chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast discomfort, Eye irritation, Headache, Limb discomfort
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Dec2020 17:00 (Lot number: EJ1685) at the age of 50 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; REQUIP; AMBIEN. The following information was reported: OCULAR DISCOMFORT (non-serious), EYE IRRITATION (non-serious) all with onset Dec2020, outcome "not recovered" and all described as "pressure burning to my left eye"; PAIN (non-serious) with onset Dec2020, outcome "not recovered", described as "I have had pain"; HEADACHE (non-serious) with onset Dec2020, outcome "not recovered", described as "headache"; LYMPHADENOPATHY (non-serious) with onset Dec2020, outcome "not recovered", described as "Occasional swelling of right side axillary lymph nodes which cases discomfort in left axilla, arm and left breast"; AXILLARY PAIN (non-serious), LIMB DISCOMFORT (non-serious), BREAST DISCOMFORT (non-serious) all with onset Dec2020, outcome "not recovered" and all described as "discomfort in left axilla, arm and left breast". The events "pressure burning to my left eye", "I have had pain", "headache", "occasional swelling of right side axillary lymph nodes which cases discomfort in left axilla, arm and left breast", "discomfort in left axilla, arm and left breast", "discomfort in left axilla, arm and left breast", "discomfort in left axilla, arm and left breast" and "pressure burning to my left eye" were evaluated at the physician office visit. Therapeutic measures were taken as a result of ocular discomfort, pain, headache, lymphadenopathy, axillary pain, limb discomfort, breast discomfort, and eye irritation. Additional information: Pregnancy at time of Vaccination is reported as No. Facility where the most recent COVID-19 vaccine was administered is Workplace clinic. Prior to vaccination, was the patient was not diagnosed with COVID-19 and since the vaccination, has the patient not tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Ocular discomfort, Pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Dec2020 17:00 (Lot number: EJ1685) at the age of 50 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; REQUIP; AMBIEN. The following information was reported: OCULAR DISCOMFORT (non-serious), EYE IRRITATION (non-serious) all with onset Dec2020, outcome "not recovered" and all described as "pressure burning to my left eye"; PAIN (non-serious) with onset Dec2020, outcome "not recovered", described as "I have had pain"; HEADACHE (non-serious) with onset Dec2020, outcome "not recovered", described as "headache"; LYMPHADENOPATHY (non-serious) with onset Dec2020, outcome "not recovered", described as "Occasional swelling of right side axillary lymph nodes which cases discomfort in left axilla, arm and left breast"; AXILLARY PAIN (non-serious), LIMB DISCOMFORT (non-serious), BREAST DISCOMFORT (non-serious) all with onset Dec2020, outcome "not recovered" and all described as "discomfort in left axilla, arm and left breast". The events "pressure burning to my left eye", "I have had pain", "headache", "occasional swelling of right side axillary lymph nodes which cases discomfort in left axilla, arm and left breast", "discomfort in left axilla, arm and left breast", "discomfort in left axilla, arm and left breast", "discomfort in left axilla, arm and left breast" and "pressure burning to my left eye" were evaluated at the physician office visit. Therapeutic measures were taken as a result of ocular discomfort, pain, headache, lymphadenopathy, axillary pain, limb discomfort, breast discomfort, and eye irritation. Additional information: Pregnancy at time of Vaccination is reported as No. Facility where the most recent COVID-19 vaccine was administered is Workplace clinic. Prior to vaccination, was the patient was not diagnosed with COVID-19 and since the vaccination, has the patient not tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: just had a little fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY) (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: FATIGUE (non-serious), outcome "unknown", described as "just had a little fatigue".  Additional: Other HCP himself was patient and he queried if there was allergic reaction, was there a maximum amount of time before it would show up. "When he got vaccination, he had to wait 15 to 30 minutes."He was totally fine, just had a little fatigue."    No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 12:45 (Lot number: F1t8028) at the age of 26 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Nov2021 13:30, outcome "recovered" (2021), described as "Pain in the arm". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.  Additional information: The patient did not receive any other vaccine in four weeks. The patient did have covid prior vaccination and was not tested for covid post vaccination. The patient did have known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID- 19. Since the vaccination, patient had not been tested for COVID-19.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: One day after I got my first vaccine, I started to have a constant smell of gasoline. It lasted for a few days and they went away.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: 8732) at the age of 42 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: PAROSMIA (non-serious) with onset 02Apr2021, outcome "recovered" (Apr2021), described as "One day after I got my first vaccine, I started to have a constant smell of gasoline. It lasted for a few days and they went away.". Therapeutic measures were not taken as a result of parosmia.  Additional information: It was reported that one day after the first vaccine, the patient started to have a constant smell of gasoline. It lasted for a few days, and they went away. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Blister, Product use issue
Clinical narrative: I wear a Dexcom 6 Glucose transmitter. Never had any allergic reactions before. 24 hours after both Pfizer '||CHR(38)||' Influenza vaccinations, large blisters formed around G6 patch on stomach area.; other vaccine 4weeks product: Influenza; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in leg left, administration date 03Nov2021 13:30 (Lot number: FF2589) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA), administered in arm left, administration date 03Nov2021 (Batch/Lot number: unknown). Relevant medical history included: "Addison''s Disease" (unspecified if ongoing), notes: Relevant medical history and concurrent conditions: Addison's Disease, Diabetes type 2; "Diabetes type 2" (unspecified if ongoing), notes: Relevant medical history and concurrent conditions: Addison's Disease, Diabetes type 2; "Fish and heavy dosages of aspirin" (unspecified if ongoing), notes: Fish and heavy dosages of aspirin; "Fish and heavy dosages of aspirin" (unspecified if ongoing), notes: Fish and heavy dosages of aspirin. The patient's concomitant medications were not reported. Past drug history included: Fish and heavy dosages of aspirin, reaction(s): "Allergy"; Fish and heavy dosages of aspirin, reaction(s): "Aspirin: allergy", notes: Fish and heavy dosages of aspirin. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EM9810, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 24Feb2021 and and Bnt162b2 (Dose Number: 1 Batch/Lot No: EN6502, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM),administration date: 24Feb2021 when the patient was 56 years old, for COVID-19 immunization. The following information was reported: BLISTER (non-serious) with onset 04Nov2021 14:30, outcome "recovering", described as "I wear a Dexcom 6 Glucose transmitter. Never had any allergic reactions before. 24 hours after both Pfizer '||CHR(38)||' Influenza vaccinations, large blisters formed around G6 patch on stomach area."; PRODUCT USE ISSUE (non-serious) with onset 03Nov2021, outcome "unknown", described as "other vaccine 4weeks product: Influenza". Therapeutic measures were not taken as a result of blister.  Additional information:Other vaccine 4weeks product included Influenza on 03Nov2021(Left Arm) as dose 1.Covid prior vaccination was reported as yes. Covid tested post vaccination was reported as no.Prior to vaccination the patient was diagnosed with COVID-19.Since the vaccination the patient had not been tested for COVID-19.No treatment was receive for the adverse event.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Ear pain, Feeling abnormal, Headache
Clinical narrative: Pain in back of neck, especially behind right ear; Pain in back of neck, especially behind right ear; headaches; brain fog; Pain in back; My normal aches and pains at 76 are intensifying.my knees, myback, my thumbs; My normal aches and pains at 76 are intensifying.my knees, myback, my thumbs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Oct2021 15:00 (Lot number: FF2590) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "prediabetic" (unspecified if ongoing), notes: other medical history: prediabetic; "Minor arthritis" (unspecified if ongoing), notes: other medical history: Minor arthritis; "Slight kidney:kidney disorder" (unspecified if ongoing), notes: other medical history: Slight kidney; "fatty liver" (unspecified if ongoing), notes: other medical history: fatty, liver. Concomitant medication(s) included: SYNTHROID; LIOTHYRONINE; METFORMIN; AZELASTINE. Past drug history included: Iodine (slightly), reaction(s): "known allergies: iodine (slightly)", notes: known allergies: iodine (slightly). Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9263, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 20Feb2020, when the patient was 76 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 29Jan2021, when the patient was 76 years old, for Covid-19 immunization. The following information was reported: NECK PAIN (non-serious), EAR PAIN (non-serious) all with onset 31Oct2021, outcome "not recovered" and all described as "Pain in back of neck, especially behind right ear"; HEADACHE (non-serious) with onset 31Oct2021, outcome "not recovered", described as "headaches"; FEELING ABNORMAL (non-serious) with onset 31Oct2021, outcome "not recovered", described as "brain fog"; BACK PAIN (non-serious) with onset 31Oct2021, outcome "not recovered", described as "Pain in back"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 31Oct2021, outcome "not recovered" and all described as "My normal aches and pains at 76 are intensifying.my knees, myback, my thumbs". Therapeutic measures were not taken as a result of neck pain, ear pain, headache, feeling abnormal, back pain, arthralgia, pain in extremity.  Additional information: The patient experienced pain in back of neck, especially behind right ear. She had this after the last vaccine, and it was finally improving but now it is worse. Her normal aches and pains at 76 are intensifying. her knees, her back, her thumbs (esp. the right one and minor headaches. She have brain fog most every day and it hurts above her eyes.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Pain in back of neck, especially behind right ear; Pain in back of neck, especially behind right ear; headaches; brain fog; Pain in back; My normal aches and pains at 76 are intensifying.my knees, myback, my thumbs; My normal aches and pains at 76 are intensifying.my knees, myback, my thumbs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Oct2021 15:00 (Lot number: FF2590) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "prediabetic" (unspecified if ongoing), notes: other medical history: prediabetic; "Minor arthritis" (unspecified if ongoing), notes: other medical history: Minor arthritis; "Slight kidney:kidney disorder" (unspecified if ongoing), notes: other medical history: Slight kidney; "fatty liver" (unspecified if ongoing), notes: other medical history: fatty, liver. Concomitant medication(s) included: SYNTHROID; LIOTHYRONINE; METFORMIN; AZELASTINE. Past drug history included: Iodine (slightly), reaction(s): "known allergies: iodine (slightly)", notes: known allergies: iodine (slightly). Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9263, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 20Feb2020, when the patient was 76 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 29Jan2021, when the patient was 76 years old, for Covid-19 immunization. The following information was reported: NECK PAIN (non-serious), EAR PAIN (non-serious) all with onset 31Oct2021, outcome "not recovered" and all described as "Pain in back of neck, especially behind right ear"; HEADACHE (non-serious) with onset 31Oct2021, outcome "not recovered", described as "headaches"; FEELING ABNORMAL (non-serious) with onset 31Oct2021, outcome "not recovered", described as "brain fog"; BACK PAIN (non-serious) with onset 31Oct2021, outcome "not recovered", described as "Pain in back"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 31Oct2021, outcome "not recovered" and all described as "My normal aches and pains at 76 are intensifying.my knees, myback, my thumbs". Therapeutic measures were not taken as a result of neck pain, ear pain, headache, feeling abnormal, back pain, arthralgia, pain in extremity.  Additional information: The patient experienced pain in back of neck, especially behind right ear. She had this after the last vaccine, and it was finally improving but now it is worse. Her normal aches and pains at 76 are intensifying. her knees, her back, her thumbs (esp. the right one and minor headaches. She have brain fog most every day and it hurts above her eyes.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: first 2 shots had very minor side effects only pain on the administration site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Mar2021 (Lot number: EWS318) as dose 1, single and intramuscular, administered in arm left, administration date 23Mar2021 (Lot number: EWS318) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "known allergies:Only penicillin" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST SODIUM taken for asthma (ongoing); LEVOCETRIZINE HYDROCHLORIDE taken for hypersensitivity (ongoing); ADVAIR taken for asthma (ongoing); SPIRIVA taken for asthma (ongoing); NASONEX taken for hypersensitivity (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "first 2 shots had very minor side effects only pain on the administration site".  No follow-up attempts are possible. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness in arm of vaccination; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Nov2021 13:00 (Lot number: 5127) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Nov2021 07:00, outcome "recovering", described as "arm soreness in arm of vaccination". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.  Additional Information: The patient did not have any known allergies. The patient did not have any other vaccine in 4 weeks. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: body pain; shiver; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Nov2021 19:00 (Lot number: FH8028) 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: PAIN (non-serious) with onset 05Nov2021, outcome "recovered" (Nov2021), described as "body pain"; CHILLS (non-serious) with onset 05Nov2021, outcome "recovered" (Nov2021), described as "shiver". Therapeutic measures were not taken as a result of pain, chills.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since vaccination, the patient had not been tested for covid-19. No known allergies. Device date: 06Nov2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received three Pfizer BioNTech for kids the vaccines and all three boxes are expired; administered to 5 kids yesterday; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: FK5127, Expiration Date: Aug2021) 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: EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "received three Pfizer BioNTech for kids the vaccines and all three boxes are expired; administered to 5 kids yesterday".  Additional information: Pharmacist stated we received on Friday, Friday not on Thursday we received three Pfizer BioNTech for kids the vaccines and all three boxes are expired as of Aug2021. Pharmacist stated, we did vaccination like 5 kids yesterday. We didn't realize until, when we enter all the information with the LOT# and everything that's when, we found out.  Asked why we get expired medication over here for kids and why do you just send expired vaccines. It's so risky. Stated that there is any damage to those kids because it is not my responsibility right now. You guys sent three expired boxes to vaccinate kids, not you the company and patient wanted to know why first thing, want you to find out for me is one, what is the safety window after the expiration date.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202101534624 Same product and event, different patient; PFIZER INC-202101534625 Same product and event, different patient; PFIZER INC-202101534626 Same product and event, different patient; PFIZER INC-202101534627 Same product and event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Bad ringing in her ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day 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: TINNITUS (non-serious), outcome "unknown", described as "Bad ringing in her ears".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Neck pain, Pain
Clinical narrative: I felt a headache since I received it; neck pain; which radiate to the top of my head; leg tingling; fast heart rate; I always have to clear my throat; 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), administration date 02Nov2021 (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: HEADACHE (non-serious) with onset Nov2021, outcome "unknown", described as "I felt a headache since I received it"; NECK PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "neck pain"; PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "which radiate to the top of my head"; PARAESTHESIA (non-serious) with onset Nov2021, outcome "unknown", described as "leg tingling"; HEART RATE INCREASED (non-serious) with onset Nov2021, outcome "unknown", described as "fast heart rate"; THROAT IRRITATION (non-serious) with onset Nov2021, outcome "unknown", described as "I always have to clear my throat". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Consumer further stated, " Consumer wanted, and thought consumer wanted to report it because honestly consumer did not want to get the second vaccine."
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia, Throat irritation
Clinical narrative: I felt a headache since I received it; neck pain; which radiate to the top of my head; leg tingling; fast heart rate; I always have to clear my throat; 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), administration date 02Nov2021 (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: HEADACHE (non-serious) with onset Nov2021, outcome "unknown", described as "I felt a headache since I received it"; NECK PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "neck pain"; PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "which radiate to the top of my head"; PARAESTHESIA (non-serious) with onset Nov2021, outcome "unknown", described as "leg tingling"; HEART RATE INCREASED (non-serious) with onset Nov2021, outcome "unknown", described as "fast heart rate"; THROAT IRRITATION (non-serious) with onset Nov2021, outcome "unknown", described as "I always have to clear my throat". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Consumer further stated, " Consumer wanted, and thought consumer wanted to report it because honestly consumer did not want to get the second vaccine."
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: minor paresthesia two times during a 12 hour period. the first time was within the first hour of administration, the second time was 10 hours later.; arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8-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: PARAESTHESIA (non-serious), outcome "unknown", described as "minor paresthesia two times during a 12 hour period. the first time was within the first hour of administration, the second time was 10 hours later."; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness".  Additional information: After receiving the initial dose of the Covid vaccine, patient experienced minor paresthesia two times during a 12 hour period. the first time was within the first hour of administration, the second time was 10 hours later. Arm soreness was also reported. Event took place after use of product.  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: Dizziness, Vomiting
Clinical narrative: Ever since receiving the shot I get dizzy spells sometimes 6 times a day to where I have to throw up.; Ever since receiving the shot I get dizzy spells sometimes 6 times a day to where I have to throw up.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 14:30 (Lot number: 301308A) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "depression" (unspecified if ongoing); "bipolar adhd" (unspecified if ongoing); "Allergies" (unspecified if ongoing), notes: known_allergies Yes. Concomitant medication(s) included: CELEXA; LITHIUM; VESI Q. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 310308A, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 09Sep2021, for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious), VOMITING (non-serious) all with onset 02Oct2021 17:00, outcome "not recovered" and all described as "Ever since receiving the shot I get dizzy spells sometimes 6 times a day to where I have to throw up.". Therapeutic measures were not taken as a result of dizziness, vomiting.  Additional information: The patient have any known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store.  Follow-Up (15Nov2021): Follow-up attempts are completed. No further information is expected. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Feeling abnormal, Headache
Clinical narrative: headaches; reports a lot of pressure; 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 67 year-old male patient received bnt162b2 (COMIRNATY), administration date 08Aug2021 (Batch/Lot number: unknown) as dose 1, single and administration date 29Aug2021 (Batch/Lot number: unknown) as dose 2, 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 Aug2021, outcome "not recovered", described as "headaches"; FEELING ABNORMAL (non-serious) with onset Aug2021, outcome "not recovered", described as "reports a lot of pressure". The events "headaches" and "reports a lot of pressure" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, feeling abnormal.  Additional information: PQC Present: No. AE Present: Yes. Question: Call comes in via (withheld).  Caller is a 67 year old consumer, DOB #  He received his first dose of the Pfizer BioNTech Covid-19 vaccine on 08Aug2021, and his second dose on 29Aug2021.  He has been having headaches since then.  States he has been to the doctor twice, and has not gotten any relief.  Reports that it is very annoying, and he cannot be around people when they're talking a lot, because it hurts.   He also reports a lot of pressure.  He has had shots and medications from the doctors.  He later states that he will get a CT.  The handwriting on his vaccine card from # is difficult for him to read, but he says for the first dose, it looks like FB0178 (he thought perhaps the 0 was a D); for the second dose, possibly FC3184.  He mentions that on the back of the card, it says 017Y1 for the first, and 1791 for the second.  He is asking if headaches are common after getting the vaccine.  E-transmitted back to Agency for possible additional AE information, as he declined filing a report before warm transferred. Response: Spoke from Experience.  LAB; Revised: 29Oct2021.  Referred back to HCP for further guidance and treatment. Reaction/event as reported by primary source: still having side effects    Is the patient also the reporter? Yes. Reporter type: Consumer or other non health professional. Is Pfizer covid 19 vaccine a Pfizer product? Yes. NDC number of Pfizer covid 19 vaccine: Not Provided. Expiry Date of Pfizer covid 19 vaccine: Not Provided. Other Products: Not Provided. Patient History: Not Provided. Investigation Assessment: Not Provided. The caller is calling about the Pfizer covid 19 vaccine and he is still having side effects. The caller wants to know how long its going to take before he can be himself again? The caller is 67 years old.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Laryngitis, Pain in extremity
Clinical narrative: Laryngitis or Hoarse voice set in 27 hours following booster along with congestion.; Laryngitis or Hoarse voice set in 27 hours following booster along with congestion.; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 17:45 (Lot number: FD0809) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 05Nov2021 (Batch/Lot number: unknown). The patient had no relevant medical history. Concomitant medication(s) included: NYQUIL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 03:30 PM), administration date: 02Apr2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 10Mar2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: LARYNGITIS (non-serious), DYSPHONIA (non-serious) all with onset 06Nov2021 20:00, outcome "not recovered" and all described as "Laryngitis or Hoarse voice set in 27 hours following booster along with congestion."; PAIN IN EXTREMITY (non-serious) with onset 06Nov2021 20:00, outcome "not recovered", described as "sore arm". Therapeutic measures were not taken as a result of laryngitis, dysphonia, pain in extremity.  Additional information: The patient had no known allergies. The patient had no covid prior vaccination and not tested for covid post vaccination. No other vaccines within 4 weeks of vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Pain in extremity, SARS-CoV-2 test
Clinical narrative: sore arm both times that all; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Sep2021 (Lot number: 301308A) at the age of 32 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asymptomatic COVID-19", start date: May2021 (unspecified if ongoing). Concomitant medication(s) included: DEPO-PROVERA. Vaccination history included: Bnt162b2 (Dose 1, single, Batch/Lot number: FC3183, Anatomical Site of injection: Right arm), administration date: 26Aug2021, when the patient was 32 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm both times that all". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: Menstrual period lasted more than 6 days; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Oct2021 12:30 (Lot number: Ff2589) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Route of Administration: Intramuscular), administration date: Jan2021, when the patient was 42 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1), administration date: Dec2020, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: OLIGOMENORRHOEA (non-serious) with onset 02Nov2021, outcome "not recovered", described as "Menstrual period lasted more than 6 days". Therapeutic measures were not taken as a result of oligomenorrhoea.  Additional Information: The patient did not have any known allergies. The patient did not receive any other vaccine in 4 weeks. The patient did not have COVID prior to vaccination. The patient was not tested positive post vaccination. Menstraul period lasted more than 6 days. Before the booster shot, usually the period stopped at day 4. Now, by day 6, the flow is still medium. I need to change 4-5 pads per day.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: First Dose: Feels Lousy/Second Dose: Feels Lousy; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Mar2021 (Lot number: ER8733) at the age of 63 years as dose 1, single and administered in arm right, administration date 18Apr2021 (Lot number: ER8731) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESCITALOPRAM taken for anxiety (ongoing). The following information was reported: MALAISE (non-serious) with onset 29Mar2021, outcome "recovered" (19Apr2021), described as "First Dose: Feels Lousy/Second Dose: Feels Lousy".  Additional information: Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. AE(s) following prior vaccinations: None. Patient's Medical History (including any illness at time of vaccination): Thyroid Cancer, Anxiety, Undiagnosed autoimmune stuff going on, thyroid, skin condition, connective tissue. Concomitant medication included Thyroid Replacement taken for thyroid cancer. Date of start of drug: 28Mar2021. Batch/lot number: FG3527. First Dose: Feels Lousy. Date of start of reaction/event: 29Mar2021. Date of end of reaction/event: 29Mar2021. Outcome: Recovered. Second Dose: Feels Lousy. Date of start of reaction/event: 19Apr2021. Date of end of reaction/event: 19Apr2021.Outcome: Recovered. Relatedness of drug to reaction(s)/event(s): Reaction assessed: First Dose: Feels Lousy. Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection. Drug result: Related. Relatedness of drug to reaction(s)/event(s): Reaction assessed: Second Dose: Feels Lousy. Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection. Drug result: Related. Relevant Tests: None. Investigation assessment: No.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Retching
Clinical narrative: chills; tiredness; periodic dry heaves over 2.5 day period; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, SINGLE), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; RETCHING (non-serious), outcome "unknown", described as "periodic dry heaves over 2.5 day period".  Additional information: She did not become aware of the side effects until after the 24 hour period.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Mild body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 2020 (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: PAIN (non-serious), outcome "unknown", described as "Mild body aches". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: itchy at the injection site; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A child patient 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: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "itchy at the injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: have been suffering with some form of warts on the cuticles of both of my thumbnails for 12 to 15 years/Now, 6 months after your vaccine they are GONE; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Warts on the cuticles of both of my thumbnails" (unspecified if ongoing), notes: warts on the cuticles of both of my thumbnails for 12 to 15 years. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "have been suffering with some form of warts on the cuticles of both of my thumbnails for 12 to 15 years/Now, 6 months after your vaccine they are GONE".  Additional information: Patient had visited many dermatologist with injections, freezings and medications to no avail. These warts were very painful with drying, cracking and bleeding. Now, 6 months after your vaccine they are gone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration
Clinical narrative: My first was 16Apr. Today I just had my second dose; small headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, I did have a small reaction with the first shot.), administration date: 16Apr2021, for Covid-19 Immunization, reaction(s): "small reaction with the first shot". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 08Nov2021, outcome "unknown", described as "My first was 16Apr. Today I just had my second dose"; HEADACHE (non-serious) with onset 08Nov2021, outcome "unknown", described as "small headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Cheilitis, Lip blister
Clinical narrative: my lips turned red and blisters broke out a the next day; my lips turned red and blisters broke out a the next day; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administration date 07Oct2021 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 2, Reported Event: after the second pfizer shot my lips broke out and blisters and turned red and dry and they have lasted for about a month and a half and then it cleared up), administration date: 03Mar2021, for Covid-19 immunization, reaction(s): "my lips broke out and blisters and turned red and dry", "my lips broke out and blisters and turned red and dry", "my lips broke out and blisters and turned red and dry"; Bnt162b2 (dose number: 1), for Covid-19 immunization. The following information was reported: CHEILITIS (non-serious) with onset 07Oct2021, outcome "unknown", LIP BLISTER (non-serious) with onset 08Oct2021, outcome "unknown" and all described as "my lips turned red and blisters broke out a the next day".  Additional information: After the second Pfizer shot my lips broke out and blisters and turned red and dry and they have lasted for about a month and a half and then it cleared up and then after my booster shot on 07Oct2021 that night my lips turned red and blisters broke out a the next day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.