chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: CANCER IN THEIR BODY AND NEED SURGERY; This spontaneous report received from a consumer via a company representative via media concerned multiple patients. The patient's weight, height, and medical histories were not reported. The patients previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy dates were not reported, 01 total administered for covid-19 prophylaxis.  On an unspecified date, the patients experienced cancer in their body and need surgery following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The outcome of cancer in their body and need surgery was not reported. The patients additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy dates were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced cancer in their body and need surgery after taking these Covid shots and boosters (Dose number in series 2). As per the reporter, "as a result of these covid shots and boosters there are a lot of people we have talked to at the hospital that "surprising now have cancer" in their body and need surgery after taking these Covid shots and boosters. It is all the makers of this covid shot not sure about JJ." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cancer in their body and need surgery was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20221123551 (Dose number in series 1). This case, from the same reporter is linked to 20221123504 and 20221124203.; Sender's Comments: V0: 20221123543- Cancer in their body and need surgery. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: CANCER IN THEIR BODY AND NEED SURGERY; This spontaneous report received from a consumer via a company representative via social media (social media account) concerned multiple patients of an unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced cancer in their body and need surgery.  It was reported that, "as a result of these COVID shots and boosters there are a lot of people we have talked to at the hospital that "surprising now have cancer" in their body and need surgery after taking these Covid shots and boosters." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cancer in their body and need surgery was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221123504, 20221123543 and 20221124203. Sender's Comments: V0: 20221123551-cancer in their body and need surgery. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer, Illness
Clinical narrative: This spontaneous report received from a consumer via a company representative via social media (social media) concerned a 38-year-old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, administered in 2021 on right arm for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 2021, the patient experienced sick nonstop. In 2022, the patient experienced breast cancer. It was reported as "totally know how you feel because my neice who is only 38 was forced by her work to get the covid shot end of 2021 and then she became sick nonstop for almost this past year and then all of a sudden now where covid shot was given found out few months ago she has breast cancer and must have surgery in next few weeks to remove lumps in right breast which is same side as covid shot given and close to where shot was administered". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from breast cancer, and the outcome of sick nonstop was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221123543, 20221123551 and 20221123504. Sender's Comments: V0: 20221124203-Breast cancer. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Dyspnoea, Illness
Clinical narrative: HEART PAIN; SHORTNESS OF BREATH; VERY SICK; This spontaneous report received from a consumer via company representative through social media (social media) concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced heart pain, shortness of breath, and very sick. It was reported as, "This is all very nice but it is not the whole store. My wife is a nurse. Her work forced her to get a shot. She chose the vaccine on a Monday. Within 24 hours she became VERY sick. By Thursday I thought I was going to have to take her to the hospital. She began to recover but could started to have heart issues that lasted a month. Which included a great deal of heart pain and shortness of breath. Symptoms lasted a little longer than a month. Be aware that there is potential side effects which can be quite severe. None of these covid drugs, no matter who makes the drug, have been fully tested, and no one knows the long term impact. But studies and other places looking at side effects do not look promising". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart pain, and shortness of breath, and was recovering from very sick. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221125875-Heart pain. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer via company representative via media concerned multiple patients of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced blood clots and died. As per the reporter it was reported as "I have high blood pressure and take a statin, had phizer and had no problems with it. I have had friends die of blood clots from the J&J vaccine." It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221127438-Blood clots. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: BLOOD CLOTS
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: LITTLE TIRED; This spontaneous report received from a patient via a company representative through an social media concerned a female of an unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. The drug latency period was 1 day. No concomitant medications were reported.  On an unspecified date, the patient was little tired next day following the first dose of the vaccination (dose number in series 1).  The patient received additional booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  The patient had no adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2). The reporter stated that " My husband and I both had the J&J vaccine. A little tired the next day after the first shot, nothing after the second shot. Are we supposed to get more shots". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little tired was not reported. This report was non-serious. This case, from the same reporter is linked to 20221129480.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: ARM HURTING; FEELING TIRED; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's past medical history included: cough or cold (that lingered for 2 months in December (unspecified year and date). Patient states this was before covid or vaccines came out. Patient reports it took 2 months before it went away), and concurrent conditions included: glaucoma, and anti-seizure medicine user, and other pre-existing medical conditions included: The patient had no exposure to SARS-COV2-virus prior to vaccination. The patient had no diabetes, hypertension, heart disease, autoimmune disorders and immunosuppressive disorders, and not being treated with immune-modulating or immuno-suppressive medications or received other vaccines within past 30 days, no illness at the time of vaccination, no past history of similar event, no history of allergy to vaccine, drug, or food, no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days, and no family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: 18-FEB-2022) dose was not reported, administered on 05-MAY-2021 for covid-19 prophylaxis. Age at time of vaccination 6 decade old. Concomitant medications included zonisamide for anti-seizure, latanoprost for glaucoma, and timolol maleate for glaucoma. On an unspecified date, the patient experienced arm hurting, and feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm hurting and feeling tired was not reported. This report was non-serious. This case, involving the same patient is linked to 20221057885.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Hypersomnia, Pain, Peripheral swelling
Clinical narrative: PAIN; SWOLLEN RED ARM DESCRIBED AS COVID ARM; SLEPT FOR 30 HOURS ONLY WAKING UP FOR WATER AND BATHROOM; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. The patient never experienced any pain or discomfort (Dose number in series 1).  On an unspecified date the patient received non-company suspect vaccine included: covid-19 vaccine (unspecified manufacturer, not J and J) (Dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2).  On an unspecified date, the patient experienced pain, swollen red arm described as Covid arm and slept for 30 hours only waking up for water and bathroom (Dose number in series 2).  As per the reporter, "Johnson & Johnson I also had Both my vaccines never experienced any pain or discomfort. But when I got the booster (not J and J) supposedly compatible I had Pain and swollen Red Arm described as Covid Arm. I slept for 30 hours only waking up for water and bathroom. Not sure anyone knows the true story of how this affects us". The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with covid-19 vaccine was not reported. The outcome of the pain, swollen red arm described as covid arm, slept for 30 hours only waking up for water and bathroom and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Fatigue, Pain in extremity
Clinical narrative: SORE ARM; FATIGUE; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: flu (Early 30's the patient almost died from the flu). The patient previously received first dose and second dose of covid-19 vaccine (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, start therapy date were not reported administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine (Dose number in series 1). The patient previously received third dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total, start therapy date were not reported administered for covid-19 prophylaxis. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine (Dose number in series 2). The patient received fourth dose of covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered, start therapy date were not reported for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 3). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm, and fatigue (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, fatigue and revaccination with different covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20221131432.
Sex: U
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: DIED SUDDENLY; This spontaneous report received from a consumer via a social media (J and J Corporate Online search) and by a company representative concerned multiple patients of an unspecified age, sex, race and ethnicity. The patients weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patients died suddenly two days after having the shot from unknown cause. It was unknown if an autopsy was performed. It was reported that "l know thousands of people who died suddenly two days after having the "jab" shot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date, the patients died suddenly from unknown cause of death. This report was serious (Death).; Sender's Comments: V0- 20221131401-Died Suddenly. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: MORE TIRED; WEAKER THEN EVER BEFORE; This spontaneous report received from a patient via company representative through social media concerned a patient of an unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (form of admin, route of admin, and batch number were not reported) dose, start therapy date were not reported 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date (after the patient received two shots), the patient was more tired, and weaker then ever before (dose number in series 2). It was reported as "agree ever since got the two shots I have become more tired and weaker then ever before so I believe Covid shot has something to do with it long term effects got shots in April". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from more tired, and weaker then ever before. This report was non-serious. This case, involving the same patient is linked to 20221131316 (dose number in series 1).
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dyspnoea
Clinical narrative: STROKE; BREATHING ISSUES; This spontaneous report received from a patient via a company representative through a social media (JNJ Corporate) concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported.  On an unspecified date, the patient experienced stroke within 24 hours of the vaccination, and had really bad breathing issues. The reporter stated that "I had a Stroke within 24hrs of being vaxxed..now I have really bad breathing issues.. It's a Nightmare." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke and breathing issues was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20221133047-COVID-19 VACCINE Ad26.COV2.S-Stroke-The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was stored at room temperature post puncture; No adverse event; administered vaccine more than 12 hours post puncture of the vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered vaccine more than 12 hours post puncture of the vial), PRODUCT STORAGE ERROR (Vial was stored at room temperature post puncture) 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)) (batch no. 030M20A) for COVID-19 prophylaxis. No Medical History information was reported. On 10-Nov-2022 at 3:25 PM, 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-Nov-2022 at 3:25 PM, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered vaccine more than 12 hours post puncture of the vial). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored at room temperature post puncture). an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered vaccine more than 12 hours post puncture of the vial), PRODUCT STORAGE ERROR (Vial was stored at room temperature post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered vaccine more than 12 hours post puncture of the vial) and PRODUCT STORAGE ERROR (Vial was stored at room temperature post puncture). No concomitant medications were reported. It was reported that, vaccine vial was first punctured on 09-Nov-2022 at 12 noon and was administer to the patient on 10-Nov-2022 at 15:25. The vial size reported was 2.5 milliliter. The vial was initially stored in the refrigerator on 08-Nov-2022. The vial was stored at room temperature post puncture. The vial did not undergo any temperature excursion. No treatment details were reported This case was linked to MODERNATX, INC.-MOD-2022-670595 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2022-670595: Same reporter case.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: dose given beyond 30-day expiration date; dose given beyond 30-day expiration date; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date) and PRODUCT STORAGE ERROR (dose given beyond 30-day expiration date).    Concomitant products were not reported.  It was reported the vial was initially stored in the refrigerator on 13-Sep-2022 and administered on 18-Oct, 25-Oct, 01-Nov, 02-Nov and 08-Nov. The vial did not underwent any temperature excursion. It was unknown if individual vials or unbroken cartons were used. The vial size was unknown.  Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: experiencing their arm being sore and swollen; experiencing their arm being sore and swollen; itchiness; redness; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (experiencing their arm being sore and swollen), PERIPHERAL SWELLING (experiencing their arm being sore and swollen), PRURITUS (itchiness) and ERYTHEMA (redness) 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 PAIN IN EXTREMITY (experiencing their arm being sore and swollen), PERIPHERAL SWELLING (experiencing their arm being sore and swollen), PRURITUS (itchiness) and ERYTHEMA (redness). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (experiencing their arm being sore and swollen), PERIPHERAL SWELLING (experiencing their arm being sore and swollen), PRURITUS (itchiness) and ERYTHEMA (redness) outcome was unknown.            No concomitant product reported by reporter. From few days ago, patient was having some reactions due to the vaccine.  Patient had put hydrocortisone in affected area as treatment medication.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Hip arthroplasty
Clinical narrative: had hip replacement on 17 Nov 2021; This spontaneous case was reported by a patient and describes the occurrence of HIP ARTHROPLASTY (had hip replacement on 17 Nov 2021) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 025L20A and 011J20A) for COVID-19 prophylaxis.     Patient had no known drug allergies to medications, food and other products.  Patient had never been diagnosed with or tested positive for COVID-19. Patient didn't had acute illnesses at the time of vaccination and up to one month before or any chronic or long-standing health conditions.    On 30-Dec-2020 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021 at 3:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HIP ARTHROPLASTY (had hip replacement on 17 Nov 2021). At the time of the report, HIP ARTHROPLASTY (had hip replacement on 17 Nov 2021) outcome was unknown.      No prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination or at the time of the adverse event were reported.   Reportedly, other vaccines given on the same day as moderna covid-19 vaccine were none. Other vaccines received within one month prior to dose of moderna vaccine were none.  It was reported that on 10 Oct 2021, patient had experienced extreme inflammation in both hips especially the surgical hip and after 5 weeks, the situation persists. Even if it backs down for a day or two it returned with a vengeance and also reported that anti-inflammatories were useless and the hip replacement surgery was performed on 17 Nov 2021.   This case was linked to MOD-2022-672436, MOD-2022-669954 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Neck pain, Pyrexia
Clinical narrative: general feeling of feeling ill; Fever; neck achy flare up; Knees and shoulders achy flare up; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (general feeling of feeling ill), PYREXIA (Fever), NECK PAIN (neck achy flare up) and ARTHRALGIA (Knees and shoulders achy flare up) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch nos. 4782589 and 4782589) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) modified-release tablet for Rheumatoid arthritis.    No other medical history was reported.  Concurrent medical conditions included Rheumatoid arthritis.   On 11-Apr-2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 13-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 13-May-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (general feeling of feeling ill), PYREXIA (Fever), NECK PAIN (neck achy flare up) and ARTHRALGIA (Knees and shoulders achy flare up). At the time of the report, MALAISE (general feeling of feeling ill) and PYREXIA (Fever) outcome was unknown and NECK PAIN (neck achy flare up) and ARTHRALGIA (Knees and shoulders achy flare up) had not resolved.            Concomitant product use was not provided by the reporter.  The patient reported knees, neck and shoulders achy in the morning. Second dose of Moderna vaccine caused fever and general feeling of feeling ill.  Treatment information was not provided.  The reporter's causality for the events of Knees and shoulders achy flare up and neck achy flare up with Upadacitinib modified-release tablet was reasonable possibility. The reporter's causality for the events of fever and general feeling of feeling ill with Upadacitinib modified-release tablet was no reasonable possibility.  It was unknown if patient was enrolled in COVID-19-vaccine trial.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Dandruff, Psoriasis
Clinical narrative: Dandruff; Psoriasis on face; This spontaneous case was reported by a consumer and describes the occurrence of DANDRUFF (Dandruff) and PSORIASIS (Psoriasis on face) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic).   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)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DANDRUFF (Dandruff) and PSORIASIS (Psoriasis on face). At the time of the report, DANDRUFF (Dandruff) and PSORIASIS (Psoriasis on face) had not resolved.      No concomitant product use was reported.  Moderna covid-19 vaccine MPID was reported. Humira (Adalimumab solution for injection) was single dose pen.  No treatment information was provided.  The reporter's causality for the events of dandruff and psoriasis on face with Adalimumab solution for injection was no reasonable possibility.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Moderna bivalent booster administered instead of monovalent primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna bivalent booster administered instead of monovalent primary series) and NO ADVERSE EVENT (No adverse event) in a 14-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna bivalent booster administered instead of monovalent primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna bivalent booster administered instead of monovalent primary series) 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 WRONG PRODUCT ADMINISTERED (Moderna bivalent booster administered instead of monovalent primary series).    Concomitant medication was not provided.  A pediatric patient inadvertently received Moderna COVID-19 bivalent booster shot prior to receiving any of primary series doses. Patient has not reported any adverse reactions to this dose.  Treatment information was not provided.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19/sore throat and coughing a lot in bed and so forth; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19/sore throat and coughing a lot in bed and so forth) in an 84-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination.     Patient had no Allergies.  Previously administered products included for Product used for unknown indication: Flu vaccine (Flu yearly around the same time as with the reporter). Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Hypertension and AFib. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 16-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Nov-2022, the patient experienced COVID-19 (COVID-19/sore throat and coughing a lot in bed and so forth). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19/sore throat and coughing a lot in bed and so forth) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2022, SARS-CoV-2 test: Positive.         Concomitant medications also includes high blood medications and other medications for male stuff.  The patient received first dose on 26-Jan-2021 with lot number 030L20A, second dose on 23-Feb-2021 with lot number 031L20A, 1st booster dose on 3-Nov-2021 with lot number 032F21 and 2nd booster dose on 8-Apr-2022 with lot number 002M21A.  It was reported that initially, patient had sore throat then on (08-Nov-2022) coughing a lot in bed and so forth and did a home test on 09-Nov-2022 and it came out positive.   The AE did not cause patient to seek medical care.  The patient does not experienced a similar event in the past.  The symptoms were getting better.  Patient was prescribed with Paxlovid.   This case was linked to US-MODERNATX, INC.-MOD-2022-672556, US-MODERNATX, INC.-MOD-2022-672560 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-672556:Wife's bivalent dose US-MODERNATX, INC.-MOD-2022-672560:Wife's second booster
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; Patient received eceived Monovalent booster instead of Bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received eceived Monovalent booster instead of Bivalent) and NO ADVERSE EVENT (no adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 082B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received eceived Monovalent booster instead of Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received eceived Monovalent booster instead of Bivalent) 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 WRONG PRODUCT ADMINISTERED (Patient received eceived Monovalent booster instead of Bivalent).    Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-672524, US-MODERNATX, INC.-MOD-2022-672557 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-672524:1st Elderly patient US-MODERNATX, INC.-MOD-2022-672557:2nd Elderly patient
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    Concomitant medications were not reported.  27 adult patients received pediatric dose of Bivalent  COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                  No treatment information was provided by the reporter.  This case contains information for the 11 of 27 adult patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    Concomitant medications were not reported.  27 adult patients received pediatric dose of Bivalent  COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                  No treatment information was provided by the reporter.  This case contains information for the 26 of 27 adult patients described by the reporter.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Malaise, Pain in extremity
Clinical narrative: Malaise; Sore arms; a nurse accidentally administered 2 doses of Pfizer bivalent adult to a 14-year-old patient on each arm; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A 14-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 14 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1st, Date: 26May2021, Site of injection: Left Arm, Route of administration: Intramuscular, Batch/ Lot number: Not available / Provided at time of report completion), administration date: 26May2021, for COVID-19 Immunization; BNT162b2 (Dose: 2nd, Date: 17Jun2021, Site of injection: Left Arm, Route of administration: Intramuscular, Batch/ Lot number: Not available / Provided at time of report completion), administration date: 17Jun2021, for COVID-19 Immunization; BNT162b2 (Dose: 3rd, Date: 21Jan2022, Site of injection: Left Arm, Route of administration: Intramuscular, Batch/ Lot number: Obscured by other product labelling), administration date: 21Jan2022, for COVID-19 Immunization. The following information was reported: MALAISE (non-serious) with onset 22Oct2022, outcome "recovered"; PAIN IN EXTREMITY (non-serious) with onset 22Oct2022, outcome "recovered", described as "Sore arms"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 22Oct2022, outcome "unknown", described as "a nurse accidentally administered 2 doses of Pfizer bivalent adult to a 14-year-old patient on each arm". Therapeutic measures were not taken as a result of malaise, pain in extremity. Additional information: It was reported that, a patient who accidentally administered 2 doses of a Bivalent adult booster to a 14-year-old patient on each arm (Site of injection: Left + Right Arm). She said that it happened on Saturday and it's been 24hrs and she mentioned that there were no side effects reported yet and the patient was still doing ok. They wanted to know what they could advise the parents regarding the situation. Considered the Pfizer product had a causal effect to the adverse event was Yes. Specific relevant test for thromboembolic events with thrombocytopenia was unknown.  Follow-up (09Nov2022): This is a spontaneous follow-up report received from a contactable Pharmacist. This Pharmacist reported in response to HCP letter sent which included that: Updated information included: Reporter information slider #02 updated, Patients information (Patient initial, age at vaccination), Historical vaccine added. Product details (vaccination date, dose number, dose description, batch / lot number, route of administration, anatomical site of injection) added. Vaccine facility information added. New event (Malaise and Sore arms) added