chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Lymphadenopathy, Mastitis, Nipple infection, Swelling
Clinical narrative: possibly infected right breast; inflamed; Swollen; nipple (lymph node); nipple (lymph node); This is a spontaneous report from a contactable consumer (Patient). A 34-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6207), dose 1st via an unspecified route of administration, administered in Left arm on 23Mar2021 13:15 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced possibly infected right breast, inflamed, swollen, nipple (lymph node) all were on 26Mar2021 12:00. No other vaccine in four weeks. No COVID prior vaccination. No treatment was given for events. The patient has not tested COVID-19 Since the vaccination. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Illness, Loss of consciousness, Malaise
Clinical narrative: Passed out; Cannot make it on the second dose schedule; missed from receiving her second dose; She has vomitted; she is still sick; can't keep her head up and has headaches; Feeling sick; She cannot eat; This is a spontaneous report from a contactable consumer (reported for herself). The female patient (80 unit not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot no: not reported) on an unknown route of administration on 06Mar2021 as SINGLE DOSE for COVID-19 immunization. Patient's medical history included Diabetes. Concomitant medications were not reported. It was reported that the patient had the first dose of the vaccine on 06Mar2021 and now can't keep up with herself. The patient has vomited and can't keep her head up and has headaches. and stated she knew the vomiting goes on for 14 days but today was 23 days and she was still feeling the same. Patient was due for her second dose of the vaccine and wanted to know if she should still get her second dose or if she should wait a couple weeks until she feels better. Upon follow-up (29Mar2021, on an unknown date the patient had passed out, cannot make it on the second dose schedule; missed from receiving her second dose, cannot eat, vomiting, Feeling sick. The patient reported that she experienced different symptoms like she passed out and was in IV fluid (as treatment) after the first dose. Now the patient cannot make it on the second dose schedule. The patient was reported that the treatment was advised by her physician because the patient passed out and missed from receiving her second dose. The patient cannot eat, vomiting and she was still sick, up until now, that is why she cannot go to get the second dose of vaccine. Limited information was available over the call. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Vomiting
Clinical narrative: Passed out; Cannot make it on the second dose schedule; missed from receiving her second dose; She has vomitted; she is still sick; can't keep her head up and has headaches; Feeling sick; She cannot eat; This is a spontaneous report from a contactable consumer (reported for herself). The female patient (80 unit not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot no: not reported) on an unknown route of administration on 06Mar2021 as SINGLE DOSE for COVID-19 immunization. Patient's medical history included Diabetes. Concomitant medications were not reported. It was reported that the patient had the first dose of the vaccine on 06Mar2021 and now can't keep up with herself. The patient has vomited and can't keep her head up and has headaches. and stated she knew the vomiting goes on for 14 days but today was 23 days and she was still feeling the same. Patient was due for her second dose of the vaccine and wanted to know if she should still get her second dose or if she should wait a couple weeks until she feels better. Upon follow-up (29Mar2021, on an unknown date the patient had passed out, cannot make it on the second dose schedule; missed from receiving her second dose, cannot eat, vomiting, Feeling sick. The patient reported that she experienced different symptoms like she passed out and was in IV fluid (as treatment) after the first dose. Now the patient cannot make it on the second dose schedule. The patient was reported that the treatment was advised by her physician because the patient passed out and missed from receiving her second dose. The patient cannot eat, vomiting and she was still sick, up until now, that is why she cannot go to get the second dose of vaccine. Limited information was available over the call. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a spontaneous report from a non-contactable consumer (Patient). A 50-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: ER8727, expiry date: unknown), via an unspecified route of administration in right arm on 24Mar2021 at 09:00, (at the age of 50-year-old) as a single dose, for COVID-19 immunisation. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The patient concomitant medication was none. The patient previously took codeine and experienced allergies (known allergies_ codeine). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient experienced bell's palsy on 26Mar2021, at 07:00. The patient visited physician office and emergency room. The patient received steroids as treatment to the event. The outcome of the event was recovering  No follow up attempts are possible. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Cutaneous vasculitis
Clinical narrative: Leukocytoclastic vasculitis; This is a spontaneous report from a contactable other hcp. An 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, in arm right on 23Feb2021 (Batch/Lot Number: EN6201) and dose 2 via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported); both as single dose for Covid-19 immunisation (age at vaccination was 83 years). It was unknown if other vaccine was received in four weeks. The patient medical history and concomitant medications were not reported. She was not pregnant. On an unspecified date in year 2021, the patient had leukocytoclastic vasculitis after each of the 2 vaccines. No treatment was received. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown whether patient had Covid prior vaccination or not and whether patient tested for Covid post vaccination or not. Outcome for leukocytoclastic vasculitis was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported event leukocytoclastic vasculitis cannot be excluded. Case will be reassessed upon receipt of additional information. 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: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Disorganised speech, Electrocardiogram, Investigation
Clinical narrative: Stroke like symptom- babble; could not form words to communicate to wife or EMT; 24 hrs before he didn't feel well nothing in particular-no headache, no stomach issue, no fever, no tremors or motor skill issues.; This is a spontaneous report received from a contactable consumer (patient). An 86-year- old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 18Feb2021 as a single dose and first dose on 28Jan2021 as a single dose and both the doses (at the age of 86-years-old) for COVID-19 immunisation. The patient medical history included Prior stroke, Kidney disease and inactive pituitary gland. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received concomitant medication within two weeks of vaccination (names not specified). The patient did not receive any vaccine within 4 weeks prior to the vaccine. On 09Mar2021, the patient had stroke like symptom- babble, could not form words to communicate to wife or EMT and he didn't feel well on an unknown date in Mar2021 (24 hrs before) (as reported). It was reported that patient had no headache, no stomach issue, no fever, no tremors or motor skill issues. The patient visited emergency room and was hospitalised on an unknown date in Mar2021 for the events Stroke like symptom- babble, could not form words to communicate to wife or EMT for 2 days. Therapeutic measures were taken as a result of events stroke like symptom- babble, could not form words to communicate to wife or EMT. The patient had undergone laboratory test and procedures on an unknown date in Mar2021 includes EKG, heart CT, monitored blood, a full MRI (next morning) and the results were not reported. The outcome of the events Stroke like symptom- babble, could not form words to communicate to wife or EMT was recovered on an unknown date in Mar2021 while for another event was unknown.  Information about batch number and lot number is requested.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Malaise
Clinical narrative: Stroke like symptom- babble; could not form words to communicate to wife or EMT; 24 hrs before he didn't feel well nothing in particular-no headache, no stomach issue, no fever, no tremors or motor skill issues.; This is a spontaneous report received from a contactable consumer (patient). An 86-year- old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 18Feb2021 as a single dose and first dose on 28Jan2021 as a single dose and both the doses (at the age of 86-years-old) for COVID-19 immunisation. The patient medical history included Prior stroke, Kidney disease and inactive pituitary gland. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received concomitant medication within two weeks of vaccination (names not specified). The patient did not receive any vaccine within 4 weeks prior to the vaccine. On 09Mar2021, the patient had stroke like symptom- babble, could not form words to communicate to wife or EMT and he didn't feel well on an unknown date in Mar2021 (24 hrs before) (as reported). It was reported that patient had no headache, no stomach issue, no fever, no tremors or motor skill issues. The patient visited emergency room and was hospitalised on an unknown date in Mar2021 for the events Stroke like symptom- babble, could not form words to communicate to wife or EMT for 2 days. Therapeutic measures were taken as a result of events stroke like symptom- babble, could not form words to communicate to wife or EMT. The patient had undergone laboratory test and procedures on an unknown date in Mar2021 includes EKG, heart CT, monitored blood, a full MRI (next morning) and the results were not reported. The outcome of the events Stroke like symptom- babble, could not form words to communicate to wife or EMT was recovered on an unknown date in Mar2021 while for another event was unknown.  Information about batch number and lot number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: cellulitis-active infection; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient recently developed cellulitis-active infection and currently on antibx (antibiotic). The patient stated that she was supposed to get 2nd shot of Pfizer Covid vaccine tomorrow (30Mar2021). The patient asked if she can still get her shot. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hallucination, Headache, Influenza like illness, Nausea
Clinical narrative: Hallucinations; Fever; Shaking chills; Headache; Bodyaches; Flu-like symptoms; Teeth chattering; Arm soreness; Extreme nausea; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm, at age 54 years, on 26Mar2021 09:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  Patient's medical history includes multiple sclerosis, hypothyroid, postconcussive syndrome and migraines from unspecified dates.  The patient is not pregnant. Patient did not have other vaccine in four weeks. Patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported.  Patient previously took codeine  for unspecified indication and had known allergies on an unspecified date, and other unspecified medications in two weeks. Patient historically took first dose of BNT162B2 (Product=COVID 19, Brand=Pfizer, administration time=05:00 PM, Vaccine location= Left arm) on 03Mar2021 at age 54 years for COVID-19 immunization. On 26Mar2021 20:00, 11 hours after vaccine administration, patient experienced fever, shaking chills, headache, hallucinations, body aches, flu-like symptoms, teeth chattering, arm soreness, extreme nausea. Therapeutic measures were taken as a result of these events which include paracetamol (TYLENOL). COVID was not tested post vaccination. Facility type of vaccine was at a public health clinic/veterans administration facility. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Hallucinations; Fever; Shaking chills; Headache; Bodyaches; Flu-like symptoms; Teeth chattering; Arm soreness; Extreme nausea; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm, at age 54 years, on 26Mar2021 09:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  Patient's medical history includes multiple sclerosis, hypothyroid, postconcussive syndrome and migraines from unspecified dates.  The patient is not pregnant. Patient did not have other vaccine in four weeks. Patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported.  Patient previously took codeine  for unspecified indication and had known allergies on an unspecified date, and other unspecified medications in two weeks. Patient historically took first dose of BNT162B2 (Product=COVID 19, Brand=Pfizer, administration time=05:00 PM, Vaccine location= Left arm) on 03Mar2021 at age 54 years for COVID-19 immunization. On 26Mar2021 20:00, 11 hours after vaccine administration, patient experienced fever, shaking chills, headache, hallucinations, body aches, flu-like symptoms, teeth chattering, arm soreness, extreme nausea. Therapeutic measures were taken as a result of these events which include paracetamol (TYLENOL). COVID was not tested post vaccination. Facility type of vaccine was at a public health clinic/veterans administration facility. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Illness, Loss of consciousness
Clinical narrative: Tightening in the chest; Feeling dizzy; Thought she was going to pass out, faint; Thought she was going to pass out, faint; Not breathing real well; Sick; Needed magnifier to read small writing on card; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6204; Expiration date were not reported) on 24Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included low blood pressure; and used to pass out. The patient had unspecified concomitant medications ("fewer pills"). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6206; Expiration date was not reported) on 03Mar2021 for COVID-19 immunization. On 24Mar2021, the patient thought she was going to pass out and faint; was not breathing real well; and was sick. On 29Mar2021, the patient had tightening in the chest; and was feeling dizzy. In Mar2021, the patient needed a magnifier to read small writing on card. It was unknown if the patient had received treatment for the events. The outcome of the events was recovering for 'thought she was going to pass out and faint', 'tightening in the chest' and 'feeling dizzy'; was recovered in Mar2021 for 'not breathing real well'; and was unknown for 'sick' and 'needed magnifier to read small writing on card'.  Follow-up action is needed. Further information is requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Visual impairment
Clinical narrative: Tightening in the chest; Feeling dizzy; Thought she was going to pass out, faint; Thought she was going to pass out, faint; Not breathing real well; Sick; Needed magnifier to read small writing on card; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6204; Expiration date were not reported) on 24Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included low blood pressure; and used to pass out. The patient had unspecified concomitant medications ("fewer pills"). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6206; Expiration date was not reported) on 03Mar2021 for COVID-19 immunization. On 24Mar2021, the patient thought she was going to pass out and faint; was not breathing real well; and was sick. On 29Mar2021, the patient had tightening in the chest; and was feeling dizzy. In Mar2021, the patient needed a magnifier to read small writing on card. It was unknown if the patient had received treatment for the events. The outcome of the events was recovering for 'thought she was going to pass out and faint', 'tightening in the chest' and 'feeling dizzy'; was recovered in Mar2021 for 'not breathing real well'; and was unknown for 'sick' and 'needed magnifier to read small writing on card'.  Follow-up action is needed. Further information is requested.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in my ears.; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7534), via an unspecified route of administration, at the age of 43 years, administered on the left arm on 24Mar2021 18:30 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included risankizumab rzaa (SKYRIZI [RISANKIZUMAB RZAA]) taken for an unspecified indication, start and stop date were not reported. The patient received first dose of COVID vaccine BNT162B2 (lot number: EN6202) on 03Mar2021 in the right arm for COVID-19 immunization. The patient experienced ringing in ears (disability) on 26Mar2021 15:45. No treatment was received for the event. The outcome of the event was not recovered.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Insomnia
Clinical narrative: loss of hearing two days after vaccine; up for 48 hours after the vaccine; This is a spontaneous report from a contactable consumer (patient). A 95-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6208) via an unspecified route of administration, administered in Arm Right, at the age of 95-year-old, on 20Mar2021 11:30, as SINGLE DOSE for covid-19 immunisation.  Medical history was not reported. Concomitant medications included atenolol; dutasteride; apixaban (ELIQUIS); and methenamine.  The patient received amoxcillin and experienced allergy and first dose of of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ENF6200) via an unspecified route of administration, administered in Arm Right on 27Feb2021 11:45, as SINGLE DOSE for covid-19 immunisation.  It was reported that the patient received other vaccine (unspecified) four weeks before receiving the COVID vaccine. The patient was up for 48 hours after the vaccine on 22Mar2021, then loss of hearing two days after vaccine on 22Mar2021. The patient did not receive any treatment in response to the events. The event loss of hearing two days required emergency room visit. The patient was not diagnosed with COVID before vaccination and was not tested since vaccination. Outcome of the events was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Ear discomfort, Fatigue
Clinical narrative: pneumonia; congestion; Vomiting; Chills; cough; exhaustion; headache; ears burning; lung pain; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date not reported), via an unspecified route of administration, administered in the left arm on 27Mar2021 at 09:45 as a single dose for COVID-19 immunization.  The patient's medical history was not reported. The patient had no known allergies. The patient did not have COVID prior to the vaccination. Concomitant medication included duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported. On 28Mar2021 at 12:30, the patient experienced vomiting, chills, cough, exhaustion, headache, ears burning, lung pain, shortness of breath and congestion. The patient went to doctor on 30Mar2021 and apparently, she has pneumonia. The patient also mentioned that she barely had a stuffy nose before taking the vaccine. The patient has a rapid response nasal swab COVID test on 29Mar2021 with a negative result and a PCR nasal swab COVID test also on 29Mar2021 with an unknown result. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered.  Information on the batch/lot number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pneumonia, Pulmonary congestion, Pulmonary pain, SARS-CoV-2 test
Clinical narrative: pneumonia; congestion; Vomiting; Chills; cough; exhaustion; headache; ears burning; lung pain; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date not reported), via an unspecified route of administration, administered in the left arm on 27Mar2021 at 09:45 as a single dose for COVID-19 immunization.  The patient's medical history was not reported. The patient had no known allergies. The patient did not have COVID prior to the vaccination. Concomitant medication included duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported. On 28Mar2021 at 12:30, the patient experienced vomiting, chills, cough, exhaustion, headache, ears burning, lung pain, shortness of breath and congestion. The patient went to doctor on 30Mar2021 and apparently, she has pneumonia. The patient also mentioned that she barely had a stuffy nose before taking the vaccine. The patient has a rapid response nasal swab COVID test on 29Mar2021 with a negative result and a PCR nasal swab COVID test also on 29Mar2021 with an unknown result. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered.  Information on the batch/lot number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: pneumonia; congestion; Vomiting; Chills; cough; exhaustion; headache; ears burning; lung pain; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date not reported), via an unspecified route of administration, administered in the left arm on 27Mar2021 at 09:45 as a single dose for COVID-19 immunization.  The patient's medical history was not reported. The patient had no known allergies. The patient did not have COVID prior to the vaccination. Concomitant medication included duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported. On 28Mar2021 at 12:30, the patient experienced vomiting, chills, cough, exhaustion, headache, ears burning, lung pain, shortness of breath and congestion. The patient went to doctor on 30Mar2021 and apparently, she has pneumonia. The patient also mentioned that she barely had a stuffy nose before taking the vaccine. The patient has a rapid response nasal swab COVID test on 29Mar2021 with a negative result and a PCR nasal swab COVID test also on 29Mar2021 with an unknown result. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Herpes zoster, Hypertension
Clinical narrative: diagnosed with a mild infection in the upper right lobe of her lung.; high blood pressure with systolic and diastolic  over 100 and was diagnosed with a mild infection in the upper right lobe of her lung.; rapid heart rate; shingles; had an ugly rash on the upper right side of her back; This is a spontaneous report from Pfizer via a contactable consumer (reporting for herself). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 05Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient stated that she went to the emergency room (ER) in between the first and second dose of the vaccine with rapid heart rate, high blood pressure with systolic and diastolic over 100 and was diagnosed with a mild infection in the upper right lobe of her lung. The patient stated three days later, she was diagnosed with shingles. The patient also stated that she received the first dose of the vaccine on 5Feb2021 and the second dose on 27Mar2021, stating she has gone past the six weeks window. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, Rash
Clinical narrative: diagnosed with a mild infection in the upper right lobe of her lung.; high blood pressure with systolic and diastolic  over 100 and was diagnosed with a mild infection in the upper right lobe of her lung.; rapid heart rate; shingles; had an ugly rash on the upper right side of her back; This is a spontaneous report from Pfizer via a contactable consumer (reporting for herself). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 05Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient stated that she went to the emergency room (ER) in between the first and second dose of the vaccine with rapid heart rate, high blood pressure with systolic and diastolic over 100 and was diagnosed with a mild infection in the upper right lobe of her lung. The patient stated three days later, she was diagnosed with shingles. The patient also stated that she received the first dose of the vaccine on 5Feb2021 and the second dose on 27Mar2021, stating she has gone past the six weeks window. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: diagnosed with a mild infection in the upper right lobe of her lung.; high blood pressure with systolic and diastolic  over 100 and was diagnosed with a mild infection in the upper right lobe of her lung.; rapid heart rate; shingles; had an ugly rash on the upper right side of her back; This is a spontaneous report from Pfizer via a contactable consumer (reporting for herself). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 05Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient stated that she went to the emergency room (ER) in between the first and second dose of the vaccine with rapid heart rate, high blood pressure with systolic and diastolic over 100 and was diagnosed with a mild infection in the upper right lobe of her lung. The patient stated three days later, she was diagnosed with shingles. The patient also stated that she received the first dose of the vaccine on 5Feb2021 and the second dose on 27Mar2021, stating she has gone past the six weeks window. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Animal bite, Cellulitis
Clinical narrative: cellulitis; bit by her dog and needs a tetanus shot; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 08Mar2021, as single dose, for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced cellulitis. On 26Mar2021, the patient was bit by her dog and needs a tetanus shot/a dose of TDAP. The reporter was aware of the 14-day exclusion period for vaccines and knew that the tetanus vaccine trumps the COVID-19 vaccine in priority so the reporter would like to make sure what to do in this situation. The reporter wanted information about the patient getting the second dose longer that 3 weeks after the first dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of event cellulitis cannot be totally excluded.  The case will be reassessed if additional information becomes available.  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: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Eye haemorrhage, Feeling abnormal, Influenza like illness
Clinical narrative: Within about 12 hours after taking the vaccine a capillary in the white part of my eye bust and the left side of my left eye was/is bloody; It's been about 2 days and for the first day and a half I experienced the normal flu like symptoms.; dazed; when I leaned back to put eye drops in eye I lost my balance a little which does not normally happen; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP7534), via an unspecified route of administration, administered in left arm on 27Mar2021 14:30 at single dose for COVID-19 immunisation. The patient's medical history included asthma, prediabetic, low thyroid, overweight but not obese, and capillary in the white part of his eye bust (right eye) about 4 months ago. The patient's concomitant medications included alprazolam (XANAX), colecalciferol (VITAMIN D), montelukast sodium (SINGULAIR), and levothyroxine sodium (SYNTHROID). The patient previously took cryproheptadine hydrochloride (CYPRO) and had known allergies. The patient also previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. The patient had no COVID prior to vaccination and has not been tested for COVID post-vaccination. The vaccine facility type was Public Health Department. The patient has no other vaccine in four weeks. On 29Mar2021 at 14:00, it's been about 2 days and for the first day and a half, the patient experienced the normal flu like symptoms. Now after about two days (29Mar2021 at 14:00), he feel just a little out of it, dazed. Also when he leaned back to put eye drops in his eye, he lost his balance a little which does not normally happen. Also within about 12 hours after taking the vaccine, a capillary in the white part of his eye bust and the left side of his left eye was bloody. No treatment was received for the events. The outcome of the events were not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Hyperhidrosis
Clinical narrative: When she was able to fall asleep she woke biting my tongue like a seizure; Severe left arm and shoulder pain; Severe left arm and shoulder pain; Fever that gradually went higher to 103.7; Severe headache; Jaw pain; Blurred vision; Tired; Sweaty; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 27Mar2021 15:00  as SINGLE DOSE for covid-19 immunisation.  Medical history included Known allergies: Sulfa's and sulfurs, Unknown blood clotting disorder, Arnold chiari malformation syndrome, sinusitis. Concomitant medication included apixaban (ELIQUIS) taken for Unknown blood clotting disorder. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6199) on 06Mar2021, 04:00AM on left arm for covid-19 immunisation (55 years old). On 28Mar2021, 04:00, the patient stated that she had severe left arm and shoulder pain, fever that gradually went higher to 103.7 then a day later the fever went down. Severe headache with jaw pain, blurred vision. When she was able to fall asleep she woke biting my tongue like a seizure. Currently she is tired and sweaty, fever has gone, arm pain gone within a day and a half. Therapeutic measures were taken as a result of all the events included At home pain and fever medicine. The patient was not pregnant. Outcome of the events pain in arm and fever was recovered on an unspecified date while outcome of the remaining events was recovering.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain in jaw, Pyrexia, Seizure like phenomena, Vision blurred
Clinical narrative: When she was able to fall asleep she woke biting my tongue like a seizure; Severe left arm and shoulder pain; Severe left arm and shoulder pain; Fever that gradually went higher to 103.7; Severe headache; Jaw pain; Blurred vision; Tired; Sweaty; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 27Mar2021 15:00  as SINGLE DOSE for covid-19 immunisation.  Medical history included Known allergies: Sulfa's and sulfurs, Unknown blood clotting disorder, Arnold chiari malformation syndrome, sinusitis. Concomitant medication included apixaban (ELIQUIS) taken for Unknown blood clotting disorder. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6199) on 06Mar2021, 04:00AM on left arm for covid-19 immunisation (55 years old). On 28Mar2021, 04:00, the patient stated that she had severe left arm and shoulder pain, fever that gradually went higher to 103.7 then a day later the fever went down. Severe headache with jaw pain, blurred vision. When she was able to fall asleep she woke biting my tongue like a seizure. Currently she is tired and sweaty, fever has gone, arm pain gone within a day and a half. Therapeutic measures were taken as a result of all the events included At home pain and fever medicine. The patient was not pregnant. Outcome of the events pain in arm and fever was recovered on an unspecified date while outcome of the remaining events was recovering.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, SARS-CoV-2 test
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9809), via an unspecified route of administration in the left arm, on 13Feb2021 15:00, as single dose, for COVID-19 immunisation. Medical history included asthma. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included formoterol fumarate, mometasone furoate (DULERA); and morniflumate (FLOMAX), both taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) received at age 68 years, via an unspecified route of administration in the left arm, on 23Jan2021, for COVID-19 immunisation. The patient received other vaccines (unspecified) within 4 weeks prior to BNT162B2. On 20Mar2021 at 09:00, the patient developed compromised taste sensations, could not form a tight seal around mouth, was spilling fluids from right side, and could not close right eye. He was diagnosed with Bell's Palsy. The event resulted to physician office visit. Treatment for the event included unspecified anti-viral tablets (as reported). Laboratory test include COVID-19 PCR test which was negative on 23Feb2021. The outcome of the event was not recovered.  No follow up attempts are needed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Inflammation
Clinical narrative: Lupus Flared up; Chill; Body ache; Headache; Feeling weak; Fatigue; neck inflammation and Back Inflammation; This is a spontaneous report from a contactable consumer (patient). A 20-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, administered in left arm on 07Mar2021 12:45 at a single dose for covid-19 immunization. Medical history included lupus, immunocompromise, asthma, and allergies to shellfish, all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, and there were no other medications that the patient received within 2 weeks. On 24Mar2021, the patient experienced chill after 30 minutes, body ache for 2 days, headache, feeling weak and fatigue or 2 days then disappeared, and reported after 2 weeks lupus flared up, had a neck inflammation and back Inflammation. Patient stated that one week after Covid vaccine, patient started taking lupus meds too. The events resulted in emergency room/department or urgent care and patient received prednisone as treatment and to reduce the inflammation. Since the vaccination (2021), has the patient been tested for COVID-19 which was a negative nasal swab. The patient was recovering from the reported events.  Information on the lot/ batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test, Systemic lupus erythematosus
Clinical narrative: Lupus Flared up; Chill; Body ache; Headache; Feeling weak; Fatigue; neck inflammation and Back Inflammation; This is a spontaneous report from a contactable consumer (patient). A 20-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, administered in left arm on 07Mar2021 12:45 at a single dose for covid-19 immunization. Medical history included lupus, immunocompromise, asthma, and allergies to shellfish, all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, and there were no other medications that the patient received within 2 weeks. On 24Mar2021, the patient experienced chill after 30 minutes, body ache for 2 days, headache, feeling weak and fatigue or 2 days then disappeared, and reported after 2 weeks lupus flared up, had a neck inflammation and back Inflammation. Patient stated that one week after Covid vaccine, patient started taking lupus meds too. The events resulted in emergency room/department or urgent care and patient received prednisone as treatment and to reduce the inflammation. Since the vaccination (2021), has the patient been tested for COVID-19 which was a negative nasal swab. The patient was recovering from the reported events.  Information on the lot/ batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Apathy, COVID-19, Decreased appetite, Diarrhoea
Clinical narrative: COVID-19 nasal swab test that was positive; COVID-19 nasal swab test that was positive; Shortness of breath; Angina; chest pain; Fatigue; Diarrhea; Weight loss; Will and desire gone; No appetite; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BINTECH COVID-19 VACCINE), via an unspecified route of administration in right arm, the first dose (Lot Number: EM9809) on 01Mar2021 and the second dose (Lot Number: EN6203) on 22Mar2021 at 13:30 (01:30 PM), both at a single dose, for COVID-19 immunization. The patient's medical history included heart attack, three stents, and diabetes. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in a hospital facility. On 22Mar2021 at 16:00, the patient experienced shortness of breath, angina, fatigue, diarrhea, weight loss, chest pains, will and desire gone, and no appetite. The patient underwent COVID-19 nasal swab test that was negative on 20Mar2021 and positive on 25Mar2021. The patient was hospitalized in Mar2021 for all events for 2 days. It was unknown if treatment was received for the adverse events. The patient had not recovered from the events.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Dyspnoea, Fatigue, SARS-CoV-2 test, Weight
Clinical narrative: COVID-19 nasal swab test that was positive; COVID-19 nasal swab test that was positive; Shortness of breath; Angina; chest pain; Fatigue; Diarrhea; Weight loss; Will and desire gone; No appetite; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BINTECH COVID-19 VACCINE), via an unspecified route of administration in right arm, the first dose (Lot Number: EM9809) on 01Mar2021 and the second dose (Lot Number: EN6203) on 22Mar2021 at 13:30 (01:30 PM), both at a single dose, for COVID-19 immunization. The patient's medical history included heart attack, three stents, and diabetes. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in a hospital facility. On 22Mar2021 at 16:00, the patient experienced shortness of breath, angina, fatigue, diarrhea, weight loss, chest pains, will and desire gone, and no appetite. The patient underwent COVID-19 nasal swab test that was negative on 20Mar2021 and positive on 25Mar2021. The patient was hospitalized in Mar2021 for all events for 2 days. It was unknown if treatment was received for the adverse events. The patient had not recovered from the events.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: COVID-19 nasal swab test that was positive; COVID-19 nasal swab test that was positive; Shortness of breath; Angina; chest pain; Fatigue; Diarrhea; Weight loss; Will and desire gone; No appetite; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BINTECH COVID-19 VACCINE), via an unspecified route of administration in right arm, the first dose (Lot Number: EM9809) on 01Mar2021 and the second dose (Lot Number: EN6203) on 22Mar2021 at 13:30 (01:30 PM), both at a single dose, for COVID-19 immunization. The patient's medical history included heart attack, three stents, and diabetes. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in a hospital facility. On 22Mar2021 at 16:00, the patient experienced shortness of breath, angina, fatigue, diarrhea, weight loss, chest pains, will and desire gone, and no appetite. The patient underwent COVID-19 nasal swab test that was negative on 20Mar2021 and positive on 25Mar2021. The patient was hospitalized in Mar2021 for all events for 2 days. It was unknown if treatment was received for the adverse events. The patient had not recovered from the events.