chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Flatulence, Injection site erythema, Muscle spasms
Clinical narrative: Vaccination site is red; Vaccination site swollen; Vaccination site warmth; Vaccination site pain; Vaccination site has a hard lump; Bloating; Cramps; diarrhea; Gas; This is a spontaneous report received from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Unknown) via an unspecified route of administration on the left arm on 13Mar2021 at 04:30 AM (at the age of 51-years-old), as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. Medical history included urticaria. The patients allergies included pollen and dust. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 2 weeks prior to the COVID-19 vaccine. On 14Mar2021 at 06:00 AM, patient noted that vaccination site was red, swollen, warm, painful, with a hard lump, bloating, cramps, diarrhoea and gas. No therapeutic measures were taken as a result of the events experienced. The clinical outcome of the events vaccination site red, swollen, warm, painful, hard lump, bloating, cramps, diarrhoea and gas was not recovered at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Vaccination site is red; Vaccination site swollen; Vaccination site warmth; Vaccination site pain; Vaccination site has a hard lump; Bloating; Cramps; diarrhea; Gas; This is a spontaneous report received from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Unknown) via an unspecified route of administration on the left arm on 13Mar2021 at 04:30 AM (at the age of 51-years-old), as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. Medical history included urticaria. The patients allergies included pollen and dust. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 2 weeks prior to the COVID-19 vaccine. On 14Mar2021 at 06:00 AM, patient noted that vaccination site was red, swollen, warm, painful, with a hard lump, bloating, cramps, diarrhoea and gas. No therapeutic measures were taken as a result of the events experienced. The clinical outcome of the events vaccination site red, swollen, warm, painful, hard lump, bloating, cramps, diarrhoea and gas was not recovered at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Discomfort, Mass
Clinical narrative: a palpable supraclavicular mass on my left collarbone; got worse a few days after 2nd injection (bigger and moreuncomfortable); got worse a few days after 2nd injection (bigger and moreuncomfortable); This is a spontaneous report from a contactable female consumer (Patient). A 31-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration in arm left on 05Feb2021 14:15 (at the age of 31-years-old) as second dose, single for COVID-19 immunization. The patient medical history included polycystic ovarian syndrome, shortness of breath, heart palpitations, vitamin D deficiency, seasonal allergies, allergy to horse serum and cats. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EL8982) via an unspecified route of administration in arm left on 15Jan2021 as first single, dose for COVID-19 immunization. The patient received unspecified medications with 2 weeks of vaccination. The patient received COVID-19 vaccine Pfizer/BioNtech (dose 1) prior to the COVID second dose within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not tested for COVID-19 post vaccination. On an unspecified date in Jan2021 (10-days after receiving first dose COVID-19 vaccine), patient experienced a palpable supraclavicular mass on my left collarbone. Patient had reported to PCP, he ordered ultrasound and LDH/CBC/CMP labs. Then followed up with ENT Head/Neck Specialist for further follow-up. Mass varied in prominence over about 6 weeks and got worse a few days after 2nd injection (bigger and more uncomfortable). Now much smaller and less prominent but still noticeable upon examination. The patient did not receive any treatment for the events. Patient had doctor or other healthcare professional office/clinic visit for the event. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported) via an unspecified route of administration on 11Mar2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced an allergy after the 1st dose. The outcome of event was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at injection site; This is a spontaneous report from a contactable consumer, the patient. A 36- year-old non- pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) solution for injection, administrated at arm left on 16Mar2021 12:30 PM as a single dose for COVID9 immunisation (age at vaccination is 36 year). Medical history included guttate psoriasis. Concomitant medication included Fluocinolone ointmentmanufacturer unknown). The patient is not allergies to medications, food, or other products. At an other Pfizer facility the most recent COVID-19 vaccine was administered to the patient. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 16Mar2021 the patient developed Sore arm at injection site. The patient does not received any treatment for the adverse event. The clinical outcome for the event Sore arm at injection site was not resolved. Pfizer have permission to contact the reporter about this report. Pfizer does not have permission to contact the patient's healthcare provider about this report. No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain in extremity, Vertigo
Clinical narrative: Vertigo; Fatigued; Arm started getting sore; Felt dizzy; This is spontaneous report from a contactable consumer, the patient.  A 29-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via unspecified route of administration in the left arm on 08Mar2021 at 09:30, (at the age of 29-years-old) as a single dose for COVID-19 immunization. Medical history included immune suppression, obese, allergy to latex and past drug history included allergy to oxycodone. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccination. Concomitant medications included terbinafine (MANUFACTURER UNKNOWN) and ciprofloxacin (MANUFACTURER UNKNOWN)  for unknown indication from unknown date. Past medication included oxycodone (MANUFACTURER UNKNOWN). Patient had experienced sore arm about 6 hours after receiving the vaccine  and also experienced fatigue and dizziness on 08Mar2021 at 15:45. Patient's arm was even more sore after 24 hours on 09Mar2021 and also experienced vertigo. The patient did not receive any treatment for the reported events. The clinical outcome of events sore arm, fatigue, dizziness and vertigo were recovered .No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: Escalated nausea; Escalated vomiting; severe diarrhea; Headache.; This is a spontaneous report received from a contactable consumer, the patient. A 26 -year-old non-pregnant female patient received her first dose of BNT162B2(PFIZER BIONTECH COVID-19 MRNA VACCINE; Lot number: GP7534) via an unspecified route of administration in the left arm on 16Mar2021 at 12:15 for COVID-19 immunisation. Medical history included clostridium difficile (C Diff) and gastroparesis. The patient had previously received hyoscyamine, haldol and had experienced allergy. The patient had not taken any other vaccinations within 4 weeks of covid-19 vaccination. She was not diagnosed with COVID-19. Concomitant medications included clonazepam, DIFICID, Gabapentin, PANTOP R, TROKENDI for an unknown indication. Since the vaccination, the patient had not been tested for COVID-19. The patient had experienced escalated nausea, vomiting, headache and severe diarrhoea on 17Mar2021 at 05:00. The patient did not receive treatment for the reported events. The clinical outcome of events escalated nausea, vomiting, headache and severe diarrhoea was not resolved. No further Follow ups are needed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Pyrexia
Clinical narrative: Aching joints; Fever (103.5); This is a spontaneous report received from a contactable consumer, the patient. A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot/batch number: EL3249) via unspecified route of administration on left arm on 16Mar2021 at 14:45 as a single dose for COVID-19 immunisation. Patients past medical history included Angina.  Patient past drug history include first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot/batch number: EL3248) via unspecified route of administration on left arm on 23Feb2021 at 14:45 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. Patient took unknown medications within two weeks of vaccination an has no known allergies. The patient experienced aching joints and fever at a temperature of 103.5 (units unspecified) on 17Mar2021 at 01:00 am. The patient did not receive any treatment for the reported events. The clinical outcome of joint pain and fever were resolving.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Soreness in area of vaccination site; Slight headache; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 16Mar2021 at 12:45 PM (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included diagnosis with COVID-19. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. On 16Mar2021 at 18:00, the patient had soreness in area of vaccination site and slight headache. The patient did not receive treatment for the events. The clinical outcome of soreness in area of vaccination site and slight headache was recovering at the time of reporting. No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain of skin
Clinical narrative: chills; body aches; Skin hurting; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6200), via an unspecified route of administration in the left arm on 09Mar2021 at13:00 (at the age of 69-years-old), as a unknown single dose for COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Concomitant medications included Zafirlucast (MANUFACTURERUNKNOWN),Fluoxetine(MANUFACTURER UNKNOWN), Ropinerol(MANUFACTURER UNKNOWN),XIIDRA, Acyclovir (MANUFACTURER UNKNOWN),low dose Aspirin (MANUFACTURER UNKNOWN), for an unknown indication from an unspecified date and unknown if ongoing. On 10Mar2021, the patient experienced chills, body aches, felt like skin was hurting. The patient was took Tylenol (MANUFACTURER UNKNOWN) for the treatment for adverse events. The clinical outcomes of chills, body aches, skin  hurting was recovered. No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Stiff neck on left side; Headache; Low grade fever; Chills; This is a spontaneous report received from a contactable consumer, the patient. A 52-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 17Mar2021 at 24:00 (at the age of 52-years-old) as a single dose for COVID-19 Immunisation. The patient medical history and concomitant medications were not reported. The patient past drug history included first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the left arm on 24Feb2021 at 24:00 as a single dose for COVID 19 Immunisation. Prior to vaccination it was unknown, whether the patient was diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID 19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 17Mar2021 at 16:45 the patient experienced headache, stiff neck on left side, low grade fever, chills. It was unknown whether the patient received any treatment for adverse events. The clinical outcome of the events headache, stiff neck on left side, low grade fever, chills was recovering at the time of the report. No follow up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Migraine, Nausea
Clinical narrative: Severe headache/migraine; Chills; Nausea; Diarrhea; This is a spontaneous report from a contactable other health care professional , the patient. A 39-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route in the left arm on 12Mar2021 at 18:00 PM (at the age of 39-year-old) as a single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included Prilosec 40 mg taken within two weeks of vaccination for unknown indication. The Patient did not have any allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced severe headache/migraine, chills, nausea and diarrhea on 12Mar2021.The patient did not receive treatment for the reported event. The clinical outcome of the migraine headache, chills, nausea, and diarrhea was recovered on unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pruritus, SARS-CoV-2 test, Swelling face
Clinical narrative: Swollen face; severe itchiness; tiredness; dull headache; This is a spontaneous report received from a non-contactable consumer(patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Lot number: EN6207, expiry date: not reported) via an unspecified route of administration at UNKNOWN SINGLE DOSE on 11Mar2021 for COVID-19 immunisation. Medical history included breast cancer. The patient was allergic to poultry. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication was not reported. The patient previously took tamoxifen and had allergic reaction to drug. On 11Mar2021, the patient experienced swollen face, severe itchiness, tiredness and dull headache which were still lasting even after 6 days (as reported). On an unspecified date, post the vaccination, the patient underwent a nasal swab test and the result was unknown. The patient did not receive any treatment for the events. The clinical outcome for the events swollen face, severe itchiness, tiredness and dull headache was reported as not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's first name added in patient tab, Patient's age/unit added in patient tab, duplicate reported indication of BNT162B2 removed, treatment received ticked as No, Concomitant therapy left blank since no information provided about the concomitant drug.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Bone pain, Fatigue, Pain in extremity
Clinical narrative: Fever; GI upset; fatigue; extreme joint pain; Bone pain; Swollen arm; sore arm; This is a spontaneous report from a contactable patient. A 69-years elderly non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; batch Number: En6200), via an unspecified route of administration in left arm on 27Feb2021 at 01:30 PM as a single dose for COVID-19 immunisation. Medical history included primarily history of pneumonia, arthritis, spinal stenosis, possibly prior Lyme disease. The patient reported allergies included Nickel allergy, Bextra, redux, skelaxin, latex and or bandage adhesive. Concomitant medication included Advil pm (MANUFACTURER UNKNOWN), B12 inj (MANUFACTURER UNKNOWN), emergen-c (MANUFACTURER UNKNOWN) for unknown indication. Prior to vaccination, the patient had 4 negative covid swab tests approx from April - oct/nov 2020 during illness onset March 2020. The patient was tested positive with COVID-19 in OCT/NOV 2020. Since the vaccination, patient has not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore and swollen arm for approximately 1 week, 99-100 C temperature on 1.5 week, GI upset, continuing fatigue, extreme joint and bone pain on 27Feb2021 at 07:00 PM. The clinical outcome of sore and swollen arm, temperature, GI upset, fatigue, extreme joint and bone pain were recovering. No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Fever; GI upset; fatigue; extreme joint pain; Bone pain; Swollen arm; sore arm; This is a spontaneous report from a contactable patient. A 69-years elderly non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; batch Number: En6200), via an unspecified route of administration in left arm on 27Feb2021 at 01:30 PM as a single dose for COVID-19 immunisation. Medical history included primarily history of pneumonia, arthritis, spinal stenosis, possibly prior Lyme disease. The patient reported allergies included Nickel allergy, Bextra, redux, skelaxin, latex and or bandage adhesive. Concomitant medication included Advil pm (MANUFACTURER UNKNOWN), B12 inj (MANUFACTURER UNKNOWN), emergen-c (MANUFACTURER UNKNOWN) for unknown indication. Prior to vaccination, the patient had 4 negative covid swab tests approx from April - oct/nov 2020 during illness onset March 2020. The patient was tested positive with COVID-19 in OCT/NOV 2020. Since the vaccination, patient has not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore and swollen arm for approximately 1 week, 99-100 C temperature on 1.5 week, GI upset, continuing fatigue, extreme joint and bone pain on 27Feb2021 at 07:00 PM. The clinical outcome of sore and swollen arm, temperature, GI upset, fatigue, extreme joint and bone pain were recovering. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Influenza like illness, Rash
Clinical narrative: shingles; flu like Symptoms; shingle rash; This is a spontaneous report from a contactable consumer (patient).  A 76-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6205), via an unspecified route of administration, in Left Arm on 03Mar2021 as a 2nd dose, single dose for COVID-19 immunisation. The patient's Medical history reported as None. The patient's concomitant medications were not reported. Patient had not COVID prior vaccination and not tested COVID post vaccination. No known allergies reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EM9809), via an unspecified route of administration, in Arm Left on 10Feb2021 as a single dose for covid-19 immunisation. On 04Mar2021 at 10:00 AM, the patient experienced shingles, flu like symptoms, shingle rash. Reported that patient was diagnosed with shingles 5 days after receiving COVID vaccine. Had flu like Symptoms 20 hours after receiving 2nd dose. Had shingle rash 3days after receiving 2nd dose of vaccine. Still have shingle rash. The patient stated that please contact me as I have several questions. Reported that patient visited doctor or other healthcare professional office/clinic after AE. Patient had not received treatment for events. Explicit consent was yes. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Mar2021 (evening), patient had shingles and took first dose of medicine (treatment). On 15Mar2021, patient was scheduled to get second shot and patient was in line to get it. Patient wanted to know if it is okay to get this shot. Outcome of event was unknown. No follow-up attempts are possible; information about lot or batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Herpes zoster, Pruritus, Rash, Sensitive skin
Clinical narrative: Looks like shingles; Rash/Hives on left side of my trunk/ribs; Rash/Hives on left side of my trunk/ribs; Tiny, little blisters; Rash/Hives on left side of my trunk/ribs/Tiny, little blisters/Moderate sensitivity and itch; Rash/Hives on left side of my trunk/ribs/Tiny, little blisters/Moderate sensitivity and itch; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6205), via an unspecified route of administration into left arm on 05Mar2021 as a single dose for Covid-19 immunisation. Medical history included hypertension. Concomitant medications included metoprolol succinate (TOPROL XL) 50 mg; rosuvastatin calcium (CRESTOR) as 5 mg 1x/day. The patient previously took morphine and experienced allergy. The patient did not received any vaccine in four weeks. On 08Mar2021 at 07:00 am patient experienced 3-inch Rash/Hives on left side of my trunk/ribs. Tiny, little blisters. Moderate sensitivity and itch. Looks like shingles. It was reported that I never received the Shingles vaccine. (I have photos). No treatment was received for the events. No COVID prior vaccination and COVID not tested post vaccination. The outcome of the events was reported as recovering.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Looks like shingles; Rash/Hives on left side of my trunk/ribs; Rash/Hives on left side of my trunk/ribs; Tiny, little blisters; Rash/Hives on left side of my trunk/ribs/Tiny, little blisters/Moderate sensitivity and itch; Rash/Hives on left side of my trunk/ribs/Tiny, little blisters/Moderate sensitivity and itch; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6205), via an unspecified route of administration into left arm on 05Mar2021 as a single dose for Covid-19 immunisation. Medical history included hypertension. Concomitant medications included metoprolol succinate (TOPROL XL) 50 mg; rosuvastatin calcium (CRESTOR) as 5 mg 1x/day. The patient previously took morphine and experienced allergy. The patient did not received any vaccine in four weeks. On 08Mar2021 at 07:00 am patient experienced 3-inch Rash/Hives on left side of my trunk/ribs. Tiny, little blisters. Moderate sensitivity and itch. Looks like shingles. It was reported that I never received the Shingles vaccine. (I have photos). No treatment was received for the events. No COVID prior vaccination and COVID not tested post vaccination. The outcome of the events was reported as recovering.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer, the patient. A male patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL2747), via unspecified route of administration in left arm on 16Mar2021 at 14:45 hours as a single dose for COVID-19 immunisation. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL2747) via unspecified route of administration in left arm on 25Feb2021 at 13:45 hours for COVID-19 immunisation. Medical history was not reported. Patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) and LIPITOR. On 17Mar2021 at 16:00 hours, the patient experienced headache. Therapeutic measures taken as a result of event headache included self-treatment with Ibuprofen from an unknown date. The clinical outcome of reported event headache was resolving.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash erythematous
Clinical narrative: red bumpy rash on chest; feels like a pin prick, then itching; it spread to back, stomach, arms, legs, waist; red bumpy rash on chest; feels like a pin prick, then itching; it spread to back, stomach, arms, legs, waist; red bumpy rash on chest; feels like a pin prick, then itching; it spread to back, stomach, arms, legs, waist; This is a spontaneous report from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES).     A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 27Feb2021, at 09:15 as single dose for covid-19 immunization at the age of 61-years.  The patient was not pregnant at the time of vaccination. Medical history included rheumatoid arthritis and asthma from an unknown date. Concomitant medications included verapamil (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; etanercept (ENBREL) taken for an unspecified indication, start and stop date were not reported; atenolol (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, start and stop date were not reported; morphine (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The  patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient previously took  Cosine comparing sulfur and experienced drug allergy.  On 27Feb2021, at 10:30, the  patient experienced red bumpy rash on chest; feels like a pin prick, then itching; it spread to back, stomach, arms, legs, waist. Details were as follows: one hour after the vaccine, the patient started getting red bumpy rash on chest. It felt like a pin prick, then itching occurred. It spread to her back stomach, arms, legs  and waist. It was now going on three weeks. Therapeutic measures included  unspecified many antihistamines and hydrocortisone cream, however the patient noted that nothing helped. The outcome of events was not recovered.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: After the first vaccine patient was down for 4 days with achey body, tiredness, fever, chills; After the first vaccine patient was down for 4 days with achey body, tiredness, fever, chills; After the first vaccine patient was down for 4 days with achey body, tiredness, fever, chills; After the first vaccine patient was down for 4 days with achey body, tiredness, fever, chills; This is a spontaneous report from a contactable consumer (patient).   A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261), dose 1 via an unspecified route of administration, administered in Arm Right on 01Feb2021 12:00 (at the age of 78-year-old) as 1st dose, single for COVID-19 immunisation. Medical history was none and no known allergies. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID. The patient did not receive any other vaccines within four weeks. Post vaccination, the patient had not been tested for COVID. After the first vaccination in Feb2021, the patient was down for 4 days with achy body, tiredness, fever and chills. The outcome of the events was unknown.  Follow-up attempts possible. No further information expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: father received the first dose of Pfizer COVID 19 vaccine on 04Mar, he tested positive for coronavirus on 15Mar.; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's son) reported that a 67-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, administered in the arm on 04Mar2021 (Lot Number: EN6206) as single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient could have possibly gotten the shingles vaccine (prior vaccination within 4 weeks). The reporter stated that his father received the first dose of Pfizer COVID 19 vaccine on 04Mar2021. PCR COVID test done on 15Mar2021 and he tested positive for coronavirus. The reporter is asking if his father could get the 2nd dose of the vaccine if he contracted coronavirus after the 1st dose. The outcome of the event was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore upper arm the first day after; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6207) via an unspecified route of administration in right arm on 16Mar2021 at 11:00 hours (at 64 years) as an unknown, single for COVID-19 immunization. Patient's Medical history was not reported. Concomitant medications included Synthroid, atorvastatin (MANUFACTURER UNKNOWN), olmesartan medoxomil (MANUFACTURER UNKNOWN) for an unknown indication. Patient did not have any Known allergies and other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. On 17Mar2021 at 02:00 hours the patient experienced sore upper arm. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. On unknown date in Mar2021 the patient recovered from the event sore upper arm.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's First Name, Patient's Age/Units, Relevant Med History, For Suspect vaccine; Indication "Covid-19 immunization" captured twice, removed one, No Drug Code for Con-Med "Olmesartan Medoxomill": Re-coded as "OLMESARTAN MEDOXOMIL" in tab, Treatment Received, None removed from Concomitant Therapy since Con-Meds already coded in Product tab, Information "if other vaccine in four weeks" missed in consolidated narrative and Initial information and event tab details reviewed and updated.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, Vaccination site erythema
Clinical narrative: Fever; Rigours; Myalgia; Headache; site redness; This is a spontaneous report received from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: not provided), via an unspecified route of administration in her left arm on 11Jan2021 at 12:00AM (at the age of 54-years-old), for covid-19 dose1 immunisation. The patients medical history included abnormal cholesterol and COVID-19 dose 1 vaccination. Past drug history was not reported. Concomitant medications were not reported. The patient has reported no allergies to medications, food or other products. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient has received other medications within 2 weeks of vaccination The patient has not tested positive for COVID-19 since having the vaccine. The patient has not diagnosed with COVID-19 prior to vaccination. On 12Jan2021, the subject experienced fever, rigors, myalgia, headache, vaccination site redness post 12 hours of vaccination, the subject was treated with acetaminophen (Trade Name: Tylenol). The clinical outcome of the events fever, rigors, myalgia, headache, vaccination site redness was resolved. No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a non-contactable consumer, the patient. A 40-years-old age female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 16Mar2021 at 02:00 PM (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient had no symptoms associated with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had no allergies to food, medication or other products. On 16Mar2021 at 03:00 PM, the patient experienced swelling sore arm. Therapeutic measures were not taken as a result of event. The clinical outcome for the sore arm was recovering at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hot flush
Clinical narrative: Hot flash. Feet felt like on fire for 6 hours.; Hot flash felt like on fire for 6 hours.;This is a spontaneous report from a non-contactable consumer, the patient. A 35-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via unspecified route of administration and anatomical site on 16Mar2021 at the age of 35-years-old as a single dose for COVID-19 Immunisation. The patient was allergic to dairy, bactrin and iodine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient concomitant medication includes thyroid, anti-anxiety and allergy medications (unspecified). The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination the patient was not been tested for COVID-19. On an unknown date, the patient experienced hot flash, feet felt like on fire for 6 hours. No therapeutic measure was taken for the adverse event. The clinical outcome of the event hot flash was unknown.   Information about lot/ batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's First Name added, patient's Age/Units captured as 35 years per administration date 16Mar2021 conservatively, since event onset date not provided. For suspect vaccine: Indication "COVID-19 Immunisation" captured twice, removed one. Unknown removed from Lot# field, known_allergies, bactrin, iodine captured as past drug event, known_allergies Dairy was already captured as relevant history. Notes updated  Pending PSSR review. For event: Treatment Received NO was selected due to provided if_treatment_ae No. Event " Hot flash Feet felt like on fire for 6 hours."Also coded as Feeling hot. Final sentence "Information about lot/batch number cannot be obtained. No further information is expected." updated as "No follow-up attempts are needed; information about lot/batch number cannot be obtained." Per SER055
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles after Covid 19 vaccine; This is a spontaneous report from a contactable other health care professional (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198, Expiration date: Jun2021), via an unspecified route of administration in right arm on 25Feb2021 at 08:30 as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included over the counter antacid tablet at night, other than that she was not on any medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive additional vaccines on same date with the Pfizer vaccine. She had her first dose on 25Feb2021 and she was supposed to have her second Covid 19 vaccine on 18Mar2021 but she woke up with shingles on 18Mar2021. She called the pharmacy where she received the first Covid 19 vaccine and was told she would have 45 days to get her second Covid 19 vaccine. She did not know if it was 45 days from when she received the first shot or 45 days from when she was supposed to get the second shot. The shingles was on her right side around her waist and belly button on the right side on her torso. No relevant tests were performed. The patient did not visit emergency room or physician office. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Two days post first covid dose I developed Shingles; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number: Not reported), via an unspecified route in the left arm on 02Mar2021 at 13:30, as a single dose for covid-19 immunization. Medical history included polycythemia vera and prostate cancer. No known allergies have been mentioned. Concomitant medications included telmisartan, carvedilol, hydroxyurea and levetiracetam (Keppra). Historical vaccine included shingrix vaccine series in 2018. Patient did not receive any other vaccine in four weeks. Prior to the vaccination, patient has not tested positive for covid. After vaccination, patient has not been tested for covid. On 04Mar2021 at 10:00, two days post first covid dose, patient experienced Shingles. Patient received unknown treatment for the event. The clinical outcome of the event was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at vaccination site; This is a spontaneous report from a contactable healthcare professional. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EN6206), intramuscularly administered in the left arm on 07Mar2021 (at the age of 57-years-old) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient has no known allergies. The patient had no COVID prior to the vaccination. The patient did not receive any other vaccines within four weeks of the COVID-19 vaccination. The patient experienced soreness at vaccination site for 2 days from 07Mar2021. No treatment was received for the event. The patient was not tested for COVID post vaccination. The outcome of the event was recovered on 09Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid on 02Mar2021/lingering symptom of a smell issue; This is a spontaneous report from a contactable consumer (Patient). A 47-years-old male patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection,Lot number and Expiry date:Unknown), dose 1 via an unspecified route of administration on 28Feb2021 as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 02Mar2021, the patient was tested positive for covid and on an unspecified date patient experienced lingering symptom of a smell issue. The patient was scheduled to receive the 2nd dose of the vaccine 21Mar2021. The patient treating doctor said he should wait 90 days before getting the 2nd shot as his antibodies are already high. The doctor was concerned about the side effects. The outcome of the event tested positive for covid on 02Mar2021/lingering symptom of a smell issue was unknown.  No follow up attempts are possible. Information about lot/batch number cannot been obtained.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: two allergic reactions; This is a spontaneous report from a contactable pharmacist via a program. A contactable Pharmacist reported similar event for 2 patients. This is 1st of two reports. A patient of unspecified age and gender received bnt162b2 (PFIZER Covid-19 Vaccine, formulation: solution for injection, Batch/Lot Number: EP7534), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced two allergic reactions. Outcome of the event was unknown.   No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021323766 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: had the first dose of the Pfizer Covid-19 vaccine on 08Mar2021 and on (10Mar2021) they are both tested Covid-19 Positive; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer or other non-healthcare professional reported similar events for two patients (Wife and Husband). This is 1st of two reports. A female patient of an unspecified age received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation; solution for injection) dose 1 via an unspecified route of administration on 08Mar2021 (Batch/Lot number: not reported) as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, consumer stated that she was tested positive for covid-19 on 10Mar2021, after the first dose on 08Mar2021. Patient wanted to know if it was safe to take the second dose. The patient underwent lab tests and procedures which included sars-cov-2 test results positive on 10Mar2021. Reporter assessed case seriousness as no. Outcome of the event was unknown.  Follow-up (25Mar2021): This follow-up consists of no new safety information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021325997 Same reporter/product/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: got the first dose of Covid 19 vaccine last 15Mar2021 and tested positive on the next day; got sick; This is a spontaneous report from a contactable consumer or other non hcp (Patient's Mother) communicated to from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE,formulation:solution for injection), dose 1 via an unspecified route of administration on 15Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter states that her daughter got the first dose of covid 19 vaccine on 15Mar2021 and tested positive on the next day on 16Mar2021, the husband of her daughter was positive also that is why her daughter got sick in Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 16Mar2021. Reporter asked if her daughter needs to continue with the second dose. The outcome of the events was unknown.   No follow-up attempt are possible. Information about lot/batch number cannot be obtained.