks. Concomitant medication(s) included lisinopril (LISINOPRIL); carvedilol (CARVEDILOL); apixaban (APIXABAN); clopidogrel (CLOPIDOGREL). The patient previously took entresto and experienced drug hypersensitivity. No covid prior vaccination. No covid tested post vaccination. On Feb2021 patient experienced fever of 101d for 2 -3 days, drop in blood pressure resulting in fall in in bathroom, arm ache, weak low energy. The patient underwent lab tests which included blood pressure measurement: drop on Feb2021 drop in blood pressure resulting in fall in in bathroom, body temperature: 101 on Feb2021. No treatment required for events. The outcome for all events was recovering.  No follow-up attempts are possible; information about lot/batch number could not be obtained.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever of 101d for 2 -3 days.; drop in blood pressure resulting in fall in in bathroom; Arm ache; weak low energy; drop in blood pressure resulting in fall in in bathroom; This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 12Feb2021 14:00 as DOSE 1, SINGLE for covid-19 immunisation (Age at vaccination 75 years). Medical history included cardiac disorder, implantable defibrillator insertion/ pacemaker. No other vaccine in four weeks. Concomitant medication(s) included lisinopril (LISINOPRIL); carvedilol (CARVEDILOL); apixaban (APIXABAN); clopidogrel (CLOPIDOGREL). The patient previously took entresto and experienced drug hypersensitivity. No covid prior vaccination. No covid tested post vaccination. On Feb2021 patient experienced fever of 101d for 2 -3 days, drop in blood pressure resulting in fall in in bathroom, arm ache, weak low energy. The patient underwent lab tests which included blood pressure measurement: drop on Feb2021 drop in blood pressure resulting in fall in in bathroom, body temperature: 101 on Feb2021. No treatment required for events. The outcome for all events was recovering.  No follow-up attempts are possible; information about lot/batch number could not be obtained.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Pain in extremity, Pruritus, Rash, Vaccination site rash
Clinical narrative: rash on arm; arm ache shortly after 1st dose; Itchy arm; a group of pimples develop in a 4"-5" radius from the point of the injection; This is a spontaneous report from a contactable consumer. This 78-year-old male consumer (patient) received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EL9265), dose 1 via an unspecified route of administration, administered in Arm Left on 01Feb2021 18:15 as DOSE 1, SINGLE for covid-19 immunisation (Age at vaccination 78 years). Medical history included blood pressure abnormal, cerebrovascular accident, neuropathy peripheral, arthritis, stenosis, blood triglycerides increased, rubber sensitivity and CAT SCAN dye injections allergy. Concomitant medication(s) included lisinopril (LISINOPRIL); simvastatin (SIMVASTATIN); pramipexole (PRAMIPEXOLE); amitriptyline hydrochloride (AMITRIPTYLIN). I was treated for Melanoma Stage Three in 2019 through Feb2020 with the immunotherapy drug Opdivo. I tolerated the drug very well but it has caused full-body itching. I don't know if the effect of the Opdivo on my immune system has effected my reaction to the Covid vaccine. No covid prior vaccination. No covid tested post vaccination. On 01Feb2021 20:00 patient experienced rash on arm, arm ache shortly after 1st dose, itchy arm, a group of pimples develop in a 4"-5" radius from the point of the injection These were very itchy. I expected them to clear-up in 2-3 days but it has been 17 days and I still have remnants of the rash and 2-3 fading "pimples." I have not seen this particular side-effect listed so I thought I should report it. The patient underwent lab tests and procedures which included computerised tomogram: unknown result. I am scheduled to receive my second shot on 22Feb2021. No treatment was received for events. The outcome of all events was recovering.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Hypokinesia, Illness
Clinical narrative: she got pretty sick after the vaccine; fever that evening with temperature of 100.7/fever 99.5 - 99.7 degrees F; she couldn't lift her head off the pillow; total couldn't move; felt like flu; chills; This is a spontaneous report from a non-contactable consumer (patient herself). A 52 (Unit: unknown) aged female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history included allergies. The patient's concomitant medications were not reported. It was stated that patient previously took Zyrtec an hour before vaccination. On an unspecified date, patient experienced, she got pretty sick after the vaccine, developed fever that evening with temperature of 100.7, for 30 hours she couldn't lift her head off the pillow, total couldn't move, felt like the flu, started at 21:30 with chills got into bed. Chills stopped 2 hours later. By Sunday at midnight, she started feeling better, but still running fever 99.5 - 99.7 degrees F and couldn't lift her head- trying to decide if the second dose will be worse. The patient underwent lab tests and procedures which included body temperature: 100.7 and 99.5-99.7 fahrenheit on an unspecified date. The outcome of the events got pretty sick, felt like the flu and total couldn't move was recovering, for the events fever and couldn't lift her head was not recovered and for event chills was recovered (stopped 2 hours later) on an unspecified date.  No follow-up attempts are possible. Information about lot/batch number cannot be requested.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: she got pretty sick after the vaccine; fever that evening with temperature of 100.7/fever 99.5 - 99.7 degrees F; she couldn't lift her head off the pillow; total couldn't move; felt like flu; chills; This is a spontaneous report from a non-contactable consumer (patient herself). A 52 (Unit: unknown) aged female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history included allergies. The patient's concomitant medications were not reported. It was stated that patient previously took Zyrtec an hour before vaccination. On an unspecified date, patient experienced, she got pretty sick after the vaccine, developed fever that evening with temperature of 100.7, for 30 hours she couldn't lift her head off the pillow, total couldn't move, felt like the flu, started at 21:30 with chills got into bed. Chills stopped 2 hours later. By Sunday at midnight, she started feeling better, but still running fever 99.5 - 99.7 degrees F and couldn't lift her head- trying to decide if the second dose will be worse. The patient underwent lab tests and procedures which included body temperature: 100.7 and 99.5-99.7 fahrenheit on an unspecified date. The outcome of the events got pretty sick, felt like the flu and total couldn't move was recovering, for the events fever and couldn't lift her head was not recovered and for event chills was recovered (stopped 2 hours later) on an unspecified date.  No follow-up attempts are possible. Information about lot/batch number cannot be requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Lethargy, Pain, Pyrexia
Clinical narrative: Mild aches; lethargy; fever 100.7; This is a spontaneous report from a contactable Consumer (patient). A 51-Years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown) via unspecified route of administration in left arm on 17Feb2021 15:45 (age at vaccination was 51 years), as DOSE 2, SINGLE for COVID-19 immunisation at hospital. The patient medical history included known allergies of penicillin. He did not receive other vaccine in four weeks. He received gabapentin (NEURONTIN) in two weeks. He had not Covid prior vaccination and he did not test Covid post vaccination. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient experienced Mild aches, 100.7 fever, lethargy on 18Feb2021 07:00 AM. He did not receive treatment for adverse events. The outcome of events was recovering.  Information about lot/batch number has been requested. Follow-up attempts were completed. No further information was expected.