chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: dizziness; weakness; fatigue; loss of appetite; shortness of breath; This is a spontaneous report from a contactable Nurse. An 80-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL1284, Expiration date was not reported), via intramuscular, administered in left arm on 14Jan2021 15:00 as first dose single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), atrial fibrillation (A-Fib), coronary artery disease (CAD), hypercholesterolemia, GERD, benign prostatic hyperplasia (BPH) and peripheral vascular disorder (PVD). The patient concomitant medication was not reported. Patient did not receive any other vaccine in four weeks. Patient received other medications in two weeks. Patient did not have covid prior vaccination. Patient did not test covid post vaccination. Resident within 15 minutes of vaccination complained of dizziness, he then subsequently had other symptoms of weakness, fatigue, no fever, loss of appetite, shortness of breath on 14Jan2021 03:15 AM. Patient received treatment of prednisone. The patient underwent lab tests and procedures which included nasal swab test: negative on 03Feb2021. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Increased appetite, Musculoskeletal stiffness, Nausea
Clinical narrative: Arm got stiff; Little headache; Little nausea; She ate a lot; This is a spontaneous report received from a contactable consumer. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, and Lot Number: EL3646), via an intramuscularly in left arm on 07Jan2021 (at the age of 66-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that on an unspecified date in Jan2021 her arm got stiff, she had a little nausea and a little headache. She didn't get sick to her stomach, but she ate a lot. The patient had things going on long before the 2 weeks but did not provide any other details. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 3 patients. This is 3rd of 3 reports. A female patient of unspecified age received first dose of BNT162B2 (COMIRNATY, Solution for injection) via unspecified route of administration as single dose for COVID-19 immunization. The patient's medical history and concomitants were not reported. On an unspecified date the patient experienced diarrhoea. The outcome for the events was unknown.  No follow up attempts are possible. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130627 similar report from same reporter
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Mild fever of 100.4; Headache; sore arm; fatigue; headache Aches; This is a spontaneous report from a contactable nurse (Patient himself). This 33-year-old male nurse (Patient) received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via Intramuscular in left arm on 04Jan2021 at 10:00 and second dose via Intramuscular in left arm on 27Jan2021 at 12:30, both as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No prior vaccinations within 4 weeks. The patient was diagnosed with COVID-19 prior to vaccination. The patient tested with COVID-19 post vaccination was unknown. On 27Jan2021 at 17:00, the patient experienced mild fever of 100.4, headache aches, sore arm, fatigue. No treatment was received for the adverse events. The outcome of the events was recovering.  Information on the lot/batch number has been requested.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Mild fever of 100.4; Headache; sore arm; fatigue; headache Aches; This is a spontaneous report from a contactable nurse (Patient himself). This 33-year-old male nurse (Patient) received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via Intramuscular in left arm on 04Jan2021 at 10:00 and second dose via Intramuscular in left arm on 27Jan2021 at 12:30, both as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No prior vaccinations within 4 weeks. The patient was diagnosed with COVID-19 prior to vaccination. The patient tested with COVID-19 post vaccination was unknown. On 27Jan2021 at 17:00, the patient experienced mild fever of 100.4, headache aches, sore arm, fatigue. No treatment was received for the adverse events. The outcome of the events was recovering.  Information on the lot/batch number has been requested.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dyspnoea, Pyrexia, Vomiting
Clinical narrative: Fever; Chills; breathing poorly; vomiting every 30 min for hours and can't hold any food or liquid down; She can't eat or hold anything down.; This is a spontaneous report from a contactable consumer (mother). A 24-year-old female patient received first dose of BNT162B2 (COVID Vaccine, solution for injection, Batch/lot number: EL3246, NDC number and expiry date: Unknown) via an unspecified route of administration on 05Jan2021 (in the beginning of Jan2021) in left upper arm as single dose for COVID-19 immunization. Patient was allergic to penicillin when she was little. Patient's medical history (including any illness at time of vaccination) and relevant family medical history was none. There was no administration of other products. No previous immunization with the Pfizer vaccine was done. Patient did not receive any prior vaccinations (within 4 weeks). None of the vaccines were administered on same date of Pfizer suspect. No relevant tests were done. Caller explained that with the first vaccine, patient had a reaction, but it was not as bad as this one. She had a fever, was breathing poorly, vomiting every 30 min for hours and could not hold any food or liquid down, so she was just vomiting bile. She had chills and fever, but the breathing had been a big issue ever since the first vaccine. Events did not require a visit to Emergency Room or Physician Office. Outcome of the events chills, fever, was breathing poorly, vomiting every 30 min for hours and could not hold any food or liquid down was not recovered. Investigation Assessment: No.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer.This consumer reported similar events for 3 patients. This is 3rd of 3 reports.A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were unknown. It was reported that patient's family members too also had a little diarrhea. On an unknown date, the patient experienced diarrhea.The outcome of the event was unknown.  Information on Lot/batch number was requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021124300 similar report from same reporter
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Bradyphrenia, Nausea, Vomiting
Clinical narrative: nauseous; threw up; Just feeling sluggish now; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration, administered in right arm on 05Feb2021 13:30 as first dose single for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Patient did not receive any other vaccine in four weeks and any other medications in two weeks. Prior to the vaccination the patient did not have COVID. Patient did not test COVID post vaccination. It was reported that three days after getting the Pfizer vaccine, patient got very nauseous and threw up and just feeling sluggish now on 08Feb2021 04:00 PM. Patient did not receive treatment for the events. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Headache, Pain in extremity
Clinical narrative: she had is a rash from the bottom of her chin through the torso, under her breasts; she had a sore arm for a day after the first injection; a slight headache; This is a spontaneous report from a contactable consumer (patient) reporting about herself.   A 63-year-old female patient (63 rears age at vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EH9899, Expiration date not reported), intramuscularly, in left arm on 30Dec2020 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. A week later after vaccination, on 07Jan2021, the patient experienced allergic rash. When it first came it was just the chin to the breast, it lasted about 4 days then completely stopped and a slight headache. The patient went into the urgent care at the time of report to get an antihistamine for relief because she tried over the counter products and they are not working. Treatment medications for rash included over-the-counter product Cetaphil cleanser (Lot: 316776), Dove peak moisture bath wash (Lot: 08280JU41), Witch hazel astringent (Lot: 53849), Benadryl cream (lot: 2910LV/1, Expiration: Sep2022) and tablets (Lot: SMF075, Expiration: Jul2022), Triderma eczema fast healing face and body cream (Lot: 05440289, Expiration: Oct2023) and calamine lotion (Lot: 541128, Expiration: Nov2017).The outcome of all the events was reported as recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Nausea
Clinical narrative: Nausea; Shortness of breath; Coughing; This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A female patient of an unspecified age received 1st dose of bnt162b2 (Pfizer-BioNTech covid-19 vaccine, Solution for injection Batch/Lot number was not reported), via an unspecified route of administration on 15Jan2021 at 12:30PM as 1st dose single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 15Jan2021 at 2 PM patient experienced feeling shortness of breath and coughing and by 16Jan2021 she had severe nausea and having lots of issue. She missed the next week of work. She was still having some shortness of breath and is being followed by her primary care physician. Patient had other diagnosis that her providers felt was important for her to receive the vaccine even though they did have concerns about how she might react. Information on the Batch/Lot number has been requested. The outcome of the events shortness of breath was not recovered and outcome of coughing and severe nausea was unknown.  Follow-up attempts completed. No further information expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Feeling cold
Clinical narrative: A high grade fever/fever; Chills; Inability to get warm; I had pain down my injection arm into my fingers, up my neck and into my jaw; I had pain down my injection arm into my fingers, up my neck and into my jaw; I had pain down my injection arm into my fingers, up my neck and into my jaw; Myalgia and Arthralgia total body; Myalgia and Arthralgia total body; Pounding headache/Headache off and on/headaches; Sweat through 3 outfits/sweat through my clothes; Issues with temperature regulation; Fatigue; This is a spontaneous report from a contactable other hcp (patient). A 31-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 31Jan2021 14:50 (Batch/Lot Number: EL3249) as single dose for COVID-19 immunisation. Medical history included allergy to allegra (medication) and many foods (fresh fruit, wheat, rye, oats, barley, soy, almonds). The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 12Jan2021 (lot number Ek9231) in the right arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received the vaccine at 2:50pm. By ~midnight (01Feb2021, 12.00am) she developed a high grade fever (unable to take, but she would guess between 101-103 based on symptoms). She had fever and chills, with inability to get warm for hours. She had pain down her injection arm into her fingers, up her neck and into her jaw that lasted for at least an hour. Myalgia and Arthralgia total body the first night. The next day she continued to have a fever but decided to take IB profen (Ibuprofen) due to a pounding headache. Within 1 hour the headache subsided and her fever improved. That night her fever spiked again to 101 (able to check this time). No chills, but she sweat through 3 outfits. Headache off and on. Next day she continued to sweat through her clothes and her fever maintained at 99.0. All of her symptoms lasted for 3 full days and on the 4th day she still was experiencing issues with temperature regulation, headaches and fatigue. She took tylenol and IB profen about 24 hours after the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events chills, inability to get warm, Myalgia and Arthralgia total body and pain down her injection arm into her fingers, up her neck and into her jaw was recovered on 01Feb2021 and other events was recovered in Feb2021.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Myalgia, Neck pain, Pain in extremity
Clinical narrative: A high grade fever/fever; Chills; Inability to get warm; I had pain down my injection arm into my fingers, up my neck and into my jaw; I had pain down my injection arm into my fingers, up my neck and into my jaw; I had pain down my injection arm into my fingers, up my neck and into my jaw; Myalgia and Arthralgia total body; Myalgia and Arthralgia total body; Pounding headache/Headache off and on/headaches; Sweat through 3 outfits/sweat through my clothes; Issues with temperature regulation; Fatigue; This is a spontaneous report from a contactable other hcp (patient). A 31-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 31Jan2021 14:50 (Batch/Lot Number: EL3249) as single dose for COVID-19 immunisation. Medical history included allergy to allegra (medication) and many foods (fresh fruit, wheat, rye, oats, barley, soy, almonds). The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 12Jan2021 (lot number Ek9231) in the right arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received the vaccine at 2:50pm. By ~midnight (01Feb2021, 12.00am) she developed a high grade fever (unable to take, but she would guess between 101-103 based on symptoms). She had fever and chills, with inability to get warm for hours. She had pain down her injection arm into her fingers, up her neck and into her jaw that lasted for at least an hour. Myalgia and Arthralgia total body the first night. The next day she continued to have a fever but decided to take IB profen (Ibuprofen) due to a pounding headache. Within 1 hour the headache subsided and her fever improved. That night her fever spiked again to 101 (able to check this time). No chills, but she sweat through 3 outfits. Headache off and on. Next day she continued to sweat through her clothes and her fever maintained at 99.0. All of her symptoms lasted for 3 full days and on the 4th day she still was experiencing issues with temperature regulation, headaches and fatigue. She took tylenol and IB profen about 24 hours after the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events chills, inability to get warm, Myalgia and Arthralgia total body and pain down her injection arm into her fingers, up her neck and into her jaw was recovered on 01Feb2021 and other events was recovered in Feb2021.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Pyrexia, Temperature regulation disorder
Clinical narrative: A high grade fever/fever; Chills; Inability to get warm; I had pain down my injection arm into my fingers, up my neck and into my jaw; I had pain down my injection arm into my fingers, up my neck and into my jaw; I had pain down my injection arm into my fingers, up my neck and into my jaw; Myalgia and Arthralgia total body; Myalgia and Arthralgia total body; Pounding headache/Headache off and on/headaches; Sweat through 3 outfits/sweat through my clothes; Issues with temperature regulation; Fatigue; This is a spontaneous report from a contactable other hcp (patient). A 31-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 31Jan2021 14:50 (Batch/Lot Number: EL3249) as single dose for COVID-19 immunisation. Medical history included allergy to allegra (medication) and many foods (fresh fruit, wheat, rye, oats, barley, soy, almonds). The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 12Jan2021 (lot number Ek9231) in the right arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received the vaccine at 2:50pm. By ~midnight (01Feb2021, 12.00am) she developed a high grade fever (unable to take, but she would guess between 101-103 based on symptoms). She had fever and chills, with inability to get warm for hours. She had pain down her injection arm into her fingers, up her neck and into her jaw that lasted for at least an hour. Myalgia and Arthralgia total body the first night. The next day she continued to have a fever but decided to take IB profen (Ibuprofen) due to a pounding headache. Within 1 hour the headache subsided and her fever improved. That night her fever spiked again to 101 (able to check this time). No chills, but she sweat through 3 outfits. Headache off and on. Next day she continued to sweat through her clothes and her fever maintained at 99.0. All of her symptoms lasted for 3 full days and on the 4th day she still was experiencing issues with temperature regulation, headaches and fatigue. She took tylenol and IB profen about 24 hours after the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events chills, inability to get warm, Myalgia and Arthralgia total body and pain down her injection arm into her fingers, up her neck and into her jaw was recovered on 01Feb2021 and other events was recovered in Feb2021.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Dyspnoea, Mitral valve disease
Clinical narrative: Mitral valve disease; Breathing difficult; This is a solicited report based on the information received by Pfizer from AbbVie (Manufacturer Control No: 21K-163-3759679-00). A contactable 77-year-old male consumer received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: not reported: Expiration date: not reported) dose 1 via unspecified route of administration on unspecified date as 1st dose, single for COVID-19 immunisation. The patient received Imbruvica (Ibrutinib) tablet 280mg, once in a day, orally for CLL (Chronic lymphocytic leukaemia). The patient's medical history includes Melanoma. Patient's concomitant medication includes Amlodipine Besylate 10mg for unknown indication, Aspirin (adult low dose) 81mg for unknown indication, Atenolol 100mg for unknown indication, Eliquis (Apixaban) 5mg for unknown indication, Hydrochlorothiazide 12.5mg for unknown indication, Imfinzi (Durvalumab) for unknown indication, Lasix (Furosemide) for unknown indication, Opdivo (Nivolumab) for unknown indication, Pravastatin Sodium for unknown indication on unspecified dates. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On Nov2020 patient experienced breathing difficult and mitral valve disease on unspecified date. The patient had no known allergies. Causality for Imbruvica(Ibrutinib): The reporter's causality for the event(s) of Trouble Breathing with Imbruvica(Ibrutinib) was no reasonable possibility. The reporter's causality for the event(s) of Possible Mitral Valve Issue was not provided.The outcome of all the events was unknown.  Follow-up (07May2021): Follow-up attempts completed. No further information expected. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on the information available ,Vaccine BNT162B2 or comirnarity was unrelated to the events dyspnea and mitral valve disease.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.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Not having her normal monthly menstrual period; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 02Jan2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, after the first dose of vaccination, the patient was not having her normal monthly menstrual period. The outcome of the event was unknown. The patient had received the second dose of vaccination on 27Jan2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache
Clinical narrative: headache; discomfort around her chest area; This is a spontaneous report from a non-contactable consumer (patient) A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), on 16Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced headache and discomfort around her chest area on an unspecified date in 2021.Events were non serious.Final outcome of the events was unknown.  Patient wanted to know if she can take Aspirin to treat her headache and the discomfort around her chest area. No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Swelling, Vaccination site swelling
Clinical narrative: chills; mild swelling at injection site; moderate headache; back aches; swelling under left arm pit; This is a spontaneous report from a non-contactable consumer (patient).  A 26-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), via an unspecified route of administration, in left arm on 16Feb2021 at 14:45 at single dose for covid-19 immunisation. Medical history included frequent premature ventricular contraction (PVC's,heart). No Covid prior vaccination. Patient was not Covid tested post vaccination. No known allergies. Concomitant medication included diltiazem taken for an unspecified indication, start and stop date were not reported. On 17Feb2021 at 08:30 the patient experienced chills, mild swelling at injection site, moderate headache, back aches and swelling under left arm pit. The final outcome of all the events was recovering. No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Arm pain; aches; tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 49-year old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 17Feb2021 12:30 (Lot Number: EL3247) as single dose (at age of 49-year-old) for covid-19 immunisation. Medical history included asthma. Patient received first dose of bnt162b2 (BNT162B2) on 26Jan2021 at 12:00 PM in Left arm (at age of 49-year-old) for covid-19 immunisation, lot number: EL3247. Concomitant medications in two weeks included ubidecarenone (COQ10), ergocalciferol (VIT D), glucosamine (GLUCOSAMINE). Patient did not receive any other vaccine in four weeks. On 18Feb2021 patient experienced arm pain, aches, tiredness. Patient was able to perform work but at a reduced pace. No treatment was received for the events. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Patient had not recovered from the events, at the time of the report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: small amount of soreness at the injection site; This is a spontaneous report from a contactable consumer(patient)  A 82-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), on 17Feb2021 at single dose for covid-19 immunisation .  The patient medical history was not reported. Concomitant medication included acetylsalicylic acid (ASPIRIN) taken for unspecified medical conditions, start and stop date were not reported.  The patient experienced small amount of soreness at the injection site on an unspecified date in 2021 with outcome of unknown.  Patient asked if it's okay to continue to take her Aspirin. No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Defaecation urgency, Dizziness, Headache, Malaise
Clinical narrative: headache; stomach was bothering; had to run to the bathroom several times; feeling horrible; body aches; nausea; Dizzy; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 15Feb2021 (Batch/Lot Number: EN9581) as 2nd dose, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took the first dose of   BNT162b2 on an unspecified date and he had no effects. The patient reported that he woke up on 16Feb2021 feeling horrible, with body aches and nausea. On 17Feb2021 he felt a little better, but on 18Feb2021 he woke up with a headache and had to run to the bathroom several times, his stomach was bothering him on 18Feb2021. On an unspecified date in Feb2021. The patient stated that he felt like his whole body was aching and he had bad headache. He was feeling better than the day before reporting because he was still not feeling like an 100%. He got a bad headache, he felt little bit dizzy and he ran to the bathroom several times which was he did not know his stomach was bothering. The event pain, feeling horrible and nausea were resolving, the outcome of the other events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: headache; stomach was bothering; had to run to the bathroom several times; feeling horrible; body aches; nausea; Dizzy; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 15Feb2021 (Batch/Lot Number: EN9581) as 2nd dose, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took the first dose of   BNT162b2 on an unspecified date and he had no effects. The patient reported that he woke up on 16Feb2021 feeling horrible, with body aches and nausea. On 17Feb2021 he felt a little better, but on 18Feb2021 he woke up with a headache and had to run to the bathroom several times, his stomach was bothering him on 18Feb2021. On an unspecified date in Feb2021. The patient stated that he felt like his whole body was aching and he had bad headache. He was feeling better than the day before reporting because he was still not feeling like an 100%. He got a bad headache, he felt little bit dizzy and he ran to the bathroom several times which was he did not know his stomach was bothering. The event pain, feeling horrible and nausea were resolving, the outcome of the other events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: scheduled to get an allergy shot 12 days after first dose of COVID vaccine; This is a spontaneous report from a contactable consumer (patient)  A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection,) on 10Feb2021  at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. Patient Since 22Feb2021 patient was getting allergy shots 12 days after his first dose of vaccine; Second dose of vaccine was scheduled until 03Mar2021. Patient was asking if she have to wait 7 days in between or 14 days (as reported). At the time of the reporting.The patient was treated due to the event. At the time of the reporting event outcome was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Back disorder, Condition aggravated, Jaw disorder, Musculoskeletal discomfort
Clinical narrative: an exacerbation of an underlying back issue; an exacerbation of an underlying back issue; felt it in his opposite shoulder; felt it in his opposite shoulder and jaw.; This is a spontaneous report from a contactable consumer reporting for himself  A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 15Feb2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included an unspecified back issue. Concomitant medications were not reported. On an unspecified date after vaccination patient reported an exacerbation of an underlying back issue. He also felt it in his opposite shoulder and jaw. At the time of the reporting events outcome was unknown.    Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report from a non-contactable nurse. A 78-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), intramuscular on an unspecified date (at the age of 78-years-old) as 1st dose, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced rash, developed the next day after receiving her first Pfizer vaccine, occurring across her midsection of abdomen. It lasted for 2 weeks. No other problems with the vaccination. Reports that her physician recommended that she continue with second dose as scheduled. The outcome of event was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in arm; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 17Feb2021 as unknown, single for COVID-19 immunisation. The patient reported that he only had soreness in his arm that was vaccinated. He stated that his arm was a little sore. Patient asked if he could shovel snow after getting vaccinated. He said the only problem he was having was his arm was a little sore not hugely sore and there was no other symptom. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Heart rate increased, Hypertension
Clinical narrative: Experienced severe pressure and pain all around her heart, severe rapid heart beat, felt like she was going to have a heart attack; High blood pressure for almost 3 weeks; Severe rapid heart beat; This is a spontaneous report from a contactable consumer reporting for herself  A 61 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On an unspecified date the patient experienced severe pressure and pain all around her heart, severe rapid heart beat, and high blood pressure for almost 3 weeks. She felt like she was going to have a heart attack. She is now on prednisone.  AT the time of the reporting event outcome was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Therapeutic response unexpected
Clinical narrative: After the first injection I had excruciating Left Arm pain at the injection site that started about 8 hours after the vaccination and lasted about 20 hours.I have psoriasis and I have had it for abou; psoriasis appeared to be getting better; This is a spontaneous report from a contactable other HCP (patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE formulation: Solution for injection, lot number: EL1283, Expiration date; unknown), via intramuscular in Left Arm on 19-JAN-2021 14:15 at single dose for COVID-19 immunization. Patient medical history included hypertension, lymphocytic colitis, psoriasis. Concomitant medication included LISINOPRIL (lisinopril), LASIX (furosemide), AMLODIPINE (amlodipine), LIPITOR (atorvastatin), METOPROLOL SUCCINATE (metoprolol succinate). The patient experienced after first dose she had excruciating Left Arm pain at the injection site that started about 8 hours after the vaccination and lasted about 20 hours. She had psoriasis and she had it for about 45 years. After the first injection, psoriasis appeared to be getting better. The outcome of event was not recovered. A contactable Physician stated that she/ he was no informed bythe patient regarding the reported adverse event with the use of the product.  Follow-up (19Apr2021 and 10May2021): New information from a contactable Physician included statement about communication by the patient regarding the reported adverse event with the use of the product. Follow-up attempts are completed. No further information is expected
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: missed menstrual cycle after 2nd dose. has been 38 days since last cycle. not pregnant; This is a spontaneous report from a contactable other healthcare professional (hcp; patient herself). A 26-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, administered in left arm on 05Feb2021 as second dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of the event and vaccination. Patient received the first dose of bnt162b2 for covid-19 immunization on 15Jan2021 at 03:45 PM (at the age of 26 years old), intramuscular in the left arm. The patient previously took, azithromycin and had known allergies.  The patient had no Covid prior vaccination The patient had no other vaccine in four weeks. In Feb2021, patient had missed menstrual cycle after 2nd dose and has been 38 days since last cycle. Patient was not pregnant. Patient was not tested for Covid post vaccination. Patient did not receive any treatments for the event reported. The outcome of the event was not recovered.   Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Investigation, Pulmonary pain, SARS-CoV-2 test, Wheezing
Clinical narrative: Horrible pain in lungs; Gasping for air; Wheezing; This is a spontaneous report from a contactable consumer (patient, self-reported). This 47-year-old non-pregnant female patient bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in left arm on 01Feb2021 at 09:30, single for COVID-19 immunization at hospital. The patient medical history included that she was allergic to pollen and dust. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have other medications in two weeks. On 01Feb2021 at 21:00 in the evening, the patient had a horrible pain in her lungs and was gasping for air and she could not stop gasping and wheezing so she went to the Emergency room. The patient treated with inhaler. The patient underwent lab tests and procedures which included blood test and unknown results and had COVID-19 SARS-coV-2 test (nasal swab) was negative on 10Feb2021. Outcome of the events were recovered on an unknown date in Feb2021.  Information about lot/ batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Myalgia
Clinical narrative: This is a spontaneous report from a contactable other hcp (patient herself).  A 52-year-old female patient received the first dose of BNT162B2, (COMIRNATY, solution for injection, Batch/lot number: EL-3247, Expiry Date: unknown) on 22Feb2021 14:45, via an unspecified route of administration, in left arm as UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history included atrial fibrillation. The patient's concomitant medications included famotidine; ibuprofen (ADVIL [IBUPROFEN]); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient experienced mild fatigue on 22Feb2021 18:00, left arm and injection site soreness on 22Feb2021 18:00, mild muscle soreness 6-18 hrs after administration. The symptoms were gone at 24 hrs. The outcome of the events was recovered after 24 hours, on 23Feb2021. No follow-up attempts possible, no further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysstasia, Headache, Insomnia, Intermenstrual bleeding
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3247; Expiration date was not reported) via an unspecified route of administration, administered in the left arm on 10Feb2021 11:30 (at the age of 31-years-old) as second dose, single for COVID-19 immunization at a workplace clinic. The patient's medical history was not reported. Concomitant medication included norethindrone taken for an unspecified indication, start and stop date were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3247) via an unspecified route of administration, administered in the left arm on 19Jan2021 11:30 for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. No other vaccine was given in four weeks. The patient was not Covid positive prior vaccination and was not tested for Covid post vaccination. On 10Feb2021, on the night of receiving the second dose, the patient experienced chills and could not sleep for the entire night. On 11Feb2021, the next day, the patient experienced bad headache which made it difficult to stand up, her entire left arm (the arm where she got the shot) was swollen. On 14Feb2021, on the third day after her shot, the patient had irregular menstrual spotting, which was one week before her period. It was reported that she has a regular and consistent cycle but this menstrual spotting is unusual for her cycle. No treatment was given for the events. The outcome of event entire left arm (the arm where she got the shot) was swollen was recovered on 14Feb2021 (reported as for approximately three days); the outcome of the other events was recovered on an unspecified date in Feb2021. No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3247; Expiration date was not reported) via an unspecified route of administration, administered in the left arm on 10Feb2021 11:30 (at the age of 31-years-old) as second dose, single for COVID-19 immunization at a workplace clinic. The patient's medical history was not reported. Concomitant medication included norethindrone taken for an unspecified indication, start and stop date were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3247) via an unspecified route of administration, administered in the left arm on 19Jan2021 11:30 for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. No other vaccine was given in four weeks. The patient was not Covid positive prior vaccination and was not tested for Covid post vaccination. On 10Feb2021, on the night of receiving the second dose, the patient experienced chills and could not sleep for the entire night. On 11Feb2021, the next day, the patient experienced bad headache which made it difficult to stand up, her entire left arm (the arm where she got the shot) was swollen. On 14Feb2021, on the third day after her shot, the patient had irregular menstrual spotting, which was one week before her period. It was reported that she has a regular and consistent cycle but this menstrual spotting is unusual for her cycle. No treatment was given for the events. The outcome of event entire left arm (the arm where she got the shot) was swollen was recovered on 14Feb2021 (reported as for approximately three days); the outcome of the other events was recovered on an unspecified date in Feb2021. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Exposure to SARS-CoV-2, Visual impairment
Clinical narrative: Diarrhea; My eyesight is degraded; She was exposed to a covid patient; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EN6201; Expiry date: unknown), via an unspecified route of administration as a single dose on 17Feb2021 for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient mentioned she was exposed to a covid patient on 20Feb2021 but she believed it was on 20Feb or the 21st. On an unknown date, the patient developed diarrhea and the patient could barely read the LOT number as she was 79 years old as her eyesight was degraded. The events assessed as non-serious. Patient had concern if we had specific information on this and if it will still be safe for her to get her second shot of the vaccine. she was exposed to Covid. She stated she was not tested and was exposed, somebody came into her house with COVID. Patient had concern regarding how will this impact the fact that she will receive the second shot in other two weeks from now and I just received the shot like a few days before I was exposed shortly in the time after receiving the vaccine. She was exposed to Covid from her son possibly 3 or 4 days after getting vaccinated. The clinical outcome of the events was unknown.  Follow-up: (24Feb2021): This is a spontaneous report from a contactable consumer. This is a female consumer reported for herself that: The reporter was not a health care professional. It was unknown if the reporter's contact information available to you or a sub-contracted party. . Consumer further stated, "she doesnt believe there was a problem with the vaccine, and that was not her concern. There was no concern with the LOT# of the vaccine, the concern was special circumstances because she was exposed shortly in the time after receiving the vaccine."  No follow-up attempts are possible, information about lot/batch no. cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Amenorrhoea, Body temperature, Body temperature increased, Chills
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional via a Pfizer sales representative.  A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (batch/lot number: EL9262) as 2nd dose, single for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS). The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 on an unspecified date as 1st dose, single for COVID-19 immunization. On an unspecified date, the patient experienced soft tissue swelling and erythema at injection site, elevated temperature, chills, headache, body aches, fatigue, mild abdominal cramping twice, bleeding/spotting in vaginal area, has not had a period in over 22 months. The patient underwent lab tests and procedures which included body temperature: elevated on an unspecified date, weight: 150 (unit unspecified) on an unspecified date. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.