chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Dose number: 3; Dose number: 3; body aches; headache; chills; arm that rec'd the shot was extremely sore; This is a spontaneous report from a contactable consumer (Patient).   A 70-year-old female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration, administered in arm left on 11Oct2021 11:00 (at the age of 70-year-old) (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation, administered a Pharmacy or Drug Store.  Medical history included thyroid disorder. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) in two weeks included omega-3 [omega-3 nos] (OMEGA-3 [OMEGA-3 NOS]); vit d [vitamin d nos] (VIT D [VITAMIN D NOS]); ubidecarenone (COQ-10); cholesterol (CHOLESTEROL), all taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm right Feb2021 11:00 AM (at the age of 69-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient previously received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm right Mar2021 10:00 AM (at the age of 69-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. No other vaccine in four weeks. The patient experienced arm that received the shot was extremely sore during the night (medically significant) in Oct2021 10:00 PM with outcome of recovered in Oct2021, received dose number: 3 (non-serious) on 11Oct2021 11:00 with outcome of unknown, body aches (non-serious) in Oct2021 10:00 PM with outcome of recovered in Oct2021, headache (non-serious) in Oct2021 10:00 PM with outcome of recovered in Oct2021, chills (non-serious) on Oct2021 10:00 PM with outcome of recovered in Oct2021. No treatment received. COVID was not tested post vaccination.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Dysstasia, Headache
Clinical narrative: feeling faint/ feeling like she's going to faint; dizzy; Third dose: has pain throughout her body; She states it is hard to stand up; throwing up; headache; diarrhea; high fever/ temperature before she called was 103.5; She got the booster yesterday and she has been quite ill/ really sick right now; Third dose: she's so weak right now; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in left arm on 14Oct2021 11:30 (Lot Number: FF2590) (at the age of 72-years-old) as dose 3 (booster), single for covid-19 immunisation. The patient no medical history. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in left arm on 03Feb2021 (Lot Number: E51666) (at the age of 71-years-old) as dose 1, single for covid-19 immunisation; and bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in left arm on 26Feb2021 (Lot Number: EN6206) (at the age of 71-years-old) as dose 2, single for covid-19 immunisation and experienced high fever, dizzy, was throwing up, headache, felt like needles and couldn't stand up after dose 2. Patient took vaccine because she works in healthcare, not as a clinician, but leads a national group. Patient got the booster a day before reporting and she has been quite ill with that one. After the third dose on 14Oct2021, she had those symptoms (high fever, dizzy, throwing up), as well as feeling faint, diarrhea, and a headache. She stated it was hard to stand up on 14Oct2021, and she had thought she was in pretty good shape for her age. She also mentioned that this was only the second time in her life she's had a headache; the first was after the second dose. Her fever was 103-104 F for 2.5 days in 2021. Now it was closer to 102-103 F. Her maximum temperature was 103.5 F on the morning of day of reporting. Patient stated that she was experiencing the same symptoms, but a little worse, now she can't stand up without feeling like she's going to faint, her temperature before she called was 103.5 F. She got the shot at 14Oct2021 11:30, and the symptoms started around and they got really bad at night on 14Oct2021, they are all ongoing and worsened. She stated she has a very high temperature, very dizzy, she had pain throughout her body, she never had headaches, but she has one. The patient stated that she doesn't take anything, she did take an ibuprofen last night 14Oct2021, she usually never takes anything, but she had gotten it just in case and she took one and that was it. The events did not require visit to emergency room and physician office. She stated just put that just she's really sick right now, she was so weak right now in Oct2021. The outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain, Presyncope, Pyrexia, Vomiting
Clinical narrative: feeling faint/ feeling like she's going to faint; dizzy; Third dose: has pain throughout her body; She states it is hard to stand up; throwing up; headache; diarrhea; high fever/ temperature before she called was 103.5; She got the booster yesterday and she has been quite ill/ really sick right now; Third dose: she's so weak right now; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in left arm on 14Oct2021 11:30 (Lot Number: FF2590) (at the age of 72-years-old) as dose 3 (booster), single for covid-19 immunisation. The patient no medical history. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in left arm on 03Feb2021 (Lot Number: E51666) (at the age of 71-years-old) as dose 1, single for covid-19 immunisation; and bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in left arm on 26Feb2021 (Lot Number: EN6206) (at the age of 71-years-old) as dose 2, single for covid-19 immunisation and experienced high fever, dizzy, was throwing up, headache, felt like needles and couldn't stand up after dose 2. Patient took vaccine because she works in healthcare, not as a clinician, but leads a national group. Patient got the booster a day before reporting and she has been quite ill with that one. After the third dose on 14Oct2021, she had those symptoms (high fever, dizzy, throwing up), as well as feeling faint, diarrhea, and a headache. She stated it was hard to stand up on 14Oct2021, and she had thought she was in pretty good shape for her age. She also mentioned that this was only the second time in her life she's had a headache; the first was after the second dose. Her fever was 103-104 F for 2.5 days in 2021. Now it was closer to 102-103 F. Her maximum temperature was 103.5 F on the morning of day of reporting. Patient stated that she was experiencing the same symptoms, but a little worse, now she can't stand up without feeling like she's going to faint, her temperature before she called was 103.5 F. She got the shot at 14Oct2021 11:30, and the symptoms started around and they got really bad at night on 14Oct2021, they are all ongoing and worsened. She stated she has a very high temperature, very dizzy, she had pain throughout her body, she never had headaches, but she has one. The patient stated that she doesn't take anything, she did take an ibuprofen last night 14Oct2021, she usually never takes anything, but she had gotten it just in case and she took one and that was it. The events did not require visit to emergency room and physician office. She stated just put that just she's really sick right now, she was so weak right now in Oct2021. The outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Pain, Pyrexia
Clinical narrative: severe coughing; Fever two days 101; chills; body pain; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 62-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 16Oct2021 at 14:00 (at the age of 62 years old), as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient was not pregnant at time of vaccination. The patient medical history was not reported. The patient had no known allergies. Concomitant medication(s) included Amiloride, Phentermine and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN [ACETYLSALICYLIC ACID; CAFFEINE; PARACETAMOL]), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 20Feb2021 (at the age of 62-year-old), as dose 1,single and patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 13Mar2021(at the age of 62-year-old), as dose 2, single for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. On 16Oct2021 at 20:00, the patient experienced severe coughing, fever two days 101, chills and body pain. The patient underwent lab tests which included body temperature: 101 on 16Oct2021. No treatment was received to treat the events. The outcome of the events was resolving at the time of this report.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Deafness
Clinical narrative: Didn't have any hearing in the right ear; This is a spontaneous report from a contactable consumer (patient).  A 58-year-old patient of an unspecified gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 02Oct2021 (Lot Number: 30125BA), at the age of 58 years old, as 1st single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient's concomitant medications were not reported. The patient stated that after having had the 2nd shot, they didn't have any hearing in the right ear (exact start date not specified). The patient went to the emergency room on 17Oct2021, to see if they would pour some wax or something out of the ear but instead they did a CT scan and there was nothing that they could see, however they wanted to keep the patient overnight to perform an MRI, but the patient chose to go home (on 17Oct2021). The patient also had a blood test done at ER, however, no results were provided. The patient was scheduled to take the next shot on the 23rd but the patient didn't want to/was afraid to, since the first shot had affected the patient like that. The patient had not recovered from the event.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Large Left DVT and PE; Large Left DVT and PE; This is a spontaneous report from a contactable Physician reporting for a patient. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 28Aug2021 (Lot Number: FC3183), at the age of 62-year-old, as dose 2, single for COVID-19 immunisation. The vaccine was administered at Pharmacy or Drug Store. Medical history included diabetes mellitus type2, asthma, hypertension, hyperlipidemia. The patient did not have COVID prior to vaccination. Concomitant medications included salbutamol (PROVENTIL); allopurinol (ZYLOPRIM); atorvastatin calcium (LIPITOR); colecalciferol (VIT D); metformin (METFORMIN); lisinopril (LISINOPRIL).  The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Aug2021 05:00 PM (Lot Number: EW0179), at the age of 62-year-old, as dose 1, single for COVID-19 immunisation. The patient has known allergies to sulfamethoxazole-trimethoprim sulfamethoxazole.  On 16Oct2021 the patient experienced Large Left deep vein thrombosis (DVT) and pulmonary embolism (PE). The events resulted in emergency room/department or urgent care and treatments included Direct-Acting Oral Anticoagulant (DOAC). On 16Oct2021 the patient was tested for COVID-19 Nasal Swab Hospital Respiratory Panel and result was negative. The events were resolving.; Sender's Comments: Based on the limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported event Deep vein thrombosis and Pulmonary embolism cannot be ruled out. 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: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vitamin B12, Vitamin B12 decreased
Clinical narrative: Low B12; This is a spontaneous report from a contactable consumer (patient/hospital aid).  A 43-year-old female patient received the 2nd single dose via an unspecified route of administration, administered in the left arm, on 29Sep2021 (Lot Number: EW0176; Expiration Date: Nov2021), at the age of 43 years old, for COVID-19 immunisation. Medical history included ongoing high cholesterol, ongoing hypothyroidism, anxiety, and venous insufficiency (untreated). There were no allergies to report. Concomitant medications included ongoing daily atorvastatin, ongoing daily levothyroxine, and duloxetine for anxiety. The patient had received the 1st single dose of BNT162b2, administered in the left arm, on 08Sep2021 (Lot EW0171; Expiry 30Nov2021), always at the age of 43 years old. The patient experienced with the 1st dose and 2nd dose suspected cerebral venous sinus thrombosis with increased intracranial pressure and associated papilledema. During blood tests run on 11Oct2021 for the above issues,  a low B12 was also revealed, due to which the patient had to start B12 supplement. The patient had not recovered from all the reported event.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101392617 Same patient and drug, different event, only 2nd dose
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis, Intracranial pressure increased, Investigation, Papilloedema, Platelet count
Clinical narrative: Low B12; This is a spontaneous report from a contactable consumer (patient/hospital aid).  A 43-year-old female patient received the 2nd single dose via an unspecified route of administration, administered in the left arm, on 29Sep2021 (Lot Number: EW0176; Expiration Date: Nov2021), at the age of 43 years old, for COVID-19 immunisation. Medical history included ongoing high cholesterol, ongoing hypothyroidism, anxiety, and venous insufficiency (untreated). There were no allergies to report. Concomitant medications included ongoing daily atorvastatin, ongoing daily levothyroxine, and duloxetine for anxiety. The patient had received the 1st single dose of BNT162b2, administered in the left arm, on 08Sep2021 (Lot EW0171; Expiry 30Nov2021), always at the age of 43 years old. The patient experienced with the 1st dose and 2nd dose suspected cerebral venous sinus thrombosis with increased intracranial pressure and associated papilledema. During blood tests run on 11Oct2021 for the above issues,  a low B12 was also revealed, due to which the patient had to start B12 supplement. The patient had not recovered from all the reported event.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101392617 Same patient and drug, different event, only 2nd dose
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vitamin B12
Clinical narrative: Low B12; This is a spontaneous report from a contactable consumer (patient/hospital aid).  A 43-year-old female patient received the 2nd single dose via an unspecified route of administration, administered in the left arm, on 29Sep2021 (Lot Number: EW0176; Expiration Date: Nov2021), at the age of 43 years old, for COVID-19 immunisation. Medical history included ongoing high cholesterol, ongoing hypothyroidism, anxiety, and venous insufficiency (untreated). There were no allergies to report. Concomitant medications included ongoing daily atorvastatin, ongoing daily levothyroxine, and duloxetine for anxiety. The patient had received the 1st single dose of BNT162b2, administered in the left arm, on 08Sep2021 (Lot EW0171; Expiry 30Nov2021), always at the age of 43 years old. The patient experienced with the 1st dose and 2nd dose suspected cerebral venous sinus thrombosis with increased intracranial pressure and associated papilledema. During blood tests run on 11Oct2021 for the above issues,  a low B12 was also revealed, due to which the patient had to start B12 supplement. The patient had not recovered from all the reported event.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101392617 Same patient and drug, different event, only 2nd dose
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vitamin B12, Vitamin B12 decreased
Clinical narrative: Cerebral venous sinus thrombosis; Increased intracranial pressure; Papilledema; This is a spontaneous report from a contactable consumer (patient/hospital aid).  A 43-year-old female patient received the 1st single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 08Sep2021, in the left arm (Lot EW0171; Expiry 30Nov2021), and the 2nd single dose via an unspecified route of administration, administered in the left arm, on 29Sep2021 (Lot Number: EW0176; Expiration Date: Nov2021), for COVID-19 immunisation. Both doses were administered at the age of 43 years old.  Medical history included ongoing high cholesterol, ongoing hypothyroidism, anxiety, and venous insufficiency (untreated). There were no allergies to report. Concomitant medications included ongoing daily atorvastatin, ongoing daily levothyroxine, and duloxetine for anxiety. The patient stated that on 09Sep2021, the day after having received the 1st shot, she went for blood work and her platelets shot up to 550. On 10Sep2021, she started suffering from headache. She's had headaches for the whole month of Sep2021, she started getting blurry vision and getting dizzy. On 25Sep2021, platelets were 514. She then got the 2nd shot on 29Sep2021 and everything got worse. Her Primary Care Physician referred her to a Neurologist and was waiting to perform an MRI. The Neurologist stated the patient has a cerebral venous sinus thrombosis, and also has her going to see an ophthalmologist since she got papilledema associated with increased intracranial pressure. The headaches were so bad, she couldn't even lift her head and the vision got blurry and she was dizzy to the point of fainting. The reporter clarified that the cerebral venous sinus thrombosis had not been officially diagnosed yet since they are waiting for an MRI exam to be done. The neurologist had prescribed Topamax and Fioricet, which the patient has started taking. Additionally the patient stated that blood work on 11Oct2021 revealed high D-Dimer and low B12 due to which she had to start B12 supplement. The patient had not recovered from all the reported events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101392586 Same patient and drug, different event, only 2nd dose
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis, Intracranial pressure increased, Investigation, Papilloedema, Platelet count
Clinical narrative: Cerebral venous sinus thrombosis; Increased intracranial pressure; Papilledema; This is a spontaneous report from a contactable consumer (patient/hospital aid).  A 43-year-old female patient received the 1st single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 08Sep2021, in the left arm (Lot EW0171; Expiry 30Nov2021), and the 2nd single dose via an unspecified route of administration, administered in the left arm, on 29Sep2021 (Lot Number: EW0176; Expiration Date: Nov2021), for COVID-19 immunisation. Both doses were administered at the age of 43 years old.  Medical history included ongoing high cholesterol, ongoing hypothyroidism, anxiety, and venous insufficiency (untreated). There were no allergies to report. Concomitant medications included ongoing daily atorvastatin, ongoing daily levothyroxine, and duloxetine for anxiety. The patient stated that on 09Sep2021, the day after having received the 1st shot, she went for blood work and her platelets shot up to 550. On 10Sep2021, she started suffering from headache. She's had headaches for the whole month of Sep2021, she started getting blurry vision and getting dizzy. On 25Sep2021, platelets were 514. She then got the 2nd shot on 29Sep2021 and everything got worse. Her Primary Care Physician referred her to a Neurologist and was waiting to perform an MRI. The Neurologist stated the patient has a cerebral venous sinus thrombosis, and also has her going to see an ophthalmologist since she got papilledema associated with increased intracranial pressure. The headaches were so bad, she couldn't even lift her head and the vision got blurry and she was dizzy to the point of fainting. The reporter clarified that the cerebral venous sinus thrombosis had not been officially diagnosed yet since they are waiting for an MRI exam to be done. The neurologist had prescribed Topamax and Fioricet, which the patient has started taking. Additionally the patient stated that blood work on 11Oct2021 revealed high D-Dimer and low B12 due to which she had to start B12 supplement. The patient had not recovered from all the reported events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101392586 Same patient and drug, different event, only 2nd dose
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vitamin B12
Clinical narrative: Cerebral venous sinus thrombosis; Increased intracranial pressure; Papilledema; This is a spontaneous report from a contactable consumer (patient/hospital aid).  A 43-year-old female patient received the 1st single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 08Sep2021, in the left arm (Lot EW0171; Expiry 30Nov2021), and the 2nd single dose via an unspecified route of administration, administered in the left arm, on 29Sep2021 (Lot Number: EW0176; Expiration Date: Nov2021), for COVID-19 immunisation. Both doses were administered at the age of 43 years old.  Medical history included ongoing high cholesterol, ongoing hypothyroidism, anxiety, and venous insufficiency (untreated). There were no allergies to report. Concomitant medications included ongoing daily atorvastatin, ongoing daily levothyroxine, and duloxetine for anxiety. The patient stated that on 09Sep2021, the day after having received the 1st shot, she went for blood work and her platelets shot up to 550. On 10Sep2021, she started suffering from headache. She's had headaches for the whole month of Sep2021, she started getting blurry vision and getting dizzy. On 25Sep2021, platelets were 514. She then got the 2nd shot on 29Sep2021 and everything got worse. Her Primary Care Physician referred her to a Neurologist and was waiting to perform an MRI. The Neurologist stated the patient has a cerebral venous sinus thrombosis, and also has her going to see an ophthalmologist since she got papilledema associated with increased intracranial pressure. The headaches were so bad, she couldn't even lift her head and the vision got blurry and she was dizzy to the point of fainting. The reporter clarified that the cerebral venous sinus thrombosis had not been officially diagnosed yet since they are waiting for an MRI exam to be done. The neurologist had prescribed Topamax and Fioricet, which the patient has started taking. Additionally the patient stated that blood work on 11Oct2021 revealed high D-Dimer and low B12 due to which she had to start B12 supplement. The patient had not recovered from all the reported events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101392586 Same patient and drug, different event, only 2nd dose
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dizziness, Heart rate
Clinical narrative: felt like a fib episode where her heart rate was high; dizziness/felt light headed; This is a spontaneous report from a contactable consumer (patient) A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE ), dose 3 via an unspecified route of administration on 18Oct2021 10:00 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation  .  Age ta vaccination :75 years.Medical history included , atrial fibrillation (diagnosed  with a fib, 2 years ago (a couple years ago).     The patient's concomitant medications were not reported.  The clinical course was reported as follows: "The patient  received the Pfizer BionTech covid 19  booster this morning she was fine until 2 hours ago, dizziness, felt like a fib episode where her heart rate was high, she was diagnosed  with a fib, 2 years ago (a couple years ago) , her apple watch notified her of her heart rate was 110 to 120 beats per minute. Caller states, her AFib it's not constant it comes and goes, intermittent, sometimes it doesn't happen all the time maybe once a month or once every other month, not on a daily basis. It was unusual for it to happen during the day. She said that it usually happen overnight or in the morning.  "I am calling my cardiologist when we hang up".  Then the patient added again : I received the booster dose at 10AM almost 6 hours ago, did a yoga class and zoom, had lunch, then felt light headed, I usually don't feel that it is fast.  I checked my smart watch my heart rate was in the 110's to 120's bpm.  Started feeling this way 4 hours after the booster dose". The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive COVID-19 test; Positive COVID-19 test; This is a spontaneous report from a contactable consumer (Pfizer employee) reporting for a patient. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single, and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, both for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had positive COVID-19 test. The event was reported as non serious. It was unknown if treatment was received. The event was resolving.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer
Clinical narrative: Breast cancer; This is a spontaneous report from a non-contactable consumer (patient's husband).  A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation  .  The patient medical history was not reported. Concomitant medication(s) included ivermectin (IVERMECTIN) taken for an unspecified indication, start and stop date were not reported.  The  reporter stated his wife took vaccine, and she got breast cancer on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, SARS-CoV-2 test negative
Clinical narrative: flare of  RA; This is a spontaneous report from a contactable physician.   A 75 year old female patient received both doses of BNT162b2 (COMIRNATY, Solution for injection, Lot number: unknown) intramuscular on an unknown date at single dose for COVID-19 immunization. Past drug history included Methotrexate 20 mg SC weekly and Xeljanz XR 11 mg and experienced infection, shingles in Apr2018 and a flare of RA in Nov2018. The patient did have bronchitis in Mar2020, hospitalization but COVID- 19 test was negative, patient has 4-6 swollen joints. The patient received COVID 19 vaccine, on an unknown date, held Methotrexate two weeks after both shots but had some flare of RA. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of flare of RA . The case will be reassessed once new information is 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
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest pain, Illness, Weight, Weight decreased
Clinical narrative: a 17 year old football player that is bed-ridden, has heart problems, and was pulled out of school since getting the vaccine; he has lost 25 pounds; They had to pull the patient out of the school because he is so sick; pain in his chest; This is a spontaneous report from a contactable consumer.  A 17-year-old male patient received first dose of bnt162b2 (COMIRNATY; Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Patient was a 17 year old football player that was bed-ridden for 3 months and had heart problems on an unknown date. He also experienced pain in his chest and he had lost 25 pounds on an unknown date. The patient was pulled out of school on an unspecified date since getting the vaccine, because he was so sick. Outcome of all the events was unknown.The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Drug ineffective, Myocardial infarction, Suspected COVID-19
Clinical narrative: Breakthrough COVID; Breakthrough COVID; Three strokes; Heart attack; This is a spontaneous report from a contactable consumer (wife who reported for her husband). A male patient of an unspecified age received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on Apr2021 (first dose; Lot number was not reported) and on Apr2021 (second dose; Lot number was not reported) both as single doses for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On Jul2021 the patient experienced breakthrough covid, serious due to hospitalization for a week in Jul2021. The patient also experienced three strokes and a heart attack on an unknown date in 2021. Patient was in an assisted living home and there were breakthroughs all the time in there. The final outcome of the events was unknown.The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal eruption, Stomatitis
Clinical narrative: sores eruptions inside my mouth; mouth sores; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0161), administered in the left arm on 13Apr2021 at 10:30 (at the age of 63-years-old) at dose 1, single for COVID-19 immunisation. Medical history included known allergies: sulfa drugs; hypothyroidism. No COVID prior vaccination; no COVID tested post vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), vitamin B complex, vitamin C (ascorbic acid); all reported as other medications in two weeks. No other vaccine in four weeks. Within 5 days of first dose, on 17Apr2021, patient had sores eruptions inside her mouth. 6 months later, she still had them. Patient had seen her primary doctor, a dentist, and an ENT doctor. She had taken prescribed anti-viral and anti-fungal mouth rinse medications (prescribed by primary doctor) to address these mouth sores. She still had them. Event resulted in doctor or other healthcare professional office/clinic visit. The patient then received the second dose of BNT162b2 (lot number: EW0173) on 04May2021 at 11:00 AM in the right arm. The patient had not recovered from the events.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives with itching, after second shot; Hives with itching, after second shot; This is a spontaneous report from a contactable consumer (patient).    A 71-year-old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6204; Expiration Date: Jun2021), via an unspecified route of administration in right arm on 09Mar2021 (at 70 years) as single dose for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease (COPD) form 2021 (reported as approximately 10 weeks before; it was very early stage and it was very mild) . Patient stated that she was allergic to all vaccines and specifically to her allergies with vaccine (all taken for immunization) she reported the Shingles vaccine and her first flu shot, but not the Pneumonia vaccine and she clarified that she broke out in hives and itches. Previously on 16Feb2021 (at 70 years) patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9266; Expiration Date: 31May2021), in Arm Right for covid-19 immunisation.  There were no concomitant medications.  On 09Mar2021 the patient experienced hives with itching, after second shot also described as follows: when she had the second shot, she broke out in hives and itched. She had to have a steroid shot and then was put on 7 days of steroids. She stated that her effects did clear up with the medications 10 days later. Patient recovered from hives with itching on 19Mar2021. Patient was hesitant for getting the booster shot. In Oc2021 she got a Flu vaccine (she can take a flu shot with no additives and that was the one that she took).
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Anaphylactic reaction, Dyspnoea, Glossodynia, Heart rate, Heart rate increased
Clinical narrative: anaphylactic reaction; allergic reaction; swelling face; tongue hurts; difficulty breathing; fast heart beat; rash; swelling of face/throat; sore throat; Pfizer Covid 19 Vaccine booster dose on 6Oct2021/received her flu shot and her Pfizer Covid 19 Vaccine booster dose on 06Oct2021 simultaneously; Pfizer Covid 19 Vaccine booster dose on 6Oct2021; received her flu shot and her Pfizer Covid 19 Vaccine booster dose on 06Oct2021 simultaneously; This is a spontaneous report from a Pfizer sponsored program from a non-contactable consumer (patient) based on information received by Pfizer from a regulatory authority (Manufacturer Control Number#: 202101341896). A female patient of an unspecified age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 06Oct2021 at dose 3 (booster), single for COVID-19 immunisation; influenza vaccine on 06Oct2021 at single dose for flu immunization. Medical history and concomitant medications were not reported. Patient confirmed that she had received her flu shot and her Pfizer COVID 19 vaccine booster dose on 06Oct2021 simultaneously. She explained that she believed that she had been misled by the pharmacist (who administered the vaccines). She explained she spoke to the pharmacist the morning of the report after spending the night in the emergency room (ER) and was referred to Pfizer for guidance. She noted she had been to the ER twice, received an epinephrine injection and was told that was all that could be done for her. The allergic reaction/anaphylactic reaction was described as follows: in Oct2021, her face was swollen, tongue hurt, sore throat, experiencing (almost every side effect on the list she was reading including severe ones) difficulty breathing, swelling of face/throat, fast heart beat and rash all over body. She explained she looked like a monster. Seeking help. She noted that her healthcare professional (HCP) was having surgery, she had no access at that moment to see her doctor. She asked what the risks of the vaccine were and what she should do about side effects. The patient went to the emergency department and received medical treatment, that included epinephrine injection USP auto-injector. The patient was hospitalized for the events in Oct2021. The outcome of the events was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Hypersensitivity, Immunisation, Off label use, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: anaphylactic reaction; allergic reaction; swelling face; tongue hurts; difficulty breathing; fast heart beat; rash; swelling of face/throat; sore throat; Pfizer Covid 19 Vaccine booster dose on 6Oct2021/received her flu shot and her Pfizer Covid 19 Vaccine booster dose on 06Oct2021 simultaneously; Pfizer Covid 19 Vaccine booster dose on 6Oct2021; received her flu shot and her Pfizer Covid 19 Vaccine booster dose on 06Oct2021 simultaneously; This is a spontaneous report from a Pfizer sponsored program from a non-contactable consumer (patient) based on information received by Pfizer from a regulatory authority (Manufacturer Control Number#: 202101341896). A female patient of an unspecified age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 06Oct2021 at dose 3 (booster), single for COVID-19 immunisation; influenza vaccine on 06Oct2021 at single dose for flu immunization. Medical history and concomitant medications were not reported. Patient confirmed that she had received her flu shot and her Pfizer COVID 19 vaccine booster dose on 06Oct2021 simultaneously. She explained that she believed that she had been misled by the pharmacist (who administered the vaccines). She explained she spoke to the pharmacist the morning of the report after spending the night in the emergency room (ER) and was referred to Pfizer for guidance. She noted she had been to the ER twice, received an epinephrine injection and was told that was all that could be done for her. The allergic reaction/anaphylactic reaction was described as follows: in Oct2021, her face was swollen, tongue hurt, sore throat, experiencing (almost every side effect on the list she was reading including severe ones) difficulty breathing, swelling of face/throat, fast heart beat and rash all over body. She explained she looked like a monster. Seeking help. She noted that her healthcare professional (HCP) was having surgery, she had no access at that moment to see her doctor. She asked what the risks of the vaccine were and what she should do about side effects. The patient went to the emergency department and received medical treatment, that included epinephrine injection USP auto-injector. The patient was hospitalized for the events in Oct2021. The outcome of the events was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Product use issue, Rash, Swelling face
Clinical narrative: anaphylactic reaction; allergic reaction; swelling face; tongue hurts; difficulty breathing; fast heart beat; rash; swelling of face/throat; sore throat; Pfizer Covid 19 Vaccine booster dose on 6Oct2021/received her flu shot and her Pfizer Covid 19 Vaccine booster dose on 06Oct2021 simultaneously; Pfizer Covid 19 Vaccine booster dose on 6Oct2021; received her flu shot and her Pfizer Covid 19 Vaccine booster dose on 06Oct2021 simultaneously; This is a spontaneous report from a Pfizer sponsored program from a non-contactable consumer (patient) based on information received by Pfizer from a regulatory authority (Manufacturer Control Number#: 202101341896). A female patient of an unspecified age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 06Oct2021 at dose 3 (booster), single for COVID-19 immunisation; influenza vaccine on 06Oct2021 at single dose for flu immunization. Medical history and concomitant medications were not reported. Patient confirmed that she had received her flu shot and her Pfizer COVID 19 vaccine booster dose on 06Oct2021 simultaneously. She explained that she believed that she had been misled by the pharmacist (who administered the vaccines). She explained she spoke to the pharmacist the morning of the report after spending the night in the emergency room (ER) and was referred to Pfizer for guidance. She noted she had been to the ER twice, received an epinephrine injection and was told that was all that could be done for her. The allergic reaction/anaphylactic reaction was described as follows: in Oct2021, her face was swollen, tongue hurt, sore throat, experiencing (almost every side effect on the list she was reading including severe ones) difficulty breathing, swelling of face/throat, fast heart beat and rash all over body. She explained she looked like a monster. Seeking help. She noted that her healthcare professional (HCP) was having surgery, she had no access at that moment to see her doctor. She asked what the risks of the vaccine were and what she should do about side effects. The patient went to the emergency department and received medical treatment, that included epinephrine injection USP auto-injector. The patient was hospitalized for the events in Oct2021. The outcome of the events was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Caller states he had all of the side effects and was in bed for a couple of days and took him out of commission; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on (19Oct2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) via medical information team. A male patient of unspecified age and gender received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on unknown date, at dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that he had all of the side effects and was in bed for a couple of days and took him out of commission from an unspecified date. He asked if this happened fairly easily. The outcome of the events was unknown at the time of report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Pain, Pyrexia
Clinical narrative: Headache; Tired; Achy; Felt crappy/Felt very lousy; fever; This is a spontaneous report from a contactable consumer (patient). An 80-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered at Health Department via an unspecified route in left arm on an unspecified date, at the age of 80-years-old, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included metoprolol succinate taken from 2019 and ongoing, ciclosporin (RESTASIS) taken from 2020 and ongoing and paracetamol (TYLENOL) taken as needed from an unspecified date and ongoing, all taken for unspecified indications. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (solution for injection; Lot #: EL9269) administered via an unspecified route in right arm on 11Feb2021 at 10:45 (at the age of 80-years-old) and, after which, she had headache and felt tired, achy and crappy. The patient reported that, on an unspecified date after the second vaccine dose, she experienced all the above plus fever at night for three days. She had vaccine on Friday and felt good on Wednesday. All the reported events resolved after 5 days without any treatment.  The Lot number for the vaccine, BNT162B2 was not provided and will be requested during Follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021154659 same drug and patient, different event and drug dose
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, Eye pruritus, SARS-CoV-2 test
Clinical narrative: So I went up and got a rapid test for the heck of it and I tested positive; So I went up and got a rapid test for the heck of it and I tested positive; My eyes were itching; This is a spontaneous report from a contactable consumer (herself). A female patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced so I went up and got a rapid test for the heck of it and I tested positive (drug ineffective) (covid-19), my eyes were itching on an unspecified date. Caller stated, her eyes were itching she do have allergies so she put drop in and it goes away. So she went up and got a rapid test for the heck of it and she tested positive. but she felt fine, she had no symptoms other than her itchy eyes that went away with her allergies. She was great but she had to quarantine for 10 days. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date. The treatment measures taken as a result of event my eyes were itching included drop. The clinical outcome of the event my eyes were itching was resolved on an unknown date.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.