chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests normal, Chills, Headache, Impaired quality of life, Insomnia
Clinical narrative: tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch; She can't sleep; Her quality of life is not good since then; headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch), INSOMNIA (She can't sleep), IMPAIRED QUALITY OF LIFE (Her quality of life is not good since then), HEADACHE (headache) and CHILLS (chills) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch), INSOMNIA (She can't sleep), IMPAIRED QUALITY OF LIFE (Her quality of life is not good since then), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). At the time of the report, TINNITUS (tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) had not resolved and INSOMNIA (She can't sleep) and IMPAIRED QUALITY OF LIFE (Her quality of life is not good since then) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: Negative. On an unknown date, Magnetic resonance imaging: Negative.         No concomitant product reported by the reporter. It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that the doctors kept saying they don't know enough about the COVID vaccines. They had other patients who had tinnitus. They say to wait it out and let it go away. She did wait it out and do what they were saying. Her quality of life was not good since then. that the ringing turned into a piercing sound and it's pulsating in her left ear only. It was a high pitch. It  was repetitive like a ceiling fan. It was all day. It was a high-pitched pierce. It was hard to turn it off and not think about it. No treatment medication reported by the reporter.   This case was linked to MOD-2022-685668 (Patient Link).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging normal, Pyrexia, Tinnitus
Clinical narrative: tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch; She can't sleep; Her quality of life is not good since then; headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch), INSOMNIA (She can't sleep), IMPAIRED QUALITY OF LIFE (Her quality of life is not good since then), HEADACHE (headache) and CHILLS (chills) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch), INSOMNIA (She can't sleep), IMPAIRED QUALITY OF LIFE (Her quality of life is not good since then), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). At the time of the report, TINNITUS (tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) had not resolved and INSOMNIA (She can't sleep) and IMPAIRED QUALITY OF LIFE (Her quality of life is not good since then) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: Negative. On an unknown date, Magnetic resonance imaging: Negative.         No concomitant product reported by the reporter. It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that the doctors kept saying they don't know enough about the COVID vaccines. They had other patients who had tinnitus. They say to wait it out and let it go away. She did wait it out and do what they were saying. Her quality of life was not good since then. that the ringing turned into a piercing sound and it's pulsating in her left ear only. It was a high pitch. It  was repetitive like a ceiling fan. It was all day. It was a high-pitched pierce. It was hard to turn it off and not think about it. No treatment medication reported by the reporter.   This case was linked to MOD-2022-685668 (Patient Link).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Pyrexia, Tinnitus
Clinical narrative: tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch; Her quality of life is not good since then; She can't sleep; headache; chills; fever; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch), IMPAIRED QUALITY OF LIFE (Her quality of life is not good since then), INSOMNIA (She can't sleep), HEADACHE (headache) and CHILLS (chills) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch), IMPAIRED QUALITY OF LIFE (Her quality of life is not good since then), INSOMNIA (She can't sleep), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). At the time of the report, TINNITUS (tinnitus, ear ringing/the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) had not resolved and IMPAIRED QUALITY OF LIFE (Her quality of life is not good since then) and INSOMNIA (She can't sleep) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: (Negative) Negative. On an unknown date, Magnetic resonance imaging: (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   The patient reports that she got tinnitus, ear ringing. It's constant and high-pitched. She can't sleep. It's driving her crazy. She's had MRI and hearing tests, but everything was negative. The doctors kept saying they don't know enough about the COVID vaccines. She did wait it out and do what they were saying. Her quality of life was not good since then. After the first shot, she had a headache. She never had headache before. That night she could hear a sound like a radio wave. She wasn't sure what it was. She never heard it before. It wasn't until the second shot on 21-Apr-2021 that the ringing turned into a piercing sound and it's pulsating in her left ear only. It's a high pitch. It's repetitive like a ceiling fan. It's all day. It's a high-pitched pierce. It's hard to turn it off and not think about it. After the second shot, she had the ringing, chills, fever, and headache.  No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Food allergy
Clinical narrative: allergic reaction to shrimp; This spontaneous case was reported by a patient and describes the occurrence of FOOD ALLERGY (allergic reaction to shrimp) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: flu shot. Past adverse reactions to the above products included No adverse event with flu shot.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FOOD ALLERGY (allergic reaction to shrimp). At the time of the report, FOOD ALLERGY (allergic reaction to shrimp) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported.  The patient received bivalent booster on 08-Dec-2022 and was taking Amoxicillin to prevent infections since 07-Dec-2022 because of a teeth surgery.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I got the Maderna booster and a week later got Covidr; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I got the Maderna booster and a week later got Covidr) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I got the Maderna booster and a week later got Covidr). At the time of the report, COVID-19 (I got the Maderna booster and a week later got Covidr) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient got the Moderna booster and a week later got Covid. No Concomitant medication was reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: We had an excursion where Moderna product was stored in the fridge and experienced multiple warm excursions.; We had an excursion where Moderna product was stored in the fridge and experienced multiple warm excursions.; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm excursions.), PRODUCT STORAGE ERROR (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm excursions.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm excursions.), PRODUCT STORAGE ERROR (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm excursions.) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm excursions.), PRODUCT STORAGE ERROR (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm excursions.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm excursions.) and PRODUCT STORAGE ERROR (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm excursions.).    No concomitant medication was provided by the reporter  It was reported that Moderna product was stored in the fridge and experienced multiple warm excursions. Data shows the vaccine was above 46F for 27 hours. The max temperature reached was 49.658F. It was also reported that LOT was placed directly in the freezer and was moved to the fridge on 17-Nov-2022 and was not used after 26-Nov-2022 at 12pm EST. The vaccines were assumed to be administered on 25-Nov-2022, which would be more than 24 hours at room temperature. Temperature logs have been attached to the parent case NA22-00002036.  No treatment medication was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursion; Product Storage Error; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursion), PRODUCT STORAGE ERROR (Product Storage Error) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursion), PRODUCT STORAGE ERROR (Product Storage Error) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursion), PRODUCT STORAGE ERROR (Product Storage Error) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursion) and PRODUCT STORAGE ERROR (Product Storage Error).    No concomitant medication was provided by the reporter  It was reported that Moderna product was stored in the fridge and experienced multiple warm excursions. Data shows the vaccine was below 36F for a total of 166 hours. The minimum temperature reached was 31.658 F. The vaccine was above 46F for a total of 67 hours. The max temperature reached was 50.234 F.  No treatment medication was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; number of doses were administered BUD in different dates to pediatric patients from 6 months to 11 years:; number of doses were administere BUD in different dates to pediatric patients from 6 months to 11 years; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (number of doses were administered BUD in different dates to pediatric patients from 6 months to 11 years:), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (number of doses were administere BUD in different dates to pediatric patients from 6 months to 11 years) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR9236B, AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (number of doses were administered BUD in different dates to pediatric patients from 6 months to 11 years:) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (number of doses were administere BUD in different dates to pediatric patients from 6 months to 11 years). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (number of doses were administered BUD in different dates to pediatric patients from 6 months to 11 years:), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (number of doses were administere BUD in different dates to pediatric patients from 6 months to 11 years) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (number of doses were administered BUD in different dates to pediatric patients from 6 months to 11 years:) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (number of doses were administere BUD in different dates to pediatric patients from 6 months to 11 years).    No concomitant medications were reported.   It was unknown if patients experienced any adverse events.  No treatment details were reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: he has COVID-19 after the COVID-19 Vaccines; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (he has COVID-19 after the COVID-19 Vaccines) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (First dose: 12Jan2021) on 12-Jan-2021, MODERNA COVID-19 VACCINE (Dose 2: 09-Feb-2021) on 09-Feb-2021, MODERNA COVID-19 VACCINE (3rd dose: 15Sep2021) on 15-Sep-2021 and MODERNA COVID-19 VACCINE (4th dose: 06Apr2022) on 06-Apr-2022. Past adverse reactions to the above products included No adverse drug reaction with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE and MODERNA COVID-19 VACCINE. Concurrent medical conditions included Hypertension (Diagnosed 5-6 years ago), Cholesterol high and HDL (Diagnosed 8-9 years ago.). Concomitant products included ROSUVASTATIN for Cholesterol high, LISINOPRIL for Hypertension.    On 26-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (he has COVID-19 after the COVID-19 Vaccines). At the time of the report, COVID-19 (he has COVID-19 after the COVID-19 Vaccines) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was also reported that vaccine didn't seem to protect the patient. Patient took vitamins and normal stuff for health.  No treatment medication was provided by the reporter.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date.; No AEs were reported; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date) and NO ADVERSE EVENT (No AEs were reported) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date.) and NO ADVERSE EVENT (No AEs were reported). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date.) and NO ADVERSE EVENT (No AEs were reported) outcome was unknown.      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No AEs were reported) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date).    No concomitant medications were reported. No treatment medications were reported.  Patient identifiers for patient number 2 were documented in this case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine administered 24 days post Beyond Use Date; Product Storage Error; Product temperature excursion issue; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 24 days post Beyond Use Date), PRODUCT STORAGE ERROR (Product Storage Error), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 24 days post Beyond Use Date), PRODUCT STORAGE ERROR (Product Storage Error), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 24 days post Beyond Use Date), PRODUCT STORAGE ERROR (Product Storage Error), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered 24 days post Beyond Use Date), PRODUCT STORAGE ERROR (Product Storage Error) and PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue).    No concomitant medication was reported. It was reported that vaccine administered 24 days post Beyond Use Date. There was an excursion where Moderna product was stored in the fridge and experienced multiple cold excursions and was punctured 24 days post Beyond Use Date. Data shows the vaccine was below 36F for a total of 1 hour. The minimum temperature reached was 35.4F.  Lot 083B22A was delivered and placed in the freezer 30-Aug-22. Lot 083B22A was relocated to the fridge on9-Sep-22. Vial was punctured on 15-nov-22 at 12:09 PM EST. This was the only puncture for this vial and it was damaged out 15-nov-22 at 9 PM EST. Vaccine was only administered once on 15-nov-22 at 12:09 PM EST. No treatment medication was reported.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: the bottoms of my feet feels like I'm walking on needles; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (the bottoms of my feet feels like I'm walking on needles) in a 66-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Aug 2022: I had Covid) in August 2022. Concurrent medical conditions included Diabetes.    On 10-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (the bottoms of my feet feels like I'm walking on needles). At the time of the report, LIMB DISCOMFORT (the bottoms of my feet feels like I'm walking on needles) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were reported. No treatment medicine were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bone densitometry, COVID-19, Lower limb fracture
Clinical narrative: Broke leg; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of LOWER LIMB FRACTURE (Broke leg) and COVID-19 (COVID-19) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced LOWER LIMB FRACTURE (Broke leg) and COVID-19 (COVID-19). At the time of the report, LOWER LIMB FRACTURE (Broke leg) and COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Bone densitometry: Improved.  Concomitant product use was not provided by the reporter.  Dosage text was reported as booster dose.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Investigation, Magnetic resonance imaging, SARS-CoV-2 antibody test
Clinical narrative: joint pain in her knee/she was in a lot of pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 30-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "knee pain" (unspecified if ongoing), notes: started before Apr2022; "knee surgery", start date: Apr2022 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Comirnaty (DOSE 1, SINGLE), for covid-19 immunisation; Comirnaty (DOSE 2, SINGLE), for covid-19 immunisation. The following information was reported: ARTHRALGIA (medically significant) with onset 2022, outcome "unknown", described as "joint pain in her knee/she was in a lot of pain". The patient underwent the following laboratory tests and procedures: Blood test: Negative, notes: Her daughter also had every conceivable blood test and everything was negative; 30 medical tests: negative, notes: everything comes back negative; Magnetic resonance imaging: no tear, notes: they did a MRI possibly so they did surgery but there was no tear; SARS-CoV-2 antibody test: positive, notes: positive for COVID 19 antibodies. Therapeutic measures were taken as a result of arthralgia.  Clinical course: Her daughter had two surgeries for knee pain, which the first was Apr2022 and the second was Nov2022. Both were negative and normal, they had thought it was a meniscus tear for the first one and they did a MRI possibly so they did surgery but there was no tear. Then the surgeon assumed pain was from scar tissue then had the second surgery in Nov2022, and there was no scar tissue. Her daughter also had every conceivable blood test and everything was negative. She had dozens of lab results, which everything was negative other than having antibodies for COVID, which was expected since she had the shots. The joint pain was to the left knee, she was in a lot of pain, unknown when that started exactly or if it has gotten better or worse since it started.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Overdose, Product preparation error, Pyrexia
Clinical narrative: given the pfizer maroon cap vaccine without diluent; 0.2ml (undiluted); high fever; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A 3-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2022 as dose 2 (maroon cap), 0.2 ml single (Lot number: FT9142, Expiration Date: 31Dec2022) at the age of 3 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1; Manufacturer unknown), for COVID-19 immunization. The following information was reported: OVERDOSE (non-serious) with onset 02Dec2022, outcome "unknown", described as "0.2ml (undiluted)"; PRODUCT PREPARATION ERROR (non-serious) with onset 02Dec2022, outcome "unknown", described as "given the pfizer maroon cap vaccine without diluent"; PYREXIA (non-serious) with onset 02Dec2022, outcome "unknown", described as "high fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: States there was an incident in which a toddler was given the pfizer maroon cap vaccine without diluent. States she needs information on how much the dosage would have been. States she followed up with the mom, so far the child had a high fever one day after the vaccine was administered. States the child was given Motrin which brought it back down and seems to be ok right now. Confirms dose volume that was administered to the 3 yr old male patient was 0.2ml. NDC number of Pfizer Covid vaccine: 59267007801. The Pfizer covid vaccine that was administered for toddlers age 3-4 and she had made a report with interaction; they had a 2nd dose administered on a toddler and it was given without the diluent at the dose of 0.2mL and she did file this information in an initial report but did not know if there was any other information as far as what to look for and side effects and this happened on the 02Dec.It was said they had a toddler that received his second dose without the dose being diluted. Caller asking what they need to do. It was mentioned that they had a toddler that received his second dose without the dose being diluted. Reported that they do have a patient who received the second dose of Pfizer covid-19 maroon cap without diluent.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: in July we got the Covid me and her and both of our shots are up to date and everything; in July we got the Covid me and her and both of our shots are up to date and everything; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 03Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 10Nov2021 as dose 1, single (Batch/Lot number: unknown) and on 01Dec2021 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "in July we got the Covid me and her and both of our shots are up to date and everything". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: in July we got the Covid.  Clinical course: Except in July reporter and grand child got the Covid, the reporter and grand child and both of their shots are up to date and everything, the reporter mean everything she wasn't even sick, and the reporter wasn't sick either, but suddenly both tested positive at home test and reporter's granddaughter had.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: she got really sick with all three of the vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), 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), for COVID-19 immunization, reaction(s): "she got really sick with all three of the vaccines"; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "she got really sick with all three of the vaccines". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "she got really sick with all three of the vaccines".  Additional information: Daughter was 44 and she got really sick with all three of the vaccines. Daughter never said that to her before. Thinks a lot of people just don't say anything and don't report it. Will talk to her daughter about calling and filing a report. Thought she was feeling better. Its wearing off. Doesn't know how the symptoms work through the system exactly. Starting to feel a little bit better. Doesn't know that she will make it to her appt Wednesday though. She can't shower to get out of house. She walks and rides a bike everyday. So this has really put her our. Doesn't get sick very often at all.  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, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose Number: 3 Moderna Booster (first two vaccination doses were Pfizer); This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "known allergies: Guava" (unspecified if ongoing), notes: known allergies: Guava (food); "smoking" (unspecified if ongoing), notes: quit smoking 5 yrs ago. Concomitant medication(s) included: BUPROPION HCL XL, start date: 01Sep2022. Past drug history included: Rocephin, reaction(s): "known allergies: Rocephin"; Clindamycin, reaction(s): "known allergies: Clindamycin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Jun2022, outcome "unknown", described as "Dose Number: 3 Moderna Booster (first two vaccination doses were Pfizer)"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: She began this medication at 11:30 pm on 03Dec. On 04Dec, she started tasting metal with every meal she ate. She could still taste the food itself but had an added metal taste. Today 06Dec at 2:21 was she was smelling cigarettes everywhere and could taste them as well. She quit smoking 5 yrs ago. She has never had any smell or taste issues when sick in past.  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 the available information in the case, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "most families of antibiotics" (unspecified if ongoing), notes: most families of antibiotics. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medications in two weeks. Known allergies: most families of antibiotics. Anti-viral details: Product: Covid-19 treatment, Brand: Paxlovid, Treatment start date: 02Dec2022 (Lot number: paa183750, Indication: Treatment of Covid-19).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna Dose Number: 4 / Pfizer / BioNTech Dose Number: 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 24Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: amoxicillin", notes: known allergies: amoxicillin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Oct2022, outcome "not recovered", described as "Moderna Dose Number: 4 / Pfizer / BioNTech Dose Number: 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Nov2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Nov2022) Positive; (27Nov2022) Negative; (05Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: tested positive for Covid on 23Nov2022 and started Paxlovid. On 27Nov2023 tested negative and all symptoms were gone. On 04Dec2022 covid symptoms returned (head congestion) and tested positive on 05Dec2022. Event COVID 19 treatment included Paxlovid, treatment started on 23Nov2022 and treatment stop date was 27Nov2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: keeps getting Coronavirus and he has been vaccinated; keeps getting Coronavirus and he has been vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "keeps getting Coronavirus and he has been vaccinated". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: he was positive.  Clinical information: Reporter states her Cousin keeps getting Coronavirus too and he has been vaccinated. He is of (Ethnicity withheld) decent, and (Ethnicity withheld) people have a gene where they get sick all the time, like (Ethnicity withheld) people get Sickle Cell. She doesn't know if Pfizer took that into consideration. It doesn't seem like the vaccine has any effect on the patient. She states she was around her cousin hugging him and sitting close to him and he was positive and he asked if she got the coronavirus and she did not. Reporter declines to complete a report for her cousin.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201356307 similar report from same reporter;
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Husband had Covid after receiving the Pfizer Primary series vaccines; Husband had Covid after receiving the Pfizer Primary series vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Husband had Covid after receiving the Pfizer Primary series vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Her Husband had Covid.  Clinical course: Caller has been Exposed 2x to Covid 19 and never got it. Her Husband had Covid after receiving the Pfizer Primary series vaccines, He had a mild case but "his taste buds still weren't the same. "She mentioned her husband developed Covid after receiving all of his Covid-19 vaccines and his taste buds are still effected.   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, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I just tested positive for Covid for the 1st time 10 days ago; I just tested positive for Covid for the 1st time 10 days ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Granulomatosis with polyangiitis" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing), notes: Being a high risk person with an autoimmune disease; "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "I just tested positive for Covid for the 1st time 10 days ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Patient just tested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient just tested positive for COVID for the 1st time 10 days ago. Patient had all COVID vaccines. Being a high risk person with an autoimmune disease patient got on Paxlovid that day. The next day patient felt much better and the rest of the time patient was on Paxlovid patient felt better than patient do when patient get a mild cold. Now 5 days after being off of it, patient feel horrible. Patient thought Paxlovid dosing should be extended for immunocompromised people past 5 days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.