chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Dizziness, Dry mouth, Fatigue
Clinical narrative: Full diarrhea; Fever; Loose stools; Fatigue; Queasiness; Breast gland swollen; Dry mouth; slight dizziness; Tickle in throat; Dry cough; cold; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 66-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in the right arm on 08Mar2021 (at the age of 66-years-old) at 10:00 for COVID-19 immunisation. The patients medical history included pernicious anemia, rheumatoid arthritis, lupus, connective tissue and fibromyalgia. The patient was allergic to tetracycline. The patients concomitant medications was not reported, however, the patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. On 08Mar2021, immediately the patient experienced dry mouth and slight dizziness, tickle in throat & dry cough, cold and slight headache. On 10Mar2021, the second to the eight day, she experienced loose stools, fatigue, queasiness and swollen breast gland. On 16Mar2021, the eight day, she experienced full diarrhea, slight fever and cold which broke overnight and had taken TYLENOL. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was taken for these events. The clinical outcome of the events loose stools, fatigue, queasiness and swollen breast gland was resolved on 16Mar2021 while the events of dry mouth, slight dizziness, tickle in throat, dry cough, cold, slight headache, full diarrhea and slight fever was recovered on an unspecified date.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Nasopharyngitis, Nausea, Pyrexia
Clinical narrative: Full diarrhea; Fever; Loose stools; Fatigue; Queasiness; Breast gland swollen; Dry mouth; slight dizziness; Tickle in throat; Dry cough; cold; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 66-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in the right arm on 08Mar2021 (at the age of 66-years-old) at 10:00 for COVID-19 immunisation. The patients medical history included pernicious anemia, rheumatoid arthritis, lupus, connective tissue and fibromyalgia. The patient was allergic to tetracycline. The patients concomitant medications was not reported, however, the patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. On 08Mar2021, immediately the patient experienced dry mouth and slight dizziness, tickle in throat & dry cough, cold and slight headache. On 10Mar2021, the second to the eight day, she experienced loose stools, fatigue, queasiness and swollen breast gland. On 16Mar2021, the eight day, she experienced full diarrhea, slight fever and cold which broke overnight and had taken TYLENOL. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was taken for these events. The clinical outcome of the events loose stools, fatigue, queasiness and swollen breast gland was resolved on 16Mar2021 while the events of dry mouth, slight dizziness, tickle in throat, dry cough, cold, slight headache, full diarrhea and slight fever was recovered on an unspecified date.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Full diarrhea; Fever; Loose stools; Fatigue; Queasiness; Breast gland swollen; Dry mouth; slight dizziness; Tickle in throat; Dry cough; cold; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 66-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in the right arm on 08Mar2021 (at the age of 66-years-old) at 10:00 for COVID-19 immunisation. The patients medical history included pernicious anemia, rheumatoid arthritis, lupus, connective tissue and fibromyalgia. The patient was allergic to tetracycline. The patients concomitant medications was not reported, however, the patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. On 08Mar2021, immediately the patient experienced dry mouth and slight dizziness, tickle in throat & dry cough, cold and slight headache. On 10Mar2021, the second to the eight day, she experienced loose stools, fatigue, queasiness and swollen breast gland. On 16Mar2021, the eight day, she experienced full diarrhea, slight fever and cold which broke overnight and had taken TYLENOL. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was taken for these events. The clinical outcome of the events loose stools, fatigue, queasiness and swollen breast gland was resolved on 16Mar2021 while the events of dry mouth, slight dizziness, tickle in throat, dry cough, cold, slight headache, full diarrhea and slight fever was recovered on an unspecified date.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Nausea, Pain
Clinical narrative: achy; painful muscle; painful joints; nausea; This is a spontaneous report from a non-contactable nurse, the patient. A female patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727), via an unspecified route of administration in the left arm on 22Mar2021 at 15:00 hours as a single dose for COVID-19 vaccination. Medical history included autoimmune thyroiditis, environmental allergies and basal cell skin cancer. The patient was allergic to topical neosporin. The patient was on unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EM9809), via an unspecified route of administration in the left arm on 01Mar2021 at 15:30 hours as a single dose for COVID-19 vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not tested for COVID-19. On 23Mar2021 at 03:00, the patient experienced achiness, painful joints, painful muscle and nausea. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure was taken as result of events and included the treatment with Tylenol. The clinical outcome of achy, painful muscle, painful joints and nausea were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dysgeusia
Clinical narrative: Metallic blood taste in mouth 2.5 hours from getting 2nd shot Lost some taste; Lost some taste; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old female non pregnant patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: El3248), via an unspecified route of administration in right arm on 23Mar2021 at 09:45 (at the age of 42 years) as a single dose for COVID-19 immunisation. Medical history of the patient includes nose bleeds. Concomitant medications include Ibuprofen (MANUFACTURER UNKNOWN), vitamin c (MANUFACTURER UNKNOWN) and vitamin d (MANUFACTURER UNKNOWN) for unknown indication taken within 2 weeks of medication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: El3248), via an unspecified route of administration in right arm on 02Mar2021 at 10:00 (at the age of 42 years old) as a single dose for COVID-19 immunisation. 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 and since the vaccination, the patient was not tested for COVID-19. On 23Mar2021 at 12:00 PM the patient experienced metallic blood taste in mouth 2.5 hours from getting second shot and lost some taste. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic effects were taken as a result of the events. The clinical outcome of the events metallic blood taste in mouth and lost taste was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Dementia, Drug ineffective, SARS-CoV-1 test
Clinical narrative: Dementia seems to worsen; Patient who received the Pfizer-Biontech Covid19 vaccine, and contracted Sars-CoV-2 a few days later.; drug ineffective; This is a spontaneous report received from a contactable physician.A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EM9809), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunization.Medical history included covid-19 and dementia.The patient's concomitant medications were not reported.The physician reported that patient who received the Pfizer-Biontech Covid19 vaccine, and contracted Sars-CoV-2 a few days later.The patient was also treated with antibody therapy, and the second dose of vaccine has been deferred for the 90 days after this therapy. The reporter would like to know if the patient should receive the second dose or re-start the series. The person contracted Covid at a couple days so assumed the first dose did not work at all. The patient had Covid infection then given the vaccine, the dementia seems to worsened with Covid. The reporter stated that having a Sars-CoV-2 infection has been shown to worsen dementia and asked what the effects would be if the patient were to then receive a Covid vaccine. The reporter would like to know if the first dose of the vaccine was efficacious, since the patient tested positive for Sars-CoV-2 shortly after receiving it and what reporter have seen as far as efficacy if patient contracted Sars-Cov-2 in between doses and how does it affect immunity. Therapeutic measures were taken as a result of covid-19. The patient underwent lab tests which included sars-cov-2 test: positive. The outcome of the events were unknown.; Sender's Comments: As there is temporal relationship in the case provided, the causal association between the event and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Got a rash one week after first vaccine on chest, stomach, arms, buttocks and thigh area.; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6202), via an unspecified route of administration in the right arm on 13Mar2021 at 08:30 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. Medical history included kidney transplant and high blood pressure. Concomitant medications included tacrolimus (PROGRAF), sulfamethoxazole; trimethoprim (BACTRIM), nifedipine (PROCARDIA) and metoprolol (MANUFACTURER UNKNOWN), all from unknown dates for unspecified indications. The patient was allergic to milk. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 at 19:00, one week after the first vaccine, the patient got a rash on chest, stomach, arms, buttocks and thigh area. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of rash and included treatment with Zyrtec 10 mg, 1 daily. The clinical outcome of the event rash was recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Migraine, Nausea, Pain, Pyrexia
Clinical narrative: Severe tinnitus; Migraine; Body aches; Nausea; Diarrhea; Fever; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 12Feb2021 at 08:00, (at the age of 59- years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis and neuropathy. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had a history of allergy to lidocaine, Phenergan and trazadone. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN) and hormonal replacement therapy NORCO, both for unknown indication. The patient had experienced nausea, diarrhoea, severe tinnitus, fever, body aches and migraine on 13Feb2021 at 16:00. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events nausea, diarrhoea, tinnitus, fever, pain and migraine was not resolved at the time of this report.  No further information expected. Information on lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe tinnitus; Migraine; Body aches; Nausea; Diarrhea; Fever; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 12Feb2021 at 08:00, (at the age of 59- years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis and neuropathy. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had a history of allergy to lidocaine, Phenergan and trazadone. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN) and hormonal replacement therapy NORCO, both for unknown indication. The patient had experienced nausea, diarrhoea, severe tinnitus, fever, body aches and migraine on 13Feb2021 at 16:00. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events nausea, diarrhoea, tinnitus, fever, pain and migraine was not resolved at the time of this report.  No further information expected. Information on lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Malaise, Myalgia
Clinical narrative: Night sweats second night after injection; Injection site pain; Extreme tiredness; Muscle pain; Skin pain under clothing; Joint pain; Feeling unwell; fuzzy head; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received the second dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA Vaccine, Lot number: ep7534) via an unspecified route of administration on the left arm on 21Mar2021 at 13:45 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included pre diabetes and the patient was having normal body mass index (BMI) for his age. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), fosinopril (MANUFACTURER UNKNOWN) and diclofenac (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA Vaccine, Lot number: ep7534) via an unspecified route of administration on the left arm on 25FebMar2021 at 17:30 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Past drug history also included ELAVIL and CIALIS for which patient developed allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 at 04:00, the patient experienced injection site pain, extreme tiredness, muscle pain, skin pain under clothing, joint pain, feeling unwell and fuzzy head. On 23Mar2021, the patient experienced night sweats. The patient was not treated for the reported events. The clinical outcome of the events injection site pain, extreme tiredness, muscle pain, skin pain under clothing, joint pain, feeling unwell and fuzzy head was resolved on 23Mar2021, while that of night sweats was resolved on 24Mar2021.   No follow up attempts are needed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Pain of skin, Vaccination site pain
Clinical narrative: Night sweats second night after injection; Injection site pain; Extreme tiredness; Muscle pain; Skin pain under clothing; Joint pain; Feeling unwell; fuzzy head; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received the second dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA Vaccine, Lot number: ep7534) via an unspecified route of administration on the left arm on 21Mar2021 at 13:45 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included pre diabetes and the patient was having normal body mass index (BMI) for his age. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), fosinopril (MANUFACTURER UNKNOWN) and diclofenac (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA Vaccine, Lot number: ep7534) via an unspecified route of administration on the left arm on 25FebMar2021 at 17:30 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Past drug history also included ELAVIL and CIALIS for which patient developed allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 at 04:00, the patient experienced injection site pain, extreme tiredness, muscle pain, skin pain under clothing, joint pain, feeling unwell and fuzzy head. On 23Mar2021, the patient experienced night sweats. The patient was not treated for the reported events. The clinical outcome of the events injection site pain, extreme tiredness, muscle pain, skin pain under clothing, joint pain, feeling unwell and fuzzy head was resolved on 23Mar2021, while that of night sweats was resolved on 24Mar2021.   No follow up attempts are needed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination site pain
Clinical narrative: Mild body aches; Mild body aches and head ache; Soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248), via an unspecified route of administration in the right arm on 22Mar2021 at 12:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient previously received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248), via an unspecified route of administration in the right arm on 01Mar2021 at 12:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The Patient previously took Penicillin for unknown indication and experienced an allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 23Mar2021 at 12:00, the patient experienced mild body aches, headache and soreness at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the mild body aches, headache and vaccination site pain was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain in left knee; This is a spontaneous report from a contactable consumer, the patient. A 52-years-old non- pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ep6955), via an unspecified route of administration in the right arm on 22Mar2021 at 09:15 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On 23Mar2021 at 12:00, the patient experienced joint pain in the left knee. The patient did not receive any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event joint pain in the left knee was unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching on both arms and nape of neck; Hives on upper right arm; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6207), via an unspecified route of administration in left arm on 17Mar2021 at 16:00 (at the age of 67 years old) as a single dose for COVID-19 immunisation. Medical history included breast cancer, acid reflux and osteoporosis and seasonal allergies (tree and grass pollen). Past drug history included penicillin, erythromycin (Z pack) and surgical adhesive tape form which patient had allergy. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), FOSAMAX, fluticasone spray (MANUFACTURER UNKNOWN) and multi vitamins (MANUFACTURER UNKNOWN); all for unknown indication started on an unknown date and it was unknown if ongoing. Prior to vaccination, the patient had not had symptoms associated with COVID-19. Since vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 19:00 (within three hours of injection), the patient experienced itching and hives appeared on upper right arm which was opposite to arm from injection site. Symptoms went after another three hours. However, the next morning and every day since, both arms and nape of neck had itched, but no rash or hives appeared. The patient took a low dose antihistamine (unspecified) the morning after the shot and visited primary care physician (PCP) as part of a regular schedule visit that week. The physician advised taking a daily dose of CLARITIN or ZYRTEC. The patient did not receive any treatment for the event at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of event hives was resolved on an unknown date in 2021 while the outcome of event itching on both arms and nape of neck was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Lymphadenopathy, Nausea
Clinical narrative: Headache; Dizziness; Fatigue; Nausea; Swollen lymph node; Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 20Mar2021 at 10:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included losartan (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and labetalol (MANUFACTURER UNKNOWN), all for unknown indication within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 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 20Mar2021, at 19:00, the patient experienced headache, dizziness, fatigue, nausea, swollen lymph nodes, sore arm. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events headache, dizziness, fatigue, nausea, swollen lymph nodes and sore arm was resolved on an unknown date in Mar2021.  Information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Headache; Dizziness; Fatigue; Nausea; Swollen lymph node; Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 20Mar2021 at 10:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included losartan (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and labetalol (MANUFACTURER UNKNOWN), all for unknown indication within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 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 20Mar2021, at 19:00, the patient experienced headache, dizziness, fatigue, nausea, swollen lymph nodes, sore arm. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events headache, dizziness, fatigue, nausea, swollen lymph nodes and sore arm was resolved on an unknown date in Mar2021.  Information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: This is a spontaneous report received from a contactable consumer, the patient. A 49-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 59267-1000-01) via an unspecified route of administration in the left arm on 18Mar2021 at 17:45 (at the age of 49-year-old), as a single dose for COVID-19 immunization. The patient medical history included trigeminal neuralgia, depression, high blood pressure, overweight and allergy to ginger. The patient past historical drug included hydrocodone (MANUFACTURER UNKNOWN). Concomitant medications included carbamazepine (MANUFACTURER UNKNOWN), thyroxine (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN) all started since an unknown date for unknown indication. 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. Since the vaccination, the patient had not been tested positive for COVID-19. On 14Mar2021 at 13:00, the patient experienced headache, sore joints, chills, sweats, and extreme tiredness. The patient reported that what she had weren't adverse, but she wanted to let us know of side-effects she had. The patient reported that she was still having sweats and chills. But the others were gone. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The patient did not receive any treatment for the events. The clinical outcome of the events headache, sore joints, chills, sweats, and extreme tiredness were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: On Sunday night, my hands became very itchy; overnight my entire body became itchy; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via unspecified route of administration on right arm on 20Mar2021 (at the age of 60-year-old) at 11:15 AM as a single dose for COVID-19 immunisation. Medical history included asthma and Chronic obstructive pulmonary disease (COPD). The patient reported no known allergies to medications, food, or other products  Concomitant medications included spiriva (MANUFACTURER UNKNOWN), SYMBICORT, montelukast (MANUFACTURER UNKNOWN), FLONASE and prednisone (MANUFACTURER UNKNOWN) for unspecified indications. 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 and not tested for COVID post vaccination. On 21Mar2021 at 08:30 PM patient experienced generalised itching. It was reported that on Sunday night, the patients hands had become very itchy; overnight her entire body became itchy but she did not develop a rash or hives and her breathing was fine. Although it was Tuesday and she still had itchiness. Therapeutic measures were taken as a result of event and included self-treatment with benadryl. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event generalised itching was not recovered.   Information about lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pruritus
Clinical narrative: Swollen lymph nodes in right axillary area; Itchy skin; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6207), via an unspecified route of administration in the right arm on 20Mar2021 at 09:45 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic with penicillin, cupro and erythromycin (MANUFACTURER UNKNOWN). Concomitant medications included unspecified birth control medications, acyclovir (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN) and escitalopram oxalate (LEXAPRO); all for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6198), via an unspecified route of administration in the left arm on 20Feb2021 at 09:45 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccine, the patient had not been tested for COVID-19. On 20Mar2021, the patient experienced swollen lymph nodes in right axillary area and itchy skin. The patient did not receive any treatment for the swollen lymph nodes and itchy skin. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of swollen lymph nodes and itchy skin was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Pain, Palpitations
Clinical narrative: Body aches; Joint pain; Chills; Dizzy; Heart palpitations; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in the left arm on 22Mar2021 at 12:30 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to food, medications and other products. The patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264), via an unspecified route of administration in the left arm on 01Mar2021 at 12:30 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021 at 01:00, the patient experienced body aches, joint pain, chills, dizzy and heart palpitations. The patient underwent lab tests and procedures, which included PCR (nasal swab) on 27Oct2020 and tested negative. Therapeutic measures were taken as a result of the events and included treatment with 2 gelcaps of acetaminophen 500 mg, every 6 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events general body pain, joint pain, chills, dizzy and palpitations was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headaches; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received first dose of BNT162b2 (Pfizer BioNTech Covid 19 mRNA Vaccine; lot number: EN6198) via an unspecified route of administration in the right arm on 01Mar2021 at 15:30 as a single dose (at the age of 73-years-old) for COVID-19 immunisation and also received second dose of BNT162b2 (Pfizer BioNTech Covid 19 mRNA Vaccine; lot number: ER8727) via an unspecified route of administration in the left arm on 22Mar2021 at 13:15 as a single dose for COVID-19 immunisation. The patient had known allergies to food, medicine and other products. Medical history included diabetes. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 01Mar2021 at 15:00, the patient experienced headaches and fatigue. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headaches and fatigue was resolving.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea
Clinical narrative: More difficulty breathing/ just taking a breath seems more difficult; Light-headedness; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant patient female received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER2613), via an unspecified route of administration in the right arm on 23Mar2021 at 12:30 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety and ADHD. The patient was not aware of medications, food or other products allergies. Concomitant medication included lisdexamfetamine (VYVANSE), fluoxetine (PROZAC), mirtazapine (MANUFACTURER UNKNOWN) and clonazepam (CLONAPIN); all for unspecified indications from unknown dates. 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 23Mar2021, the patient experienced light-headedness and more difficulty in breathing. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events difficult breathing and light headedness were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Swelling face
Clinical narrative: redness on face especially in the eye area; Rash on face especially in the eye area; Swelling all on face especially in the eye area; This is a spontaneous report from a contactable healthcare professional, the patient. A 63-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration, via unspecified route of administration in the left arm on 05MAR2021 at 12:00 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included 5q minus MDS (Del 5q MDS). Concomitant medication included luspatercept (MANUFACTURER UNKNOWN) taken for an unspecified indication. The patient was allergic to revlimid. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 07Mar2021 at 03:00AM, the patient experienced redness, rash and swelling all on face especially in the eye area. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as results of events and included treatment with benadryl, zertec and pepcid. The clinical outcome of events redness of face, swelling of face and rash on face was resolved on an unknown date.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Nausea, Vomiting
Clinical narrative: light headed; nausea; vomiting 3 x throughout day; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) as a single dose via an unspecified route on 02Mar2021 at 18:15 (at the age of 62-years-old) for COVID-19 immunisation. Medical history included low thyroid. The patient had a history of allergy to penicillin. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), vitamin E(MANUFACTURER UNKNOWN), CENTRUM, calcium (MANUFACTURER UNKNOWN). 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. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar2021 at 08:00, the patient experienced light headed, nausea, vomiting 3 times throughout day. On 04Mar2021, the patient body temperature was 96.6 degrees F at 09:30, 97.5 degrees F at 14:30 and 98.4 degrees F at 19:30. On 05Mar2021, the patient body temperature was 96.6 degrees F at 08:50; 98.1 degrees F at 23:30; 97.3 degrees F at 12:00, felt light headed when first got up, but it seemed to improve later in the day. The patient had appointment for second shot on 03Mar2021 at 20:10. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events light headed, nausea, vomiting 3 times throughout day was resolved on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Myalgia
Clinical narrative: Injection site pain; Injection site pain and swelling; Fatigue; Chills; Fever; Muscle and joint pain; Muscle and joint pain; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. An 82-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 left arm on 05Mar2021 at 14:00 (at the age of 82-years old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Mar2021 at 18:00, patient experienced injection site pain and swelling, fatigue, chills, fever, muscle and joint pain, loss of appetite. The patient underwent lab tests and procedures, which included PCR (nasal swab) on 15Mar2021 and tested negative. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events vaccination site pain and vaccination site swelling, fatigue, chills, fever, muscle pain, joint pain and appetite lost was recovering at the time of this report.   Information on the lot/batch number has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site pain; Injection site pain and swelling; Fatigue; Chills; Fever; Muscle and joint pain; Muscle and joint pain; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. An 82-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 left arm on 05Mar2021 at 14:00 (at the age of 82-years old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Mar2021 at 18:00, patient experienced injection site pain and swelling, fatigue, chills, fever, muscle and joint pain, loss of appetite. The patient underwent lab tests and procedures, which included PCR (nasal swab) on 15Mar2021 and tested negative. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events vaccination site pain and vaccination site swelling, fatigue, chills, fever, muscle pain, joint pain and appetite lost was recovering at the time of this report.   Information on the lot/batch number has been requested.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via unspecified route of administration on 22Mar2021 at 14:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. 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 had not been tested for COVID-19. On an unknown date after first dose, the patient experienced arm soreness. The patient also experienced arm soreness on 22Mar2021 at 16:00. The patient stated that it felt like onset of arm soreness was faster when compared with vaccine 1 and magnitude of pain was seemingly lower than vaccine 1. The patient did not receive any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of arm soreness was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Musculoskeletal stiffness, Myalgia
Clinical narrative: Light headedness; Stiff and painful muscles in my neck and shoulders; Headache; Painful muscles; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unknown route of administration in the left arm on 18Mar2021 at 14:30 as a single dose for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. Concomitant medications were reported as prescriptions however exact medications were not specified. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not diagnosed with COVID-19 prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. On 19Mar2021 at 10:00, the patient mostly experienced constant headache with times of sharp pain and light headedness, stiff and painful muscles in her neck and shoulders. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events constant headache, light headedness, stiff and painful muscles in neck and shoulders was recovering.   No follow-up attempts are needed. No further information is expected.