chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Haematemesis, Haemoptysis, Headache, Thrombosis
Clinical narrative: coughed clots of blood; her head started to hurt from thinking about what happened; After it happened, when she started to cough blood, it has not occurred again. Caller previously stated the condition had worsened; threw blood; describes it as a blood clot; This is a spontaneous report from a contactable consumer (patient).  A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 02Aug2021 10:00 (Lot Number: EW0180) at the age of 55-year-old as single dose for covid-19 immunisation.  Medical history included covid-19 and cough.  Prior vaccinations, no other vaccinations within four weeks prior to the first administration was taken. There was no family medical history relevant to events. No relevant tests were done. The patient's concomitant medications were not reported. Caller received the first dose of the Pfizer Covid-19 vaccine on Monday 02Aug2021, before she got the vaccine he told the vaccine administrator that she had had Covid-19 and as a consequence still had cough so she asked if she could get the vaccine and they said yes, from time to time she coughs, it is not very often but when it happens it hits her strong and coughs phlegm. She usually coughs, but today, the cough has blood in it.  She coughed up clotted blood.  About 10 minutes ago she coughed but instead of expelling phlegm, she threw blood, she describes it as a blood clot in Aug2021, she didn't know if it was because of the coughing effort, she would like to know if this may be due to the vaccine. She also mentioned that after this her head started to hurt from thinking about what happened on 05Aug2021. It happened 10 minutes ago. Patient confirmed information above.  Instead of phlegm, she coughed clots of blood on 05Aug2021. She had been coughing the whole time before she got the shot.  After it happened, when she started to cough blood, it has not occurred again. Caller previously stated the condition had worsened in Aug2021. She was not on any medication.  She only took paracetamol (TYLENOL) for the pain.  These events did not require emergency room or physician office.  She was going to call the clinic to see if she can be checked, but had not been yet.  Outcome of coughed clots of blood and when she started to cough blood, it has not occurred again/previously stated the condition worsened was not recovered, of other events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Condition aggravated, Cough, Interstitial lung disease, SARS-CoV-2 test
Clinical narrative: Interstitial fibrosis in lungs; Cough started; Cough started and progressively got worse; This is a spontaneous report from a contactable healthcare professional (patient). A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 07May2021 at 12:30 (Batch/Lot Number: ER8736) (at the age of 62-years-old) as dose 1, single for COVID-19 immunisation. Medical history included pulmonary fibrosis, fibromyalgia, lyme disease, chronic fatigue, right bundle branch block (RBBB), hypertension (HTN), gastrooesophageal reflux disease with esophagitis, depression, anxiety (ANX), restless leg syndrome (RLS), asthma, overactive bladder (OAB), clinical hypothyroid, obstructive sleep apnea, notalgia paresthetica, dysesthesia, osteoarthritis, polymyalgia, Obsessive-compulsive disorder (OCD), penicillin allergy, latex allergy, adhesive tape allergy, soy allergy, egg allergy, allergy to cow's milk, food allergy (Corn, Sugarbeet, Wheat, Peanut butter) and had COVID-19 prior to vaccination. Concomitant medications included losartan; thyroid; ropinirole hydrochloride (REQUIP); celecoxib (CELEXA); bupropion hydrochloride (WELLBUTRIN XL); all taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR), albuterol sulfate, budesonide, formoterol fumarate (SYMBICORT); all taken for asthma, start and stop date were not reported. The patient previously took allopurinol (ELAVIL), azithromycin (Z-PAK), gabapentin and experienced drug allergy. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 10May2021, cough started and progressively got worse. Patient was on Symbicort INH and albuterol INH already for asthma. Patient was also taking Singulair. Patient was put on a tapering dose of prednisone 50 mg a day for 2 days, then 40 mg a day for 2 days, 30 mg for 2 days, 20 mg for 2 days, 10 mg for 2 days then stopped. Patient still have the cough. Chest x-rays on 10May2021, showed interstitial fibrosis in lungs. The patient received prednisone taper, Symbicort and albuterol as treatment for the events. The patient underwent nasal swab (COVID-19 test) on 27May2021 with negative result. Outcome of events was resolved with sequel (as reported).
Sex: U
Vaccine: COVID19
Symptoms: Abdominal distension, Blood test, Breast tenderness, Mammogram, Postmenopausal haemorrhage
Clinical narrative: developed menstruation; stomach bloating; breast tenderness; This is a spontaneous report from contactable consumers (one is the patient). A 59-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 intramuscular, administered in right arm on 15Mar2021 (Batch/Lot Number: EN6206) as dose 1, single for covid-19 immunisation. Medical history included tonsillectomy from 1969, c-section from 1990 and 1993, removal of benign Ovarian polyp from 2011, seasonal allergies and 18 months post menopause. Family history included mother: breast cancer three times, at 55 years menopause, alive-well receptor negative, lumpectomy radiation whole breast, Stage 1, lymph nodes negative; at 71 years old, mastectomy (Same breast as above), lymph node negative, Stage 1, Arimidex /15 years and at 83 years old, invasive ductal carcinoma, lumpectomy pinpoint radiation, accelerated partial, breast irradiation (APBI), receptor post-2016-open heart Surgery (BRCA negative) and father: died of medullary thyroid cancer (not carrier). Concomitant medications included ongoing fexofenadine hydrochloride (ALLEGRA) taken for seasonal allergies, ongoing fluticasone propionate (FLONASE ALLERGY RELIEF) taken for seasonal allergies, and ongoing calcium carbonate, colecalciferol (CALCIUM & VITAMIN D3). On 22Mar2021, one week after receiving first dose, the patient developed menstruation. Symptoms included stomach bloating and breast tenderness. The patient was 18 months post menopause. The patient underwent lab tests and procedures which included routine blood test: excellent negative in Aug2020 (yearly well checkup) and yearly mammogram: negative in Aug2020. The patient received 2nd dose of bnt162b2 on 06Apr2021 and got her period that lasted for 4 days and was very light. Outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Loss of personal independence in daily activities, Pain
Clinical narrative: The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 05Aug2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in arm left on 28Jul2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. There were no medical history and concomitant medications. No investigation assessment. Two days after her first injection (as reported) her left arm and fingers started going numb from the elbows down on 28Jul2021. She did not have strength used to have in her left hand and fingers. As a result that she was unable to button clips on bra, cannot open bottles or containers, cannot hold onto or grip things like steering wheel can hold wheel straight but if turn cannot use left hand safely enough. It comes and goes and is not constant. Today it hurts really bad. She cannot use her fingers to type correctly today. Seriousness of the events is medically significant and at times disabling. Her strength was affecting her daily living. She had not had a stroke but feels that way on that side. Treatment included she was taking prescription steroids. The outcome of events was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: A causal relationship between BNT162B2 and the reported events cannot be excluded based on temporal association.  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 .
Sex: U
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis
Clinical narrative: she has a patient who's symptoms sound like they have Hashimoto's and it started after the Pfizer COVID vaccine was given in 2 days; This is a spontaneous report from a contactable Nurse via Pfizer sponsored program. A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, patient who's symptoms sound like they have Hashimoto's and it started after the Pfizer COVID vaccine was given in 2 days. Reporter also asking if the Pfizer COVID vaccine could trigger a flare up for a patient with Hashimoto's disease. Reporter stated she had a 14 year old patient with muscular dystrophy (specifically Becker Muscular Dystrophy) and is on preventative a cardiac medication lisinopril for 5 years. Reporter was requesting if there is any data regarding vaccine use in patients with muscular dystrophy and if the vaccine would be recommended for young men with those conditions. In response provided disclaimer that Pfizer is unable to make treatment recommendations on a case by case basis for individual patients and mentioned Contraindications in EUA PI. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information given in narrative, the causal relationship between the event Hashimoto's disease and the suspect vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Sex: F
Vaccine: COVID19
Symptoms: Fall, Gait inability
Clinical narrative: fall; She is currently homebound unable to walk; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 22Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. She was just discharged from the hospital due to a fall.  She is currently homebound unable to walk. She states the hospitalization was not due to vaccine. Her first dose was administered at her house by an ambulance.  She is calling to see how to schedule her second dose. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: She has a UTI and was hospitalized; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0217), via an unspecified route of administration on 07Jul2021 at dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of the Pfizer COVID-19 vaccine on 07Jul2021 and the second dose was scheduled for 28Jul2021. After her first dose, she experienced urinary tract infection (UTI) on an unspecified date in 2021 and was hospitalized from an unspecified date in 2021. She was now in a rehab facility and would like to have someone come out to give her the second dose of the vaccine. For her first dose, she called the state health department and they sent someone to give her the vaccine. She then stated that she has been on the phone for 2 hours and has 5 numbers that she called, and she would just like to schedule her second dose. She stated, "I just want my second dose, but I guess they just want me to die". The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: C-reactive protein, C-reactive protein increased, Cyst, Fatigue, Full blood count
Clinical narrative: infection; CBC/16.7/high; CRP/11.80/high; inflammation; felt that existing bump on my neck is more bigger/bump on top of it; difficulty moving my neck/ head area; fatigue; fever; body aches/pain; felt more swollen lymph nodes at my jaw area & my back neck area/bump/ lymph node in my neck; stiffness; cyst; This is a spontaneous report from a contactable consumer (patient). A 39-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular, administered in arm right (also reported as R upper arm) on 08Feb2021 18:00 (Lot Number: EM9810) as dose 2, single (at the age of 39 years old) for COVID-19 immunisation. Medical history and family history included ongoing diabetes. Concomitant medications included metformin and glimepiride taken for diabetes mellitus; ascorbic acid (VIT C), vit d [vitamin d nos] (VIT D [VITAMIN D NOS]) and fish oil taken for supplements; all from an unspecified start date and ongoing. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular administered in right (R) upper arm on 18Jan2021 06:00 pm (Lot number: EL3247) as dose 1, single (at the age of 39 years old) for COVID-19 immunisation and experienced body aches, swollen lymph node, mild discomfort, 4/10 pain, bump on neck. It was reported that comes the second dose, after like 17 hours (09Feb2021 11:00), patient felt so fatigue, fever, body aches and "felt that the existing bump in my neck is more bigger and felt a marble like cyst/ bump on top of it. Felt more swollen lymph nodes at my jaw area & my back neck area (also reported as back of the neck area). Felt pain, stiffness and had some difficulty moving my neck/ head area so went to the hospital for a check". Patient was advised to take round the clock TYLENOL. Stated that "Till now the bump/ lymph node in my neck remains". The patient underwent lab tests and procedures on 04May2021 which included c-reactive protein (CRP): 11.80 (high, consider since of inflammation/ infection) and complete blood count (CBC): 16.7 (high). Therapeutic measures were taken as a result of body aches/pain, stiffness, difficulty moving my neck/ head area. The outcome of the event "felt that existing bump on my neck is more bigger/bump on top of it" and "felt more swollen lymph nodes at my jaw area & my back neck area/bump/ lymph node in my neck" was not recovered while unknown for the other events.  The patient provided information regarding the reported adverse events with the use of the product. It was considered that Pfizer product had a causal effect to the adverse event.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Full blood count abnormal, Infection, Inflammation, Lymphadenopathy, Movement disorder
Clinical narrative: infection; CBC/16.7/high; CRP/11.80/high; inflammation; felt that existing bump on my neck is more bigger/bump on top of it; difficulty moving my neck/ head area; fatigue; fever; body aches/pain; felt more swollen lymph nodes at my jaw area & my back neck area/bump/ lymph node in my neck; stiffness; cyst; This is a spontaneous report from a contactable consumer (patient). A 39-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular, administered in arm right (also reported as R upper arm) on 08Feb2021 18:00 (Lot Number: EM9810) as dose 2, single (at the age of 39 years old) for COVID-19 immunisation. Medical history and family history included ongoing diabetes. Concomitant medications included metformin and glimepiride taken for diabetes mellitus; ascorbic acid (VIT C), vit d [vitamin d nos] (VIT D [VITAMIN D NOS]) and fish oil taken for supplements; all from an unspecified start date and ongoing. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular administered in right (R) upper arm on 18Jan2021 06:00 pm (Lot number: EL3247) as dose 1, single (at the age of 39 years old) for COVID-19 immunisation and experienced body aches, swollen lymph node, mild discomfort, 4/10 pain, bump on neck. It was reported that comes the second dose, after like 17 hours (09Feb2021 11:00), patient felt so fatigue, fever, body aches and "felt that the existing bump in my neck is more bigger and felt a marble like cyst/ bump on top of it. Felt more swollen lymph nodes at my jaw area & my back neck area (also reported as back of the neck area). Felt pain, stiffness and had some difficulty moving my neck/ head area so went to the hospital for a check". Patient was advised to take round the clock TYLENOL. Stated that "Till now the bump/ lymph node in my neck remains". The patient underwent lab tests and procedures on 04May2021 which included c-reactive protein (CRP): 11.80 (high, consider since of inflammation/ infection) and complete blood count (CBC): 16.7 (high). Therapeutic measures were taken as a result of body aches/pain, stiffness, difficulty moving my neck/ head area. The outcome of the event "felt that existing bump on my neck is more bigger/bump on top of it" and "felt more swollen lymph nodes at my jaw area & my back neck area/bump/ lymph node in my neck" was not recovered while unknown for the other events.  The patient provided information regarding the reported adverse events with the use of the product. It was considered that Pfizer product had a causal effect to the adverse event.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck mass, Pain, Pyrexia
Clinical narrative: infection; CBC/16.7/high; CRP/11.80/high; inflammation; felt that existing bump on my neck is more bigger/bump on top of it; difficulty moving my neck/ head area; fatigue; fever; body aches/pain; felt more swollen lymph nodes at my jaw area & my back neck area/bump/ lymph node in my neck; stiffness; cyst; This is a spontaneous report from a contactable consumer (patient). A 39-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular, administered in arm right (also reported as R upper arm) on 08Feb2021 18:00 (Lot Number: EM9810) as dose 2, single (at the age of 39 years old) for COVID-19 immunisation. Medical history and family history included ongoing diabetes. Concomitant medications included metformin and glimepiride taken for diabetes mellitus; ascorbic acid (VIT C), vit d [vitamin d nos] (VIT D [VITAMIN D NOS]) and fish oil taken for supplements; all from an unspecified start date and ongoing. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular administered in right (R) upper arm on 18Jan2021 06:00 pm (Lot number: EL3247) as dose 1, single (at the age of 39 years old) for COVID-19 immunisation and experienced body aches, swollen lymph node, mild discomfort, 4/10 pain, bump on neck. It was reported that comes the second dose, after like 17 hours (09Feb2021 11:00), patient felt so fatigue, fever, body aches and "felt that the existing bump in my neck is more bigger and felt a marble like cyst/ bump on top of it. Felt more swollen lymph nodes at my jaw area & my back neck area (also reported as back of the neck area). Felt pain, stiffness and had some difficulty moving my neck/ head area so went to the hospital for a check". Patient was advised to take round the clock TYLENOL. Stated that "Till now the bump/ lymph node in my neck remains". The patient underwent lab tests and procedures on 04May2021 which included c-reactive protein (CRP): 11.80 (high, consider since of inflammation/ infection) and complete blood count (CBC): 16.7 (high). Therapeutic measures were taken as a result of body aches/pain, stiffness, difficulty moving my neck/ head area. The outcome of the event "felt that existing bump on my neck is more bigger/bump on top of it" and "felt more swollen lymph nodes at my jaw area & my back neck area/bump/ lymph node in my neck" was not recovered while unknown for the other events.  The patient provided information regarding the reported adverse events with the use of the product. It was considered that Pfizer product had a causal effect to the adverse event.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracted COVID after being vaccinated; contracted COVID after being vaccinated; This is a spontaneous report from a contactable other healthcare professional (patient) (as reported). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient contracted COVID after being vaccinated on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective / COVID-19 cannot be ruled out.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Presyncope, Productive cough, Pyrexia
Clinical narrative: almost passed out; a high grade of fever temperature 102.9 degrees Fahrenheit; coughing up green stuff; Every bone in body hurt; Tinnitus got really bad; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 04Aug2021 (at 54-year-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing tinnitus, he was under the care of the medical facility for his tinnitus and they were giving him hearing aids soon, he has had tinnitus for about 4 years from working; ongoing penicillin allergy. There were no concomitant medications. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the pfizer suspect. No other vaccinations within four weeks. The patient stated that last night (04Aug2021) tinnitus got really bad. On 05Aug2021 the patient experienced was having a high grade of fever temperature 102.9 degrees Fahrenheit. It's dropping down some 102F. He stated that this started around lunch time. It was currently down to 100.8 degrees Fahrenheit. It was decreasing fast. The patient experienced coughing up green stuff on 05Aug2021. He had been trying not to do it because when he did cough he almost passed out. The patient experienced every bone in body hurt, started in the morning of 05Aug2021 and had gotten worse. He thought it may have plateaued out. He stated maybe it was from the fever. It was also reported that his fever was 102.7 on 05Aug2021. He was going to call 911. The events did not result in emergency room visit or physician office visit. The seriousness of the events was unspecified. The outcome of the events almost passed out, coughing up green stuff, every bone in body hurt was not recovered; outcome of event Fever was recovering; outcome of event tinnitus got really bad was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: almost passed out; a high grade of fever temperature 102.9 degrees Fahrenheit; coughing up green stuff; Every bone in body hurt; Tinnitus got really bad; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 04Aug2021 (at 54-year-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing tinnitus, he was under the care of the medical facility for his tinnitus and they were giving him hearing aids soon, he has had tinnitus for about 4 years from working; ongoing penicillin allergy. There were no concomitant medications. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the pfizer suspect. No other vaccinations within four weeks. The patient stated that last night (04Aug2021) tinnitus got really bad. On 05Aug2021 the patient experienced was having a high grade of fever temperature 102.9 degrees Fahrenheit. It's dropping down some 102F. He stated that this started around lunch time. It was currently down to 100.8 degrees Fahrenheit. It was decreasing fast. The patient experienced coughing up green stuff on 05Aug2021. He had been trying not to do it because when he did cough he almost passed out. The patient experienced every bone in body hurt, started in the morning of 05Aug2021 and had gotten worse. He thought it may have plateaued out. He stated maybe it was from the fever. It was also reported that his fever was 102.7 on 05Aug2021. He was going to call 911. The events did not result in emergency room visit or physician office visit. The seriousness of the events was unspecified. The outcome of the events almost passed out, coughing up green stuff, every bone in body hurt was not recovered; outcome of event Fever was recovering; outcome of event tinnitus got really bad was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased, Thyroid function test
Clinical narrative: Her TSH was very elevated/TSH was 3 times out of normal range at 14.69/ on 01Mar2021 result was 14.16/on 04May2021 result was 6.6; This is a spontaneous report from a contactable nurse, the patient. This 78-year-old female patient reported for herself that she received the second dose of BNT162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Lot number: Unknown) via an unspecified route on 13Feb2021 (at the age of 78-years-old) as a single dose for COVID-19 immunization. Medical history included diagnosis of Hashimoto's hypothyroidism last year (2020). Concomitant medication included levothyroxine sodium (SYNTHROID) since early 1980s for hypothyroidism; she is trying to regulate her dose of her medication. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: unknown) via unspecified route on 23Jan2021 as a single dose for COVID-19 immunization. Patient reported that she had a routine lab test on 01Mar2021 which was abnormal. The other parameters for thyroid panel were within normal limits, but her TSH was very elevated. Her TSH was 3 times out of normal range at 14.69, with the range being 0.40-4.50.  When she got the first set of results, she thought there was a lab error and drew them again. TSH was redrawn on 11Mar2021 and the result was 14.16 and another lab draw on 04May2021 with the result of 6.6. She stated the only thing that is different, is that she had taken the vaccines. She also stated she is being followed by an endocrinologist. The outcome of the event was unknown.  The lot/batch number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Pregnancy test, SARS-CoV-2 test, Urticaria, Vision blurred
Clinical narrative: Blurred vision; Hives on neck; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection), intramuscular, administered in Arm Left on 12Jul2021 13:05 (Batch/Lot Number: EW0181) as SINGLE for covid-19 immunization. Medical history included EMR colon surgery from 01Jun2021 to an unknown date. This was 3 weeks before the vaccine and polypectomy from 17May2021 to an unknown date. There were no concomitant medications was reported. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection), intramuscular, administered in Arm Left on 21Jun2021 13:00 (Batch/Lot Number: EW0180) as SINGLE for covid-19 immunization and developed Covid arm rash. On 14Jul2021 18:30, the patient had hives on neck whereas, blurred vision on 15Jul2021 18:30. The patient underwent lab tests and procedures which included EKG as normal on 28May2021, pregnancy Test (Blood work) as normal on 28May2021. Also, the patient underwent covid test as negative on 16Nov2020, 14May2021, 30May2021 and on 13Jun2021. The outcome of events was recovered on an unknown date.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: the bleeding has not stopped for approximately 100 days; This is a spontaneous report received from a contactable consumer (patient) via company representative. A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 12Apr2021 as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included levetiracetam (KEPPRA), from unspecified date. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on unspecified date as dose 1, single for COVID-19 immunization. It was reported that patient received second dose on 12Apr2021 and on 26Apr2021 began menstruating (normal cycle time) but the bleeding had not stopped for approximately 100 days. She took KEPPRA. Otherwise healthy and normal. The event took place after use of product. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Atrial fibrillation, Thrombosis
Clinical narrative: blood clots; A-fib; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 58-year-old patient of an unspecified gender received bnt162b2 (BNT162B2), via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation; and tofacitinib citrate (XELJANZ), via an unspecified route of administration from 2018 (Batch/Lot number was not reported) to an unspecified date at unknown dosing regimen for an unspecified indication. The patient's medical history and concomitant medications were not reported. The reporter stated that the patient had blood clots and A-fib (2021) while on Xeljanz. The reporter also mentioned that the patient had Covid vaccine on Feb2021 and the clots in Jul2021. It was added that the events took place after the use of the product. The action taken in response to the events for tofacitinib citrate was unknown. The outcome of the events was unknown.; Sender's Comments: Based on available information, a contributory role of suspect drugs bnt162b2 (BNT162B2) and tofacitinib citrate (XELJANZ), with the reported atrial fibrillation and thrombosis cannot be excluded. Additional information including complete clinical course, medical history, action taken with the suspect products, and event outcome, would be helpful in assessing this case.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: menopause for 11 years/About 2 months after her 2nd shot had light bleeding for about 3 weeks; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (Lot Number: EN 8729), dose 2 via an unspecified route of administration, administered in arm left on 10Apr2021 (at the age of 61-years-old) as dose 2, single for COVID-19 immunization. Medical history included asthma, Hashimoto's hypothyroidism, migraine headaches and menopause. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (Lot Number: EN 6207), administered in right arm on 19Mar2021 (at the age of 60-years-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was in menopause for 11 years and have never had vaginal bleeding since. About 2 months after her 2nd shot on 05Jun2021, the patient had light bleeding for about 3 weeks. The patient received no treatment for the event. The patient recovered from the event on unspecified date.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Postmenopausal haemorrhage
Clinical narrative: She is postmenopausal 3-4 years/had her menstrual cycle from 15Jul2021-30Jul2021; It was heavy with clots; This is a spontaneous report from a contactable physician. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 14Jul2021 (Batch/Lot number was not reported) (at the age of 51-year-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at time of vaccination. The patient had no COVID-19 prior to vaccination. The patient's medical history included postmenopausal (3-4 years). Concomitant medications were not reported. The patient received the first vaccine on 14Jul2021, and she had her menstrual cycle from 15Jul2021-30Jul2021. It was heavy with clots. She is postmenopausal 3-4 years. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events which included patient was sent for Ultrasound to r/o other cause of post-menopausal bleeding. It was unknown if the patient has been tested for COVID-19 since the vaccination. The outcome of the events was recovered on 30Jul2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event of Postmenopausal bleeding and Heavy periods. 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.
Sex: M
Vaccine: COVID19
Symptoms: Neonatal respiratory distress
Clinical narrative: Respiratory distress; Pneumothorax; This is a spontaneous report from a contactable nurse (patient's mother). This nurse reported for both mother and baby. This is the baby case.   A 34-year-old mother received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 30Apr2021 15:00 approx as dose 1, single and on 14May2021 15:00 approx (lot number: EW0153) as dose 2; intramuscular in the left deltoid for COIVD-19 immunization. The male neonatal patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via transplacental. Mother's medical history includes anxiety, insomnia and pericarditis with pericardial effusion Jun2019. The mother did not smoke, drink or illicit drug use during this pregnancy. The patient's medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO), minerals NOS, vitamins NOS (PRENATAL VITAMINS), diphenhydramine hydrochloride (UNISOM), zolpidem tartrate (AMBIEN) and anti-D immunoglobulin (RHOGAM). On 14May2021, the mother received 2nd dose of vaccination, 29 weeks and 3 days pregnant. On 15May2021 (as reported), the patient started having contractions. On 14May2021, the mother went to labor and delivery, admitted for preterm labor. The mother delivered premature live birth on 28Jun2021 at 36 weeks due to IUGR & oligohydramnios via C-section. Apgar score: 1min 6; 5min 7. The baby (patient) stayed 1 week in the NICU due to respiratory distress and pneumothorax. It was reported that this may or may not be all related to the COVID vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021691803 mother case
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Arthralgia, Heavy menstrual bleeding, Inappropriate schedule of product administration, Ovarian cyst
Clinical narrative: no period prior to vaccine , post menopausal x 5 years.; right ovarian cyst; heavy bleeding daily( still to this day)/Menorrhagia; joint pain; hair loss; first dose:05Mar2021; second dose: 05Mar2021; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration administered in left arm on 05Mar2021 (Batch/Lot Number: EN6206) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in left arm on 05Mar2021 (Batch/Lot Number: ER8727) as DOSE 2, SINGLE for covid-19 immunisation at Hospital. No other vaccine in four weeks. No other medications in two weeks. The patient did not have covid prior vaccination. No known allergies nor other medical history. The patient's concomitant medications were not reported. On 05Apr2021, the patient experienced menorrhagia, heavy bleeding daily (still to this day), no period prior to vaccine, post menopausal x 5 years. joint pain, hair loss, right ovarian cyst. Surgery for endometrial ablation and cystectomy scheduled for Sep2021. The events resulted in Doctor or other healthcare professional office/clinic visit. The treatment for events included ultrasound, biopsy, surgery scheduled. The covid tested post vaccination included Nasal Swab on 29Jul2021 with negative result. The patient was not recovered form the events, outcome of 'first dose:05Mar2021; second dose: 05Mar2021' was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage, SARS-CoV-2 test
Clinical narrative: no period prior to vaccine , post menopausal x 5 years.; right ovarian cyst; heavy bleeding daily( still to this day)/Menorrhagia; joint pain; hair loss; first dose:05Mar2021; second dose: 05Mar2021; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration administered in left arm on 05Mar2021 (Batch/Lot Number: EN6206) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in left arm on 05Mar2021 (Batch/Lot Number: ER8727) as DOSE 2, SINGLE for covid-19 immunisation at Hospital. No other vaccine in four weeks. No other medications in two weeks. The patient did not have covid prior vaccination. No known allergies nor other medical history. The patient's concomitant medications were not reported. On 05Apr2021, the patient experienced menorrhagia, heavy bleeding daily (still to this day), no period prior to vaccine, post menopausal x 5 years. joint pain, hair loss, right ovarian cyst. Surgery for endometrial ablation and cystectomy scheduled for Sep2021. The events resulted in Doctor or other healthcare professional office/clinic visit. The treatment for events included ultrasound, biopsy, surgery scheduled. The covid tested post vaccination included Nasal Swab on 29Jul2021 with negative result. The patient was not recovered form the events, outcome of 'first dose:05Mar2021; second dose: 05Mar2021' was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Appendicitis, Influenza like illness, Laboratory test
Clinical narrative: Patient was taken to ER on 29May2021 where tests confirmed appendicitis; patient developed flu like symptoms; abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 13-year-old male patient received bnt162b2 (BNT162B2, Lot Number: Ew0177), dose 1 via an unspecified route of administration, administered in left arm on 26May2021 15:30 (at the age of 13-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took azithromycin (Zithromax) and amoxicillin;clavulanic acid (AUGMENTIN), and experienced hives to both drugs. 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 developed flu like symptoms and abdominal pain on 28May2021 at 10:30 AM, requiring pick up from school. Patient was taken to ER on 29May2021 where tests confirmed appendicitis. The patient received surgery on 30May2021. The adverse events resulted in Emergency room/department or urgent care. The patient was hospitalized in May2021 for 1 day due to the reported events. Therapeutic measures were taken as a result of the events. The patient recovered from the events on unspecified date in 2021.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Lymphadenopathy, Nodule, Pain, Peripheral swelling
Clinical narrative: on the opposite arm she had a knot on her right wrist/in between the forearm and underarm the skin was also knots; the knots on her arm might be a reflex of swollen lymph nodes; Arthritis; on the bottom of her thumb got swollen and another know developed; she had severe pain; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 59-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced had severe pain on 02Aug2021 (2 hours after vaccine administration) with outcome of unknown, on the opposite arm she had a knot on her right wrist/in between the forearm and underarm the skin was also knots on 03Aug2021 with outcome of unknown, the knots on her arm might be a reflex of swollen lymph nodes on 03Aug2021 with outcome of unknown, arthritis on 03Aug2021 with outcome of unknown, and on the bottom of her thumb got swollen and another 'know' developed on 03Aug2021 with outcome of unknown.  The patient underwent lab tests and procedures which included  ultrasound of her veins, then her doctor told her she had two things going on: Arthritis and the knots on her arm might be a reflex of swollen lymph nodes on 04Aug2021. The events involved emergency room visit.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: on the opposite arm she had a knot on her right wrist/in between the forearm and underarm the skin was also knots; the knots on her arm might be a reflex of swollen lymph nodes; Arthritis; on the bottom of her thumb got swollen and another know developed; she had severe pain; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 59-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced had severe pain on 02Aug2021 (2 hours after vaccine administration) with outcome of unknown, on the opposite arm she had a knot on her right wrist/in between the forearm and underarm the skin was also knots on 03Aug2021 with outcome of unknown, the knots on her arm might be a reflex of swollen lymph nodes on 03Aug2021 with outcome of unknown, arthritis on 03Aug2021 with outcome of unknown, and on the bottom of her thumb got swollen and another 'know' developed on 03Aug2021 with outcome of unknown.  The patient underwent lab tests and procedures which included  ultrasound of her veins, then her doctor told her she had two things going on: Arthritis and the knots on her arm might be a reflex of swollen lymph nodes on 04Aug2021. The events involved emergency room visit.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest discomfort, Decreased appetite, Fatigue, Pain in extremity
Clinical narrative: heart felt like it was fluttering; Had no appetite; felt like something was sitting on chest; Slept all day; felt tired; sore arm/arm hurt very badly; This is a spontaneous report from a contactable consumer. A 12-year-old male patient received bnt162b2, intramuscular, administered in Arm Left on 12Jul2021 17:00 (Lot Number: ew0181) as DOSE 1, SINGLE at age of 12-year-old for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced heart felt like it was fluttering on 13Jul2021 19:00, sore arm/arm hurt very badly on 12Jul2021 19:00, felt tired on 13Jul2021, had no appetite on 13Jul2021 19:00, felt like something was sitting on chest on 13Jul2021 19:00, slept all day on 13Jul2021 19:00. Evening had sore arm. Next morning felt tired and arm hurt very badly. Had no appetite. Evening of next day felt like something was sitting on chest and heart felt like it was fluttering. Slept all day and next day woke up felt ok. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.