chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: OVER 50 PATIENTS WITH NEW OR REOCCURRING CANCER DIAGNOSIS; This spontaneous report received from a consumer via a company representative via social media (J and J Corporate account) concerned multiple (over 50) patients of an 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 (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered, 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.  Reporter stated that, "Anyone with a brain, didn't get the vax. I begged my hubs not to get it and now has a new cancer diagnosis. Even my Dr said she has over 50 patients with new or reoccurring cancer diagnosis, since getting the vax". On an unspecified date, over 50 patients diagnosed with new or reoccurring cancer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of over 50 patients with new or reoccurring cancer diagnosis was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221223452.; Sender's Comments: V0: 20221223430- over 50 patients with new or reoccurring cancer diagnosis.  Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: CANCER; This spontaneous report received from a consumer via a company representative via media concerned a male of 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 (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.  On an unspecified date, the patient experienced cancer (new cancer diagnosis). It was reported that "anyone with a brain, didn't get the vax. I begged my hubs not to get it and now has a new cancer diagnosis". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cancer was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221223430.; Sender's Comments: V0: 20221223452-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 Agency Causality is considered indeterminate. The company causality is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Muscle spasticity
Clinical narrative: DEVELOPED SPASTICITY FROM THE VACCINE/BODY OVER THE EDGE; COULD NOT STAND TO WALK AFTER 15 MINUTE OBSERVATION PERIOD POST VACCINATION; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: spasticity in legs, multiple sclerosis relapse (Progressed to secondary progressive multiple sclerosis), pleural effusions, bedridden, pain, legs tired, tired, sees dots and bright stars, skin wrinkly, pericardial effusion, iron deficiency anemia, and wheely walker user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included melatonin, modafinil, tizanidine, and vaccinium macrocarpon. On APR-2021, the patient experienced developed spasticity from the vaccine/body over the edge, and could not stand to walk after 15 minute observation period post vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from could not stand to walk after 15 minute observation period post vaccination, developed spasticity from the vaccine/body over the edge. This report was non-serious. This report was associated with a product quality complaint: 90000262551.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: TWO WEEKS AFTER HAD A BALL ON THE CHEST NEXT TO HEART WHICH HURTS; This spontaneous report received from a consumer concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic, non alcoholic, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and there was no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: 20-JAN-2022) dose was not reported, administered on 08-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 57 years old. Concomitant medications included metformin for diabetic, acetylsalicylic acid for drug used for unknown indication, and atorvastatin for drug used for unknown indication.  On MAR-2021, the patient experienced two weeks after had a ball on the chest next to heart which hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from two weeks after had a ball on the chest next to heart which hurts. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: IDIOPATHIC THROMBOCYTOPENIC PURPURA; This spontaneous report received from a consumer via a company representative concerned a female of 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 (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced idiopathic thrombocytopenic purpura (ITP) immediately after the J and J vaccine. Nothing was working and reporter believes their hematologist was not quite up to par regarding treatment. Patient had not yet done splenectomy. Reporter was asking for advice before a splenectomy and wanted to know about success rate for the splenectomy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of idiopathic thrombocytopenic purpura was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221224980-idiopathic thrombocytopenic purpura . The event has a compatible/suggestive temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID TWICE; This spontaneous report received from a consumer via a company representative through social media concerned a patient of 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) (suspension for injection, route of admin, and batch number and expiry 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 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 and expiry 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, the patient got covid twice (Dose number in series 2). As per reporter "got the vaccines and still got covid twice. They worked so well didn't they. Those were the lies and conspiracy theories" (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid twice was not reported. This report was non-serious. This report was associated with a product quality complaint 90000262861.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: HAD THAT TOO; 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 had that too. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had that too was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: DEATHLY ILL; 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 was not reported, administered on SEP-2021 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 SEP-2021, the patient experienced deathly ill. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deathly ill. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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 was not reported, administered on MAR-2021 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 DEC-2021, the patient experienced covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid. This report was non-serious. This report was associated with a product quality complaint: 90000262891. This case, from the same reporter is linked to 20221225992.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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 was not reported, administered on MAR-2021 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 DEC-2021, the patient experienced covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid. This report was non-serious. This case, from the same reporter is linked to 20221225991. This report was associated with a product quality complaint: 90000262890.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Injection site bruising
Clinical narrative: BRUISE ON THE LOCATION; 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 ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had not infected with covid-19 infection. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (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. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received first booster, dose 2 with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date 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. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). The patient received second booster, dose 3 with Non-company suspect vaccine covid-19 vaccine (unspecified manufacturer), (Dose number in series 3), (form of admin, route of admin, and batch number and expiry date were not reported), dose, start therapy date were not reported for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine (Dose number in series 3). No concomitant medications were reported.  On an unspecified date, the patient experienced bruise on the location (Injection site bruising) (Dose number in series 3). It was reported as "I got the shot and the boosters and nothing bad happened. Yeah, it felt like a bruise on the location, no big deal. I also didn't get Covid" The action taken with covid-19 vaccine ad26.cov2.s, and covid-19 vaccine was not applicable. The outcome of the bruise on the location and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hair growth abnormal
Clinical narrative: FACIAL HAIR WAS NOT GROWING THE SAME; This spontaneous report received from a health care professional via other manufacturer (Pfizer) concerned a 5 decade old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: smoker. Patient was health care worker. The patient had previously received tozinameran (Dose number in series 1) (form of administration was not reported, intramuscular and batch number: EK5730, expiry 6-JAN-2021) dose was not reported, administered to left arm on 16-DEC-2020 for covid-19 prophylaxis. On 16-DEC-2020 at 09:50 AM, patient experienced eye puffiness, light headedness, scratchy throat within 10 minutes after vaccination (Dose number in series 1). The patient was treated with epinephrine, famotidine and diphenhydramine hydrochloride for eye puffiness, light headedness, and scratchy throat in the emergency department. The patient felt completely back to normal within an hour and was released. 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 was not reported, 01 total was administered on APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 5 decade old. No concomitant medications were reported. On JUN-2022, the patient reported that facial hair was not growing the same (Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of facial hair was not growing the same was not reported. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; primary series of Moderna COVID19 Vaccine expired on 25Nov2022 but it was administered 8Dec2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (primary series of Moderna COVID19 Vaccine expired on 25Nov2022 but it was administered 8Dec2022.) and NO ADVERSE EVENT (No Adverse Event) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 054B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 08-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (primary series of Moderna COVID19 Vaccine expired on 25Nov2022 but it was administered 8Dec2022.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (primary series of Moderna COVID19 Vaccine expired on 25Nov2022 but it was administered 8Dec2022.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (primary series of Moderna COVID19 Vaccine expired on 25Nov2022 but it was administered 8Dec2022.).    No concomitant drug information was provided.  It was confirmed that there was no parental exposure. It was reported that the patient had not received any other vaccine in 4 weeks prior to COVID-19 vaccine. The reporter didn't knew if the patient had experienced any adverse event since the patient was not contacted.  No treatment drug information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk, Immunisation reaction
Clinical narrative: messenger RNA was found in breastmilk by women who took the vaccine afterwards; Lipid nanoparticles which exist for later than 2 days and stay in body fluids. They pass through placenta barriers as well; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (messenger RNA was found in breastmilk by women who took the vaccine afterwards) and IMMUNISATION REACTION (Lipid nanoparticles which exist for later than 2 days and stay in body fluids. They pass through placenta barriers as well) in a  patient of an unknown age and gender exposed to mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) , while the mother received the product for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the mother received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with EXPOSURE VIA BREAST MILK (messenger RNA was found in breastmilk by women who took the vaccine afterwards) and IMMUNISATION REACTION (Lipid nanoparticles which exist for later than 2 days and stay in body fluids. They pass through placenta barriers as well). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, EXPOSURE VIA BREAST MILK (messenger RNA was found in breastmilk by women who took the vaccine afterwards) had resolved and IMMUNISATION REACTION (Lipid nanoparticles which exist for later than 2 days and stay in body fluids. They pass through placenta barriers as well) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Transmammary), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Patient age was reported as 0 years.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient accidentally received 0.5ml Bivalent booster instead of first primary dose; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of NO ADVERSE EVENT (no adverse event) and WRONG PRODUCT ADMINISTERED (patient accidentally received 0.5ml Bivalent booster instead of first primary dose) in a 31-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 07-Dec-2022, the patient experienced NO ADVERSE EVENT (no adverse event). On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (patient accidentally received 0.5ml Bivalent booster instead of first primary dose). At the time of the report, NO ADVERSE EVENT (no adverse event) had not resolved and WRONG PRODUCT ADMINISTERED (patient accidentally received 0.5ml Bivalent booster instead of first primary dose) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient accidentally received 0.5ml Bivalent booster instead of first primary dose).    Moderna is authorized to communicate with the vaccine recipient's primary healthcare professional regarding this notification No Concomitant Medication was provided by reporter. No Treatment Medication was provided by reporter.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Blister, Chills, Fatigue, Injection site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (having blisters that looked like pimples.), PRURITUS (itchy blisters), PUSTULE (blisters filled with puss), PAIN (painful blisters) and FATIGUE (fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 030A21A and 004M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient was healthy.  Concurrent medical conditions included Dry eyes. Concomitant products included CICLOSPORIN (RESTASIS) for Dry eyes, PREDNISONE for an unknown indication.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.      Most recent FOLLOW-UP information incorporated above includes: On 08-Dec-2022: Follow up information included reporter details added, new events added, suspect vaccine and concomitant drug details updated, and event description updated in narrative supplement.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pruritus, Pustule
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (having blisters that looked like pimples.), PRURITUS (itchy blisters), PUSTULE (blisters filled with puss), PAIN (painful blisters) and FATIGUE (fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 030A21A and 004M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient was healthy.  Concurrent medical conditions included Dry eyes. Concomitant products included CICLOSPORIN (RESTASIS) for Dry eyes, PREDNISONE for an unknown indication.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.      Most recent FOLLOW-UP information incorporated above includes: On 08-Dec-2022: Follow up information included reporter details added, new events added, suspect vaccine and concomitant drug details updated, and event description updated in narrative supplement.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin normal, Blister, Blood test normal, Chills, Fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (having blisters that looked like pimples.), PRURITUS (itchy blisters), PUSTULE (blisters filled with puss), PAIN (painful blisters) and FATIGUE (fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 030A21A and 004M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient was healthy.  Concurrent medical conditions included Dry eyes. Concomitant products included CICLOSPORIN (RESTASIS) for Dry eyes, PREDNISONE for an unknown indication.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.      Most recent FOLLOW-UP information incorporated above includes: On 08-Dec-2022: Follow up information included reporter details added, new events added, suspect vaccine and concomitant drug details updated, and event description updated in narrative supplement.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Genital blister, Injection site pain, Laboratory test, Pruritus, Pustule
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (having blisters that looked like pimples.), PRURITUS (itchy blisters), PUSTULE (blisters filled with puss), PAIN (painful blisters) and FATIGUE (fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 030A21A and 004M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient was healthy.  Concurrent medical conditions included Dry eyes. Concomitant products included CICLOSPORIN (RESTASIS) for Dry eyes, PREDNISONE for an unknown indication.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.      Most recent FOLLOW-UP information incorporated above includes: On 08-Dec-2022: Follow up information included reporter details added, new events added, suspect vaccine and concomitant drug details updated, and event description updated in narrative supplement.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin lesion, Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (having blisters that looked like pimples.), PRURITUS (itchy blisters), PUSTULE (blisters filled with puss), PAIN (painful blisters) and FATIGUE (fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 030A21A and 004M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient was healthy.  Concurrent medical conditions included Dry eyes. Concomitant products included CICLOSPORIN (RESTASIS) for Dry eyes, PREDNISONE for an unknown indication.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.      Most recent FOLLOW-UP information incorporated above includes: On 08-Dec-2022: Follow up information included reporter details added, new events added, suspect vaccine and concomitant drug details updated, and event description updated in narrative supplement.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Head injury, Headache, Loss of consciousness, Syncope
Clinical narrative: passed out; Fainted; hit his head; headache; tired; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) and SYNCOPE (Fainted) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), SYNCOPE (Fainted) (seriousness criterion medically significant), HEAD INJURY (hit his head), HEADACHE (headache) and FATIGUE (tired). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), HEAD INJURY (hit his head) and HEADACHE (headache) had resolved and SYNCOPE (Fainted) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.  It was reported that 24 hours after 2nd shot of vaccine patient was passed out and hit his head. He had weird headache before passing out. He was tired and fainted. Patient was transported to the hospital on Feb-2021.  Treatment information was not provided.  Company Comment: This is a spontaneous case concerning a 77-year-old male patient with no reported medical history, who experienced the unexpected, serious (medically significant) events of Loss of consciousness and Syncope. 24 hours after receiving a dose of mRNA-1273 vaccine (second COVID-19 vaccine) the patient passed out and hit his head. The patient had weird headache before passing out. The patient was tired and fainted and was transported to a hospital. Clinical course, diagnostic tests and treatment details were not provided in the case. At the time of the report, the event Loss of consciousness had resolved while the outcome of the event Syncope was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 08-Dec-2022: Added new events.; Sender's Comments: This is a spontaneous case concerning a 77-year-old male patient with no reported medical history, who experienced the unexpected, serious (medically significant) events of Loss of consciousness and Syncope. 24 hours after receiving a dose of mRNA-1273 vaccine (second COVID-19 vaccine) the patient passed out and hit his head. The patient had weird headache before passing out. The patient was tired and fainted and was transported to a hospital. Clinical course, diagnostic tests and treatment details were not provided in the case. At the time of the report, the event Loss of consciousness had resolved while the outcome of the event Syncope was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pain
Clinical narrative: The patient states her arm, where she got the shot, it's still sore.; There's a little white round circle.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (The patient states her arm, where she got the shot, it's still sore.) and VACCINATION SITE DISCOLOURATION (There's a little white round circle.) 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. 021H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose, lot EN6204) on 17-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (2nd dose, lot AR8733) on 08-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (4th dose Pfizer and lot FJ6369) on 02-May-2022; for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (3rd dose Moderna (booster) and lot 939905) on 05-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 24-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (The patient states her arm, where she got the shot, it's still sore.) and VACCINATION SITE DISCOLOURATION (There's a little white round circle.). At the time of the report, VACCINATION SITE PAIN (The patient states her arm, where she got the shot, it's still sore.) and VACCINATION SITE DISCOLOURATION (There's a little white round circle.) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were reported. No treatment medicine were reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was first punctured on 08-Dec-2022 at 1:10 PM and then administered on 09-Dec-2022 at 8:30 AM; No adverse event; Dose administered more than 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was first punctured on 08-Dec-2022 at 1:10 PM and then administered on 09-Dec-2022 at 8:30 AM) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:None;Question:Was there parental vaccine exposure?Answer:No.     On 09-Dec-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) .5 milliliter. On 09-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 08-Dec-2022 at 1:10 PM and then administered on 09-Dec-2022 at 8:30 AM) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was first punctured on 08-Dec-2022 at 1:10 PM and then administered on 09-Dec-2022 at 8:30 AM) 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 (Dose administered more than 12 hours post puncture) and PRODUCT STORAGE ERROR (The vial was first punctured on 08-Dec-2022 at 1:10 PM and then administered on 09-Dec-2022 at 8:30 AM).    Patient dose details reported as: 1st dose: Moderna batch/lot number 027L20A-Administered on 12-Jan-2021  2nd dose: Moderna batch/lot number 043L20A-Administered on 09-Feb-2021 3rd dose: Moderna batch/lot number 037F21A-Administered on 06-Dec-2021  4th dose: Moderna batch/lot number 058A22A-Administered on 07-Jun-2022  On 09-Dec-2022 patient received fifth dose as additional booster dose.  No concomitant medication information was provided.  Patient didn´t report side effects.  No treatment medication were provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome, Vaccination failure
Clinical narrative: 2 doses of the Moderna COVID-19 10FEB2021 and 16MAR2021 vaccine and now has "long covid."; Long covid started in September, which symptoms are continuing up until today; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION FAILURE (2 doses of the Moderna COVID-19 10FEB2021 and 16MAR2021 vaccine and now has "long covid.") and POST-ACUTE COVID-19 SYNDROME (Long covid started in September, which symptoms are continuing up until today) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POST-ACUTE COVID-19 SYNDROME (Long covid started in September, which symptoms are continuing up until today). On an unknown date, the patient experienced VACCINATION FAILURE (2 doses of the Moderna COVID-19 10FEB2021 and 16MAR2021 vaccine and now has "long covid."). At the time of the report, VACCINATION FAILURE (2 doses of the Moderna COVID-19 10FEB2021 and 16MAR2021 vaccine and now has "long covid.") outcome was unknown and POST-ACUTE COVID-19 SYNDROME (Long covid started in September, which symptoms are continuing up until today) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient had received 2 doses of the Moderna COVID-19 10FEB2021 and 16MAR2021 vaccine and now had long covid. Long covid started in September, which symptoms are continuing up until today. No treatment information was provided.  Company Comment:  This is a spontaneous case concerning a 35-year-old, female patient with no reported medical history, who experienced the unexpected non-serious event of Post-acute COVID-19 syndrome and vaccination failure. Patient received 2 doses of mRNA-1273 vaccine and approximately 18 months later, experienced long COVID. No further information on clinical course, sars-Cov-2 tests and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 35-year-old, female patient with no reported medical history, who experienced the unexpected non-serious event of Post-acute COVID-19 syndrome and vaccination failure. Patient received 2 doses of mRNA-1273 vaccine and approximately 18 months later, experienced long COVID. No further information on clinical course, sars-Cov-2 tests and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; The patient got half dose of the bivalent booster, not full dose. T; This spontaneous case was reported by a pharmacist and describes the occurrence of NO ADVERSE EVENT (No adverse event) and UNDERDOSE (The patient got half dose of the bivalent booster, not full dose. T) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-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) 1 dosage form. On 25-Nov-2022, the patient experienced NO ADVERSE EVENT (No adverse event) and UNDERDOSE (The patient got half dose of the bivalent booster, not full dose. T). At the time of the report, NO ADVERSE EVENT (No adverse event) and UNDERDOSE (The patient got half dose of the bivalent booster, not full dose. T) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (The patient got half dose of the bivalent booster, not full dose. T).    Concomitant medications were not reported.                                       No treatment information was provided by the reporter.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (inadvertently administered with the Moderna COVID-19 Vaccine Bivalent instead of the first dose of the primary series) and NO ADVERSE EVENT (No Adverse Event) in a 10-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 prophylaxis.     The patient's past medical history included Febrile seizure (febrile seizure when patient was younger). Previously administered products included for Drug use for unknown indication: flu shot (flu shot). Past adverse reactions to the above products included No adverse event with flu shot.    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 WRONG PRODUCT ADMINISTERED (inadvertently administered with the Moderna COVID-19 Vaccine Bivalent instead of the first dose of the primary series) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (inadvertently administered with the Moderna COVID-19 Vaccine Bivalent instead of the first dose of the 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 (inadvertently administered with the Moderna COVID-19 Vaccine Bivalent instead of the first dose of the primary series).    No concomitant medication was reported. A 10 year old patient was inadvertently administered with the Moderna COVID-19 Vaccine Bivalent instead of the first dose of the primary series. HCP did not know the exact date of the administration because the vaccine was not administered in that facility. No treatment medication was reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: n adult patient was adminsitered with the pediatric monovalent vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (n adult patient was adminsitered with the wrong monovalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR7479B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (n adult patient was adminsitered with the wrong monovalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (n adult patient was adminsitered with the wrong monovalent vaccine) 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 (n adult patient was adminsitered with the wrong monovalent vaccine).    No relevant concomitant medications were reported. No treatment medication reported.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 hours post puncture Vial was first punctured on 08Dec2022 and then administered on 09Dec2022) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     It was reported patient had no medical history/ conditions, allergy, concomitant diseases and risk factor.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Batch number: 043L20A.) on 09-Feb-2021, Moderna COVID-19 vaccine (Batch number: 037K20A.) on 09-Mar-2021 and Moderna COVID-19 vaccine (Batch number: 037F21A.) on 17-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine.          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 EXPIRED PRODUCT ADMINISTERED (12 hours post puncture Vial was first punctured on 08Dec2022 and then administered on 09Dec2022).    Concomitant products were not reported.  It was reported that dose administered more than 12 hours post puncture Vial was first punctured on 08-Dec-2022 at 1:10 PM and then administered on 09-Dec-2022 at 8:30 AM. Patient did not report side effects.  Treatment medications were not reported.