chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Peripheral swelling, Spinal operation
Clinical narrative: STROKE; BACK OPERATION; ANKLE OPERATION; KNEE OPERATION; ANEURYSM; HAND SWELLING; JOINT SWELLING OF HAND; This spontaneous report received from a patient concerned an adult female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry was not reported) dose was not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. Age at time of vaccination 59 years old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. Non-company suspect drug included: upadacitinib (form of admin unknown, oral, batch number and expiry was not reported) dose and frequency and therapy dates were not reported, ongoing treatment for moderate to severe rheumatoid arthritis. On an unspecified date, the patient experienced stroke, back operation, ankle operation, knee operation, aneurysm, left hand shaking, hand swelling, and joint swelling of hand (Knuckle swelling). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of upadacitinib was not changed. The patient was recovering from stroke, and aneurysm, had not recovered from hand swelling, and joint swelling of hand, and the outcome of back operation, ankle operation and knee operation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220860405- covid-19 vaccine ad26.cov2.s -Stroke, Back operation, Ankle operation, Knee operation, aneurysm. The event(s) 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(s). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Myocardial infarction
Clinical narrative: HEART ATTACK; 3 STROKES; This spontaneous legal received from a lawyer 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 was not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total, start therapy date was 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 suffered from a heart attack after received the Janssen covid-19 vaccine. The patient was also suffered 3 strokes as well. The patient was alleged injury 05-MAR-2021, but the law clerk was not sure if that was when the patient received the vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart attack and 3 strokes was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Medical Assessment comment not required as per standard operating procedure for legal case.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Ear discomfort, Feeling abnormal, Off label use, Paraesthesia
Clinical narrative: This spontaneous report received from a patient concerned a 58 year old white male. The patient's height and weight were not reported. The patient's concurrent conditions included: pre diabetic, hepatitis c (positive but not active genotype 3), chronic pain syndrome, arthritis, bipolar, anxiety disorder, smoker (nicotine) and allergy. The patient was previously received Moderna covid-19 vaccine (elasomeran) (dose number in series 1) (form of administration, route of administration were not reported, batch number: 012H21PZ and expiry: unknown) dose was not reported, administered to the right arm on 01-SEP-2021 for covid-19 prophylaxis. It was unknown whether the patient had any adverse events following vaccination with Moderna covid-19 vaccine (elasomeran) (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 not reported, batch number: 1808980 expiry: unknown) dose was not reported, 1 total administered to the right arm on 01-OCT-2021 for covid-19 prophylaxis which was an off label dosing frequency. The drug was associated with Off label use. Age at time of vaccination 58 years old. Concomitant medications included lisinopril (drug started on OCT-2021), metformin (drug started MAY-2022), omeprazole (drug started on JAN-2022) and sildenafil (drug started on AUG-2022). The patient also received non-company co-suspect drug Pfizer (Paxlovid) (form of administration, route of administration, batch number, and expiry were not reported) dose was not reported, administered on 17-AUG-2022 for treatment of COVID-19. On 18-AUG-2022, the patient experienced fogged mental state, ears popping, anxiety and tingling in the skin (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with Pfizer (Paxlovid) was unknown. The patient recovered from fogged mental state, ears popping, anxiety, and tingling in the skin on 19-AUG-2022, and the outcome of off label dosing frequency was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Colitis ulcerative
Clinical narrative: COLITIS ULCERATIVE AGGRAVATED; This spontaneous report received from a patient via other company concerned an adult female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, 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. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis. No concomitant medications were reported.  On an unspecified date, the patient experienced colitis ulcerative aggravated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from colitis ulcerative aggravated. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220863481- covid-19 vaccine ad26.cov2.s - colitis ulcerative aggravated. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Peripheral swelling, Somnolence
Clinical narrative: This spontaneous report received from a patient concerned a 5 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, pre-diabetic, and shrimp allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 15:00 for covid-19 prophylaxis. Age at time of vaccination 42 years old. No concomitant medications were reported. On an unspecified date, the patient experienced drowsy at night, swelling in the right arm, and injection site area was still swollen and looks like lump. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site area was still swollen and looks like lump, and swelling in the right arm, and the outcome of drowsy at night was not reported. This report was non-serious.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS) in a 46-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS). At the time of the report, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The reporter did some research and found a case report of postural orthostatic tachycardia syndrome in a patient after being the administration of the 1st dose of the Moderna Covid-19 vaccine. No treatment medications were reported. The publication was Unknown. Company Comment: This spontaneous case concerns a 46-year-old male patient with no medical history reported, who experienced the unexpected non-serious AESI of Postural orthostatic tachycardia syndrome that occurred in the context of first dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2022-633799 (E2B Linked Report). Sender's Comments: This spontaneous case concerns a 46-year-old male patient with no medical history reported, who experienced the unexpected non-serious AESI of Postural orthostatic tachycardia syndrome that occurred in the context of first dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-633799: Reporter's case (Female Patient).
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose given >12 hours post puncture), PRODUCT STORAGE ERROR (vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 3 days) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 vaccination. No Medical History information was reported. On 22-Aug-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose given >12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 3 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose given >12 hours post puncture), PRODUCT STORAGE ERROR (vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 3 days) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (dose given >12 hours post puncture) and PRODUCT STORAGE ERROR (vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 3 days). No concomitant medications were provided by the reporter. Moderna vaccine for 6 months to 5 years old was first punctured on 19-Aug-2022 around 10 AM. It was unknown if the vial was initially stored in the refrigerator. The vial was stored at room temperature post puncture. The vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 3 days. Later the vaccine was administered on 22-Aug-2022 at 9 AM. No treatment medications were provided by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dental discomfort, Lip swelling
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of LIP SWELLING (severe lip swelling) and DENTAL DISCOMFORT (Dentist wont do dental work until it is resolved) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy (allergy to Penicillin), Allergic reaction to antibiotics (allergy to Cefalexin), Ragweed allergy and Osteoarthrosis (mild). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced LIP SWELLING (severe lip swelling). On an unknown date, the patient experienced DENTAL DISCOMFORT (Dentist wont do dental work until it is resolved). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, LIP SWELLING (severe lip swelling) and DENTAL DISCOMFORT (Dentist wont do dental work until it is resolved) outcome was unknown. She has had severe lip swelling after receiving the Moderna vaccine second shot and booster doses. She had not received Botox. She got a steroid shot after the second vaccination but it didn't help. She had lip swelling the last time she was allergic to a medication. It was reported that the dentist wont do dental work until it is resolved. This case was linked to MOD-2021-123424 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Calcification of muscle, Joint stiffness, Magnetic resonance imaging, Muscle tightness, Vaginal haemorrhage
Clinical narrative: calcification in her right ankle that needed surgery; tightness in her right ankle but it was barely mild at the beginning; tightness in her left hip but it was barely mild at the beginning; 2 weeks of bleeding heavy, but it was not her period; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (2 weeks of bleeding heavy, but it was not her period), JOINT STIFFNESS (tightness in her right ankle but it was barely mild at the beginning), MUSCLE TIGHTNESS (tightness in her left hip but it was barely mild at the beginning) and CALCIFICATION OF MUSCLE (calcification in her right ankle that needed surgery) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 9399U1) for COVID-19 vaccination.   The patient's past medical history included Surgery on 13-Jun-2022. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) and PARACETAMOL (TYLENOL) for Pain and Inflammation.   On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Oct-2021, the patient experienced VAGINAL HAEMORRHAGE (2 weeks of bleeding heavy, but it was not her period). On 30-Oct-2021, the patient experienced JOINT STIFFNESS (tightness in her right ankle but it was barely mild at the beginning) and MUSCLE TIGHTNESS (tightness in her left hip but it was barely mild at the beginning). On 13-Jun-2022, the patient experienced CALCIFICATION OF MUSCLE (calcification in her right ankle that needed surgery). On 30-Oct-2021, VAGINAL HAEMORRHAGE (2 weeks of bleeding heavy, but it was not her period) had resolved. At the time of the report, JOINT STIFFNESS (tightness in her right ankle but it was barely mild at the beginning) and MUSCLE TIGHTNESS (tightness in her left hip but it was barely mild at the beginning) had not resolved and CALCIFICATION OF MUSCLE (calcification in her right ankle that needed surgery) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: a calcification in her ankle.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not have Allergies with medications, food and other products.  Patient never had COVID + test or diagnosis.  Patient did not mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Patient did not receive other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The AE cause patient to seek medical care visited orthopedic doctor, surgeon.  The patient did not experience a similar event in the past.  Treatment reported as Surgery, physical therapy, and pain medicine and anti-inflammatory like Advil or Tylenol.   This case was linked to MOD-2021-339090 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Inflammation, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: haven't been able to work; It feels like it's burning up some days and some other days it's not as bad.; it's like swollen; swollen red; inflammation/inflamed; hurts really bad; arm has been acting really bad ever since/where they gave me the shot/hurt every day/pain is central; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (haven't been able to work), BURNING SENSATION (It feels like it's burning up some days and some other days it's not as bad.), SWELLING (it's like swollen), ERYTHEMA (swollen red) and INFLAMMATION (inflammation/inflamed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced VACCINATION SITE PAIN (arm has been acting really bad ever since/where they gave me the shot/hurt every day/pain is central). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (haven't been able to work), BURNING SENSATION (It feels like it's burning up some days and some other days it's not as bad.), SWELLING (it's like swollen), ERYTHEMA (swollen red), INFLAMMATION (inflammation/inflamed) and PAIN IN EXTREMITY (hurts really bad). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (haven't been able to work), BURNING SENSATION (It feels like it's burning up some days and some other days it's not as bad.), SWELLING (it's like swollen), ERYTHEMA (swollen red), INFLAMMATION (inflammation/inflamed), PAIN IN EXTREMITY (hurts really bad) and VACCINATION SITE PAIN (arm has been acting really bad ever since/where they gave me the shot/hurt every day/pain is central) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site pain
Clinical narrative: haven't been able to work; It feels like it's burning up some days and some other days it's not as bad.; it's like swollen; swollen red; inflammation/inflamed; hurts really bad; arm has been acting really bad ever since/where they gave me the shot/hurt every day/pain is central; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (haven't been able to work), BURNING SENSATION (It feels like it's burning up some days and some other days it's not as bad.), SWELLING (it's like swollen), ERYTHEMA (swollen red) and INFLAMMATION (inflammation/inflamed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced VACCINATION SITE PAIN (arm has been acting really bad ever since/where they gave me the shot/hurt every day/pain is central). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (haven't been able to work), BURNING SENSATION (It feels like it's burning up some days and some other days it's not as bad.), SWELLING (it's like swollen), ERYTHEMA (swollen red), INFLAMMATION (inflammation/inflamed) and PAIN IN EXTREMITY (hurts really bad). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (haven't been able to work), BURNING SENSATION (It feels like it's burning up some days and some other days it's not as bad.), SWELLING (it's like swollen), ERYTHEMA (swollen red), INFLAMMATION (inflammation/inflamed), PAIN IN EXTREMITY (hurts really bad) and VACCINATION SITE PAIN (arm has been acting really bad ever since/where they gave me the shot/hurt every day/pain is central) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial initially stored in the refrigerator on either 30-Jun-2022 or 01-Jul-2022 and then administered on 01-Aug-2022; No adverse event; Received expired  2nd dose after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired  2nd dose after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on either 30-Jun-2022 or 01-Jul-2022 and then administered on 01-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired  2nd dose after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on either 30-Jun-2022 or 01-Jul-2022 and then administered on 01-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired  2nd dose after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on either 30-Jun-2022 or 01-Jul-2022 and then administered on 01-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired  2nd dose after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on either 30-Jun-2022 or 01-Jul-2022 and then administered on 01-Aug-2022).    Concomitant drugs were not reported. It was reported that patient received expired 2nd dose (6-11 year) beyond 30 days in the refrigerator.  The 3 doses 1 vial was initially stored in the refrigerator on either 30-Jun-2022 or 01-Jul-2022 not sure which day. The vial did not undergo any temperature excursions. Treatment medications were not provided. This case is created for pediatric patient 2.   This case was linked to US-MODERNATX, INC.-MOD-2022-636320, US-MODERNATX, INC.-MOD-2022-636330 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-636320:Paediatric patient -1 US-MODERNATX, INC.-MOD-2022-636330:Paediatric patient -3
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation
Clinical narrative: the skin in hands and between fingers was peeling during 3 or 4 weeks; This spontaneous case was reported by a nurse and describes the occurrence of SKIN EXFOLIATION (the skin in hands and between fingers was peeling during 3 or 4 weeks) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 027C21A) for COVID-19 vaccination.     Patient had no allergies and no medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient never had COVID positive test or diagnosis.    On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN EXFOLIATION (the skin in hands and between fingers was peeling during 3 or 4 weeks). On 04-Jul-2021, SKIN EXFOLIATION (the skin in hands and between fingers was peeling during 3 or 4 weeks) had resolved with sequelae.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is not under any concomitant or regular medication. It was reported that patient had no symptoms after dose 1. It was reported as the symptoms were ongoing but not as drastic as in the beginning with residual effects. Patient did not seek any medical care and not experienced a similar event in the past. It was also reported that the symptoms were improved. No treatment has been given but patient had to wash skin constantly with dove soap and water.   This case was linked to MOD-2022-636339 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: symptoms less pronounced, but itching in her feet/itching in her lower legs/itching in her chest/inching in her breast/very little itching in her back; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (symptoms less pronounced, but itching in her feet/itching in her lower legs/itching in her chest/inching in her breast/very little itching in her back) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049L21A and 033H21A) for COVID-19 vaccination.     Patient did not have any allergies to medications, food and other products. Patient did not have COVID + test or diagnosis. Patient did not have any acute and chronic illnesses at the time of vaccination. Patient did not receive any other vaccines within 1 month prior to Moderna COVID-19 vaccine.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced PRURITUS (symptoms less pronounced, but itching in her feet/itching in her lower legs/itching in her chest/inching in her breast/very little itching in her back). At the time of the report, PRURITUS (symptoms less pronounced, but itching in her feet/itching in her lower legs/itching in her chest/inching in her breast/very little itching in her back) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient was not under any concomitant or regular medication.  After the 1st and 2nd booster, the symptoms were less pronounced but the skin in the feet, lower legs, chest, breast and very little in the back was itching. This symptom was still ongoing but not as drastic as in the beginning, and patent had to wash the skin constantly with dove soap and water. No treatment had been given.  It was also reported that the symptoms were improved with residual effects.  The event did not cause patient to seek medical care(office visit, Urgent care, ER, hospitalized).  Patient had not experienced any similar event in the past.   This case was linked to MOD-2022-636336 (Patient Link).
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event, Wrong technique in product usage process
Clinical narrative: No adverse event; patient pulled away from the 2nd dose of the Moderna Covid-19 vaccine and most of the dose leaked down the patients leg.; patient pulled away from the 2nd dose of the Moderna Covid-19 vaccine and most of the dose leaked down the patients leg.; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (patient pulled away from the 2nd dose of the Moderna Covid-19 vaccine and most of the dose leaked down the patients leg.), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (patient pulled away from the 2nd dose of the Moderna Covid-19 vaccine and most of the dose leaked down the patients leg.) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Aug-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2022, the patient experienced ACCIDENTAL UNDERDOSE (patient pulled away from the 2nd dose of the Moderna Covid-19 vaccine and most of the dose leaked down the patients leg.) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (patient pulled away from the 2nd dose of the Moderna Covid-19 vaccine and most of the dose leaked down the patients leg.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patient pulled away from the 2nd dose of the Moderna Covid-19 vaccine and most of the dose leaked down the patients leg.), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (patient pulled away from the 2nd dose of the Moderna Covid-19 vaccine and most of the dose leaked down the patients leg.) 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 assessments were provided for ACCIDENTAL UNDERDOSE (patient pulled away from the 2nd dose of the Moderna Covid-19 vaccine and most of the dose leaked down the patients leg.) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (patient pulled away from the 2nd dose of the Moderna Covid-19 vaccine and most of the dose leaked down the patients leg.).    No concomitant medications was reported. No treatment medications was reported.  The patient pulled away from the 2nd dose of the Moderna Covid-19 vaccine and most of the dose leaked down the patients leg. the patient received the vaccine in the left thigh. No other adverse reactions were reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 19-Aug-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In July 2022, the patient experienced COVID-19 (COVID-19). In 2022, COVID-19 (COVID-19) had resolved.            Company comment: This is a spontaneous case concerning a 69-year-old male patient with Hidradenitis suppurativa on treatment with Adalimumab, who experienced the non-serious  unexpected AESI COVID-19, approximately 7 months after the third dose of mRNA-1273.  A SARS-CoV-2 test was performed without reported results. Clinical findings, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.  The patient took adalimumab (solution for injection in pre-filled pen). No concomitant medications were reported. The reporter causality of adalimumab (Humira) for an event of COVID-19 was not provided. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. No treatment medications were reported.   This case was linked to MOD-2022-636464 (Patient Link).; Sender's Comments: Company comment: This is a spontaneous case concerning a 69-year-old male patient with Hidradenitis suppurativa on treatment with Adalimumab, who experienced the non-serious  unexpected AESI COVID-19, approximately 7 months after the third dose of mRNA-1273.  A SARS-CoV-2 test was performed without reported results. Clinical findings, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 1st dose on 12Feb2021 and 2nd dose on 24Mar2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 12Feb2021 and 2nd dose on 24Mar2021) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 028L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu shot (about 20 years ago.). Past adverse reactions to the above products included Autoimmune disorder with flu shot.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 12Feb2021 and 2nd dose on 24Mar2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 12Feb2021 and 2nd dose on 24Mar2021) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 12Feb2021 and 2nd dose on 24Mar2021).    Patient has not had COVID No concomitant medication was provided by reporter. No treatment medication was provided by reporter. It was reported that patient has a funny immune system and got an autoimmune disorder from the flu shot about 20 years ago   This case was linked to MOD-2022-636503 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Die from the vax) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 2021 The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication provided. No treatment information mentioned. Reporter mentioned 2 friends in their 40s who died after the vaccine. Both were healthy, one was forced to take it or would lose their job. Company comment: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced unexpected, medically significant Death, which occurred at an unknown time with regards to vaccination with mRNA-1273. No further information was provided. The cause of death is unknown, and no autopsy result was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced unexpected, medically significant Death, which occurred at an unknown time with regards to vaccination with mRNA-1273. No further information was provided. The cause of death is unknown, and no autopsy result was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reported Cause(s) of Death: Unknown cause of death.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored at room temperature for 25 hours post puncture; No Adverse event; Dose administered more than 12 hours post puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was stored at room temperature for 25 hours post puncture) and NO ADVERSE EVENT (No Adverse event) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 055A22A) for COVID-19 prophylaxis.     The patient had no known allergies. The reporter believe that patient never had tested or diagnosed with COVID-19.     On 25-Aug-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2022 at 9:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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 stored at room temperature for 25 hours post puncture) 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 stored at room temperature for 25 hours post puncture) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture) and PRODUCT STORAGE ERROR (The vial was stored at room temperature for 25 hours post puncture).    It was reported that patient took several regular medications. The patient received pneumococcal vaccine on 25-Aug-2022, on the same day of COVID-19 vaccination.  The patient received booster dose.  The patient did not seek medical care for the adverse event. Total 1 dose was administered.  The vial was first punctured on 24-Aug-2022 at 8 AM. The vial was stored in room temperature post puncture. The vial was exposed to room temperature for 25 hours. The vial did not undergo any temperature excursions.  No treatment  medications were reported.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Lymphadenopathy
Clinical narrative: substantial bruising on my side ribcage and side of my breast; First swelling in my armpit; This spontaneous case was reported by a patient and describes the occurrence of CONTUSION (substantial bruising on my side ribcage and side of my breast) and LYMPHADENOPATHY (First swelling in my armpit) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no medical conditions.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONTUSION (substantial bruising on my side ribcage and side of my breast) and LYMPHADENOPATHY (First swelling in my armpit). At the time of the report, CONTUSION (substantial bruising on my side ribcage and side of my breast) and LYMPHADENOPATHY (First swelling in my armpit) had resolved.            No concomitant medications were reported. Patient had received all moderna vaccine and boosters dose. No treatment medications were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Thyroid disorder
Clinical narrative: they got blood work that showed that their thyroid issue; This spontaneous case was reported by a patient and describes the occurrence of THYROID DISORDER (they got blood work that showed that their thyroid issue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H2RB, 026D21A and 011D21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Rheumatoid arthritis and Hypertension.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced THYROID DISORDER (they got blood work that showed that their thyroid issue). The patient was treated with METHIMAZOLE for Thyroid disorder NOS, at a dose of 10 milligram. At the time of the report, THYROID DISORDER (they got blood work that showed that their thyroid issue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, Blood test: showed thyroid issue..         Patient was on medication for Rheumatoid Arthritis and High blood pressure.
Age: 34.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthropathy
Clinical narrative: Hip issues after COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPATHY (Hip issues after COVID vaccine) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and Ulcerative colitis.    No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced ARTHROPATHY (Hip issues after COVID vaccine). At the time of the report, ARTHROPATHY (Hip issues after COVID vaccine) outcome was unknown.            No concomitant medications was reported.   It was unknown if patient was enrolled in a COVID-19 vaccine trial.   No treatment medications was reported.  The reporter's causality for the event of hip issues after covid vaccine with Humira was not provided. The reporter assessed event hip issues after covid vaccine as probably related to Moderna COVID-19 vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event, Product storage error
Clinical narrative: Vial initially stored in the refrigerator on 21-Apr-2022 and then administered on 02-Jun-2022; No adverse event; Dose administered after 30-day Use By Date; Dose 1 administered on 19-Apr-2022 and Dose 2 administered on 02-Jun-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 19-Apr-2022 and Dose 2 administered on 02-Jun-2022), PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 21-Apr-2022 and then administered on 02-Jun-2022) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 002M21A and 002M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 02-Jun-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 19-Apr-2022 and Dose 2 administered on 02-Jun-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 21-Apr-2022 and then administered on 02-Jun-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 19-Apr-2022 and Dose 2 administered on 02-Jun-2022), PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 21-Apr-2022 and then administered on 02-Jun-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (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 administered after 30-day Use By Date), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 19-Apr-2022 and Dose 2 administered on 02-Jun-2022) and PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 21-Apr-2022 and then administered on 02-Jun-2022).    Reported that vial did not undergo any temperature excursions. Reported that patient was administered the Moderna Covid-19 vaccine as second primary series dose by intramuscular injection after the 30 days beyond use date. Patient did not experience any symptoms following vaccination. No additional doses, medications, or treatments have been administered at that time.   This case was linked to US-MODERNATX, INC.-MOD-2022-637076 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-637076:Patient( C-B)