chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination site pain
Clinical narrative: I just got that November the 30th and my problem with that is well, other than having arm pain. Just get like some arm pain for a day or two, where the injection was.; About four or five days after I got this vaccine I came down with Covid.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (About four or five days after I got this vaccine I came down with Covid.) and VACCINATION SITE PAIN (I just got that November the 30th and my problem with that is well, other than having arm pain. Just get like some arm pain for a day or two, where the injection was.) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 07-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (About four or five days after I got this vaccine I came down with Covid.). On an unknown date, the patient experienced VACCINATION SITE PAIN (I just got that November the 30th and my problem with that is well, other than having arm pain. Just get like some arm pain for a day or two, where the injection was.). At the time of the report, COVID-19 (About four or five days after I got this vaccine I came down with Covid.) and VACCINATION SITE PAIN (I just got that November the 30th and my problem with that is well, other than having arm pain. Just get like some arm pain for a day or two, where the injection was.) outcome was unknown.            No relevant concomitant medications were reported.   Patient received three or four Moderna COVID19 vaccine doses in the past. Patient had arm pain that was normal with all the shots. Just get like some arm pain for a day or two, where the injection was.   Patient never had covid 19 in the past couple of years and all of a sudden after the latest vaccine patient came down with it a couple of days later. Patient was wondering if that could possibly be some sort of a side effect from the vaccine itself. Patient thought possibly that somehow it might have affected the immune system. Somehow it made patient more susceptible to it. Patient mentioned being sick and was coughing during the call.  No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-753225 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-753225:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: I just got that November the 30th and my problem with that is well, other than having arm pain. Just get like some arm pain for a day or two, where the injection was.; About four or five days after I got this vaccine I came down with Covid.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (About four or five days after I got this vaccine I came down with Covid.) and VACCINATION SITE PAIN (I just got that November the 30th and my problem with that is well, other than having arm pain. Just get like some arm pain for a day or two, where the injection was.) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 07-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (About four or five days after I got this vaccine I came down with Covid.). On an unknown date, the patient experienced VACCINATION SITE PAIN (I just got that November the 30th and my problem with that is well, other than having arm pain. Just get like some arm pain for a day or two, where the injection was.). At the time of the report, COVID-19 (About four or five days after I got this vaccine I came down with Covid.) and VACCINATION SITE PAIN (I just got that November the 30th and my problem with that is well, other than having arm pain. Just get like some arm pain for a day or two, where the injection was.) outcome was unknown.            No relevant concomitant medications were reported.   Patient received three or four Moderna COVID19 vaccine doses in the past. Patient had arm pain that was normal with all the shots. Just get like some arm pain for a day or two, where the injection was.   Patient never had covid 19 in the past couple of years and all of a sudden after the latest vaccine patient came down with it a couple of days later. Patient was wondering if that could possibly be some sort of a side effect from the vaccine itself. Patient thought possibly that somehow it might have affected the immune system. Somehow it made patient more susceptible to it. Patient mentioned being sick and was coughing during the call.  No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-753225 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-753225:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination site pain
Clinical narrative: arm pain with all the shots, where the injection was; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (arm pain with all the shots, where the injection was) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm pain with all the shots, where the injection was). At the time of the report, VACCINATION SITE PAIN (arm pain with all the shots, where the injection was) outcome was unknown.            Concomitant Medication was not product reported.  Patient received 3 or 4 Moderna COVID19 vaccine doses. Patient had arm pain, which was normal with all the shots. Just get like some arm pain for a day or two, where the injection was.   Treatment information was not product reported.   This case was linked to MOD-2023-752926 (Patient Link).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm pain with all the shots, where the injection was; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (arm pain with all the shots, where the injection was) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm pain with all the shots, where the injection was). At the time of the report, VACCINATION SITE PAIN (arm pain with all the shots, where the injection was) outcome was unknown.            Concomitant Medication was not product reported.  Patient received 3 or 4 Moderna COVID19 vaccine doses. Patient had arm pain, which was normal with all the shots. Just get like some arm pain for a day or two, where the injection was.   Treatment information was not product reported.   This case was linked to MOD-2023-752926 (Patient Link).
Sex: F
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident
Clinical narrative: On 10OCT2022 she was hospitalized for a suspected stroke; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (On 10OCT2022 she was hospitalized for a suspected stroke) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 10-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced CEREBROVASCULAR ACCIDENT (On 10OCT2022 she was hospitalized for a suspected stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 10-Oct-2022 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (On 10OCT2022 she was hospitalized for a suspected stroke) had not resolved.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 69-year-old female patient, with no medical history reported, who experienced the unexpected and serious (due to hospitalization and medically significant) AESI of Cerebrovascular accident, which occurred 6 days after an unspecified dose of mRNA-1273.222 vaccine. As reported, patient was hospitalized for a suspected stroke. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-752965 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-752965:Same Patient (Spikevax 2023-2024 case)
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: They got the Covid shots that were recommended only with Moderna or the other one but they all did get covid after having the injections; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (They got the Covid shots that were recommended only with Moderna or the other one but they all did get covid after having the injections) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (They got the Covid shots that were recommended only with Moderna or the other one but they all did get covid after having the injections). At the time of the report, COVID-19 (They got the Covid shots that were recommended only with Moderna or the other one but they all did get covid after having the injections) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   This case is considered as invalid as the number of friends were involved without particular identifier of friend.  Concomitant medication use information was not provided by reporter.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Caller mentioned all of her friends got all vaccines and still got Covid. They got the Covid shots that were recommended only with Moderna or the other one. but they all did get covid after having the injections. About 5 people that she knows that did get the vaccine. Caller did not know if they got a milder case of covid, but they did get the disease.  Treatment medication use information was not provided by reporter.  This case contains information for patient 1 out of 5.   This case was linked to US-MODERNATX, INC.-MOD-2023-752955 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-752955:Master case
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: They got the Covid shots that were recommended only with Moderna or the other one but they all did get covid after having the injections; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (They got the Covid shots that were recommended only with Moderna or the other one but they all did get covid after having the injections) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (They got the Covid shots that were recommended only with Moderna or the other one but they all did get covid after having the injections). At the time of the report, COVID-19 (They got the Covid shots that were recommended only with Moderna or the other one but they all did get covid after having the injections) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Suspect product dosage text was reported as unknown. No treatment medication was reported. This case is reported for patient 2 out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-752955 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-752955:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: They got the Covid shots that were recommended only with Moderna or the other one but they all did get covid after having the injections; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (They got the Covid shots that were recommended only with Moderna or the other one but they all did get covid after having the injections) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (They got the Covid shots that were recommended only with Moderna or the other one but they all did get covid after having the injections). At the time of the report, COVID-19 (They got the Covid shots that were recommended only with Moderna or the other one but they all did get covid after having the injections) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  Reporter had friends who got all vaccines and still got Covid. They got the Covid shots that were recommended only with Moderna or the other one, but they all did get covid after having the injections. About 5 people that she knows that did get the vaccine. Reporter does not know if they got a milder case of COVID, but they did get the disease.  No treatment drug was reported.  This case contains information for the 3rd of 5 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-752955 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-752955:Patient 1 (Master case)
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: They got the Covid shots that were recommended only with Moderna or the other one but they all did get covid after having the injections; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (They got the Covid shots that were recommended only with Moderna or the other one but they all did get covid after having the injections) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (They got the Covid shots that were recommended only with Moderna or the other one but they all did get covid after having the injections). At the time of the report, COVID-19 (They got the Covid shots that were recommended only with Moderna or the other one but they all did get covid after having the injections) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  Reporter had friends who got all vaccines and still got Covid. They got the Covid shots that were recommended only with Moderna or the other one, but they all did get covid after having the injections. About 5 people that she knows that did get the vaccine. Reporter does not know if they got a milder case of COVID, but they did get the disease.  No treatment drug was reported.  This case contains information for the 4th of 5 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-753009 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-753009:Patient 1 (Master case) US-MODERNATX, INC.-MOD-2023-752955:Patient 4
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: They got the Covid shots that were recommended only with Moderna or the other one but they all did get covid after having the injections; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (They got the Covid shots that were recommended only with Moderna or the other one but they all did get covid after having the injections) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (They got the Covid shots that were recommended only with Moderna or the other one but they all did get covid after having the injections). At the time of the report, COVID-19 (They got the Covid shots that were recommended only with Moderna or the other one but they all did get covid after having the injections) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  About 5 people that she knows that did get the vaccine. Reporter did not know if they got a milder case of covid but they did get the disease.  No treatment information was reported.  This case contains information for the patient number 5 out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-753009 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-753009:Master case (Patient 1)
Age: 61.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: diagnosed with COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (diagnosed with COVID-19) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for an unknown indication.    Previously administered products included for COVID-19 prophylaxis: Moderna (Dose:1, Lot number: 037B21A, dose: 0.5 ml, site: Left arm) on 12-Apr-2021, Moderna (Dose:2, Lot number: 022021A, dose: 0.5 ml, site: Left arm) on 11-May-2021, Moderna (Dose:3, Lot number: 069H21A, dose: 0.5 ml and site: Left arm) on 20-Dec-2021. Past adverse reactions to the above products included No adverse event with Moderna, Moderna and Moderna. Concomitant products included OMEPRAZOLE for GERD, ROSUVASTATIN for Hyperlipidemia.   On 14-Oct-2022 at 5:15 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient received dose of INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) (unknown route) 1 dosage form. On 16-Nov-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (diagnosed with COVID-19). At the time of the report, COVID-19 (diagnosed with COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2023, SARS-CoV-2 test: Positive.         No treatment medications were provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Caller got the sore arm after having the Moderna vaccines; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Caller got the sore arm after having the Moderna vaccines) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A, 028A21A and 032F21A) for COVID-19 prophylaxis.     The patient's past medical history included Heart fluttering (She had a heart that would flutter, and they would give them a pill for that, but they haven't had that in a while.). Concurrent medical conditions included Blood pressure abnormal (Taking a medication for blood pressure).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Caller got the sore arm after having the Moderna vaccines). At the time of the report, PAIN IN EXTREMITY (Caller got the sore arm after having the Moderna vaccines) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Caller takes blood pressure medication and did not like mixing medications. Treatment information was not reported.  Patient received fourth dose on14Jul-2022 with Lot no.: 0141322A and received fifth dose on 07-Dec-2022 with Lot no: 09822A. Caller did not mind the pain in the arm but got the sore arm after having the Moderna vaccines.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cancer in remission
Clinical narrative: covid 19; She has stage 4 cancer and is in remission.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) and CANCER IN REMISSION (She has stage 4 cancer and is in remission.) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19) and CANCER IN REMISSION (She has stage 4 cancer and is in remission.). At the time of the report, COVID-19 (covid 19) and CANCER IN REMISSION (She has stage 4 cancer and is in remission.) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient was lives in a nursing home. Caught COVID for the second time. She was quarantined for 11 days after her diagnosis. They just told her she was free to leave quarantine but did not provide her a follow up test. They were telling her that she can receive a COVID-19 vaccine next week. She has stage 4 cancer and was in remission. She believed that her injection was not given into her muscle.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-751551 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-751551:Different patient, same reporter
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Dysuria, Eye pain, Headache
Clinical narrative: I had sore arm, chills, slight headache that came and went; Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate; Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate; Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate; I had sore arm, chills, slight headache that came and went; I had sore arm, chills, slight headache that came and went; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (I had sore arm, chills, slight headache that came and went), BACK PAIN (Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate), EYE PAIN (Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate), DYSURIA (Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate) and CHILLS (I had sore arm, chills, slight headache that came and went) in a 56-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 07-Dec-2023, the patient experienced PAIN IN EXTREMITY (I had sore arm, chills, slight headache that came and went), BACK PAIN (Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate), EYE PAIN (Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate), DYSURIA (Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate), CHILLS (I had sore arm, chills, slight headache that came and went) and HEADACHE (I had sore arm, chills, slight headache that came and went). On 09-Dec-2023, PAIN IN EXTREMITY (I had sore arm, chills, slight headache that came and went), BACK PAIN (Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate), EYE PAIN (Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate), DYSURIA (Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate), CHILLS (I had sore arm, chills, slight headache that came and went) and HEADACHE (I had sore arm, chills, slight headache that came and went) had resolved.            No Concomitant medications provided by the reporter. No treatment medications provided by the reporter.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I had sore arm, chills, slight headache that came and went; Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate; Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate; Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate; I had sore arm, chills, slight headache that came and went; I had sore arm, chills, slight headache that came and went; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (I had sore arm, chills, slight headache that came and went), BACK PAIN (Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate), EYE PAIN (Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate), DYSURIA (Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate) and CHILLS (I had sore arm, chills, slight headache that came and went) in a 56-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 07-Dec-2023, the patient experienced PAIN IN EXTREMITY (I had sore arm, chills, slight headache that came and went), BACK PAIN (Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate), EYE PAIN (Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate), DYSURIA (Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate), CHILLS (I had sore arm, chills, slight headache that came and went) and HEADACHE (I had sore arm, chills, slight headache that came and went). On 09-Dec-2023, PAIN IN EXTREMITY (I had sore arm, chills, slight headache that came and went), BACK PAIN (Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate), EYE PAIN (Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate), DYSURIA (Eyes hurt and lower back pain wich I believe were my kidneys because it hurt to urinate), CHILLS (I had sore arm, chills, slight headache that came and went) and HEADACHE (I had sore arm, chills, slight headache that came and went) had resolved.            No Concomitant medications provided by the reporter. No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: arm soreness; feeling sick; 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 46-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "Sjogren's disease" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing); "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN taken for hypertension; PROZAC oral taken for depression, anxiety; LEVOTHYROXINE oral taken for autoimmune thyroiditis. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm soreness"; MALAISE (non-serious), outcome "recovered", described as "feeling sick". Additional information: Patient said she had Pfizer for the Covid vaccinations since Covid started. She said she normally got side effects like arm soreness and feeling sick for 24 hours which were "no big deal" for her. Patient did not know how many (dose), every time Pfizer came out with one she got it so she did not know how many she had gotten over the 5, 6, 7.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300434532 same patient/reporter, different dose number/event;
Age: 37.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient had two positive rapid antigen tests on 04Dec2023 and was symptomatic for COVID-19 infection; Patient had two positive rapid antigen tests on 04Dec2023 and was symptomatic for COVID-19 infection; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 37-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 11:30 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 27Sep2023 as dose 1, single (Batch/Lot number: unknown), in left arm for influenza immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Dec2023, outcome "recovering" and all described as "Patient had two positive rapid antigen tests on 04Dec2023 and was symptomatic for COVID-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Dec2023) Positive, notes: Nasal Swab; (04Dec2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: Patient had No other vaccine in four weeks. Patient had No Other medications in two weeks. Patient had two positive rapid antigen tests on 04Dec2023 and was symptomatic for COVID-19 infection - loss of smell, cough, congestion, runny nose, severe headache, nausea and vomiting, and extreme fatigue for several days prior to testing positive. Patient had No covid prior vaccination. Patient was covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Palatal disorder, Swollen tongue, Throat tightness
Clinical narrative: tongue began to swell; upper palate felt weird-a hot fire like sensation.; upper palate felt weird-a hot fire like sensation.; throat began to tighten and slightly restrict; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Dec2023 at 12:00 as dose 1, single (Lot number: Unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allerygy: pineapple" (unspecified if ongoing); "Allerygy:shellfish" (unspecified if ongoing); "Allerygy:almonds" (unspecified if ongoing); "covid-19" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE; FAMODINE. Vaccination history included: pfizer (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Vaccine Administration Time: 11:15 AM), administration date: 18Dec2022, when the patient was 55-year-old, for covid-19 immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACTURE UNKOWN.), for covid-19 immunisation. The following information was reported: THROAT TIGHTNESS (non-serious) with onset 06Dec2023 at 12:15, outcome "recovered" (Dec2023), described as "throat began to tighten and slightly restrict"; SWOLLEN TONGUE (non-serious) with onset 06Dec2023 at 12:15, outcome "recovered" (Dec2023), described as "tongue began to swell"; PALATAL DISORDER (non-serious), BURNING SENSATION (non-serious) all with onset 06Dec2023 at 12:15, outcome "recovered" (Dec2023) and all described as "upper palate felt weird-a hot fire like sensation.". Therapeutic measures were taken as a result of swollen tongue, palatal disorder, burning sensation, throat tightness. Additional information: Event reported as: within 5 minutes, tongue began to swell and upper palate felt weird-a hot fire like sensation. Within 10 minutes, throat began to tighten and slightly restrict. Took several Benedryl over several hours-symptoms fully subsided in approx. 5 hours. The patient was not hospitalized for events. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient was diagnosed with Covid-19 prior to vaccination. Since the vaccination, the patient was not tested for Covid-19. Dose received reported as more than 3.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunology test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 74-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "psoriatic arthritis" (unspecified if ongoing); "ASHD" (unspecified if ongoing); "Type 2 DM" (unspecified if ongoing); "known allergies: penicllin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (03Dec2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Immunology test: (03Dec2023) Negative, notes: ELISA negative 7th day. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 26Nov2023 to 01Dec2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccine failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 22Nov2023 to 26Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 59-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 at 08:45 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in right arm 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 Nov2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: completed the five days of paxlovid, tested negative for covid. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid treatment from 24Nov2023 to 29Nov2023. Clinical Course: No Known Allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Booster shot on Friday last week and on Saturday I am kind of felt like I got COVID; showing signs of COVID now and I was not sure; Booster shot on Friday last week and on Saturday I am kind of felt like I got COVID; showing signs of COVID now and I was not sure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Dec2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 02Dec2023, outcome "unknown" and all described as "Booster shot on Friday last week and on Saturday I am kind of felt like I got COVID; showing signs of COVID now and I was not sure". Clinical course: Consumer stated, got a COVID-19 Booster shot on Friday last week and on Saturday patient kind of felt like got COVID and feel like showing signs of COVID now and patient was not sure. Patient wanted to known if patient can take a COVID test since patient just got the vaccine just like less than a week ago. Upon clarified the booster shot name as Pfizer COVID-19 vaccine, consumer stated, Yes, it was the Pfizer because patient had got now like this is about patients fifth vaccination through the course of time and patient always got the Pfizer.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Discomfort, Injection site pain, Peripheral swelling, Pruritus, Rash
Clinical narrative: Patient reports more pain than normal during the injection.  She started feeling itching and she said she got some red bumps and swelling on her right arm.  By Sunday 12/10/2023 she felt itching in her body, the area was irritating, and she felt uncomfortable.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Rash erythematous, Skin irritation
Clinical narrative: Patient reports more pain than normal during the injection.  She started feeling itching and she said she got some red bumps and swelling on her right arm.  By Sunday 12/10/2023 she felt itching in her body, the area was irritating, and she felt uncomfortable.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy, Injection site pain, Injection site reaction, Joint range of motion decreased, Magnetic resonance imaging abnormal
Clinical narrative: After receiving the Covid-19 vaccine on 04/16/2021 I had the usual sore and stiff arm at the injection site in my left shoulder. The pain got worse over time to a sharp pain. Went to see my PCP on 11/09/2021 as pain was getting worse. PCP gave me a steroid shot in my left shoulder. Steroid shot helped with some of the pain to make pain bearable. Pain returned and went back to see my PCP but was unavailable at the time so I went to see Dr in the same doctors office on 08/23/2022. He perscribed Hydrocodone and Meloxicam. On 10/11/2022 went back to my PCP as pain has not gone away and was getting decreased range of motion. My PCP gave me my second steroid shot in my shoulder. The second steroid shot was was inneffective for the pain. Went back to PCP on 11/28/2022 for the pain. PCP perscribed Methylprednisolone (Steroid medpack), Tizanidine and Etadolac. I got some relief from the pain but once the meds were done pain started coming back. PCP did one more round of Methylprednisolone for the last try for the pain. PCP told me that if this last round of steriods and if they dont work I need to get an MRI done. Still having pain in the shoulder after the last round of steroids so I made an appointment to see an Orthopedic Doctor. My Orthopedic Dr is DR MD. I saw DR on 02/02/2023 for a consultation. He did an X-ray on my shoulder but showed nothing. He then had me schedule an MRI with contrast to see what was happening in my shoulder. MRI was done 02/08/2023. Saw Dr on 02/23/2023 to go over the results of the the MRI. Results from MRI showed Non traumatic partial tear of left rotator cuff, Disorder of shoulder, Osteoarthritis of left acromioclavicular joint, Bicepts Tendinitis, High-Grade Partial-Thickness Supraspinatus/ Infraspinatus Rotator cuff tear with AC DJD. Up to this point in my life I have no problems with my left shoulder. I did not have any accidents or strains at the time of my vaccine that would cause me pain. Whether it be from to high of injection location or Covid-19 vaccine I don't know. I know my pain started from the day I received the Pfizer Covid-19 vaccination. For the record my Primary Care Physician mentioned above is DR MD.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Osteoarthritis, Rotator cuff syndrome, Scan with contrast abnormal, X-ray limb normal
Clinical narrative: After receiving the Covid-19 vaccine on 04/16/2021 I had the usual sore and stiff arm at the injection site in my left shoulder. The pain got worse over time to a sharp pain. Went to see my PCP on 11/09/2021 as pain was getting worse. PCP gave me a steroid shot in my left shoulder. Steroid shot helped with some of the pain to make pain bearable. Pain returned and went back to see my PCP but was unavailable at the time so I went to see Dr in the same doctors office on 08/23/2022. He perscribed Hydrocodone and Meloxicam. On 10/11/2022 went back to my PCP as pain has not gone away and was getting decreased range of motion. My PCP gave me my second steroid shot in my shoulder. The second steroid shot was was inneffective for the pain. Went back to PCP on 11/28/2022 for the pain. PCP perscribed Methylprednisolone (Steroid medpack), Tizanidine and Etadolac. I got some relief from the pain but once the meds were done pain started coming back. PCP did one more round of Methylprednisolone for the last try for the pain. PCP told me that if this last round of steriods and if they dont work I need to get an MRI done. Still having pain in the shoulder after the last round of steroids so I made an appointment to see an Orthopedic Doctor. My Orthopedic Dr is DR MD. I saw DR on 02/02/2023 for a consultation. He did an X-ray on my shoulder but showed nothing. He then had me schedule an MRI with contrast to see what was happening in my shoulder. MRI was done 02/08/2023. Saw Dr on 02/23/2023 to go over the results of the the MRI. Results from MRI showed Non traumatic partial tear of left rotator cuff, Disorder of shoulder, Osteoarthritis of left acromioclavicular joint, Bicepts Tendinitis, High-Grade Partial-Thickness Supraspinatus/ Infraspinatus Rotator cuff tear with AC DJD. Up to this point in my life I have no problems with my left shoulder. I did not have any accidents or strains at the time of my vaccine that would cause me pain. Whether it be from to high of injection location or Covid-19 vaccine I don't know. I know my pain started from the day I received the Pfizer Covid-19 vaccination. For the record my Primary Care Physician mentioned above is DR MD.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Dyspnoea, Fall, Throat tightness
Clinical narrative: PATIENT REPORTED THAT SHE GOT HER VACCINE AND SHE THEN WENT HOME TO HANG CHRISTMAS LIGHTS. AS SHE WAS HANGING CHRISTMAS LIGHTS, HER THROAT CLOSED UP AND SHE COULD NOT BREATH. SHE FELL ONTO HER BACK. SHE HAD HER CELL PHONE WITH HER AND CALLED 911 FOR HERSELF. SHE WAS TAKEN TO THE EMERGENCY ROOM VIA AMBULANCE.