chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd booster-Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd booster-Dose administered after 30-day Use By Date) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd booster-Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd booster-Dose administered after 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient was administered 2nd booster dose after 30 days use by date. The manufacturer expiration date was 05-Jul-2022.  The date the vial initially stored in the refrigerator was 02-Mar-2022. It was also reported that the vial didn't undergo any temperature excursions.  No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient received doses more than 12 hours post-puncture and stored in room temperature; 4 patients received doses >12 hours post-puncture; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients received doses >12 hours post-puncture) and PRODUCT STORAGE ERROR (patient received doses more than 12 hours post-puncture and stored in room temperature) in an 80-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients received doses >12 hours post-puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient received doses more than 12 hours post-puncture and stored in room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients received doses >12 hours post-puncture) and PRODUCT STORAGE ERROR (patient received doses more than 12 hours post-puncture and stored in room temperature) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was unknown when the vial was initially stored in the refrigerator. Moderna vial set to the counter on 31 Mar 2022 at 12:10 PM. The vial was first punctured on 31 Mar 2022 at 12:25 PM and it was administered on 01 Apr 2022 at 1:30 PM, 2:15 PM, 2:30 PM and 3:30 PM to 4 patients.  Post puncture the vial was stored in room temperature and did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was a little over 25 hours and 20 minutes before the first dose was administered.  No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient recieved dose more than 12 hours post-puncture; Patient recieved dose more than 12 hours post-puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient recieved dose more than 12 hours post-puncture) and PRODUCT STORAGE ERROR (Patient recieved dose more than 12 hours post-puncture) in a 73-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient recieved dose more than 12 hours post-puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient recieved dose more than 12 hours post-puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient recieved dose more than 12 hours post-puncture) and PRODUCT STORAGE ERROR (Patient recieved dose more than 12 hours post-puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.                             Reporter stated that the vial was first punctured on 31-Apr-2022 at 12:25 PM. It was stored at room temperature post puncture. Total amount of time the vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius which is 46 degree Fahrenheit to 77 degree Fahrenheit) was a little over 25 hours and 20 minutes before the first dose was administered.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-532656, MOD-2022-532500 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received dose more than 12 hours post-puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose more than 12 hours post-puncture) in a 72-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose more than 12 hours post-puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose more than 12 hours post-puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Reporter stated that the vial was first punctured on 31-Apr-2022 at 12:25 PM. It was stored at room temperature post puncture. Total amount of time the vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius which is 46 degree Fahrenheit to 77 degree Fahrenheit) was a little over 25 hours and 20 minutes before the first dose was administered.  No treatment information was provided.   This case was linked to MOD-2022-532654, MOD-2022-532500, MOD-2022-532655 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm is killing him today like with the other 3 injections; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Arm is killing him today like with the other 3 injections) in an 80-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Patient don't have allergies. Patient don't have medical history of  Acute and Chronic illnesses at the time of vaccination. Patient not had COVID-19 test and diagnosis. Patient not had other vaccines given within 1 month prior to Moderna COVID-19 vaccine.     On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm is killing him today like with the other 3 injections). At the time of the report, VACCINATION SITE PAIN (Arm is killing him today like with the other 3 injections) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Products were reported. No Treatment information was reported.   This case was linked to MOD-2022-532675, MOD-2022-532678, MOD-2022-532374 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm is killing him today like with the other 3 injections; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Arm is killing him today like with the other 3 injections) in an 80-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm is killing him today like with the other 3 injections). At the time of the report, VACCINATION SITE PAIN (Arm is killing him today like with the other 3 injections) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-532671, MOD-2022-532678, MOD-2022-532374 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is killing like with the other 3 injections; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Arm is killing like with the other 3 injections) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no allergies for medications, food and other products. Patient has never been diagnosed with Covid.     On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is killing like with the other 3 injections). At the time of the report, PAIN IN EXTREMITY (Arm is killing like with the other 3 injections) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided.  Patient did not received other vaccine given within 1 month prior to Moderna COVID-19 vaccine.  No treatment medications were provided.   This case was linked to MOD-2022-532671, MOD-2022-532675, MOD-2022-532374 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Decrease in joint pain after getting the Moderna covid19 vaccine/kneed and back pain has gone for 4 days/no night crams; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Decrease in joint pain after getting the Moderna covid19 vaccine/kneed and back pain has gone for 4 days/no night crams) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee pain (for several years) and Back pain (for several years).    On 01-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Decrease in joint pain after getting the Moderna covid19 vaccine/kneed and back pain has gone for 4 days/no night crams). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Decrease in joint pain after getting the Moderna covid19 vaccine/kneed and back pain has gone for 4 days/no night crams) outcome was unknown.            No concomitant medications were reported.  Reporter stated that they had the second booster with Moderna on the 01-Apr-2022, and that patient suffered for bad knee pain and back pain for years, and after two hours of getting the vaccine, their pain was reduced. Patient's knee and back pain had gone for 4 days. Also patient had no night crams.  No treatment medications were reported.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine was stored in the refrigerator 03-Mar-2022 and administered on 04-Apr-2022; Patient received expired vaccine, beyond 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine, beyond 30-day Use By Date) and PRODUCT STORAGE ERROR (The vaccine was stored in the refrigerator 03-Mar-2022 and administered on 04-Apr-2022) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine, beyond 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was stored in the refrigerator 03-Mar-2022 and administered on 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine, beyond 30-day Use By Date) and PRODUCT STORAGE ERROR (The vaccine was stored in the refrigerator 03-Mar-2022 and administered on 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  The vaccines placed in refrigerator on 03-Mar-2022, and doses administered to patient after 30-day use by date on 04-Apr-2022 around 9AM . The patient received first booster dose.  Treatment information was not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Ocular hyperaemia, Thirst
Clinical narrative: very thirsty; Day number 7, one of my eyes (left eye) got bright bright bright red , It was deep deep red; really sick for like 5 days [after second shot]; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (very thirsty), OCULAR HYPERAEMIA (Day number 7, one of my eyes (left eye) got bright bright bright red , It was deep deep red) and ILLNESS (really sick for like 5 days [after second shot]) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0251321A and 010A21A) for COVID-19 vaccination.     The patient did not have any allergies and was never tested or diagnosed for Covid-19. The patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Myalgic encephalomyelitis (since she was 25 years old, did not flare after the Moderna doses).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OCULAR HYPERAEMIA (Day number 7, one of my eyes (left eye) got bright bright bright red , It was deep deep red). On an unknown date, the patient experienced THIRST (very thirsty) and ILLNESS (really sick for like 5 days [after second shot]). At the time of the report, THIRST (very thirsty) and OCULAR HYPERAEMIA (Day number 7, one of my eyes (left eye) got bright bright bright red , It was deep deep red) outcome was unknown and ILLNESS (really sick for like 5 days [after second shot]) had resolved.            No concomitant medication information was provided. The patient did not experience a similar event in the past. The patient stated that her red eye never turned into conjunctivitis and It was experienced around sunday. The patient did not seek medical care. The patients stated that she was over 50 years old. The variant in her area was the omicron B.A.2. She asked what was the vaccine that was being administered in pharmacies right now. The patient also asked if Moderna was making new vaccines for the new variants and stated that she was not sure if she should get the second booster. The patient asked how often people get rash or the red eye after the Moderna vaccine. No treatment medication were provided.   This case was linked to MOD-2022-532802, MOD-2022-532815 (Patient Link).   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: achy arm [after booster dose]; felt tired [after booster dose]; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achy arm [after booster dose]) and FATIGUE (felt tired [after booster dose]) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 0251321A and 010A21A) for COVID-19 vaccination.     The patient did not have any allergies and was never tested or diagnosed for Covid-19. The patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Myalgic encephalomyelitis (since she was 25 years old. did not flare after the Moderna doses.).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (achy arm [after booster dose]) and FATIGUE (felt tired [after booster dose]). At the time of the report, PAIN IN EXTREMITY (achy arm [after booster dose]) and FATIGUE (felt tired [after booster dose]) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-532806, MOD-2022-532802 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose were administered after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose were administered after the published expiration date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     Patient has no known allergies.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose were administered after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose were administered after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 28-Mar-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. Reporter does not know if patient had positive COVID test. No treatment information were reported.   This case was linked to MOD-2022-532912 (Patient Link).   Reporter did not allow further contact
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Nightmare, Psychotic disorder
Clinical narrative: Psychotic episodes which was progressive every week and he ended up in a mental facility; nightmares; when he got the vaccines it pushed him all the way back to being like a toddler in some cases; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 19 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 04Jun2021 14:30 (Lot number: EW0172, Expiration Date: 01Aug2021) at the age of 19 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: PSYCHOTIC DISORDER (hospitalization), outcome "unknown", described as "Psychotic episodes which was progressive every week and he ended up in a mental facility"; NIGHTMARE (non-serious), outcome "unknown", described as "nightmares"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "when he got the vaccines it pushed him all the way back to being like a toddler in some cases". The event "psychotic episodes which was progressive every week and he ended up in a mental facility" was evaluated at the physician office visit. Therapeutic measures were taken as a result of psychotic disorder.
Sex: U
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: have little natural immunity from catching the variants/only immunity is from the original vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "have little natural immunity from catching the variants/only immunity is from the original vaccine".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: pain in her arm; painful to turn her neck too; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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 (1st dose, ), for COVID-19 Immunization; Bnt162b2 (2nd dose, ), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in her arm"; NECK PAIN (non-serious), outcome "unknown", described as "painful to turn her neck too".  Additional information: Caller wanted to know about the timing for the second booster dose of Pfizer-BioNTech COVID-19 Vaccine. Caller on behalf of a friend of hers wanted to know if the side effects that her friend experienced after receiving a Pfizer-BioNTech COVID-19 vaccine (booster dose) had been reported. Caller stated that her friend had received the first, second and booster dose of Pfizer vaccine. After the booster dose, she experienced pain in her arm and it was painful to turn her neck too. Caller stated that her friend is an older person. She wanted to know if those side effects had been reported and if her friend should receive the second booster dose that was recently announced. Caller stated that she had already waited on hold for 22 minutes when I offered to put her on hold while I looked for her information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Protein total, Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "tinnitus". 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.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral venous sinus thrombosis, Headache, Investigation, Migraine
Clinical narrative: extremely painful headaches; migraine; Cerebral Venous Sinus Thrombosis (CVST); This is a spontaneous report received from contactable consumer via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The reporter is the patient.  A 43 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 08Apr2021, on 14:00 (Lot number: ER8727) at the age of 42 years as dose 2, single for covid-19 immunization. Relevant medical history included attention deficit hyperactivity disorder (ADHD). Concomitant medications included: ADDERALL and VYVANSE. Vaccination history included the first dose of BNT162B2; Lot number EN6199, into the left arm on 18Mar2021, at  02:00 pm), when the patient was 42 years old, for COVID-19 Immunization. On 17Apr2021, at  17:00, the patient experienced extremely painful headaches, which was serious as it was life-threatening, and involved hospitalization from 25Jun2021; on 17Apr2021, at 17:00, the patient experienced migraine, which was serious as it was life-threatening, and caused and prolonged hospitalization from 25Jun2021. On 17Apr2021, at 17:00, the patient experienced Cerebral Venous Sinus Thrombosis (CVST), which was serious as it was life-threatening and involved hospitalization.  The patient underwent laboratory tests and procedures, which included diagnosed as having Cerebral Venous Sinus Thrombosis (CVST), on Friday, 02Jul. Therapeutic measures were taken as a result of headache, migraine, cerebral venous sinus thrombosis. Details were as follows: On, 17Apr2021, nine days after receiving the second vaccination, patient started to get extremely painful headaches that went on for weeks. Eventually, they got so bad that he went to the emergency room on 25Jun2021. Believing it was a migraine, the hospital sent the patient home. The headache didn't get better. Eventually, he was diagnosed as having Cerebral Venous Sinus Thrombosis (CVST) on Friday, 02Jul.  The adverse events (AE)( resulted In doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, involved hospitalization,  and was life threatening illness (immediate risk of death from the event).   The AE treatment, included Eliquis, Lovenox, Acetazolamide. There was no positive covid vaccination, post vaccination. There were no known allergies. The clinical outcome of extremely painful headaches, migraine and Cerebral Venous Sinus Thrombosis (CVST) was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Nodule
Clinical narrative: 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) (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: NODULE (hospitalization), outcome "unknown", described as "Developed a knot underneath her arm". The patient underwent the following laboratory tests and procedures: mammogram: unknown result. The patient reported that, she developed a knot underneath her arm and was currently at the hospital to get a second mammogram relative to the knot. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Clarified question with caller and she states the expiration date printed on the vial is 11/2021; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Lot number: FE3592, Expiration Date: Nov2021) as dose number unkown, 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 "Clarified question with caller and she states the expiration date printed on the vial is 11/2021".  Additional information-The caller was calling about the purple cap formulation of the vaccine and wanted to confirm the expiration date for her vaccine specific lot number. She was looking online and information she read was the expiration date was 6 months from initial expiration date, and all vaccines in that time frame so far; Lot withheld. Clarified question with caller and she stated the expiration date printed on the vial was Nov2021. She states. she wants to know does that vial with this expiration date had 6 month expiration date or was it extended. She also asked if it was given to patients after expiration what do we do. She stated doses were given after the extended expiration date of 28Feb2022.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: hair growth increased; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program. The reporter is the patient.  A 62 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "alopecia universalis" (unspecified if ongoing), notes: I have had alopecia universalis for 30 years or so. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "hair growth increased".  Additional information: Clinical course: It was reported that patient saw that some people said they had hair loss after receiving the Pfizer vaccine for covid. Patient have had alopecia universalis for 30 years or so and she noticed minimal hair growth after receiving three doses of Pfizer covid vaccine. She was not saying the vaccine caused the hair growth. She just stating it has happened.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia areata
Clinical narrative: Alopecia areata; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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 (prev dose lot unknown reason: Not available/not provided to the notifier at the time of completion of the report, DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (prev dose lot unknown reason: Not available/not provided to the notifier at the time of completion of the report, DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: ALOPECIA AREATA (non-serious) with onset 20Sep2021, outcome "unknown", described as "Alopecia areata". The event "alopecia areata" was evaluated at the physician office visit.  Additional information: The patient did not have any other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient was not tested COVID post vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: their daughter, was diagnosed with a COVID-19 infection between her first and second dose of the Pfizer COVID-19 vaccine; their daughter, was diagnosed with a COVID-19 infection between her first and second dose of the Pfizer COVID-19 vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 7 year-old female 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "their daughter, was diagnosed with a COVID-19 infection between her first and second dose of the Pfizer COVID-19 vaccine".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold-like symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 14 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 14 years 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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold-like symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dry throat, Inappropriate schedule of product administration, Interchange of vaccine products, Off label use
Clinical narrative: off-label use; Inappropriate schedule of drug administered; Inappropriate schedule of drug administered; dry throat; diarrhoea; vomiting; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Dec2021 (Lot number: FD7218) at the age of 38 years as dose 2, single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), administered in arm left, administration date 07Apr2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. Relevant medical history included: "Aspirin allergy" (unspecified if ongoing); "Interchange of vaccine product" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "off-label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown" and all described as "Inappropriate schedule of drug administered"; DRY THROAT (non-serious), outcome "recovering", described as "dry throat"; DIARRHOEA (non-serious) with onset 16Mar2022, outcome "recovering", described as "diarrhoea"; VOMITING (non-serious) with onset 16Mar2022, outcome "recovering", described as "vomiting".  Additional information: The reporter's assessment of the causal relationship of the events with the suspect product was reported as Possible at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: off-label use; Inappropriate schedule of drug administered; Inappropriate schedule of drug administered; dry throat; diarrhoea; vomiting; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Dec2021 (Lot number: FD7218) at the age of 38 years as dose 2, single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), administered in arm left, administration date 07Apr2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. Relevant medical history included: "Aspirin allergy" (unspecified if ongoing); "Interchange of vaccine product" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "off-label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown" and all described as "Inappropriate schedule of drug administered"; DRY THROAT (non-serious), outcome "recovering", described as "dry throat"; DIARRHOEA (non-serious) with onset 16Mar2022, outcome "recovering", described as "diarrhoea"; VOMITING (non-serious) with onset 16Mar2022, outcome "recovering", described as "vomiting".  Additional information: The reporter's assessment of the causal relationship of the events with the suspect product was reported as Possible at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Crohn's disease, Genital contusion, Urticaria
Clinical narrative: crohn's disease flare up; bruising on genital area; bruising on neck; hives on neck and genital area; MARKETING PROGRAM NAME NOT AVAILIBLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4334132-00.  A 75 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1158187) at citrate free for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant), outcome "recovering", described as "crohn's disease flare up"; GENITAL CONTUSION (non-serious), outcome "recovering", described as "bruising on genital area"; CONTUSION (non-serious), outcome "recovering", described as "bruising on neck"; URTICARIA (non-serious), outcome "recovering", described as "hives on neck and genital area". The action taken for adalimumab was unknown.  Clinical information: It was reported that, on an unknown dates, the patient experienced bruising on genital area, bruising on Neck, crohn's disease flare up and hives on neck and genital area. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of bruising on genital area, bruising on neck and hives on neck and genital area with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of crohn's disease flare up with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of bruising on genital area, bruising on neck and hives on neck and genital area Pfizer BioNTech Covid-19 Vaccine (TOZINAMERAN) was possible. The reporter's causality for the event(s) of crohn's disease flare up with Pfizer BioNTech Covid-19 Vaccine (TOZINAMERAN) was not reported. Concomitant drugs and dates of administration was not reported. Other relevant history was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriatic arthropathy, Vaccination site urticaria
Clinical narrative: whelp formation around injection site; psoriatic arthritis flare up; This is a non-interventional study report from the marketing program received from a contactable reporter(s) (Consumer or other non HCP). This is a solicited report received via a sponsored program. Other Case identifier(s): 22K-163-4337752-00 (AbbVie).  A 34 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 34 years as dose 1, single, intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 01Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) citrate free at unknown for psoriatic arthropathy. The patient's relevant medical history was not reported. Concomitant medication(s) included: COSENTYX. The following information was reported: PSORIATIC ARTHROPATHY (medically significant) with onset Aug2021, outcome "unknown", described as "psoriatic arthritis flare up"; VACCINATION SITE URTICARIA (non-serious), outcome "recovering", described as "whelp formation around injection site". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a covid-19 vaccine trial.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of whelp formation around injection site with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of psoriatic arthritis flare up was not provided.  Causality for Pfizer Biontech Covid-19 Vaccine (Tozinameran): The reporter's causality for the event(s) of whelp formation around injection site with Pfizer Biontech Covid-19 Vaccine (Tozinameran) was Not Reported. The reporter's causality for the event(s) of psoriatic arthritis flare up was Probable.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on available information the events psoriatic arthropathy, vaccination site urticaria were assessed as possibly related to the suspect vaccine BNT162B2 based on  temporal association. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Drug ineffective, Illness, Influenza
Clinical narrative: covid five times; covid five times; shoulder pain; flu two or three times; illness; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4339039-00.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Apr2021 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid five times"; ARTHRALGIA (non-serious), outcome "unknown", described as "shoulder pain"; INFLUENZA (non-serious), outcome "unknown", described as "flu two or three times"; ILLNESS (non-serious), outcome "unknown", described as "illness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: patient experienced covid five times. The action taken for upadacitinib was dosage permanently withdrawn. Clinical information: she had nausea with the second covid vaccine with Rinvoq (Upadacitinib). She felt she had shoulder pain due to being off of her medication a lot due to illness. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for Rinvoq (Upadacitinib) The reporter's causality for the event(s) of covid five times, shoulder pain, flu two or three times, Headache, Nausea with the second covid vaccine unknown onset and Headache, nausea with the second covid vaccine unknown onset was not provided.  The reporter's assessment of the causal relationship of the [covid five times, shoulder pain, flu two or three times and illness] with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Drug Ineffective and COVID-19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.