chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: Broken out in a rash on her arm and thighs; reddish blotchy looking; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 17Feb2021 07:45 (Batch/Lot Number: EL9267) as dose, 1 single (at the age of 42-year) for covid-19 immunisation. Medical history included ongoing Blood pressure high, Autoimmune disease, sensitive skin. There were no concomitant medications. Historical vaccine of flu for immunization and had bumps, rash. She mentioned she does get the Flu Vaccine and it's possible the same thing happens, gets the bumps and rashes. However, they occur within a few hours and goes away. The patient got the vaccine, first dose, at 7:45 AM this morning. Right afterwards, physically she felt fine. However, she has Broken out in a rash on her arm and thighs. It was reddish blotchy looking. The rash was not itchy. She feels fine, but just wanted to know if she should report this and if this was something she should be worried about. The events occurred on 17Feb2021. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Erythema, Hypoacusis, Insomnia, Pruritus
Clinical narrative: Hard of hearing; her toe was itching; My toe started swelling and red; My toe started swelling and red; I hadn't been able to sleep; I put a little bit non-itch (Unspecified Medication) and all of the sudden rash went right down my arm; This is a spontaneous report from a contactable consumer (Patient). A 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EWS138), via an unspecified route of administration on 03Feb2021 (at the age of 83-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history included high cholesterol, restless legs syndrome, depression, and memory disturbance. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL1283), via an unspecified route of administration on 13Jan2021 (at the age of 83-year-old), as single dose for COVID -19 immunization. Concomitant medications included levothyroxine sodium (SYNTHROID); atorvastatin (LIPITOR); apoaequorin (PREVAGEN) taken for her memory, start and stop dates were not reported. Patient was taking pills for depression and cholesterol, which was not clarified. On 18Feb2021, 15 days after second dose of vaccine, the patient's toe was itching, her toe started swelling and red and put a little bit non-itch (unspecified Medication) and all of the sudden rash went right down her arm and also felt hard to hear. Patient thought she had an attack of gout. So, took a blood test and it wasn't that. Patient was not been able to sleep and had been living on Benadryl. Patient had been itching all over. Patient thought of going to dermatologist. Patient would like to rule out the fact that it might be the injection that caused all these. The patient underwent lab test and procedure which included blood test: it was not gout, on an unspecified date. The clinical outcome of all events was unknown.  Follow-up attempts completed. No further information expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: Hard of hearing; her toe was itching; My toe started swelling and red; My toe started swelling and red; I hadn't been able to sleep; I put a little bit non-itch (Unspecified Medication) and all of the sudden rash went right down my arm; This is a spontaneous report from a contactable consumer (Patient). A 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EWS138), via an unspecified route of administration on 03Feb2021 (at the age of 83-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history included high cholesterol, restless legs syndrome, depression, and memory disturbance. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL1283), via an unspecified route of administration on 13Jan2021 (at the age of 83-year-old), as single dose for COVID -19 immunization. Concomitant medications included levothyroxine sodium (SYNTHROID); atorvastatin (LIPITOR); apoaequorin (PREVAGEN) taken for her memory, start and stop dates were not reported. Patient was taking pills for depression and cholesterol, which was not clarified. On 18Feb2021, 15 days after second dose of vaccine, the patient's toe was itching, her toe started swelling and red and put a little bit non-itch (unspecified Medication) and all of the sudden rash went right down her arm and also felt hard to hear. Patient thought she had an attack of gout. So, took a blood test and it wasn't that. Patient was not been able to sleep and had been living on Benadryl. Patient had been itching all over. Patient thought of going to dermatologist. Patient would like to rule out the fact that it might be the injection that caused all these. The patient underwent lab test and procedure which included blood test: it was not gout, on an unspecified date. The clinical outcome of all events was unknown.  Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Hyperhidrosis, Nausea
Clinical narrative: Severe vertigo; I had very little sleep; neck ache/severe pain in my neck, head (forehead, specifically), and upper shoulders; Headache/severe pain in my neck, head (forehead, specifically), and upper shoulders; shoulder ache/severe pain in my neck, head (forehead, specifically), and upper shoulders; nausea; sweats; chills; This is a spontaneous report received from a contactable consumer (Patient). A 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration, administered in Arm Left on 16Feb2021 09:30 (at the age of 61-year-old) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included acebutolol (ACEBUTOLOL), primidone (PRIMIDONE), atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]), losartan (LOSARTAN), fexofenadine hydrochloride (ALLEGRA). The patient previously took codeine in Tylenol 3 and experienced codeine in Tylenol 3 allergy. Patient did not receive any other vaccine with four weeks of Pfizer COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID-19 since vaccination. Patient historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number unknown), Solution for injection, via an unspecified route of administration, administered in Arm Left on 26Jan2021 09:30 as single dose for covid-19 immunisation. On 17Feb2021 00:30, the patient experienced severe vertigo, had very little sleep, neck ache/severe pain in my neck, head (forehead, specifically), and upper shoulders, shoulder ache/severe pain in my neck, head (forehead, specifically) and upper shoulders, nausea, sweats and, chills. It was reported that, he received his 2nd dose of the vaccine at 9:25 am on 16Feb2021, yet did not exhibit adverse effects until shortly after midnight (12:30 am, 17Feb2021). He had very little sleep the remainder of the night, and then experienced severe pain in his neck, head (forehead, specifically), and upper shoulders until around 9:30 pm that same day (17Feb2021). Two doses of acetaminophen (1.25 g) were taken that day, about 8 hr apart, to help reduce severity of symptoms. The remainder of the evening of 17Feb2021 were uneventful with no side effects. The events were recovered on 17Feb2021.  Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Sleep disorder, Vertigo
Clinical narrative: Severe vertigo; I had very little sleep; neck ache/severe pain in my neck, head (forehead, specifically), and upper shoulders; Headache/severe pain in my neck, head (forehead, specifically), and upper shoulders; shoulder ache/severe pain in my neck, head (forehead, specifically), and upper shoulders; nausea; sweats; chills; This is a spontaneous report received from a contactable consumer (Patient). A 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration, administered in Arm Left on 16Feb2021 09:30 (at the age of 61-year-old) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included acebutolol (ACEBUTOLOL), primidone (PRIMIDONE), atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]), losartan (LOSARTAN), fexofenadine hydrochloride (ALLEGRA). The patient previously took codeine in Tylenol 3 and experienced codeine in Tylenol 3 allergy. Patient did not receive any other vaccine with four weeks of Pfizer COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID-19 since vaccination. Patient historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number unknown), Solution for injection, via an unspecified route of administration, administered in Arm Left on 26Jan2021 09:30 as single dose for covid-19 immunisation. On 17Feb2021 00:30, the patient experienced severe vertigo, had very little sleep, neck ache/severe pain in my neck, head (forehead, specifically), and upper shoulders, shoulder ache/severe pain in my neck, head (forehead, specifically) and upper shoulders, nausea, sweats and, chills. It was reported that, he received his 2nd dose of the vaccine at 9:25 am on 16Feb2021, yet did not exhibit adverse effects until shortly after midnight (12:30 am, 17Feb2021). He had very little sleep the remainder of the night, and then experienced severe pain in his neck, head (forehead, specifically), and upper shoulders until around 9:30 pm that same day (17Feb2021). Two doses of acetaminophen (1.25 g) were taken that day, about 8 hr apart, to help reduce severity of symptoms. The remainder of the evening of 17Feb2021 were uneventful with no side effects. The events were recovered on 17Feb2021.  Follow-up attempts completed. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: mild chills; mild body ache; fever 100.8; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 16Feb2021 13:30 (age at the vaccination 57-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included fish oil, ciclosporin (RESTASIS), risperidone (RISPERDAL) and multivitamins. Historical vaccine included first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 26Jan2021 02:45 PM for COVID-19 immunization. Patient did not have covid prior vaccination. Patient did not test covid post vaccination. Patient got second shot on 16Feb 1:30 pm. patient did not experience anything on the same day. Patient got mild chills and mild body ache and fever 100.8 on second day on 17Feb2021 09:00 am. Patient was fine on the third day. Patient did not receive treatment for the adverse events. The patient underwent lab tests and procedures which included body temperature: 100.8 on 17Feb2021. The outcome of the events was recovered on an unspecified date in 2021. .  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 7+ days of redness, swelling, heat over the injection site. By day 3 localized reaction spread to a raised hot, painful rash approx 4x5 inches; 7+ days of redness, swelling, heat over the injection site. By day 3 localized reaction spread to a raised hot, painful rash approx 4x5 inches; 7+ days of redness, swelling, heat over the injection site. By day 3 localized reaction spread to a raised hot, painful rash approx 4x5 inches; 7+ days of redness, swelling, heat over the injection site. By day 3 localized reaction spread to a raised hot, painful rash approx 4x5 inches.; This is a spontaneous report from a contactable Nurse (patient herself). This 44-year-female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration Left arm on 12Feb2021 13:30 as single dose for COVID-19 immunisation. Medical history included Polycystic, Depression, Deep vein thrombosis and Pulmonary Embolism. Concomitant medications included Levothyroxine, escitalopram oxalate (LEXAPRO), ASA, ibuprofen, apap. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration in Left arm on 22Jan2021 for COVID-19 immunization. On 15Feb2021 patient experienced with 7+ days of redness, swelling, heat over the injection site, localized reaction spread to a raised hot, painful rash approx 4x5 inches. Patient did not receive any treatment for the events. Outcome of events was recovering.  Lot/Batch number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: little tired; sore shoulder/very sore shoulder/very mildly sore shoulder; mild headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in right arm on 17Feb2021 at 08:30 (at the age of 40-year-old) as dose 2, single for COVID-19 immunisation at workplace clinic. The patient medical history and concomitant medications were not reported. The patient had no known allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm on 27Jan2021 at 07:30 (at the age of 40-year-old) as dose 1, single for COVID-19 immunisation Prior to the vaccination, the patient was not had COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that after 1st injection, the patient did not experience any side effects. After 2nd injection, on dame day (17Feb2021), the patient experienced a little tired, sore shoulder, mild headache. On day 2, a little tired, very sore shoulder, mild headache and on day 3, very mildly sore shoulder. The patient was not received any adverse events. The outcome of the events was reported as resolved on an unknown date.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Swelling face
Clinical narrative: her eyes were swollen; her face that was swollen; This is a spontaneous report from a contactable Consumer (patient). A female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Mar2021, the patient experienced eyes were swollen, her husband told her it was her face that was swollen. Patient took 2 Benadryl and the day after as well. The outcome of the events was resolved on unspecified date of 2021.  Information regarding Lot/Batch number requested.  Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 antibody test
Clinical narrative: rash over abdomen, back and suprapubic region; This is a spontaneous report from a contactable nurse (patient). A 22-years-old female non pregnant patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 11Feb2021 16:15 (at the age of 22-years-old) (Batch/Lot Number: EL9269) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included ethinylestradiol/norgestimate (TRI FEMYNOR), spironolactone, creatine monohydrate for all drug are taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of bnt162b2 (Lot number:EL9261) administered in Arm Right on 21Jan2021 01:00 PM for covid-19 immunisation. The patient experienced rash over abdomen, back and suprapubic region on 12Feb2021 17:00. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 18Feb2021. Patient did not receive any treatment for adverse event. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient has no known allergies. Prior vaccination patient did not tested for covid and post vaccination patient tested for covid. Outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Work up with swollen eyelids in both eyes on 20Feb2021; This is a spontaneous report from a contactable consumer (patient). A 42-years-old female non pregnant patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 15:30 (at the age of 42-years-old) (Batch/Lot Number: EN6201) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included known allergies of penicillin from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol/norelgestromin (XULANE) taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of bnt162b2 (Lot number: EL8982) administered in Right arm on 29Jan2021 11:45 AM for covid-19 immunisation. The patient experienced work up with swollen eyelids in both eyes on 20Feb2021 05:00. Treatment for event was recommended to take Claritin and antihistamine eye. Prior vaccination and post vaccination: patient did not tested covid. Outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Headache; Fatigue; Fever; Injection site pain; This is a spontaneous report from a non-contactable consumer (patient). A 55 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot Number: EN6201) via an unspecified route, administered in Left Arm on 19Feb2021 at 04:30 PM (55-year-old at vaccination) as Dose 1, Single for Covid-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history was reported as none. Known allergies was reported as none. The patient's concomitant medications were not reported. Facility type vaccine was reported as Other. The patient had no covid prior vaccination. The patient was not tested for covid post vaccination. The patient had not received any other vaccine within four weeks prior to vaccination. On 19Feb2021 at 12:00 AM, the patient experienced headache, fatigue, fever, injection site pain. No treatment medications received for the resulted events. The outcome of events was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information was expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Nausea, Pyrexia
Clinical narrative: chills; Nausea; Vomiting; No Energy; 102 fever; headache (massive); This is a spontaneous report from a contactable other healthcare professional (patient). A 48-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN5318 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 02Feb2021 at 18:00 hours as dose 2, single (at the age of 48-years-old) for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, diabetes and sleep apnea (all from an unknown date and unknown if ongoing). Patient had no known allergies. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL8982 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 12Jan2021 at 18:00 hours as dose 1, single (at the age of 48-years-old) for COVID-19 immunisation. Patient had no other vaccine in four weeks. Patient received unspecified concomitant medications in two weeks. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for the COVID-19, post vaccination. On 03Feb2021 at 6:00 hours, patient had headache (massive), at 11:00 hours, patient started with chills, 102 fever, nausea, vomiting and had no energy. On 04Feb2021, patient had relief from nausea and vomiting but still had headache, chills, fever and no energy and at 18:00 hours (48 hours after shot), patient had relief from fever and chills. On 05Feb2021 at 11:00 hours (65 hours after shot), patient had relief from headache. Patient received no treatment for the events. The outcome of chills and 102 fever was recovered on 04Feb2021 at 18:00 hours, nausea and vomiting was recovered on 04Feb2021, headache (massive) recovered on 05Feb2021 at 11:00 hours, no energy was recovered on Feb2021.  Follow-up attempts completed. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: chills; Nausea; Vomiting; No Energy; 102 fever; headache (massive); This is a spontaneous report from a contactable other healthcare professional (patient). A 48-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN5318 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 02Feb2021 at 18:00 hours as dose 2, single (at the age of 48-years-old) for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, diabetes and sleep apnea (all from an unknown date and unknown if ongoing). Patient had no known allergies. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL8982 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 12Jan2021 at 18:00 hours as dose 1, single (at the age of 48-years-old) for COVID-19 immunisation. Patient had no other vaccine in four weeks. Patient received unspecified concomitant medications in two weeks. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for the COVID-19, post vaccination. On 03Feb2021 at 6:00 hours, patient had headache (massive), at 11:00 hours, patient started with chills, 102 fever, nausea, vomiting and had no energy. On 04Feb2021, patient had relief from nausea and vomiting but still had headache, chills, fever and no energy and at 18:00 hours (48 hours after shot), patient had relief from fever and chills. On 05Feb2021 at 11:00 hours (65 hours after shot), patient had relief from headache. Patient received no treatment for the events. The outcome of chills and 102 fever was recovered on 04Feb2021 at 18:00 hours, nausea and vomiting was recovered on 04Feb2021, headache (massive) recovered on 05Feb2021 at 11:00 hours, no energy was recovered on Feb2021.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: When he got the first shot it was sore; This is a spontaneous report from a contactable consumer. A 80-year-old male patient received BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number and Expiration date: was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE dose for covid-19 immunisation. The patient medical history and concomitant was not reported. It was reported that, the patient experienced when he got the first shot it was sore on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Pain at injection site; Extreme fatigue; This is a spontaneous report from a contactable consumer (Daughter in law). A 79-years-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Formulation: Solution for injection, Batch/lot number and  expiry date: unknown), via an unknown route of administration (location of administration was unknown) on an unspecified date in 2021 as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced pain at injection site and extreme fatigue. The patient taking COVID vaccine last night. She primarily experienced pain at injection site and extreme fatigue. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is little sore; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and expiration date: was not reported), via an unspecified route of administration on 09Feb2021 as DOSE NUMBER, UNKNOWN SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Feb2021 the patient experienced arm is little sore. Outcome of event was unknown.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021187758 Same reporter/product, different patient/events
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Renal pain
Clinical narrative: Severe pain/pain was located in the back, abdomen, right kidney/back area; Severe pain/pain was located in the back, abdomen, right kidney/back area; Severe pain/pain was located in the back, abdomen, right kidney/back area; This is a spontaneous report from a contactable consumer (Patient wife).   A 75-years-old male patient received first dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248), via an unspecified route of administration, administered in arm left on 09Feb2021 12:10 (at the age of 75-years-old) as dose 1, single for covid-19 immunization. Vaccination facility: Hospital. Vaccine was Administered at Facility. Medical history included ongoing blood thinner, Heart/heart condition and aneurysm (He has an old aneurysm that is still there, this was about 12 years ago). Concomitant medication included rivaroxaban (XARELTO) for blood thinner, iron (MANUFACTURER UNKNOWN) for an unspecified indication, metoprolol succinate (MANUFACTURER UNKNOWN) for heart, all from an unspecified start date and ongoing. Prior vaccinations no other medication received within 4 weeks. It was reported that Caller on the line calling about her husband. He received the first shot, the first shot of the COVID 19 Vaccine and had a possible side effect. She mentioned her husband was on a blood thinner. He did not know prior to getting the vaccine he should have notified the person administering he was on a blood thinner. Did not know until after looked at paper work. Caller explained the patient was in severe pain. She was calling to see if this severe pain was possibly related to the vaccine. She also added, patient has a heart condition. He has an old aneurysm that was still there. Caller explained the severe pain started 5 AM this morning. As of now the pain was almost gone. The pain was located in the back, abdomen, right kidney/back area. Caller reiterated she was calling about the blood thinner because patient did not know should have notified the ones administering he was on a blood thinner. Caller stated she was debating on taking her husband to the ER, but would have to go 100 miles and does not want to do that. She stated if the severe pain continues then they would have to go to the Hospital. She added, with the aneurysm it could break and something want to be careful with. The adverse events did not require a visit to emergency room and Physician's Office. The outcome for the events was reported as resolving.   Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Pain, Product preparation issue
Clinical narrative: They reported significant body aches.; 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; This is a spontaneous report from contactable physician. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications was not reported. It was reported that 15 persons received Pfizer vaccine from vials that had been reconstituted with 1.3 mL instead of 1.8 mL which led to Overdose and Inappropriate dilution of medication and reported significant body aches. The clinical outcome for the events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188834 Same reporter/drug/event, different patient.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Right shoulder soreness with decreased ROM; injection site soreness; This is a spontaneous report from a contactable physician (patient). A 66-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3248) via intramuscular route of administration, administered in Arm Right on 12Jan2021 15:00 (at the age of 66 years old) as dose 2, single for COVID-19 immunisation at hospital. Medical history included asthma, breast Cancer survivor x 10 years, osteopenia. Concomitant medication received within two weeks included fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma, start and stop date were not reported. The patient previously took tussionex [hydrocodone;phenyltoloxamine] and experienced allergy. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EK5730) via intramuscular route of administration, administered in Arm Right on 23Dec2020 06:30 (at the age of 66 years old) as single for COVID-19 immunisation. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced injection site soreness on 12Jan2021, right shoulder soreness with decreased rom on 14Jan2021 12:45. Reported as, within 6-8 hours of injection, usual expected injection site soreness occurred, but then within 48 hours this intensified and Right shoulder soreness with decreased ROM that barely responded to acetaminophen 500-650 mg BID- TID. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient did not tested for COVID post vaccination. Therapeutic measures were taken as a result of injection site soreness, right shoulder soreness with decreased rom. Outcome of all the events were recovering.  Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cold sweat, Fatigue, Myalgia
Clinical narrative: chills; strong muscle pain in the body; cold sweats; 38.2F; fatigue; Started with pain in the vaccinated arm (left) spreading to the left side; This is a spontaneous report from a non-contactable consumer (patient). A 56-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) (at the age of 56-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No covid prior vaccination. Not tested for covid post vaccination. On 17Feb2021, at 12:00 AM, started with pain in the vaccinated arm (left) spreading to the left side. Next day, on 18Feb2021 patient experienced chills (electric matrass pad & 2 blankets), strong muscle pain in the body, cold sweats, 38.2F, fatigue. No treatment was given. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: chills; strong muscle pain in the body; cold sweats; 38.2F; fatigue; Started with pain in the vaccinated arm (left) spreading to the left side; This is a spontaneous report from a non-contactable consumer (patient). A 56-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) (at the age of 56-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No covid prior vaccination. Not tested for covid post vaccination. On 17Feb2021, at 12:00 AM, started with pain in the vaccinated arm (left) spreading to the left side. Next day, on 18Feb2021 patient experienced chills (electric matrass pad & 2 blankets), strong muscle pain in the body, cold sweats, 38.2F, fatigue. No treatment was given. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact, Psoriasis
Clinical narrative: psoriasis-like spots on my stomach; I have developed new spots on my upper arms.; This is a spontaneous report from a contactable consumer. A 32-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EM9810), dose 1 via an unspecified route of administration, administered in left arm on 06Feb2021 at 10:00 (at the age of 32-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. No other vaccine in four weeks. No COVID prior vaccination. Other medications in two weeks reported as none. Patient had Known allergies and other medical history reported as none. Patient was healthy with no previous skin conditions or problems. Adverse event start date: 08Feb2021 at 08:00 AM. 46 hours after the first vaccine patient developed psoriasis-like spots on stomach. Within the first four days patient noticed them on back, sides, thighs and arms. As of today (two weeks since first injection) developed new spots on upper arms. AE resulted in: Doctor or other health care professional office/clinic visit. No treatment received. The outcome of the events were unknown. Follow-up attempts completed. No further information expected
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Axillary pain, Chest discomfort, Dizziness, Fatigue
Clinical narrative: face flush; Body aches; under left arm felt/Large lump under left armpit and sore; Dizzy; I could barely taste salt & fresh lemon; Headache; brain fog; tiredness; Tightness in chest/chest congestion & a bit of tightness; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 56-years-old non pregnant female patient received bnt162b2 (solution for injection, age at vaccination: 56-years) ,dose 2 via an unspecified route of administration, administered in Arm Left on 20Feb2021 10:15 (Batch/Lot Number: EN6200) as DOSE 2, SINGLE for covid-19 immunisation. Patients medical history was reported as none. Past vaccine included bnt162b2 (solution for injection) ,dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 12.00 (Batch/Lot Number: unknown) as DOSE NUMBER 1, SINGLE DOSE for covid-19 immunisation. Concomitant medication included vitamin c [ascorbic acid] taken for an unspecified indication, start and stop date were not reported. There were no allergies. The were no COVID infection prior to vaccination. COVID test was not performed post vaccination. On 20Feb2021 the patient experienced slight headache, tired-ness, brain fog, chest congestion & a bit of tightness. On 21Feb2021, headache, tightness in chest, body aches, under left arm felt pinch with slight pain, dizzy, tired, face flushed red, top of left arm slightly sore. Patient could barely taste salt & fresh lemon. Took advil at 5pm and it helped face flush and body aches. On 22Feb2021, large lump under left armpit & sore, small bit of brain fog, slight pressure on chest, taste to salt back, slight headache. Advil was taken as a Therapeutic measures for the events face flush, body ache. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Flushing, Headache, Pain
Clinical narrative: face flush; Body aches; under left arm felt/Large lump under left armpit and sore; Dizzy; I could barely taste salt & fresh lemon; Headache; brain fog; tiredness; Tightness in chest/chest congestion & a bit of tightness; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 56-years-old non pregnant female patient received bnt162b2 (solution for injection, age at vaccination: 56-years) ,dose 2 via an unspecified route of administration, administered in Arm Left on 20Feb2021 10:15 (Batch/Lot Number: EN6200) as DOSE 2, SINGLE for covid-19 immunisation. Patients medical history was reported as none. Past vaccine included bnt162b2 (solution for injection) ,dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 12.00 (Batch/Lot Number: unknown) as DOSE NUMBER 1, SINGLE DOSE for covid-19 immunisation. Concomitant medication included vitamin c [ascorbic acid] taken for an unspecified indication, start and stop date were not reported. There were no allergies. The were no COVID infection prior to vaccination. COVID test was not performed post vaccination. On 20Feb2021 the patient experienced slight headache, tired-ness, brain fog, chest congestion & a bit of tightness. On 21Feb2021, headache, tightness in chest, body aches, under left arm felt pinch with slight pain, dizzy, tired, face flushed red, top of left arm slightly sore. Patient could barely taste salt & fresh lemon. Took advil at 5pm and it helped face flush and body aches. On 22Feb2021, large lump under left armpit & sore, small bit of brain fog, slight pressure on chest, taste to salt back, slight headache. Advil was taken as a Therapeutic measures for the events face flush, body ache. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Immunoglobulins abnormal, Malaise, SARS-CoV-2 test
Clinical narrative: IGG antibodies; feeling ill; This is a spontaneous report from a contactable pharmacist.A female patient in her 50's received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) as Dose number unknown, single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced IGG antibodies and feeling ill.The patient underwent lab tests and procedures which included blood immunoglobulin G: positive and sars-cov-2 test: negative.The outcome of the events were unknown.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Vaccination site pain
Clinical narrative: muscle soreness at injection site; Chills; fever (100.5F); This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Left on 18Feb2021 10:00 (at the age of 34-years-old) as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included Ibuprofen at 600 mg, as needed and vitamin d3. The patient's medical history was not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Left on 27Jan2021 02:00 PM (at the age of 34-years-old) as single dose for covid-19 immunisation and experienced muscle soreness at injection site starting 1 day after injection and lasting 3 days. On 18Feb2021, the patient experienced muscle soreness at injection site starting day of vaccination and lasting 3 days, chills and fever (100.5F) starting 12 hours post-vaccination and lasting until about 30 hours post-vaccination. The patient underwent lab tests and procedures which included body temperature: 100.5 Fahrenheit on 18Feb2021. The patient did not receive any treatment for the adverse events. The outcome of the events was recovered on an unspecified date.   Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Myalgia, Neck pain, Vaccination site pain
Clinical narrative: inner elbow was sore; feels numb; I have terrible muscle pain in my upper left arm where I received the injection which radiates up my neck and shoulder blade; I have terrible muscle pain in my upper left arm where I received the injection which radiates up my neck and shoulder blade; I have terrible muscle pain in my upper left arm where I received the injection which radiates up my neck and shoulder blade; I have terrible muscle pain in my upper left arm where I received the injection which radiates up my neck and shoulder blade; This is a spontaneous report from a contactable other healthcare professional, (patient). A 53-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 11Feb2021 14:45 (at the age of 53-years-old) as a single dose for covid-19 immunization. Medical history included autoimmune thyroiditis: Hashimoto thyroid, hypertension. The patient did not have any allergies. The patient had no other vaccine within four weeks and other medications was received within 2 weeks of vaccination (not sepcified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Feb2021, the patient experienced inner elbow was sore for a day. Since, I have terrible muscle pain in my upper left arm where I received the injection which radiates up my neck and shoulder blade. Sometimes it feels numb and radiates down my arm to my fingers. The patient did not receive any treatment. Outcome of the event was unknown. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Increased appetite, Influenza like illness
Clinical narrative: fatigue; malaise; I then noticed a set of flu-like symptoms; pain at injection site; muscle pain; joint pain; fever; chills; increased thirst; increased appetite; insomnia; This is a spontaneous report from a non-contactable consumer. This male consumer (patient) reported that: A 31-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 19Feb2021 at 11:45 as single dose for covid-19 immunisation. Medical history included known peanuts allergy. Patient not diagnosed with covid-19 prior to vaccination. Concomitant medication(s) included colecalciferol (D3) and cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for an unspecified indication, start and stop date were not reported. The patient previously took bactrim and experienced drug allergy. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 29Jan2021 at 11:45 as single dose for covid-19 immunisation. Patient reported shortly after the injection was administered on 19Feb2021 at 13:00, I experienced fatigue and malaise. I then noticed a set of flu-like symptoms that persisted for around two days. These included pain at injection site, muscle pain, joint pain, fatigue, fever, chills, increased thirst, increased appetite, insomnia. All have resolved except the pain at the injection site. Since vaccination patient not tested for covid-19. No therapeutic measures were taken as a result of the events. The outcome of the event pain at the injection site was recovering and all other events were recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.