chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Fatigue, Headache
Clinical narrative: lose smell and taste; lose smell and taste; Positive Rapid Covid Test; progressively fatigue; he had a headache; at night he had chills; fever with more fatigue; fever with more fatigue; This is a spontaneous report from a contactable other HCP (patient). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), (Lot number: EL3248, expiry date: 31Mar2021), via unspecified route of administration in left deltoid on 08Jan2021 as single dose for COVID-19 immunization. Patients medical history was not reported. Patient concomitant medications are Multivitamins, Zinc, colecalciferol (VITAMIN D), fexofenadine hydrochloride (ALLEGRA), Aspirin, and famotidine (PEPCID) from unspecified date and unknown still ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 20Jan2021, Patient underwent Rapid Covid Test (nasal swab test), tested positive for SARS-CoV-2 test positive. On 26Jan2021, Caller clarified that b he did not have any further symptoms at all, no fever, everything had resolved. Caller clarified that the reason he got tested was because he was having symptoms, on the 19Jan2021 Tuesday he became progressively fatigue at lunch he had a headache, and probably by 7-8pm at night he had chills and fever with more fatigue. He had No chest pain, No shortness of breath, and No wheezing. The symptoms improved, the headache improved Friday, he had mild lingering fatigue and low-grade temperature for next day or so, but it was Tuesday at which he had no symptoms at all. He did lose smell and taste for 24 hours, it was on Friday 22Jan2021, 100% percent couldn't even smell Vicks Menthol. His Second Dose is schedule for 29Jan2021. He enquired about contraindication to getting the second dose of the vaccine. The Outcome of events was recovering for pyrexia ,headache, fatigue The outcome of chills, loss of smell and taste was unknown. Follow-up (28Jan2021): This is a follow-up spontaneous report from a contactable other HCP (patient). New information includes clinical information.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: lose smell and taste; lose smell and taste; Positive Rapid Covid Test; progressively fatigue; he had a headache; at night he had chills; fever with more fatigue; fever with more fatigue; This is a spontaneous report from a contactable other HCP (patient). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), (Lot number: EL3248, expiry date: 31Mar2021), via unspecified route of administration in left deltoid on 08Jan2021 as single dose for COVID-19 immunization. Patients medical history was not reported. Patient concomitant medications are Multivitamins, Zinc, colecalciferol (VITAMIN D), fexofenadine hydrochloride (ALLEGRA), Aspirin, and famotidine (PEPCID) from unspecified date and unknown still ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 20Jan2021, Patient underwent Rapid Covid Test (nasal swab test), tested positive for SARS-CoV-2 test positive. On 26Jan2021, Caller clarified that b he did not have any further symptoms at all, no fever, everything had resolved. Caller clarified that the reason he got tested was because he was having symptoms, on the 19Jan2021 Tuesday he became progressively fatigue at lunch he had a headache, and probably by 7-8pm at night he had chills and fever with more fatigue. He had No chest pain, No shortness of breath, and No wheezing. The symptoms improved, the headache improved Friday, he had mild lingering fatigue and low-grade temperature for next day or so, but it was Tuesday at which he had no symptoms at all. He did lose smell and taste for 24 hours, it was on Friday 22Jan2021, 100% percent couldn't even smell Vicks Menthol. His Second Dose is schedule for 29Jan2021. He enquired about contraindication to getting the second dose of the vaccine. The Outcome of events was recovering for pyrexia ,headache, fatigue The outcome of chills, loss of smell and taste was unknown. Follow-up (28Jan2021): This is a follow-up spontaneous report from a contactable other HCP (patient). New information includes clinical information.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Lymphadenopathy, Musculoskeletal chest pain
Clinical narrative: nausea; sweating; body aches; swollen axillary lymph nodes; headache; fingers and ribs hurt; fingers and ribs hurt; chills; potential reaction with facial serum resulting in facial swelling; This is a spontaneous report from a contactable other healthcare professional(patient). A 33-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Formulation: Solution for injection, Lot number: EL0142 and Expiration date: 12Jan2021), via intramuscular route of administration in right arm, on 12Jan2021 at 10:00, as a single dose for COVID-19 immunisation.  The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Formulation: Solution for injection, Lot number: EH9899 and Expiration date was not reported), via intramuscular route of administration in left arm, on 22Dec2020 at 13:45, as a single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, was not the patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient had no allergies to medications, food, or other products. The patient medical history and concomitant medications were not reported. On 13Jan2021 at 12:00, the patient experienced nausea, sweating, body aches, swollen axillary lymph nodes, headaches, fingers and ribs hurt, chills, sweating that lasted day, potential reaction with facial serum resulting in facial swelling. The adverse event resulted in in Doctor or other healthcare professional office/clinic visit. The treatment was received for events, steroid cream for face. The outcome of the events was reported as recovered on unspecified date.  Follow-up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Swelling face
Clinical narrative: nausea; sweating; body aches; swollen axillary lymph nodes; headache; fingers and ribs hurt; fingers and ribs hurt; chills; potential reaction with facial serum resulting in facial swelling; This is a spontaneous report from a contactable other healthcare professional(patient). A 33-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Formulation: Solution for injection, Lot number: EL0142 and Expiration date: 12Jan2021), via intramuscular route of administration in right arm, on 12Jan2021 at 10:00, as a single dose for COVID-19 immunisation.  The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Formulation: Solution for injection, Lot number: EH9899 and Expiration date was not reported), via intramuscular route of administration in left arm, on 22Dec2020 at 13:45, as a single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, was not the patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient had no allergies to medications, food, or other products. The patient medical history and concomitant medications were not reported. On 13Jan2021 at 12:00, the patient experienced nausea, sweating, body aches, swollen axillary lymph nodes, headaches, fingers and ribs hurt, chills, sweating that lasted day, potential reaction with facial serum resulting in facial swelling. The adverse event resulted in in Doctor or other healthcare professional office/clinic visit. The treatment was received for events, steroid cream for face. The outcome of the events was reported as recovered on unspecified date.  Follow-up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Pain
Clinical narrative: chills; weakness; fatigue; body aches; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3248), via an unspecified route of administration, administered in left arm on 26Jan2021 at 14:30 as single dose for COVID-19 immunisation. The medical history included that the patient previously took penicillin and experienced allergy. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL1284), via an unspecified route of administration, administered in left arm on 04Jan2021 at 14:30 as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other concomitant medication within 2 weeks of vaccination. On 27Jan2021 the patient experienced chills, weakness, fatigue, body aches. The patient did not receive treatment for events. The outcome of event was recovering.  Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: tiredness; muscle ache; chills; This is a spontaneous report from a contactable physician (patient, reported for herself). A 30-years-old female patient (who was not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EK5730, Expiration date: unknown), dose 1 via an unspecified route of administration, in Arm Left on 21Dec2020 15:00 (at the age of 30-years-old) as single for covid-19 immunisation. Patient also received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3246, Expiration date: unknown) via an unspecified route of administration, in Arm Left on 11Jan2021 15:00 ((at the age of 30-years-old) as single for covid-19 immunisation. The patient medical history included asthma. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient has been tested for COVID-19, Since the vaccination. It was reported that after first shot of vaccination on an unknown date the patient had experienced tiredness, muscle ache and chills for about 20 hours. The patient took second shot on 11Jan2021, no adverse reactions were experienced. However, the patient had concerns in regards if Pfizer Covid vaccines were effective on her. She had an antibody testing on 27Jan2021 with SARS-CoV-2 Abbotts antibody kit and Vitalix nasal swab test with a reported IgG antibody test that has 99.63% specificity and 100% sensitivity that was completely negative at 16 days following the second dose of Pfizer COVID-19 vaccine, and she had the first dose exactly three weeks prior. She had read information from Pfizer indicating that its vaccine exhibits a robust induction of antibody response. Hence, she wanted to get advice from Pfizer on how to proceed with her concern as a health care provider who is constantly exposed to the virus and was wondering if re-vaccination would be advised. There was no treatment provided as a result of events. The patient underwent lab tests and procedures which included SARS-CoV-2 Abbotts antibody kit and Vitalix nasal swab test on 27Jan2021. The outcome of the events was unknown. The events were considered as non-serious by the reporter.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Dyspnoea, Investigation, SARS-CoV-2 test
Clinical narrative: Aching on left side of her chest/ achy on the left side of her chest; Shortness of breath where it was hard to get a deep breath; This is a spontaneous report from a contactable consumer or other non hcp (the patient reported for herself).     A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/ lot number: EL9261. Expiry date: UNKNOWN) via an unspecified route of administration, in the region of left arm on 21Jan2021 at 12:20 (At the age of 66-years-old) as 0.3 mL, single for COVID-19 immunisation (reported as virus protection). Medical history was not reported. History of all previous immunization with the Pfizer vaccine considered as suspect and any additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. No Prior vaccination within 4 weeks of the vaccination.  On 23JAN2021, the patient experienced aching on left side of her chest, shortness of breath where it was hard to get a deep breath. Patient was advised by her doctor to call and report the side effects that she has experienced since receiving the first dose of the Covid-19 vaccine. Patient went to the emergency room on 27Jan2021 due to the events, Aching on left side, shortness of breath. They were unable to find anything wrong with her heart. She did not have any blood clots. She also had an X-ray of her lungs. Because of these symptoms she had a COVID test on 23Jan2021 at the urgent care. The test was negative. She may have been exposed to COVID on 01Jan2021. Her next dose is 11Feb2021. She wants to get the second dose. Her doctor said she needs to speak with Pfizer for recommendations about the next dose. Both the events were reported as ongoing. The outcome of the events was reported as not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: He has a bad hip and needs to take Tylenol before he rides the bike; This is a spontaneous report received from a contactable consumer (Patient) via a Pfizer-sponsored program. CEP ID: 002191  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date after vaccination, the patient had a bad hip and needs to take Tylenol before he rides the bike. Patient likes to ride his stationary bike. Patient read online that before getting the COVID-19 vaccine that patients were not supposed to take Tylenol or ibuprofen and wanted to know if he was okay to take the Tylenol now to ride his back or does he need to wait until the shots are over. Patient has not taken Tylenol and would not like to do a safety report. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness near injection site on second day; This is a spontaneous report from a contactable consumer (patient). A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 19Jan2021 at 15:45 (at the age of 25-years-old) as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient's had no medical history were reported. The patient's concomitant medications were reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination.The patient did not receive any other medications within two weeks prior to the vaccination.On 20Jan2021 at 12:00, the patient experienced soreness near injection site on second day. The patient did not received any treatment for the events. The outcome of the events was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Body temperature, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever of 100; 21Jan2021 6:00am woke up with bad body aches; This is a spontaneous report from a contactable Other HCP (patient). This 39-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number paa156051) intramuscularly on left arm on 20Jan2021 at 12:00 (at the age of 39 years) as single dose for COVID-19 immunisation. The patient had medical history asthma, depression, high cholesterol, tested positive for COVID-19 on 05Oct2020 and patient's known allergies included cephalexin, robaxin, naproxen, latex. The patient concomitant medications included cetirizine hydrochloride (ZYRTEC), venlafaxine hydrochloride (EFFEXOR), pravastatin, omeprazole taken 2 weeks prior of vaccination. Patient had no other vaccine prior to 4 weeks of vaccination. The patient had COVID prior to vaccination. On 21Jan2021 at 6:00, the patient woke up with bad body aches, which went away around 12:00. Then returned around 15:00 on/off for the day. On 22Jan2021, the patient woke up at 09:00 and felt good. At about 12:30 patient started having body aches and fever of 100, lasted all evening. Went to bed and woke up with no other symptoms on 23Jan2021. The patient received no treatment for events. The patient tested for COVID post vaccination. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Body temperature increased, Chills, Dizziness
Clinical narrative: low-grade fever; headache; body ache; dizzy; weak; queasy; chills; shaky; fatigue/tired another 24 hours/Third day still tired.; mild brain fog; higher fever 101.5+/couldn't get fever below 100.; This is a spontaneous report from a contactable other health care professional. A 48-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247) via an unspecified route of administration in right arm on 25Jan2021 11:30 as second dose, single for COVID-19 immunization. The patient previously received first dose on 04Jan2021 11:00, (lot number: EL0142) via an unspecified route of administration in right arm as first dose, single for COVID-19 immunization. Medical history included non-Hodgkins lymphoma from 1995, invasive ductal carcinoma 2009 with breast reconstruction; phrenic nerve paralysis left side; cardiomyopathy. Concomitant medications included metoprolol 100 mg, vitamin D [COLECALCIFEROL], beclometasone dipropionate (QVAR) 80 ug. No known allergies reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 (nasal swab, rapid test) post vaccination on 21Jan2021 test result was pending. On 25Jan2021 24:00, the patient experienced mild brain fog at 3pm; fatigue at 7pm; 11pm low-grade fever, headache, body aches; 4 am higher fever 101.5+, headache, body ache, dizzy, weak, queasy, chills, fatigue. Started ibuprofen and took every 4 hours and could not get fever below 100. Fever broke early hours the next day, but still was queasy, shaky, dizzy, achy and tired another 24 hours. Third day still tired. The patient received treatment for the events as OTC non-steroidal anti-inflammatory drugs. The events were non serious. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021007634 same patient/drug, different vaccine dose/event
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Nausea, Pain
Clinical narrative: low-grade fever; headache; body ache; dizzy; weak; queasy; chills; shaky; fatigue/tired another 24 hours/Third day still tired.; mild brain fog; higher fever 101.5+/couldn't get fever below 100.; This is a spontaneous report from a contactable other health care professional. A 48-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247) via an unspecified route of administration in right arm on 25Jan2021 11:30 as second dose, single for COVID-19 immunization. The patient previously received first dose on 04Jan2021 11:00, (lot number: EL0142) via an unspecified route of administration in right arm as first dose, single for COVID-19 immunization. Medical history included non-Hodgkins lymphoma from 1995, invasive ductal carcinoma 2009 with breast reconstruction; phrenic nerve paralysis left side; cardiomyopathy. Concomitant medications included metoprolol 100 mg, vitamin D [COLECALCIFEROL], beclometasone dipropionate (QVAR) 80 ug. No known allergies reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 (nasal swab, rapid test) post vaccination on 21Jan2021 test result was pending. On 25Jan2021 24:00, the patient experienced mild brain fog at 3pm; fatigue at 7pm; 11pm low-grade fever, headache, body aches; 4 am higher fever 101.5+, headache, body ache, dizzy, weak, queasy, chills, fatigue. Started ibuprofen and took every 4 hours and could not get fever below 100. Fever broke early hours the next day, but still was queasy, shaky, dizzy, achy and tired another 24 hours. Third day still tired. The patient received treatment for the events as OTC non-steroidal anti-inflammatory drugs. The events were non serious. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021007634 same patient/drug, different vaccine dose/event
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Tremor
Clinical narrative: low-grade fever; headache; body ache; dizzy; weak; queasy; chills; shaky; fatigue/tired another 24 hours/Third day still tired.; mild brain fog; higher fever 101.5+/couldn't get fever below 100.; This is a spontaneous report from a contactable other health care professional. A 48-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247) via an unspecified route of administration in right arm on 25Jan2021 11:30 as second dose, single for COVID-19 immunization. The patient previously received first dose on 04Jan2021 11:00, (lot number: EL0142) via an unspecified route of administration in right arm as first dose, single for COVID-19 immunization. Medical history included non-Hodgkins lymphoma from 1995, invasive ductal carcinoma 2009 with breast reconstruction; phrenic nerve paralysis left side; cardiomyopathy. Concomitant medications included metoprolol 100 mg, vitamin D [COLECALCIFEROL], beclometasone dipropionate (QVAR) 80 ug. No known allergies reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 (nasal swab, rapid test) post vaccination on 21Jan2021 test result was pending. On 25Jan2021 24:00, the patient experienced mild brain fog at 3pm; fatigue at 7pm; 11pm low-grade fever, headache, body aches; 4 am higher fever 101.5+, headache, body ache, dizzy, weak, queasy, chills, fatigue. Started ibuprofen and took every 4 hours and could not get fever below 100. Fever broke early hours the next day, but still was queasy, shaky, dizzy, achy and tired another 24 hours. Third day still tired. The patient received treatment for the events as OTC non-steroidal anti-inflammatory drugs. The events were non serious. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021007634 same patient/drug, different vaccine dose/event
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Swelling
Clinical narrative: I noticed, there is like a ball on my armpit, it's swollen and it's painful.; I noticed, there is like a ball on my armpit, it's swollen and it's painful.; I noticed, there is like a ball on my armpit, it's swollen and it's painful.; This is a spontaneous report from a contactable consumer or other non hcp. A 38-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown) via an unspecified route of administration on an unspecified date (At the age of  38-years-old)  as single dose for COVID-19 immunization.  The patient medical history was reported as none. The patient's concomitant medication was reported as No, just Vitamins, start and stop dates were unspecified.  When probed for the concern, patient stated he received second vaccine, (today is Thursday) on Tuesday patient noticed, there was a ball like on his armpit, it's swollen and it was painful. Patient inquired whether that was normal. Regarding the lot number, the reporter stated that, he took the card home, does not have it with him. Patient stated that there were No Lab test and no Treatment was received. Patient reported he noticed it this morning(as reported), he kind of felt something but this morning it's really swollen. The outcome of the events was reported as an unknown.   Information about lot and batch number was requested.  Follow-up (16Apr2021): 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Rash on face, red, raised -cheeks, forehead, chin area-ongoing; Rash on face, red, raised -cheeks, forehead, chin area-ongoing; Soreness and swelling of left arm; Soreness and swelling of left arm; This is a spontaneous report from a contactable consumer. A 71-years-old female patient (not Pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in left arm on 03Feb2021 at 11:45 as 1ST dose, single for covid-19 immunization. Medical history included blood cholesterol increased, drug hypersensitivity, known_allergies of penicillin. Concomitant medication(s) within 2 weeks of vaccination included rosuvastatin, glucosamine & chondroitin; COQ10; fis. Facility where the most recent COVID-19 vaccine was administered included School or  Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 05Feb2021, the patient experienced rash on face, red, raised -cheeks, forehead, chin area-ongoing, soreness and swelling of left arm. The events assessed as non-serious. The treatment of antihistamine, aloe vera cream received for the events. The outcome of the events soreness and swelling of left arm was recovered where the events rash on face, red, raised -cheeks, forehead, chin area was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Feeling of body temperature change, Headache, Malaise
Clinical narrative: feeling hot and cold and hot and cold; cough; sneeze; She had a little fever/behind her leg was 100.4F; a tiny hemorrhage in her eye; gigantic headache/very bad headache; wasn't feeling good; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took diclofenac sodium. On an unspecified date in Feb2021, a couple of days before receiving her first vaccine dose, the patient took a dose of diclofenac (2 tablets, 15 mg each) and wanted to know if the vaccine will still work. Moreover she was going to receive Botox injections in between her two vaccine doses, her neurologist says that it's fine, but she wanted to have more information, if available. She also stated that she is due for her Botox injection but might postpone the shot so that it will not interfere with her COVID-19 vaccine. On an unspecified date she experienced a tiny hemorrhage in her eye that may have resulted from a cough or a sneeze; she had a rough night feeling hot and cold and hot and cold and she had a little fever stating that her infrared thermometer said that behind her leg temperature was 100.4 F (but her arm was different, along with her forehead). On 11Feb2021 the patient experienced gigantic headache/very bad headache, but she does not think the headache was caused by the vaccine, and wasn't feeling good. She wanted to know if she can take diclofenac for her headache. The patient underwent lab tests and procedures which included body temperature: 100.4 Fahrenheit on an unspecified date. At the time of the report the events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Pyrexia, Sneezing
Clinical narrative: feeling hot and cold and hot and cold; cough; sneeze; She had a little fever/behind her leg was 100.4F; a tiny hemorrhage in her eye; gigantic headache/very bad headache; wasn't feeling good; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took diclofenac sodium. On an unspecified date in Feb2021, a couple of days before receiving her first vaccine dose, the patient took a dose of diclofenac (2 tablets, 15 mg each) and wanted to know if the vaccine will still work. Moreover she was going to receive Botox injections in between her two vaccine doses, her neurologist says that it's fine, but she wanted to have more information, if available. She also stated that she is due for her Botox injection but might postpone the shot so that it will not interfere with her COVID-19 vaccine. On an unspecified date she experienced a tiny hemorrhage in her eye that may have resulted from a cough or a sneeze; she had a rough night feeling hot and cold and hot and cold and she had a little fever stating that her infrared thermometer said that behind her leg temperature was 100.4 F (but her arm was different, along with her forehead). On 11Feb2021 the patient experienced gigantic headache/very bad headache, but she does not think the headache was caused by the vaccine, and wasn't feeling good. She wanted to know if she can take diclofenac for her headache. The patient underwent lab tests and procedures which included body temperature: 100.4 Fahrenheit on an unspecified date. At the time of the report the events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: headache; chills; fever; sore muscles; This is a spontaneous report from contactable Consumer (patient).A 77-years-old (non-pregnant) female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: BN5318 and expiry date was not reported) dose 2 via an unspecified route of administration in left arm on 12Feb2021 12:00 (at 77-years age) as a 2nd single dose for COVID-19 immunisation and received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL8982 and expiry date was not reported) dose 1 via an unspecified route of administration in left arm on 22Jan2021 12:00 as a 1st single dose for COVID-19 immunisation. The patient medical history included AFib and latex allergy. Concomitant medication(s) included rivaroxaban (XARELTO); flecainide (FLECAINIDE); amlodipine (AMLODIPINE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Feb2021 at 01:00 AM the patient experienced with headache, chills, fever and sore muscles. The patient had no covid tested post vaccination. The patient did not receive any treatment medication for the events. The outcome of the events was recovered.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Headache, Inflammation, Lip swelling, Oral pain
Clinical narrative: ulcers; sore mouth; dryness; painful can't eat; crushing headache; Lips swollen; Lots of imflamation; This is a spontaneous report from a contactable consumer (patient, self-reported). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN5318 and expiry date was not provided), via an unspecified route of administration, in Arm Right, on 11Feb2021 at 15:45 PM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included known allergies-sulpha drug. Concomitant medications were not reported. The patient did not receive any vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 13Feb2021 at 12:00 AM, within 24 to 48 hours, she had a massive sore mouth, ulcers, dryness, and so painful couldn't eat. She also woke up with crushing headache. Her lips swollen and could not stand anything hardly warm on her lips and lots of imflamation. The events resulted in emergency room/department or urgent care. The patient did not receive any treatment for the events. Outcome of the events was not recovered.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Ulcer
Clinical narrative: ulcers; sore mouth; dryness; painful can't eat; crushing headache; Lips swollen; Lots of imflamation; This is a spontaneous report from a contactable consumer (patient, self-reported). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN5318 and expiry date was not provided), via an unspecified route of administration, in Arm Right, on 11Feb2021 at 15:45 PM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included known allergies-sulpha drug. Concomitant medications were not reported. The patient did not receive any vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 13Feb2021 at 12:00 AM, within 24 to 48 hours, she had a massive sore mouth, ulcers, dryness, and so painful couldn't eat. She also woke up with crushing headache. Her lips swollen and could not stand anything hardly warm on her lips and lots of imflamation. The events resulted in emergency room/department or urgent care. The patient did not receive any treatment for the events. Outcome of the events was not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Pruritus
Clinical narrative: Mild itch on face, eyes and arms. Previously reported reaction  was a little more intense and it included my scalp.; Mild itch on face, eyes and arms. Previously reported reaction  was a little more intense and it included my scalp.; This is a spontaneous report from a contactable consumer (Patient). A 67-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 01:45 (Batch/Lot Number: EL8982) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included high cholesterol, arthritis, glaucoma candidate, GERD, Osteopenia, lumbar radiculopathy penicillin allergy and sulfonamide allergy. Concomitant medication(s) included lovastatin (LOVASTATIN) taken for an unspecified indication, start and stop date were not reported; lansoprazole (LANSOPRAZOLE) taken for an unspecified indication, start and stop date were not reported and unspecified medications. The patient previously took Cortisone, Dexamethasone, Clindamycin, Neurontin, Gabapentin, Carbamazepine, Endocet, Metoprolol, Pamalor and experienced allergies for all medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162B2), via an unspecified route of administration, administered in Arm right on 20Jan2021 02:00 PM (Batch/Lot Number: EL3246) as 1ST DOSE, SINGLE for covid-19 immunisation and expereinced mild itch on face, eyes and arms and scalp. On 10Feb2021 14:15 the patient experienced Mild itch on face, eyes and arms. Previously reported reaction was a little more intense and it included her scalp. No treatment were received for the events. The outcome of the events were recovered on an unspecified date.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm pain at site of injection; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Feb2021 15:30 (Lot Number: EL9269, Expiration date: unknown, at the age of 60-years-old) as first dose, single dose for covid-19 immunisation. Medical history included ongoing hypothyroid. No known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported and supplements (vitamins). No covid prior vaccination. Covid not tested post vaccination. The patient experienced arm pain at site of injection on 23Feb2021 20:30. No treatment was received. The outcome of the event was not recovered.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Extreme whole body itching with no rash; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL9264), via an unspecified route of administration, administered in Arm Left on 22Feb2021 08:15 (at an age of 79-years-old) as single dose for covid-19 immunisation. Medical history included type 2 diabetes mellitus. Concomitant medications included metformin (MANUFACTURER UNKNOWN), via an unspecified route of administration from an unspecified date at 500 mg unknown frequency for unknown indication; doxycycline (MANUFACTURER UNKNOWN), via an unspecified route of administration from an unspecified date at 20 mg unknown frequency for unknown indication. The patient previously took bnt162b2 (Product=COVID 19, brand=Pfizer, lot number=EL9265, lot unknown=False, administration date=31Jan2021, administration time=08:00 AM, vaccine location=Left arm, dose number=1). On 22Feb2021 17:00, the patient experienced extreme whole body itching with no rash. The patient did not receive any treatment for the events. The clinical outcome for the extreme whole body itching with no rash was recovering.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test normal, Computerised tomogram normal, Hypoaesthesia, Pain
Clinical narrative: Numbness, tingling and weakness / pain on right side of body that has spread to entire body neck down.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Numbness, tingling and weakness / pain on right side of body that has spread to entire body neck down.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Disorientation, Hypokalaemia, Hypopnoea, Hypotension
Clinical narrative: Patient post-vaccination (Pfizer/0.3ml/1st dose administered @10:23a) appeared to be seizing in his chair during observation @ 10:26a.  I rushed to him, requesting aid from his colleagues to help lay him on the ground and elevate his feet. He was unresponsive and disoriented, with shallow breathing and weak pulse, so I activated EMS @ 10:26a.  He appeared to seize again so I instructed two men to help roll him onto his side, at which time, an RN managing the vaccines, took over monitoring while I talked to 911.  EMS was on scene @ 10:29a. RN reports he'd had a vagal response, most likely due to witnessed severe anxiety during IM injection (name /right deltoid @ 10:23a). RN gave him Gatorade and he quickly became AOx3.  When EMS arrived, he was able to stand up, with assist, and be placed on the gurney.  EMS monitored him for ~ 20min onsite, at which time he became hypotensive, resulting in transport to the nearest ER with O2 and IV management.  Per HR representative for a business patient was discharged @ ~2p the same day, with diagnosis of severe dehydration and hypokalemia, his reaction most likely a vagal event.  Unknown if medications were given outpatient.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, Pulse abnormal, Seizure, Unresponsive to stimuli
Clinical narrative: Patient post-vaccination (Pfizer/0.3ml/1st dose administered @10:23a) appeared to be seizing in his chair during observation @ 10:26a.  I rushed to him, requesting aid from his colleagues to help lay him on the ground and elevate his feet. He was unresponsive and disoriented, with shallow breathing and weak pulse, so I activated EMS @ 10:26a.  He appeared to seize again so I instructed two men to help roll him onto his side, at which time, an RN managing the vaccines, took over monitoring while I talked to 911.  EMS was on scene @ 10:29a. RN reports he'd had a vagal response, most likely due to witnessed severe anxiety during IM injection (name /right deltoid @ 10:23a). RN gave him Gatorade and he quickly became AOx3.  When EMS arrived, he was able to stand up, with assist, and be placed on the gurney.  EMS monitored him for ~ 20min onsite, at which time he became hypotensive, resulting in transport to the nearest ER with O2 and IV management.  Per HR representative for a business patient was discharged @ ~2p the same day, with diagnosis of severe dehydration and hypokalemia, his reaction most likely a vagal event.  Unknown if medications were given outpatient.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature abnormal
Clinical narrative: temperature excursion with vaccine administration
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: temperature excursion with vaccine administered
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Body temperature decreased, Chest pain
Clinical narrative: Friday, 4/16/21 woke up nauseous.  Worked all day.  Went to a store after work.  Felt nauseous did not eat dinner.  Around 9:30 PM arm pain from vaccine that I had been having got worse and my sternum hurt,  Got the chills.  I could not get warm.  Lied down in bed took my temperature...usually I am 98.6...I was 97.1.  After 2 hours I warmed up.  I was in alot of pain....feet, knees, legs, lower back, arms. neck hurt, were weak and stiff.  When I tried to get up from the bed..it was like my mind no longer knew how to "get up".  I tried to count, 1,2,3..get up on 3!! after many attempts I finally made it happen.  I was very unsteady and had to hold on to things.  Walking took a long time.  The bed and couch hurt to sit or lie on.  The only place to sit and feel like I could get up was on a tall stool on my kitchen island.  I used ice packs, cold showers, Tylenol, and topical creams.  I called my Primary care Doctor on Monday, 4/19/21 I was scared.  My legs ached at all times.  As of 5/1/21 I now have pins and needle sensations in my fingers and toes.  I have a pain in my neck to my jaw now when I chew at times.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysstasia, Gait disturbance, Mastication disorder, Musculoskeletal stiffness
Clinical narrative: Friday, 4/16/21 woke up nauseous.  Worked all day.  Went to a store after work.  Felt nauseous did not eat dinner.  Around 9:30 PM arm pain from vaccine that I had been having got worse and my sternum hurt,  Got the chills.  I could not get warm.  Lied down in bed took my temperature...usually I am 98.6...I was 97.1.  After 2 hours I warmed up.  I was in alot of pain....feet, knees, legs, lower back, arms. neck hurt, were weak and stiff.  When I tried to get up from the bed..it was like my mind no longer knew how to "get up".  I tried to count, 1,2,3..get up on 3!! after many attempts I finally made it happen.  I was very unsteady and had to hold on to things.  Walking took a long time.  The bed and couch hurt to sit or lie on.  The only place to sit and feel like I could get up was on a tall stool on my kitchen island.  I used ice packs, cold showers, Tylenol, and topical creams.  I called my Primary care Doctor on Monday, 4/19/21 I was scared.  My legs ached at all times.  As of 5/1/21 I now have pins and needle sensations in my fingers and toes.  I have a pain in my neck to my jaw now when I chew at times.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain in extremity, Pain in jaw, Paraesthesia
Clinical narrative: Friday, 4/16/21 woke up nauseous.  Worked all day.  Went to a store after work.  Felt nauseous did not eat dinner.  Around 9:30 PM arm pain from vaccine that I had been having got worse and my sternum hurt,  Got the chills.  I could not get warm.  Lied down in bed took my temperature...usually I am 98.6...I was 97.1.  After 2 hours I warmed up.  I was in alot of pain....feet, knees, legs, lower back, arms. neck hurt, were weak and stiff.  When I tried to get up from the bed..it was like my mind no longer knew how to "get up".  I tried to count, 1,2,3..get up on 3!! after many attempts I finally made it happen.  I was very unsteady and had to hold on to things.  Walking took a long time.  The bed and couch hurt to sit or lie on.  The only place to sit and feel like I could get up was on a tall stool on my kitchen island.  I used ice packs, cold showers, Tylenol, and topical creams.  I called my Primary care Doctor on Monday, 4/19/21 I was scared.  My legs ached at all times.  As of 5/1/21 I now have pins and needle sensations in my fingers and toes.  I have a pain in my neck to my jaw now when I chew at times.