chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: left arm is burning; overall body aches; Chills; Fever; Nausea; Sneezing; This is a spontaneous report from a contactable consumer (patient) via Regulatory Authority.  A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 25Feb2021 08:30 (lot number: EL9266; expiry date: unknown) at the age of 27-years-old, as dose 1, single, for Covid-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. Concomitant medication included medical marijuana. The patient was not pregnant at the time of vaccination. The vaccine was administered in the hospital. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient has not been tested for COVID-19 since vaccination. On 25Feb2021, at 21:00, the patient's left arm was burning, experienced overall body aches, chills, fever, nausea, and sneezing. The patient did not receive treatment for the events. Outcome of the events was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Oropharyngeal pain, Vaccination site bruising
Clinical narrative: sore throat; chills; headache; fatigue; bruise and bump at injection site; bruise and bump at injection site; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318), via an unspecified route of administration, administered in the left arm on 10Feb2021, at 12:15 (at the age of 70 years old) as dose 1, single for COVID-19 immunisation. Medical history included known allergies: sulfa drugs, contrast dye, and bee venom. She was not pregnant at the time of report. The patient's concomitant medications were not reported. The patient did not receive any other vaccines prior to the COVID vaccine. On 21Feb2021, 12 days after injection (as reported), the patient got sore throat, chills, headache, fatigue, and bruise and bump at injection site. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. At the time of report, the patient has not recovered form the events.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: sore throat; chills; headache; fatigue; bruise and bump at injection site; bruise and bump at injection site; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318), via an unspecified route of administration, administered in the left arm on 10Feb2021, at 12:15 (at the age of 70 years old) as dose 1, single for COVID-19 immunisation. Medical history included known allergies: sulfa drugs, contrast dye, and bee venom. She was not pregnant at the time of report. The patient's concomitant medications were not reported. The patient did not receive any other vaccines prior to the COVID vaccine. On 21Feb2021, 12 days after injection (as reported), the patient got sore throat, chills, headache, fatigue, and bruise and bump at injection site. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. At the time of report, the patient has not recovered form the events.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Breast pain, Lymph node pain
Clinical narrative: Left armpit aching; left breast started aching; Shoulder ache; Lymph node tender on left side; This is a spontaneous report from a contactable consumer (patient).   A non-pregnant 67-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 25Feb2021 13:15 (at the age of 67 years old) as dose 2, single for COVID-19 immunisation. The patient previously received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered on arm left on 04Feb2021 13:00 (at the age of 67 years old) as dose 1, single for COVID-19 immunisation. Medical history included sulfa drugs allergy and breast lift and implants (silicone gel implant, May2010). Concomitant medications were not reported. On 25Feb2021 20:00, the patient experienced left armpit aching, left breast started aching, shoulder ache, and lymph node tender on left side. It was reported that the injection site was fine. The facility type vaccine was reported as other. There was no other vaccine in four weeks. Prior to COVID, patient had no vaccination and not COVID tested post vaccination. There was no treatment for the adverse events. The outcome the events was not recovered.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Laryngitis, Pain, Pharyngeal swelling, Swelling face
Clinical narrative: Swelling in face and throat; Swelling in face and throat; Laryngitis; Widespread pain; This is a spontaneous report from a contactable healthcare professional (patient) received via Regulatory Authority. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm, on 19Dec2020 at 05:15 PM (Batch/Lot Number: Ej1685) (at the age of 41 years old) as dose 1, single for COVID-19 immunisation in a hospital. Medical history included chronic allergies and endometriosis. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included omalizumab (XOLAIR); montelukast sodium (SINGULAIR); cetirizine hydrochloride (ZYRTEC); duloxetine hydrochloride (CYMBALTA); vitamin B complex; lansoprazole (PREVACID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling in face and throat, laryngitis, and widespread pain on 07Jan2021. The events resulted to physician office visit. The patient received prednisone as treatment for the events. The patient did not recover from the events on the time of the report. The patient was administered the second dose of BNT162B2 on 09Jan2021, single (at the age of 41-years-old) (Batch/Lot Number: Ej1686) in the right arm for COVID-19 immunisation in a hospital.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site induration, Injection site swelling, Nausea
Clinical narrative: injection site was hard and swollen; injection site was hard and swollen; headache; nausea; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 52 (unit not specified) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and Expiration date: not reported) via an unspecified route of administration on an unspecified date in Feb2021 as dose 1, single for COVID-19 immunisation. The patient was immunocompromised (taking an immunosuppressant). Concomitant medication included an unspecified immunosuppressant. On an unspecified date in 2021, the patient reported that the injection site was hard and swollen (described as "size of a quarter and looks like a huge hive"), headache, and nausea. The patient was concerned as the events has lasted over a week and the patient was taking an immunosuppressant. The outcome of the reported events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Flushing, Headache, Pain in extremity
Clinical narrative: Swollen arm; flushed face; headache; chills; fever; arm hurt to touch or sleep on; tired; shaking; This is a spontaneous report from a non-contactable consumer (patient).   A 75-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Right arm on 25Feb2021 10:00, at the age of 75-years-old, (Batch/Lot Number: EN6203) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included High cholesterol, drug allergy (cannot take statins due to side effect).  There were no concomitant medications.  The patient did not have COVID-19 prior the vaccination. On 26Feb2021 02:00, the patient experienced swollen arm, flushed face, headache, chills, fever, arm hurt to touch or sleep on, tired, and shaking. The patient was not tested for COVID-19 post vaccination. The outcome of the events was recovering. No treatment was received for the events.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Tremor
Clinical narrative: Swollen arm; flushed face; headache; chills; fever; arm hurt to touch or sleep on; tired; shaking; This is a spontaneous report from a non-contactable consumer (patient).   A 75-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Right arm on 25Feb2021 10:00, at the age of 75-years-old, (Batch/Lot Number: EN6203) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included High cholesterol, drug allergy (cannot take statins due to side effect).  There were no concomitant medications.  The patient did not have COVID-19 prior the vaccination. On 26Feb2021 02:00, the patient experienced swollen arm, flushed face, headache, chills, fever, arm hurt to touch or sleep on, tired, and shaking. The patient was not tested for COVID-19 post vaccination. The outcome of the events was recovering. No treatment was received for the events.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine increased, Dehydration, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: dehydration; increased serum creatinine level; Fever; Vomiting; Nusea; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 09Feb2021 at 16:45 (at the age of 66-years-old) (Lot Number: EM9809) as dose 1, single for COVID-19 immunisation.  Medical history included end stage renal disease and S/P Renal Transplant. The patient has no known allergies. The patient did not receive other vaccine in four weeks. Other medications were received in two weeks. The patient did not have COVID prior to vaccination and had been tested for COVID post-vaccination.  On 17Feb2021 at 08:00, the patient experienced nausea, vomiting, fever, dehydration, and increased serum creatinine level. Treatment was received for the events. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 18Feb2021. The outcome of the events was recovering/resolving.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: dehydration; increased serum creatinine level; Fever; Vomiting; Nusea; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 09Feb2021 at 16:45 (at the age of 66-years-old) (Lot Number: EM9809) as dose 1, single for COVID-19 immunisation.  Medical history included end stage renal disease and S/P Renal Transplant. The patient has no known allergies. The patient did not receive other vaccine in four weeks. Other medications were received in two weeks. The patient did not have COVID prior to vaccination and had been tested for COVID post-vaccination.  On 17Feb2021 at 08:00, the patient experienced nausea, vomiting, fever, dehydration, and increased serum creatinine level. Treatment was received for the events. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 18Feb2021. The outcome of the events was recovering/resolving.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Myalgia
Clinical narrative: Chills; Headache that felt like my head was going to explode.; Fever, temp of 101; severe joint and muscle pain; severe joint and muscle pain; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EN6202), dose 2 via an unspecified route of administration, administered in left arm on 25Feb2021 16:00 (at the age of 80-year-old) as dose 2, single for COVID-19 immunization. Medical history included CAD (Coronary artery disease), GERD, inflammatory arthritis, allergies to penicillin and sulfa, and Covid-19. Concomitant medications included lisinopril (ZESTRIL); carvedilol; estradiol; pantoprazole. The patient previously received the first dose bnt162b2 administered in left arm on 04Feb2021 02:30 PM (Lot number: EL9264) as single dose for COVID-19 immunization. No other vaccine in four weeks. On 26Feb2021 at 05:00 AM, the patient experienced chills, fever, temp of 101, severe joint and muscle pain, headache that felt like my head was going to explode. The patient received no treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible.  No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; Headache that felt like my head was going to explode.; Fever, temp of 101; severe joint and muscle pain; severe joint and muscle pain; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EN6202), dose 2 via an unspecified route of administration, administered in left arm on 25Feb2021 16:00 (at the age of 80-year-old) as dose 2, single for COVID-19 immunization. Medical history included CAD (Coronary artery disease), GERD, inflammatory arthritis, allergies to penicillin and sulfa, and Covid-19. Concomitant medications included lisinopril (ZESTRIL); carvedilol; estradiol; pantoprazole. The patient previously received the first dose bnt162b2 administered in left arm on 04Feb2021 02:30 PM (Lot number: EL9264) as single dose for COVID-19 immunization. No other vaccine in four weeks. On 26Feb2021 at 05:00 AM, the patient experienced chills, fever, temp of 101, severe joint and muscle pain, headache that felt like my head was going to explode. The patient received no treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible.  No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Nausea, Presyncope
Clinical narrative: extreme nausea; heavy chest; Vasovagal reaction; extreme dizziness; This is a spontaneous report from a contactable pharmacist. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 14Jan2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if the patient received other vaccines within 4 weeks before vaccination. The patient experienced extreme nausea, heavy chest, vasovagal reaction and extreme dizziness without being able to recover for 30 minutes (laying down for 30min not able to stand without extreme dizziness and heavy chest)  to continue normal activities of work on 14Jan2021, 4 hours after the vaccination. The adverse events resulted to none. The outcome of events was recovered on 14Jan2021.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Eye pain, Myalgia, Taste disorder
Clinical narrative: Maybe taste affected; Chills; Pain in joints and muscle; Pain in joints and muscle; Eyes aching; This is a spontaneous report from a Contactable (patient). A 69-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 23Feb2021 10:15 (Batch/Lot Number: EL9269) (at the age of 69 years) as dose number unknown, single for covid-19 immunisation. Medical history included major anxiety and depression, aortic valve regurgitation, bladder disorder (taking Botox for bladder problems), multiple sclerosis, hypersensitivity, all from an unknown date and unknown if ongoing. No other vaccine in four weeks. Concomitant medications included fluoxetine; duloxetine; trazodone; pantoprazole; metformin hydrochloride (METFO); all taken for an unspecified indication, start and stop date were not reported. The patient experienced maybe taste affected, chills, pain in joints and muscle, eyes aching, all on 24Feb2021 with outcome of not recovered. It was unknown if treatment was received for events. No COVID prior vaccination and patient was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Twelve hours after the vaccine, I developed chills.; fever that went up to 100.4; Headache upon waking; aches; sore arm; This is a spontaneous report from a contactable consumer (patient) via Covid-19 Adverse Event Self-Reporting Solution .  A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 15Feb2021 09:30 (lot number: EM9810; expiry date: unknown) as dose 2, single, for Covid-19 immunisation. Medical history included intracranial hypertension with papilladema, digestive issues from removed gallbladder, and Covid-19 on an unknown date (prior vaccination). The patient had no known allergies. Concomitant medications included acetazolamide, colestipol hydrochloride, and esomeprazole magnesium  taken for unspecified indications, start and stop dates were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Jan2021 (lot number: EL1283; expiry date: unknown) at 11:15 AM in left arm for Covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient has not been tested for COVID-19 since vaccination. On 15Feb2021, twelve hours after the vaccine (at 21:30), the patient developed chills. Through the night she developed a fever that went up to 100.4. Headache upon waking. Chills, aches, sore arm, and fever throughout the day. Fever broke around 36 hours and then she was fine at 48 hours post vaccine. The patient did not receive treatment for the events. Outcome of the events was recovered on unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue, Myalgia, Nausea
Clinical narrative: chills; fever; muscle pain; nausea; stomach pain; tiredness/fatigue; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: 59267-1000-02/EN6202), via an unspecified route of administration, administered in the left arm on 25Feb2021, at 15:15 (at the age of 61 years old) as dose 1, single for COVID-19 immunisation. Medical history included heart/ atrial tachycardia and known allergies: sufa (as reported). She was not pregnant at the time of report. Concomitant medications included sotalol (reported as sotalo6) 40 mg and 80 mg, pantoprazole, and aspirin. She did not receive any other vaccines prior to the COVID vaccine. The patient previously took magnesium and experienced allergies. On 26Feb2021, at 11:00, the patient experienced chills, fever, muscle pain, nausea, stomach pain, and tiredness/fatigue. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of the events. At the time of report, the patient has not recovered from the events.  No follow up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills; fever; muscle pain; nausea; stomach pain; tiredness/fatigue; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: 59267-1000-02/EN6202), via an unspecified route of administration, administered in the left arm on 25Feb2021, at 15:15 (at the age of 61 years old) as dose 1, single for COVID-19 immunisation. Medical history included heart/ atrial tachycardia and known allergies: sufa (as reported). She was not pregnant at the time of report. Concomitant medications included sotalol (reported as sotalo6) 40 mg and 80 mg, pantoprazole, and aspirin. She did not receive any other vaccines prior to the COVID vaccine. The patient previously took magnesium and experienced allergies. On 26Feb2021, at 11:00, the patient experienced chills, fever, muscle pain, nausea, stomach pain, and tiredness/fatigue. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of the events. At the time of report, the patient has not recovered from the events.  No follow up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pain, Pyrexia, Tremor
Clinical narrative: High fever; Trouble catching my breath; Shaking; Body aches; This is a spontaneous report from a contactable consumer (patient).   A 30-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6203) via an unspecified route of administration, administered in arm left on 24Feb2021 18:00 (at the age of 30 years old) as dose 1, single for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included alprazolam (XANAX) and blood pressure (as reported). Allergies to medications, food, or other products was reported to none. On 26Feb2021 19:30, the patient experienced high fever, trouble catching breath, shaking, and body aches. There was no other vaccine in four weeks. No COVID prior vaccination and not COVID tested post vaccination. There was no treatment for the events. The outcome of the event was recovering.   No follow up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Nausea, Pain
Clinical narrative: Fever; chills; diarrhea; nausea; body aches; exhaustion; This is a spontaneous report from a contactable consumer (patient) received via COVAES. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 25Feb2021 at 08:15 AM (Batch/Lot Number: En6200) (at the age of 42 years old) as dose 2, single for COVID-19 immunisation in a clinic. Medical history included Hashimotos and lyme. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included oxcarbazepine (TRILEPTAL); sertraline hydrochloride (ZOLOFT); levothyroxine; mirtazapine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was previously administered the first dose of BNT162B2 on 28Jan2021 at 01:30 PM (at the age of 42-years-old) (Batch/Lot number: El9263) in the right arm for COVID-19 immunisation. The patient previously took lamotrigine (LAMICTAL); topiramate (TOPAMAX) (reported as topi max); carbamazepine; oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) and experienced allergies. The patient experienced fever, chills, diarrhea, nausea, body aches, and exhaustion on 25Feb2021 at 07:00 PM. The events were reported as non-serious. The patient did not receive any treatment for the events. The patient was recovering from the events on the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; chills; diarrhea; nausea; body aches; exhaustion; This is a spontaneous report from a contactable consumer (patient) received via COVAES. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 25Feb2021 at 08:15 AM (Batch/Lot Number: En6200) (at the age of 42 years old) as dose 2, single for COVID-19 immunisation in a clinic. Medical history included Hashimotos and lyme. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included oxcarbazepine (TRILEPTAL); sertraline hydrochloride (ZOLOFT); levothyroxine; mirtazapine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was previously administered the first dose of BNT162B2 on 28Jan2021 at 01:30 PM (at the age of 42-years-old) (Batch/Lot number: El9263) in the right arm for COVID-19 immunisation. The patient previously took lamotrigine (LAMICTAL); topiramate (TOPAMAX) (reported as topi max); carbamazepine; oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) and experienced allergies. The patient experienced fever, chills, diarrhea, nausea, body aches, and exhaustion on 25Feb2021 at 07:00 PM. The events were reported as non-serious. The patient did not receive any treatment for the events. The patient was recovering from the events on the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Peripheral swelling
Clinical narrative: My right hand is swollen and my wrist hurts; My right hand is swollen and my wrist hurts; This is a spontaneous report from two contactable consumers (patient and patient's wife). These consumers reported similar events for two patients. This is the first of two reports.  An 85-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 20Feb2021 10:00 (Batch/Lot Number: EN6200) (at the age of 85-years-old) as DOSE 1, SINGLE for COVID-19 immunisation.  Medical history was none. The patient's concomitant medications were not reported.  On 21Feb2021, the patient experienced his right hand was swollen and his wrist hurts. The patient had this swollen, he never had any swelling in his body and he had this swollen hand and it was the opposite arm, it was the right and he had the shot in the left arm.Therapeutic measures were taken as a result of the events which included hand wrapped with ice pack. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Hot flush, Pyrexia, Rash
Clinical narrative: Chills; Diarrhea; hot flashes; Low grade fever; rash on the leg; Vomiting; This is a spontaneous report from a contactable consumer (patient himself) via a Pfizer-sponsored program, Covax US Support. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration, on 18Feb2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as 1st dose on 28Jan2021 for COVID-19 immunisation. The patient had both of the inoculations and he was having really bad side effects and was am not sure if these are from the vaccine or not. On 19Feb2021, the day after, it was reported that the patient experienced chills, diarrhea, vomiting, hot flashes, rash on the leg and low-grade fever. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Chills; Diarrhea; hot flashes; Low grade fever; rash on the leg; Vomiting; This is a spontaneous report from a contactable consumer (patient himself) via a Pfizer-sponsored program, Covax US Support. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration, on 18Feb2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as 1st dose on 28Jan2021 for COVID-19 immunisation. The patient had both of the inoculations and he was having really bad side effects and was am not sure if these are from the vaccine or not. On 19Feb2021, the day after, it was reported that the patient experienced chills, diarrhea, vomiting, hot flashes, rash on the leg and low-grade fever. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Somnolence, Vaccination site pruritus
Clinical narrative: Red rash approximately an inch wide and 2 inches long; spread to about 3 inches wide and about 5 inches long; tender to the touch; Rash; it is itchy; Sleepy; Right arm at injection site itched; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9269), via an unspecified route of administration in right arm, on 25Feb2021 at 01:30 PM (13:30) (at the age of 77 years), as dose 2, single, for COVID-19 immunization. The patient's medical history included being anemic due to chronic kidney disease (CKD), cancer, depression, and allergies to sulfa. The patient's concomitant medications included bupropion, valproate semisodium (DIVALPROEX), levothyroxine, and other unspecified medications. The patient previously took oxycodone and experienced allergies; first dose of BNT162B2 (Lot Number: EN5318) on 01Feb2021 at 12:30 PM (at the age of 77 years) for COVID-19 immunization (left arm); and the first dose of influenza vaccine inactivated SAG 3V (FLUAD; Lot Number: PFS 2020-21Bu) on 12Jan2021 (at the age of 76 years) for immunization. The patient was not diagnosed with COVID-19 prior vaccination. The patient did not look at site later that day. On 25Feb2021 (during the first night; also reported as Wednesday), it (right arm at injection site) itched. Then next morning (26Feb2021), the patient checked it and saw a red rash approximately an inch wide and 2 inches long. The day of reporting (28Feb2021; Sunday), the rash has spread to about 3 inches wide and about 5 inches long. It is tender to the touch and now it is itchy. It is still red. The patient also was sleepy on 25Feb2021 and needed to take a 1.5-hour nap. No treatment was administered for the events. The patient has not been tested for COVID-19 post vaccination. The patient had not recovered from the events.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Myalgia, Pyrexia
Clinical narrative: Chills; fever (38 C); weakness; muscle pain; mild diarrhea; This is a spontaneous report from a contactable consumer (patient).  A 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 18Feb2021 13:00 (Batch/Lot Number: EL3247) as DOSE 2, SINGLE for COVID-19 immunisation.  Medical history was reported none. The patient had no allergies to medications, food, or other products. The patient was not pregnant at time of vaccination. Prior to vaccination,  the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered in workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included calcium  taken for supplement, start and stop date were not reported.  The patient previously received the first dose of BNT162B2, via an unspecified route of administration, administered in arm right on 27Jan2021 12:00 (Batch/Lot Number: EL3247) as DOSE 1, SINGLE for COVID-19 immunisation. On 19Feb2021, the patient experienced chills, fever (38 C), weakness, muscle pain, mild diarrhea, lasted for one day following the vaccination. The patient started experiencing the symptoms on Friday 19Feb2021, and reported on Monday 22Feb2021, when she had no more symptoms and could conclude that the adverse effects were finished. Treatment was not received for the adverse events. The outcome of the event was recovered on unspecified date in Feb2021.  Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dry skin, Rash erythematous
Clinical narrative: There was rash was all over the body/it was red in color; Little dry skin; This is a spontaneous report from a contactable physician. An 87-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6201; Expiration Date: Jul2021), via an unspecified route of administration, administered in left arm (reported left shoulder) on 21Feb2021 (at 87 years old) as dose 2, single for COVID-19 immunization. Medical history included colon cancer. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9261), on 30Jan2021 (at 87 years old), for COVID-19 immunization. It was reported that after the patient came home on 21Feb2021, the rash was all over the body. He wanted to know what he should do. He has little dry skin, no fever, no pain, no headache. He got the rash on Sunday, 21Feb2021, and went there, it was so cold there, that his whole body was covered, and so he did not see the rash till he went to bed at night on Monday. The was rash was all over the body, there was no temperature when touching it, it was red in color, there was no texture when looking at it, the skin appeared smooth, however his skin was a little dry. The patient underwent blood tests which were all normal on an unknown date. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: worsened after getting the second dose/about 30 spots of pink light colored dots/pink dots that don't itch, they are not all round, they can be oblong, they are a lighter pink; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 16Feb2021 (Batch/lot number unknown), as dose 2, single, for COVID-19 immunisation, at a hospital. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection) received on 26Jan2021 (Batch/lot number unknown), at age 74 years old, as dose 1, single, for COVID-19 immunisation, after which the patient had a little rash. The patient did not notice the rash too much after the first dose. The patient described the rash as dots a quarter inch to the size of a quarter that do not itch. He stated that since they were where his suspenders go that the skin might just be getting irritated. On an unspecified date, the rash worsened after getting the second dose. The patient described the rash as "pink dots that don't itch, they are not all round, they can be oblong, they are a lighter pink". It was located only on his chest and shoulders, was not itchy, but was about 30 spots of pink light-colored dots. The patient tried NEOSPORIN (not helpful) and Melluca oil which only made the rashes darker. The patient called a local clinic to schedule an appointment and they asked him to talk to Pfizer first to see what their recommendations were. The patient would like to know if there was anything that he could put on his rash to treat it. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Facial paralysis, Musculoskeletal stiffness, Swelling face, X-ray
Clinical narrative: unable to blink left eye and move left side of mouth. Right side face looks dissformed.; Stiffness; swelling of face; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received BNT162b2 (BNT162B2), via an unspecified route of administration administered in right arm on 29Jan2021 at 14:00 (Batch/Lot Number: EN5318) (at the age of 68-years-old) as dose 1, single for COVID-19 immunisation. Vaccination facility type was hospital. Medical history included previous cancers, and known allergies: shrimp. The patient has no COVID prior to vaccination and unknown if patient was tested for COVID post vaccination. Concomitant medications included lisinopril, levothyroxine sodium, atorvastatin calcium and acetylsalicylic acid (ASPRIN), all taken as of two weeks for an unspecified indications, start and stop dates were not reported. The patient previously took olmesartan medoxomil (BENICAR) and ciprofloxacin (CIPRO) and experienced allergy. The patient did not receive any other vaccine in four weeks. On 27Feb2021, the patient experienced stiffness, swelling, of face, unable to blink left eye and move left side of mouth. Right side face looks diss-formed. Treatment for the events included Prednisone and Valacyclovir. Relevant tests and procedures included X-Rays and Computerized tomography (CT) Scan on an unspecified date in 2021. The events resulted in a doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The outcome of the events was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling, Pruritus
Clinical narrative: arm was swollen; arm was very itchy; arm was red; arm was fevered to touch/hot to touch; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm, on 26Feb2021 09:45 (Batch/lot number: EL9266), at age 72 years old, as dose 2, single, for COVID-19 immunisaiton, at a clinic. The patient was not pregnant at the time of vaccination. Relevant medical history included Hashimoto disease and known allergy to some band aid products both from unknown dates, not reported if ongoing or not. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included levothyroxine taken for an unknown indication, start and stop dates not reported. The patient previously took bacitracin and ciprofloxacin (CIPRO) and experienced allergies to both. Historical vaccine included BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), administered in the left arm, on 05Feb2021 09:45 (Batch/lot number: EL9264), at age 72 years old, as dose 1, single, for COVID-19 immunisation. The patient did not have other vaccines in four weeks. On 28Feb2021 09:45, 48 hours after the second injection, the patient's arm was red, swollen, fevered to touch/hot to touch and very itchy. At the time of the report, it was still very itchy a little swollen but not hot to the touch. No treatment was given for the events. The patient recovered from "arm was fevered to touch/hot to touch" on an unspecified date and was recovering from "arm was swollen" and "arm was red". The outcome of "arm was very itchy" was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Pyrexia
Clinical narrative: Severe joint pain; Fever ranging from 100.2-101.7; This is a spontaneous report from a contactable consumer (patient) received via COVAES. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 27Feb2021 08:30 (Batch/Lot Number: EN6205) (at the age of 49-years-old) as dose 2, single for COVID-19 immunisation. Medical history included high blood pressure, asthma, history of breast cancer and allergies from peanuts, corn and tomatoes. The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medications included atenolol; omeprazole; tocopherol (VITAMIN E); and ergocalciferol (VITAMIN D); all taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in right arm (Batch/Lot Number: EL9266) (at the age of 49-years-old) on 06Feb2021 at 08:30 for COVID-19 immunisation. The patient experienced severe joint pain (almost unable to sit and stand) and fever ranging from 100.2-101.7 (unit not reported) on 28Feb2021 at 11:00. The patient received no treatment for the events. The adverse events resulted to none. The outcome of event severe joint pain was recovered on 02Mar2021 at 11:00; while outcome of event fever ranging from 100.2-101.7 was recovering.   No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Pharyngeal swelling
Clinical narrative: double vision; throat began swelling; This is a spontaneous report from a contactable consumer (patient). A male patient (Age: 72; Unit: Unknown) received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 19Feb2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received first dose of Pfizer vaccine on 19Feb2021. Within 5 minutes of receiving the shot, his throat began swelling and it went. He also experienced double vision, time after vaccine unspecified. Patient asked if this is a reported side effect, if he can receive the second dose, and the efficacy of one dose. The outcome of the events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Urticaria
Clinical narrative: Swelling of the lips; hives on upper body; This is a spontaneous report from a contactable consumer (patient).   A 72-years-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration on 09Feb2021 15:30 (at the age of 72 years old) as dose number unknown, single for COVID-19 immunisation. The patient medical history was reported as none and there was concomitant medication in two weeks (also reported as there was other medication in two weeks). Known allergies was reported as not sure. On 27Feb2021, the patient experienced swelling of the lips, and hives on upper body. There was no other vaccine in four weeks. The events resulted in Emergency room/department or urgent care. Patient had no COVID prior vaccination and not COVID tested post vaccination. Treatment was received on all events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Oropharyngeal pain, Pyrexia
Clinical narrative: chills; fever; sore throat; This is a spontaneous report from a contactable consumer. An 87-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 87 years old on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history was not reported. Concomitant medication included palbociclib (IBRANCE). On an unspecified date, the patient experienced chills, fever and sore throat (believes sore throat is due to dry environment at facility). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis
Clinical narrative: cough; colds; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 01Mar2021, the patient woke up with a cough and colds. She said that it could be that the vaccine was causing her cough. She reported that she had her first dose on Saturday, 27Feb2921 and said that she was fine on 28Feb2021, but on 01May2021, she woke up with a cough and colds. She asked if it was due to the vaccine. She asked if she can take guaifenesin (MUCINEX). She knows she can take Tylenol but not ibuprofen. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.