chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood glucose increased, Blood pressure increased
Clinical narrative: blood pressure went much too high; blood glucose went high also; After the first shot, I experienced very bad GI problems. Did not associate this with the vaccine at the time. Received the second shot on 2/27/21 and condition worsened. Not only did I experience ter; This is a spontaneous report from a contactable consumer (patient). This 86-year-old male patient receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose (Lot: EL3247) on 27Jan2021 06:30 PM at single dose on Left arm, second dose on 27FEB2021 at single dose on Left arm, both for COVID-19 immunization. Medical history included Diabetes mellitus. The patient was not diagnosed with COVID-19 prior to vaccination. Allergies to medications, food, or other products was no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, or any other medications the patient received within 2 weeks of vaccination. After the first shot, the patient experienced very bad GI problems. Did not associate this with the vaccine at the time. Received the second shot on 27FEB2021 and condition worsened. Not only did patient experience terrible GI problems, his blood pressure went much too high and blood glucose went high also. The events onset date was reported as 28JAN2021. The adverse event "GI problems" result in doctor or other healthcare professional office/clinic visit. There was treatment received for the adverse event, medications to lower blood pressure and blood glucose. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was Recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Drug ineffective, Oropharyngeal pain, Suspected COVID-19
Clinical narrative: has been exposed and currently has a sore throat and cough; has been exposed and currently has a sore throat and cough; Sore throat; Cough; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported that a male patient of an unspecified age received the first dose of BNT162B2 (lot number and expiration date not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is waiting for his result for today but has been exposed and currently has a sore throat and cough on an unspecified date. He is scheduled to get his second dose on 01Apr2021. The reporter asked if her husband will test positive with the COVID-19 virus, can he still get the second dose on the scheduled date or does he need to reschedule it. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Sinus headache
Clinical narrative: Have sinus headache; This is a spontaneous report received from a contactable consumer (patient) to a Pfizer Sponsored Program.  A female patient of an unspecified age received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown) via an unspecified route of administration on Mar2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced have sinus headache on Mar2021. Caller received second vaccine shot yesterday and have sinus headache and wanted to know if she can take Excedrin. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) via an unspecified route of administration, in right arm on 19Mar2021 (at the age of 47-year-old) at single dose for COVID-19 immunization. The patient's medical history included hypothyroidism and asthma. The patient has no allergies to medications, food, or other products. The patient's concomitant medications included unspecified thyroid medication. The patient was not pregnant and didn't receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient hasn't been tested for COVID-19. The patient experienced swollen lymph nodes on 23Mar2021. The patient didn't receive any treatment for the event. Outcome of the event was not resolved.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Hypersensitivity
Clinical narrative: soreness; headache; allergies; This is a spontaneous report received from a contactable male consumer (Patient) via Pfizer sponsored program. A male patient of unspecified age received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 23Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that after his 1st dose he experienced soreness and headache (from allergies), so patient wants to ask if he can take Aspirin and Antihistamines prior to his 2nd dose. The patient also mentioned that he did not take any of the drugs yet because he wants to make sure that there are no contraindications. Outcome of events was not reported.  Information on lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient (not pregnant at time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 at 11:15 AM (Lot number: PFR EN6204) as single dose for covid-19 immunization. Medical history included diagnosed with COVID-19. No known allergies to medications, food, or other products. Concomitant medications included azelastine and woman multi day vitamin that patient received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient did not test for COVID-19. On 27Mar2021 at 04:00 AM, the patient experienced low grade fever, chills, aching, pain/heaviness at injection site. Lab data included COVID-19 was positive prior to vaccination. There was no treatment received for the adverse events. The outcome of events was recovered on unspecified date. This report was assessed by the patient was non-serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating or no congenital anomaly/birth defect.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient (not pregnant at time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 at 11:15 AM (Lot number: PFR EN6204) as single dose for covid-19 immunization. Medical history included diagnosed with COVID-19. No known allergies to medications, food, or other products. Concomitant medications included azelastine and woman multi day vitamin that patient received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient did not test for COVID-19. On 27Mar2021 at 04:00 AM, the patient experienced low grade fever, chills, aching, pain/heaviness at injection site. Lab data included COVID-19 was positive prior to vaccination. There was no treatment received for the adverse events. The outcome of events was recovered on unspecified date. This report was assessed by the patient was non-serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating or no congenital anomaly/birth defect.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Had a couple of PEs (pulmonary embolism); This is a spontaneous report from a non-contactable physician via a Pfizer sales representative. A patient of unspecified age and gender received the second dose of  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 medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. The patient had a couple of PEs (pulmonary embolism) on an unspecified date with outcome of unknown.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. The company cannot completely exclude a causal relationship between the pulmonary embolism and suspect vaccine BNT162B2. Additional information regarding relevant medical history, underlying conditions and concomitant medications will aid in comprehensive assessment of the case. 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 Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate decreased, Paraesthesia
Clinical narrative: Heart rate dropped to below 50 ppm; finger tips heavily tingled the morning after the injection.; This is a spontaneous report received from a contactable consumer (patient). A 64-years-old male patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 64-years-old ,via an unspecified route of administration, administered in Arm Left on 29Mar2021 12:30 (Lot Number: ER8730) as single dose for Covid-19 immunisation. Medical history included cardiac failure, diabetes 2, obese. No Allergies to medications, food, or other products The patient's concomitant medications were not reported. The patient experienced heart rate dropped to below 50 ppm on 30Mar2021 10:00 with outcome of recovered, finger tips heavily tingled the morning after the injection on 30Mar2021 10:00 with outcome of recovered. No treatment received for adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were other medications the patient received within 2 weeks of vaccination. 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 needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: body rash, hands, feet, head; This is a spontaneous report from a non-contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ep6955), dose 1 via an unspecified route of administration at the age of 59-years administered in arm left on 25Mar2021 12:00 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced body rash, hands, feet, head on 28Mar2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, did not test covid post vaccination, did not receive treatment for event. The outcome of the event was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal infection, Abdominal pain upper, Acne, Chest discomfort, Decreased appetite
Clinical narrative: loss of appetite; pretty bad headache; body aches; tightness in her chest; Ringing in ears; stomach cramps; slept 15 hours; lump; pimple; infection on the abdomen; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, in Arm Left on 24Feb2021 (Lot Number: EN6202) as SINGLE DOSE for COVID-19 immunization. Medical history included a lot of allergies from an unknown date and unknown if ongoing. Concomitant medications included losartan taken for high blood pressure, start and stop date were not reported; formoterol fumarate, mometasone furoate (DULERA) taken for bronchial hyperreactivity, start and stop date were not reported; fluticasone to help her breathe, start and stop date were not reported; fexofenadine a decongestant for allergies, start and stop date were not reported; tolnaftate antifungal solution for toenail, start and stop date were not reported; and fluorometholone taken for plugged up tear duct, start and stop date were not reported.  The patient previously had flu shot once about 15 years ago and it was terrible. With the first dose, the patient started to have loss of appetite, pretty bad headache, body aches, tightness in her chest, ringing in her ears, and stomach cramps. She slept 15 hours the first night. She got up to go the bathroom and then went right back to bed. That happened after first dose and she wasn't too anxious to get the second dose. These were pretty strong. For 24 hours after onset they were pretty severe. Then she experienced variation of these and lessening of severity over seven days. By the next Wednesday she felt her normal self. She got both shots on Wednesday. She didn't have fever or any other problems that COVID people get. The patient had an infection on the abdomen. She took Cephalexin for 10 days. The infection on the abdomen started in early Mar2021. It was like a lump in Mar2021. She went to the dermatologist because there is cancer in her family. The dermatologist told her not to worry. Then it erupted like a big pimple in Mar2021. The outcome of the events was unknown.  Follow-up attempts are needed. Information on lot/batch number is available.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mass, Pain, Somnolence, Tinnitus
Clinical narrative: loss of appetite; pretty bad headache; body aches; tightness in her chest; Ringing in ears; stomach cramps; slept 15 hours; lump; pimple; infection on the abdomen; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, in Arm Left on 24Feb2021 (Lot Number: EN6202) as SINGLE DOSE for COVID-19 immunization. Medical history included a lot of allergies from an unknown date and unknown if ongoing. Concomitant medications included losartan taken for high blood pressure, start and stop date were not reported; formoterol fumarate, mometasone furoate (DULERA) taken for bronchial hyperreactivity, start and stop date were not reported; fluticasone to help her breathe, start and stop date were not reported; fexofenadine a decongestant for allergies, start and stop date were not reported; tolnaftate antifungal solution for toenail, start and stop date were not reported; and fluorometholone taken for plugged up tear duct, start and stop date were not reported.  The patient previously had flu shot once about 15 years ago and it was terrible. With the first dose, the patient started to have loss of appetite, pretty bad headache, body aches, tightness in her chest, ringing in her ears, and stomach cramps. She slept 15 hours the first night. She got up to go the bathroom and then went right back to bed. That happened after first dose and she wasn't too anxious to get the second dose. These were pretty strong. For 24 hours after onset they were pretty severe. Then she experienced variation of these and lessening of severity over seven days. By the next Wednesday she felt her normal self. She got both shots on Wednesday. She didn't have fever or any other problems that COVID people get. The patient had an infection on the abdomen. She took Cephalexin for 10 days. The infection on the abdomen started in early Mar2021. It was like a lump in Mar2021. She went to the dermatologist because there is cancer in her family. The dermatologist told her not to worry. Then it erupted like a big pimple in Mar2021. The outcome of the events was unknown.  Follow-up attempts are needed. Information on lot/batch number is available.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Melaena, Nausea
Clinical narrative: tarry stool; Nausea; diarrhea; stomach pain; This is a spontaneous report from a contactable consumer reported for herself.  A 22-years-old female patient received dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, vaccine location: right arm, on 25Mar2021 18:00 (Lot Number: ER8727) at the age of 22 years as SINGLE DOSE for covid-19 immunisation. Pregnant at the time of vaccination: No. Medical history included type 1 diabetes mellitus, coeliac disease, asthma, arthritis, post-traumatic stress disorder, food allergy (strawberries) and seasonal allergy. Concomitant medications included insulin lispro (HUMALOG); escitalopram (ESCITALOPRAM); trazodone (TRAZODONE); lorazepam (LORAZEPAM). On 26Mar2021 the patient experienced tarry stool, nausea, diarrhea and stomach pain; all with outcome of not recovered. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnosed with COVID-19 and, since the vaccination, the patient did not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure like violent tremors in the middle of the night.; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received second dose of BNT162B2 [PFIZER-BIONTECH COVID-19 VACCINE (also reported as MODERNA; pending clarification), solution for injection, lot number and expiry date were not reported], via an unspecified route of administration, administered in the left arm on 25Mar2021 13:00 (at the age of 39 years old) at a single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing. There were no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient experienced seizure like violent tremors in the middle of the night on 26Mar2021 04:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications received within 2 weeks of vaccination. The outcome of the event was recovering.  Information on the batch/lot number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Pulmonary thrombosis
Clinical narrative: Hospitalized with blood clots in his lungs and a-fib; Hospitalized with blood clots in his lungs and a-fib; This is a spontaneous report from a contactable consumer. A 74-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 01Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included covid-19 prior vaccination: Yes. The patient had no known allergies. The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. On 22Mar2021 at 10:00 (reported as 3 weeks after the his second shot), the patient was hospitalized with blood clots in his lungs and a-fib. The patient was currently in the hospital. The patient was treated with oxygen and anticoagulant. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear congestion, Rash, Systemic lupus erythematosus, Upper respiratory tract congestion
Clinical narrative: Lupus; Skin Rash; congestion in ears and head; congestion in ears and head; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249), via an unspecified route of administration, administered in right arm on 02Feb2021 12:00 at single dose for COVID-19 immunisation. The patient's medical history included known allergies to shellfish. There were no concomitant medications. The patient was not pregnant at the time of reporting. Prior to vaccination, the patient had no COVID and patient was not tested for COVID post vaccination. The vaccine facility type was hospital. On 05Feb2021 at 07:00 AM, the patient experienced skin rash, and congestion in ears and head. The patient was diagnosed with lupus on 25Feb2021 (also reported as 25Mar2021 - pending confirmation). Events resulted to Emergency Room visit and Physician Office visit. Therapeutic measures were taken as a result of the events and included steroid shots, antihistamines shots, and antibiotics. The outcome of the events was not recovered. Seriousness of the events was disability.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Syncope
Clinical narrative: must have fainted; severe nausea; This is a spontaneous report from a contactable consumer.  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered on right arm on 25Mar2021 14:00 (Batch/Lot Number: EW6204) at single dose (at the age of 55 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included estradiol, progesterone, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) and spironolactone, all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, on 04Mar2021 (Lot number: EN6198), 02:00 PM on the right arm. The patient stated on 26Mar2021, "woke up with severe nausea, went to restroom, must have fainted, because I came to with my face on the register vent". The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea
Clinical narrative: must have fainted; severe nausea; This is a spontaneous report from a contactable consumer.  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered on right arm on 25Mar2021 14:00 (Batch/Lot Number: EW6204) at single dose (at the age of 55 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included estradiol, progesterone, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) and spironolactone, all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, on 04Mar2021 (Lot number: EN6198), 02:00 PM on the right arm. The patient stated on 26Mar2021, "woke up with severe nausea, went to restroom, must have fainted, because I came to with my face on the register vent". The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Haematochezia, Limb mass, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: arm started swell a little bit; woke me up at 5 O'clock this morning in pain; arm started swell a little bit; woke me up at 5 O'clock this morning in pain; shoulder is kind of swollen; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; arm kind of still stiff and sore; Blood in stool; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613 and expiration date not provided) via an unspecified route of administration administered in the arm, on 23Mar2021 as a single dose for COVID-19 immunization. Medical history included breast cancer survivor. The patient's concomitant medications were not reported. The patient stated that she was trying to figure out what to do. On 26Mar2021, her arm started to swell a little bit. When she woke up, it woke her up at 5 o'clock in pain and her shoulder was kind of swollen, it has got big old knot and it was red and it was apparent itchy and she could not scratch it so, she thought about it and she got an ice pack, so she put ice on it. She was holding ice on it now, trying to sooth it. She was wondering where she would go for reaction, she knew she had reaction like this before so she had a side effect from it, and her arm was kind of still stiff and sore. She did not go to the emergency or urgent care because she looked at left and she looked at the right and like she said, it was swollen and she got big old knot and it was red. She also stated that she did not take Tylenol today. She did not know what she wanted to get through to somebody and she needed to speak to somebody on what she needed to do. She also said that on an unspecified date in Mar2021, in her stool, she found some blood. She had another appointment with her "thyroid" (not clarified) and she does not know the results yet. The outcome of the events was not recovered.   Information about lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Swelling
Clinical narrative: arm started swell a little bit; woke me up at 5 O'clock this morning in pain; arm started swell a little bit; woke me up at 5 O'clock this morning in pain; shoulder is kind of swollen; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; arm kind of still stiff and sore; Blood in stool; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613 and expiration date not provided) via an unspecified route of administration administered in the arm, on 23Mar2021 as a single dose for COVID-19 immunization. Medical history included breast cancer survivor. The patient's concomitant medications were not reported. The patient stated that she was trying to figure out what to do. On 26Mar2021, her arm started to swell a little bit. When she woke up, it woke her up at 5 o'clock in pain and her shoulder was kind of swollen, it has got big old knot and it was red and it was apparent itchy and she could not scratch it so, she thought about it and she got an ice pack, so she put ice on it. She was holding ice on it now, trying to sooth it. She was wondering where she would go for reaction, she knew she had reaction like this before so she had a side effect from it, and her arm was kind of still stiff and sore. She did not go to the emergency or urgent care because she looked at left and she looked at the right and like she said, it was swollen and she got big old knot and it was red. She also stated that she did not take Tylenol today. She did not know what she wanted to get through to somebody and she needed to speak to somebody on what she needed to do. She also said that on an unspecified date in Mar2021, in her stool, she found some blood. She had another appointment with her "thyroid" (not clarified) and she does not know the results yet. The outcome of the events was not recovered.   Information about lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hip fracture, Immobile, Upper limb fracture
Clinical narrative: Broken hip; Broken arm; currently immobile; This is a spontaneous report received rom a Pfizer sponsored program . A contactable consumer (patient sister)reported that a 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose via an unspecified route of administration on 06Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The Caller reported that her sister who had the first shot of the Pfizer vaccine. Her sister had surgery on a broken hip and arm. The broken hip and arm happened just this week (unspecified date in Mar2021). Her second shot scheduled for tomorrow (27Mar2021). Her sister was currently immobile and unable to come in for the shot. The 21 days was up tomorrow (27Mar2021). The reporter was concerned about the efficacy of the shot if it was not given within the 21 days. Outcome of the events broken hip and arm was not recovered and that for currently immobile was unknown.  Follow-up (26Mar2021): This is a spontaneous report received from a Pfizer sponsored program.  Information on patient second shot of vaccine was reported.  Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea at rest
Clinical narrative: Dyspnea - Difficulty breathing at rest, felt like a weight was on her chest; Dyspnea - Difficulty breathing at rest, felt like a weight was on her chest; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the right arm on 27Mar2021 15:45 (03:45 PM) (lot number Er8732) as a single dose for COVID-19 immunization.  Medical history included asthma. The patient had no known allergies. Concomitant medication(s) included salbutamol sulfate (ALBUTEROL) and Breo (unspecified) (other medications in two weeks). The patient had no other vaccine in four weeks. The patient had no Covid prior to vaccination and has not had Covid tested post vaccination. The patient experienced dyspnea - difficulty breathing at rest, felt like a weight was on her chest on 28Mar2021 10:00 AM. Therapeutic measures were taken as a result of the events which included albuterol. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID 2 days later; This is a spontaneous report from a contactable consumer. This 32-year-old female consumer (patient) reported that she received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection) via an unspecified route of administration as a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On an unknown date, two days later after vaccination, the patient tested positive for COVID-19. The Event took place after use of the product. Symptoms were aches, chills, fever, cough, sore throat, fatigue, headache, loss of taste and smell, nausea, congestion. The Outcome of the events were unknown. Follow-up (31Mar2021) This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported in response to the query. Follow-up (01Apr2021) This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported in response to the query.  Information related to batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: tested positive for covid today; tested positive for covid today; This is a spontaneous report received from a male non contactable HCP (patient) reported for him self. A male patient of an unknown age received BNT162B2(BNT162B2 formulation: solution for injection, Batch/lot no: not reported), via an unknown route of administration as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. In January after the complete vaccine series, the patient tested positive for covid-19. The outcome of the events covid-19 and vaccination failure was unknown. The reporter does not wish to be contacted for follow-up.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The contributory role of the suspect BNT162B2(BNT162B2 formulation: solution for injection, Batch/lot no: not reported),  to reported vaccination failure and COVID-19 (tested positive for covid) is possible.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: A fib; This is a spontaneous report from a contactable healthcare professional.  A 76-year-old female patient received BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered on right arm on 26Mar2021 14:30 (Batch/Lot Number: EP6955) at single dose (at the age of 76 years old) for COVID-19 immunisation.  Medical history included have not been in Afib for 4 months prior. Concomitant medication included metoprolol, lisinopril and rivaroxaban (XARELTO), all taken for an unspecified indication, start and stop date were not reported. The patient received BTN162B2, dose 1 for COVID-19 immunisation. 1 hour and 5 minutes after injection (26-MAR-2021 15:35)  of second dose, the patient went into a fib. Have not been in Afib for 4 months prior. The patient received no treatment. The outcome of the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of atrial fibrillation due to temporal relationship.  Case will be re-assessed upon the additional information provided.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Feeling cold, Feeling hot, Nausea, Vaccination site pain
Clinical narrative: arm sore at injection site; head felt warm; face was ice cold; slight nausea; no appetite; This is a spontaneous report based on information received by Pfizer. A contactable consumer reported for herself that an 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced arm sore at injection site, head felt warm, after waking up face was ice cold, slight nausea and no appetite on unspecified dates. The outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Myalgia, SARS-CoV-2 test
Clinical narrative: tested positive for covid after he got the 1st dose last 03/04/2021; tested positive for covid after he got the 1st dose last 03/04/2021; muscle pain; This is a spontaneous report from a contactable male consumer (patient, self-reported).  A male patient of an unknown age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was unknown), via an unspecified route of administration, on 04Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It reported that, the patient tested positive for COVID-19 after he got the 1st dose on 04Mar2021. He also experienced muscle pain. His 2nd dose will be on 26Mar2021. On an unspecified date in Mar2021 the patient underwent SARS-CoV-2 test and result was positive. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: I'm a little off balance; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer(patient) reported that a patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Lot number was not reported, expiration date: Not reported), via an unspecified route of administration on Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient called due to takin the Pfizer-BioNTech COVID-19 Vaccine and stated that they gave the Pfizer vaccine yesterday, patient was little off balance on Mar2021. Patient had seizure medicine changed on Monday or Tuesday and feel like patient was off balance. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Pain
Clinical narrative: felt achy, pain and whole body excruciating pain; lost appetite; tired; This is a spontaneous report based on information received by Pfizer from (Mylan) GI-2021-2801, license party for (BioNTech Covid-19 Vaccine). A contactable consumer (patient herself) reported for 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. The patient experienced felt achy, pain, whole body with excruciating pain, couldn't get out of bed, lost appetite and tired on unknown date. The outcome of events was unknown.  No Follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive after 5 days of receiving their 1st dose of the vaccine last 07MAR2021; tested positive after 5 days of receiving their 1st dose of the vaccine last 07MAR2021; This is spontaneous report from a contactable consumer (Patient) received from a female patient of an unspecified age received BNT162B2 (Pfizer COVID-19 Vaccine, Formulation: solution for injection, Batch/Lot number was not reported) first dose via an unspecified route of administration on 07Mar2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medication were not reported. patient, called and stated that she and her husband, was tested positive after 5 days of receiving their first dose of the vaccine last 07Mar2021. Then they got their monoclonal infusion 3 days after they tested positive, and they are now negative to Covid-19. Patient asked they can proceed with their 2nd dose which will be schedule on 28Mar2021. On 12Mar2021 the patient underwent lab tests and procedures which included sars-cov-2 test: positive, on Mar2021again underwent for lab tests and procedures which included sars-cov-2 test: negative.  Follow up information received on(26Mar2021): No new information was added.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Prostate cancer
Clinical narrative: prostate cancer; This is a spontaneous report from a contactable consumer (patient) reported for himself via Pfizer. A 74-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Mar2021 as single dose for covid-19 immunization. Medical history included liver transplant. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Feb2021 as single dose for covid-19 immunization. The patient had been recently diagnosed with prostate cancer and taking immunosuppressants, he wanted to know that if it affected the vaccine effectiveness. Treatment received for the event including take immunosuppressants. The outcome of the event was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive after 5 days of receiving their 1st dose of the vaccine last 07MAR2021; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported a male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported and expiration date not reported) via an unspecified route of administration on 07Mar2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on 12Mar2021, tested positive after 5 days of receiving their first dose of the vaccine last 07Mar2021 (covid-19). The patient underwent lab tests which included, sars-cov-2 test: positive on 12Mar2021 after 5 days of receiving their 1st dose of the vaccine, unknown date in Mar2021 sars-cov-2 test: negative, they got their monoclonal infusion 3 days after they tested positive. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021353595 same product, AE/ different patient.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: blood clot on the lungs; This is a spontaneous report from a Pfizer sponsored program. Received from a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), 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 already got the 1st dose of the vaccine and have a 2nd dose schedule tomorrow. They wanted to reschedule the 2nd dose because the patient was in the hospital and might have a blood clot on the lungs. Treatment was received. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Thrombocytopenia
Clinical narrative: thrombocytopenia; This is a Literature-spontaneous report. The author reported different events for 4 patients. This is the 2nd of 4 reports.  A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was identified with "thrombocytopenia" at an unspecified time after receiving the Pfizer vaccine without additional details regarding platelet count, clinical course, or treatment. The outcome of the event was unknown.   No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of event thrombocytopenia cannot be excluded.  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. Linked Report same reporter, different patient, same suspect , different event.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: getting covid from the first covid vaccine; getting covid from the first covid vaccine.; This is a spontaneous report from a non-contactable consumer (patient's sister) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer wanted to know if her sister should receive the second dose of the COVID vaccine due to her having side effects and getting COVID from the first COVID vaccine 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.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: yesterday at midnight, he threw up; This is a spontaneous report received from a contactable male consumer (patient) to a Pfizer sponsored program.   A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: UNKNOWN Expiration date: UNKNOWN), via an unspecified route of administration on 24Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date of Mar2021, the patient experienced vomiting. The caller said that he and his wife received the 1st dose yesterday (24Mar2021) at noon, but yesterday at midnight, he threw up. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, at single dose on 13Mar2021 (Lot number: unknown) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported, on 18Mar2021, the patient tested positive for COVID. She completed the 10 days of quarantine. She returned for her COVID test on 29Mar2021, it was positive. She was told that she could keep testing positive for 2-3 weeks even without any symptoms. She was concerned that she will have to restart the whole COVID vaccine series after having tested positive for COVID. The patient would like to know if she can get the 2nd dose of the COVID vaccine after having tested positive for COVID although she no longer had symptoms. Event outcome was unknown.  Information on the lot/batch number has been requested