chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Skin disorder
Clinical narrative: rash on the left eye/ rash on his left thigh, a lot of little bumps; rash on his left thigh, a lot of little bumps; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 64 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, NDC/EXP: unknown, LOT: EN6198), administration date: 25Feb2021, when the patient was 63-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Single, NDC/EXP: unknown, LOT: EN6207), administration date: 18Mar2021, when the patient was 63-year-old, for COVID-19 immunization; BNT162b2 (Dose 3 (Booster), Single, DC/EXP: not provided , LOT: EW0153), administration date: 14Oct2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: SKIN DISORDER (non-serious) with onset 14Apr2022, outcome "unknown", described as "rash on his left thigh, a lot of little bumps"; RASH (non-serious) with onset 14Apr2022, outcome "unknown", described as "rash on the left eye/ rash on his left thigh, a lot of little bumps". Therapeutic measures were taken as a result of rash, skin disorder.  Additional Information: Reporter received the second booster dose of Pfizer-BioNTech COVID-19 Vaccine 2 days ago (13Apr2022). Previous day morning (14Apr2022) he began developing a rash on the left eye. He wanted to know if this was a reported side effect for the vaccine. The second booster, was a rash involved in it. on Thursday morning he woke up with rash on his left thigh, a lot of little bumps. He says his first dose was 25Feb2021, LOT: EN6198. He says his second dose was 18Mar2021, LOT: EN6207. He says his third dose was 14Oct2021 with LOT: EW0153. Caller clarifies that his fourth dose or second booster dose was on 13Apr2022, after which he got the rash to his thigh the next morning, provides LOT: FM0698. He put rubbing alcohol on it just once, and the rash didn't change. Reporter provides no further details about the unspecified rubbing alcohol. He says the rash is on the left outside thigh and top, and is on the same side he got the shot on, clarified to he got the second booster dose injected in his left arm.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram, Electrocardiogram, Magnetic resonance imaging, Myocarditis
Clinical narrative: myocarditis; chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), in Mar2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant) with onset Mar2022, outcome "unknown"; CHEST PAIN (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Echocardiogram: Abnormal; Electrocardiogram: Abnormal; Magnetic resonance imaging: Post event scarring on MRI; Troponin: High Tropinon. Clinical Course: A potential AE has been reported to the Contact Center. Reporter reported for their son that he was hospitalized and has been waiting patiently March, 2.5 days after the booster for myocarditis. The booster was a Pfizer Product. Lot Number was not provided. Any other additional information was not provided  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: myocarditis; chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), in Mar2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant) with onset Mar2022, outcome "unknown"; CHEST PAIN (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Echocardiogram: Abnormal; Electrocardiogram: Abnormal; Magnetic resonance imaging: Post event scarring on MRI; Troponin: High Tropinon. Clinical Course: A potential AE has been reported to the Contact Center. Reporter reported for their son that he was hospitalized and has been waiting patiently March, 2.5 days after the booster for myocarditis. The booster was a Pfizer Product. Lot Number was not provided. Any other additional information was not provided  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Facial pain, Inflammation, Neck pain, Pain
Clinical narrative: swelling of the back of her neck and spine; swelling of the back of her neck and spine/ neck was swollen; States it felt duller than normal to the touch and she felt it a little on the left side of her face; pain going from the base of her neck to the left shoulder; States it felt inflamed/ she is concerned, is wondering if its normal or just inflammation; pain on the back of her neck, that traveled down to the left side of her body during the day; pain on the back of her neck, that traveled down to the left side of her body during the day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 34-year-old female patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 3 (booster), single (Lot number: FK9894) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic neck and jaw pain" (unspecified if ongoing), notes: Chronic neck and jaw pain; "Chronic neck and jaw pain" (unspecified if ongoing), notes: Chronic neck and jaw pain. There were no concomitant medications. Vaccination history included: BNT162b2 (First Dose of the Pfizer Covid Vaccine:  , Lot Number: FC3182; , NDC and Expiry Date unknown; , Received in the caller's left arm.), administration date: 10Sep2021, when the patient was 34-year-old, for Covid-19 immunization; BNT162b2 (Second Dose of the Pfizer Covid Vaccine: , Lot Number: Reported as being either 3013518A or 3013519A; , NDC and Expiry Date unknown; , Received in the caller's left arm.), administration date: 01Oct2021, when the patient was 34-year-old, for Covid-19 immunization. The following information was reported: FACIAL PAIN (non-serious) with onset 14Apr2022, outcome "unknown", described as "States it felt duller than normal to the touch and she felt it a little on the left side of her face"; INFLAMMATION (non-serious) with onset 14Apr2022, outcome "unknown", described as "States it felt inflamed/ she is concerned, is wondering if its normal or just inflammation"; ARTHRALGIA (non-serious) with onset 14Apr2022, outcome "not recovered", described as "pain going from the base of her neck to the left shoulder"; NECK PAIN (non-serious) with onset 14Apr2022, outcome "unknown", PAIN (non-serious) with onset 14Apr2022, outcome "not recovered" and all described as "pain on the back of her neck, that traveled down to the left side of her body during the day"; SWELLING (non-serious) with onset 14Apr2022, outcome "unknown", described as "swelling of the back of her neck and spine/ neck was swollen"; SWELLING (non-serious), outcome "unknown", described as "swelling of the back of her neck and spine".
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swelling of the back of her neck and spine; swelling of the back of her neck and spine/ neck was swollen; States it felt duller than normal to the touch and she felt it a little on the left side of her face; pain going from the base of her neck to the left shoulder; States it felt inflamed/ she is concerned, is wondering if its normal or just inflammation; pain on the back of her neck, that traveled down to the left side of her body during the day; pain on the back of her neck, that traveled down to the left side of her body during the day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 34-year-old female patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 3 (booster), single (Lot number: FK9894) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic neck and jaw pain" (unspecified if ongoing), notes: Chronic neck and jaw pain; "Chronic neck and jaw pain" (unspecified if ongoing), notes: Chronic neck and jaw pain. There were no concomitant medications. Vaccination history included: BNT162b2 (First Dose of the Pfizer Covid Vaccine:  , Lot Number: FC3182; , NDC and Expiry Date unknown; , Received in the caller's left arm.), administration date: 10Sep2021, when the patient was 34-year-old, for Covid-19 immunization; BNT162b2 (Second Dose of the Pfizer Covid Vaccine: , Lot Number: Reported as being either 3013518A or 3013519A; , NDC and Expiry Date unknown; , Received in the caller's left arm.), administration date: 01Oct2021, when the patient was 34-year-old, for Covid-19 immunization. The following information was reported: FACIAL PAIN (non-serious) with onset 14Apr2022, outcome "unknown", described as "States it felt duller than normal to the touch and she felt it a little on the left side of her face"; INFLAMMATION (non-serious) with onset 14Apr2022, outcome "unknown", described as "States it felt inflamed/ she is concerned, is wondering if its normal or just inflammation"; ARTHRALGIA (non-serious) with onset 14Apr2022, outcome "not recovered", described as "pain going from the base of her neck to the left shoulder"; NECK PAIN (non-serious) with onset 14Apr2022, outcome "unknown", PAIN (non-serious) with onset 14Apr2022, outcome "not recovered" and all described as "pain on the back of her neck, that traveled down to the left side of her body during the day"; SWELLING (non-serious) with onset 14Apr2022, outcome "unknown", described as "swelling of the back of her neck and spine/ neck was swollen"; SWELLING (non-serious), outcome "unknown", described as "swelling of the back of her neck and spine".
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He mentions that he recently got covid (4th day of being infected); He mentions that he recently got covid (4th day of being infected); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "He mentions that he recently got covid (4th day of being infected)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: He mentions that he recently got covid.  clinical information: Caller stated that last year after he received his second dose of Pfizer covid vaccine, he was hospitalized due to myocarditis. The myocarditis was not present now but he does have few concerns regarding the Pfizer BioNtech covid vaccine. He mentioned that he recently got covid (4th day of being infected) and would like to know if the myocarditis reaction from the vaccine would have any effect on his situation now. Was he more prone to myocarditis from Covid just because he had the myocarditis from the Covid vaccine. Caller would like to know which component of the vaccine is associated with myocarditis. Caller would like to know if Paxlovid can be started 3-5 days within testing positive for covid. Caller stated it would be helpful if Pfizer would send reports to people with myocarditis and follows up with them to see if they got the booster dose or if they were infected with Covid and to come up with some statistics of this occurrences. It would be helpful if pfizer conducted more research about myocarditis. Caller would like to know if he could still receive the Pfizer BioNtech covid vaccine Booster dose despite his history of myocarditis and his current covid infection. He wanted to know what criteria would make him eligible for "Subjects at High Risk of Progressing to Severe COVID-19 Illness" given that he had myocarditis but the myocarditis occured last year after his second dose and he does not have it now. He also asked if he could take the Paxlovid to prevent infection from Covid given his history of myocarditis.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: non allergic asthma diagnosed in her 20s around age 25 or 26, Continuing : True. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation. Vaccination history included: BNT162b2 (Dose : 1, Date of Administration:21Jan2021, Lot number:EL8982), administration date: 21Jan2021, when the patient was 50-year-old, for COVID-19 Immunization; BNT162b2 (Dose : 2, Date of Administration:17Feb2021, Lot number:EN6198), administration date: 17Feb2021, when the patient was 50-year-old, for COVID-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset Oct2021, outcome "recovered" (Dec2021), described as "shingles". The event "shingles" required physician office visit. Therapeutic measures were taken as a result of herpes zoster.  Additional Information: Caller reports never having shingles before or the Shingrix vaccine. Treatment received for herpes zoster was Valtrex.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200584927 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; 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 female patient received BNT162b2 (BNT162B2), as dose number unknown (booster) , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown".  Additional information: Caller stated she and her husband received the Pfizer covid vaccine booster dose a week ago on Saturday, they mixed his vaccination information with her information. Caller stated she wanted to report the side effect she was experiencing, headache. She was stated it was worse today, had severe headache; she said today it was more than anything, it was terrible. Caller wanted to know if she experiences it again should she go to emergency department since her PCP was not in today.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Menstruation delayed
Clinical narrative: Revive 1st shot 2 day before period was suppose to start. Not 8 days later no period; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 24 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROPRANOLOL. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 08Apr2022, outcome "not recovered", described as "Revive 1st shot 2 day before period was suppose to start. Not 8 days later no period". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation delayed. Additional information: No other vaccine was given in four weeks. Other medication which patient received in two weeks was Propranolol. Received 1st shot 2 days before period was supposed to start. Not 8 days later no period. She was not pregnant have taken 5 tests all were negative. Doctor think this is just a skipped period. Have never had a missed period except when pregnant. This effects women's mental health, and patient feel that they have a right to know. Especially has a health care worker who had to be vaccinated. Adverse events start time: 12:00 AM. Patient did not have Covid prior vaccination. Patient was not tested for Covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: Extreme pain in back and thighs; Extreme pain in back and thighs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 at 12:00 as dose 4 (booster), single (Lot number: F54989) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 14Apr2022, outcome "not recovered" and all described as "Extreme pain in back and thighs". Therapeutic measures were not taken as a result of back pain, pain in extremity. No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 test, Urticaria
Clinical narrative: Hives at first and constant itching since; Hives at first and constant itching since; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 2, single (Lot number: EL3248) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes Type 2" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC. Past drug history included: Metformin, reaction(s): "known allergies: Metformin". Vaccination history included: BNT162b2 (Dose number 1, vaccine location: Right arm, lot number: EJ7686), administration date: 25Feb2021, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: URTICARIA (non-serious), PRURITUS (non-serious) all with onset 22Mar2021, outcome "not recovered" and all described as "Hives at first and constant itching since". The events "hives at first and constant itching since" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria, pruritus.  Additional Information: Facility type vaccine was Pharmacy or Drug Store. No, other vaccine in four weeks.  No covid prior to vaccination. Tested positive post vaccination.Other medications in two weeks was Ozempic. Treatment received included Zolar and Dupixant. Covid test type post vaccination was Nasal Swab on 24Jan2022 which resulted negative.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: Immediately after receiving the shot, I experienced sharp pain in my abdomen/the pain has progressed and keeps getting worse and worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2022 at 13:15 as dose 4 (booster), single (Lot number: FJ4991) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; SPIRONOLACTONE; METFORMIN; PRAVASTATIN. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FC3183, Location of injection: Arm Right, Vaccine Administration Time: 03:15 AM), administration date: 24Sep2021, when the patient was 57-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EN6198, Location of injection: Arm Right, Vaccine Administration Time: 12:00 AM), administration date: 27Feb2021, when the patient was 56-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL9269, Location of injection: Arm Left, Vaccine Administration Time: 01:00 AM), administration date: 06Feb2021, when the patient was 56-year-old, for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 18Mar2022 at 13:15, outcome "not recovered", described as "Immediately after receiving the shot, I experienced sharp pain in my abdomen/the pain has progressed and keeps getting worse and worse". The events "immediately after receiving the shot, i experienced sharp pain in my abdomen/the pain has progressed and keeps getting worse and worse" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of abdominal pain.  Additional Information: : Immediately after receiving the shot, I experienced sharp pain in my abdomen. I did not tell the pharmacy technician who gave me the shot because I thought this was temporary and it would subside. Unfortunately the pain has progressed and keeps getting worse and worse. Facility type vaccine: Pharmacy or Drug Store. If other vaccine in four weeks: No. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: Unknown. Other medical history: Diabetes, High BP.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Rash, Skin exfoliation
Clinical narrative: Rash on right arm. Light flaking, dry skin. Diameter approximately 3 inches.; Rash on right arm. Light flaking, dry skin. Diameter approximately 3 inches.; Rash on right arm. Light flaking, dry skin. Diameter approximately 3 inches.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2022 at 19:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, lot unknown reason: Unable to locate or read the details, Vaccine location: Left Arm , Administration Time: 06:00 PM), administration date: 07May2021, when the patient was 35-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, lot unknown reason: Unable to locate or read the details, Vaccine location: Left Arm , Administration Time: 08:00 PM), administration date: 13Apr2021, when the patient was 35-year-old, for COVID-19 immunization. The following information was reported: RASH (non-serious), DRY SKIN (non-serious), SKIN EXFOLIATION (non-serious) all with onset 25Feb2022 at 12:00, outcome "recovered" (2022) and all described as "Rash on right arm. Light flaking, dry skin. Diameter approximately 3 inches.". Therapeutic measures were not taken as a result of rash, dry skin, skin exfoliation.  Additional information: The patient was not received other vaccine in four weeks. The patient had no other medications in two weeks. The patient was not covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, SARS-CoV-2 test
Clinical narrative: Long term memory loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 at 17:30 as dose 1, single (Lot number: ER2613) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "IBS" (unspecified if ongoing); "asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Macrodantin, reaction(s): "known allergies: Macrodantin", notes: known allergies: Macrodantin; Morphine, reaction(s): "known allergies: Morphine", notes: known allergies: Morphine. The following information was reported: AMNESIA (non-serious) with onset 20May2021, outcome "recovered with sequelae", described as "Long term memory loss". The event "long term memory loss" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of amnesia.  Additional information:  Patient was no covid prior to vaccination. Patient had covid tested post vaccination. There is no other vaccine in four weeks. There is Other medications in two weeks
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, SARS-CoV-2 test, Tinnitus
Clinical narrative: had tinnitus in both ears; ringing in ears; 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 (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Adhesives" (unspecified if ongoing), notes: Known allergies: Adhesives. The patient's concomitant medications were not reported. Past drug history included: Lidocaine cream, reaction(s): "Allergies: lidocaine cream", notes: known allergies: Lidocaine cream. Vaccination history included: BNT162b2 (Dose number: 2, Lot number: ER8731, Dose administration time=10:00AM, vaccine location=Left arm, brand: Pfizer), administration date: 08Apr2021, when the patient was 61-year-old, for Covid-19 Immunization; BNT162b2 (Dose number:1, Lot number: ER2613, Dose administration time= 12:00PM , vaccine location=Left arm, brand: Pfizer), administration date: 18Mar2021, when the patient was 61-year-old, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 12Oct2021 at 13:00, outcome "not recovered", described as "had tinnitus in both ears"; TINNITUS (non-serious) with onset 12Oct2021 at 13:00, outcome "not recovered", described as "ringing in ears". The events "had tinnitus in both ears" and "ringing in ears" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus, tinnitus.  Additional information:  Following the booster vaccination (3rd shot) I have had tinnitus in both ears. At the time I did not associate this issue with the vaccination as it was not listed as a possible adverse side effect. He tinnitus continued to persist. I visited my family physician in Jan when the ringing in ears had not stopped. I had a hearing screen performed by an audiologist in late Feb2022. Hearing screen showed no issues. There was no infection. My family physician has me scheduled for a visit with an ENT but I can't get in until Jun. The tinnitus is high pitched and borderline between uncomfortable and painful. I recently read an article and saw a news report indicating rare complaints of tinnitus and realized my tinnitus corresponded exactly with receiving the Pfizer booster shot. Patient has no covid prior vaccination and patient has covid tested post vaccination.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: First Booster: Had Soreness on injection site and tenderness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 25Oct2021 at 12:01 as dose 3 (booster), single (Lot number: 30155BA1) at the age of 71 years, in left top arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia", start date: 1993 (unspecified if ongoing), notes: Fibromyalgia; "Angina attack" (unspecified if ongoing), notes: Angina attack; "Rheumatoid arthritis" (unspecified if ongoing), notes: Rheumatoid arthritis, Diagnosed with years ago.; "Mild stroke TIA" (unspecified if ongoing); "Mild stroke TIA" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT NUMBER: EN6199, Route of administration: Left top arm, Time the Vaccination Was Given: 13:23, Vaccine Administered at Facility? No), administration date: 12Mar2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, LOT NUMBER: EW0164, Route of administration: left top arm, Time the Vaccination Was Given: 12:57, Vaccine Administered at Facility? no), administration date: 24Apr2021, when the patient was 71-year-old, for COVID-19 Immunization, reaction(s): "First dose: 12Mar2021, Second dose: 24Apr2021". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Oct2021, outcome "unknown", described as "First Booster: Had Soreness on injection site and tenderness". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: First Booster: Had Soreness on injection site and tenderness: The caller clarifies the caller did have soreness on injection site and tenderness after receiving the first booster Unknown Pfizer Vaccine. The caller had soreness on injection site and tenderness for the first few hours after receiving the first booster Unknown Pfizer Vaccine and not that much. The caller tries to maintain pain from Rheumatoid Arthritis with Tylenol. No additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect.Prior Vaccinations (within 4 weeks) If applicable, no list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s).  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Left lymph node was softball- sized this time; Aches; Fever; Headache; Sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 07Mar2022 at 17:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: Mar2020 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot no: EW0175), for COVID-19 immunization, reaction(s): "So Sick"; Bnt162b2 (Dose 2, Lot no: EW0186), for COVID-19 immunization, reaction(s): "So Sick". The following information was reported: PAIN (non-serious) with onset 2022, outcome "recovered" (2022), described as "Aches"; PYREXIA (non-serious) with onset 2022, outcome "recovered" (2022), described as "Fever"; HEADACHE (non-serious) with onset 2022, outcome "recovered" (2022); LYMPHADENOPATHY (non-serious) with onset 2022, outcome "recovered" (2022), described as "Left lymph node was softball- sized this time"; ILLNESS (non-serious) with onset 2022, outcome "recovered" (2022), described as "Sick".  Additional Information: Patient was submitting this because patient had to get a third (booster) shot for work. Because patient was so sick with the first 2 shots (6 days each time), patient didn't want to be boosted but had to for work plus travel. Once again had a bad reaction to the 3rd dose. Patient stated there really needs to be a smaller dose for people like patient who had COVID plus react to the vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid 19 on 14Apr2022 after being fully vaccinated.; Tested positive for Covid 19 on 14Apr2022 after being fully vaccinated.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: 3247), on 23Mar2021 as dose 2, single (Lot number: 3247) and on 01Dec2021 as dose 3 (booster), single (Lot number: ED0809) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Apr2022, outcome "unknown" and all described as "Tested positive for Covid 19 on 14Apr2022 after being fully vaccinated.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Apr2022) Positive. Clinical course: Patient's symptoms were generally mild and include cough, nasal congestion and fatigue.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Sep2021 as dose 1, single (Lot number: EN6201), on 10Mar2021 as dose 2, single (Lot number: EN6198), in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: MOTEGRITY, start date: 07Mar2022; LEVOTHYROXINE, start date: 06Feb1922; INSULIN; ACINON ELI LILLY, start date: Mar1990; MUCINEX, start date: 31Mar2022; ADVIL CONGESTION RELIEF, start date: 31Mar2022; TYLENOL, start date: 31Mar2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.clinical course: Patient reported that at starting Paxlovid had intense muscle pain in neck and left shoulder blade. Patient took Tylenol and ibuprofen & ice packs 24/7 to manage the pain. Patient also reported that when 5 day dose of Paxlovid ended , on day 6 & 7 the pain had started to decrease .
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 at 12:00 as dose 1, single (Lot number: En6202), in left arm, on 03Apr2021 at 12:00 as dose 2, single (Lot number: Ew0151), in left arm and on 17Nov2021 at 12:00 as dose 3 (booster), single (Lot number: Fh8028) at the age of 63 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Other medical history: Diabetes high blood pressure anxiety; "high blood pressure" (unspecified if ongoing), notes: Other medical history: Diabetes high blood pressure anxiety; "anxiety" (unspecified if ongoing), notes: Other medical history: Diabetes high blood pressure anxiety; "Known allergies: Bee sting" (unspecified if ongoing), notes: Known allergies: Bee sting. Concomitant medication(s) included: BYSTOLIC, start date: 01Nov2021; ZOLOFT, start date: 01Nov2021; ATIVAN, start date: 01Nov2021; NATUREMADE, start date: 01Nov2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Anti-viral details: product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 14Apr2022, Treatment stop date: 15Apr2022. Therapeutic measures were taken as a result of vaccination failure, Covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pruritus, Rash, Swelling
Clinical narrative: neck was itching and it was little bumps and a little swollen.; neck was itching and it was little bumps and a little swollen.; neck was itching and it was little bumps and a little swollen; rash on her neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PRURITUS (non-serious), SWELLING (non-serious), MASS (non-serious) all with onset Dec2021, outcome "unknown" and all described as "neck was itching and it was little bumps and a little swollen."; RASH (non-serious) with onset Dec2021, outcome "unknown", described as "rash on her neck".  Additional information: The reporter thinks she may have had the same thing after the covid vaccine and booster but hers was less. They looked the same it was on her neck and arms and was trying to figure that out but it was in Dec. She got her booster dose on 02Nov2021. The caller started to get the rash on her neck sometime in Dec. The patient neck was itching and it was little bumps and a little swollen. The caller has never had skin issues before.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE, SUSPECTED COVID-19, outcome "unknown" and all described as "COVID-19".  Clinical courses: It was unknown if there were other medications in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Malaise, Sleep disorder
Clinical narrative: had a severe headache for 2 days; lost his appetite/ loss of appetite; very tired; he slept for 2 days; he still doesn't feel real good; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) reporting for a patient (husband) via medical information team.  An 89-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Caller reports that his husband had no symptoms with the first two doses of the Pfizer Covid-19 vaccine), for COVID-19 immunization, reaction(s): "no symptoms"; Bnt162b2 (Dose 2, Caller reports that his husband had no symptoms with the first two doses of the Pfizer Covid-19 vaccine), for COVID-19 immunization, reaction(s): "no symptoms". The following information was reported: HEADACHE (non-serious) with onset Apr2022, outcome "recovered" (Apr2022), described as "had a severe headache for 2 days"; SLEEP DISORDER (non-serious) with onset Apr2022, outcome "unknown", described as "he slept for 2 days"; MALAISE (non-serious) with onset Apr2022, outcome "unknown", described as "he still doesn't feel real good"; DECREASED APPETITE (non-serious) with onset Apr2022, outcome "unknown", described as "lost his appetite/ loss of appetite"; FATIGUE (non-serious) with onset Apr2022, outcome "unknown", described as "very tired".  Additional information: NDC number and Expiry Date of COVID-19 Vaccines were Not Provided. Other Products were Not Provided. Other Conditions were Not Provided. Investigations were Not Provided. The reporter is a 88 year-old female calling about the booster dose of the Pfizer Covid-19 vaccine. She reported that she and her husband who is 89 years old received booster dose of the Pfizer Covid-19 vaccine last Friday 08Apr2022. She reported that her husband had a severe headache for 2 days and lost his appetite. She reports her husband had no symptoms or side effects with the first 2 doses of the COVID-19 vaccine. She states her husband had a severe headache for 2 days and he still doesn't feel real good. She states her husband has never had any reactions to the previous 2 doses of the COVID-19 vaccine. She states at her and her husband's age she is continuing to be told that she needs a COVID-19 booster and now she is hearing reports that she will need a 4th COVID-19 booster dose. She states if she can be sent a letter to explain why she needs a 4th COVID-19 dose she would be grateful. She states her and her husband have been really faithful with all this and she doesn't understand why this has happened. She states that she has told Pfizer about all there is to know for her husband. She states he gets severe headaches, loss of appetite and very tired. She states he slept for 2 days. The case was reported as non-serious.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4358310-00 (RA). A 40-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for Covid-19 immunization; adalimumab (HUMIRA), (Lot number: 1155993) at unknown (citrate free), subcutaneous for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Covid". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for BNT162b2: The reporter's causality for the event(s) of "Covid" with BNT162b2 was related (reported as Possible). Causality for adalimumab (HUMIRA): The reporter's causality for the event(s) of "Covid" with adalimumab (HUMIRA) was a reasonable possibility. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on available information the events of Drug ineffective, Covid-19 are assessed as possibly related to the suspect vaccine BNT162B2 based on temporal association.
Sex: F
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: Ever since there is the redness about 3 inches, 5, 6 inches and that hasn't gone away; its warm to the touch kind of hard; its warm to the touch kind of hard; It's warm and hard to the touch and sore; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 55-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for autoimmune disorder. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 14Apr2022, outcome "not recovered", described as "Ever since there is the redness about 3 inches, 5, 6 inches and that hasn't gone away"; VACCINATION SITE PAIN (non-serious) with onset 14Apr2022, outcome "not recovered", described as "It's warm and hard to the touch and sore"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE INDURATION (non-serious) all with onset 14Apr2022, outcome "not recovered" and all described as "its warm to the touch kind of hard".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.