chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pain, Swelling, Vaccination site pain
Clinical narrative: Vaccination site pain; Pain; Swelling; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), SWELLING (Swelling), COVID-19 (COVID-19) and VACCINATION SITE PAIN (Vaccination site pain) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet for Rheumatoid arthritis.    No Medical History information was reported.   On 09-Mar-2021, the patient UPADACITINIB (RINVOQ) (Oral) dosage was changed to 15 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. In 2021, the patient experienced COVID-19 (COVID-19). On 14-Aug-2021, the patient experienced PAIN (Pain) and SWELLING (Swelling). On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, PAIN (Pain) and SWELLING (Swelling) had not resolved and COVID-19 (COVID-19) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs Not Reported.  The patient was still experiencing pain and swelling on regular basis. He experienced severe arm pain for two days after covid vaccine shot. The patient was contracted to covid-19 in spring 2021.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Primary reporter contact for lot number information was not available.  The reporter's causality for the event(s) of PAIN, SWELLING, CONTRACTED COVID-19 and HAD SEVERE ARM PAIN AFTER COVID VACCINE SHOT was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   Treatment Drugs Not Reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, Psoriasis, Vaccination site pain
Clinical narrative: CONTRACTED COVID 19; Psoriasis flare-up; HUMIRA PEN CAUSED PAIN; SORE ARM with HUMIRA (ADALIMUMAB); This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (CONTRACTED COVID 19), PSORIASIS (Psoriasis flare-up), VACCINATION SITE PAIN (HUMIRA PEN CAUSED PAIN) and PAIN IN EXTREMITY (SORE ARM with HUMIRA (ADALIMUMAB)) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) unknown. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to unknown. On an unknown date, the patient experienced COVID-19 (CONTRACTED COVID 19), PSORIASIS (Psoriasis flare-up), VACCINATION SITE PAIN (HUMIRA PEN CAUSED PAIN) and PAIN IN EXTREMITY (SORE ARM with HUMIRA (ADALIMUMAB)). At the time of the report, COVID-19 (CONTRACTED COVID 19), VACCINATION SITE PAIN (HUMIRA PEN CAUSED PAIN) and PAIN IN EXTREMITY (SORE ARM with HUMIRA (ADALIMUMAB)) had resolved and PSORIASIS (Psoriasis flare-up) outcome was unknown.            No information on concomitant medication were reported. 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 PSORIASIS FLARE UP, HUMIRA PEN CAUSED PAIN, CONTRACTED COVID 19 and SORE ARM was not provided. No treatment details were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Back pain, COVID-19, Feeling abnormal, Immunisation reaction
Clinical narrative: Felt horrible; Reaction to COVID booster was worse than having COVID; Had side effects in hands; Partial Humira dose injection; COVID-19; Anxiety; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt horrible), IMMUNISATION REACTION (Reaction to COVID booster was worse than having COVID), MUSCULOSKELETAL DISORDER (Had side effects in hands), ANXIETY (Anxiety) and BACK PAIN (Back pain) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult Crohn's disease).   On 20-Nov-2020, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. In April 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 01-Jan-2022, the patient experienced COVID-19 (COVID-19). On 27-Feb-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Partial Humira dose injection). In 2022, the patient experienced ANXIETY (Anxiety) and BACK PAIN (Back pain). On an unknown date, the patient experienced FEELING ABNORMAL (Felt horrible), IMMUNISATION REACTION (Reaction to COVID booster was worse than having COVID) and MUSCULOSKELETAL DISORDER (Had side effects in hands). In February 2022, COVID-19 (COVID-19) had resolved. In 2022, ANXIETY (Anxiety) and BACK PAIN (Back pain) had resolved. At the time of the report, FEELING ABNORMAL (Felt horrible), IMMUNISATION REACTION (Reaction to COVID booster was worse than having COVID), MUSCULOSKELETAL DISORDER (Had side effects in hands) and INCORRECT DOSE ADMINISTERED (Partial Humira dose injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2021, SARS-CoV-2 test: (Positive) Positive. On 12-Jan-2022, Tuberculin test: Unknown.         No concomitant medication was reported. No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of had side effects in hands, felt horrible, partial Humira dose injection, anxiety, COVID-19 and back pain was not provided. The reporter's causality for the event of reaction to COVID booster was worse than having COVID with Humira (adalimumab) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Musculoskeletal disorder, SARS-CoV-2 test, Tuberculin test
Clinical narrative: Felt horrible; Reaction to COVID booster was worse than having COVID; Had side effects in hands; Partial Humira dose injection; COVID-19; Anxiety; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt horrible), IMMUNISATION REACTION (Reaction to COVID booster was worse than having COVID), MUSCULOSKELETAL DISORDER (Had side effects in hands), ANXIETY (Anxiety) and BACK PAIN (Back pain) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult Crohn's disease).   On 20-Nov-2020, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. In April 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 01-Jan-2022, the patient experienced COVID-19 (COVID-19). On 27-Feb-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Partial Humira dose injection). In 2022, the patient experienced ANXIETY (Anxiety) and BACK PAIN (Back pain). On an unknown date, the patient experienced FEELING ABNORMAL (Felt horrible), IMMUNISATION REACTION (Reaction to COVID booster was worse than having COVID) and MUSCULOSKELETAL DISORDER (Had side effects in hands). In February 2022, COVID-19 (COVID-19) had resolved. In 2022, ANXIETY (Anxiety) and BACK PAIN (Back pain) had resolved. At the time of the report, FEELING ABNORMAL (Felt horrible), IMMUNISATION REACTION (Reaction to COVID booster was worse than having COVID), MUSCULOSKELETAL DISORDER (Had side effects in hands) and INCORRECT DOSE ADMINISTERED (Partial Humira dose injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2021, SARS-CoV-2 test: (Positive) Positive. On 12-Jan-2022, Tuberculin test: Unknown.         No concomitant medication was reported. No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of had side effects in hands, felt horrible, partial Humira dose injection, anxiety, COVID-19 and back pain was not provided. The reporter's causality for the event of reaction to COVID booster was worse than having COVID with Humira (adalimumab) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 18-Dec-2021, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Malaise, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-2020; Taste loss; Not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-2020), AGEUSIA (Taste loss) and MALAISE (Not feeling well) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-2020), AGEUSIA (Taste loss) and MALAISE (Not feeling well). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-2020) outcome was unknown and AGEUSIA (Taste loss) and MALAISE (Not feeling well) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive for COVID-2020.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medications were not reported.  MODERNA COVID-19 VACCINE (ELASOMERAN) 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 of not feeling well, tested positive for COVID-2020 and taste loss was not provided.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 42.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Arthralgia
Clinical narrative: Very achy /joints are achy/ dull ache; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (Very achy /joints are achy/ dull ache) in a 42-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for Flu vaccination.    Patient does not have allergy to medications, food or other products.    On 22-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 23-Sep-2022 at 7:00 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced ARTHRALGIA (Very achy /joints are achy/ dull ache). At the time of the report, ARTHRALGIA (Very achy /joints are achy/ dull ache) had not resolved.            Concomitant product use was not provider by the reporter.  On 08-MAR-2021, patient received First dose 0.5 mL of Moderna COVID-19 Vaccine with batch number 041L20A. On 05-APR-2021, patient received Second dose 0.5mL of Moderna COVID-19 Vaccine with batch number 041L20A. On 18-NOV-2021, patient received Third dose (First booster) dose of Moderna COVID-19 Vaccine with batch number 034F21A.  Patient's symptoms were reported as stable.  No treatment information was reported.   This case was linked to MOD-2022-650279 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Back injury, Back pain, Body temperature, Chills, Pyrexia
Clinical narrative: Hurt my back/pain in his back; Lifted something that was too heavy and injured his back; Shivering; Fever; Injection site soreness; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (Hurt my back/pain in his back), BACK INJURY (Lifted something that was too heavy and injured his back), VACCINATION SITE PAIN (Injection site soreness), CHILLS (Shivering) and PYREXIA (Fever) 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.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 14-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 14-Sep-2022, the patient experienced VACCINATION SITE PAIN (Injection site soreness). On 21-Sep-2022, the patient experienced BACK PAIN (Hurt my back/pain in his back), BACK INJURY (Lifted something that was too heavy and injured his back), CHILLS (Shivering) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Hurt my back/pain in his back), BACK INJURY (Lifted something that was too heavy and injured his back), VACCINATION SITE PAIN (Injection site soreness), CHILLS (Shivering) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Sep-2022, Body temperature: 100.6.         Patient had received 4 doses of the Moderna COVID-19 vaccine by intramuscular injection, 2 in Mar-2021, 1 in Aug-2021, and the most recent bivalent booster dose on 14-Sep-2022.   Patient took a CDC gummy in the morning after doing that napped that afternoon. Later, woke up from his nap and patient was shivering and had a fever of 100.6. He continued to had pain in his back and a fever. Patient was taking Tylenol for his symptoms. Patient spoke to his HCP who did not seem to have any notion about what caused his symptoms.
Age: 73.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Vaccination site pain
Clinical narrative: Hurt my back/pain in his back; Lifted something that was too heavy and injured his back; Shivering; Fever; Injection site soreness; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (Hurt my back/pain in his back), BACK INJURY (Lifted something that was too heavy and injured his back), VACCINATION SITE PAIN (Injection site soreness), CHILLS (Shivering) and PYREXIA (Fever) 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.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 14-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 14-Sep-2022, the patient experienced VACCINATION SITE PAIN (Injection site soreness). On 21-Sep-2022, the patient experienced BACK PAIN (Hurt my back/pain in his back), BACK INJURY (Lifted something that was too heavy and injured his back), CHILLS (Shivering) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Hurt my back/pain in his back), BACK INJURY (Lifted something that was too heavy and injured his back), VACCINATION SITE PAIN (Injection site soreness), CHILLS (Shivering) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Sep-2022, Body temperature: 100.6.         Patient had received 4 doses of the Moderna COVID-19 vaccine by intramuscular injection, 2 in Mar-2021, 1 in Aug-2021, and the most recent bivalent booster dose on 14-Sep-2022.   Patient took a CDC gummy in the morning after doing that napped that afternoon. Later, woke up from his nap and patient was shivering and had a fever of 100.6. He continued to had pain in his back and a fever. Patient was taking Tylenol for his symptoms. Patient spoke to his HCP who did not seem to have any notion about what caused his symptoms.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No adverse event; Moderna monovalent vaccine was administered 2 days after use by date to 2 patients; Date the vial was initially stored in the refrigerator on 18Aug2022 and Date of administration of vaccine on 19Sep2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered 2 days after use by date to 2 patients), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18Aug2022 and Date of administration of vaccine on 19Sep2022) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 082B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Sep-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered 2 days after use by date to 2 patients) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18Aug2022 and Date of administration of vaccine on 19Sep2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered 2 days after use by date to 2 patients), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18Aug2022 and Date of administration of vaccine on 19Sep2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered 2 days after use by date to 2 patients) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18Aug2022 and Date of administration of vaccine on 19Sep2022).    No concomitant medications were provided. It was reported that the vial size was 5.5mL and it was an individual vial. The vial did not undergo any temperature excursions. No treatment medications were reported.   This case was linked to MODERNATX, INC.-MOD-2022-649978 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-649978:Patient 2
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered 2 days after use by date to 2 patients), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18Aug2022 and date of administration of vaccine on 19Sep2022) and NO ADVERSE EVENT (No adverse event) in a 26-year-old male patient who received mRNA-1273 (batch no. 082B22A) for COVID-19 vaccination.No Medical History information was reported. On 19-Sep-2022, the patient received dose of mRNA-1273  (Intramuscular) 1 dosage form. On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered 2 days after use by date to 2 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18Aug2022 and date of administration of vaccine on 19Sep2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered 2 days after use by date to 2 patients), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18Aug2022 and date of administration of vaccine on 19Sep2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273(Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered 2 days after use by date to 2 patients) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18Aug2022 and date of administration of vaccine on 19Sep2022). No concomitant medications were provided. Vial size was 5.5mL. The vial did not undergo any temperature excursions and the vial was initially stored in refrigerator on 18-Aug-2022. No treatment medications were reported
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: First booster dose gave me a bad reaction; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (First booster dose gave me a bad reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (First booster dose gave me a bad reaction). At the time of the report, IMMUNISATION REACTION (First booster dose gave me a bad reaction) outcome was unknown.            No concomitant medication was reported.  Patient mentioned that she received Moderna's Primary series, first booster and the new Bivalent as a second booster. Batch number of new Bivalent second booster was AS7146B. The patient heard in the internet that some batches of the Moderna New Bivalent were contaminated. She was worried and would like to know if the lot number AS7146B that she received was contaminated or not. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Therapeutic response unexpected
Clinical narrative: since received the Moderna vaccine,asthma has improved; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (since received the Moderna vaccine,asthma has improved) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (since received the Moderna vaccine,asthma has improved) and NO ADVERSE EVENT (No adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (since received the Moderna vaccine,asthma has improved) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications were not reported. No treatment information was provided by the reporter.
Age: 41.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Malaise, Off label use, Product use issue, Pyrexia, Somnolence
Clinical narrative: got both shots at the same time; got both shots at the same time; fever; slept a lot; very sick for 48 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 41-year-old female patient received BNT162b2 (BNT162B2), on 16Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 16Sep2022 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history was not reported. Concomitant medication(s) included: XELJANZ. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset Sep2022, outcome "unknown", described as "fever"; SOMNOLENCE (non-serious) with onset Sep2022, outcome "unknown", described as "slept a lot"; MALAISE (non-serious) with onset Sep2022, outcome "unknown", described as "very sick for 48 hours"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 16Sep2022, outcome "unknown" and all described as "got both shots at the same time". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing). 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 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: tiny pin point of blood in his arm after the administration; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "tiny pin point of blood in his arm after the administration". The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious), outcome "unknown", described as "tiny pin point of blood in his arm after the administration".  Additional information: Caller explained that, for the first four doses, he did not had any problem during the administration. The people administering the vaccine had a good technique and there was only a tiny pin point of blood in his arm after the administration.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201177784 same patient/drug/event, different dose number;
Sex: U
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Fatigue, Nausea, Rash
Clinical narrative: I got a rash; I was allergic to Propylene glycol; nausea; and I would be like fatigued; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Nov2021 as dose 4 (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, SINGLE; Lot number: Unknown), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: Unknown), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: Unknown), for Covid-19 immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "I got a rash"; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "I was allergic to Propylene glycol"; NAUSEA (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "and I would be like fatigued".  Additional information: Patient so far received the Pfizer vaccine and had two boosters. Patient went in on that day to get another booster, it had been a while, the last one patient had in Nov2021. Patient was due so, went in and told them that the patient allergic to Propylene glycol. Patient took propylene glycol in medication not knowing and got a rash, nausea and would be like fatigued. When patient first had the first shot, the first Pfizer shot, patient was fine. patient did not have any kind of symptoms at all and the second one.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Discomfort, Myalgia
Clinical narrative: soreness or muscle pain; I just feel like, I guess it is like chest pain; or pumping in the chest; I am having some kind of discomfort but I don't know is this pain or what; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "soreness or muscle pain"; CHEST PAIN (non-serious), outcome "unknown", described as "I just feel like, I guess it is like chest pain"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "or pumping in the chest"; DISCOMFORT (non-serious), outcome "unknown", described as "I am having some kind of discomfort but I don't know is this pain or what".  Additional information: Consumer stated, I was calling about side effects of the Pfizer vaccine, second booster (Clarified as Pfizer Covid-19 booster vaccine). I was trying to get information. I am asking concerning the, I am trying to see what should be expected, not common. When probed for the side-effects: Consumer stated, I just feel like, I guess it is like chest pain or pumping in the chest. I don't know if it is like soreness or muscle pain or what, I don't know. When paraphrased the concern, Consumer stated, "No, I am asking ma'am. I am having some kind of discomfort but I don't know is this pain or what this is. Is it supposed to be muscle pain or what? I am asking a question." Consumer was informed about the role of Pfizer Drug Safety and also informed that Pfizer Medical Information is the right department to answer the question. Consumer was provided with the number of Pfizer Medical Information as # and was requested to select option 3, timings as 8 AM to 9 PM Monday to Friday as per EST. Further probing could not be done as the consumer hung up the call abruptly. Thus, product details (LOT, NDC, UPC and expiration date) were unknown. Hence limited information was available over the call. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Malaise
Clinical narrative: felt unwell; palpitations; chest pain; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 25-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 25 years for covid-19 immunisation. The patient's relevant medical history was not reported. No previous cardiac anomalies prior. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, The initial series with Pfizer SARS Covid-19 and 2 between Apr2021), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE, The initial series with Pfizer SARS Covid-19 and 2 between Apr2021), for COVID-19 Immunization. The following information was reported: CHEST PAIN (medically significant) with onset Dec2021, outcome "not recovered"; MALAISE (medically significant) with onset Dec2021, outcome "not recovered", described as "felt unwell"; PALPITATIONS (medically significant) with onset Dec2021, outcome "not recovered". The event "palpitations" required physician office visit. The patient underwent the following laboratory tests and procedures: Echocardiogram: unremarkable; Electrocardiogram: unremarkable; Electrocardiogram ambulatory: unremarkable. Therapeutic measures were not taken as a result of malaise, palpitations, chest pain. Clinical course: Seriousness assessment was not life threatening but persistent and bothersome. Significant but not life threatening. The significance is persisting. He considering going to the Emergency Room but he did not feel his symptoms were life threatening.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug 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: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: felt unwell; palpitations; chest pain; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 25-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 25 years for covid-19 immunisation. The patient's relevant medical history was not reported. No previous cardiac anomalies prior. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, The initial series with Pfizer SARS Covid-19 and 2 between Apr2021), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE, The initial series with Pfizer SARS Covid-19 and 2 between Apr2021), for COVID-19 Immunization. The following information was reported: CHEST PAIN (medically significant) with onset Dec2021, outcome "not recovered"; MALAISE (medically significant) with onset Dec2021, outcome "not recovered", described as "felt unwell"; PALPITATIONS (medically significant) with onset Dec2021, outcome "not recovered". The event "palpitations" required physician office visit. The patient underwent the following laboratory tests and procedures: Echocardiogram: unremarkable; Electrocardiogram: unremarkable; Electrocardiogram ambulatory: unremarkable. Therapeutic measures were not taken as a result of malaise, palpitations, chest pain. Clinical course: Seriousness assessment was not life threatening but persistent and bothersome. Significant but not life threatening. The significance is persisting. He considering going to the Emergency Room but he did not feel his symptoms were life threatening.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Had the Pfizer Covid 19 vaccine primary series and booster, and is now taking Paxlovid, for Covid; Had the Pfizer Covid 19 vaccine primary series and booster, and is now taking Paxlovid, for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had the Pfizer Covid 19 vaccine primary series and booster, and is now taking Paxlovid, for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: diagnosed with Covid-19, after being vaccinated. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient reported that she received the Pfizer Covid 19 vaccine primary series and a booster. She was presently taking Paxlovid, and she wanted to know if she could get a Flu vaccine and the Pfizer Bivalent Covid booster and if she can have a glass of wine while she was taking Paxlovid. She also wanted to know how long she should wait after completing her Paxlovid course before she gets a Flu shot, and the Pfizer Bivalent Covid booster vaccine. Patient declined to complete a report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Glomerular filtration rate, SARS-CoV-2 test, Vaccination failure
Clinical narrative: she thought she was going to die; her mind went totally blank; shortness of breath; couldn't move or do anything; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team, Program ID. The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "kidney damage" (unspecified if ongoing), notes: most recent GFR of 52; "Blood pressure high" (ongoing), notes: well controlled. Concomitant medication(s) included: LISINOPRIL taken for hypertension (ongoing). Vaccination history included: BNT162b2 (Dose 1, Lot number: EN5318), administration date: 29Jan2021, when the patient was 75-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Lot number: EL9266), administration date: 22Feb2021, when the patient was 75-year-old, for COVID-19 immunization; BNT162b2 (Dose 3 (Booster), Lot number: 30130BA), administration date: 26Sep2021, when the patient was 76-year-old, for Covid-19 Immunization; BNT162b2 (Dose 4 (Booster), Lot number: FK9896), administration date: 30Mar2022, when the patient was 76-year-old, for Covid-19 Immunization. The following information was reported: MOVEMENT DISORDER (non-serious) with onset Sep2022, outcome "recovering", described as "couldn't move or do anything"; MENTAL IMPAIRMENT (non-serious) with onset Sep2022, outcome "recovering", described as "her mind went totally blank"; DYSPNOEA (non-serious) with onset Sep2022, outcome "recovering", described as "shortness of breath"; NEAR DEATH EXPERIENCE (medically significant) with onset 19Sep2022, outcome "recovering", described as "she thought she was going to die". The patient received her 5th dose, the Bivalent, was just a week ago on 12Sep2022, so they didn't have the 2-3 week time to fully build immunity. Confirmed she tested positive for Covid-19 on 19Sep2022. Patient stated with the Covid-19 her mind went totally blank for 24 hours and she hadn't been eating with the Covid. She mentioned that she had shortness of breath. She coughs while on the phone. She also reported that she had a runny nose. For 24 hours she couldn't move or do anything on Sunday (18sep2022) or Monday (19Sep2022) and on Monday (19Sep2022) she thought she was going to die. She states after 2 doses of Paxlovid, she feels better than she did and she was able to walk her dog 1 mile today. Seriousness Criteria: patient stated being 77 with reactive airway, she would consider it to be Moderate, but certainly not disabling. The patient underwent the following laboratory tests and procedures: Glomerular filtration rate: (unspecified date) 52, notes: most recent; SARS-CoV-2 test: (19Sep2022) Positive.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Glomerular filtration rate, Mental impairment, Movement disorder, Near death experience
Clinical narrative: she thought she was going to die; her mind went totally blank; shortness of breath; couldn't move or do anything; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team, Program ID. The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "kidney damage" (unspecified if ongoing), notes: most recent GFR of 52; "Blood pressure high" (ongoing), notes: well controlled. Concomitant medication(s) included: LISINOPRIL taken for hypertension (ongoing). Vaccination history included: BNT162b2 (Dose 1, Lot number: EN5318), administration date: 29Jan2021, when the patient was 75-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Lot number: EL9266), administration date: 22Feb2021, when the patient was 75-year-old, for COVID-19 immunization; BNT162b2 (Dose 3 (Booster), Lot number: 30130BA), administration date: 26Sep2021, when the patient was 76-year-old, for Covid-19 Immunization; BNT162b2 (Dose 4 (Booster), Lot number: FK9896), administration date: 30Mar2022, when the patient was 76-year-old, for Covid-19 Immunization. The following information was reported: MOVEMENT DISORDER (non-serious) with onset Sep2022, outcome "recovering", described as "couldn't move or do anything"; MENTAL IMPAIRMENT (non-serious) with onset Sep2022, outcome "recovering", described as "her mind went totally blank"; DYSPNOEA (non-serious) with onset Sep2022, outcome "recovering", described as "shortness of breath"; NEAR DEATH EXPERIENCE (medically significant) with onset 19Sep2022, outcome "recovering", described as "she thought she was going to die". The patient received her 5th dose, the Bivalent, was just a week ago on 12Sep2022, so they didn't have the 2-3 week time to fully build immunity. Confirmed she tested positive for Covid-19 on 19Sep2022. Patient stated with the Covid-19 her mind went totally blank for 24 hours and she hadn't been eating with the Covid. She mentioned that she had shortness of breath. She coughs while on the phone. She also reported that she had a runny nose. For 24 hours she couldn't move or do anything on Sunday (18sep2022) or Monday (19Sep2022) and on Monday (19Sep2022) she thought she was going to die. She states after 2 doses of Paxlovid, she feels better than she did and she was able to walk her dog 1 mile today. Seriousness Criteria: patient stated being 77 with reactive airway, she would consider it to be Moderate, but certainly not disabling. The patient underwent the following laboratory tests and procedures: Glomerular filtration rate: (unspecified date) 52, notes: most recent; SARS-CoV-2 test: (19Sep2022) Positive.