chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin, Haemoglobin decreased, Heavy menstrual bleeding, Menstruation delayed, SARS-CoV-2 test
Clinical narrative: period was 1 week late; extremely heavy bleeding during last period; extremely heavy bleeding during last period,  3 weeks prior to period had light bleeding for whole 3 weeks. my period was 1 week late. my hemoglobin dropped from 11 to 7.5 after having my period; This is a spontaneous report from a contactable other nurse (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 27Sep2021 09:00 (Batch/Lot Number: 30145bh) as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration, administered in Arm Left on 18Oct2021 09:00 (Batch/Lot Number: fe3590) as dose 2, single for Covid-19 immunisation. The patient was non-pregnant 31-year-old at the time of vaccination. Medical history included sleep apnoea syndrome. 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 Levaquin, Advair, Solumedrol, and Benadryl and experienced allergy. On 05Oct2021, the patient experienced extremely heavy bleeding during last period, 3 weeks prior to period had light bleeding for whole 3 weeks. Her period was 1 week late. My hemoglobin dropped from 11 to 7.5 after having my period. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events as reported "not given blood in ER now get iron transfusion". The patient underwent lab tests and procedures which included haemoglobin: 7.5 on Oct2021, haemoglobin: 11 on Oct2021, and PCT test: negative on 19Oct2021. The outcome of events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of Menstruation delayed, Heavy menstrual bleeding and Haemoglobin decreased. 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: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Feeling abnormal, Hypoaesthesia, Hypotension
Clinical narrative: Booster; She woke up and could not move at all like she was dead; She took her blood pressure and first she had no pressure; She felt like she would pass out; She felt dizzy like she would pass out; Her left arm felt numb; Her lymph node under her arm was inflamed; This is a spontaneous report from a contactable registered nurse (patient).  A female patient of an unspecified age received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Oct2021 at 09:00, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient previously received the first and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose, for COVID-19 immunisation. Nurse stated that she wanted report serious side effects after she received the booster shot from the hospital. On an unspecified date, in Oct2021, the patient felt dizzy, she felt like she would pass out, her left arm felt numb, her lymph node under her arm was inflamed, she woke up and could not move at all like she was dead. She took her blood pressure and first she had no pressure.   The adverse events were described as "patient woke up and could not move at all like she was dead. She went to the bathroom and felt like she would pass out. Stated that she wanted to call 911 and she put salt under tongue and drank a lot of water. Stated that she put her feet up on the sofa. Stated that she took her blood pressure and first she had no pressure. Stated that she drank more water. Stated that she felt dizzy like she would pass out. Stated that checked her pressure and it came up 77/33. No further details provided. Stated that her pressure today (22Oct2021) is in the 120s and yesterday it was in the 110s (21Oct2021). Stated that her lymph node under her arm was inflamed. Stated was in the left arm where she had the vaccine". Clinical outcome of the adverse events was unknown at time of this report.   The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a possible causal association between the events and 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.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenitis, Movement disorder
Clinical narrative: Booster; She woke up and could not move at all like she was dead; She took her blood pressure and first she had no pressure; She felt like she would pass out; She felt dizzy like she would pass out; Her left arm felt numb; Her lymph node under her arm was inflamed; This is a spontaneous report from a contactable registered nurse (patient).  A female patient of an unspecified age received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Oct2021 at 09:00, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient previously received the first and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose, for COVID-19 immunisation. Nurse stated that she wanted report serious side effects after she received the booster shot from the hospital. On an unspecified date, in Oct2021, the patient felt dizzy, she felt like she would pass out, her left arm felt numb, her lymph node under her arm was inflamed, she woke up and could not move at all like she was dead. She took her blood pressure and first she had no pressure.   The adverse events were described as "patient woke up and could not move at all like she was dead. She went to the bathroom and felt like she would pass out. Stated that she wanted to call 911 and she put salt under tongue and drank a lot of water. Stated that she put her feet up on the sofa. Stated that she took her blood pressure and first she had no pressure. Stated that she drank more water. Stated that she felt dizzy like she would pass out. Stated that checked her pressure and it came up 77/33. No further details provided. Stated that her pressure today (22Oct2021) is in the 120s and yesterday it was in the 110s (21Oct2021). Stated that her lymph node under her arm was inflamed. Stated was in the left arm where she had the vaccine". Clinical outcome of the adverse events was unknown at time of this report.   The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a possible causal association between the events and 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: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Investigation, Paraesthesia
Clinical narrative: Getting numbness in right hand real bad; tingling in my left hand and in my feet sometimes; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received bnt162b2 (BNT162B2 reported as Pfizer COVID 19 Vaccine), at vaccination age of 72-year-old via an unspecified route of administration on 13Apr2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history included blockage in heart and has got congestive heart problem. Concomitant medications included apixaban (ELIQUIS); isosorbide mononitrate; torasemide (TORSEMIDE); and clopidogrel bisulfate (PLAVIX), all indication, start and stop date were not reported. The patient previously received a flu shot. On an unspecified date in 2021, the patient experienced getting numbness in right hand really bad and tingling in his left hand and in his feet sometimes. The patient reported that he took his last Pfizer shot in 13Apr2021. He was 72-year-old and he have got congestive heart problem (intent history), but anyway. But now (2021), he was getting some numbness in his right hand really bad and some tingling in his left hand and in his feet sometimes. He will go to his cardiologist on Wednesday, he said we are having some problems with Pfizer shot is causing this. He said it has nothing to do with his heart. The patient wants to know if it is true and what he needs to do because he is due to get his booster in two weeks. He added that it just got worst and worst. It was getting worst every month. When asked about treatment, the patient responded with no, he does not know if any of that do with Pfizer could be caused by his flu shot until Wednesday (further clarification unknown). He went to his heat doctor, his cardiologist on the 20th for a checkup for his heart. So, he was telling about the tingling in his feet, his hands, and the numbness. He said there is a problem (incomplete sentence), some people are having allergic reactions to Pfizer. He said did you take Pfizer and the patient said yes. Well, see his problem is he was due to take his booster in two weeks. The last person, they won't give me his booster in two weeks and he needed to speak to somebody with Pfizer because he doesn't want to take this booster since his numinous and his legs will get worse. He added that he was on wheelchair (pending clarification). The patient underwent lab tests and procedures which included investigation with unknown results on an unspecified date. The outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaginal haemorrhage
Clinical narrative: Started bleeding, as if she was beginning her menstruation/There was a lot of bleeding; Booster; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: FE3590), via an unspecified route of administration, administered in the left arm on 18Oct2021 12:00 (at the age of 47-years-old) as dose 3 (booster), single for COVID-19 immunization. The patient has no relevant medical history. Th patient has no known allergies. The patient has no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) on 18Jan2021 13:00 (lot number: EL3247) as dose 1, single, then on 08Feb2021 13:00 (lot number: EM9810) as dose 2, single - both administered in the right arm at the age of 47-years-old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks of the COVID-19 vaccine. Prior to vaccination, the patient had no COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 18Oct2021 12:00, the patient received dose 3 (booster), single of BNT162B2. On 18Oct2021 16:00, the patient started bleeding, as if she was beginning her menstruation. There was a lot of bleeding, and she needed change her sanitary pad every hour. The bleeding lasted for 6 days. The patient reported that she was not due to get her period and she was not perimenopausal. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as result of the event. The outcome of the event was recovered on 24Oct2021.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 with fever 13 day (low grade) and flu like symptoms; tested positive for COVID-19 with fever 13 day (low grade) and flu like symptoms; This is a spontaneous report from a contactable consumer. An adult male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) on an unspecified date (lot number was not reported) as dose 2 single and on an unspecified date (lot number was not reported) as dose 1, single both via an unspecified route of administration for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Sep2021 the patient tested positive for COVID-19 with fever 13 day (low grade) and flu like symptoms. The event resulted in a doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The patient recovered from the events on an unknown date in 2021.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Fatigue, Hypertension, Loss of personal independence in daily activities, Muscle twitching
Clinical narrative: heart flutters; muscle twitching in my calves/mild muscle twitching/muscle twitching in my left arm; high blood pressure spikes; stabbing pains in various areas throughout my body; The fatigues became extreme; unable to do normal daily activities; pins and needles; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3182), dose 2 via an unspecified route of administration, administered in Arm Left on 27Aug2021 10:30 (at the age of 58years) as dose 2, single for Covid-19 immunization. Medical history included hypothyroid. Concomitant medications included levothyroxine, liothyronine (NP THYROID); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); vitamin d3 (VITAMIN D3); cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]); and magnesium (MAGNESIUM); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of Comirnaty (Batch/Lot No: FA7485) on 05Aug2021 (at the age of 58years) for Covid-19 immunization. The patient reported that after her first dose, she had cold symptoms, a sore arm, sneezing, runny nose, cough, headache, and low energy. Between the first and second dose she started having extreme fatigue and becoming easily out of breath. She also noticed some vision problems and brain fog. On 27Aug2021 12:00, the patient experienced heart flutters, muscle twitching in my calves/mild muscle twitching/muscle twitching in my left arm, high blood pressure spikes, stabbing pains in various areas throughout my body, the fatigues became extreme, unable to do normal daily, pins and needles. The patient clarified that after her second dose, she immediately started having vibrations in her left foot as if she was standing on the phone that was vibrating that went into pretty constant pins and needles and muscle twitching in her calves that intensified and she started having the muscle twitching in my left arm as well as high blood pressure spikes, heart flutters, pins and needles, stabbing pains in various areas throughout her body. The fatigues became extreme, and she was unable to do normal daily activities. It went on for 6 weeks and now she has her energy back, but mild muscle twitching and pins and needles continue. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the events. There was no treatment received for the adverse event. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: heart flutters; muscle twitching in my calves/mild muscle twitching/muscle twitching in my left arm; high blood pressure spikes; stabbing pains in various areas throughout my body; The fatigues became extreme; unable to do normal daily activities; pins and needles; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3182), dose 2 via an unspecified route of administration, administered in Arm Left on 27Aug2021 10:30 (at the age of 58years) as dose 2, single for Covid-19 immunization. Medical history included hypothyroid. Concomitant medications included levothyroxine, liothyronine (NP THYROID); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); vitamin d3 (VITAMIN D3); cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]); and magnesium (MAGNESIUM); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of Comirnaty (Batch/Lot No: FA7485) on 05Aug2021 (at the age of 58years) for Covid-19 immunization. The patient reported that after her first dose, she had cold symptoms, a sore arm, sneezing, runny nose, cough, headache, and low energy. Between the first and second dose she started having extreme fatigue and becoming easily out of breath. She also noticed some vision problems and brain fog. On 27Aug2021 12:00, the patient experienced heart flutters, muscle twitching in my calves/mild muscle twitching/muscle twitching in my left arm, high blood pressure spikes, stabbing pains in various areas throughout my body, the fatigues became extreme, unable to do normal daily, pins and needles. The patient clarified that after her second dose, she immediately started having vibrations in her left foot as if she was standing on the phone that was vibrating that went into pretty constant pins and needles and muscle twitching in her calves that intensified and she started having the muscle twitching in my left arm as well as high blood pressure spikes, heart flutters, pins and needles, stabbing pains in various areas throughout her body. The fatigues became extreme, and she was unable to do normal daily activities. It went on for 6 weeks and now she has her energy back, but mild muscle twitching and pins and needles continue. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the events. There was no treatment received for the adverse event. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone increased
Clinical narrative: Elevated thyroid stimulating hormone (TSH); This is a spontaneous report from a contactable consumer or other non healthcare professional. A 74 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: EN6202) via an unspecified route of administration, administered in Arm Left on 24Feb2021 as dose 1, single for COVID-19 immunization at Pharmacy or drug store. Medical history included coeliac disease from 05Feb1947 and ongoing Diagnosed in 2014 , hypothyroidism from 1985 and ongoing Diagnosed in 1985, depression from 1972 and ongoing Diagnosed in 1972 , hypertension from 1992 and ongoing Diagnosed in 1992. Concomitant medication(s) included levothyroxine taken for hypothyroidism; citalopram taken for depression; estradiol for old age all from an unspecified start date and ongoing. Prior vaccinations was none. The patient experienced elevated thyroid stimulating hormone causing blood thyroid stimulating hormone increased on 08Mar2021 13:11. The patient underwent lab tests and procedures which included blood thyroid stimulating hormone 5.340 uiu/ml on 31Dec2019, blood thyroid stimulating hormone: 4.933 uiu/ml on 17Aug2020, blood thyroid stimulating hormone 4.838 uiu/ml on 08Mar2021 and blood thyroid stimulating hormone: 8.141 uiu/ml on 14Sep2021. It was reported that, Thyroid supplement stopped working. First step was switched from generic levothyroxine to name-brand Synthroid & new bloodwork scheduled for 03Nov2021. Next step- increased dosage of Synthroid if 03Nov2021 bloodwork, showed no improvement for return of hypothyroidism. Symptoms was many. The outcome of the event was unknown.  Follow-Up (27Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Decreased appetite, Dizziness
Clinical narrative: Fever over 100.4; Injection site pain; extreme tiredness; Headache; Muscle pain; Chills; Joint pain; Injection site swelling; Nausea; Dizziness; No appetite; he had the Pfizer COVID-19 vaccine booster shot; This is a spontaneous report from a contactable consumer (patient himself). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 22Oct2021 at 17:00 (5:00 PM) at the age of 70 years old (Batch/Lot Number: EW0219, Expiration date: unknown) as dose 3 (booster), single for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient had no prior vaccination (4 weeks). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered on 20Mar2021, probably at 11:00 am at the age of 69 years old (Batch/Lot number: ER2613, Expiration date: unknown) as dose 1, single, and then administered on 11Apr2021 at the age of 69 years old (Batch/Lot number: EW0158, Expiration date: unknown) as dose 2, single for COVID-19 immunization. The patient reported that on 22Oct2021, he had the Pfizer COVID-19 vaccine booster shot, so he was having fever over 100.4, injection site pain, extreme tiredness, headache, muscle pain, chills, joint pain, injection site swelling, nausea, dizziness, and no appetite, which were persisting. Therapeutic measures were taken as a result of all the events, which included 2 aspirins an hour prior reporting. At the time of the report, the patient had not recovered from fever over 100.4, injection site pain, extreme tiredness, headache, muscle pain, chills, joint pain, injection site swelling, nausea, dizziness, and no appetite.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Myalgia, Nausea
Clinical narrative: Fever over 100.4; Injection site pain; extreme tiredness; Headache; Muscle pain; Chills; Joint pain; Injection site swelling; Nausea; Dizziness; No appetite; he had the Pfizer COVID-19 vaccine booster shot; This is a spontaneous report from a contactable consumer (patient himself). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 22Oct2021 at 17:00 (5:00 PM) at the age of 70 years old (Batch/Lot Number: EW0219, Expiration date: unknown) as dose 3 (booster), single for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient had no prior vaccination (4 weeks). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered on 20Mar2021, probably at 11:00 am at the age of 69 years old (Batch/Lot number: ER2613, Expiration date: unknown) as dose 1, single, and then administered on 11Apr2021 at the age of 69 years old (Batch/Lot number: EW0158, Expiration date: unknown) as dose 2, single for COVID-19 immunization. The patient reported that on 22Oct2021, he had the Pfizer COVID-19 vaccine booster shot, so he was having fever over 100.4, injection site pain, extreme tiredness, headache, muscle pain, chills, joint pain, injection site swelling, nausea, dizziness, and no appetite, which were persisting. Therapeutic measures were taken as a result of all the events, which included 2 aspirins an hour prior reporting. At the time of the report, the patient had not recovered from fever over 100.4, injection site pain, extreme tiredness, headache, muscle pain, chills, joint pain, injection site swelling, nausea, dizziness, and no appetite.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Fever over 100.4; Injection site pain; extreme tiredness; Headache; Muscle pain; Chills; Joint pain; Injection site swelling; Nausea; Dizziness; No appetite; he had the Pfizer COVID-19 vaccine booster shot; This is a spontaneous report from a contactable consumer (patient himself). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 22Oct2021 at 17:00 (5:00 PM) at the age of 70 years old (Batch/Lot Number: EW0219, Expiration date: unknown) as dose 3 (booster), single for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient had no prior vaccination (4 weeks). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered on 20Mar2021, probably at 11:00 am at the age of 69 years old (Batch/Lot number: ER2613, Expiration date: unknown) as dose 1, single, and then administered on 11Apr2021 at the age of 69 years old (Batch/Lot number: EW0158, Expiration date: unknown) as dose 2, single for COVID-19 immunization. The patient reported that on 22Oct2021, he had the Pfizer COVID-19 vaccine booster shot, so he was having fever over 100.4, injection site pain, extreme tiredness, headache, muscle pain, chills, joint pain, injection site swelling, nausea, dizziness, and no appetite, which were persisting. Therapeutic measures were taken as a result of all the events, which included 2 aspirins an hour prior reporting. At the time of the report, the patient had not recovered from fever over 100.4, injection site pain, extreme tiredness, headache, muscle pain, chills, joint pain, injection site swelling, nausea, dizziness, and no appetite.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Fatigue, Headache, Immunisation
Clinical narrative: 104.5 fever; Upset stomach; Sore on shot site; Aches; Headache; Exhausted; Booster; This is a spontaneous report from a contactable consumer (patient). A 52-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number was not reported), via an unspecified route of administration, administered in the left arm on 23Oct2021 11:00 (at the age of 52-years-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included mental health disorder, chronic obstructive pulmonary disease (COPD), diabetes, and hypertension. The patient has no known allergies. Concomitant medications included lithium, mirtazapine, ciprofloxacin hydrochloride (QUELL), quetiapine, and cefaclor (SERA). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) for dose 1 and dose 2 - both administered in the left arm on unspecified date as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks of the COVID-19 vaccine. Prior to vaccination, the patient had no COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 23Oct2021 11:00, the patient received dose 3 (booster), single of BNT162B2. On 23Oct2021 22:00, the patient experienced 104.5 fever, upset stomach, sore on shot site, aches, headache, and exhausted. Therapeutic measures were not taken as result of the events. The outcome of the events was recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: 104.5 fever; Upset stomach; Sore on shot site; Aches; Headache; Exhausted; Booster; This is a spontaneous report from a contactable consumer (patient). A 52-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number was not reported), via an unspecified route of administration, administered in the left arm on 23Oct2021 11:00 (at the age of 52-years-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included mental health disorder, chronic obstructive pulmonary disease (COPD), diabetes, and hypertension. The patient has no known allergies. Concomitant medications included lithium, mirtazapine, ciprofloxacin hydrochloride (QUELL), quetiapine, and cefaclor (SERA). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) for dose 1 and dose 2 - both administered in the left arm on unspecified date as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks of the COVID-19 vaccine. Prior to vaccination, the patient had no COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 23Oct2021 11:00, the patient received dose 3 (booster), single of BNT162B2. On 23Oct2021 22:00, the patient experienced 104.5 fever, upset stomach, sore on shot site, aches, headache, and exhausted. Therapeutic measures were not taken as result of the events. The outcome of the events was recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Welts on both arms appeared in a straight line on both arms several days after 1st dose, which I now think are related to the vaccine; This is a spontaneous report from a contactable consumer (patient himself).  A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number FF2589), via an unspecified route of administration, on 30Sep2021 14:30 (at the age of 71-year-old) at single dose for COVID-19 immunisation. The patient did not have a medical history and concomitant medications were provided. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Welts on both arms appeared in a straight line on both arms several days after 1st dose (Oct2021), which he now thinks are related to the vaccine. The event was reported as non-serious. No treatments were given for the event. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was recovering from the event.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202101440822 Same reporter, different vaccine dose (2nd dose), different event
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Fall, Loss of consciousness, Pain
Clinical narrative: then blacked out and fell between the tub and bathroom vanity/unconscious; Severe paid in the abdomen just below my ribs; then blacked out and fell between the tub and bathroom vanity; Severe pain in my left side due to the impact with the vanity cabinet; This is a spontaneous report from a contactable consumer (patient himself).  A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number FH8020), via an unspecified route of administration, on 21Oct2021 14:30 (at the age of 71-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number FF2589) via intramuscular in the left arm, on 30Sep2021 (at the age of 71-year-old) for COVID-19 immunisation and developed welts. The patient did not have a medical history and concomitant medications were provided. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Just over 48 hours after the second dose, on 23Oct2021 at 18:00, while in the shower, he had severe pain in the abdomen just below his ribs, then blacked out and fell between the tub and bathroom vanity. Not sure how long he was unconscious but finally managed to get his legs down from the tub and get on his feet. Severe pain in his left side due to the impact with the vanity cabinet. No treatments were given for the events. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was recovering from the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101440721 Same reporter, different vaccine dose (1st dose), different event
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Investigation, Paraesthesia, Spinal cord disorder, Tachycardia
Clinical narrative: enlargement of the spinal cord; tachycardia; paresthesia; burning feeling in the head/face; This is a spontaneous report from a non-contactable consumer. This reporter reported two reports. This is one of the two reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation.  The patient medical history was not reported. There were no concomitant medications. It was reported that, at the time of the call the reporter mentioned to the agent that he met with a patient who experienced the same events after the vaccination, which was tachycardia, paraesthesia, burning feeling in the head/face. The reporter mentioned that the patient was feeling better. After a spinal cord test [reporter did not remember which one] it was found that the patient symptoms were caused by an enlargement of the spinal cord. The outcome was unknown for the reported event.  The events occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101506751 same reporter/AE/SD, different patient
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Off label use, Overdose, Product preparation error, Vaccination site pain
Clinical narrative: I went today and got the Pfizer booster shot, I initially received the J&J; I went today and got the Pfizer booster shot, I initially received the J&J; Overdose /administered the booster to her they did not dilute it all, so there was no saline solution that they mixed in; administered the booster to her they did not dilute it all, so there was no saline solution that they mixed in; Pain at the injection site; This is a spontaneous report from a contactable Consumer or other non-HCP (Patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: FF8841), via an unspecified route of administration on 25Oct2021, as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported), as Dose1, single and Dose 2, single and Covid-19 vaccine J&J (COVID-19 VACCINE JANSSEN, Lot number: not reported), as Dose1, single and Dose 2, single all via an unspecified route of administration on an unspecified date for COVID-19 immunization. It was reported that reporter was a little worried because she went on the day and got the Pfizer booster shot, she initially received the J&J (further clarification unknown) on 20Mar2021 and then she was eligible for the booster and got at the stop and shop pharmacy, and she just got a call from them a half an hour ago said that there was an error that when they administered the booster to her they did not dilute it all, so there was no saline solution that they mixed in. So, they told her that there might be some additional pain at the injection site (not clarified further), but other than that she really did not have anything to worry about, just drink fluid and take Ibuprofen. On an unknown date in 2021, the patient experienced pain at the injection site. Reporter also stated but when she went online, and she was looking at some of the information back in January they were talking about if there was not enough dilution that was almost like you were getting overdose of the vaccine and she was just really worried about that. The case was not serious. Outcome of the event Pain at the injection site was unknown at the time of this report.  This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 67.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Antibody test, Nephrolithiasis, Ultrasound kidney
Clinical narrative: Kidney stone; This is a solicited report based on the information received by Pfizer (MFR Control No. #21K-163-4122796-00). The male contactable consumer (patient) reported for himself.   A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported; information was not available in the patient's file) as dose 1, single (at the age of 67 years old) for COVID-19 immunization;.  Medical history included moderate to severe adult Crohn's Disease from an unknown date. The patient's concomitant medications were not reported. The patient previously took vancomycin and experienced vancomycin allergy, and sulfa drugs and experienced sulfa drugs allergy. On unknown dates, the patient experienced no antibodies for COVID vaccine and COVID vaccine did not work; assessed as non-serious by reporter. On 15Oct2021, the patient experienced kidney stone. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient underwent lab tests and procedures which included antibody test: No antibodies for covid vaccine on unspecified date, ultrasound kidney: Kidney stone on Oct2021. The action taken in response to the event for adalimumab was dose not changed. The outcome of the event was not recovered.  Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of NO ANTIBODIES FOR COVID VACCINE, COVID VACCINE DID NOT WORK and KIDNEY STONE with HUMIRA(ADALIMUMAB) was no reasonable possibility.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the event Nephrolithiasis and the suspect 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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Myalgia, Pain in extremity, Pallor
Clinical narrative: fever of 100.4.; bad pain in legs and feet; lost all colour in her hands and her fingernails were gray; severe joint and muscle aches in legs; severe joint and muscle aches in legs; Loss of appetite.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the third dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 07Oct2021 14:00 (02:00 PM) (Lot Number: 30145BA) as DOSE 3 (BOOSTER), SINGLE (received at the age of 67-years-old) for COVID-19 immunisation. The vaccine was administered at a Public Health Clinic facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included arthritis, high blood pressure, high cholesterol, and known allergy to sulfa drugs. The patient was not pregnant at the time of vaccination and adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on an unspecified date (Lot Number: EN6200) as DOSE 1 SINGLE; second dose, via an unspecified route of administration, administered in Arm Left on an unspecified date (Lot Number: EN6208) as DOSE 2 SINGLE for COVID-19 immunisation. The patient previously took tramadol and experienced allergy. On 08Oct2021 04:30 AM, the patient experienced severe joint and muscle aches in legs, and loss of appetite. By 6:00 PM of the same date, she had a fever of 100.4, bad pain in legs and feet, lost all colour in her hands and her fingernails were gray. She spent the rest of evening and night in bed. The patient took Tylenol to break the fever, but she did not receive any corrective treatment for the other reported events. By the next day (09Oct2021), she was much better, just a little run down. Outcome of the events was recovered on an unspecified date in Oct2021.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever of 100.4.; bad pain in legs and feet; lost all colour in her hands and her fingernails were gray; severe joint and muscle aches in legs; severe joint and muscle aches in legs; Loss of appetite.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the third dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 07Oct2021 14:00 (02:00 PM) (Lot Number: 30145BA) as DOSE 3 (BOOSTER), SINGLE (received at the age of 67-years-old) for COVID-19 immunisation. The vaccine was administered at a Public Health Clinic facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included arthritis, high blood pressure, high cholesterol, and known allergy to sulfa drugs. The patient was not pregnant at the time of vaccination and adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on an unspecified date (Lot Number: EN6200) as DOSE 1 SINGLE; second dose, via an unspecified route of administration, administered in Arm Left on an unspecified date (Lot Number: EN6208) as DOSE 2 SINGLE for COVID-19 immunisation. The patient previously took tramadol and experienced allergy. On 08Oct2021 04:30 AM, the patient experienced severe joint and muscle aches in legs, and loss of appetite. By 6:00 PM of the same date, she had a fever of 100.4, bad pain in legs and feet, lost all colour in her hands and her fingernails were gray. She spent the rest of evening and night in bed. The patient took Tylenol to break the fever, but she did not receive any corrective treatment for the other reported events. By the next day (09Oct2021), she was much better, just a little run down. Outcome of the events was recovered on an unspecified date in Oct2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Gastrooesophageal reflux disease, Immunodeficiency
Clinical narrative: low resistance to diseases; Chronic obstructive pulmonary disease (COPD); Acid Reflux; This is a spontaneous report received from a contactable consumer (patient) based on information received by Pfizer from National Service center (manufacturer control number: 02036017). An unspecified age female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE) via an unspecified route of administration in 2021 (Lot Number: EN6201; Expiration Date: Jun2021) as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration in 2021 (Lot Number: EL9266; Expiration Date: May2021) as single dose for COVID-19 immunization. On 10Aug2021, the patient experienced shoulder surgery. This occurred after receiving 2 shots of the Pfizer covid vaccine. In 2021, the patient had some underlying health conditions, such as low resistance to diseases, chronic obstructive pulmonary disease (COPD) and Acid Reflux. The outcome of events was unknown.  No Follow-up attempts are possible. No Further information expected.