chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast pain, COVID-19, Inflammation, SARS-CoV-2 test
Clinical narrative: Pain in  My left breast; got covid; inflammation flared up again/inflammation has come back and it was on the top of my Left rib cage; This spontaneous case was reported by a patient and describes the occurrence of INFLAMMATION (inflammation flared up again/inflammation has come back and it was on the top of my Left rib cage), BREAST PAIN (Pain in  My left breast) and COVID-19 (got covid) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067h21a, 030m20a and 039k20a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic (she just had diabetic but she was perfectly healthy), Dust allergy and Allergy to animal (Cats allergy). Concomitant products included APIXABAN (ELIQUIS), DILTIAZEM and METFORMIN for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced INFLAMMATION (inflammation flared up again/inflammation has come back and it was on the top of my Left rib cage). On 24-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (got covid). On an unknown date, the patient experienced BREAST PAIN (Pain in  My left breast). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INFLAMMATION (inflammation flared up again/inflammation has come back and it was on the top of my Left rib cage) and BREAST PAIN (Pain in  My left breast) had not resolved and COVID-19 (got covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jul-2022, SARS-CoV-2 test: Positive.         On 24-Jul-2022, patient got COVID and shortly after the inflammation flared up again. She also had pain in her left breast, and she had been to the gynecologist. The Endocrinologist, her family doctor agreed that it was muscular, and it seems that the inflammation had come back. It was on the top of her left rib cage; they all agreed that it was muscular. She had gynecologist, endocrinologists, rheumatologist, immunologist and primary physician visits for events. Patient further stated that, events were ongoing, and it was terrible painful in her left breast and under her left breast where the ends, the other doctors ruled out any other causes.  The patient stated that, the symptoms were improved for a short time and now they were worse.  Patient had not experience similar events in the past.   This case was linked to MOD-2022-676036 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Alopecia, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (significant hair loss) and VACCINATION SITE PAIN (soreness in the site of injection) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu shot (Flu shot 1 month before bivalent booster.) in September 2022. Past adverse reactions to the above products included No adverse event with flu shot. Concurrent medical conditions included Drug allergy (Codeine) and Drug allergy (Vicodin).       No concomitant medication was reported.    Reportedly, patients doctor did not recommend any treatment and told her it would be solved within a few months. Patient wanted someone to call her back to follow up on her case and tell if this would stop.  Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (first dose of Moderna Monovalent today but received the Moderna Bivalent instead) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and 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.    ADMINISTERED (first dose of Moderna Monovalent today but received the Moderna Bivalent instead).    No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2022: Live Follow-up  No New Information accepted
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: every time she got the Moderna vaccine, she got a cough for 7 months; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (every time she got the Moderna vaccine, she got a cough for 7 months) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Specific product reported as: No, product was inferred.  .     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (every time she got the Moderna vaccine, she got a cough for 7 months). At the time of the report, COUGH (every time she got the Moderna vaccine, she got a cough for 7 months) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction, incontrollable coughing and could not catch her breath; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction, incontrollable coughing and could not catch her breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction, incontrollable coughing and could not catch her breath) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reaction, incontrollable coughing and could not catch her breath) outcome was unknown.            No concomitant medications were reported. It was reported that patient experienced anaphylactic reaction within 20 minutes after the vaccination. The patient was sent to the hospital by ambulance from the clinic. On 07-Nov-2022, the patient started treatment, but no medications were reported.  Company comment: This spontaneous case concerns a unspecified age old female patient, with no medical history, who experienced expected serious (medical significant) event of anaphylactic shock, which occurred on same day within 20 minutes of booster dose of mRNA-1273 vaccine. After vaccination Patient experienced incontrollable coughing, could not catch her breath, Patient sent to the hospital by ambulance from clinic. No further information on risk factors, investigations, treatment given was available in the report. At the time of reporting outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a unspecified age female patient, with no medical history, who experienced expected serious (medical significant) event of anaphylactic shock, which occurred on same day within 20 minutes of booster dose of mRNA-1273 vaccine. After vaccination Patient experienced incontrollable coughing, could not catch her breath, Patient sent to the hospital by ambulance from clinic. No further information on risk factors, investigations, treatment given was available in the report. At the time of reporting outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-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 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). O     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 POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No concomitant medications were reported. It was reported a temperature excursion that occurred several days ago in the Freezer. It was found that vaccines were viable. The patient received the booster dose. No treatment medications were reported.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 58-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    ] No concomitant medications were reported. It was reported a temperature excursion that occurred several days ago in the Freezer. It was found that vaccines were viable. The patient received the booster dose. No treatment medications were reported.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine; No adverse event; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and NO ADVERSE EVENT (No adverse event) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-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 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) 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 POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine).    Concomitant medications details were not reported by the reporter.  Reportedly, Pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. the excursion was found out in an audit and all the vaccines were viable.  Treatment details were not reported by the reporter.
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Body temperature, Chest discomfort, Dyspnoea, Feeling abnormal, Heart rate
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (felt uncomfortable), MALAISE (felt not well), HEART RATE INCREASED (heart rate is fast (95 to almost 100, his usual is in the 80s, it is on and off)), CHEST DISCOMFORT (chest discomfort) and PALPITATIONS (palpitations) in a 43-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. The occurrence of additional non-serious events is detailed below.                No relevant concomitant medications were reported.   Patient had the bivalent Moderna booster dose, 21-Nov-2022 at around 6:00pm and 2 hours after that, they felt uncomfortable and not well. 22-Nov-2022, he has a fever (37.5C) and his heart rate is fast (95 to almost 100, his usual is in the 80s, it is on and off). He checks his O2 sats and it has been 96-98. He states that it was not that bad.  Adverse event caused patient to seek medical care.  The patient did not experienced a similar event in the past.  No treatment information was provided.
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Heart rate increased, Malaise, Oxygen saturation, Palpitations, Pyrexia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (felt uncomfortable), MALAISE (felt not well), HEART RATE INCREASED (heart rate is fast (95 to almost 100, his usual is in the 80s, it is on and off)), CHEST DISCOMFORT (chest discomfort) and PALPITATIONS (palpitations) in a 43-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. The occurrence of additional non-serious events is detailed below.                No relevant concomitant medications were reported.   Patient had the bivalent Moderna booster dose, 21-Nov-2022 at around 6:00pm and 2 hours after that, they felt uncomfortable and not well. 22-Nov-2022, he has a fever (37.5C) and his heart rate is fast (95 to almost 100, his usual is in the 80s, it is on and off). He checks his O2 sats and it has been 96-98. He states that it was not that bad.  Adverse event caused patient to seek medical care.  The patient did not experienced a similar event in the past.  No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: doses administered after excursion; No adverse event; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.         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 POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No concomitant medications were reported.  The pharmacist reported that, temperature excursion occurred several days ago in the freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer, and they just found out about the excursion in an audit.   No adverse event reported for the patient.  No treatment medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines which underwent a temperature excursion in the freezer were viable) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.     Reporter reported that a temperature excursion that occurred several days ago in the Freezer. The excursion was found out in an audit and all the vaccines were viable.  No treatment medications were provided.
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Hyperkeratosis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERKERATOSIS (Feet soles were hardened) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 4782588) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.            No concomitant medication was reported. No treatment information was provided. It was unknown if patient was enrolled in COVID-19 vaccine trial.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Gout, Hypersensitivity, Interchange of vaccine products
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Gout), HYPERSENSITIVITY (Allergy), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 63-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.        Concurrent medical conditions included Hypothyroidism, Kidney stones, Testosterone low, Enlarged prostate, Sleep apnea and Allergy (Patient had muscle weakness when treated with statins).   In 2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 03-May-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). In 2022, the patient experienced GOUT (Gout) and HYPERSENSITIVITY (Allergy). At the time of the report, GOUT (Gout), HYPERSENSITIVITY (Allergy), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.             The reporter's causality for the co-suspect for event Gout, Re-vaccination with different COVID-19 Vaccine and allergy was possible.  No concomitant medication reported. No treatment medication reported.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.), POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.        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 (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.).    Concomitant medications were not reported.   Temperature excursion occurred several days ago in the Freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer. Patient did not report any adverse reaction. The patient received the booster dose. The excursion was noticed in audit.   Treatment medications were not reported.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable store) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.          F   No concomitant medications were reported.  The pharmacist reported that, temperature excursion occurred several days ago in the freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer, and they just found out about the excursion in an audit.   No adverse event reported for the patient.  No treatment medications were reported.
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines which underwent a temperature excursion in the freezer were viable) and NO ADVERSE EVENT (No adverse event) in a 37-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.     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 POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines which underwent a temperature excursion in the freezer were viable).    No concomitant medications were provided.  Temperature excursion occurred several days ago in the Freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer. Patient did not report any adverse reaction. The patient received the booster dose.  No treatment medications were provided.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received vaccine that underwent a temperature excursion in the freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (Received vaccine that underwent a temperature excursion in the freezer) and NO ADVERSE EVENT (No adverse event) in a 53-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.          No Concomitant medications were provided.  Reporter reported that a temperature excursion that occurred several days ago in the Freezer.   Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.   Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.  Patient did not reported any adverse event.  No treatment medications were provided.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines which underwent a temperature excursion in the freezer), POOR QUALITY PRODUCT ADMINISTERED (patients received vaccine that underwent a temperature excursion in the Freezer) and NO ADVERSE EVENT (No adverse event) in a 39-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.       Concomitant medications were not reported.   Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer. Just found out about the excursion today in an audit and No adverse event reported.  Treatment medications were not reported.
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 34-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.     The pharmacist reported that, temperature excursion occurred several days ago in the freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the freezer, and they just found out about the excursion in an audit. No adverse event reported for the patient.   No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-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 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.          No adverse event reported for the patient.  No treatment medications were reported.
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) and ARTHRALGIA (Joint pains) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 immunisation.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 Vaccine (The same as the reactions he had with Pfizer COVID-19 Vaccine.) and Pfizer COVID-19 Vaccine (The same as the reactions he had with Pfizer COVID-19 Vaccine.). Past adverse reactions to the above products included Joint pain with Pfizer COVID-19 Vaccine; and Sickness with Pfizer COVID-19 Vaccine.    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 ILLNESS (Sickness) and ARTHRALGIA (Joint pains). At the time of the report, ILLNESS (Sickness) outcome was unknown and ARTHRALGIA (Joint pains) had not resolved.            No concomitant medication was provided.  Patient had experienced joint pains, sickness and it reportedly lasted for a long time.  At the time of report, the patient still had those joint pains.  Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines which underwent a temperature excursion in the freezer were viable) and NO ADVERSE EVENT (No adverse event) in a 39-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.         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 POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines which underwent a temperature excursion in the freezer were viable).    No concomitant medications were provided.  Reporter reported that a temperature excursion that occurred several days ago in the Freezer. The excursion was found out in an audit and all the vaccines were viable.  No treatment medications were provided.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received vaccine that underwent a temperature excursion in the freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (Received vaccine that underwent a temperature excursion in the freezer) and NO ADVERSE EVENT (No adverse event) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.     No Concomitant medications were provided. Reporter reported that a temperature excursion that occurred several days ago in the Freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.   Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question. Patient did not reported any adverse event. No treatment medications were provided.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question), POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.         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 (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) and POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question).    Concomitant medications details was not reported.  Reportedly, the pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. The patient received vaccine from a vial that underwent a temperature excursion in the freezer.  The patient received the booster dose.  All the vaccines were found to be viable.  Treatment details was not reported.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    excursion).    No Concomitant medications were provided. Reporter reported that a temperature excursion that occurred several days ago in the Freezer.  Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.  Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question. Patient did not report any adverse event.  No treatment medications were provided.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) and NO ADVERSE EVENT (No adverse event) in a 39-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.     Concomitant medications details was not reported.  Reportedly, the pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. The patient received vaccine from a vial that underwent a temperature excursion in the freezer.  The patient received the booster dose.  All the vaccines were found to be viable.  Treatment details was not reported.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines which underwent a temperature excursion in the freezer were viable) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines which underwent a temperature excursion in the freezer were viable) 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 POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines which underwent a temperature excursion in the freezer were viable).    No concomitant medications were provided.  Reporter reported that a temperature excursion that occurred several days ago in the Freezer. The excursion was found out in an audit and all the vaccines were viable.  No treatment medications were provided.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received vaccine that underwent a temperature excursion in the freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (Received vaccine that underwent a temperature excursion in the freezer) and NO ADVERSE EVENT (No adverse event) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.       No Concomitant medications were provided.  Reporter reported that a temperature excursion that occurred several days ago in the Freezer.   Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.   Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.  Patient did not reported any adverse event.  No treatment medications were provided.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients received vaccine that underwent a temperature excursion in the Freezer), POOR QUALITY PRODUCT ADMINISTERED (patients received vaccine that underwent a temperature excursion in the Freezer) and NO ADVERSE EVENT (No adverse event) in a 41-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.     Concomitant medications were not reported.  Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer. No adverse event reported. Treatment medications were not reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (patient had a definitive reaction to that type of vaccine), HYPOAESTHESIA ORAL (Numbness and tingling of her lips and tongue) and PARAESTHESIA ORAL (Numbness and tingling of her lips and tongue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.           The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: vial underwent a temperature excursion; No adverse event; patient received vaccine from vial that underwent a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 50-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-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 18-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent a temperature excursion) 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 POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent a temperature excursion).    Concomitant product use was not provided by the reporter.  The pharmacist reported that, temperature excursion occurred several days ago in the freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the freezer, and they just found out about the excursion in an audit. No adverse event reported for the patient.   Treatment information was not provided.
Age: 38.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 38-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.     No adverse event reported for the patient.  No treatment medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: doses administered after excursion; No adverse event; Patient administered doses of the vaccine after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-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 24-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) 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 POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No Concomitant medications were provided. Reporter reported that a temperature excursion that occurred several days ago in the Freezer.  Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.  Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question. Patient did not report any adverse event.  No treatment medications were provided.