chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: Blood pressure has been high; This is a spontaneous report from a non-contactable consumer (patient, self-reported). A 36-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0171 and expiry date was not reported), via an unspecified route of administration, on 28Apr2021 (age at vaccination: 35 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient reported that on an unspecified date, his blood pressure has been high ever since the 2nd dose vaccine. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement: high on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Ear discomfort, Headache, Hypoaesthesia
Clinical narrative: intense ear pressure; numbing of left ear and left jaw; headache; Blood pressure has increased; Numbing in right cheek; This is a spontaneous report from a non-contactable consumer. This 47-year-old female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0158) via an unspecified route of administration on 15Apr2021 at 10: 45 AM (at 47-year-old) on left arm as dose 1, single for COVID-19 immunization. The medical history of the patient included allergy to amoxicillin & tylenol with codeine. The other medical history was reported as none. The patient did not receive any other vaccine in four weeks and other medications in two weeks. She did not have covid prior to vaccination and was not tested for covid post vaccination. The patient's concomitant medications were not reported. On 15Apr2021 at 12:00PM, one hour after the vaccination, the patient experienced numbing in right cheek. In the evening at 9pm, same day, she had intense ear pressure and numbing of left ear and left jaw. She had massive headache and her blood pressure had increased. The patient visited the emergency room and physician office. She received treatment with high blood pressure medication & anti-inflammatory. The patient had not recovered.  No follow-up attempts were possible. No further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Product use issue
Clinical narrative: Arm is numb; Seems like miss or bad dosage because, they are not using as they should; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown), via unspecified route of administration on an unknown date as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) as dose 1, single for COVID-19 Immunization. On an unknown date, the patient experienced arm was numb and seemed like miss or bad dosage because, they are not using as they should. Patient reported that arm went entirely numb but patient tried to just let it be but now since today (at the time of reporting) arm of the patient was numb for a whole day. Patient mentioned that couple of days ago patient went to set appointment with the Pfizer second shot and the process for it, patient wanted to know that when one gets the second shot what did they put in the shot, the guy, he just did give patient a warm and fussy, he didn't know what he was doing and the other girl as going to be one doing the needle injection, she put like base solution that settle that in order to like a base to saline solution in order to get the vaccine in the syringe. Patient wanted to know if it sounded right at all. Patient also wanted to know if it sounded right that it comes over the Pfizer bottle and goes to patient arm or one takes it out the another bottle and preparing it with some saline solution like a base. Patient reported that seemed like miss or bad dosage because, they were not using as they should. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heavy menstrual bleeding, SARS-CoV-2 antibody test negative
Clinical narrative: Menstrual issues-heavy, long term flow; Shortness of breath; This is a spontaneous report from a contactable consumer (Patient). A 44-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8730), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 09:30 as (At the age of 44-years) DOSE 1, SINGLE for covid-19 immunization. Medical history included meniere's disease, hashimoto's; all from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; azelastine hydrochloride, fluticasone propionate (DYMISTA) taken for an unspecified indication, start and stop date were not reported. The patient previously took milk and seafood and experienced hypersensitivity. Patient was not pregnant at the time of vaccination. The patient experienced menstrual issues-heavy, long term flow (heavy menstrual bleeding), and shortness of breath (dyspnoea) on 29Mar2021 09:30. Patient was visited Doctor or other healthcare professional office/clinic visit for events. Patient was received treatment as Birth control, inhaler for events. The patient underwent lab tests and procedures which included sars-cov-2 antibody test negative: negative on 06May2021. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heavy menstrual bleeding, Off label use
Clinical narrative: Menstrual issues-heavy, long term flow; Shortness of breath; This is a spontaneous report from a contactable consumer (Patient). A 44-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8730), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 09:30 as (At the age of 44-years) DOSE 1, SINGLE for covid-19 immunization. Medical history included meniere's disease, hashimoto's; all from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; azelastine hydrochloride, fluticasone propionate (DYMISTA) taken for an unspecified indication, start and stop date were not reported. The patient previously took milk and seafood and experienced hypersensitivity. Patient was not pregnant at the time of vaccination. The patient experienced menstrual issues-heavy, long term flow (heavy menstrual bleeding), and shortness of breath (dyspnoea) on 29Mar2021 09:30. Patient was visited Doctor or other healthcare professional office/clinic visit for events. Patient was received treatment as Birth control, inhaler for events. The patient underwent lab tests and procedures which included sars-cov-2 antibody test negative: negative on 06May2021. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heavy menstrual bleeding, SARS-CoV-2 antibody test negative
Clinical narrative: other vaccine same date vaccine date=26Mar2021, other vaccine same date dose number= 2; Menstrual issues-heavy, long term flow; Shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old non-pregnant female patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration in Arm Left on 26Mar2021 09:30(age at vaccination:44 years) as DOSE 2, SINGLE for covid-19 immunisation. Patient was not pregnant at the time of vaccination, Patient didn't receive other vaccines within 4weeks prior to vaccination, patient received other medications Synthroid, dymista within 2weeks. Medical history included Meniere's disease from an unknown date and unknown if ongoing, autoimmune thyroiditis from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing, milk allergy from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; azelastine hydrochloride, fluticasone propionate (DYMISTA) taken for an unspecified indication, start and stop date were not reported. Patient didn't had covid-19 prior to vaccination. On 29Mar2021 09:30 The patient experienced other vaccine same date vaccine date=26mar2021, other vaccine same date dose number= 2, menstrual issues-heavy, long term flow, shortness of breath.Patient had physician office visits for the events. Therapeutic measures were taken as a result of other vaccine same date vaccine date=26mar2021, other vaccine same date dose number= 2 (off label use), menstrual issues-heavy, long term flow, shortness of breath was Birth control, inhaler. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06May2021. The outcome of the events off label use, heavy menstrual bleeding, dyspnoea was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heavy menstrual bleeding, Off label use
Clinical narrative: other vaccine same date vaccine date=26Mar2021, other vaccine same date dose number= 2; Menstrual issues-heavy, long term flow; Shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old non-pregnant female patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration in Arm Left on 26Mar2021 09:30(age at vaccination:44 years) as DOSE 2, SINGLE for covid-19 immunisation. Patient was not pregnant at the time of vaccination, Patient didn't receive other vaccines within 4weeks prior to vaccination, patient received other medications Synthroid, dymista within 2weeks. Medical history included Meniere's disease from an unknown date and unknown if ongoing, autoimmune thyroiditis from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing, milk allergy from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; azelastine hydrochloride, fluticasone propionate (DYMISTA) taken for an unspecified indication, start and stop date were not reported. Patient didn't had covid-19 prior to vaccination. On 29Mar2021 09:30 The patient experienced other vaccine same date vaccine date=26mar2021, other vaccine same date dose number= 2, menstrual issues-heavy, long term flow, shortness of breath.Patient had physician office visits for the events. Therapeutic measures were taken as a result of other vaccine same date vaccine date=26mar2021, other vaccine same date dose number= 2 (off label use), menstrual issues-heavy, long term flow, shortness of breath was Birth control, inhaler. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06May2021. The outcome of the events off label use, heavy menstrual bleeding, dyspnoea was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Epistaxis, Headache
Clinical narrative: blood pressure and pulse ran extremely high; 156/95; blood pressure and pulse ran extremely high; pulse of 123; nose bleeds; very bad headache; fever of 101; chills; muscle and body aches so bad; muscle and body aches so bad; nausea; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 17Apr2021 14:30 (Batch/Lot Number: ER8729), at the age of 50 years old, as dose 2, single for covid-19 immunisation in a doctor's office/urgent care. Medical history included hypertension, acid reflux, and allergies to adhesive, all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. No covid prior to vaccination and was not tested for covid post vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN); acetylsalicylic acid (BABY ASPIRIN); sucralfate (CARAFATE); acetylsalicylic acid (CARTIA); omeprazole (PROTONIX); and an unspecified blood pressure medicine.  The patient previously took cefdinir (OMICEF) and experienced allergies; dose 1 of BNT162B2 on 27Mar2021 14:15 (Lot number: ER8730) at the age of 50 years old for covid-19 immunisation. No other vaccine received in four weeks. On 18Apr2021 01:00, the patient's blood pressure and pulse ran extremely high for the week of the 2nd dose of the vaccine and her doctor had to up her blood pressure medicine the following week because it was running 156/95 with a pulse of 123 when she was just sitting still. Also, her physician had to take her off 81 mg aspirin as she was also getting nose bleeds after the vaccine from the 2nd day (18Apr2021) on until he took her off the baby aspirin and increased her blood pressure medication. On 17Apr2021, she had all the side effects the night of and the day after the shot, she had fever of 101, chills, muscle and body aches so bad she couldn't get out of bed and nausea. Also, she had very bad headache for week following and a part of second week after 2nd dose. The patient received treatment for events. The patient was recovering from the events.   Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hypertension, Myalgia, Nausea
Clinical narrative: blood pressure and pulse ran extremely high; 156/95; blood pressure and pulse ran extremely high; pulse of 123; nose bleeds; very bad headache; fever of 101; chills; muscle and body aches so bad; muscle and body aches so bad; nausea; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 17Apr2021 14:30 (Batch/Lot Number: ER8729), at the age of 50 years old, as dose 2, single for covid-19 immunisation in a doctor's office/urgent care. Medical history included hypertension, acid reflux, and allergies to adhesive, all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. No covid prior to vaccination and was not tested for covid post vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN); acetylsalicylic acid (BABY ASPIRIN); sucralfate (CARAFATE); acetylsalicylic acid (CARTIA); omeprazole (PROTONIX); and an unspecified blood pressure medicine.  The patient previously took cefdinir (OMICEF) and experienced allergies; dose 1 of BNT162B2 on 27Mar2021 14:15 (Lot number: ER8730) at the age of 50 years old for covid-19 immunisation. No other vaccine received in four weeks. On 18Apr2021 01:00, the patient's blood pressure and pulse ran extremely high for the week of the 2nd dose of the vaccine and her doctor had to up her blood pressure medicine the following week because it was running 156/95 with a pulse of 123 when she was just sitting still. Also, her physician had to take her off 81 mg aspirin as she was also getting nose bleeds after the vaccine from the 2nd day (18Apr2021) on until he took her off the baby aspirin and increased her blood pressure medication. On 17Apr2021, she had all the side effects the night of and the day after the shot, she had fever of 101, chills, muscle and body aches so bad she couldn't get out of bed and nausea. Also, she had very bad headache for week following and a part of second week after 2nd dose. The patient received treatment for events. The patient was recovering from the events.   Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: blood pressure and pulse ran extremely high; 156/95; blood pressure and pulse ran extremely high; pulse of 123; nose bleeds; very bad headache; fever of 101; chills; muscle and body aches so bad; muscle and body aches so bad; nausea; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 17Apr2021 14:30 (Batch/Lot Number: ER8729), at the age of 50 years old, as dose 2, single for covid-19 immunisation in a doctor's office/urgent care. Medical history included hypertension, acid reflux, and allergies to adhesive, all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. No covid prior to vaccination and was not tested for covid post vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN); acetylsalicylic acid (BABY ASPIRIN); sucralfate (CARAFATE); acetylsalicylic acid (CARTIA); omeprazole (PROTONIX); and an unspecified blood pressure medicine.  The patient previously took cefdinir (OMICEF) and experienced allergies; dose 1 of BNT162B2 on 27Mar2021 14:15 (Lot number: ER8730) at the age of 50 years old for covid-19 immunisation. No other vaccine received in four weeks. On 18Apr2021 01:00, the patient's blood pressure and pulse ran extremely high for the week of the 2nd dose of the vaccine and her doctor had to up her blood pressure medicine the following week because it was running 156/95 with a pulse of 123 when she was just sitting still. Also, her physician had to take her off 81 mg aspirin as she was also getting nose bleeds after the vaccine from the 2nd day (18Apr2021) on until he took her off the baby aspirin and increased her blood pressure medication. On 17Apr2021, she had all the side effects the night of and the day after the shot, she had fever of 101, chills, muscle and body aches so bad she couldn't get out of bed and nausea. Also, she had very bad headache for week following and a part of second week after 2nd dose. The patient received treatment for events. The patient was recovering from the events.   Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electric shock sensation
Clinical narrative: light headed after injection; brain felt like it was vibrating; buzzing sensation in head.it was not painful but quite annoying.; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 06Feb2021 at 09:00 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, osteoporosis and fibromyalgia. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1686) via an unspecified route of administration in the right arm on 06Feb2021 at 08:45 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Feb2021, the patient experienced light headed after injection. About 1 to 1-1/2 hours later brain felt like it was vibrating/ buzzing sensation in head which was not painful but quite annoying. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the event brain felt like it was vibrating/ buzzing sensation in head was recovered on  07Feb2021; while that of light headed after injection was recovered on an unknown date in Feb2021.   No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Heart rate decreased, Heart rate increased, Heart rate variability decreased
Clinical narrative: 7 days since the vaccine administration my night-time resting heart rate has been significantly elevated; Chest tightness for 24 hours following administration of vaccine; 7 days since the vaccineadministration my night-time heart ratevariability (HVR) has been significantlylowered (15-20ms) compared to my 30-day average night-time heart ratevariability (50-55ms).; This is a spontaneous report received from a contactable pharmacist. A 34-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 28Apr2021 15:00 (Batch/Lot Number: EW0161) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced 7 days since the vaccine administration my night-time resting heart rate has been significantly elevated, chest tightness for 24 hours following administration of vaccine and 7 days since the vaccineadministration my night-time heart ratevariability (hvr) has been significantlylowered (15-20ms) compared to my 30-day average night-time heart ratevariability (50-55ms) on 28Apr2021. The patient underwent lab tests and procedures which included heart rate increased: 55-60bpm on an unspecified date 7 days since the vaccine administration my night-time resting heart rate has been significantly elevated (55-60 bpm) compared to my 30-day average night-time resting heart rate (44-48 bpm) , heart rate variability decreased: 15-20ms on an unspecified date days since the vaccine administration my night-time heart rate variability (HVR) has been significantly lowered (15-20ms) compared to my 30-day average night-time heart rate variability (50-55ms). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event chest tightness for 24 hours following administration of vaccine was recovered on an unspecified date in Apr2021 and not recovered from other events.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood disorder, Nervous system disorder
Clinical narrative: blood issue; neurological issues; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 26Jul2021, this case now contains all required information to be considered valid.  This is spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced blood issue and neurological issues on an unspecified date. The patient stated that because of the reaction she had to talk with those 3 medical professionals they were requesting blood work and tests to confirm the blood issue she is having. She also had neurological issues and the neurologist suggested in addition more blood tests. The clinical outcome of blood issue and neurological issues was unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.  Follow-up (26Jul2021): The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 26Jul2021, this case now contains all required information to be considered valid.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Costochondritis, Dyspnoea, SARS-CoV-2 test
Clinical narrative: Costochondritis diagnosis due to four days of trouble breathing and pain in chest; Costochondritis diagnosis due to four days of trouble breathing and pain in chest; Costochondritis diagnosis due to four days of trouble breathing and pain in chest; This is a spontaneous report from a contactable consumer (patient).A 22-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration, administered in Arm Left on 05May2021 17:00 (at the age of 22-years-old) (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Known allergies: Meloxicam and other NSAIDS. Concomitant medications included oxymetazoline hydrochloride (CLARITIN ALLERGIC), ethinylestradiol, norethisterone (NORTREL [ETHINYLESTRADIOL NORETHISTERONE], sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient previously took meloxicam for drug hypersensitivity. On 05May2021 18:00, the patient experienced costochondritis diagnosis due to four days of trouble breathing and pain in chest.The AE resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with 1g Tylenol three times daily and warm compresses. The patient did not have covid prior vaccination. The patient was tested for covid post vaccination.The patient underwent lab tests and procedures which included sars-cov-2 test: pending on 09May2021. Outcome of events was not recovered.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Wheezing
Clinical narrative: Severe difficulty breathing; chest tightness; wheezing; This is a spontaneous report from a contactable consumer (patient). A 29-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 09May2021 at 14:15 hours as dose 2, single (at the age of 29-years-old) for COVID-19 immunisation. Medical history included brain cancer (from age 6 to 16) from an unknown date to unknown date. Patient had no known allergies that she was aware of. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in left arm on an unspecified date as dose 1, single for COVID-19 immunisation. Patient had no other vaccine in four weeks. Concomitant medication(s) included levonorgestrel (Mirena) intrauterine device (IUD) taken for contraception from an unspecified start date and ongoing (currently using) and had no other concomitant medications in two weeks. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19, post vaccination. On 09May2021 at 18:00 hours, patient experienced severe difficulty breathing, wheezing and chest tightness that was continued to worsen as time goes on. Patient received no treatment for the events. The outcome of all the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: I should have gotten my period on 29Apr and it is now 06May and I still don't have my period; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 35 year old non pregnant female patient received second dose of bnt162b2 (BNT162B2),via an unspecified route of administration, administered in Arm Left on 23Apr2021 07:00 (Batch/Lot Number: Pfizer ER8736)(At the age of 35-years old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included seasonal allergy, known allergies to Mango. Prior to vaccination, the patient was not diagnosed with COVID-19,Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included sertraline 50mg taken for an unspecified indication, start and stop date were not reported; fexofenadine hydrochloride (ALLEGRA 24 HOUR) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate (FLONASE ALLERGY RELIEF) taken for an unspecified indication, start and stop date were not reported. The patient experienced delay in her menstrual period and states that she should have gotten the period on 29apr and though its 06may and she still don't have her period leading to delayed period on an unknown date in 2021. No treatment received for events. Device Date is 06May2021. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Menstrual disorder, Menstruation irregular
Clinical narrative: Light bleeding; Cycle was completely off; More heavy bleeding with quarter sized clots; More heavy bleeding with quarter sized clots; This is a spontaneous report from a contactable consumer (patient). This consumer reported events for two separate vaccine doses. This is the second of two reports. This report is for the events related to the second vaccine dose.  A 27-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration, administered in the left arm on 27Apr2021 at 14:00 (Batch/Lot Number: EW0171, at age 27-years-old at vaccination) as a single dose for COVID-19 immunisation at a Public Health Clinic facility. Medical history included hypersensitivity / allergies to nature and contraception (birth control had her periods very regular). There were no known allergies. The patient did not have COVID-19 prior to the vaccination. Concomitant medications included birth control, antihistamine and allergy injections. Historical vaccine information included the patient received the first dose of BNT162B2 vaccine, via an unspecified route of administration, administered in the left arm on 06Apr2021 at 14:00 (Batch/ Lot number=EP7533, at age 27-years-old at vaccination), as a single dose for COVID-19 immunisation and experienced cramping/spotting, large clots and heavy period on 22Apr2021. The patient did not received any other vaccines within four weeks of the BNT162B2 vaccine. On 27Apr2021, the patient received the second dose of the BNT162B2 vaccine. The patient was still spotting when she received the second dose of the vaccine. On 29Apr2021, 2 days after the second vaccine, the patient had light bleeding and then afterwards she experienced more heavy bleeding with quarter size clots. It was reported that prior to the vaccine her birth control had made her periods very regular and nowhere near as heavy as this bleeding. Now her cycle was completely off. No treatment was received. The patient has not had a COVID test post vaccination. The outcome of events light bleeding, more heavy bleeding with quarter sized clots and cycle was completely off was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021514929 same patient, different dose number and event
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Fatigue, Headache, Hypoaesthesia, Respiratory rate decreased
Clinical narrative: numbness in left arm and hand; Fatigue; headaches; loss of taste; diminished breathing; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient). A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 26Apr2021 10:30 (at the age of 56-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included allergy and covid-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. On 26Apr2021 10:45, the patient experienced numbness in left arm and hand, fatigue, headaches, loss of taste, diminished breathing. Since the vaccination, the patient had not been tested for COVID-19.  The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: numbness in left arm and hand; Fatigue; headaches; loss of taste; diminished breathing; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient). A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 26Apr2021 10:30 (at the age of 56-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included allergy and covid-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. On 26Apr2021 10:45, the patient experienced numbness in left arm and hand, fatigue, headaches, loss of taste, diminished breathing. Since the vaccination, the patient had not been tested for COVID-19.  The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: After her first dose, caller reports her face becoming numb for two and half days after; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age was received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported) via an unspecified route of administration on an unspecified date in 2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included allergies to shellfish from an unknown date and unknown if ongoing. Concomitant medications were not reported. After her first dose, her face became numb for two and half days after on an unspecified date in 2021. The patient reported that she was scheduled to receive her second dose the next day. After the first one she waited for 30 minutes. Patient was asking about the side effects of the vaccine and if she should get the second dose. She was nervous that the call handler kept repeating her like that. Attempted to clarify what caller meant. She was afraid with the government. She did not want the government coming after saying that she was a snitch or something. Patient was told by call handler that they were unable to tell her whether or not she should get the second vaccine but they suggested she reach out to her primary care provider or health department if she had further questions. Patient stated no, because she already tried with VAERS and she did not want anything nefarious. She would wait for her doctor but they said to ask the allergist but the allergist cannot see her until July. She could not wait that long because she was supposed to her second dose the next day. Outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: fingers that are numb; muscle pain in her forearms; tingling in the fingers; This is a spontaneous report from a contactable consumer (patient, self-reported). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 29Mar2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. On an unspecified date, she developed fingers that were numb except for her pinkies, and a section of her palm by the thumb that was numb and painful. She also had muscle pain in her forearms. It wakes her up it hurts so badly, and she delivered two children with no epidural, so she feels like she's pretty tough. She felt these side effects were getting worse. The tingling in the fingers usually subsides throughout the day but the soreness/pain in the forearms is lasting all day now. The symptoms she believes started the next day but initially thought it might be due to sleeping on it wrong or from doing yard work. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic fatigue syndrome, Condition aggravated, Feeling abnormal, Pain in extremity
Clinical narrative: My Chronic Fatigue syndrome flared up, and is still active. I have had consistent debilitating fatigue that does not improve without rest, brain fog, and aching in my legs since receiving the vaccine.; My Chronic Fatigue syndrome flared up, and is still active. I have had consistent debilitating fatigue that does not improve without rest, brain fog, and aching in my legs since receiving the vaccine.; My Chronic Fatigue syndrome flared up, and is still active. I have had consistent debilitating fatigue that does not improve without rest, brain fog, and aching in my legs since receiving the vaccine.; My Chronic Fatigue syndrome flared up, and is still active. I have had consistent debilitating fatigue that does not improve without rest, brain fog, and aching in my legs since receiving the vaccine.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 25-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: GW0161), via an unspecified route of administration, administered in Arm Left on 16Apr2021 04:45 (at the age of 25-year-old) as dose 2, single for COVID-19 immunization. Medical history included chronic fatigue syndrome from an unknown date and unknown if ongoing, drug hypersensitivity (Nitrofurantoin) from an unknown date and unknown if ongoing, immunodeficiency from an unknown date and unknown if ongoing , hypersensitivity (silicone) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 19Mar2021 12:45 PM (at the age of 25-year-old) as dose 1, single for COVID-19 immunization. On 17Apr2021, the patient experienced my chronic fatigue syndrome flared up, and is still active. Patient had consistent debilitating fatigue that does not improve without rest, brain fog, and aching in legs since vaccination. Before the vaccine, she had not experienced these symptoms in months. No treatment was taken as a result of events. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Pain, Pain in extremity
Clinical narrative: body aches and tiredness but not fever etc.  pain in left underarm (side of shot) - pain still persists.  Pain across upper chest and breast bone area.  pain remains (intermittently) across the upper; body aches and tiredness but not fever etc.  pain in left underarm (side of shot) - pain still persists.  Pain across upper chest and breast bone area.  pain remains (intermittently) across the upper; body aches and tiredness but not fever etc.  pain in left underarm (side of shot) - pain still persists.  Pain across upper chest and breast bone area.  pain remains (intermittently) across the upper; body aches and tiredness but not fever etc.  pain in left underarm (side of shot) - pain still persists.  Pain across upper chest and breast bone area.  pain remains (intermittently) across the upper; This is a spontaneous report from a contactable consumer or other non hcp (Patient) via a regulatory authority.  A 57-year-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIOTEH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20Apr2021 10:45 (Age at vaccination: 57-year-old) as dose number unknown, single for covid-19 immunization. Medical history included slight reflux and Dry eyes both from an unknown date. Concomitant medication included sertraline hydrochloride (ZOLOFT), ciclosporin (RESTASIS), pantoprazole all taken for an unspecified indication. patient did not receive other vaccine in four weeks. Patient had no covid prior vaccination. It was reported that on 20Apr2021 02:00, patient experienced body aches and tiredness but not fever etc. pain in left underarm (side of shot) pain still persists. Pain across upper chest and breast bone area. Pain remains (intermittently) across the upper chest. Winded but not hard to breath and not short of breath. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Patient was not tested for covid post vaccination. Therapeutic measures were taken as a result of events with Advil 2 tablets 2xs day for 7 days. The outcome for the events was unknown.  No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade fevers; This is a spontaneous report from a contactable consumer (patient husband), from a Pfizer sponsored program.  A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 05May2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 13Apr2021 as dose 1, single for covid-19 immunization. The reporter states that he is 62 y/o and wife is 65 y/o. They both received their second Pfizer Covid vaccines on 05May2021 and on 06May2021 he reports they have low grade fevers. The reporter together with his wife, got their first dose of the vaccine 3 weeks ago (13Apr2021). The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in the inner thigh; This is a spontaneous report from a contactable consumer (patient daughter) from Medical information team. This team reported in response to query sent via email.   A 43-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 06May2021 (at the age of 43-year-old) as dose 2, single for covid-19 immunization. Time dose was not provided. The patient's medical history and concomitant medications were not reported. Patient  previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 16Apr2021 (at the age of 43-year-old) as dose 1, single for covid-19 immunization. No events occurred with first dose of vaccine. Caller said her mom did not have any other vaccinations the same days that she had the Pfizer COVID-19 vaccines, or in the four weeks before hand. No other products were taken. Caller stated that her mother experienced a side effect after having the second dose of the Pfizer Covid-19 vaccine on Thursday. On 06May2021, she was experiencing numbness in the inner thigh that night after the vaccine which she still has that, and she would like to know if there are any reports of this and what could she take. Enquiry stated that Pfizer is unable to provide treatment recommendations for individual patients, we suggest that you consult your physician regarding the symptoms. The patient did not receive any treatment. The outcome of event hypoaesthesia was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.