chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm pain; arm with shot is swollen getting red; arm with shot is swollen getting red; Injection site is swelling and the pain is worse; Injection site is swelling and the pain is worse/Injection site pain; Arm was stiff; Crohn's disease went crazy/worse Crohn's flare; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age (reported as '75', units unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration in the arm on 06Feb2021 at a single dose for COVID-19 immunization. Medical history included ongoing Crohn's disease. The patient's concomitant medications were not reported. The patient previous had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), on an unspecified date for COVID-19 immunization. The patient had her Pfizer second shot received on Saturday (06Feb2021) and after the shot she had arm pain (same as after the first shot) and Crohn's disease went crazy and she keep wanted to run to bathroom. Arm hurt a few days then it went away. Injection site pain started again last night and her arm with shot is swollen and getting red, she put ice on it and it's hurting. Today, it was slightly more red and swollen. The injection site is swelling, and the pain is worse than the 1st dose. The patient has Crohn's disease and was having a whole problem with that at the moment. She had gotten the second Covid shot on Saturday and on Sunday (07Feb2021), had the worse Crohn's flare she's actually ever had in 35 years. The day after the shot (07Feb2021), her arm was stiff and that is what happened after the first shot also. It cleared up on Monday and Tuesday. Last evening, Wednesday, her upper arm on the injections site arm started to hurt and get swollen. Since it was last night, she had no one to call and called the pharmacy and was told to put ice on it and she did. It's getting worse and worse and angry like and getting more swollen. The patient wanted to know what she should do in this situation. The outcome of the event "arm was stiff" was recovered on Feb2021 while the other events were unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Constipation, Erythema, Full blood count abnormal, Gastrointestinal pain, Haematochezia
Clinical narrative: Arm pain; arm with shot is swollen getting red; arm with shot is swollen getting red; Injection site is swelling and the pain is worse; Injection site is swelling and the pain is worse/Injection site pain; Arm was stiff; Crohn's disease went crazy/worse Crohn's flare; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age (reported as '75', units unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration in the arm on 06Feb2021 at a single dose for COVID-19 immunization. Medical history included ongoing Crohn's disease. The patient's concomitant medications were not reported. The patient previous had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), on an unspecified date for COVID-19 immunization. The patient had her Pfizer second shot received on Saturday (06Feb2021) and after the shot she had arm pain (same as after the first shot) and Crohn's disease went crazy and she keep wanted to run to bathroom. Arm hurt a few days then it went away. Injection site pain started again last night and her arm with shot is swollen and getting red, she put ice on it and it's hurting. Today, it was slightly more red and swollen. The injection site is swelling, and the pain is worse than the 1st dose. The patient has Crohn's disease and was having a whole problem with that at the moment. She had gotten the second Covid shot on Saturday and on Sunday (07Feb2021), had the worse Crohn's flare she's actually ever had in 35 years. The day after the shot (07Feb2021), her arm was stiff and that is what happened after the first shot also. It cleared up on Monday and Tuesday. Last evening, Wednesday, her upper arm on the injections site arm started to hurt and get swollen. Since it was last night, she had no one to call and called the pharmacy and was told to put ice on it and she did. It's getting worse and worse and angry like and getting more swollen. The patient wanted to know what she should do in this situation. The outcome of the event "arm was stiff" was recovered on Feb2021 while the other events were unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mucous stools, Peripheral swelling, Thrombosis
Clinical narrative: Arm pain; arm with shot is swollen getting red; arm with shot is swollen getting red; Injection site is swelling and the pain is worse; Injection site is swelling and the pain is worse/Injection site pain; Arm was stiff; Crohn's disease went crazy/worse Crohn's flare; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age (reported as '75', units unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration in the arm on 06Feb2021 at a single dose for COVID-19 immunization. Medical history included ongoing Crohn's disease. The patient's concomitant medications were not reported. The patient previous had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), on an unspecified date for COVID-19 immunization. The patient had her Pfizer second shot received on Saturday (06Feb2021) and after the shot she had arm pain (same as after the first shot) and Crohn's disease went crazy and she keep wanted to run to bathroom. Arm hurt a few days then it went away. Injection site pain started again last night and her arm with shot is swollen and getting red, she put ice on it and it's hurting. Today, it was slightly more red and swollen. The injection site is swelling, and the pain is worse than the 1st dose. The patient has Crohn's disease and was having a whole problem with that at the moment. She had gotten the second Covid shot on Saturday and on Sunday (07Feb2021), had the worse Crohn's flare she's actually ever had in 35 years. The day after the shot (07Feb2021), her arm was stiff and that is what happened after the first shot also. It cleared up on Monday and Tuesday. Last evening, Wednesday, her upper arm on the injections site arm started to hurt and get swollen. Since it was last night, she had no one to call and called the pharmacy and was told to put ice on it and she did. It's getting worse and worse and angry like and getting more swollen. The patient wanted to know what she should do in this situation. The outcome of the event "arm was stiff" was recovered on Feb2021 while the other events were unknown.  Information about batch/lot number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness, Magnetic resonance imaging
Clinical narrative: lost complete hearing in her left ear/hearing was almost completely gone based on the audiology test; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EN5318 and expiry date unknown, via unspecified route of administration at the left arm on 02Feb2021 15:30 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no covid prior vaccination. On 02Feb2021 16:00 (30 minutes after receiving the vaccination), The patient lost complete hearing in her left ear. The patient informed that it came on very suddenly and did not improve by the next morning. The patient contacted her doctor at the clinic and was scheduled for a hearing test on Thursday at 9:30 and an appointment with an ENT afterwards. The hearing was almost completely gone based on the audiology test (Feb2021). The patient began very high levels of steroids for a 14-day program and her hearing has started to return. The patient also had an MRI done on Monday (Feb2021) showing no abnormalities. The patient was not covid tested post vaccination. The patient informed that this seemed to be a very real coincidence that the vaccine triggered this response to her hearing. The outcome of the event was recovering. The event was considered serious (disability).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Chills, Confusional state, Disorientation
Clinical narrative: hallucination; severe confusion; dizziness/light headedness; disorientation; fatigue; tachycardia; anxiety; full body weakness; full body muscle aches; chills; headache; This is a spontaneous report from a contactable healthcare professional (patient). A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3247), intramuscular in left arm on 22Jan2021 at a single dose for COVID-19 immunisation. Medical history included generalised anxiety and allergies: Sulfa sensitive. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient's concomitant medications were not reported. On 22Jan2021, 45-60 minutes after vaccination, patient experienced hallucination, severe confusion, dizziness/light headedness, disorientation, fatigue, tachycardia, anxiety, full body weakness, then on 22Jan2021, 8 hours after, patient had full body muscle aches, headache, chills, fatigue, confusion, hallucination, anxiety, tachycardia, 16 hours after, experienced  confusion, full body muscle aches, headache, chills, fatigue, confusion, hallucination, tachycardia, anxiety, then 48 hours after, had confusion, full body muscle aches (TYLENOL helped), headache, fatigue, confusion, hallucination, tachycardia, anxiety, then 1 week after vaccination, patient was experiencing confusion, anxiety, and hallucinations throughout the entire week. Patient was unsure if she ever had a fever, as she did not check her temperature. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID saliva test: negative on 27Jan2021 and negative on 10Feb2021. Therapeutic measures were taken as a result of full body muscle aches. No treatment was received for the other adverse events. The outcome of the events was recovered with sequelae.; Sender's Comments: Based on the limited information currently available, a possible contributory role of the suspect drug in the reported event hallucination cannot be completely excluded given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hallucination, Headache, Myalgia
Clinical narrative: hallucination; severe confusion; dizziness/light headedness; disorientation; fatigue; tachycardia; anxiety; full body weakness; full body muscle aches; chills; headache; This is a spontaneous report from a contactable healthcare professional (patient). A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3247), intramuscular in left arm on 22Jan2021 at a single dose for COVID-19 immunisation. Medical history included generalised anxiety and allergies: Sulfa sensitive. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient's concomitant medications were not reported. On 22Jan2021, 45-60 minutes after vaccination, patient experienced hallucination, severe confusion, dizziness/light headedness, disorientation, fatigue, tachycardia, anxiety, full body weakness, then on 22Jan2021, 8 hours after, patient had full body muscle aches, headache, chills, fatigue, confusion, hallucination, anxiety, tachycardia, 16 hours after, experienced  confusion, full body muscle aches, headache, chills, fatigue, confusion, hallucination, tachycardia, anxiety, then 48 hours after, had confusion, full body muscle aches (TYLENOL helped), headache, fatigue, confusion, hallucination, tachycardia, anxiety, then 1 week after vaccination, patient was experiencing confusion, anxiety, and hallucinations throughout the entire week. Patient was unsure if she ever had a fever, as she did not check her temperature. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID saliva test: negative on 27Jan2021 and negative on 10Feb2021. Therapeutic measures were taken as a result of full body muscle aches. No treatment was received for the other adverse events. The outcome of the events was recovered with sequelae.; Sender's Comments: Based on the limited information currently available, a possible contributory role of the suspect drug in the reported event hallucination cannot be completely excluded given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tachycardia
Clinical narrative: hallucination; severe confusion; dizziness/light headedness; disorientation; fatigue; tachycardia; anxiety; full body weakness; full body muscle aches; chills; headache; This is a spontaneous report from a contactable healthcare professional (patient). A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3247), intramuscular in left arm on 22Jan2021 at a single dose for COVID-19 immunisation. Medical history included generalised anxiety and allergies: Sulfa sensitive. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient's concomitant medications were not reported. On 22Jan2021, 45-60 minutes after vaccination, patient experienced hallucination, severe confusion, dizziness/light headedness, disorientation, fatigue, tachycardia, anxiety, full body weakness, then on 22Jan2021, 8 hours after, patient had full body muscle aches, headache, chills, fatigue, confusion, hallucination, anxiety, tachycardia, 16 hours after, experienced  confusion, full body muscle aches, headache, chills, fatigue, confusion, hallucination, tachycardia, anxiety, then 48 hours after, had confusion, full body muscle aches (TYLENOL helped), headache, fatigue, confusion, hallucination, tachycardia, anxiety, then 1 week after vaccination, patient was experiencing confusion, anxiety, and hallucinations throughout the entire week. Patient was unsure if she ever had a fever, as she did not check her temperature. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID saliva test: negative on 27Jan2021 and negative on 10Feb2021. Therapeutic measures were taken as a result of full body muscle aches. No treatment was received for the other adverse events. The outcome of the events was recovered with sequelae.; Sender's Comments: Based on the limited information currently available, a possible contributory role of the suspect drug in the reported event hallucination cannot be completely excluded given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, SARS-CoV-2 test
Clinical narrative: cellulitus around left eye which spread down left cheek, across chin and started up the right cheek; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on the left arm, on 16Jan2021 at 12:00, at a single dose for Covid-19 immunization. The patient has no medical history and no known allergies. Concomitant medication included amoxicillin. On 24Jan2021, the patient experienced cellulitis around left eye which spread down left cheek, across chin and started up the right cheek. The adverse event resulted in doctor or other healthcare professional office/clinic visit, hospitalization. The patient was hospitalized for 6 days. The patient has no Covid prior vaccination and was Covid tested post vaccination. The patient had a nasal swab on 28Jan2021 and result was negative. The patient was recovering from the event.  Information on lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site area was red; injection site was swollen; injection site area was painful; injection site area was warm to touch; This is a spontaneous report from a contactable nurse and consumer. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number: EL9265, intramuscular on 29Jan2021 11:30 at a single dose in the left arm for COVID-19 immunization.  Medical history included asthma from 2010, hypothyroidism diagnosed in 2000, obesity from 1995, hypertension from 2000. She has allergies to medications and environmental, allergic to Gadolinium dye. She had an anaphylactic reaction in a hospital, mostly due to food and environmental. No additional vaccines administered on the same date and no prior vaccinations within 4 weeks. Concomitant medication included benralizumab (FASENRA PEN) for asthma (taking for a couple of years).  The patient previously took hydrochlorothiazide and experienced allergy. The patient received the first covid vaccine dose on 29Jan2021 and was fine until this morning (11Feb2021 at 9:00) when she woke up and the left arm injection site area was red, swollen, painful and warm to touch. Her height was under 5 feet. The outcome of the events was not recovered. The events Left arm injection site area is red, swollen, painful and warm to touch were assessed as serious-medically significant. Causality of the events to the suspect drug was related.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "the left arm injection site area was red, swollen, painful and warm to touch" and the administration of the COVID-19vaccine, BNT162B2, based on the reasonable temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache, Loss of consciousness
Clinical narrative: slight soreness on head; Knees extremely sore; passed out; fuzzy feeling; This is a spontaneous report from a contactable consumer(patient).   A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9809) on 10Feb2021 at 16:30 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included type 2 diabetes mellitus, hypertension and allergy to Victoza. Concomitant medications included metformin, dulaglutide (TRULICITY), atorvastatin and fluoxetine. On 10Feb2021 at 21:00 about the patient five hours after vaccine in kitchen washing dishes, passed out. No symptoms or light headedness leading up to this event. Patient woke up on floor hit head minor and knees. On 11Feb2021 the patient complained slight soreness on head, fuzzy feeling. Knees extremely sore, small cut on ankle. Her doctor adviced to report this due to the time event happened in relation to vaccine (as reported). No treatment reported for events. At the time of the reporting the patient was recovering from the events.  .
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Off label use, Product use issue
Clinical narrative: Miscarriage 8 days after receiving 2nd vaccine at 6 weeks pregnant; receiving 2nd vaccine at 6 weeks pregnant; receiving 2nd vaccine at 6 weeks pregnant; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration in the left arm on 28Jan2021 08:30 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 07Jan2021 at 09:00 AM for COVID-19 immunization. Patient was pregnant. Patient has no other vaccines in four weeks and no other medications in two weeks. Patient has no COVID prior vaccination and no known allergies. On 05Feb2021 at 06:00 PM, patient experienced miscarriage 8 days after receiving 2nd vaccine at 6 weeks pregnant. No treatment received for the event miscarriage. The event resulted in doctor's office/clinic visit. The patient was not tested for COVID post vaccination. The outcome of the event miscarriage was recovering.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on the compatible temporal association, a possible contributory role of the vaccination with BNT162B2 in triggering the onset of miscarriage in this patient at 6 weeks pregnant cannot be excluded. Additional information regarding relevant medical history, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. 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: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous
Clinical narrative: Miscarriage 8 days after receiving 2nd vaccine at 6 weeks pregnant; receiving 2nd vaccine at 6 weeks pregnant; receiving 2nd vaccine at 6 weeks pregnant; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration in the left arm on 28Jan2021 08:30 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 07Jan2021 at 09:00 AM for COVID-19 immunization. Patient was pregnant. Patient has no other vaccines in four weeks and no other medications in two weeks. Patient has no COVID prior vaccination and no known allergies. On 05Feb2021 at 06:00 PM, patient experienced miscarriage 8 days after receiving 2nd vaccine at 6 weeks pregnant. No treatment received for the event miscarriage. The event resulted in doctor's office/clinic visit. The patient was not tested for COVID post vaccination. The outcome of the event miscarriage was recovering.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on the compatible temporal association, a possible contributory role of the vaccination with BNT162B2 in triggering the onset of miscarriage in this patient at 6 weeks pregnant cannot be excluded. Additional information regarding relevant medical history, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dyspnoea
Clinical narrative: trouble breathing; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that she is a 26-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization at a hospital. Patient has a history of breathing problems (unspecified). On 06Feb2021, patient went into hospital due to trouble breathing. Treatment included antibiotics (unspecified) and prednisone 125 mg intravenous (IV) in the hospital and then took oral prednisone 40 mg for 4 days after being discharged on 10Feb2021. Patient further stated that she was in emergency for 4 days, and was given 125 mgs of prednisone, and that she was there in the emergency, but didn't want to stay, and was sent with prednisone and antibiotics, she was off the antibiotics not the prednisone after discharge. As of 11Feb2021, patient was off of prednisone. The patient had an unspecified blood work in the hospital and was reported to be everything was fine in Feb2021 had blood work.  Outcome of the event was unknown. The patient does not feel like her breathing problems were related to the COVID-19 vaccine since she has a history of breathing problems that were aggravated in cold weather. The patient was to receive the second dose on 18Feb2021 and has inquired if she can take the shot given her problem.  Information on batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blindness, Fatigue
Clinical narrative: she is legally blind; felt a little tired; a little anxious; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for herself, a female patient of an unspecified age (reported as 63, no units) who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she had the first dose of the vaccine and felt a little tired and a little anxious one day but she felt it was because she was nervous about getting it. The patient stated she was legally blind and it was hard for her to read some things. The patient asked how long side effects will last, if she would get any, and if how long do the symptoms last after the second dose. She also asked if one did not have any side effects after the first vaccine, could they still get side effects after the second. The patient asked if people can take their medications as usual after receiving the vaccine, and if she could take Tylenol after the vaccine if she get symptoms. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Mental impairment
Clinical narrative: mental fog; Headache; fatigue; pain in armpit; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location: arm left) on 05Feb2021 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and patient's concomitant medications were not reported. Patient is not pregnant. Patient has no covid prior vaccination. It was unknown if patient got tested post vaccination. It was unknown if patient had vaccine in four weeks and unknown if other medications in two weeks. The patient experienced mental fog (medically significant); headache, fatigue, and pain in armpit. All the events occurred on 06Feb2021. It was reported that the events were continuing after 6 days. No treatment was provided for the events. Facility type vaccine was nursing home. Outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Disorientation, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 test
Clinical narrative: disoriented/disorientation; low oxygen saturation; acute CHF; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El3247, expiry date: unknown), via an unspecified route of administration on 23Jan2021 15:15 (at the age 69 years old) at a single dose, in the right arm for covid-19 immunisation. Medical history included fibromyalgia and polymyalgia. The patient's concomitant medications included other medications both prescribed and over the counter. The patient had no other vaccine in four weeks. The patient was not diagnosed with covid-19 prior to vaccination. On 24Jan2021 at 0900, the patient experienced disorientation that was present then went away and the patient seemed to be okay; low oxygen saturation and acute congestive heart failure (CHF). On Monday, she was disoriented again and went to emergency room (ER). All the events resulted in emergency room visit and hospitalization for seven days. The patient underwent lab test and procedures which included nasal swab covid test on 25Jan2021 which showed negative. Outcome of all the events was recovered on unspecified date.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, Syncope
Clinical narrative: fainted; Nausea; Headache; Slight fever; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 06Feb2021 17:00 at a single dose for COVID-19 immunization. Medical history included asthma. The patient's concomitant medications were not reported. The patient is not pregnant. On 07Feb2021 09:15, the patient fainted 16 hours after getting the shot. The patient also experienced nausea, headache and slight fever. The events were assessed as serious (medically significant). No treatment was received for the events. The outcome of the events was recovered on an unspecified date.  Information about batch/lot number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Aneurysm, Blood pressure measurement, Dizziness, Headache, Hypertension
Clinical narrative: sustained high blood pressure; Have 2 aneurysms; Continuous headache; some dizziness; This is a spontaneous report from a contactable 68-year-old female consumer reported for herself. A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL9262), via an unspecified route of administration (right arm) on 26Jan2021, 17:15 at SINGLE DOSE for covid-19 immunisation, at 68 years old. Medical history included allergies: Penicillin from an unspecified date. Patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is taking unspecified concomitant medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot  EH 9899, at 68 years old), on 05Jan2021, 16:30, right arm for COVID-19 immunization. The patient experienced sustained high blood pressure, have 2 aneurysms, continuous headache, and some dizziness on 26Jan2021. Therapeutic measures were taken as a result of the events which include 3 different blood pressure medications, still not under control; medications and monitoring of pressure. She mentioned she has 2 aneurysms so she needs to keep her pressure normal. Outcome of the events was not recovered. The event was considered non-serious by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Sepsis, Tremor, Urinary tract infection
Clinical narrative: He had an infection, a UTI, Sepsis; He had an infection, a UTI, Sepsis; walking to the car when he started shaking; he felt freezing; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (reporter's husband). A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Report's husband who got his first vaccine at the same time (unknown date reported as two and a half weeks ago) as the reporter, she was walking to the car when the patient started shaking and said he felt freezing on unknown date. Later that night reporter had to call an ambulance. He was rushed to ER (emergency room) and hospitalized for 5 days. The patient had an infection, a UTI, Sepsis. He did not know had a UTI and the doctors believe that between the COVID vaccine and infection the two went crazy and beat up on each other. The patient was in the hospital for five days after his COVID shot. It was a combination of an infection and he didn't know and didn't have any symptoms. The two just clashed. He was very sensitive about it. He was feeling better and clean and clear. He was getting the second one. The outcome of events was recovering.  Information about lot/batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: pneumonia; Diagnosed with COVID after getting the first dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program, via a contactable consumer (reporting for himself). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on his right arm on 21Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 27Jan2021, the patient was diagnosed with COVID after getting the first dose of the vaccine and experienced pneumonia. The outcome of the event was unknown.  Information about batch/lot number requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dysphagia, Feeling abnormal, Mental impairment
Clinical narrative: felt like I might pass out /dizzy; brain fog/hard time thinking; tightness of chest and throat; difficulty swallowing; hard time thinking and talking normal; hard time thinking and talking normal; This is a spontaneous report from a contactable consumer (patient)   A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: en9815) on 11Feb2021 at 15:45 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included congenital adrenal hyperplasia and slight lactose intolerance. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), prednisone and naphazoline hydrochloride (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]). On 11Feb2021 patient experienced dizzy, felt like she was to pass out, brain fog/hard time thinking and talking normal, tightness of chest and throat, difficulty swallowing. Events resulted in visit to emergency room.  The latter 2 events continued to get worse so they gave the patient an epinephrine injection (reported as EPI shot). Benadryl IV was also administered. At the time of the reporting the patient was recovering from reported events.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: felt like I might pass out /dizzy; brain fog/hard time thinking; tightness of chest and throat; difficulty swallowing; hard time thinking and talking normal; hard time thinking and talking normal; This is a spontaneous report from a contactable consumer (patient)   A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: en9815) on 11Feb2021 at 15:45 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included congenital adrenal hyperplasia and slight lactose intolerance. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), prednisone and naphazoline hydrochloride (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]). On 11Feb2021 patient experienced dizzy, felt like she was to pass out, brain fog/hard time thinking and talking normal, tightness of chest and throat, difficulty swallowing. Events resulted in visit to emergency room.  The latter 2 events continued to get worse so they gave the patient an epinephrine injection (reported as EPI shot). Benadryl IV was also administered. At the time of the reporting the patient was recovering from reported events.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose decreased, Investigation, Presyncope
Clinical narrative: had a sudden severe sugar drop to 38; close to passing out; This is a spontaneous report from a contactable consumer (Patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: 59267-1000-01), via unknown route of administration on left arm on 05Feb2021, at 17:00 at the age of 73 years old at a single dose for COVID-19 immunization administered at Pharmacy or drug Store. Medical history included hypoglycemia. Concomitant medications included diltiazem, lansoprazole, cimetidine, acarbose and omeprazole (ZOL). Past drug event included allergy to doxycyclene. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient stated, "I have hypoglycaemia", "On 05Feb2021, about 4 hrs after vaccine I had a sudden severe sugar drop to 38. No warning signs like I usually have. Followed normal process of bringing sugar back up with Glucose tablets, boost and protein bar. Was close to passing out and just wanted to make someone aware that this could happen. I did call and talk to the pharmacist about it". The patient assessed the events as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the events on an unspecified date in Feb2021.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Disease recurrence
Clinical narrative: A-Fib recurred with a vengeance; A-Fib recurred with a vengeance; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9262), via an unspecified route of administration on 10Feb2021 13:00 at single dose (arm left) for Covid-19 immunization. Medical history included atrial fibrillation (AFib) treated well with Diltiazem. The patient had no allergies to medications, food and other products. Concomitant medication included diltiazem for Afib. On 11Feb2021 11:00, 22 hours after vaccine, A-Fib recurred with a vengeance, requiring an emergency room (ER) visit and overnight stay in hospital in order to stabilize. The patient was hospitalized on 11Feb2021 to 12Feb2021. The patient was treated with diltiazem I.V. for 12 hours. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient received diltiazem within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient been tested for COVID-19. Outcome of event was recovered on an unspecified date.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood electrolytes, Condition aggravated, Dry eye, Ear swelling, Eye irritation
Clinical narrative: Salivary gland infection; Sjogren's syndrome (mouth inflammation); Sjogren's syndrome (mouth inflammation); Lymph gland infection; Tooth disorder (rancid); Swelling in upper cheeks and ears; Swelling in upper cheeks and ears; Eyes are burning and a little bit dry; Eyes are burning and a little bit dry; Mouth really hurt to me; Flu; This is a spontaneous report from a contactable consumer reporting for herself. A 50-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# CL3302), via an unspecified route of administration, on 01Feb2021, at single dose, for COVID-19 immunisation. Medical history included COVID-19 from Apr2020 to an unknown date, Sjogren's syndrome from 2015 and ongoing (was under control), fibromyalgia, autoimmune disorder, ongoing hormone level abnormal (taking estrogen), ongoing eye disorder. Concomitant medications included ongoing ciclosporin (RESTASIS) for eye disorder, famotidine (PEPCID), albuterol [salbutamol] (unknown manufacturer), ongoing estradiol (ESTROGEN) for hormone level abnormal. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation and experienced pain, asthma and nasal irritation. The patient experienced salivary gland infection (medically significant) in Feb2021 with outcome of unknown, Sjogren's syndrome (mouth inflammation) (medically significant) in Feb2021 with outcome of unknown, lymph gland infection in Feb2021 with outcome of unknown, tooth disorder (rancid) in Feb2021 with outcome of unknown, swelling in upper cheeks and ears in Feb2021 with outcome of unknown, eyes are burning and a little bit dry in Feb2021 with outcome of unknown, mouth really hurt to me in Feb2021 with outcome of unknown, flu in Feb2021 with outcome of unknown. The patient went to the emergency room for Sjogren's syndrome (mouth inflammation) and tooth disorder (rancid). On unknown date the patient underwent lab tests and procedures which included blood electrolytes: unknown results, full blood count: unknown results, investigation: unknown results, monocyte count: normal. Therapeutic measures were taken as a result of the events and included treatment with Salagen and Tylenol. The reporter stated she believed to have a reaction from the vaccine shot.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Influenza, Investigation, Lymph gland infection, Monocyte count
Clinical narrative: Salivary gland infection; Sjogren's syndrome (mouth inflammation); Sjogren's syndrome (mouth inflammation); Lymph gland infection; Tooth disorder (rancid); Swelling in upper cheeks and ears; Swelling in upper cheeks and ears; Eyes are burning and a little bit dry; Eyes are burning and a little bit dry; Mouth really hurt to me; Flu; This is a spontaneous report from a contactable consumer reporting for herself. A 50-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# CL3302), via an unspecified route of administration, on 01Feb2021, at single dose, for COVID-19 immunisation. Medical history included COVID-19 from Apr2020 to an unknown date, Sjogren's syndrome from 2015 and ongoing (was under control), fibromyalgia, autoimmune disorder, ongoing hormone level abnormal (taking estrogen), ongoing eye disorder. Concomitant medications included ongoing ciclosporin (RESTASIS) for eye disorder, famotidine (PEPCID), albuterol [salbutamol] (unknown manufacturer), ongoing estradiol (ESTROGEN) for hormone level abnormal. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation and experienced pain, asthma and nasal irritation. The patient experienced salivary gland infection (medically significant) in Feb2021 with outcome of unknown, Sjogren's syndrome (mouth inflammation) (medically significant) in Feb2021 with outcome of unknown, lymph gland infection in Feb2021 with outcome of unknown, tooth disorder (rancid) in Feb2021 with outcome of unknown, swelling in upper cheeks and ears in Feb2021 with outcome of unknown, eyes are burning and a little bit dry in Feb2021 with outcome of unknown, mouth really hurt to me in Feb2021 with outcome of unknown, flu in Feb2021 with outcome of unknown. The patient went to the emergency room for Sjogren's syndrome (mouth inflammation) and tooth disorder (rancid). On unknown date the patient underwent lab tests and procedures which included blood electrolytes: unknown results, full blood count: unknown results, investigation: unknown results, monocyte count: normal. Therapeutic measures were taken as a result of the events and included treatment with Salagen and Tylenol. The reporter stated she believed to have a reaction from the vaccine shot.