chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Pulse started racing; I felt dizzy; Short of breath; Anxious; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 31Dec2020 11:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient was not diagnosed with Covid prior to vaccination. The patient has no known allergies. Concomitant medication includes vitamins NOS (MULTIVITAMIN). The patient did not receive other vaccines in the last four weeks. The patient received the vaccine in a  facility. About 5 minutes after (31Dec2020 11:35 AM) the patient received the vaccine, the patient's pulse started racing, and she felt dizzy, short of breath and anxious. The adverse events result in a doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The patient has not been Covid tested post vaccination. The outcome of the events was recovered on an unspecified date.  The following information on the batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenitis
Clinical narrative: soreness in the underarm area and felt it was lymph nodes; inflamed lymph nodes; This is a spontaneous report received from a contactable other health professional. A male patient of an unspecified age received BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date: unknown), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced soreness in the underarm and felt it was the lymph nodes. The reporter thought it was inflamed lymph nodes. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Headache
Clinical narrative: Extreme dizziness; headache; Felt hot but no fever; This is a spontaneous report from a non-contactable healthcare professional (patient). An adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient experienced extreme dizziness, headache and felt hot but no fever on 11Jan2021. The outcome of events was recovered on unspecified date. No treatment was given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in the Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Malaise, Pyrexia
Clinical narrative: Chills; fever with a temperature max of 103 Fahrenheit; Headache; Malaise; This is a spontaneous report from a non-contactable physician (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration (left arm) on 04Jan2021 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK5730) via an unspecified route of administration (left arm) on 16Dec2020 for Covid-19 immunization. The patient's medical history was reported as none.  There were no concomitant medications.  The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient experienced chills followed by fever with a temperature max of 103 Fahrenheit for 1 day, headache, and malaise on 04Jan2021 (20:00). The patient was treated with Motrin. The outcome of events was recovered on an unspecified date. The patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Limb mass, Maternal exposure during pregnancy, Musculoskeletal stiffness, Off label use, Pain in extremity
Clinical narrative: upper left arm feels sore and tighter; upper left arm feels sore and tighter, it feels like there's a small lump present there; Pregnant at the time of vaccination: Yes; Pregnant at the time of vaccination: Yes; Pregnant at the time of vaccination: Yes; Sore arm for 2 days after receiving vaccine/upper left arm feels sore; exposed to 2 COVID positive coworkers in the pharmacy; This is a spontaneous report from a contactable pharmacist (patient herself). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown (reported as "misplaced/discarded")), intramuscular (left arm), on 31Dec2020 13:30, at single dose, for covid-19 immunization. Medical history included allergies: iodine and, postural orthostatic tachycardia. Concomitant medications included ergocalciferol (VITAMIN D); docosahexaenoic acid, eicosapentaenoic acid (OMEGA-3); probiotics NOS and; prenatal multivitamin. The patient was pregnant at the time of vaccination (last menstrual date: 05Dec2020, gestational period: 3 weeks, delivery date: 11Sep2021). The patient experienced sore arm for 2 days after receiving vaccine on 31Dec2020 (no treatment was received for this adverse event); no other side effects experienced. Then the patient was exposed to 2 COVID positive coworkers in the pharmacy on 31Dec2020, 02Jan2021, 03Jan2021, 04Jan2021, and 06Jan2021 (no treatment was received for this adverse event). The patient was informed about the exposure on 11Jan2021 and on the same day she had a PCR COVID test via nasal swab submitted. The test result came back on 12Jan2021 and it was negative. Today (13Jan2021 14:00), the patient stated that her upper left arm feels sore and tighter, it feels like there's a small lump present there (no treatment was received for these adverse events). The patient had no Covid prior to vaccination and had no other vaccine in four weeks. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue, SARS-CoV-2 test
Clinical narrative: upper left arm feels sore and tighter; upper left arm feels sore and tighter, it feels like there's a small lump present there; Pregnant at the time of vaccination: Yes; Pregnant at the time of vaccination: Yes; Pregnant at the time of vaccination: Yes; Sore arm for 2 days after receiving vaccine/upper left arm feels sore; exposed to 2 COVID positive coworkers in the pharmacy; This is a spontaneous report from a contactable pharmacist (patient herself). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown (reported as "misplaced/discarded")), intramuscular (left arm), on 31Dec2020 13:30, at single dose, for covid-19 immunization. Medical history included allergies: iodine and, postural orthostatic tachycardia. Concomitant medications included ergocalciferol (VITAMIN D); docosahexaenoic acid, eicosapentaenoic acid (OMEGA-3); probiotics NOS and; prenatal multivitamin. The patient was pregnant at the time of vaccination (last menstrual date: 05Dec2020, gestational period: 3 weeks, delivery date: 11Sep2021). The patient experienced sore arm for 2 days after receiving vaccine on 31Dec2020 (no treatment was received for this adverse event); no other side effects experienced. Then the patient was exposed to 2 COVID positive coworkers in the pharmacy on 31Dec2020, 02Jan2021, 03Jan2021, 04Jan2021, and 06Jan2021 (no treatment was received for this adverse event). The patient was informed about the exposure on 11Jan2021 and on the same day she had a PCR COVID test via nasal swab submitted. The test result came back on 12Jan2021 and it was negative. Today (13Jan2021 14:00), the patient stated that her upper left arm feels sore and tighter, it feels like there's a small lump present there (no treatment was received for these adverse events). The patient had no Covid prior to vaccination and had no other vaccine in four weeks. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Fatigue, Full blood count, Metabolic function test, Pain
Clinical narrative: a little tiredness and achiness the next day; a little tiredness and achiness the next day; This is a spontaneous report from a contactable physician (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140, expiry date: 31Mar2021) intramuscular on left arm (left deltoid) single dose for COVID-19 immunization on 21Dec2020, 10:20 am, at 43-year-old. No medical history, drug allergies and family history. Concomitant medication included: multivitamins (unspecified) daily whenever she remembered to take them. The patient had no issues with that vaccination, maybe a little tiredness and achiness the next day (22Dec2020), but no reactions, no asthma, anaphylaxis or anything. Had a CBC, CMP, and 2 chest x-rays and they were all normal. The patient was not deceased. Relevant tests included: CBC, CMP and twice Chest X-ray; all with normal results. Action taken for BNT162B2 was not applicable. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Headache, Pain, Pyrexia
Clinical narrative: fever; dizziness; headache/head hurts feeling like it is going to split; aches all over; medicine taste in her mouth; This is a spontaneous report from a contactable consumer via the Medical Information Team. This consumer reported similar events for different patients. This is the second of two reports.  A female patient of unspecified age received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, unknown lot number and expiration date), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date) on an unknown date. It was reported that the patient that she got her second vaccine and her friend got the vaccine same day and she is feeling the same way she is feeling: had fever, dizziness, headache (also reported as head hurts feeling like it is going to split), aches all over, medicine taste in her mouth, and has been in bed all day; all on unspecified dates. The outcome of the events was unknown.   Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021025705 same reporter/drug/event, different patients
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Migraine, Pain, Product use issue, Pyrexia
Clinical narrative: Intense pain in left injection arm; Fever; Could not sleep; aches all over; other vaccine same date vaccine date on 04Jan2021; Day 6 -10 migraines hit; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm at 23:30 on 04Jan2021 at single dose for COVID-19 immunization and other vaccine same date vaccine date on 04Jan2021 on left arm. Medical history included allergies to penicillin, allergy to bananas, wheat (patient do eat products w wheat), dairy; Melanoma 3rd degree 1987 & 2005, allergies, sinus surgery resolved problems. Concomitant medication included venlafaxine, omeprazole, bupropion hydrochloride (WELLBUTRIN). It was reported that patient had no other vaccine in four weeks. The patient previously took ampicillin and experienced drug allergy. No issues until middle of night of first injection. The patient experienced intense pain in left injection arm; fever; could not sleep, other aches all over on 05Jan2021. Used ice packs & Motrin. Fever left after two days. Intense pain continued. 5th day switched to heating pad & took 2 tablets of Tylenol every 6 hours. Called patient's doctor on days 6 & 8. Suggested patient alternate Tylenol & Motrin every 6 or 8 hours. Day 6 -10 migraines hit. The outcome of event fever was recovered on 07Jan2021. The outcome of events migraine and Product use for unapproved combination was unknown. The outcome of rest events was not recovered.  Information on the LOT/Batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Intense pain in left injection arm; Fever; Could not sleep; aches all over; other vaccine same date vaccine date on 04Jan2021; Day 6 -10 migraines hit; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm at 23:30 on 04Jan2021 at single dose for COVID-19 immunization and other vaccine same date vaccine date on 04Jan2021 on left arm. Medical history included allergies to penicillin, allergy to bananas, wheat (patient do eat products w wheat), dairy; Melanoma 3rd degree 1987 & 2005, allergies, sinus surgery resolved problems. Concomitant medication included venlafaxine, omeprazole, bupropion hydrochloride (WELLBUTRIN). It was reported that patient had no other vaccine in four weeks. The patient previously took ampicillin and experienced drug allergy. No issues until middle of night of first injection. The patient experienced intense pain in left injection arm; fever; could not sleep, other aches all over on 05Jan2021. Used ice packs & Motrin. Fever left after two days. Intense pain continued. 5th day switched to heating pad & took 2 tablets of Tylenol every 6 hours. Called patient's doctor on days 6 & 8. Suggested patient alternate Tylenol & Motrin every 6 or 8 hours. Day 6 -10 migraines hit. The outcome of event fever was recovered on 07Jan2021. The outcome of events migraine and Product use for unapproved combination was unknown. The outcome of rest events was not recovered.  Information on the LOT/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Flu-like symptom; Arm pain; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sales representative. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 12Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient experienced flu-like symptom and arm pain after receiving first dose of Pfizer COVID-19 vaccine on 12Jan2021. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea
Clinical narrative: Chills; Diarrhea; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient has chills and diarrhea on an unspecified date. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Sinus congestion, Vertigo, Vomiting
Clinical narrative: Headache; congestion (sinus); severe vertigo; Vomiting; Nausea; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), via an unspecified route of administration on 29Dec2020 at a single dose on the right arm for COVID-19 immunization. The patient's medical history was reported as none. There were no concomitant medications. On 06Jan2021, the patient experienced severe vertigo. Patient also experienced headache, congestion (sinus) on an unspecified date. On 05Jan2021, patient experienced vomiting and nausea. Patient stated that she went to her primary care and was given patch for nausea and was given a different sinus brand to clear up the congestion. Patient stated that with all these, she is pretty sure that she does not want the second dose. Patient stated that she has symptoms of the vaccine than rather COVID and wanted to know what were the recommendations. The outcome of the event congestion (sinus) was not recovered, vomiting was recovered 05Jan2021, while the other events was recovering.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Deafness, Dysstasia, Gait disturbance, Nausea
Clinical narrative: seeing gray spots room started spinning felt nauseous collapsed on the table; loss of vision; loss of hearing; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; loss of the onion ability to stand up or walk; loss of the onion ability to stand up or walk; This is a spontaneous report from a contactable other health professional (patient), a 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) at left arm on 14Jan2021 08:30 AM at single dose for covid-19 immunization in a public health facility. Medical history was none. Allergies to medications, food, or other products was No. Patient was not pregnant at the time of vaccination. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. the patient received within 2 weeks of vaccination included amphetamine salts 15 mg. Patient woke up in the middle of the night got out of bed walk down a set of stairs started seeing gray spots room started spinning felt nauseous collapsed on the table. Had to call her husband to carry her back up the stairs. she had loss of vision loss of hearing and the onion ability to stand up or walk. He laid her back in bed to pick up his phone and call emergency services within five minutes everything had gone back to normal. adverse event start date was 15Jan2021 03:00 AM. the adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The final outcome of the events was unknown (if patient recovered: Unknown). It was reported as non-serious. Seriousness criteria Results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all no.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Vertigo, Visual impairment
Clinical narrative: seeing gray spots room started spinning felt nauseous collapsed on the table; loss of vision; loss of hearing; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; loss of the onion ability to stand up or walk; loss of the onion ability to stand up or walk; This is a spontaneous report from a contactable other health professional (patient), a 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) at left arm on 14Jan2021 08:30 AM at single dose for covid-19 immunization in a public health facility. Medical history was none. Allergies to medications, food, or other products was No. Patient was not pregnant at the time of vaccination. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. the patient received within 2 weeks of vaccination included amphetamine salts 15 mg. Patient woke up in the middle of the night got out of bed walk down a set of stairs started seeing gray spots room started spinning felt nauseous collapsed on the table. Had to call her husband to carry her back up the stairs. she had loss of vision loss of hearing and the onion ability to stand up or walk. He laid her back in bed to pick up his phone and call emergency services within five minutes everything had gone back to normal. adverse event start date was 15Jan2021 03:00 AM. the adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The final outcome of the events was unknown (if patient recovered: Unknown). It was reported as non-serious. Seriousness criteria Results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all no.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Myalgia
Clinical narrative: Generalized muscle aches; lethargy; This is a spontaneous report from a contactable physician. A 62-year-old male patient received first (1st) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EH9899, via an unspecified route of administration in the left arm, on 18Dec2020 12:45 at a SINGLE DOSE for covid-19 immunization.  Medical history included hypertension (HTN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN HCT), amlodipine and aripiprazole (ABILIFY).  On 19Dec2020, the patient experienced generalized muscle aches and lethargy. The outcome of events was not recovered.  Therapeutic measures were taken as a result of events included OTC motrin and Tylenol.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: her husband received the Covid vaccine last Friday and was positive for Covid 19; positive for Covid 19; This is a spontaneous report from a non-contactable consumer reporting for herself and her husband. This case is for the reporter's husband.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not reported) via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 08Jan2021 (Friday) and was positive for COVID-19 on 11Jan2021 (Monday). The outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021024045 same reporter/product/event, different patient
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Severe dizziness; Nausea; This is a spontaneous report from a contactable consumer (patient) reported a 70-years-old 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 from an unspecified date, at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021 at 14:30, the patient experienced severe dizziness and nausea.  Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering. The reporter assessed the events as non-serious.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in left arm where injection was given; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248), intramuscular (left arm) from 14Jan2021 18:00 to 14Jan2021 18:00 at a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included vitamin D3. The patient previously took hydrocodone and had allergy. The patient experienced soreness in left arm where injection was given on 15Jan2021 09:00. The patient did not receive any treatment for the event. The outcome of the event was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Lymphadenopathy, Swelling, Swelling face, Vaccination site swelling
Clinical narrative: swelling in shot arm; swelling in left side of neck; Facial swelling; The arm, neck, face swelling seemed to be lymphatic; shoulder swelling; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 12Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included nasal sinus allergies (otherwise healthy), some shellfish sensitivities and mouth swelling with some spices allergy from an unknown date and unknown if ongoing. Concomitant medication included clarithromycin (CLARITIN). The patient previously took codeine and experienced itching reaction. The patient stated, "The night of the vaccine I awoke at 1am with moderate amount of swelling in shot arm, swelling in left side of neck and facial swelling on 13Jan2021 01:15 AM. No breathing problems so I did not go to hospital. Some swelling went down with Benadryl. On the second night, swelling came back in same places with neck/shoulder swelling being worse." The patient called her doctor who set up an appointment for 15Jan2021. Sweeping is some better on the third day have continued to take Benadryl, Motrin seemed to make it worse (as reported). The patient further stated, "My doctor has advised me not to take the second dose of Pfizer COVID 19 vaccine due to the swelling going beyond just arm swelling. The arm, neck, face swelling seemed to be lymphatic." all on 13Jan2021 01:15 AM. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment was given to the patient for the event, over the counter medications - Benadryl and Motrin. The outcome of the events was recovering. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events ware considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and were not a congenital anomaly/birth defect. The patient was not pregnant.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Swelling and redness and itching at injection site; Swelling and redness and itching at injection site; Swelling and redness and itching at injection site; product=COVID 19, brand=Pfizer, dose 1 administration date: 27Dec2020, dose 2 administration date: 13Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 13Jan2021 at 17:00 at a single dose for COVID-19 immunization. Relevant medical history included thyroid cancer. The patient has no known allergies. Concomitant medications included thyroid (ARMOR THYROID) and ibuprofen (ADVIL). The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) on 27Dec2020 at 10:00 A.M., in the left arm for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital.  The patient has not been tested for COVID-19 since vaccination. On 14Jan2021 at 09:00 A.M., the patient experienced swelling and redness and itching at injection site. The patient did not receive treatment for the events. Outcome of the events was recovering.   Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Inappropriate schedule of product administration
Clinical narrative: arthralgia; fatigue; insomnia; soreness at site of injection; swollen lymph nodes on left anterior clavicular region; Fever (99.9 at highest); chills; first dose was received on 27Dec2020/2nd dose on 13Jan2021; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302 and expiry date:May2021), via an unspecified route of administration on the left arm on 13Jan2021 13:30 at single dose for covid-19 immunisation. The first dose was received on 27Dec2020 13:30 on the left arm, Medical history included hypertension, anxiety, GERD (gastrooesophageal reflux disease) and insomnia. Concomitant medication included atenolol, omeprazole (PRILOSEC), hydroxyzine hydrochloride (VISTARIL) and unspecified multivitamins. The patient previously took neomycine and experienced drug hypersensitivity. The patient experienced fever (99.9 at highest), chills, arthralgia, fatigue, insomnia, soreness at site of injection, swollen lymph nodes on left anterior clavicular region on 14Jan2021 05:45. No treatment was given for the events. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The reporter considered the events non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Lymphadenopathy, Pyrexia, Vaccination site pain
Clinical narrative: arthralgia; fatigue; insomnia; soreness at site of injection; swollen lymph nodes on left anterior clavicular region; Fever (99.9 at highest); chills; first dose was received on 27Dec2020/2nd dose on 13Jan2021; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302 and expiry date:May2021), via an unspecified route of administration on the left arm on 13Jan2021 13:30 at single dose for covid-19 immunisation. The first dose was received on 27Dec2020 13:30 on the left arm, Medical history included hypertension, anxiety, GERD (gastrooesophageal reflux disease) and insomnia. Concomitant medication included atenolol, omeprazole (PRILOSEC), hydroxyzine hydrochloride (VISTARIL) and unspecified multivitamins. The patient previously took neomycine and experienced drug hypersensitivity. The patient experienced fever (99.9 at highest), chills, arthralgia, fatigue, insomnia, soreness at site of injection, swollen lymph nodes on left anterior clavicular region on 14Jan2021 05:45. No treatment was given for the events. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The reporter considered the events non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Chills; fever; nausea; headache; body aches; This is a spontaneous report from a contactable nurse (patient). A 25-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), intramuscular on 14Jan2021 13:00 at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. No allergies to medications, food, or other products. Concomitant medication included linaclotide (LINZESS). The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular on 26Dec2020, 11:00 AM at a single dose on left arm for COVID-19 immunization. The patient experienced chills, fever, nausea, headache, and body aches on 15Jan2021 02:15, after the second dose. No treatment received for the events. The outcome of the events was recovered. The events were considered as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was the Hospital. No other vaccines received within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Night sweats, Pain in extremity, Pyrexia
Clinical narrative: Malaise; Febrile; Night sweat; Sore arm; This is a spontaneous report from a contactable consumer. A 60-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 13Jan2021 at a single dose in the right arm for Covid-19 immunization. The patient's medical history was not reported. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included varicella zoster vaccine rge (cho) (SHINGRIX, booster) on 08Jan2021 (within 4 weeks) in the left arm, ibuprofen, acetaminophen and thyroid medicine (unspecified). The vaccination was administered in the hospital. On 14Jan2021 08:00 AM, patient experienced malaise, febrile, night sweat, and sore arm. No treatments were received in response to the events. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The events malaise, febrile, night sweat, and sore arm were recovering at the time of the report.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: metallic taste in his mouth; This is a spontaneous report from a non-contactable healthcare professional. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced metallic taste in his mouth on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever/temperature ranged from 101 to 103; chills/severe chills that stayed for two days with tiredness; fatigue; body pains; This is a spontaneous report from a contactable physician (patient). A 33-year-old male received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), intramuscular on the right arm on 11Jan2021 16:15 at a single dose for covid-19 immunisation. The first dose was received on 24Dec2020 11:00, intramuscular on the left arm. The patient's medical history and concomitant medications were not reported. The night of second dose on 12Jan2021 02:30, patient developed fever, chills, body pains and fatigue. Temperature ranging from 101 to 103, with severe chills that stayed for two days with tiredness. Events was subsided by Tylenol and energy drink. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and was tested by nasal swab on 14Jan2021 (pending results) been since the vaccination.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Smear test
Clinical narrative: Fever/temperature ranged from 101 to 103; chills/severe chills that stayed for two days with tiredness; fatigue; body pains; This is a spontaneous report from a contactable physician (patient). A 33-year-old male received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), intramuscular on the right arm on 11Jan2021 16:15 at a single dose for covid-19 immunisation. The first dose was received on 24Dec2020 11:00, intramuscular on the left arm. The patient's medical history and concomitant medications were not reported. The night of second dose on 12Jan2021 02:30, patient developed fever, chills, body pains and fatigue. Temperature ranging from 101 to 103, with severe chills that stayed for two days with tiredness. Events was subsided by Tylenol and energy drink. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and was tested by nasal swab on 14Jan2021 (pending results) been since the vaccination.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Chest pain, Discomfort, Lymphadenopathy
Clinical narrative: L Axillary lymphadenopathy; Fever 102.8 (H); muscle aches/heaviness; Migraine; Tachycardia; Chest pressure/pain; Chest pressure/pain; elevated BP; malaise; This is a spontaneous report from a contactable 39-year-old female Nurse reported for herself.  A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number E10140), intramuscular in arm left on 11Jan2021 12:30 at single dose for COVID-19 immunization. Medical history included Low BP, depression, insomnia, latex allergy. The patient was allergy to morphine and diltiazem (CARDIZEM). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, E10140) on 24Dec2020 10:45 AM, intramuscular in left arm at age of 39 years old for Covid-19 immunization. Concomitant medication included cefixime (FLEXERIL), diphenhydramine hydrochloride (UNISOM), acetylsalicylic acid (ASPIRIN) and ibuprofen. The patient experienced l axillary lymphadenopathy, fever 102.8, muscle aches/heaviness, migraine, tachycardia, chest pressure/pain, elevated bp, malaise, all on 11Jan2021 23:00 with outcome of recovered with sequelae. The patient underwent lab tests and procedures which included blood pressure: elevated on 11Jan2021, body temperature: 102.8 on 11Jan2021 (H), nasal swab: negative on 12Jan2021 (Covid test post vaccination). The events were non-serious, result in emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient received Bolus of IV (intravenous) fluids for treatment.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Myalgia, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: L Axillary lymphadenopathy; Fever 102.8 (H); muscle aches/heaviness; Migraine; Tachycardia; Chest pressure/pain; Chest pressure/pain; elevated BP; malaise; This is a spontaneous report from a contactable 39-year-old female Nurse reported for herself.  A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number E10140), intramuscular in arm left on 11Jan2021 12:30 at single dose for COVID-19 immunization. Medical history included Low BP, depression, insomnia, latex allergy. The patient was allergy to morphine and diltiazem (CARDIZEM). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, E10140) on 24Dec2020 10:45 AM, intramuscular in left arm at age of 39 years old for Covid-19 immunization. Concomitant medication included cefixime (FLEXERIL), diphenhydramine hydrochloride (UNISOM), acetylsalicylic acid (ASPIRIN) and ibuprofen. The patient experienced l axillary lymphadenopathy, fever 102.8, muscle aches/heaviness, migraine, tachycardia, chest pressure/pain, elevated bp, malaise, all on 11Jan2021 23:00 with outcome of recovered with sequelae. The patient underwent lab tests and procedures which included blood pressure: elevated on 11Jan2021, body temperature: 102.8 on 11Jan2021 (H), nasal swab: negative on 12Jan2021 (Covid test post vaccination). The events were non-serious, result in emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient received Bolus of IV (intravenous) fluids for treatment.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: L Axillary lymphadenopathy; Fever 102.8 (H); muscle aches/heaviness; Migraine; Tachycardia; Chest pressure/pain; Chest pressure/pain; elevated BP; malaise; This is a spontaneous report from a contactable 39-year-old female Nurse reported for herself.  A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number E10140), intramuscular in arm left on 11Jan2021 12:30 at single dose for COVID-19 immunization. Medical history included Low BP, depression, insomnia, latex allergy. The patient was allergy to morphine and diltiazem (CARDIZEM). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, E10140) on 24Dec2020 10:45 AM, intramuscular in left arm at age of 39 years old for Covid-19 immunization. Concomitant medication included cefixime (FLEXERIL), diphenhydramine hydrochloride (UNISOM), acetylsalicylic acid (ASPIRIN) and ibuprofen. The patient experienced l axillary lymphadenopathy, fever 102.8, muscle aches/heaviness, migraine, tachycardia, chest pressure/pain, elevated bp, malaise, all on 11Jan2021 23:00 with outcome of recovered with sequelae. The patient underwent lab tests and procedures which included blood pressure: elevated on 11Jan2021, body temperature: 102.8 on 11Jan2021 (H), nasal swab: negative on 12Jan2021 (Covid test post vaccination). The events were non-serious, result in emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient received Bolus of IV (intravenous) fluids for treatment.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Chills, Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: sweating; chills; fever; major fatigue; Major hair loss starting 1.5 days following the vaccination; This is a spontaneous report from a contactable other health care professional. A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0142), intramuscular on 12Jan2021 16:30 at SINGLE DOSE at Arm Left for covid-19 immunisation. Medical history included covid-19; covid prior vaccination: yes. Concomitant medication included escitalopram oxalate (LEXAPRO). Major hair loss starting 1.5 days following the vaccination on an unspecified date in Jan2021, in addition to sweating, chills, fever, and major fatigue on 13Jan2021 22:30. The patient did not receive treatment for the events. The outcome of the events was not recovered.