chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Heart rate
Clinical narrative: Afib; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (Afib) in a female 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 prophylaxis.     No Medical History information was reported.    On 15-Jun-2023, 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 ATRIAL FIBRILLATION (Afib) (seriousness criteria hospitalization and medically significant). The patient was treated with METOPROLOL at an unspecified dose and frequency and DOFETILIDE (TIKOSYN) at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (Afib) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2023, Heart rate: 138, 153 and 150.         Concomitant medication was not reported.  After booster shot, patient was sick for four days. Patient got call from cardiologist, where her pacemaker monitored and was told that patient had Afib for four days straight. Since then, patient had been hospitalized a couple of times for the high pulse rate, chest pains and irregular heartbeat. Last hospitalization was 01-Aug-2023 to 04-Aug-2023. Patient was taken off Metoprolol and was given Tikosyn instead. For a little while after patient returned home her numbers were getting better. Prior getting COVID booster, patient had normal heart rate in the 60's, 70's and 80's.    Company Comment: This is a spontaneous case concerning a female patient of an unknown age with no reported medical history, who experienced the serious (due to medically significant and Hospitalization) unexpected AESI of Atrial fibrillation. The event occurred on an unknown date after a dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5). Clinical course and supportive diagnostic procedures were not provided. The patient was treated with metoprolol and dofetilide, at an unspecified dose and frequency. The outcome of the event was reported as recovering. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) is not affected by this report.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: less dosage of the Moderna Bivalent Vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (less dosage of the Moderna Bivalent Vaccine) 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.    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 UNDERDOSE (less dosage of the Moderna Bivalent Vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (less dosage of the Moderna Bivalent 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 assessment was provided for UNDERDOSE (less dosage of the Moderna Bivalent Vaccine).    No concomitant drug information was provided.  Reporter confirmed that it was not related to any on-going clinical trial. No treatment drug information was provided.
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Rippling muscle disease
Clinical narrative: Rippling effect down her neck; Pain in her upper shoulder; This spontaneous case was reported by a consumer and describes the occurrence of RIPPLING MUSCLE DISEASE (Rippling effect down her neck) and ARTHRALGIA (Pain in her upper shoulder) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Flu shot . Past adverse reactions to the above products included No adverse event with Flu shot .    On 14-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RIPPLING MUSCLE DISEASE (Rippling effect down her neck) and ARTHRALGIA (Pain in her upper shoulder). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RIPPLING MUSCLE DISEASE (Rippling effect down her neck) and ARTHRALGIA (Pain in her upper shoulder) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient had received 5 doses of the Moderna COVID-19 vaccines on: Dose 1: 20JAN2021, lot number 012120A Dose 2: 17FEB2021, lot number 016M20A Dose 3: 1NOV2021, lot number 939904 Dose 4: 12MAY2022, lot number 004M211A. Following the first dose of the vaccine she noticed a rippling effect down her neck and onto her shoulder without pain. That did not occur with doses 2-4 however it had returned following dose 5.  That rippling effect was now associated with pain in her upper shoulder which had continued since April. Initially she had been taking Aleve and Tylenol for her symptoms which seemed to not help. She stopped using these medications and was instead using ice 2 times daily on her shoulder to help with the pain. Currently she takes some Aleve before she goes to sleep to help with the pain. She spoke with her HCP who seemed unfazed by her symtpoms. Because that had persisted so long, they agreed to schedule an MRI for October.   This case was linked to US-MODERNATX, INC.-MOD-2023-737042 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737042:Same patient (Dose 5)
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dermatitis
Clinical narrative: HCP confirms that a patient in their 60s who previously received the Moderna vaccine has a new diagnosis of Acute and Chronic Inflammatory Dermatitis; This spontaneous case was reported by a pharmacist and describes the occurrence of DERMATITIS (HCP confirms that a patient in their 60s who previously received the Moderna vaccine has a new diagnosis of Acute and Chronic Inflammatory Dermatitis) in a 7-decade-old female 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 DUPILUMAB (DUPIXENT) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (unknown route) at an unspecified dose. In November 2022, the patient experienced DERMATITIS (HCP confirms that a patient in their 60s who previously received the Moderna vaccine has a new diagnosis of Acute and Chronic Inflammatory Dermatitis). At the time of the report, DERMATITIS (HCP confirms that a patient in their 60s who previously received the Moderna vaccine has a new diagnosis of Acute and Chronic Inflammatory Dermatitis) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. HCP confirmed that a patient in their 60s who previously received the Moderna vaccine has a new diagnosis of Acute and Chronic Inflammatory Dermatitis, diagnosed November 2022. HCP informed that treatment has not commenced, however, the patient's prior treatments included antihistamines topical and over the counter. HCP explained that the patient will require additional vaccines as well as other vaccines afterwards because this treatment can effect their immune system. HCP did not have previous vaccine product information.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 during 2 hours and 50 minutes; 11 doses were administered after the excursion happened; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 during 2 hours and 50 minutes), POOR QUALITY PRODUCT ADMINISTERED (11 doses were administered after the excursion happened) and NO ADVERSE EVENT (No adverse event) in an 80-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     Relevant medical history/conditions, allergy, concomitant diseases and risk factor were unknown.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 during 2 hours and 50 minutes), POOR QUALITY PRODUCT ADMINISTERED (11 doses were administered after the excursion happened) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 during 2 hours and 50 minutes), POOR QUALITY PRODUCT ADMINISTERED (11 doses were administered after the excursion happened) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 during 2 hours and 50 minutes) and POOR QUALITY PRODUCT ADMINISTERED (11 doses were administered after the excursion happened).    Concomitant medication not reported.   It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Maximum temperature reached was 21.4°F. This was the first and only excursion.  This patient did not experience any adverse events.  This case contains information for 5th patient out of 11 patients.  Treatment medication not reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine was administered post expiration date 13-JUL-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     Patient did not describe any medical history or conditions. It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 21-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022).    No concomitant medication was reported.  The expiration date was reported as 13-JUL-2022. Caller wanted to know what the stability of the vaccine after 13-Jun-2022. No treatment information was reported.  This case contains information for patient 1 out of 4.   This case was linked to US-MODERNATX, INC.-MOD-2023-737011, US-MODERNATX, INC.-MOD-2023-737012, US-MODERNATX, INC.-MOD-2023-737013 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737011:Patient 2 US-MODERNATX, INC.-MOD-2023-737012:Patient 3 US-MODERNATX, INC.-MOD-2023-737013:Patient 4
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Rippling muscle disease
Clinical narrative: Rippling effect down her neck; Pain in her upper shoulder; This spontaneous case was reported by a patient and describes the occurrence of RIPPLING MUSCLE DISEASE (Rippling effect down her neck) and ARTHRALGIA (Pain in her upper shoulder) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012120A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RIPPLING MUSCLE DISEASE (Rippling effect down her neck) and ARTHRALGIA (Pain in her upper shoulder). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RIPPLING MUSCLE DISEASE (Rippling effect down her neck) and ARTHRALGIA (Pain in her upper shoulder) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. The patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient had received 5 doses of the Moderna COVID-19 vaccines on: Dose 2: 17-FEB-2021, lot number 016M20A Dose 3: 1-NOV-2021, lot number 939904 Dose 4: 12-MAY-2022, lot number 004M211A. Dose 5: 14-NOV-2022, lot number 060F22A Following the first dose of the vaccine patient noticed a rippling effect down to neck and onto the shoulder without pain. That did not occur with doses 2-4 however it had returned following dose 5.  That rippling effect was now associated with pain for patient in upper shoulder which had continued since April. Initially patient took treatment medication such as Aleve and Tylenol for the symptoms which seemed to not be helped. Patient stopped treatment medications and started using the ice pack two times daily on shoulder to help with the pain. Currently patient took Aleve treatment drug before patient goes to sleep to help with the pain. Patient consulted with HCP and HCP seemed unfazed by patient symptoms. Because that had persisted so long, they agreed to schedule an MRI for October.   This case was linked to US-MODERNATX, INC.-MOD-2023-738080 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738080:Same patient (Dose 5)
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine was administered post expiration date 13-JUL-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     Patient did not describe any medical history or conditions.     On 21-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered post expiration date 13-JUL-2022).    No concomitant medication was reported.   The expiration date was reported as 13-JUL-2022. Caller wanted to know what the stability of the vaccine after 13-Jun-2022.  No treatment information was reported.  This case contains information for patient 4 out of 4.   This case was linked to US-MODERNATX, INC.-MOD-2023-737010 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737010:
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Post-acute COVID-19 syndrome
Clinical narrative: covid 19; long covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) and POST-ACUTE COVID-19 SYNDROME (long covid) in a 42-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.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19) and POST-ACUTE COVID-19 SYNDROME (long covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (covid 19) and POST-ACUTE COVID-19 SYNDROME (long covid) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient had received the updated bivalent vaccine recently, but still got COVID. Reporter is not sure of the type of COVID-19 vaccine patient has received in the past, but she says it could have been Moderna. Reporter does not have the vaccination records of the patient.   The patient was given Paxlovid for her symptoms as well, and it helped her with her symptoms.   This case was linked to US-MODERNATX, INC.-MOD-2023-737195 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Aug-2023: Live follow-up information received included Patient details and updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737195:Second Son Case
Age: 38.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Breakthrough COVID after being vaccinated with Moderna COVID-19 bivalent vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Breakthrough COVID after being vaccinated with Moderna COVID-19 bivalent vaccine) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Breakthrough COVID after being vaccinated with Moderna COVID-19 bivalent vaccine). The patient was treated with SALBUTAMOL (ALBUTEROL HFA) at an unspecified dose and frequency; PREDNISONE for COVID-19, at an unspecified dose and frequency and NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Breakthrough COVID after being vaccinated with Moderna COVID-19 bivalent vaccine) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  Patient recently got COVID. Patient received the updated bivalent vaccine recently, but still got COVID. Reporter was not sure of the type of COVID-19 vaccine patient have received in the past, but reporter says it could have been Moderna. Reporter does not have the vaccination records for any of the patients.  Patient had to be put on Paxlovid for his symptoms but that helped him a lot. He was still on albuterol, cough medicine, and prednisone for his symptoms. Patient was getting better.   This case was linked to MOD-2023-737195 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Aug-2023: Live follow-up received: Patient details, treatment drug and narrative was updated.; Sender's Comments:  MOD-2023-737195:First son case
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: covid 19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (covid 19) 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. 049D22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, Lot 029L20A) on 18-Feb-2021, Moderna COVID-19 Vaccine (Dose 2, Lot 046A21A) on 18-Mar-2021, Moderna COVID-19 Vaccine (Dose 3, Lot 027H21B) on 18-Nov-2021, Moderna COVID-19 Vaccine (Dose 4 and Lot 049L21A) on 02-May-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 12-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (covid 19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (covid 19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Aug-2023, Body temperature: 100.7. On 15-Aug-2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. It was reported that patient did not seek medical attention but would do so if her symptoms worsen.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Breast swelling, Lymphadenopathy, Pyrexia
Clinical narrative: Had light temperature both times; Swelling on the right breast bellow the arm; Swelling was on glands in the left side on the neck; This spontaneous case was reported by a patient and describes the occurrence of BREAST SWELLING (Swelling on the right breast bellow the arm), LYMPHADENOPATHY (Swelling was on glands in the left side on the neck) and PYREXIA (Had light temperature both times) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ONJ2OA or O11J2OA) for COVID-19 prophylaxis.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced BREAST SWELLING (Swelling on the right breast bellow the arm) and LYMPHADENOPATHY (Swelling was on glands in the left side on the neck). On an unknown date, the patient experienced PYREXIA (Had light temperature both times). At the time of the report, BREAST SWELLING (Swelling on the right breast bellow the arm) and LYMPHADENOPATHY (Swelling was on glands in the left side on the neck) had resolved and PYREXIA (Had light temperature both times) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: Had light temperature both times.         Concomitant product use was not provided by the reporter.  Patient received first dose on the left side of the arm and second dose on the right side.  It was reported that patient had swelling in the glands from the vaccine. After the first dose swelling was on glands in the left side on the neck and on the right breast and below on the arm. Occurred after few hours after she came home. After the second dose patient got swelling again but was not as bad as the first dose.  Patient had light temperature both times.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-738115 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738115:Same patient (Booster dose)
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Skin burning sensation
Clinical narrative: painful/daily pain; skin burning every day and every night for the last two years/skin burning is mostly in the leg, arms and sometimes face.; my left arm was numb/my left leg was numb; This spontaneous case was reported by a patient and describes the occurrence of PAIN (painful/daily pain), SKIN BURNING SENSATION (skin burning every day and every night for the last two years/skin burning is mostly in the leg, arms and sometimes face.) and HYPOAESTHESIA (my left arm was numb/my left leg was numb) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 prophylaxis.     The patient's past medical history included Poison ivy rash.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced HYPOAESTHESIA (my left arm was numb/my left leg was numb). On an unknown date, the patient experienced PAIN (painful/daily pain) and SKIN BURNING SENSATION (skin burning every day and every night for the last two years/skin burning is mostly in the leg, arms and sometimes face.). At the time of the report, PAIN (painful/daily pain) and SKIN BURNING SENSATION (skin burning every day and every night for the last two years/skin burning is mostly in the leg, arms and sometimes face.) had not resolved and HYPOAESTHESIA (my left arm was numb/my left leg was numb) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient did not have receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. The patient stated that she has sought medical attention, the doctor told her that they have seen reactions, but it resolved itself within a week. The doctor also told her that they have never seen a reaction that lasted this long. She went on to state that doctors do not have answers and after 2 years it was not going away. The patient mentioned that the doctor mentioned that dermatologist said that she had a severe reaction and provided a letter where she did not have to take any other vaccines. Patient went on to say that she's only had one dose and was asked to wait more than 4 weeks, but because it continued, she was advised against it. Patient stated that she was supposed to travel outside the country but was not able to and that reaction has affected her life. She hasn't been able to leave the house for 3 yrs.  Patient said that she used topical creams which made it made it worse, coconut oil, solutions, and prescriptions, which felt like Fire on the skin. Patient stated she tried Acupuncture, and it didn't do anything.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis, Nervousness
Clinical narrative: lou gehrig's disease; Nervous; This spontaneous case was reported by a patient family member or friend and describes the occurrence of AMYOTROPHIC LATERAL SCLEROSIS (lou gehrig's disease) in a 61-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced AMYOTROPHIC LATERAL SCLEROSIS (lou gehrig's disease) (seriousness criterion medically significant) and NERVOUSNESS (Nervous). At the time of the report, AMYOTROPHIC LATERAL SCLEROSIS (lou gehrig's disease) and NERVOUSNESS (Nervous) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Caller stated the vaccine attacked on the patient's Central Nervous System. No treatment information was reported. Company comment This spontaneous case concerns a 61-year-old male with no reported medical history who experienced the unexpected, serious (medically significant) event of Amyotrophic lateral sclerosis which occurred after receiving mRNA-1273 vaccination. Latency cannot be calculated since the exact event onset date and vaccination date are unknown. Patient age and gender can be considered as risk factors. Additionally, the patient experienced non-serious event of nervousness. It was reported that the vaccine has attacked patient's central nervous system however further details on the clinical course, risk factors, etiologic and diagnostic work up, concurrent diseases, concomitant medications and event treatment were not provided. Outcome of event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-737839, US-MODERNATX, INC.-MOD-2023-737864, US-MODERNATX, INC.-MOD-2023-737856 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737839:For Bother case (Same Reporter) US-MODERNATX, INC.-MOD-2023-737864:2nd sister case US-MODERNATX, INC.-MOD-2023-737856:1st sister
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: My husband has hereditary hearing loss and tinnitus, the ringing in the ears, and with each new vaccine the tinnitus gets a little bit louder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6206) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hearing loss" (ongoing), notes: has for about 20 years; "tinnitus/ringing in the ears" (ongoing); "hearing aide" (ongoing), notes: wears hearing aides and has for about 20 years. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "My husband has hereditary hearing loss and tinnitus, the ringing in the ears, and with each new vaccine the tinnitus gets a little bit louder". Therapeutic measures were not taken as a result of tinnitus. Additional information: The reporter is calling about her husband and the Pfizer vaccine. Before they had the original two vaccines and two boosters. Her husband has hereditary hearing loss and tinnitus, the ringing in the ears, and with each new vaccine the tinnitus gets a little bit louder, and it does not come back down, it stays in an elevated level, it has happened every time. The reporter asked, "How should we approach this, do we continue taking the vaccine, and make the tinnitus even louder?". She wants to know what is in the vaccine that is causing her husband to have tinnitus, which becomes louder every time he receives the shot. They decided to choose Pfizer over other COVID-19 vaccines despite the reports about the safety. No treatment for tinnitus that know of. No prior vaccinations (within 4 weeks).
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: she has cancer and undergoing treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for Covid-19 Immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "not recovered", described as "she has cancer and undergoing treatment". Therapeutic measures were taken as a result of neoplasm malignant.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid; Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 79 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EL9264), on 27Feb2021 as dose 2, single (Lot number: EN6203) and on 10Oct2021 as dose 3 (booster), single (Lot number: FF2587) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Aug2023, outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Aug2023) Positive, notes: She tested positive for Covid on Sunday. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: She tested positive for Covid on Sunday and knowing she brought it up, aware of things, said she is 80 and should she take Paxlovid.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Every time she got the vaccine, tinnitus was a little louder; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID:.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (primary immunization series complete; manufacturer unknown), for COVID-19 immunisation, reaction: "Tinnitus aggravated". The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Every time she got the vaccine, tinnitus was a little louder". Additional information: The reporter spoke with a lady (patient) in the church that has the same problem as her husband, and that every time she got the vaccine, tinnitus got a little louder. The reporter thinks it was the COVID vaccine by Pfizer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa. The patient's concomitant medications were not reported. Past drug history included: Zantac, reaction(s): "known allergies: zantac", notes: known allergies: zantac.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: patient received COVID 19 Treatment: brand: Paxlovid from 06Aug2023 to 10Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Body surface area, Body temperature, COVID-19, Investigation
Clinical narrative: SARS coronavirus Apr2022; SARS coronavirus Apr2022; This is a spontaneous report received from contactable reporter(s) (Nurse and Physician).  A 68-year-old female patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), on 19Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing), notes: History of osteoporosis; "Colitis" (unspecified if ongoing), notes: H/O Colitis; "Diverticulitis" (unspecified if ongoing), notes: H/O Diverticulitis; "Depression" (unspecified if ongoing), notes: H/O Depression; "Anxiety" (unspecified if ongoing); "Anxiety disorder" (unspecified if ongoing); "cholecystectomy", start date: 2000 (unspecified if ongoing), notes: History of cholecystectomy: 2000; "Actinic keratosis" (unspecified if ongoing); "Former smoker", start date: 01Jan1978, stop date: 01Jan2016, notes: Smoking statue-Former smoker , Packs per day: 1 , Years smoking: 38; "sleep" (unspecified if ongoing), notes: Indication: sleep. Concomitant medication(s) included: ALENDRONATE oral taken for osteoporosis; DULOXETINE oral taken for depression, anxiety; LORAZEPAM oral taken for anxiety; MIRTAZAPINE oral taken for sleep disorder. Past drug history included: Codeine, reaction(s): "Allergies: codeine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "SARS coronavirus Apr2022". The patient underwent the following laboratory tests and procedures: Body mass index: 23.8; Body surface area: 1.6; Body temperature: 97.3 Fahrenheit; Screening: Negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information.,Linked Report(s) : US-PFIZER INC-202300253915 Same patient, different vaccine dose and different event;
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: SARS coronavirus Apr2022; SARS coronavirus Apr2022; This is a spontaneous report received from contactable reporter(s) (Nurse and Physician).  A 68-year-old female patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), on 19Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing), notes: History of osteoporosis; "Colitis" (unspecified if ongoing), notes: H/O Colitis; "Diverticulitis" (unspecified if ongoing), notes: H/O Diverticulitis; "Depression" (unspecified if ongoing), notes: H/O Depression; "Anxiety" (unspecified if ongoing); "Anxiety disorder" (unspecified if ongoing); "cholecystectomy", start date: 2000 (unspecified if ongoing), notes: History of cholecystectomy: 2000; "Actinic keratosis" (unspecified if ongoing); "Former smoker", start date: 01Jan1978, stop date: 01Jan2016, notes: Smoking statue-Former smoker , Packs per day: 1 , Years smoking: 38; "sleep" (unspecified if ongoing), notes: Indication: sleep. Concomitant medication(s) included: ALENDRONATE oral taken for osteoporosis; DULOXETINE oral taken for depression, anxiety; LORAZEPAM oral taken for anxiety; MIRTAZAPINE oral taken for sleep disorder. Past drug history included: Codeine, reaction(s): "Allergies: codeine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "SARS coronavirus Apr2022". The patient underwent the following laboratory tests and procedures: Body mass index: 23.8; Body surface area: 1.6; Body temperature: 97.3 Fahrenheit; Screening: Negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information.,Linked Report(s) : US-PFIZER INC-202300253915 Same patient, different vaccine dose and different event;
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Interchange of vaccine products, Oropharyngeal pain, Rhinorrhoea, Sneezing
Clinical narrative: She said it's the first time she has taken the Pfizer vaccine and she took Moderna vaccines prior; on Tuesday she started sneezing; She is currently experiencing sore throat/harsh throat; dry cough; runny nose; 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 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Aug2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine, for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset Aug2023, outcome "unknown", described as "She is currently experiencing sore throat/harsh throat"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 15Aug2023, outcome "unknown", described as "She said it's the first time she has taken the Pfizer vaccine and she took Moderna vaccines prior"; COUGH (non-serious) with onset Aug2023, outcome "unknown", described as "dry cough"; SNEEZING (non-serious) with onset 15Aug2023, outcome "unknown", described as "on Tuesday she started sneezing"; RHINORRHOEA (non-serious) with onset Aug2023, outcome "unknown", described as "runny nose". Additional information: Patient said she never had COVID-19. She took Moderna shots before and has never had Pfizer shot. She got Pfizer COVID vaccine, Bivalent Gray cap on Tuesday (15Aug2023). She is currently experiencing sore throat/harsh throat, dry cough and runny nose. She said she never had this before. She had a lot of sore throat. Patient was wondering if she needs to see her HCP.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 71.0
Sex: M
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 72-year-old male patient received BNT162b2 (BNT162B2), on 09Nov2022 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Positive; (Aug2023) Positive. Therapeutic measures (Paxlovid) 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.