chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 (Lot number: EN6204) at the age of 48 years as dose 2, single and administered in arm left (Lot number: EN6198, Expiration Date: 30Jun2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Shingles" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Hepatitis d vaccine. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered" (Mar2021), described as "sore arm". Therapeutic measures were taken as a result of pain in extremity.  Additional Information: The caller is a pharmacist who received the first and second dose Pfizer Covid Vaccine and finished second dose Pfizer Covid Vaccine in Mar2021. The caller had a sore arm after receiving both the first and second dose Pfizer Covid Vaccine, but really nothing. The caller states the sore arm was gone in less than a week after receiving first and second dose Pfizer Covid Vaccine. The caller did not feel the administration of the first and second dose Pfizer Covid Vaccine, but knew it was done because the caller later had sore arm. The caller got a sore arm but the arm soreness was just around deltoid area in upper arm. The caller has seen the doctor once because the caller had shingles at the beginning of the year. Caller clarifies she had shingles prior to receiving any dose of the Pfizer Covid Vaccine. Received the first dose Pfizer Covid Vaccine in the left arm and the arm soreness began the same day the first dose was received. Unknown date received first dose Pfizer Covid Vaccine, caller does not have date to provide. Second dose: had a sore arm: The sore arm began the same day received second dose, 18Mar2021. First dose: Unknown, caller states the date received is not on the vaccine card and caller does not recall the date first dose Pfizer Covid Vaccine was received. The caller stated the hand writing on the vaccine card is hard to read. Caller stated it was the worse soreness ever gotten and caller received the Hepatitis D Vaccine and the Hepatitis D Vaccine was so bad. The caller had to get up in the middle of the night and take Ibuprofen for the arm soreness the caller had after first and second dose Pfizer Covid Vaccine. Caller did not have NDC/lot/expiration date for the Hepatitis D Vaccine.   Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Very fatigued; slight headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Nov2021 10:00 (Lot number: 3302680) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRISTIQ; LIPITOR; LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Prev dose brand=Pfizer, Prev dose brand unknown=False, Prev dose lot number=FE3750, Prev dose lot unknown=False, Prev dose administrator route=Intramuscular, Prev dose administration date=21Oct2021 , Prev dose administration time=10:00AM, Prev dose dose number=1, Prev dose vaccine location=Left arm), administration date: 21Oct2021, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 11Nov2021, outcome "recovering", described as "Very fatigued"; HEADACHE (non-serious) with onset 11Nov2021, outcome "recovering", described as "slight headache". Therapeutic measures were not taken as a result of fatigue, headache.  Additional Information: The patient did not receive any other vaccine in four weeks. Patient did not get COVID prior to vaccination and was not COVID tested post vaccination. There are no known allergies or other medical history. The adverse event is reported as Not serious. After about two hours after second vaccine on 11Nov2021, patient became fatigued and had a slight headache. Patient was better next morning.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I was sick for three months now, very ill from the Pfizer shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I was sick for three months now, very ill from the Pfizer shot".  Additional information: The patient stated to have already sent a report from a terrible reaction patient had with the shot (Unspecified shot) what patient want the copy of the report that patient sent him in case they remain the booster for patient who don't want to get the booster. So patient wrote a big report to you guys till everything out nobody did following up with me. Well patient like the copy of what patient sent."  When probed to confirm the product as COVID-19 Booster, patient stated, "I don't want the booster. I didn't get the booster. I got the Pfizer shot (Unspecified shot). Yes, Pfizer." Consumer was informed about role Pfizer Drug Safety. Consumer stated, "Ma'am, this language is very hard for me to understand. You have to spoke slower I only talk somebody for another country and I don't understand when they talk. Could you please start over again what you are saying slowly?" Patient was again informed role of Pfizer Drug Safety and informed to contact the facility, patient stated, "I need to talk what? I don't want to talk anyone ma'am. I want the copy of the report what I sent to Pfizer mailed to me. I should made a copy. I already told all the reactions I had to the shot. I was sick for three months now, very ill from the Pfizer shot. I sent Pfizer a big report. I required to mail me the copy of the report I have sent." Patient stated, "I don't have my card handy. Wait a minute, Let me check. No, I feel I have handy but I don't. I don't have that handy." Further probing could not be done as consumer was unwilling to complete the report and hung up the call abruptly. Hence limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Booster swelling lump and itchy red patch at site; Booster swelling lump and itchy red patch at site; Booster swelling lump and itchy red patch at site; warm to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 14:00 (Lot number: FC3527) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Sulfa Drugs" (unspecified if ongoing); "Allergy: Penicillin" (unspecified if ongoing); "Allergy: Demerol" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3 taken for vitamin d (ongoing); ZINC taken for vitamin c (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 2, Lot number: EW0162, Anatomical location: Left arm), administration date: 12Apr2021, when the patient was 69 years old, for Covid-19 immunization, reaction(s): "sore arm"; Bnt162b2 (Dose Number: 1, Lot number: ER2613, Anatomical location: Left arm), administration date: 22Mar2021, when the patient was 69 years old, for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 12Nov2021 20:00, outcome "recovering" and all described as "Booster swelling lump and itchy red patch at site". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site swelling, vaccination site pruritus.  Additional information: Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. Other medications (Vitamin D3 and Zinc) was taken in two weeks. Booster swelling lump and itchy red patch at site. Started reaction in the evening on the 12th. Redness, itch, warm to touch, and swelling. No reaction for the two vaccines reaction just with the Booster.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Reported giving a pediatric Pfizer dose to a 12 year old; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 12 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "Reported giving a pediatric Pfizer dose to a 12 year old".  Additional information: The reporter clinical pharmacist had one of stores who had reported giving a pediatric Pfizer dose to a 12 year old and 16 year old and they are wanted to know if there was any direction to restart them with adult or they just go and get the second dose of the adult dose in three weeks.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Decreased appetite, Fatigue, Heart rate, Heart rate increased
Clinical narrative: Fatigue (over 7 days); loss of appetite; weight loss; heavy anxiety; elevated heart rate; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Aug2021 09:00 (Lot number: FD8448) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penecillin" (unspecified if ongoing), notes: Known allergies: Nickel, Penicillin; "Known allergies: Nickel" (unspecified if ongoing), notes: Known allergies: Nickel, Penicillin. There were no concomitant medications.  The following information was reported: FATIGUE (non-serious) with onset 21Aug2021 11:00, outcome "recovered" (28Aug2021), described as "Fatigue (over 7 days)"; DECREASED APPETITE (non-serious) with onset 21Aug2021 11:00, outcome "not recovered", described as "loss of appetite"; WEIGHT DECREASED (non-serious) with onset 21Aug2021 11:00, outcome "not recovered", described as "weight loss"; ANXIETY (non-serious) with onset 21Aug2021 11:00, outcome "not recovered", described as "heavy anxiety"; HEART RATE INCREASED (non-serious) with onset 21Aug2021 11:00, outcome "not recovered", described as "elevated heart rate". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, decreased appetite, weight decreased, anxiety, heart rate increased.  Additional information: There was no covid prior vaccination and covid was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Fatigue (over 7 days); loss of appetite; weight loss; heavy anxiety; elevated heart rate; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Aug2021 09:00 (Lot number: FD8448) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penecillin" (unspecified if ongoing), notes: Known allergies: Nickel, Penicillin; "Known allergies: Nickel" (unspecified if ongoing), notes: Known allergies: Nickel, Penicillin. There were no concomitant medications.  The following information was reported: FATIGUE (non-serious) with onset 21Aug2021 11:00, outcome "recovered" (28Aug2021), described as "Fatigue (over 7 days)"; DECREASED APPETITE (non-serious) with onset 21Aug2021 11:00, outcome "not recovered", described as "loss of appetite"; WEIGHT DECREASED (non-serious) with onset 21Aug2021 11:00, outcome "not recovered", described as "weight loss"; ANXIETY (non-serious) with onset 21Aug2021 11:00, outcome "not recovered", described as "heavy anxiety"; HEART RATE INCREASED (non-serious) with onset 21Aug2021 11:00, outcome "not recovered", described as "elevated heart rate". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, decreased appetite, weight decreased, anxiety, heart rate increased.  Additional information: There was no covid prior vaccination and covid was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site bruising
Clinical narrative: they hit a blood vessel because blood ran down her arm; she had a knot and bruising; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 17:15 (Batch/Lot number: unknown) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Manufacturer Unknown), for Covid-19 Immuniztion; Bnt162b2 (Dose 2, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 13Nov2021, outcome "unknown", described as "they hit a blood vessel because blood ran down her arm"; VACCINATION SITE BRUISING (non-serious) with onset 13Nov2021, outcome "recovering", described as "she had a knot and bruising". Therapeutic measures were taken as a result of vaccination site bruising.  Additional information: The caller was calling about the Pfizer booster dose of the covid vaccine. The caller had it on Saturday and thinks they hit a blood vessel when they were giving it to her. Blood ran down the caller's arm, she got a huge knot on her arm and bruising. The Pharmacist asked her if she was on blood thinners, she was not. She checked with her mother who was an RN. The caller was questioning the efficacy because it hit the blood vessel not the muscle. The first day the caller iced her arm and the next day she put heat on it. The knot was down some and the bruise was still there. The caller cannot find the lot number on her vaccination card but provides the vial number as 3230BD. Other Products, Patient History and Investigation Assessment was reported as no. History of all previous immunization with the Pfizer vaccine considered as suspect: None. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Adverse events did not result in Emergency room or physician office visit. Prior Vaccinations (within 4 weeks) and AE(s) following prior vaccinations: None. Family Medical History Relevant to AE(s): None. Relevant Tests: None. Additional lot numbers: Unknown, vial number provided as 3230BD. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hormone level abnormal, Menstruation irregular
Clinical narrative: changes in my periods/ starting a day or 2 earlier than usual; hormone imbalance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 (Lot number: EW0161) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mild asthma" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, prev dose lot number=EW0150, prev dose vaccine location=Left arm), administration date: 31Mar2021, when the patient was 35 years old, for Covid-19 Immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 2021, outcome "unknown", described as "changes in my periods/ starting a day or 2 earlier than usual"; HORMONE LEVEL ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "hormone imbalance". Therapeutic measures were not taken as a result of menstruation irregular, hormone level abnormal.  Additional information: No other vaccine in four weeks. The patient had noticed changes in her periods. They have been starting a day or 2 earlier than usual. Her periods were usually more predictable. The most current period a week after her 3rd booster has been a lot heavier than usual and started early as well. She had a nexplanon implant removed at the end of May and attributed the changes to hormone imbalance. She asked if this could still be an issue. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. No known allergies. The patient received third dose on 03Nov2021.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Fatigue, Tinnitus
Clinical narrative: Ear pressure; ear blockage; dizziness; fatigue; tinnitus/got worse; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 10:30 (Lot number: EW0161) at the age of 28 years as dose 1, single and administered in arm left, administration date 14May2021 01:15 (Lot number: EW0172) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: EAR DISCOMFORT (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Ear pressure"; EAR DISCOMFORT (non-serious) with onset 24Apr2021, outcome "not recovered", described as "ear blockage"; DIZZINESS (non-serious) with onset 24Apr2021, outcome "not recovered", described as "dizziness"; FATIGUE (non-serious) with onset 24Apr2021, outcome "not recovered", described as "fatigue"; TINNITUS (non-serious) with onset 24Apr2021, outcome "not recovered", described as "tinnitus/got worse". The events "ear pressure", "ear blockage", "dizziness", "fatigue" and "tinnitus/got worse" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of ear discomfort, ear discomfort, dizziness, fatigue, tinnitus.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Health Clinic. Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: No. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. No known allergies. It was reported that the patient experienced Ear pressure, ear blockage, dizziness, fatigue, and tinnitus began shortly after receiving first dose, got worse after second dose, and has not improved in over 6 months. The patient received Antibiotics, steroids, and allergy medication as treatment. No follow-up attempts are possible. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: had headaches with first two doses of covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 08:40 (Lot number: ER8729) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD", start date: Mar2021 (unspecified if ongoing); "Covid-19", start date: Feb2021 (unspecified if ongoing), notes: She had Covid back in February prior to the vaccine. She got vertigo bad with covid virus when she had it back in Feb2021.; "She got vertigo bad with covid virus", start date: 2021 (unspecified if ongoing), notes: She got vertigo bad with covid virus when she had it back in Feb2021.; "had surgery in Apr2021", start date: Apr2021 (unspecified if ongoing), notes: had surgery in Apr2021 and was diagnosed in Mar2021. There were no concomitant medications.  The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "had headaches with first two doses of covid vaccine".  Additional Information: had surgery in Apr2021 and was diagnosed in Mar2021. She got vertigo bad with covid virus when she had it back in Feb2021 and was prescribed meclizine by her doctor. States she took meclizine after experiencing dizziness after the covid vaccine and it did not help a whole lot. The patient did not taken Prior Vaccinations (within 4 weeks). She had Covid back in February prior to the vaccine.. Meclizine dispensed in pharmacy bottle, oval white yellow tablet, sees on the pharmacy label.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101573064 similar report from same reporter;US-PFIZER INC-202101594319 2nd dose, BNT162B2
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Motor dysfunction, Paraesthesia, Peripheral swelling
Clinical narrative: Swelling in both arms; Numbness and tingling in arms and fingers; Unable to grasp things and dropping things for a period of time; Pins and needles sensation in feet/ numbness and tingling in arms and fingers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Nov2021 08:30 (Lot number: FF8841) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hemachromatosis" (unspecified if ongoing); "known allergies: corn and corn products" (unspecified if ongoing); "known allergies: tomatoes, coconut" (unspecified if ongoing); "known allergies: pork" (unspecified if ongoing); "Known allergies: Sulpha" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, product: COVID 19, Brand: Pfizer, Lot number: EW0150, Administration time: 08:30 AM, Vaccine location: Left arm, Following first dose, swelling and numbness in right arm subsided within 12 hours.), administration date: 13Oct2021, when the patient was 55 years old, for COVID-19 immunization, reaction(s): "Swelling and numbness in right arm", "Swelling and numbness in right arm". The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 05Nov2021, outcome "recovering", described as "Swelling in both arms"; HYPOAESTHESIA (non-serious) with onset 05Nov2021, outcome "recovering", described as "Numbness and tingling in arms and fingers"; MOTOR DYSFUNCTION (non-serious) with onset 05Nov2021, outcome "recovering", described as "Unable to grasp things and dropping things for a period of time"; PARAESTHESIA (non-serious) with onset 05Nov2021, outcome "recovering", described as "Pins and needles sensation in feet/ numbness and tingling in arms and fingers".  Additional information: Other medications in two weeks include Multivitamin. No Covid prior vaccination. No Covid tested post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 16:00 (Lot number: Fk5127) at the age of 11 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Nov2021, outcome "recovering", described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Facility type vaccine: School or Student Health Clinic. No other medication in two weeks or vaccine in four weeks. No Covid prior vaccination and not tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Malaise
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 (Lot number: FK5127) at the age of 5 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Pyloric stenosis", start date: 2016, stop date: 2016, notes: Pyloric stenosis repaired 2016. Concomitant medication(s) included: FLU VACCINE VII, administration date 23Oct2021. The following information was reported: LETHARGY (non-serious) with onset 13Nov2021 10:00, outcome "recovered" (2021), described as "Lethargy"; MALAISE (non-serious) with onset 13Nov2021 10:00, outcome "recovered" (2021), described as "Malaise". Therapeutic measures were not taken as a result of lethargy, malaise. Additional Information: The patient had no other vaccine in two weeks. The patient had no Covid prior vaccination. The patient not tested Covid post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: I have experience pain around my neck and shoulders; I have experience pain around my neck and shoulders; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 15:00 (Batch/Lot number: unknown) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "DM" (unspecified if ongoing); "Known allergies: Penicllin" (unspecified if ongoing); "Known allergies:Sulfra drugs" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Cancer" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim". Vaccination history included: Bnt162b2 (previous dose details: prev dose product: COVID 19,, prev dose brand: Pfizer, prev dose administration time: 08:00 PM, prev dose number: 2,, prev dose vaccine location: Right arm), administration date: 28Jan2021, when the patient was 67 years old, for COVID-19 immunization; Bnt162b2 (prev dose product: COVID 19,, prev dose brand: Pfizer,, prev dose administration time: 08:00 PM, prev dose number:1,, prev dose vaccine location: Right arm), administration date: 14Jan2021, when the patient was 67 years old, for COVID-19 immunization. The following information was reported: NECK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 05Nov2021 12:00, outcome "not recovered" and all described as "I have experience pain around my neck and shoulders". Therapeutic measures were taken as a result of neck pain, arthralgia.  Additional information: Pharmacy or Drug Store was Facility where the most recent COVID-19 vaccine was administered. It was Unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Event continues and is sometimes relieved with Aspirin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 (Lot number: FF2590) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First vaccine, NDC/expiration: unknown, Lot: EC3182, Site: left arm), administration date: 01Sep2021, when the patient was 74 years old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "not recovered", described as "hair loss".  Additional information: Vaccination facility type was pharmacy. Vaccine was not administered at a facility. No additional vaccines were administered on same date of the Pfizer suspect. No other vaccines were received within four weeks prior to the administration of bnt162b2. Patient reported losing her hair, the hair was falling out the size of a baseball after second vaccine. AE did not require visit to emergency or physician office. No investigation assessment was reported.   Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Blood immunoglobulin G, Blood immunoglobulin M, Infectious mononucleosis
Clinical narrative: she is recovering from Mono and her IGG levels are sky high; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program.  A 18 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 05Apr2021 (Lot number: ER8734) at the age of 17 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, lot: EN6199, NDC: unknown , Expiration: unknown , route of administration: Right deltoid), administration date: 08Mar2021, when the patient was 17 years old, for Covid-19 immunization. The following information was reported: INFECTIOUS MONONUCLEOSIS (non-serious) with onset Oct2021, outcome "recovering", described as "she is recovering from Mono and her IGG levels are sky high". The event "she is recovering from mono and her igg levels are sky high" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient did not received any additional vaccines on Same Date of the Pfizer Suspect. Patient did not received prior vaccinations (within 4 weeks).  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dyskinesia, Fatigue, Muscle twitching, Myalgia
Clinical narrative: Pain; Abdominal pain/pain in her belly button area; Fatigue/Tiredness; Muscle aches; Skin rapidly moves; Twitching in the injection site of my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY, Solution for injection), administration date 16Nov2021 15:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE TWITCHING (non-serious) with onset Nov2021, outcome "unknown", described as "Twitching in the injection site of my body"; PAIN (non-serious) with onset 16Nov2021, outcome "recovered" (Nov2021), described as "Pain"; ABDOMINAL PAIN (non-serious) with onset 16Nov2021, outcome "recovered" (Nov2021), described as "Abdominal pain/pain in her belly button area"; DYSKINESIA (non-serious) with onset Nov2021, outcome "unknown", described as "Skin rapidly moves"; FATIGUE (non-serious) with onset 16Nov2021, outcome "recovered" (Nov2021), described as "Fatigue/Tiredness"; MYALGIA (non-serious) with onset 16Nov2021, outcome "recovered" (Nov2021), described as "Muscle aches". Therapeutic measures were taken as a result of pain, abdominal pain, fatigue, myalgia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; Abdominal pain/pain in her belly button area; Fatigue/Tiredness; Muscle aches; Skin rapidly moves; Twitching in the injection site of my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY, Solution for injection), administration date 16Nov2021 15:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE TWITCHING (non-serious) with onset Nov2021, outcome "unknown", described as "Twitching in the injection site of my body"; PAIN (non-serious) with onset 16Nov2021, outcome "recovered" (Nov2021), described as "Pain"; ABDOMINAL PAIN (non-serious) with onset 16Nov2021, outcome "recovered" (Nov2021), described as "Abdominal pain/pain in her belly button area"; DYSKINESIA (non-serious) with onset Nov2021, outcome "unknown", described as "Skin rapidly moves"; FATIGUE (non-serious) with onset 16Nov2021, outcome "recovered" (Nov2021), described as "Fatigue/Tiredness"; MYALGIA (non-serious) with onset 16Nov2021, outcome "recovered" (Nov2021), described as "Muscle aches". Therapeutic measures were taken as a result of pain, abdominal pain, fatigue, myalgia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Jun2021 11:00 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single for covid-19 immunization; bupropion (BUPROPION), since Jun2021 (Batch/Lot number: unknown). The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Right, Lot number: unknown, Vaccine Administration Time: 11:00 AM), administration date: 25May2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 01Sep2021 12:00, outcome "not recovered", described as "hair loss". The action taken for bupropion was unknown. Therapeutic measures were not taken as a result of alopecia.  Additional information: other medication included long time vitamins, no other vaccine in four weeks, No Covid prior vaccination, No Covid post vaccination, No allergies. She stated that she started using bupropion the same week of vaccination, so she was not sure what is causing it. She also stated that during her research she had stumbled on people saying they are experiencing hair loss after their vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: few migraines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 18:00 (Lot number: FK5127) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious) with onset 09Nov2021, outcome "unknown", described as "few migraines". Therapeutic measures were not taken as a result of migraine.  Additional Information: Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19 and the patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101609879 same reporter/drug/AE with different patient
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness of his limb; This is a spontaneous report received from a contactable reporter(s) (Other HCP) Nurse from medical information team.  A 65 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 08Sep2021 16:15 (Lot number: EW0182) at the age of 65 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious) with onset 11Sep2021, outcome "recovering", described as "Numbness of his limb". The event "numbness of his limb" was evaluated at the physician office visit. Therapeutic measures were taken as a result of hypoesthesia.  Additional information: A 65year old male patient received his first dose of Pfizer BioNtech covid vaccine on 08Sep2021 and he reported numbness of his limb on 11Sep2021. The physician has prescribed gabapentin for the patient but they want to know regarding the timing for the second of the Covid vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Pt reports numbness in limbs 3 days post vaccination. Patient received treatment received for the adverse event ;Gabapentin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination,  the patient has not been tested for COVID-19  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Headache, Tinnitus
Clinical narrative: ringing in his ears; Headache; Watery stool, maybe diarrhea; felt like being on an airplane; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A child male patient received bnt162b2 (BNT162B2), administration date 15Nov2021 07:30 (Lot number: FK5618) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 15Nov2021, outcome "not recovered", described as "Headache"; DIARRHOEA (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Watery stool, maybe diarrhea"; FEELING ABNORMAL (non-serious) with onset Nov2021, outcome "unknown", described as "felt like being on an airplane"; TINNITUS (non-serious) with onset 18Nov2021 10:00, outcome "recovered" (18Nov2021 13:00), described as "ringing in his ears". Therapeutic measures were taken as a result of headache.  Additional information: It was reported that, first dose at (withheld) on 15Nov2021 at 07:30 am. Stated that, headache immediately at first dose, lasting 48hrs so far. Stated that, gave 10mL children Motrin 24 hours after first dose. Stated that, headache slightly better, but still around. Watery stool, maybe diarrhea, one time between 24-36 hours at school. Stated that, gave another Motrin (same amount) at 36 hours as headache came back. Also expressed felt like being on an airplane. The child stated that, headaches comes and go but not as bad. Stated that, (withheld) continued to say he felt like his in an airplane. Stated that, not clear whether that's the headache or additional symptom. Stated that, (withheld) could not separate the two symptoms. Stated that, the mother reported (withheld) symptoms. Stated that, the mother reported, her son now said he was also experienced ringing in his ears from 10 to 13:00 pm today and so far it's gone. Stated that, events took place after use of product.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: Relatively well to this shot other than some lethargy for 36 hours after receiving this inoculation.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 08Mar2021 08:35 (Lot number: EL9269) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Basal cell skin cancer removal", start date: 16Feb2021, stop date: 16Feb2021, notes: removed same day; "chickenpox", start date: 06Nov2016, stop date: 25Nov2016, notes: 2 weeks illness lasted; "Basal cell skin cancer removal", start date: 11Jun2016, stop date: 25Jun2016, notes: 2 weeks  illness lasted. There were no concomitant medications. The following information was reported: LETHARGY (non-serious) with onset Mar2021, outcome "unknown", described as "Relatively well to this shot other than some lethargy for 36 hours after receiving this inoculation."  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Lymphadenopathy
Clinical narrative: inflated pectoral area with discomfort; Caller said the swelling at that time looked like a swollen lymph node located in the left arm under the armpit and was not that severe; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 42 year-old male patient received bnt162b2 (COMIRNATY), administration date 26Oct2021 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "inflated pectoral area with discomfort"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "Caller said the swelling at that time looked like a swollen lymph node located in the left arm under the armpit and was not that severe".  Additional information: Caller wanted to know if the patient can take aspirin and Tylenol in case the swelling continues. The patient is a 42-year old male. The patient received the 1st dose of Comirnaty on 26Oct2021 and had an inflated pectoral area with discomfort. Patient received the 2nd dose on 16Nov2021 and experienced the same thing. Caller and patient wanted to know more information about that, they were thinking it might be the lymphatic area they have read in the brochure. As per caller, the patient was 41 when he got the 1st dose. Caller said the swelling at that time looked like a swollen lymph node located in the left arm under the armpit and was not that severe. For the 2nd dose, the swelling is more sever. Caller mentioned "you can see it at first sight." Caller added that the patient experienced more pain, had muscle pain, as well as headache. Caller asked what they should do as it has been 72 hours since the patient got the 2nd dose. Caller also mentioned that this looks worse than the 1st one. Caller asked to clarify if in the information given to him, the swollen lymph node can be up to 10 days. Caller asked if the patient had to go the ER, who would be paying for that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, SARS-CoV-2 test
Clinical narrative: Burning of my heart; Burning of my heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 15:00 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "plantar fasciitis" (unspecified if ongoing); "Allergies: artificial flavors" (unspecified if ongoing). Concomitant medication(s) included: TYROSINE; GTA FORTE II; SELENIUM. Past drug history included: Xanthan gum, reaction(s): "Allergies: xanthan gum"; Bactrim, reaction(s): "Known allergy:Bactrim"; Z-pak, reaction(s): "Known allergy: Z-pak"; Codeine, reaction(s): "Known allergy: codeine"; Phenergen, reaction(s): "Known allergy: phenergen"; Gelatin, reaction(s): "Known allergy: gelatin"; Msg, reaction(s): "Known allergy: MSG", notes: MSG; Acacia gum, reaction(s): "Known allergy: acacia gum", notes: acacia gum; Carag, reaction(s): "Known allergy: carag", notes: carag. The following information was reported: BURNING SENSATION (non-serious), CHEST PAIN (non-serious) all with onset 20Aug2021, outcome "recovered" (22Aug2021) and all described as "Burning of my heart". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Facility the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient received other vaccines within 4 weeks prior to the COVID vaccine: No. Other medications the patient received within 2 weeks of vaccination: Supplements and reported under concomitant medications. Prior to vaccination, the patient was diagnosed with COVID-19: No. Since the vaccination, the patient has been tested for COVID-19: Yes. Patient had reported AEs more mildly after the first shot for about 2 days after the shot.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (22Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.