chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Pain in extremity
Clinical narrative: very sore arm after the first shot. very sore arm again, but not as bad, after the second shot. Muscle and joint aches. Chills. But no flu-like symptoms; very sore arm after the first shot. very sore arm again, but not as bad, after the second shot. Muscle and joint aches. Chills. But no flu-like symptoms; very sore arm after the first shot. very sore arm again, but not as bad, after the second shot. Muscle and joint aches. Chills. But no flu-like symptoms; very sore arm after the first shot. very sore arm again, but not as bad, after the second shot. Muscle and joint aches. Chills. But no flu-like symptoms; This is a spontaneous report from a contactable consumer. This 56-year-old female consumer (patient). A 56-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number: ER8731) via unknown route of administration in left arm on unspecified date in Apr2021 at 01:30 PM (at the age of 56 years old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The concomitant medications included vitamins. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number: ER8733) via unknown route of administration in left arm on unspecified date in Mar2021 at 01:00 PM (at the age of 56 years old) as DOSE 1, SINGLE for COVID-19 immunisation and very sore arm after the first shot. Patient did not have other vaccine in four weeks. On 16Apr2021 at 04:30 AM, the patient experienced very sore arm after the first shot. very sore arm again, but not as bad, after the second shot. Muscle and joint aches. Chills. But no flu-like symptoms. Patient did not receive treatment. Patient did not have covid prior vaccination and not tested covid post vaccination. The outcome of the events were not recovered.  No follow-up attempts were possible. No further information was expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pruritus, Pyrexia, Rash
Clinical narrative: Extreme fatigue; slept for approx. 24 hours; thirst; low grade fever 100.5; Very itchy; Spots all over face, torso, legs, arms -rash, itchy spots after both vaccines; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0162) via an unspecified route of administration, administered in left arm on 12Apr2021 13:30 as dose 2, single for COVID-19 immunization (at the age of 51-year-old). Medical history included known allergies: penicillin, rocephin, latex, MI, MCI, fragrance, BOP, hypothyroid, allergies, exzema and ongoing high blood pressure. Concomitant medications included Levothyroxine 125, Losartan 100, Metformin 500. No other vaccine in four weeks. No COVID prior vaccination and not tested for COVID post vaccination. The patient previously took Rocephin and experienced known allergies and historic vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER2613) via an unspecified route of administration, administered in left arm on 19Mar2021 15:45 as dose 1, single for COVID-19 immunization (at the age of 51-year-old) and experienced a rash throughout body, very itchy and spots all over face, torso, legs, arms -rash, itchy spots after both vaccines. On 14Apr2021, the patient experienced very itchy, spots all over face, torso, legs, arms -rash, itchy spots after both vaccines, extreme fatigue, slept for approx. 24 hours, thirst and low grade fever 100.5. The patient didn't receive any treatment for adverse events. On 14Apr2021, the patient underwent lab tests and procedures which included body temperature: fever 100.5 (low grade fever 100.5). The outcome of all events were recovering.  No follow-up attempts are required. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Thirst
Clinical narrative: Extreme fatigue; slept for approx. 24 hours; thirst; low grade fever 100.5; Very itchy; Spots all over face, torso, legs, arms -rash, itchy spots after both vaccines; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0162) via an unspecified route of administration, administered in left arm on 12Apr2021 13:30 as dose 2, single for COVID-19 immunization (at the age of 51-year-old). Medical history included known allergies: penicillin, rocephin, latex, MI, MCI, fragrance, BOP, hypothyroid, allergies, exzema and ongoing high blood pressure. Concomitant medications included Levothyroxine 125, Losartan 100, Metformin 500. No other vaccine in four weeks. No COVID prior vaccination and not tested for COVID post vaccination. The patient previously took Rocephin and experienced known allergies and historic vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER2613) via an unspecified route of administration, administered in left arm on 19Mar2021 15:45 as dose 1, single for COVID-19 immunization (at the age of 51-year-old) and experienced a rash throughout body, very itchy and spots all over face, torso, legs, arms -rash, itchy spots after both vaccines. On 14Apr2021, the patient experienced very itchy, spots all over face, torso, legs, arms -rash, itchy spots after both vaccines, extreme fatigue, slept for approx. 24 hours, thirst and low grade fever 100.5. The patient didn't receive any treatment for adverse events. On 14Apr2021, the patient underwent lab tests and procedures which included body temperature: fever 100.5 (low grade fever 100.5). The outcome of all events were recovering.  No follow-up attempts are required. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: overall fatigue and muscle soreness with low grade fever and chills.; overall fatigue and muscle soreness with low grade fever and chills.; overall fatigue and muscle soreness with low grade fever and chills.; overall fatigue and muscle soreness with low grade fever and chills.; This is a spontaneous report from a non-contactable other HCP (patient, self reported). A 36-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: Er8733 and expiry date was not reported), via an unspecified route of administration, in left arm, on 29Mar2021 05:45 PM, as DOSE 1, SINGLE for COVID-19 immunization (Age at vaccination: 36years). Facility type vaccine was other. The patient was not pregnant at the time of vaccination. The patient medical history included known allergies: Haldol. Concomitant medications included ibuprofen (MOTRIN). The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. The patient experienced overall fatigue and muscle soreness with low grade fever and chills on an unspecified date in 2021. The AE did not result in emergency room or physician office. The patient did not received treatment for the events. The patient underwent lab test and procedure included covid test type post vaccination: Nasal Swab with negative result on an unspecified date. Outcome of the events were recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Pyrexia
Clinical narrative: joint pain; body feels feverish; injection site soreness; This is a spontaneous report from a contactable pharmacist (patient).   A 42-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 09:30 (age at the time of vaccination was 42 years) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reportedly, the patient did not have any known allergies. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 24Mar2021 at 09:30 (age at the time of vaccination was 42 years) as single dose for COVID-19 immunisation and experienced Injection site soreness. No other vaccines were received by the patient in four weeks. Reportedly, the patient did not have covid prior vaccination. On 14Apr2021, the patient experienced injection site soreness. On 15Apr2021 at 03:00, the patient experienced joint pain and body feels feverish. Reportedly, after 2nd injection the patient experienced injection site soreness that started a couple hours after vaccine. Approximately 18 hours after the injection, joint pain started, and body felt feverish, but did not have a fever. These symptoms went away approximately 36 hours after the injection. No treatment was received for events. The patient was not tested for COVID post vaccination. The outcome of all the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: 2nd fuse excruciating ache and pain in left elbow wrist and fingers; 2nd fuse excruciating ache and pain in left elbow wrist and fingers; 2nd fuse excruciating ache and pain in left elbow wrist and fingers; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 46-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection, Batch/Lot Number: ER8733), dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 13:15 (at the age of 46-Year-old) as dose 2, single for covid-19 immunisation. The patient's medical history included allergy to cat, smoke, allergies to pollen, allergy to horse and environmental asthma. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was not 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 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection, Batch/Lot Number: EN6203), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 13:15 (at the age of 46-Year-old) as dose 1, single for covid-19 immunisation and experienced severe ache in neck/ back and rib case. On 15Apr2021 14:00, the patient experienced 2nd fuse excruciating ache and pain in left elbow wrist and fingers. The events led to emergency room/department or urgent care. The patient was treated with poison ivy and oral Cortisone. Therapeutic measures were taken as a result of events. The outcome of event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Fatigue, Headache, Nasal congestion, Nausea
Clinical narrative: Second dose, I was tired first day.; felt aches all over; headache/lingering headache; nausea/3rd-5th still have nausea; no taste; congested; This is a spontaneous report from a non-contactable consumer (patient, self-reported).   A 41-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: Er8731 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 12Apr2021 at 10:00 AM, as DOSE 2, SINGLE for COVID-19 immunization at hospital (at the age of 41-year-old). The patient was not pregnant at the time of vaccination. The patient medical history included known allergies: Amoxicillin. Concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6199 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 22Mar2021 at 03:30 PM, as dose 1, single for COVID-19 immunization and experienced just tired the next day (First dose, I was just tired the next day). On 12Apr2021 at 04:00 PM, the patient was tired first day. second day, felt aches all over, headache, nausea, no taste, congested. Third to fifth still have nausea and lingering headache and going strong. The AE did not result in emergency room or physician office. The patient did not receive any treatment for the events. Outcome of the events were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Second dose, I was tired first day.; felt aches all over; headache/lingering headache; nausea/3rd-5th still have nausea; no taste; congested; This is a spontaneous report from a non-contactable consumer (patient, self-reported).   A 41-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: Er8731 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 12Apr2021 at 10:00 AM, as DOSE 2, SINGLE for COVID-19 immunization at hospital (at the age of 41-year-old). The patient was not pregnant at the time of vaccination. The patient medical history included known allergies: Amoxicillin. Concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6199 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 22Mar2021 at 03:30 PM, as dose 1, single for COVID-19 immunization and experienced just tired the next day (First dose, I was just tired the next day). On 12Apr2021 at 04:00 PM, the patient was tired first day. second day, felt aches all over, headache, nausea, no taste, congested. Third to fifth still have nausea and lingering headache and going strong. The AE did not result in emergency room or physician office. The patient did not receive any treatment for the events. Outcome of the events were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Condition aggravated, Lymphadenopathy, Pain, Swelling
Clinical narrative: More lumps almost all over my lymph nodes area and are painful.; More lumps almost all over my lymph nodes area and are painful.; More lumps almost all over my lymph nodes area and are painful.; More lumps almost all over my lymph nodes area and are painful.; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER 8733), dose 2 via an unspecified route of administration, administered in Arm Right on 05Apr2021 (age at vaccination: 53 year) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient Known allergies reported as no. covid prior vaccination reported as no and covid tested post vaccination no. Other vaccine in fourweeks reported as no. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6208), dose 1 via an unspecified route of administration, administered in Left arm on 15Mar2021 at 03:30 PM (age at vaccination: 53 year) as DOSE 1, SINGLE for covid-19 immunisation and lumps in the base of left side of my neck, behind my right ear and right side of my groin. After second dose patient experienced Lumps all around my neck, under my armpit, behind my left ear, under my chin and on my groin area. More lumps almost all over my lymph nodes area and are painful and condition aggravated. As a result of AE patient visited physician office visit. Therapeutic measures were taken as a result of AE with Antibiotics; Waiting on blood test result. The patient underwent lab tests and procedures included blood test: unknown (waiting for results) on an unspecified date. The clinical outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache
Clinical narrative: shortness of breath; chills; headache; This is a spontaneous report from a contactable consumer (patients wife). A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: Not reported), via an unspecified route of administration on 06Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced shortness of breath, chills, headache. Her husband received the COVID-19 vaccine at the same time (he had no previous COVID-19 diagnose) he also developed shortness of breath, chills and headache, he stayed in bed for two days after which he recovered completely, caller has presented these side effects for more than 12 days. The patient had taken Ibuprofen and Acetaminophen to treat the chills. The outcome of events was recovered on an unknown date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: after the first does had sores on my left back hip; This is a spontaneous report received from a contactable consumer (patient).   A 66-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9261), via an unspecified route of administration in the left arm on 30Jan2021 (at the age of 66-year-old), as single dose for COVID-19 immunization at a Pharmacy. The patient was not pregnant at the time of vaccination. The patient's medical history included sarcoidosis. The patient had no known allergies. The patient did not have COVID prior vaccination. The patient was not tested post vaccination for COVID. Concomitant medications included Prednisone, Azathioprine, Gabapentine and Hydoxychor. On 11Feb2021, the patient reported that after the first does had sores on her left back hip. Adverse event required physician office visit. The patient did not receive any treatment for the event. The outcome of the event was not recovered.  No follow-up attempts are required. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Urticaria
Clinical narrative: outbreak of hives; His lips are swelling; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 29Mar2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received the first dose of COVID-19 vaccine last 29Mar2021 and scheduled for the second dose on 20Apr2021 (22 days apart). The patient said that he really wanted to get the second dose of vaccine, but he had an outbreak of hives since last week. His lips were swelling as well (closed to anaphylaxis), said that it was breaking out might be because he was worried about getting the second dose but claimed that this was not because of COVID-19 vaccine. The outcome of the events was unknown.  No follow up attempts were possible, Information about lot/batch number could not be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Headache, Hyperhidrosis, Pain
Clinical narrative: Chills; Headache; Ache; Pressure on his chest; Sweating; Pale; This is a spontaneous report from a contactable consumer.  A 22-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date in 2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history included myocarditis since Nov2019 ((Name) had myocarditis in November of 2019. He recovered well. Unknown if it was COVID). The patient Concomitant medications were not reported. It was reported he received the Pfizer Vaccine on Wednesday at 5pm and on an unspecified date in 2021, he started experiencing aches, chills and headache the following day. It continued on and off on Friday. Woke up Saturday with pressure on his chest and chills, sweating and pale. He presented to the ER on Saturday 2pm. They believe it's a return of myocarditis. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pallor
Clinical narrative: Chills; Headache; Ache; Pressure on his chest; Sweating; Pale; This is a spontaneous report from a contactable consumer.  A 22-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date in 2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history included myocarditis since Nov2019 ((Name) had myocarditis in November of 2019. He recovered well. Unknown if it was COVID). The patient Concomitant medications were not reported. It was reported he received the Pfizer Vaccine on Wednesday at 5pm and on an unspecified date in 2021, he started experiencing aches, chills and headache the following day. It continued on and off on Friday. Woke up Saturday with pressure on his chest and chills, sweating and pale. He presented to the ER on Saturday 2pm. They believe it's a return of myocarditis. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever above 100.4 with onset at day 6 after injection.; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0158) via an unspecified route of administration on 12Apr2021 (vaccination at the age of 41-year-old and non-pregnant at the time of vaccination) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history included COVID prior vaccination, breastfeeding after recent pregnancy and known allergies to oranges (mild). Concomitant medications were not reported. Not tested for COVID post vaccination. On 18Apr2021, the patient experienced fever above 100.4 with onset at day 6 after injection. The outcome of the events was unknown.   No follow-up attempts are possible. No further information was expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021444637 Exposure During Breastfeeding
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 test, Swelling
Clinical narrative: I noticed red, itchy patches on my left forearm, a few spots on my right forearm. I also have a itchy, swollen spot on my left t; swollen spot on my left; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 45-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 18Apr2021 09:30 (at the age of 45 years old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included I have ibs but nothing else I'm aware of. The patient have sensitives to augmentin [amoxicillin;clavulanic acid](previously took), bananas, some dairy products. Concomitant medication(s) included ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS [ASCORBIC ACID; ERGOCALCIFEROL; FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported, non drowsy allergy relief, nasal sp. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 26Mar2021 05:15 (age at vaccination 45 years) as DOSE 1, SINGLE for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks. The patient received, Multi vitamin, non-drowsy allergy relief, nasal sp as other medications in two weeks. The reporter states, on 18Apr2021 17:00. I noticed red, itchy patches on my left forearm, a few spots on my right forearm. I also have a itchy, swollen spot on my left. Treatment was unknown. The patient underwent lab tests and procedures which included sars-cov-2 test unknown on 18Apr2021 Nasal Swab. The outcome for the events was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain, Pain in extremity, Pyrexia
Clinical narrative: fever; chills; body aches; diarrhea; left arm pain; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration, administered in left arm on 29Mar2021 (age at vaccination 52 years) as DOSE 1, SINGLE for COVID-19 immunisation. Patient medical history included lyme disease and Covid 19. The patient had known allergy: seasonal and penicillin allergies. There were no concomitant medications. Patient was not pregnant at time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No List of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19 and not tested for COVID-19 since vaccination. On an unspecified date the patient experienced fever, chills, body aches, left arm pain, and diarrhea. The patient did not receive any treatment for events. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Oesophagitis, Speech disorder, Swelling
Clinical narrative: a lot of swelling collarbone up to sides of neck; trouble swallowing; esophageal swelling; voice distortion; This is a spontaneous report from a contactable consumer (reported for herself). A 53-years-old female non-pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0150/Batch number was not reported), via an unspecified route of administration, administered in arm left on 07Apr2021 at 12:30 (age at vaccination was 53 years) as dose 2, single for COVID-19 immunization at Temporary Injection Site. The patient's medical history included asthma, antiphospholipid antibodies and raynaud's phenomenon from an unknown date and unknown if ongoing. The patient has known allergies. The concomitant medications included gabapentin, pantoprazole, cetirizine hydrochloride (CETRIZINE), vita and acetylsalicylic acid (ASPRIN). 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. Post the vaccination, the patient has not been tested for COVID-19. The patient previously received Vioxx and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6205, Expiration date: unknown) via an unspecified route of administration, administered in arm left on 17Mar2021 at 13:00 (age at vaccination was 53 years) as dose 1, single for COVID-19 immunization. On 11Apr2021, the patient experienced a lot of swelling collarbone up to sides of neck, trouble swallowing, esophageal swelling and voice distortion. No treatment was received for the adverse events. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Body temperature, Erythema, Fatigue
Clinical narrative: no energy; a 101.4 fever; couldn't get out of bed; body aches; horrible neck tendon pain into back of head; horrible neck tendon pain into back of head; Redness & slight swelling itchiness; Redness & slight swelling itchiness; Redness & slight swelling itchiness; injection site Brain fog; fatigue; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 59 years-old non pregnant female patient received second dose of bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration into Left arm; on 07Apr2021, at 18:00 as DOSE 2, SINGLE (at age of 59 years-old) for covid-19 immunization. Patient medical history included allergies of pencillin, known allergy: shelfish and asthma. Patient concomitant medications were not reported. patient previously took Aleve, novocaine, septocaine and experienced Drug hypersensitivity. It was reported that patient did not have covid-19 prior to vaccination and did not undergo the lab tests for covid-19 after vaccination. Patient was not pregnant at the time of vaccination. The patient previously took first dose of bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 17Mar2021 as DOSE 1, SINGLE (at age of 59 years-old) for covid-19 immunization and experienced horrible sore throat with white spots & red, like strep throat. Sore on side of tongue. Gone in 2 days. tired no energy, fatigue, body aches throughout. 1 week later pain, itching in opposite right arm exactly where shot was given in left arm. On 08Apr2021 after the administration of second dose patient experienced 101.4 fever, couldn't get out of bed, body aches, lasted 24 hours, then horrible neck tendon pain into back of head lasted 3 days. Redness & slight swelling itchiness, red splotches at 1st & 2nd injection site Brain fog, no energy and fatigue. Patient did not receive any treatment for the AE. On 08 Apr2021 the patient underwent lab test and procedures which included body temperature and diagnosed with 101.4 fever (07Apr2021 I had a 101.4 fever next day). The clinical outcome of the events were recovering.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Neck pain, Pain, Pruritus
Clinical narrative: no energy; a 101.4 fever; couldn't get out of bed; body aches; horrible neck tendon pain into back of head; horrible neck tendon pain into back of head; Redness & slight swelling itchiness; Redness & slight swelling itchiness; Redness & slight swelling itchiness; injection site Brain fog; fatigue; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 59 years-old non pregnant female patient received second dose of bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration into Left arm; on 07Apr2021, at 18:00 as DOSE 2, SINGLE (at age of 59 years-old) for covid-19 immunization. Patient medical history included allergies of pencillin, known allergy: shelfish and asthma. Patient concomitant medications were not reported. patient previously took Aleve, novocaine, septocaine and experienced Drug hypersensitivity. It was reported that patient did not have covid-19 prior to vaccination and did not undergo the lab tests for covid-19 after vaccination. Patient was not pregnant at the time of vaccination. The patient previously took first dose of bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 17Mar2021 as DOSE 1, SINGLE (at age of 59 years-old) for covid-19 immunization and experienced horrible sore throat with white spots & red, like strep throat. Sore on side of tongue. Gone in 2 days. tired no energy, fatigue, body aches throughout. 1 week later pain, itching in opposite right arm exactly where shot was given in left arm. On 08Apr2021 after the administration of second dose patient experienced 101.4 fever, couldn't get out of bed, body aches, lasted 24 hours, then horrible neck tendon pain into back of head lasted 3 days. Redness & slight swelling itchiness, red splotches at 1st & 2nd injection site Brain fog, no energy and fatigue. Patient did not receive any treatment for the AE. On 08 Apr2021 the patient underwent lab test and procedures which included body temperature and diagnosed with 101.4 fever (07Apr2021 I had a 101.4 fever next day). The clinical outcome of the events were recovering.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: no energy; a 101.4 fever; couldn't get out of bed; body aches; horrible neck tendon pain into back of head; horrible neck tendon pain into back of head; Redness & slight swelling itchiness; Redness & slight swelling itchiness; Redness & slight swelling itchiness; injection site Brain fog; fatigue; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 59 years-old non pregnant female patient received second dose of bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration into Left arm; on 07Apr2021, at 18:00 as DOSE 2, SINGLE (at age of 59 years-old) for covid-19 immunization. Patient medical history included allergies of pencillin, known allergy: shelfish and asthma. Patient concomitant medications were not reported. patient previously took Aleve, novocaine, septocaine and experienced Drug hypersensitivity. It was reported that patient did not have covid-19 prior to vaccination and did not undergo the lab tests for covid-19 after vaccination. Patient was not pregnant at the time of vaccination. The patient previously took first dose of bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 17Mar2021 as DOSE 1, SINGLE (at age of 59 years-old) for covid-19 immunization and experienced horrible sore throat with white spots & red, like strep throat. Sore on side of tongue. Gone in 2 days. tired no energy, fatigue, body aches throughout. 1 week later pain, itching in opposite right arm exactly where shot was given in left arm. On 08Apr2021 after the administration of second dose patient experienced 101.4 fever, couldn't get out of bed, body aches, lasted 24 hours, then horrible neck tendon pain into back of head lasted 3 days. Redness & slight swelling itchiness, red splotches at 1st & 2nd injection site Brain fog, no energy and fatigue. Patient did not receive any treatment for the AE. On 08 Apr2021 the patient underwent lab test and procedures which included body temperature and diagnosed with 101.4 fever (07Apr2021 I had a 101.4 fever next day). The clinical outcome of the events were recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Hypoaesthesia, Vaccination site pain
Clinical narrative: swelling on her right eye; she is experiencing soreness and numbness on her left arm (vaccination site); she is experiencing  soreness and numbness on her left arm (vaccination site); This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route, administered in left arm on 21Apr2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On the day of reporting (22Apr2021), she was experiencing swelling on her right eye and soreness and numbness on her left arm (vaccination site) and would like to know/confirm if this was a commonly reported side effect post-administration of the vaccine as she had read on the fact sheet that swelling of the face was included on the expected/commonly reported side effects. Also, she would like to know if this went away and if she could put anything or take any medications. The outcome of events was unknown.  No follow-up attempts were needed, information about lot/batch number could not be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Intraocular pressure test, Ophthalmological examination, Vision blurred
Clinical narrative: Had very blurry vision out the side of my right eye; Achy joints; Inflammation; This is a spontaneous report from a contactable consumer (patient herself). A 69-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: ER8732, expiration date: not reported), via an unspecified route of administration, administered in Arm Right on 28Mar2021 16:30 (at the age of 69 years) as dose 2, single for covid-19 immunization in hospital. Medical history included glaucoma from an unknown date and unknown if ongoing, allergies from bananas and codeine from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN6205, expiration date: not reported), via an unspecified route of administration, administered in Arm Right on 07Mar2021 16:30 as dose 1, single for covid-19 immunization and had achy joints. Patient had no covid prior vaccination. Patient was not tested covid post vaccination. Patient had no other vaccine in four weeks. On 29Mar2021 08:00, the patient experienced had very blurry vision out the side of my right eye and on an unspecified date in Mar2021, patient had achy joints, inflammation. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient had second vaccine at 4:30 pm and the next morning at 8:00 am had very blurry vision out the side of my right eye. Patient went to a retina specialist, because when she called the eye doctor, they thought that it might be a detached retina. After examination it was determined that it wasn't a detached retina. They couldn't explain why it happened. They mentioned that since she also had achy joints, that inflammation may have caused the blurry vision. Also, her eye pressure was 20. Patient had achy joints with both vaccines for several days. Clinical outcome of the events was reported as recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: I had achy joints with both vaccines for several days.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6205) via an unspecified route of administration, administered in Arm Right on 07Mar2021 14:30 (Age at vaccination: 69-year-old) as dose 1, single for COVID-19 immunization. Medical history included glaucoma, known allergy to bananas. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergy. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Patient had not been tested for COVID-19 since the vaccination. Patient had no COVID prior vaccination. Patient reported that she had achy joints with both vaccines for several days. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Pruritus, Sleep disorder
Clinical narrative: I had been have a pain in my arm ; took it on my left arm, it has been sore; I have been getting some like bit itchy like throbbing pain in arm ; I am just continuing to get these throbbing pain in my arm like from the top of the way to my head; I have been getting some like bit itchy like throbbing pain in arm; It wakes me up throughout ; sometimes it's been like wake up to sleep, it's just totally numb; It wakes me up throughout ; sometimes it's been like wake up to sleep; This is a spontaneous report from a contactable consumer (patient) reported for self. A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously 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 at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization and after the first dose, the patient's left arm had been sore and the patient had been getting some like bit itchy like throbbing pain in arm. The patient had taken both of the Pfizer shot and the second one to that to tomorrow would be two weeks. On an unspecified date, after the second dose, the patient had a pain in arm, the patient took the vaccine in left arm and it had been sore. The patient had been getting some like bit itchy like throbbing pain in arm, the patient was just continuing to get this throbbing pain in arm like from the top of the way to head. The patient wakes up, it wakes the patient up throughout. Sometimes during the day it was not as bad and like it just sometimes, it was like wake up to sleep, it was just totally numb. The patient just wanted to know if there was anything to get that checked out and if the patient needed to be concerned about that. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: full body rash; This is a spontaneous report from a contactable consumer (patient) reported in response to Non-HCP follow-up letter sent in cross reference case that included:  A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: 9262, expiration date was not reported), via intramuscular, administered in left arm on 11Feb2021 16:00 (at the age of 69-years-old) as dose 2, single for covid-19 immunization. The patient medical history included depression. Concomitant medication included bupropion hydrochloride (WELLBUTRIN, oral) taken for depression, from an unknown date. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL1284, expiration date was not reported), via intramuscular, administered in left arm on 21Jan2021 16:00 as dose 1, single for covid-19 immunization. The patient did not receive any prior vaccinations. It was reported that on 15Feb2021 the patient experienced full body rash. Seriousness criteria: persistent. The adverse event resulted in physician office visit. Cortisone was received as treatment for the adverse event. Therapeutic measures were taken as a result of full body rash. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient) reported in response to Non-HCP follow-up letter sent in cross reference case.  A 60-years-old male patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch No: not reported/Lot Number: ER8730) via intramuscularly administered in arm right (reported as right shoulder) on 22Mar2021 at 09:30 (at the age of 60 years old) as dose 2, single for covid-19 immunization at Public Health Clinic/ facility. Medical history included covid-19 experienced from 22Oct2020 to 02Dec2020. Concomitant medication was none. Historical vaccine included patent received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE solution for injection Batch No: not reported/Lot Number: EN6201) via intramuscularly in arm right (reported as right shoulder) on 20Feb2021 at 15:48 (at the age of 60 years old) as dose 1, single for covid-19 immunization and experienced with fever and chills. Prior vaccinations administered within 4 weeks were No. On 23Mar2021, the patient experienced with fever, chills. Seriousness criteria reported as not serious. The relevant lab test underwent was none. No therapeutic measure was taken. The outcome of the event fever and chills was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021194475 same patient and drug, different dose and events
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Cough, Hypersensitivity, Illness, Nasal congestion
Clinical narrative: became ill; nasal congestion; cough; lose her sense of smell; believed them to be allergy related; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sales representative. A 53-year-old female patient reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and second dose of bnt162b2 (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient became ill with nasal congestion and a cough and believed them to be allergy related. The patient did lose her sense of smell but attributed it to the nasal congestion. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.