chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood grouping, Dizziness, SARS-CoV-2 antibody test
Clinical narrative: Mild dizziness; The initial safety information received was reporting only non-serious adverse drug reaction, Upon receipt of follow-up information on 19Oct2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (patient) and a physician. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at the age of 50-year-old), dose 1 via an unspecified route of administration, administered in arm left on 06Jun2021 17:00 (Batch/Lot Number: EW0202) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included high blood pressure, heart palpitations, Meniere's disease and COVID-19 prior vaccination; HTN (Hypertension) from 2012 and ongoing; ADD (Attention deficit hyperactivity disorder) from 2006 and ongoing; and contraception use. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for attention deficit hyperactivity disorder from 2006 and ongoing; amlodipine besilate (NORVASC) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide taken for hypertension from 2012 and ongoing; ethinylestradiol, etynodiol diacetate (KELNOR) taken for contraception from 2006 and ongoing; amlodipine taken for hypertension from 2012 and ongoing. The patient previously took amoxicillin and experienced allergies. The patient was not pregnant. The patient had no other vaccines in four weeks. The patient had not been tested for COVID since vaccination. The patient experienced mild dizziness on Jun2021 with outcome of recovering. The patient underwent lab tests and procedures which included blood grouping (ABORh): A+ on 09Jul2021; COVID Igg/ COVID Ab Igg on 09Jul2020 and on 28Jul2020 were negative; COVID Igg/COVID Ab Igg on 05Jan2021 was positive (Units: 1.47) and on 20Apr2021 was positive (Units: >10.0). It was mentioned that the patient had mild dizziness for the first 2 days after each vaccine. Seriousness Criteria: Persistent/ significant/disability /incapacity. AE required visit to physician office. The reporting physician considered that the Pfizer product had a casual effect to the adverse event. Therapeutic measures were taken as a result of mild dizziness with Meclizine.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on temporal relationship the possibility of causal association between the event dizziness and the suspect drug BNT162B2 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: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: Uncontrollably vomiting; Nausea; Diarrhea; Headache; Chills; This is a spontaneous report from a contactable consumer (patient).  A 13-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 14Aug2021 at 16:00 (Batch/Lot Number: 59267-1000-01) (age at vaccination 13-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took omnicef [cefdinir] and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not received 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 for COVID-19. The patient experienced uncontrollably vomiting, nausea, diarrhea, headache and chills on 15Aug2021 at 18:00. The adverse events resulted in emergency room/department or urgent care for fluids, EKG and Zofran. Therapeutic measures were taken for all the events. The outcome of the events was recovered with sequelae.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Had a sore arm; Was more tired than usual after the second dose of Pfizer COVID-19 vaccine; This is a spontaneous report from a contactable consumer. An adult female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Mar2021, as a single dose for COVID-19 immunisation. It was unknown if the patient had any medical history and allergies. It was unknown whether the patient was diagnosed with COVID-19 prior to the vaccination. It was unknown whether the patient receive any other vaccines within two weeks prior to the vaccination. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. The reporter was talking to a friend and he told the reporter that on an unknown date in Mar2021, the patient (his wife) had a sore arm and was more tired than usual after the second dose of Pfizer COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether the patient had tested for COVID-19, since the vaccination. It was unknown whether the patient received any therapeutic measures as a result of events. The clinical outcome of the events sore arm and was more tired than usual after the second dose of Pfizer COVID-19 vaccine was resolved on an unspecified date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Inappropriate affect, Influenza like illness, Vomiting
Clinical narrative: Today feels a little tired but they just had a hurricane and it is gloomy outside.; feels like a million dollars, feels amazing; Diarrhea; Vomiting; Flu-like symptoms; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0185 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 18Aug2021 at 11:00 AM (age at vaccination: 63 years), as dose 2, single dose for COVID-19 immunization at pharmacy. The patient's medical history included lyme disease (diagnosed years ago and she was deathly sick). Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0196 and expiry date was not reported), via an unspecified route of administration, on 28Jul2021 at 13:00 (age at vaccination: 62 years), as dose 1, single dose for COVID-19 immunization at pharmacy. Vaccine was not administered at Military Facility. The patient did not receive any vaccine prior vaccinations (within 4 weeks). The patient did not have family medical history relevant to adverse events. She had to say she felt like a million dollars on 21Aug2021 and has not felt this good in so many years, she started to feel this was about 3 or 4 days after the second dose. She was sick for a day and half, she had a little bit for vomiting, diarrhea, flu-like symptoms after the second dose on 19Aug2021. The diarrhea and flu-like symptoms recovered the next day. She took Advil as treatment. She was supposed to go somewhere on Saturday and was not sure if she was able to. She was usually asleep at 7:30 or 8 pm and instead was up till 11pm, she started feeling amazing. Today feels a little tired but they just had a hurricane and it was gloomy outside on 23Aug2021. She was good. The adverse events did not require a visit to emergency room and physician office. Outcome of the event vomiting was recovered on 19Aug2021, diarrhea and flu-like symptoms was recovered on 20Aug2021, feels like a million dollars, feels amazing was not recovered and for today feels a little tired but they just had a hurricane and it is gloomy outside, it was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Breast pain, Chills, Crying
Clinical narrative: Splitting headache; Joint pain; Injection site pain; Injection site swelling; Full body aches; Chills; Pain in eyes; Pain in breast tissue; Cramps; Middle back pain; Crying every half hour; Intense nausea; Loss of apatite; Shallow breathing; heavy head; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the left arm on 22Sep2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included heart failure, COVID-19 and known allergies to sulfa drugs. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included acetylsalicylic acid (ASPIRIN), escitalopram (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN); all  for an unknown indication from an unknown date and unknown if ongoing. On 23Sep2021, the patient experienced splitting headache, joint pain, injection site pain and swelling, full body aches, heavy head, chills, pain in eyes, pain in breast tissue, cramps, middle back pain, crying every half hour, intense nausea, loss of appetite and shallow breathing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events splitting headache, joint pain, injection site pain and swelling, full body aches, heavy head, chills, pain in eyes, pain in breast tissue, cramps, middle back pain, crying every half hour, intense nausea, loss of appetite and shallow breathing was not resolved at the time of this report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Eye pain, Head discomfort, Headache, Hypopnoea
Clinical narrative: Splitting headache; Joint pain; Injection site pain; Injection site swelling; Full body aches; Chills; Pain in eyes; Pain in breast tissue; Cramps; Middle back pain; Crying every half hour; Intense nausea; Loss of apatite; Shallow breathing; heavy head; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the left arm on 22Sep2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included heart failure, COVID-19 and known allergies to sulfa drugs. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included acetylsalicylic acid (ASPIRIN), escitalopram (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN); all  for an unknown indication from an unknown date and unknown if ongoing. On 23Sep2021, the patient experienced splitting headache, joint pain, injection site pain and swelling, full body aches, heavy head, chills, pain in eyes, pain in breast tissue, cramps, middle back pain, crying every half hour, intense nausea, loss of appetite and shallow breathing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events splitting headache, joint pain, injection site pain and swelling, full body aches, heavy head, chills, pain in eyes, pain in breast tissue, cramps, middle back pain, crying every half hour, intense nausea, loss of appetite and shallow breathing was not resolved at the time of this report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: Splitting headache; Joint pain; Injection site pain; Injection site swelling; Full body aches; Chills; Pain in eyes; Pain in breast tissue; Cramps; Middle back pain; Crying every half hour; Intense nausea; Loss of apatite; Shallow breathing; heavy head; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the left arm on 22Sep2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included heart failure, COVID-19 and known allergies to sulfa drugs. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included acetylsalicylic acid (ASPIRIN), escitalopram (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN); all  for an unknown indication from an unknown date and unknown if ongoing. On 23Sep2021, the patient experienced splitting headache, joint pain, injection site pain and swelling, full body aches, heavy head, chills, pain in eyes, pain in breast tissue, cramps, middle back pain, crying every half hour, intense nausea, loss of appetite and shallow breathing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events splitting headache, joint pain, injection site pain and swelling, full body aches, heavy head, chills, pain in eyes, pain in breast tissue, cramps, middle back pain, crying every half hour, intense nausea, loss of appetite and shallow breathing was not resolved at the time of this report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blister, Crying, Erythema
Clinical narrative: blistering; swelling; weeping; inflammation; loss of some muscle function in joint areas; weakness; redness; pins and needle feeling; LEFT arm, torso, leg unknown rash; Full Body joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), dose 1 via an unspecified route of administration, administered in the left arm on 10Sep2021 at 08:30 in a hospital (Batch/Lot Number: EW0164) at the age of 41-years-old, single, for COVID-19 immunization. Medical history included hypertension and known allergies to sulfa & e-mycins. The patient was not pregnant at the time of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ), and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XL), taken for unspecified indications, start and stop dates were not reported (both medications reported as medications the patient received within 2 weeks of vaccination). On 12Sep2021 at 06:00 PM, the patient experienced left arm, torso, leg unknown rash with blistering, redness, swelling, weeping and inflammation, full body joint pain and inflammation with weakness, pins and needle feeling, and loss of some muscle function in joint areas. The adverse events resulted in an Emergency Room/Department or urgent care visit and a doctor or other healthcare professional office/clinic visit. Treatment for the events included steroids (oral & topical) and antihistamines (IV & oral). Outcome of the events was recovered with sequelae (recovered with lasting effects) in Sep2021. The case was reported as non-serious.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events blister, swelling, crying, inflammation, muscle disorder, asthenia, erythema, paraesthesia, rash and arthralgia is assessed to be related. Standard Statement For All Other Sources: BR statement  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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Muscle disorder, Paraesthesia, Rash, Swelling
Clinical narrative: blistering; swelling; weeping; inflammation; loss of some muscle function in joint areas; weakness; redness; pins and needle feeling; LEFT arm, torso, leg unknown rash; Full Body joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), dose 1 via an unspecified route of administration, administered in the left arm on 10Sep2021 at 08:30 in a hospital (Batch/Lot Number: EW0164) at the age of 41-years-old, single, for COVID-19 immunization. Medical history included hypertension and known allergies to sulfa & e-mycins. The patient was not pregnant at the time of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ), and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XL), taken for unspecified indications, start and stop dates were not reported (both medications reported as medications the patient received within 2 weeks of vaccination). On 12Sep2021 at 06:00 PM, the patient experienced left arm, torso, leg unknown rash with blistering, redness, swelling, weeping and inflammation, full body joint pain and inflammation with weakness, pins and needle feeling, and loss of some muscle function in joint areas. The adverse events resulted in an Emergency Room/Department or urgent care visit and a doctor or other healthcare professional office/clinic visit. Treatment for the events included steroids (oral & topical) and antihistamines (IV & oral). Outcome of the events was recovered with sequelae (recovered with lasting effects) in Sep2021. The case was reported as non-serious.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events blister, swelling, crying, inflammation, muscle disorder, asthenia, erythema, paraesthesia, rash and arthralgia is assessed to be related. Standard Statement For All Other Sources: BR statement  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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: vaginal bleeding; Patient is menopausal; This is a spontaneous report from a non-contactable nurse. A non-pregnant 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Sep2021 (Batch/Lot number was not reported), at the age of 65 years old, as dose 3 (booster), single for covid-19 immunisation.  Medical history included hypertension (HTN), asthma, hypothyroidism, known allergies: all walnuts, and menopausal. Not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 after vaccination. Concomitant medications were unknown. No other vaccines within 4 weeks were received prior to COVID vaccine. The patient previously received dose 1 and doe 2 of COVID-19 vaccine (manufacturer unknown) for COVID-19 immunisation. On 28Sep2021, the patient experienced vaginal bleeding 24 HRS after booster (3RD) vaccine. Patient is menopausal and also has been on medication to keep her from bleeding. The patient received megestrol 40MG to stop post-menopausal bleeding. The event was reported as non-serious. The patient has not recovered from the event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of bnt162b2 cannot be excluded for the reported event.     The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate
Age: 41.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dental examination, Myalgia, Oral pain, Pain, Teething
Clinical narrative: aches; I felt like all my teeth were going to fall out; muscular pain; severe mouth pain; tooth pain; This is a spontaneous report from a contactable consumer (patient). A 41-years-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection, Batch/Lot Number: EW0217), dose 1 intramuscular, administered in Deltoid Left on 26Aug2021 around 3-4 pm after work (at the age of 41-Years-old)  as DOSE 1, SINGLE for covid-19 immunisation. The patient received vaccine at Pharmacy or Drug store. The patient's medical history included S/P R thyroidectomy for papillary CA with partial thyroidectomy of Right thyroid from 2007 to 2008, Hypothyroidism which is ongoing. Family medical history included hypertension both sides, gout in father, CKD in mother. Concomitant medication included levothyroxine sodium (SYNTHROID) oral taken for hypothyroidism from 2008 and ongoing. Prior vaccinations were reported as none. On 26Aug2021, the patient experienced severe mouth pain, tooth pain at night-time but especially worse on the right upper side. Visual assessment with minor without any indication of inflammation. Persisted for the next 2-3 weeks with reduction in duration from 20-22hr to 6-12 h, kept up at night to sleep. On 26Aug2021, patient had immediate muscular pain as expected.  On an 27Aug2021, patient had aches and felt like all my teeth were going to fall out. It was reported that every now and then patient will have it. The reporter assessed the event as serious (Persistent/ Significant disability/ Incapacity). Dental visit on 16Sep2021 without findings. The patient underwent lab tests and procedures which included dental examination with no acute findings on 16Sep2021. Therapeutic measures were not taken with respect to severe mouth pain, tooth pain. At the time of this report, the outcome of severe mouth pain, tooth pain was recovered with sequel, aches, I felt like all my teeth were going to fall out was not recovered and muscular pain was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Toothache
Clinical narrative: aches; I felt like all my teeth were going to fall out; muscular pain; severe mouth pain; tooth pain; This is a spontaneous report from a contactable consumer (patient). A 41-years-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection, Batch/Lot Number: EW0217), dose 1 intramuscular, administered in Deltoid Left on 26Aug2021 around 3-4 pm after work (at the age of 41-Years-old)  as DOSE 1, SINGLE for covid-19 immunisation. The patient received vaccine at Pharmacy or Drug store. The patient's medical history included S/P R thyroidectomy for papillary CA with partial thyroidectomy of Right thyroid from 2007 to 2008, Hypothyroidism which is ongoing. Family medical history included hypertension both sides, gout in father, CKD in mother. Concomitant medication included levothyroxine sodium (SYNTHROID) oral taken for hypothyroidism from 2008 and ongoing. Prior vaccinations were reported as none. On 26Aug2021, the patient experienced severe mouth pain, tooth pain at night-time but especially worse on the right upper side. Visual assessment with minor without any indication of inflammation. Persisted for the next 2-3 weeks with reduction in duration from 20-22hr to 6-12 h, kept up at night to sleep. On 26Aug2021, patient had immediate muscular pain as expected.  On an 27Aug2021, patient had aches and felt like all my teeth were going to fall out. It was reported that every now and then patient will have it. The reporter assessed the event as serious (Persistent/ Significant disability/ Incapacity). Dental visit on 16Sep2021 without findings. The patient underwent lab tests and procedures which included dental examination with no acute findings on 16Sep2021. Therapeutic measures were not taken with respect to severe mouth pain, tooth pain. At the time of this report, the outcome of severe mouth pain, tooth pain was recovered with sequel, aches, I felt like all my teeth were going to fall out was not recovered and muscular pain was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dental examination, Neck pain, Oral pain
Clinical narrative: aches; I felt like all my teeth were going to fall out; muscular pain; severe mouth pain; tooth pain; This is a spontaneous report from a contactable consumer (patient). A 41-years-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection, Batch/Lot Number: EW0217), dose 1 intramuscular, administered in Deltoid Left on 26Aug2021 around 3-4 pm after work (at the age of 41-Years-old)  as DOSE 1, SINGLE for covid-19 immunisation. The patient received vaccine at Pharmacy or Drug store. The patient's medical history included S/P R thyroidectomy for papillary CA with partial thyroidectomy of Right thyroid from 2007 to 2008, Hypothyroidism which is ongoing. Family medical history included hypertension both sides, gout in father, CKD in mother. Concomitant medication included levothyroxine sodium (SYNTHROID) oral taken for hypothyroidism from 2008 and ongoing. Prior vaccinations were reported as none. On 26Aug2021, the patient experienced severe mouth pain, tooth pain at night-time but especially worse on the right upper side. Visual assessment with minor without any indication of inflammation. Persisted for the next 2-3 weeks with reduction in duration from 20-22hr to 6-12 h, kept up at night to sleep. On 26Aug2021, patient had immediate muscular pain as expected.  On an 27Aug2021, patient had aches and felt like all my teeth were going to fall out. It was reported that every now and then patient will have it. The reporter assessed the event as serious (Persistent/ Significant disability/ Incapacity). Dental visit on 16Sep2021 without findings. The patient underwent lab tests and procedures which included dental examination with no acute findings on 16Sep2021. Therapeutic measures were not taken with respect to severe mouth pain, tooth pain. At the time of this report, the outcome of severe mouth pain, tooth pain was recovered with sequel, aches, I felt like all my teeth were going to fall out was not recovered and muscular pain was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Vomiting
Clinical narrative: Uncontrollable vomiting/Threw up; Gestation period when reaction/event was observed in the fetus: 15 weeks; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL1283), via an unspecified route of administration, administered in Arm Left on 27Jan2021 (at age of 29 years old) as single dose for COVID-19 immunization. Medical history included Asthma, Known Allergy: sulfa medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications the patient received within 2 weeks of vaccination was prenatal vitamins. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot No: EJ1686) on 08Jan2021 (at age of 29 years old) at arm left as single dose for COVID-19 immunization. Gestation period when reaction/event was observed in the fetus was 15 weeks. Patient last menstrual period date was 12Oct2020. Pregnancy Due Date was 18Jul2021. About 16hrs after second vaccine, on 28Jan2021, patient had uncontrollable vomiting. Couldn't keep down food or water. Threw up 7 times before going to the ER. Date of start of reaction/event was 28Jan2021. No Hospitalization Prolonged. The adverse event result in: Emergency room/department or urgent care. Treatment received for the adverse event (IV Zofran, fluids, bloodwork). The outcome of the event was recovered in 2021.; Sender's Comments: Based on the current available information and the close drug event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event vomiting cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Productive cough, Pulmonary function test, SARS-CoV-2 test
Clinical narrative: cough with mucus/Cough is often productive with yellow or green mucus; Sore throat; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on 07Sep2021 10:00 (Lot Number: FF2588) as DOSE 2, SINGLE for COVID-19 immunization, in the Pharmacy or Drug Store at the age of 27 years old. The patient was not pregnant at time of vaccination. Medical history included COVID from an unknown date prior to vaccination. There were no concomitant medications. The patient previously took BNT162B2, via intramuscular in the left shoulder dose 1 on 12Aug2021 10:00AM, Lot number: FC3180, for COVID-19 immunization at the age of 26 years old. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had COVID-19 tested since the vaccination (negative). The patient was diagnosed with COVID-19 prior to vaccination.The patient experienced cough with mucus and sore throat on 10Sep2021 20:00 with outcome of not recovered. The events resulted in doctor or other healthcare professional office/clinic visit. The sore throat and cough with mucus began 3 days after 2nd dose and has persisted for 3+ weeks. The patient had sore throat followed by cough with onset 3 days after 2nd vaccine dose. At the time of this report, it is now 12Oct2021 with no relief from cough. The patient ested negative for COVID on 19Sep2021. No OTC medication has provided for relief. The patient went to Asthma/Breathing center on 24Sep2021 to rule out adult onset asthma-lungs were reported to be clear, no asthma indicated by breathing tests. Cough is often productive with yellow or green mucus. No treatment given for the events. The outcome of events was not recovered. The cough was persistent, caused significant disability/incapacity.  Follow up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Aspartate aminotransferase, Aspartate aminotransferase increased, Body mass index
Clinical narrative: Elevated ALT for about 2 months; Elevated AST for about 2 months; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A 43-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8737), first dose via an unspecified route of administration, administered in left arm on 09Apr2021 (at the age of 43-year-old) as dose 1, single for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, body mass index from an unknown date and unknown if ongoing BMI>30 / <35. Concomitant medications included vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported; carvedilol (CARVEDILOL) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported. The patient was diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications in two weeks included Vitamin D3, Carvedilol, Losartan. The patient experienced elevated ALT for about 2 months, elevated AST for about 2 months since an unspecified date in Apr2021. It was reported that, "Elevated ALT and AST for about 2 months. Previous results were always within normal range. As an example, on 24Apr2021 AST was 745 and ALT was 1,578. Earlier results were higher, with results returning to normal (20/26) by 14Apr2021". Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient underwent lab tests and procedures which included alanine aminotransferase: elevated on an unspecified date, alanine aminotransferase: 26 (units unspecified) on 14Apr2021, alanine aminotransferase: 1,578 (units unspecified) on 24Apr2021, aspartate aminotransferase: elevated on an unspecified date, aspartate aminotransferase: 20 (units unspecified) on 14Apr2021, aspartate aminotransferase: 745 (units unspecified) on 24Apr2021, body mass index: >30 / <35 on an unspecified date, Sars-Cov-2 test: negative on an unspecified date in Aug2021 Nasal Swab. On 08May2021 the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0173) in left arm, as dose 1, single for COVID-19 immunisation. The patient was tested for COVID-19 since the vaccination. The outcome of the events was reported as resolved on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Elevated ALT for about 2 months; Elevated AST for about 2 months; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A 43-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8737), first dose via an unspecified route of administration, administered in left arm on 09Apr2021 (at the age of 43-year-old) as dose 1, single for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, body mass index from an unknown date and unknown if ongoing BMI>30 / <35. Concomitant medications included vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported; carvedilol (CARVEDILOL) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported. The patient was diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications in two weeks included Vitamin D3, Carvedilol, Losartan. The patient experienced elevated ALT for about 2 months, elevated AST for about 2 months since an unspecified date in Apr2021. It was reported that, "Elevated ALT and AST for about 2 months. Previous results were always within normal range. As an example, on 24Apr2021 AST was 745 and ALT was 1,578. Earlier results were higher, with results returning to normal (20/26) by 14Apr2021". Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient underwent lab tests and procedures which included alanine aminotransferase: elevated on an unspecified date, alanine aminotransferase: 26 (units unspecified) on 14Apr2021, alanine aminotransferase: 1,578 (units unspecified) on 24Apr2021, aspartate aminotransferase: elevated on an unspecified date, aspartate aminotransferase: 20 (units unspecified) on 14Apr2021, aspartate aminotransferase: 745 (units unspecified) on 24Apr2021, body mass index: >30 / <35 on an unspecified date, Sars-Cov-2 test: negative on an unspecified date in Aug2021 Nasal Swab. On 08May2021 the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0173) in left arm, as dose 1, single for COVID-19 immunisation. The patient was tested for COVID-19 since the vaccination. The outcome of the events was reported as resolved on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess, Blood test, Myalgia, Vaccination site discomfort, Vaccination site pain
Clinical narrative: still having pain in the arm at the injection site of the 1st one; it's just a sensation/it feels like bruised on the inside/or something going on in the muscle; It''s just a sensation. It''s like a muscular pain. It feels like someone one, you know, muscle punched me in my arm. It''s feels like bruised on the inside.; muscular abscess; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FD8448) via an unspecified route of administration administered in arm left (bicep) on 19Aug2021 as dose 1, single for COVID-19 immunization (age at vaccination: 54-years-old). The patient medical history included: gastrointestinal issues. Patient did not take any other products or medication. She did not have diabetes or blood pressure issue or anything like that. On an unspecified date the patient reported that it will be 2 months, since she had her first Pfizer shot and she was supposed to go and get her second shot tomorrow but she still having pain in the arm at the injection site of the first shot. She added it was just a sensation, like a muscular pain, it feels like someone, muscle punched me in her arm, it feels like bruised on the inside. She felt like she has been knuckle punched in the arm, like there was a bruise or something going on in the muscle. She did not have any kind of swelling or rash or anything noticeable. She talked to her doctor, and they said that she might need a CT scan in case there was some sort of Abs test, or in case there was some intolerance to the vaccine, to evaluate for a muscular abscess and to determine if the vaccine was administered incorrectly or if was a reaction to the vaccine. She had blood work done at her doctor's office last week or may be 2 weeks before. She was tested for a lot of things. testing for vitamin deficiency mostly because she was just going to have lot of different undecided health issues. She further added that everything was normal on her blood work. There was nothing that they found. They found low vitamin D. The number 20 so, it was kind of low vitamin D." The patient did not received treatment for the events. The outcome of the event still having pain in the arm at the injection site of the 1st one was not recovered, and outcome for rest of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vitamin D
Clinical narrative: still having pain in the arm at the injection site of the 1st one; it's just a sensation/it feels like bruised on the inside/or something going on in the muscle; It''s just a sensation. It''s like a muscular pain. It feels like someone one, you know, muscle punched me in my arm. It''s feels like bruised on the inside.; muscular abscess; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FD8448) via an unspecified route of administration administered in arm left (bicep) on 19Aug2021 as dose 1, single for COVID-19 immunization (age at vaccination: 54-years-old). The patient medical history included: gastrointestinal issues. Patient did not take any other products or medication. She did not have diabetes or blood pressure issue or anything like that. On an unspecified date the patient reported that it will be 2 months, since she had her first Pfizer shot and she was supposed to go and get her second shot tomorrow but she still having pain in the arm at the injection site of the first shot. She added it was just a sensation, like a muscular pain, it feels like someone, muscle punched me in her arm, it feels like bruised on the inside. She felt like she has been knuckle punched in the arm, like there was a bruise or something going on in the muscle. She did not have any kind of swelling or rash or anything noticeable. She talked to her doctor, and they said that she might need a CT scan in case there was some sort of Abs test, or in case there was some intolerance to the vaccine, to evaluate for a muscular abscess and to determine if the vaccine was administered incorrectly or if was a reaction to the vaccine. She had blood work done at her doctor's office last week or may be 2 weeks before. She was tested for a lot of things. testing for vitamin deficiency mostly because she was just going to have lot of different undecided health issues. She further added that everything was normal on her blood work. There was nothing that they found. They found low vitamin D. The number 20 so, it was kind of low vitamin D." The patient did not received treatment for the events. The outcome of the event still having pain in the arm at the injection site of the 1st one was not recovered, and outcome for rest of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Early menstruation. Period was a a week early following the second dose of the pfizer vaccine. This is highly abnormal for body.; 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: UNKNOWN) via an unspecified route of administration in the left arm on 21Sep2021 at 14:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported.  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 vaccination. Concomitant medications were not reported. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Aug2021 at 14:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 07Oct2021, the patient experienced early menstruation. Following the second dose of the vaccine, the patient's period was a week early, which was highly abnormal for her body. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event early menstruation was unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.