chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Pleurisy, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 83-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3249), via an unspecified route on 19Jan2021 at 11:15 (at the age of 83-years) as 1st dose, single dose in the right arm for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergies. 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 been tested for COVID-19. On 23Jan2021, the patient experienced chest pains and problems breathing and went to Emergency room and diagnosed has pleurisy. The patient received treatment for events with steroids, pain meds and muscle relaxers. The patient underwent lab tests and procedures which included nasal swab, COVID test was negative on 19Feb2021. The outcome of the events was recovering. Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Pleurisy, SARS-CoV-1 test
Clinical narrative: pleurisy; chest pains; problems breathing; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 83-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 16Feb2021 (age at vaccination was 83 years) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have any known allergies. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3249, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 19Jan2021 at 11:15 am (age at vaccination was 83 years) as 1st dose, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 23Jan2021, the patient experienced chest pains and problems breathing. Went to ER on 25Jan2021 with chest pains and problems breathing and was diagnosed with pleurisy. The patient got the second dose of vaccine on 16Feb2021. In the ER again with the same symptoms as 25Jan2021 but was not given any diagnosis. The patient received treatment with Steroids, pain meds and muscle relaxers. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Sars-cov-2 test (Nasal swab-covid test): negative on 19Feb2021. The outcome of the events was resolving.   Follow-up attempts completed. No further information expected.  Follow-up (11May2021): Updated the details of follow-up attempts (Follow-up attempts completed. No further information expected).
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Pleurisy, SARS-CoV-2 test
Clinical narrative: pleurisy; chest pains; problems breathing; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 83-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 16Feb2021 (age at vaccination was 83 years) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have any known allergies. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3249, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 19Jan2021 at 11:15 am (age at vaccination was 83 years) as 1st dose, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 23Jan2021, the patient experienced chest pains and problems breathing. Went to ER on 25Jan2021 with chest pains and problems breathing and was diagnosed with pleurisy. The patient got the second dose of vaccine on 16Feb2021. In the ER again with the same symptoms as 25Jan2021 but was not given any diagnosis. The patient received treatment with Steroids, pain meds and muscle relaxers. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Sars-cov-2 test (Nasal swab-covid test): negative on 19Feb2021. The outcome of the events was resolving.   Follow-up attempts completed. No further information expected.  Follow-up (11May2021): Updated the details of follow-up attempts (Follow-up attempts completed. No further information expected).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Tachycardia
Clinical narrative: Elevated blood pressure 211/124; Tachycardia; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 13Feb2021 12:00 as 2nd dose, single for covid-19 immunisation . Medical history included hypertension. Patient had known allergies to seafood allergy. Patient previously took first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in arm left on 24Jan202112:00 PM as single dose for covid-19 immunisation. Patient received other medications in two weeks and no other vaccine in four weeks. On 14Feb2021 01:00 AM, patient experienced tachycardia, elevated blood pressure 211/124. Patient used acetaminophen, amlodipine, metoprolol as treatment. Patient was not covid tested post vaccination and not had covid prior vaccination. The outcome of the event was recovering.  Follow-up attempts completed. No further information expected
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, X-ray
Clinical narrative: shortness of breathe / hard time breathing / difficulty of breathing; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported via Medical Information Team. A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot/batch number and expiration date were unknown) via an unspecified route of administration on 09Feb2021 as single dose for Covid-19 immunization. The patient medical history was allergic to fish oil and Zocor. The patient's concomitant medications were not reported. On 10Feb2021, patient experienced shortness of breathe / hard time breathing / difficulty of breathing later and was seen by urgent care on 14Feb2021 for shortness of breath and difficulty breathing. Patient received his first Pfizer covid vaccine on 09Feb2021. He experienced some shortness of breathe later & was seen by urgent care. Patient received steroid injection (unsure of the name) when seen at Urgent Care and a prescription for an inhaler. Patient asking that if he should still receive the second dose of Pfizer covid vaccine. Patient had a hard time breathing after 1st dose. The patient was asking how long will the difficulty of breathing less. He was experiencing heavy breathing at the time of reporting. Patient received steroid injection (unsure of the name) when seen at Urgent Care and a prescription for an inhaler and prednisone. Patient had an x-ray (negative for any findings per patient) and was prescribed prednisone. Patient reported that the symptoms got better but never went away. The patient underwent lab tests and procedures which included x-ray: negative on 14Feb2021. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Feeling abnormal, Oxygen consumption decreased
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Feb2021 (at the age of 72 years old) (Batch/Lot Number: EN6203) as unknown, single for COVID-19 immunization. Medical history included asthma, occasionally. The patient's concomitant medications were not reported. The patient previously took pneumovax and experienced Known allergies: Pneumovax (Pneumovax 23/1 Dose 25 Mcg/0.5ml Injection). On 24Feb2021 20:00, patient experienced tightness on left side of throat, increased blood pressure, 172 normal 117, decreased oxygen, 91, very lightheaded, brain fog, red swollen left cheek. The patient underwent lab tests and procedures which included blood pressure increased on 24 Feb 2021, 172 normal 117, oxygen saturation: decreased on 24Feb2021 decreased oxygen, 91. Events resulted in emergency room. Therapeutic measures were taken as a result of events with Benadryl in hospital 3 hours. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Swelling face, Throat tightness
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Feb2021 (at the age of 72 years old) (Batch/Lot Number: EN6203) as unknown, single for COVID-19 immunization. Medical history included asthma, occasionally. The patient's concomitant medications were not reported. The patient previously took pneumovax and experienced Known allergies: Pneumovax (Pneumovax 23/1 Dose 25 Mcg/0.5ml Injection). On 24Feb2021 20:00, patient experienced tightness on left side of throat, increased blood pressure, 172 normal 117, decreased oxygen, 91, very lightheaded, brain fog, red swollen left cheek. The patient underwent lab tests and procedures which included blood pressure increased on 24 Feb 2021, 172 normal 117, oxygen saturation: decreased on 24Feb2021 decreased oxygen, 91. Events resulted in emergency room. Therapeutic measures were taken as a result of events with Benadryl in hospital 3 hours. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased
Clinical narrative: Her oxygen level has been outrageous; This is a spontaneous report from a contactable consumer (patient mother). A 86-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection) via unspecified route of administration on 04Feb2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. patient previously took first dose of bnt162b2 on an unspecified date as COVID-19 immunisation. As per reported, reporters mom recently had her last COVID vaccine it's probably been 3 weeks as of yesterday or 3 weeks as of today, the whole time she had her second part of the vaccine, her oxygen level has been outrageous, she had the oxygen tank whole time since then and she just wanted to report that apparently that was the side effect because she has not had any oxygen problems in probably 10 years. The event took place on the same day, 04Feb2021. Reporter stated, Yes, when she had to go without her oxygen, yes it did get low. And as treatment patient received oxygen tank. Outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia
Clinical narrative: Fatigue; Fever of 103.9; Body pain; This is spontaneous case report received from a contactable consumer (patient). A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 10Mar2021 at 11:45AM (at the age of 68-years-old) as a single dose for COVID-19 Immunisation. Medical history included hashimoto's disease, psoriatic arthritis, peripheral neuropathy, atrial fibrillation from previous strokes and allergy to erythromycin. It was further specified that he had not received any other vaccines within 4 weeks prior to the COVID vaccine neither he had received any other medications within 2 weeks of vaccination. Furthermore, he was not been diagnosed with COVID-19 prior to vaccination neither had tested for COVID-19 since the vaccination. On 16Mar2021 at 03:00AM, patient experienced fever of 103.9, severe body aches and fatigue. Patient not taken any treatment for the reported events. The clinical outcome of the events (fever of 103.9, severe body aches and fatigue) was not recovered at the time of the report.   Information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated reporter information, added patient's first name and age, added Health Care Professional Information for vaccine administration, removed vaccination facility phone number; added test date for body temperature; added stop date and dose number of the vaccine dose.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations; This is a spontaneous report received from a contactable consumer, the patient. A 37 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247) first dose via an unknown route in left arm on 08Mar2021 at 08:30 AM as a single dose (at the age of 37 years) for COVID-19 vaccination. The patient was not allergic to the medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no COVID prior immunisation. Medical history reported as none. Concomitant medication includes ibuprofen (ADVIL) and congestion medicine occasionally. On 12Mar2021, the patient experienced heart palpitations. No therapeutic measures were taken as a result of these events. The clinical outcome of palpitation's was reported as not resolved. No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: reporter/patient details updated, patient's age added, medical history details updated, lab data corrected("COVID-19 virus test" deleted), stop date of vaccine added, concomitant drugs details updated, vaccine facility information added and treatment information added(no).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness (lightheaded); Nausea; This is a spontaneous report received from a non-contactable other healthcare professional. A 54-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH) (Lot number: EN6206) via an unspecified route of administration on 15Mar2021(at the age of 54-year-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 15Mar2021, the patient experienced Dizziness (lightheaded) and nausea after 15 mins of vaccine administration. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. Therapeutic measures included received water, snacks and Pepcid for nausea. Follow up response to the treatment was excellent. The patient was discharged on stable condition and did follow up with primary care physician. The clinical outcome of the events was resolved in Mar2021.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated information about patient, suspect product indication, Vaccination Facility Country, treatment, Concomitant Therapy.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; felt like a bad cold; This is a serious spontaneous report from a non-contactable consumer. This consumer reported similar events for herself and 1 patient. A 83-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 10Feb2021 as a 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received their first dose of the Pfizer COVID-19 vaccine on 10Feb2021, and he was scheduled to receive second dose on 03Mar2021, however, he was exposed to COVID-19. Tested positive for COVID-19 and he had very mild symptoms and reporter stated that "he has been over it for at least a week." reporter said, "it will be 10 days ago tomorrow" [tested positive 9 days ago]. Patient had been in quarantine since they were exposed and that their required isolation time will be finished tomorrow (on an unspecified date). Patient had an appointment at his doctor's office tomorrow (date unknown). She was inquiring about receiving the second dose of the Pfizer COVID-19 vaccine after testing positive for COVID-19 and wanted to know if Pfizer can reschedule patient's appointment to receive his second dose of the Pfizer COVID-19 vaccine. It was reported that, he was exposed to COVID-19 along with quite a few people and everyone else was considerably younger than him. Patient's symptoms were very mild and stated that it "felt like a bad cold" and he attribute that to having had the first dose of the Pfizer COVID-19 vaccine in his system. Reporter wanted to know if the first dose could have helped his symptoms be milder than their friend's symptoms since their friends had not yet received any of the COVID-19 vaccines yet. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021289665 Same reporter,event, product/ different patient
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Dizziness
Clinical narrative: dizziness; This is a spontaneous report from a non-contactable healthcare professional. A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6205), via an unspecified route of administration and unspecified anatomical site on 17Mar2021 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. Medical history included back surgery in Dec2020 (four months ago, from the time of reporting) and since that time the patient had episodes of dizziness, unknown if it is ongoing. In Dec2020, two days after back surgery, he had a syncopal episode and hit his head. The patient was evaluated at hospital emergency department and he reported negative computerised tomogram (CT) of head from the visit and was diagnosed with concussion. Concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), via an unspecified route of administration and unspecified anatomical site on an unspecified date, as a single dose for COVID-19 immunisation, and patient did not experience any event with the first dose of COVID vaccination. On 17Mar2021, during his fifteen minutes waiting period after the second dose of vaccination, the patient began to experience dizziness. The patient denied any other symptoms. The patient received water as a therapeutic measure. The follow up response to treatment was excellent. The patient was stable to go home and advised to follow up with primary care physician (PCP). The clinical outcome of the event dizziness was unknown at the time of report.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient age added, the first dose of BNT162B2 previous was captured as Past Drug Event and updated as Historical Vaccine, CT of head added as lab data instead of medical history, removed duplicate indication of COVID-19 immunisation, Vaccination Facility Country added, narrative updated accordingly. No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue
Clinical narrative: Lack of appetite.; Extreme fatigue; This is a spontaneous report from a non-contactable nurse (patient). A 40-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: not reported) via an unspecified route in the left arm on an unknown date (at the age of 40-year-old) for COVID-19 immunisation. Medical history and concomitant medications were not provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient developed extreme fatigue and lack of appetite. The patient did not receive treatment for adverse events. The outcome of the events was reported as not recovered. Since the vaccination, the patient had not been tested for COVID-19.   Information about lot/batch number cannot be obtained. No further information is expected  Amendment: This follow-up report is being submitted to amend previously reported information: added "patient" as primary reporter additional qualification; added patient's name, patient's age at event onset; added dose number (dose 1); added Vaccination Facility Country; removed 'none' for concomitant therapy as it's not reported if the patient received concomitant drugs.  No follow-up attempts are needed. No further information is expected. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Severe headache; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A female patient of unknown age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via unspecified route of administration in left arm on 17Mar2021 at 09:30 AM (age at vaccination unknown) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration on unknown date for COVID-19 immunisation. On 18Mar2021, the patient experienced severe headache and chills but no fever. The patient did not receive any treatment for events. The clinical outcome of severe headache and chills was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Protect Confidentiality" checked for reporter since reported for self, for all events: "Treatment Received?" captured as "No" per source reported "if treatment ae: No" and Final sentence updated from "Information about lot/batch number cannot be obtained. No further information is expected." to "No follow-up attempts are possible; information about lot/batch number cannot be obtained."
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Stomach cramps; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received first dose received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported), via an unspecified route, administered in Left Arm, of administration on 15Mar2021 at 12:45 (age of 38-year-old at vaccination) as a 1st dose, single for COVID-19 immunization. The patient's medical history included Allergy: Allergic to medications, food, or other products (Allergy to any specific substance or product was not specified). Prior to vaccination the patient was not diagnosed with Covid-19. The patient's concomitant medications included vortioxetine hydrobromide (TRINTELLIX) and lisinopril within 2 weeks of Covid-19 vaccination. The patient was vaccinated at United Center facility. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021, the patient experienced stomach cramps, diarrhea. No treatment medication was received for the resulted events by patient. Since vaccination the patient was not tested for covid-19. The clinical outcome for the events stomach cramps, diarrhea was not recovered at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  DSU amendment (16Jun2021): Added Concomitant medication (TRINTELLIX), Vaccination facility (United Center), Suspect drug Lot number (Unknown to Not reported), Dose description (1st dose, single), Event onset (changed from 15Mar2021 to 16Mar2021), Clinical course and Case closure comment. Updated narrative accordingly.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Fever; Muscle aches; Headache; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on an unknown date (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included Known allergies to chocolate. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 16Mar2021 at 08:00, the patient experienced fever, muscle aches and headache. The patient did not receive treatment for the reported events. The clinical outcome of the events fever, muscle aches and headache was recovered on an unknown date in Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient was 29 years old when event occurred, medical history added and narrative updated accordingly.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Malaise, Nausea
Clinical narrative: Nausea; Body ache; Tiredness; Headache; Feeling unwell; Left arm swollen lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via an unspecified route of administration in the left arm on 13Mar2021 at 11:45 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number: unknown) in the left arm on 20Feb2021 as single dose for COVID-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021 at 11:45, the patient experienced nausea, body ache, tiredness, headache, feeling unwell and swollen lymph nodes in left arm. The clinical outcome of the events nausea, body ache, tiredness, headache, feeling unwell and left arm swollen lymph nodes was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: added patient's information, updated first dose bnt162b2 as historical vaccine, updated concomitant therapy and amended narrative.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Nausea; Body ache; Tiredness; Headache; Feeling unwell; Left arm swollen lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via an unspecified route of administration in the left arm on 13Mar2021 at 11:45 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number: unknown) in the left arm on 20Feb2021 as single dose for COVID-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021 at 11:45, the patient experienced nausea, body ache, tiredness, headache, feeling unwell and swollen lymph nodes in left arm. The clinical outcome of the events nausea, body ache, tiredness, headache, feeling unwell and left arm swollen lymph nodes was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: added patient's information, updated first dose bnt162b2 as historical vaccine, updated concomitant therapy and amended narrative.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Myalgia, Nausea, Pyrexia
Clinical narrative: Lethargy; Fever; Chills; Nausea; Muscle aches; This is spontaneous report from non-contactable consumer (patient herself). An adult non-pregnant female patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE, Solution for injection, Lot number: EL3247) via an unspecified route of administration in left arm on 17Mar2021 as 2nd dose, single for COVID 19 immunization. Patient medical history and concomitant medication were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE, Solution for injection, Lot number: EL3247) via an unspecified route of administration in left arm on 24Feb2021 as 1st dose, single for COVID 19 immunization. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID 19. On 17Mar2021, patient experienced fever, chills, nausea, muscle aches and lethargy. No therapeutic measures were taken as a result of events. The clinical outcome of events fever, chills, nausea, muscle aches, lethargy were not resolved at the time of report.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Since only initials were reported, so was only captured in patient first name field for duplicate searching purpose, event onset date for the event Lethargy was captured as 17Mar2021 per source reported, information such as "Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No" and "Allergies to medications, food, or other products: no" were not captured in consolidated narrative, "None" was removed from "Concomitant Therapy " field since only reported "Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No" in source, not mention if took any drug.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Malaise, Nausea
Clinical narrative: Headache; Feeling unwell; Nausea; The runs; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non pregnant female patient received an unknown dose of BNT162B2 (Pfizer BioNTech Covid19 mRNA vaccine; lot number: EP 6955) via an unspecified route of administration as a single dose on 16Mar2021 for COVID-19 immunization (at the age of 48-years-old). Relevant Medical history and Concomitant medication details were not provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19, since the vaccination. On an unknown date, the patient had headache, feeling unwell, nausea and the runs. Clinical outcome of headache, feeling unwell, nausea and the runs were unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Age at Vaccination should be added as 48 years old per DOB and Vaccination date.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Muscle pain; Chills; Tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number- EN6207) via an unspecified route of administration in an unknown anatomical site on 18Mar2021 (at an age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 19Mar2021, the patient experienced muscle pain, chills and tiredness. No treatment was received for the event. The clinical outcome of muscle pain, chills and tiredness were not recovered.  This follow-up (17Jun2021) report is being submitted to amend previously reported information: patient's initial added in first name field in patient tab, final sentence should be No follow-up attempts are possible. No further information is expected. since reporter is non-contactable.  No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A male patient of 28 (units not provided) age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated that he got the first pfizer covid 19 vaccine on Tuesday and shortly went and got a test done. Caller stated he needed a negative test to travel. Caller stated his test was positive. Caller wanted to know if he should reschedule the second dose. Caller stated he had no symptoms of covid. Caller wanted to know how he would know if he was free from infection. Caller stated his father had covid in November and heard that even after quarantine you can still test positive for covid. Caller wanted to know if he should quarantine til the next dose. Caller stated his second dose was on 13Apr2021. The patient underwent lab tests and procedures which included covid-19 was positive on unknown date. The clinical outcome for the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Drug ineffective, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non hcp. A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0150, Pfizer NTEC), via an unspecified route of administration in Arm Left on 02Apr2021 (at the age of 64 years) as 1st dose, single dose for covid-19 immunisation. Medical history included she had a sinus. Concomitant medications included fluticasone, doxycycline, azithromycin, dextromethorphan hydrobromide, promethazine hydrochloride (PROMETHAZINE DM) taken for an unspecified indication, start and stop date were not reported. Patient stated, i went to took the covid test it comes up positive, bronchitis, some cold from the bronchitis on 15Apr2021. The events I went to took the Covid test it comes up positive assessed as serious (Medically significant). No treatment was received for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: Reporter stated, that we know, she went to the medical facility, they diagnosed the infection, they did a Covid test and it came back negative, no that I have but, they did a Covid test and it came back negative. When probed for the confirmation of adverse event date, reporter stated, 1st shot on 02Apr2021, from 15Apr, correct, it was 1st symptom was on 15Apr, she took the test on 20Apr, it was Sunday 19Apr, she took the test, I am sorry it was 18, she tested on 18Apr. Reporter stated, she was getting better, she still had some cold from the Bronchitis but symptoms are recovering. The outcome of the events was recovering.   Description of Product Complaint: Both the consumer and reporter were on the call. Consumer stated, I had got the vaccine , I did travelling when I came back from travelling, I went to took the Covid test to make sure that about to safe, and it comes up positive, now my last date of quarantine is 26Apr and had an appointment to took the 2nd shot on 28Apr am I able still to do that. When paraphrased the above concern, Consumer stated, My 2nd shot, kept on the 28Apr and I just want to double check, if I can still do it or do I need to get retested or what tested for the see if I am negative, so that was the two question to do I have to get tested to see If I am negative to get the 2nd dose or can get the 2nd dose at 28Apr. When probed for the name of the Pharmacy, reporter stated, had the vaccine we did not obtained it from any pharmacy. When probed for the dose of Vaccine, reporter sated, 1st dose, this was 2 dose formula and she took the only 1st one.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, Off label use
Clinical narrative: This is a spontaneous report received from a non-contactable consumer via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route on an unknown date in Dec2020 as 1st dose, single dose and via unspecified route on an unknown date in Mar2021 as 2nd dose, single dose for COVID-19 immunization. The patient medical history included ongoing COVID-19 from unknown date in 2020. Concomitant medications were not reported. It was reported that on an unknown date in Nov2020, the patient had COVID. The patient received both vaccines, one in Dec2020 and a second in Mar2021 and still contracted COVID. The reporter wanted to know if it was a false positive. The clinical outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer. A 90-years-old patient of an unspecified gender received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced shingles. Patient would like to report a case of shingles in 90-year-old mother-in-law approximately 30 days after receiving her second dose of the Covid vaccine. There do not seem to be any way to report these kinds of things. She has a terrible case of it and ended up in the hospital for 5 days, was now in her second week of rehab. Felt this was probably underreported, as personally know 3 people who have it following their vaccines. The patient was hospitalized due to events. The outcome of shingles was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Feeling abnormal, Nausea, Oral candidiasis, Pruritus
Clinical narrative: exhaustion; nausea; arthritis got worse; haven't felt right since my 1st pfizer covid 19; Red patches; size of a quarter a little itchy,on both legs and hands and wrists; thrush in her mouth; This is a spontaneous report received from a Pfizer Sponsored Program via a contactable other health professional and a female consumer (patient). A 70-year-old female patient received received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Apr2021 (at the age of 70-years-old), as 1st dose single for covid-19 immunization and tofacitinib citrate (XELJANZ XR, Formulation: Prolonged-release tablet, strength: 11 mg, Batch/Lot number was not reported), via oral route from on 23Apr2021 to 28May2021, at 11 mg, once a day for rheumatoid arthritis. The patient's medical history included rheumatoid arthritis and concomitant medications were not reported. Patient was reported that she was changing medication of tofacitinib as it wasn't working, arthritis got worse. Tofacitinib was discontinued. She had thrush (mouth) for a month, starting on 05May2021, and on 10May2021 started with red patches, size of a quarter a little itchy, on both legs and hands and wrists, doctor gave a cream, haven't felt right since my 1st dose of covid 19 vaccine on 16Apr2021 (not taken the 2nd dose). Patient reports possibly having thrush in her mouth and was "just now getting over" side effects from covid-19 vaccine. Patient stated she experienced exhaustion as well as having nausea. Patient stated all symptoms started two days after she received vaccine and believed it was related to covid vaccine and not related to. No further details or dates of covid-19 vaccine was given, and no missed doses were reported.  MD was aware. Patient to follow up with MD. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information was expected.  Follow up (08Jun2021): New information received from contactable consumer includes clinical course of the events, Sender's Comments: Reported events are probably intercurrent medical conditions and are unlikely related to tofacitinib. Events Causal relationship  with BNT162B2 cannot be excluded. Association of oral thrush with the use of tofacitinib is also possible. Case to be re-assessed upon receipt of new information.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rash, Rheumatoid arthritis
Clinical narrative: exhaustion; nausea; arthritis got worse; haven't felt right since my 1st pfizer covid 19; Red patches; size of a quarter a little itchy,on both legs and hands and wrists; thrush in her mouth; This is a spontaneous report received from a Pfizer Sponsored Program via a contactable other health professional and a female consumer (patient). A 70-year-old female patient received received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Apr2021 (at the age of 70-years-old), as 1st dose single for covid-19 immunization and tofacitinib citrate (XELJANZ XR, Formulation: Prolonged-release tablet, strength: 11 mg, Batch/Lot number was not reported), via oral route from on 23Apr2021 to 28May2021, at 11 mg, once a day for rheumatoid arthritis. The patient's medical history included rheumatoid arthritis and concomitant medications were not reported. Patient was reported that she was changing medication of tofacitinib as it wasn't working, arthritis got worse. Tofacitinib was discontinued. She had thrush (mouth) for a month, starting on 05May2021, and on 10May2021 started with red patches, size of a quarter a little itchy, on both legs and hands and wrists, doctor gave a cream, haven't felt right since my 1st dose of covid 19 vaccine on 16Apr2021 (not taken the 2nd dose). Patient reports possibly having thrush in her mouth and was "just now getting over" side effects from covid-19 vaccine. Patient stated she experienced exhaustion as well as having nausea. Patient stated all symptoms started two days after she received vaccine and believed it was related to covid vaccine and not related to. No further details or dates of covid-19 vaccine was given, and no missed doses were reported.  MD was aware. Patient to follow up with MD. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information was expected.  Follow up (08Jun2021): New information received from contactable consumer includes clinical course of the events, Sender's Comments: Reported events are probably intercurrent medical conditions and are unlikely related to tofacitinib. Events Causal relationship  with BNT162B2 cannot be excluded. Association of oral thrush with the use of tofacitinib is also possible. Case to be re-assessed upon receipt of new information.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Toothache, Urticaria
Clinical narrative: my lower jaw and teeth began to hurt; my lower jaw and teeth began to hurt; my legs got hives for a couple of days; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0171) via an unspecified route of administration in the left arm on 22Apr2021 at 11:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included having her jaw rewired in 2001, reported as 20 years ago. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in four weeks. The patient received unspecified concomitant medications in two weeks. The patient reported she had her jaw rewired 20 years ago and after she got her first dose, her lower jaw and lower teeth began to hurt. She also reported that her legs got hives for a couple of days. It was reported no treatment was received for the events. The patient received her second dose of BNT162B2 (lot EW0168) on 14May2021 at 09:15. The clinical outcomes of her lower jaw and lower teeth began to hurt, and her legs got hives for a couple of days were not recovered. It was also reported the patient had not been tested for COVID-19 since vaccination.