chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug interaction, Headache, Influenza, Malaise, Pyrexia
Clinical narrative: have interaction with the vaccine; I am not well like at all; I have been having terrible headaches; Fever; Flu; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 09Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RSV VACCINE taken for immunisation, administration date 03Nov2021. The following information was reported: DRUG INTERACTION (non-serious), outcome "unknown", described as "have interaction with the vaccine"; MALAISE (non-serious), outcome "unknown", described as "I am not well like at all"; HEADACHE (non-serious), outcome "unknown", described as "I have been having terrible headaches"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; INFLUENZA (non-serious), outcome "unknown", described as "Flu". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: pain, aching, and stiffness from my knees down on both legs; pain, aching, and stiffness from my knees down on both legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administration date 27Aug2021 (Batch/Lot number: unknown) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, lot number=FC3180,, administration date=06Aug2021,, vaccine location=Left arm), administration date: 06Aug2021, when the patient was 28 years old, for COVID-19 immunization, reaction(s): "extremely tired". The following information was reported: PAIN IN EXTREMITY (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 06Sep2021, outcome "recovered" (2021) and all described as "pain, aching, and stiffness from my knees down on both legs". Therapeutic measures were not taken as a result of pain in extremity, musculoskeletal stiffness.  Additional information: Patient had no known allergy. Patient had no adverse reaction after his first shot, besides being extremely tired for 2-3 days after getting it. After receiving his second dose of covid 19 shot on 27Aug2021 about 1.5 to 2 weeks later he started noticing pain, aching, and stiffness from knees down on both legs. This lasted for about 2 months and went away after that luckily. It made him feel like arthritis in lower legs. He was only 28 but felt as though legs were that of 80 years old for those 2 months that those pains persisted in legs (from knees down). The pain was wort in the mornings and in the evenings. Patient did not receive any other vaccine within four weeks of COVID-19 vaccine. Patient did not receive any other medication in two weeks of COVID-19 vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: pain, aching, and stiffness from my knees down on both legs; pain, aching, and stiffness from my knees down on both legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administration date 27Aug2021 (Batch/Lot number: unknown) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, lot number=FC3180,, administration date=06Aug2021,, vaccine location=Left arm), administration date: 06Aug2021, when the patient was 28 years old, for COVID-19 immunization, reaction(s): "extremely tired". The following information was reported: PAIN IN EXTREMITY (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 06Sep2021, outcome "recovered" (2021) and all described as "pain, aching, and stiffness from my knees down on both legs". Therapeutic measures were not taken as a result of pain in extremity, musculoskeletal stiffness.  Additional information: Patient had no known allergy. Patient had no adverse reaction after his first shot, besides being extremely tired for 2-3 days after getting it. After receiving his second dose of covid 19 shot on 27Aug2021 about 1.5 to 2 weeks later he started noticing pain, aching, and stiffness from knees down on both legs. This lasted for about 2 months and went away after that luckily. It made him feel like arthritis in lower legs. He was only 28 but felt as though legs were that of 80 years old for those 2 months that those pains persisted in legs (from knees down). The pain was wort in the mornings and in the evenings. Patient did not receive any other vaccine within four weeks of COVID-19 vaccine. Patient did not receive any other medication in two weeks of COVID-19 vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Incorrect dose administered
Clinical narrative: Given a full dose instead of a half dose booster. Fever that night with a headache that continued the weekend. Sore arm. Nothing severe. Worst part was the headache that lasted all weekend.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Incorrect dose administered, Pain in extremity, Pyrexia
Clinical narrative: Given a full dose instead of a half dose booster. Fever that night with a headache that continued the weekend. Sore arm. Nothing severe. Worst part was the headache that lasted all weekend.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, Chest X-ray normal, Chest pain, Electrocardiogram normal, Fibrin D dimer
Clinical narrative: pericarditis; Chest pain; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Dec2021 11:00 (Lot number: FJ1620) at the age of 36 years as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history included: "transverse mylities", start date: Apr2017 (unspecified if ongoing), notes: transverse mylities in Apr2017 post Allergy shots; "known allergies: dust mites" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "known allergies: dust mites" (unspecified if ongoing). Concomitant medication(s) included: OMEGA 3 [FISH OIL]; PROBIOTICS; VITAMIN C [ASCORBIC ACID]; VITAMIN D COMPLEX. The following information was reported: PERICARDITIS (medically significant) with onset 06Dec2021 06:00, outcome "recovering", described as "pericarditis"; CHEST PAIN (non-serious) with onset 06Dec2021 06:00, outcome "recovering", described as "Chest pain"; FATIGUE (non-serious) with onset 06Dec2021 06:00, outcome "recovering", described as "fatigue". The events "pericarditis", "chest pain" and "fatigue" were evaluated at the physician office visit and emergency room visit. Therapeutic measures prescribed Ibuprofen 600 mg 3 times daily for 2 weeks and cholchicine 0.6 twice daily for 30 days were taken as a result of pericarditis, chest pain.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypertension
Clinical narrative: pericarditis; Chest pain; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Dec2021 11:00 (Lot number: FJ1620) at the age of 36 years as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history included: "transverse mylities", start date: Apr2017 (unspecified if ongoing), notes: transverse mylities in Apr2017 post Allergy shots; "known allergies: dust mites" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "known allergies: dust mites" (unspecified if ongoing). Concomitant medication(s) included: OMEGA 3 [FISH OIL]; PROBIOTICS; VITAMIN C [ASCORBIC ACID]; VITAMIN D COMPLEX. The following information was reported: PERICARDITIS (medically significant) with onset 06Dec2021 06:00, outcome "recovering", described as "pericarditis"; CHEST PAIN (non-serious) with onset 06Dec2021 06:00, outcome "recovering", described as "Chest pain"; FATIGUE (non-serious) with onset 06Dec2021 06:00, outcome "recovering", described as "fatigue". The events "pericarditis", "chest pain" and "fatigue" were evaluated at the physician office visit and emergency room visit. Therapeutic measures prescribed Ibuprofen 600 mg 3 times daily for 2 weeks and cholchicine 0.6 twice daily for 30 days were taken as a result of pericarditis, chest pain.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Fatigue, Pericarditis
Clinical narrative: pericarditis; Chest pain; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Dec2021 11:00 (Lot number: FJ1620) at the age of 36 years as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history included: "transverse mylities", start date: Apr2017 (unspecified if ongoing), notes: transverse mylities in Apr2017 post Allergy shots; "known allergies: dust mites" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "known allergies: dust mites" (unspecified if ongoing). Concomitant medication(s) included: OMEGA 3 [FISH OIL]; PROBIOTICS; VITAMIN C [ASCORBIC ACID]; VITAMIN D COMPLEX. The following information was reported: PERICARDITIS (medically significant) with onset 06Dec2021 06:00, outcome "recovering", described as "pericarditis"; CHEST PAIN (non-serious) with onset 06Dec2021 06:00, outcome "recovering", described as "Chest pain"; FATIGUE (non-serious) with onset 06Dec2021 06:00, outcome "recovering", described as "fatigue". The events "pericarditis", "chest pain" and "fatigue" were evaluated at the physician office visit and emergency room visit. Therapeutic measures prescribed Ibuprofen 600 mg 3 times daily for 2 weeks and cholchicine 0.6 twice daily for 30 days were taken as a result of pericarditis, chest pain.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram abnormal, Electrocardiogram, Pericardial effusion, Pericarditis, Troponin I normal
Clinical narrative: pericarditis; Chest pain; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Dec2021 11:00 (Lot number: FJ1620) at the age of 36 years as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history included: "transverse mylities", start date: Apr2017 (unspecified if ongoing), notes: transverse mylities in Apr2017 post Allergy shots; "known allergies: dust mites" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "known allergies: dust mites" (unspecified if ongoing). Concomitant medication(s) included: OMEGA 3 [FISH OIL]; PROBIOTICS; VITAMIN C [ASCORBIC ACID]; VITAMIN D COMPLEX. The following information was reported: PERICARDITIS (medically significant) with onset 06Dec2021 06:00, outcome "recovering", described as "pericarditis"; CHEST PAIN (non-serious) with onset 06Dec2021 06:00, outcome "recovering", described as "Chest pain"; FATIGUE (non-serious) with onset 06Dec2021 06:00, outcome "recovering", described as "fatigue". The events "pericarditis", "chest pain" and "fatigue" were evaluated at the physician office visit and emergency room visit. Therapeutic measures prescribed Ibuprofen 600 mg 3 times daily for 2 weeks and cholchicine 0.6 twice daily for 30 days were taken as a result of pericarditis, chest pain.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VIAL FIRST PUNCTURED THE DAY BEFORE(NOT A SPECIFIC AMOUNT OF TIME BUT GREATER THAN 6 HOURS AFTER PUNCTURE; SORE ARM; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin not reported, batch number and expiry not reported) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. No adverse event reported post primary vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: 11-APR-2022) dose was not reported, 1 total, administered on 10-DEC-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 10-DEC-2021, the patient received booster shot that came from a vial first punctured the day before, not a specific amount of time but greater than 6 hours after puncture (out of specification product use). The only side effect he experienced was sore arm (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vial first punctured the day before (not a specific amount of time but greater than 6 hours after puncture) and sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20211248642.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Poor quality product administered
Clinical narrative: VIAL FIRST PUNCTURED THE DAY BEFORE(NOT A SPECIFIC AMOUNT OF TIME BUT GREATER THAN 6 HOURS AFTER PUNCTURE; SORE ARM; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin not reported, batch number and expiry not reported) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. No adverse event reported post primary vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: 11-APR-2022) dose was not reported, 1 total, administered on 10-DEC-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 10-DEC-2021, the patient received booster shot that came from a vial first punctured the day before, not a specific amount of time but greater than 6 hours after puncture (out of specification product use). The only side effect he experienced was sore arm (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vial first punctured the day before (not a specific amount of time but greater than 6 hours after puncture) and sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20211248642.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site pain; Injection site pain, redness, hard, hot.; Injection site pain, redness, hard, hot.; Injection site pain, redness, hard, hot.; Dose received :3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 15:45 (Lot number: FJ8757) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hiatal hernia" (unspecified if ongoing); "colitis" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19? Yes. Concomitant medication(s) included: TYLENOL; VITAMIN D [COLECALCIFEROL]; GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE; GLUCOSAMINE]; OMEZ [OMEPRAZOLE]. Past drug history included: Codeine, reaction(s): "Allergies: Codeine"; Vicodin, reaction(s): "Allergies: vicodin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0171, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 24Apr2021, when the patient was 57 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0151, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 08Apr2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 15:45, outcome "unknown", described as "Dose received :3"; VACCINATION SITE PAIN (non-serious) with onset 16Dec2021 04:00, outcome "not recovered", described as "Injection site pain"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE HYPERTROPHY (non-serious) all with onset 16Dec2021 04:00, outcome "not recovered" and all described as "Injection site pain, redness, hard, hot.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, vaccination site erythema, vaccination site warmth, vaccination site hypertrophy.  Additional information: Patient didn't receive other vaccines within 4 weeks prior to vaccination.  Patient had concomitant therapy of multivitamins in two weeks. Patient was tested with Covid-19 to post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, SARS-CoV-2 test, Vaccination site erythema, Vaccination site hypertrophy, Vaccination site pain
Clinical narrative: Injection site pain; Injection site pain, redness, hard, hot.; Injection site pain, redness, hard, hot.; Injection site pain, redness, hard, hot.; Dose received :3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 15:45 (Lot number: FJ8757) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hiatal hernia" (unspecified if ongoing); "colitis" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19? Yes. Concomitant medication(s) included: TYLENOL; VITAMIN D [COLECALCIFEROL]; GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE; GLUCOSAMINE]; OMEZ [OMEPRAZOLE]. Past drug history included: Codeine, reaction(s): "Allergies: Codeine"; Vicodin, reaction(s): "Allergies: vicodin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0171, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 24Apr2021, when the patient was 57 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0151, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 08Apr2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 15:45, outcome "unknown", described as "Dose received :3"; VACCINATION SITE PAIN (non-serious) with onset 16Dec2021 04:00, outcome "not recovered", described as "Injection site pain"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE HYPERTROPHY (non-serious) all with onset 16Dec2021 04:00, outcome "not recovered" and all described as "Injection site pain, redness, hard, hot.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, vaccination site erythema, vaccination site warmth, vaccination site hypertrophy.  Additional information: Patient didn't receive other vaccines within 4 weeks prior to vaccination.  Patient had concomitant therapy of multivitamins in two weeks. Patient was tested with Covid-19 to post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Injection site pain; Injection site pain, redness, hard, hot.; Injection site pain, redness, hard, hot.; Injection site pain, redness, hard, hot.; Dose received :3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 15:45 (Lot number: FJ8757) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hiatal hernia" (unspecified if ongoing); "colitis" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19? Yes. Concomitant medication(s) included: TYLENOL; VITAMIN D [COLECALCIFEROL]; GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE; GLUCOSAMINE]; OMEZ [OMEPRAZOLE]. Past drug history included: Codeine, reaction(s): "Allergies: Codeine"; Vicodin, reaction(s): "Allergies: vicodin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0171, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 24Apr2021, when the patient was 57 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0151, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 08Apr2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 15:45, outcome "unknown", described as "Dose received :3"; VACCINATION SITE PAIN (non-serious) with onset 16Dec2021 04:00, outcome "not recovered", described as "Injection site pain"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE HYPERTROPHY (non-serious) all with onset 16Dec2021 04:00, outcome "not recovered" and all described as "Injection site pain, redness, hard, hot.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, vaccination site erythema, vaccination site warmth, vaccination site hypertrophy.  Additional information: Patient didn't receive other vaccines within 4 weeks prior to vaccination.  Patient had concomitant therapy of multivitamins in two weeks. Patient was tested with Covid-19 to post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Myocardial infarction, Palpitations
Clinical narrative: heart attack; distressing heart palpitations; frightening chest pain; hard to breathe; pain; This is a spontaneous report received from contactable reporter Consumer. The reporter is the patient.  A 48-year-old male patient received bnt162b2 (COVID-19 MANUFACTURER UNKNOWN), administered in arm right, administration date 14Apr2021 13:00 (Lot number: ELU0151) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: Asthma (unspecified if ongoing); "known allergies; Egg Whites" (unspecified if ongoing), "known allergies;Legumes" (unspecified if ongoing),. The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose Number: 1, Lot number= ER2613, Administration time= 01:00 PM), administration date: 24Mar2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: myocardial infarction (medically significant) with onset Apr2021, outcome recovered; palpitations (non-serious) with onset Apr2021, outcome recovered; chest pain (non-serious) with onset Apr2021, outcome recovered; dyspnoea (non-serious) with onset Apr2021, outcome recovered; pain (non-serious) with onset Apr2021, outcome recovered. The events "heart attack", "distressing heart palpitations", "frightening chest pain", "hard to breathe" and "pain" were evaluated at the physician office visit. The patient underwent the following laboratory test: polymerase chain reaction: (16Dec2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of myocardial infarction, palpitations, chest pain, dyspnoea, pain. No Covid prior vaccination. The patient described the events as follows, "Within two week of my second COVID vaccine I had very distressing heart palpitations that would come on quickly and then cause frightening chest pain. I felt like I was having a heart attack. I would need to stop whatever I was doing. It was hard to breathe due to the pain. I would be sitting or working at my desk when these would occur. Sometimes they would also occur while exercising. This went on for about 3 weeks. They have since not returned."
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Palpitations
Clinical narrative: heart attack; distressing heart palpitations; frightening chest pain; hard to breathe; pain; This is a spontaneous report received from contactable reporter Consumer. The reporter is the patient.  A 48-year-old male patient received bnt162b2 (COVID-19 MANUFACTURER UNKNOWN), administered in arm right, administration date 14Apr2021 13:00 (Lot number: ELU0151) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: Asthma (unspecified if ongoing); "known allergies; Egg Whites" (unspecified if ongoing), "known allergies;Legumes" (unspecified if ongoing),. The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose Number: 1, Lot number= ER2613, Administration time= 01:00 PM), administration date: 24Mar2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: myocardial infarction (medically significant) with onset Apr2021, outcome recovered; palpitations (non-serious) with onset Apr2021, outcome recovered; chest pain (non-serious) with onset Apr2021, outcome recovered; dyspnoea (non-serious) with onset Apr2021, outcome recovered; pain (non-serious) with onset Apr2021, outcome recovered. The events "heart attack", "distressing heart palpitations", "frightening chest pain", "hard to breathe" and "pain" were evaluated at the physician office visit. The patient underwent the following laboratory test: polymerase chain reaction: (16Dec2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of myocardial infarction, palpitations, chest pain, dyspnoea, pain. No Covid prior vaccination. The patient described the events as follows, "Within two week of my second COVID vaccine I had very distressing heart palpitations that would come on quickly and then cause frightening chest pain. I felt like I was having a heart attack. I would need to stop whatever I was doing. It was hard to breathe due to the pain. I would be sitting or working at my desk when these would occur. Sometimes they would also occur while exercising. This went on for about 3 weeks. They have since not returned."
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Myocardial infarction, Pain, Palpitations
Clinical narrative: heart attack; distressing heart palpitations; frightening chest pain; hard to breathe; pain; This is a spontaneous report received from contactable reporter Consumer. The reporter is the patient.  A 48-year-old male patient received bnt162b2 (COVID-19 MANUFACTURER UNKNOWN), administered in arm right, administration date 14Apr2021 13:00 (Lot number: ELU0151) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: Asthma (unspecified if ongoing); "known allergies; Egg Whites" (unspecified if ongoing), "known allergies;Legumes" (unspecified if ongoing),. The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose Number: 1, Lot number= ER2613, Administration time= 01:00 PM), administration date: 24Mar2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: myocardial infarction (medically significant) with onset Apr2021, outcome recovered; palpitations (non-serious) with onset Apr2021, outcome recovered; chest pain (non-serious) with onset Apr2021, outcome recovered; dyspnoea (non-serious) with onset Apr2021, outcome recovered; pain (non-serious) with onset Apr2021, outcome recovered. The events "heart attack", "distressing heart palpitations", "frightening chest pain", "hard to breathe" and "pain" were evaluated at the physician office visit. The patient underwent the following laboratory test: polymerase chain reaction: (16Dec2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of myocardial infarction, palpitations, chest pain, dyspnoea, pain. No Covid prior vaccination. The patient described the events as follows, "Within two week of my second COVID vaccine I had very distressing heart palpitations that would come on quickly and then cause frightening chest pain. I felt like I was having a heart attack. I would need to stop whatever I was doing. It was hard to breathe due to the pain. I would be sitting or working at my desk when these would occur. Sometimes they would also occur while exercising. This went on for about 3 weeks. They have since not returned."
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Polymerase chain reaction
Clinical narrative: heart attack; distressing heart palpitations; frightening chest pain; hard to breathe; pain; This is a spontaneous report received from contactable reporter Consumer. The reporter is the patient.  A 48-year-old male patient received bnt162b2 (COVID-19 MANUFACTURER UNKNOWN), administered in arm right, administration date 14Apr2021 13:00 (Lot number: ELU0151) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: Asthma (unspecified if ongoing); "known allergies; Egg Whites" (unspecified if ongoing), "known allergies;Legumes" (unspecified if ongoing),. The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose Number: 1, Lot number= ER2613, Administration time= 01:00 PM), administration date: 24Mar2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: myocardial infarction (medically significant) with onset Apr2021, outcome recovered; palpitations (non-serious) with onset Apr2021, outcome recovered; chest pain (non-serious) with onset Apr2021, outcome recovered; dyspnoea (non-serious) with onset Apr2021, outcome recovered; pain (non-serious) with onset Apr2021, outcome recovered. The events "heart attack", "distressing heart palpitations", "frightening chest pain", "hard to breathe" and "pain" were evaluated at the physician office visit. The patient underwent the following laboratory test: polymerase chain reaction: (16Dec2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of myocardial infarction, palpitations, chest pain, dyspnoea, pain. No Covid prior vaccination. The patient described the events as follows, "Within two week of my second COVID vaccine I had very distressing heart palpitations that would come on quickly and then cause frightening chest pain. I felt like I was having a heart attack. I would need to stop whatever I was doing. It was hard to breathe due to the pain. I would be sitting or working at my desk when these would occur. Sometimes they would also occur while exercising. This went on for about 3 weeks. They have since not returned."
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Lip swelling, Mouth swelling, Periorbital swelling, Throat irritation
Clinical narrative: Anaphylaxis Reaction; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Dec2021 09:45 (Lot number: FK5618) at the age of 6 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (hospitalization, life threatening) with onset 18Dec2021 09:45, outcome "recovering", described as "Anaphylaxis Reaction". The event "anaphylaxis reaction" was evaluated at the physician office visit and emergency room visit. Unspecified therapeutic measures were taken as a result of anaphylactic reaction.   Follow-up attempts are completed. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Anaphylaxis Reaction; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Dec2021 09:45 (Lot number: FK5618) at the age of 6 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (hospitalization, life threatening) with onset 18Dec2021 09:45, outcome "recovering", described as "Anaphylaxis Reaction". The event "anaphylaxis reaction" was evaluated at the physician office visit and emergency room visit. Unspecified therapeutic measures were taken as a result of anaphylactic reaction.   Follow-up attempts are completed. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis Reaction; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Dec2021 09:45 (Lot number: FK5618) at the age of 6 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (hospitalization, life threatening) with onset 18Dec2021 09:45, outcome "recovering", described as "Anaphylaxis Reaction". The event "anaphylaxis reaction" was evaluated at the physician office visit and emergency room visit. Unspecified therapeutic measures were taken as a result of anaphylactic reaction.   Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Pain, Tenderness
Clinical narrative: Swollen lymph nodes, left side, neck, started 5hrs after injection.; Noticeable visually and tender with some pain; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 at 15:30 (Lot number: unknown) at the age of 59 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 21Dec2021 at 20:00, outcome "not recovered", described as "Swollen lymph nodes, left side, neck, started 5hrs after injection"; LYMPH NODE PAIN (non-serious) with onset 21Dec2021 at 20:00, outcome "not recovered", described as "Noticeable visually and tender with some pain". Therapeutic measures were not taken as a result of lymphadenopathy and lymph node pain.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph nodes, left side, neck, started 5hrs after injection.; Noticeable visually and tender with some pain; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 at 15:30 (Lot number: unknown) at the age of 59 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 21Dec2021 at 20:00, outcome "not recovered", described as "Swollen lymph nodes, left side, neck, started 5hrs after injection"; LYMPH NODE PAIN (non-serious) with onset 21Dec2021 at 20:00, outcome "not recovered", described as "Noticeable visually and tender with some pain". Therapeutic measures were not taken as a result of lymphadenopathy and lymph node pain.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: feeling bad; he took the booster shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 26Nov2021 (Batch/Lot number: unknown) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization; Bnt162b2 (DOSE 2), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021, outcome "unknown", described as "he took the booster shot"; FEELING ABNORMAL (non-serious) with onset 11Dec2021, outcome "unknown", described as "feeling bad". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101789569 same reporter/patient/product, different dose/event.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Immunisation, SARS-CoV-2 test
Clinical narrative: feeling bad; he took the booster shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 26Nov2021 (Batch/Lot number: unknown) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization; Bnt162b2 (DOSE 2), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021, outcome "unknown", described as "he took the booster shot"; FEELING ABNORMAL (non-serious) with onset 11Dec2021, outcome "unknown", described as "feeling bad". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101789569 same reporter/patient/product, different dose/event.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID test - minor cold symptoms; positive COVID test - minor cold symptoms; positive COVID test - minor cold symptoms; booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 39 year-old male patient received bnt162b2 (BNT162B2), administration date 29Oct2021 (Lot number: EW0171) at the age of 39 years as dose 3 (booster), single, administration date 14Apr2021 (Lot number: EW051) as dose 2, single and administration date Mar2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. There was no covid prior vaccination. Covid was tested post vaccination.  The following information was reported: IMMUNISATION (medically significant) with onset 29Oct2021, outcome "unknown", described as "booster dose"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), NASOPHARYNGITIS (non-serious) all with onset 19Dec2021, outcome "recovering" and all described as "positive COVID test - minor cold symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19, nasopharyngitis.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: positive COVID test - minor cold symptoms; positive COVID test - minor cold symptoms; positive COVID test - minor cold symptoms; booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 39 year-old male patient received bnt162b2 (BNT162B2), administration date 29Oct2021 (Lot number: EW0171) at the age of 39 years as dose 3 (booster), single, administration date 14Apr2021 (Lot number: EW051) as dose 2, single and administration date Mar2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. There was no covid prior vaccination. Covid was tested post vaccination.  The following information was reported: IMMUNISATION (medically significant) with onset 29Oct2021, outcome "unknown", described as "booster dose"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), NASOPHARYNGITIS (non-serious) all with onset 19Dec2021, outcome "recovering" and all described as "positive COVID test - minor cold symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19, nasopharyngitis.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asymptomatic COVID-19, COVID-19, Computerised tomogram thorax abnormal, Cough, Exposure to SARS-CoV-2
Clinical narrative: Moderna COVID-19 Vaccine EUA: patient hospitalized with mild, ongoing COVID-19 infection (pneumonia) and induction chemotherapy for AML. Underwent successful induction and discharged to home medically stable with follow-up in place.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Myeloid leukaemia, Myeloproliferative neoplasm, Pulmonary oedema, Respiratory viral panel
Clinical narrative: Moderna COVID-19 Vaccine EUA: patient hospitalized with mild, ongoing COVID-19 infection (pneumonia) and induction chemotherapy for AML. Underwent successful induction and discharged to home medically stable with follow-up in place.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Upper-airway cough syndrome
Clinical narrative: Moderna COVID-19 Vaccine EUA: patient hospitalized with mild, ongoing COVID-19 infection (pneumonia) and induction chemotherapy for AML. Underwent successful induction and discharged to home medically stable with follow-up in place.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myeloid leukaemia, COVID-19 pneumonia, Chemotherapy, Computerised tomogram thorax abnormal, SARS-CoV-2 test positive
Clinical narrative: Moderna COVID-19 Vaccine EUA: patient hospitalized with mild, ongoing COVID-19 infection (pneumonia) and induction chemotherapy for AML. Underwent successful induction and discharged to home medically stable with follow-up in place.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hyperaesthesia, Neck pain, Rash, Rash erythematous
Clinical narrative: neck pain, skin sensitivity, and red spots on the back of the scalp and was diagnosed with acute shingles; Information has been received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. The patient's concurrent conditions, concomitant medications and medical history were unknown. On or around 26-OCT-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (strength, dose, rout of administration, lot# and expire date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered neck pain, skin sensitivity, and red spots on the back of the scalp and was diagnosed with acute shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), his symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), he has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of acute shingles was not recovered. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).   The event of acute shingles was considered as disabled by the lawyer.