chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Nausea, Pain, Pain in extremity
Clinical narrative: Very red area by her left collar bone of 5.5 mm and increased to 9.5mm 3 days later; Very painful area by her left collar bone of 5.5 mm and increased to 9.5mm 3 days later; Nausea; Tired; Slight sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Slight sore arm), ERYTHEMA (Very red area by her left collar bone of 5.5 mm and increased to 9.5mm 3 days later), PAIN (Very painful area by her left collar bone of 5.5 mm and increased to 9.5mm 3 days later), NAUSEA (Nausea) and FATIGUE (Tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042A21A) for COVID-19 vaccination. The patient's past medical history included Unconscious.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (Slight sore arm), NAUSEA (Nausea) and FATIGUE (Tired). On 19-Apr-2021, the patient experienced ERYTHEMA (Very red area by her left collar bone of 5.5 mm and increased to 9.5mm 3 days later) and PAIN (Very painful area by her left collar bone of 5.5 mm and increased to 9.5mm 3 days later). In April 2021, FATIGUE (Tired) had resolved. At the time of the report, PAIN IN EXTREMITY (Slight sore arm), ERYTHEMA (Very red area by her left collar bone of 5.5 mm and increased to 9.5mm 3 days later), PAIN (Very painful area by her left collar bone of 5.5 mm and increased to 9.5mm 3 days later) and NAUSEA (Nausea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  No treatment information was provided.  The patient stated that when she was 20 years old she experienced something similar and was unconscious and revived in hospital and they said 5 more minutes and she could have died.   This case was linked to MOD21-176013, MOD-2021-436219 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Dyspnoea, Muscular weakness, Tinnitus
Clinical narrative: I had ringing of my ears, dizziness, weakness of both legs. I experience difficulty breathing doing normal daily activities around the house. I went to ER to get checked out couldn't find anything.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Chest pain, Dry eye, Dyspnoea
Clinical narrative: Severe headaches , abdominal pain, blurry  vision, severe fatigue, neuropathy , muscle  and joint pain , shortness of breath  dry eyes, mouth ulcers, concentrated urination Chest pain
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Mouth ulceration, Myalgia, Neuropathy peripheral
Clinical narrative: Severe headaches , abdominal pain, blurry  vision, severe fatigue, neuropathy , muscle  and joint pain , shortness of breath  dry eyes, mouth ulcers, concentrated urination Chest pain
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urinary tract disorder, Vision blurred
Clinical narrative: Severe headaches , abdominal pain, blurry  vision, severe fatigue, neuropathy , muscle  and joint pain , shortness of breath  dry eyes, mouth ulcers, concentrated urination Chest pain
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Dyspnoea, Feeling abnormal, Malaise, SARS-CoV-2 test positive
Clinical narrative: 12/07/21 presents to EC ED "malaise and feeling foggy" "shortness of breath". PMHx of " cirrhosis and MELD of 30 currently on the liver transplant list"
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Balance disorder, CSF protein increased, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Diagnosed with Guillain Barre Syndrome after receiving Pfizer Booster shot 5 days in Hospital receiving IVIM treatment. Followed by 2 weeks at  Hospital.  for inpatient rehab learning to walk and move again. Now finishing up one month of home health care by Hospital. Then will be followed by outpatient PT at  Hospital.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunoglobulin therapy, Lumbar puncture, Movement disorder, Sensory loss
Clinical narrative: Diagnosed with Guillain Barre Syndrome after receiving Pfizer Booster shot 5 days in Hospital receiving IVIM treatment. Followed by 2 weeks at  Hospital.  for inpatient rehab learning to walk and move again. Now finishing up one month of home health care by Hospital. Then will be followed by outpatient PT at  Hospital.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Balance disorder, Guillain-Barre syndrome, Lumbar puncture, Sensory loss
Clinical narrative: Diagnosed with Guillain Barre Syndrome after receiving Pfizer Booster shot 5 days in Hospital receiving IVIM treatment. Followed by 2 weeks at  Hospital.  for inpatient rehab learning to walk and move again. Now finishing up one month of home health care by Hospital. Then will be followed by outpatient PT at  Hospital.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypertension, Pharyngeal swelling, Rash, Swelling
Clinical narrative: Swelling in left shoulder/collarbone area, neck and throat, right shoulder/collarbone area. Rash on both shoulders, back, neck, face, ears, was quickly spreading.  Tightness in throat that impaired talking (breathing okay), swelling on back of tongue.  Extremely high BP and HR.  Urgent care on 12/2/21, given  50 ml Benadryl and rash went away, swelling went down (not gone completely).  Emergency room on 12/3/21 because all swelling and rash and tight throat came back.  Given IV meds of Benadryl, pepcin and epinephrine.  All symptoms went away.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Throat tightness
Clinical narrative: Swelling in left shoulder/collarbone area, neck and throat, right shoulder/collarbone area. Rash on both shoulders, back, neck, face, ears, was quickly spreading.  Tightness in throat that impaired talking (breathing okay), swelling on back of tongue.  Extremely high BP and HR.  Urgent care on 12/2/21, given  50 ml Benadryl and rash went away, swelling went down (not gone completely).  Emergency room on 12/3/21 because all swelling and rash and tight throat came back.  Given IV meds of Benadryl, pepcin and epinephrine.  All symptoms went away.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Immediate post-injection reaction, Pruritus, Swelling
Clinical narrative: 1. Adverse effect of other viral vaccines, initial encounter - (Primary) 2. Pruritus, unspecified -  Vaccine Reaction - Moderna Booster on 11/4 - immediate redness and swelling - now pruritic - did have small blisters form - has tried benadryl cream and gold bond healing lotion - denies fevers, chills.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: 1. Adverse effect of other viral vaccines, initial encounter - (Primary) 2. Pruritus, unspecified -  Vaccine Reaction - Moderna Booster on 11/4 - immediate redness and swelling - now pruritic - did have small blisters form - has tried benadryl cream and gold bond healing lotion - denies fevers, chills.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: Hives; Dermatographia; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and MECHANICAL URTICARIA (Dermatographia) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021, the patient experienced URTICARIA (Hives) and MECHANICAL URTICARIA (Dermatographia). At the time of the report, URTICARIA (Hives) and MECHANICAL URTICARIA (Dermatographia) had not resolved.            No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. It was reported that patient height was 6 feet 2 inches.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mechanical urticaria, Urticaria
Clinical narrative: Hives; Dermatographia; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and MECHANICAL URTICARIA (Dermatographia) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021, the patient experienced URTICARIA (Hives) and MECHANICAL URTICARIA (Dermatographia). At the time of the report, URTICARIA (Hives) and MECHANICAL URTICARIA (Dermatographia) had not resolved.            No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. It was reported that patient height was 6 feet 2 inches.
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: Child had received vaccine and was standing waiting for her sister. While administering vaccine to her sister, child fell to floor, hitting her eft side of face on table. Child had a seizure for around 1 1/2 minutes. Patient then stopped and was alert and oriented X4 when she sat up. Vitals were taken: 100/72, 134 HR, 97%, 95.6 temp.  Patient stated that she was fine. Assessed by EMS and recommended transport to hospital ER. Parents refused transport. They stated that they had a family member who was a physician they would consult with. Parents took child home AMA per EMS recommendation.
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Face injury, Fall, Seizure
Clinical narrative: Child had received vaccine and was standing waiting for her sister. While administering vaccine to her sister, child fell to floor, hitting her eft side of face on table. Child had a seizure for around 1 1/2 minutes. Patient then stopped and was alert and oriented X4 when she sat up. Vitals were taken: 100/72, 134 HR, 97%, 95.6 temp.  Patient stated that she was fine. Assessed by EMS and recommended transport to hospital ER. Parents refused transport. They stated that they had a family member who was a physician they would consult with. Parents took child home AMA per EMS recommendation.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash, Urticaria
Clinical narrative: hives all over their body that would appear for 1 hour and then go away; felt like burning from the inside; super itchy/ hands and feet would itch like crazy with nothing on them; really bad rash with hives all over their body/rash would appear always on their arm and legs and sometimes on their chest and belly and pubic area and back.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over their body that would appear for 1 hour and then go away), BURNING SENSATION (felt like burning from the inside), PRURITUS (super itchy/ hands and feet would itch like crazy with nothing on them) and RASH (really bad rash with hives all over their body/rash would appear always on their arm and legs and sometimes on their chest and belly and pubic area and back.) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A, 003B21A and 077C21B) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced URTICARIA (hives all over their body that would appear for 1 hour and then go away), BURNING SENSATION (felt like burning from the inside), PRURITUS (super itchy/ hands and feet would itch like crazy with nothing on them) and RASH (really bad rash with hives all over their body/rash would appear always on their arm and legs and sometimes on their chest and belly and pubic area and back.). The patient was treated with BETAHISTINE HYDROCHLORIDE (VERTEX [BETAHISTINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, URTICARIA (hives all over their body that would appear for 1 hour and then go away), BURNING SENSATION (felt like burning from the inside), PRURITUS (super itchy/ hands and feet would itch like crazy with nothing on them) and RASH (really bad rash with hives all over their body/rash would appear always on their arm and legs and sometimes on their chest and belly and pubic area and back.) outcome was unknown.            Really bad rash with hives all over their body that would appear for 1 hour and then go away and this would happen 3-4 times a day. No concomitant medication was provided by the reporter Patient has taken acupuncture herbal and antihistaminic diet as treatment medication
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: No additional AEs were reported; a patient received less than the recommended dose; it leaked from the needle due to human error; This spontaneous report was received from a pharmacist referring to a patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.     On 21-DEC-2021 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # U010533, expiration date 29-OCT-2022; strength, dose and route were not reported) for prophylaxis, which was less than the recommended dose because it leaked from the needle due to human error during the administration (accidental underdose, needle issue). The pharmacist also stated that some were splashed onto his (pharmacist) skin on his hand (split as another case). No additional AEs were reported.  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2112USA009520:
Sex: M
Vaccine: PPV
Symptoms: Accidental exposure to product, Occupational exposure to product
Clinical narrative: He also stated that some were splashed onto his skin on his hand; it leaked from the needle due to human error during the administration. He also stated that some were splashed onto his skin on his hand; This spontaneous report was received from a male pharmacist (patient of unknown age) referring to himself. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.     On 21-DEC-2021, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # U010533, expiration date 29-OCT-2022; strength, dose and route were not reported) was vaccinated to another patient (another linked case) for prophylaxis, some were splashed onto this patient (the pharmacist) skin on his hand (Accidental exposure to product, Occupational exposure to product).  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2112USA008400:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Eye haemorrhage, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; BLOOD POOLING IN HALF OF THE LEFT EYE/LEFT EYE BLOODSHOT; This spontaneous report received from a patient concerned a 55 year old female.  The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. The patient was previously treated with covid-19 vaccine ad26. cov2. s (dose number in series was 1) (suspension for injection, route of admin, batch number: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered 1 in total on 03- MAY-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series was 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series was 2) (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: 11-DEC-2021) dose was not reported, administered 1 in total on 26-NOV-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 27-NOV-2021, the patient experienced blood was pooling in half of the left eye/left eye bloodshot and cleared after 4 days. The patient visited optometrist on 06-DEC-2021 and stated that there was no residual effects (dose number in series was 2). On 21-DEC-2021, the patient experienced sneezing, on 22-DEC-2021,the patient experienced runny nose, on 23-DEC-2021, the patient experienced nasal congestion, and tested positive for COVID-19 (COVID-19 virus test) ( confirmed covid-19 infection and confirmed clinical vaccination failure) (dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pooling in half of the left eye/left eye bloodshot on 01-DEC-2021, and the outcome of confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a regulatory authority: 90000208634.; Sender's Comments: V0: 20211254348-COVID-19 VACCINE AD26.COV2.S- Blood pooling in half of the left eye. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211254348-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive 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: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: HEART ARRHYTHMIA; This spontaneous report received from a patient concerned a patient of unspecified age and sex of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose,1 total and start therapy date were not reported  for prophylactic vaccination (Dose number in series was 1).The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced heart arrhythmia "I've developed it too." (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart arrhythmia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211265817-Covid-19 vaccine ad26.cov2.s-Heart arrhythmia . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: RECURRING CHEST PAINS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced recurring chest pains. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from recurring chest pains. This report was non-serious.; Sender's Comments: V0- Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; STILL GOT COVID; This spontaneous report received from a patient via social media via a company representative concerned a male of unspecified age, race and ethnic origin. Initial information was processed along with the additional information received on 30-DEC-2021. The patient's height, and weight were not reported. No past medical history and concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series was 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient had no re-action and still got Covid 5 months later and had suspected clinical vaccination failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the still got covid and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209605.; Sender's Comments: V0: 20211266099-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive 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: SPECIAL SITUATIONS
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a consumer concerned a 55 year old male. The patient's weight was 135 to 140 pounds and height was 67 inches. The patient's concurrent conditions included: diabetes (diagnosed in 1995). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1, suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 12-MAR-2021 at left arm for prophylactic vaccination. Concomitant medications included insulin for diabetes.  On an unspecified date, the patient experienced blurred vision in his left eye. On an unspecified date in AUG-2021, the patient subsequently experienced a stroke. The patient started stumbling after the stroke and the  patient has not regained full mobility. It was reported that patient was confused and took time to respond to answer questions. Patient's motor skills were not back to 100 percent. Patient was prescribed Plavix 5mg once a day after his stroke. It was reported that patient was having therapy sessions to improve his motor skills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211266078.; Sender's Comments: V0 20211266112-COVID-19 VACCINE AD26.COV2.S- stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia, Injection site pain
Clinical narrative: CANNOT MOVE IT AND SEEMS PARALYZED; PAIN IN LEFT ARM ON INJECTION SITE; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 23-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced cannot move it and seems paralyzed, and pain in left arm on injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in left arm on injection site and cannot move it and seems paralyzed was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK; This spontaneous report received from a patient via social media through a company representative concerned a patient of unspecified age, race, ethnicity and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose and start therapy date were not reported for prophylactic vaccination. Dose number in series was 1. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced heart attack. The patient reported as "Your COVID vaccine gave me a heart attack". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart attack was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211266376-Covid-19 vaccine ad26.cov2.s-Heart attack. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction, Facial paralysis
Clinical narrative: PARTIAL PARALYSIS FACIAL; ADVERSE EFFECT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Patient stated that on an unspecified date, vaccine safety concerns wake county sheriff department medical staff untrained adverse effects including partial paralysis facial no fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the partial paralysis facial and adverse effect was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20211266713-COVID-19 VACCINE AD26.COV2.S-partial paralysis facial. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID19 INFECTION; This spontaneous report received from a patient concerned a 61 year old female of unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: thyroid issues and was taking thyroid medications, occasional alcohol user, and occasional smoker. The patient had drug allergy to Codeine, Cepacol, Flagyl. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 23-AUG-2021) dose was not reported, 1 total administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-DEC-2021 the patient had symptoms from morning. The symptoms were not severe. The patient had headache, chills, low grade fever and fatigue (suspected covid-19 infection, suspected clinical vaccination failure) (Dose number in series 1). The patient still had fatigue at the time of reporting but other symptoms had resolved (dose number in series 1). The patient had rapid Covid-19 antigen test and results came back positive on 26-DEC-2021. The patient had self treated herself at home. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with a product quality complaint, and reference number requested.; Sender's Comments: V0- 20211266733-Covid-19 vaccine ad26.CoV-2.s- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, dose number in series was 1, 1 total administrated for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The reported stated that, a family member died (date unspecified) after being fully vax (dose number in series was 1). It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date, the patient died of an unknown cause. This report was serious (Death).; Sender's Comments: V0: 20211266789-COVID-19 VACCINE AD26.COV2.S-died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: He ached in his joints; Had muscle pain; Fever; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (He ached in his joints), MYALGIA (Had muscle pain), PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at the injection site) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0308H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2021, the patient experienced ARTHRALGIA (He ached in his joints), MYALGIA (Had muscle pain), PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at the injection site). The patient was treated with PARACETAMOL (TYLENOL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (He ached in his joints), MYALGIA (Had muscle pain), PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.            No concomitant medication was provided by the reporter.  Patient has enquiring on longevity of side effects and also asked whether he can do physical activity or should he just rest?
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Headache, Myalgia, Pyrexia, Sleep disorder
Clinical narrative: No bowel movement; Was awake every hour/Couldn't go back to sleep/ Was awake every 30 minutes; Headache; Fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Was awake every hour/Couldn't go back to sleep/ Was awake every 30 minutes), BOWEL MOVEMENT IRREGULARITY (No bowel movement), HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Body aches) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069H21A and 033F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Body aches). On 28-Dec-2021, the patient experienced SLEEP DISORDER (Was awake every hour/Couldn't go back to sleep/ Was awake every 30 minutes). On 29-Dec-2021, the patient experienced BOWEL MOVEMENT IRREGULARITY (No bowel movement). At the time of the report, SLEEP DISORDER (Was awake every hour/Couldn't go back to sleep/ Was awake every 30 minutes), BOWEL MOVEMENT IRREGULARITY (No bowel movement), HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Patient hasn't tried any medication to alleviate the symptoms.
Sex: U
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: a different coworker developed appendicitis; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (a different coworker developed appendicitis) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced APPENDICITIS (a different coworker developed appendicitis) (seriousness criterion medically significant). The patient was treated with Surgery (appendectomy) for Appendicitis. At the time of the report, APPENDICITIS (a different coworker developed appendicitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported. Treatment medications was not reported. In the source document patient stated that a different coworker developed appendicitis, had an appendectomy, and was on medical leave for a week. The latter coworker also received the Moderna vaccine around the beginning of 2021. Neither of us suspect that the Moderna vaccine was related to our experiences.  Company comment: This case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the serious, unexpected event of appendicitis on unknown date after the unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient underwent appendectomy. The patient did not suspect that the event was related to the vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the serious, unexpected event of appendicitis on unknown date after the unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient underwent appendectomy. The patient did not suspect that the event was related to the vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose given greater than 12 hours post vial puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given greater than 12 hours post vial puncture) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Syncope. Concurrent medical conditions included Drug allergy (abilify), Drug allergy (Januvia), Hypertension, Type 2 diabetes mellitus, Chronic kidney disease and Depression. Concomitant products included AMLODIPINE, VALPROATE SEMISODIUM (DEPAKOTE), GLIPIZIDE and LABETALOL for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given greater than 12 hours post vial puncture). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Dose given greater than 12 hours post vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were provided concomitant medication included as AbN.   This case was linked to MOD-2021-416295 (Patient Link).
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: booster given greater than 12 hours post vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster given greater than 12 hours post vial puncture) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Drug allergy (Remeron), Drug allergy (Restyl), Latex allergy, Dementia, Chronic kidney disease, Insomnia and Hypertension. Concomitant products included AMLODIPINE BESILATE (NORVASC), DRONEDARONE HYDROCHLORIDE (MULTAQ) and MEMANTINE HYDROCHLORIDE (NAMENDA) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (booster given greater than 12 hours post vial puncture). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (booster given greater than 12 hours post vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication includes Senna.  No treatment drugs were reported.   This case was linked to MOD-2021-416295.
Sex: U
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: Appendicitis; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced APPENDICITIS (Appendicitis) (seriousness criterion medically significant). At the time of the report, APPENDICITIS (Appendicitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.   This case was linked to MOD-2021-414613, MOD-2021-414673 (Patient Link).; Sender's Comments: This case concerns a  patient of an unknown age and gender, with no reported medical history, who experienced the serious, unexpected AESI event of appendicitis, after unspecified dose of mRNA 1273 Covid-19 vaccine. Onset latency is unknown as the dates of the vaccine and event was not specified.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Pulmonary haemorrhage
Clinical narrative: Internal bleeding in the lung; Fall down; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY HAEMORRHAGE (Internal bleeding in the lung) in a male 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.     The patient's past medical history included Renal cancer stage IV (He had stage 4 renal cancer but was stable.).    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced FALL (Fall down). On an unknown date, the patient experienced PULMONARY HAEMORRHAGE (Internal bleeding in the lung) (seriousness criteria death and medically significant). The patient died on 09-Feb-2021. The reported cause of death was internal bleeding in the lung. It is unknown if an autopsy was performed. At the time of death, FALL (Fall down) outcome was unknown.            No concomitant medication information was mentioned by the reporter.  It was reported that the patient was admitted to the emergency room (ER) on Sunday, 07-Feb-2021 after a fall down. It was non-serious as nothing broke. The ER admitted the patient for observation. He died on the 09-Feb-2021 from internal bleeding in the lung. The reporter felt that moderna vaccine was responsible for his death but of course there was no proof. No treatment medication information was mentioned by the reporter.  Company Comment: This case refers to a male patient of unspecified age with a medical history of stage 4 renal cancer who experienced the unexpected serious event of Pulmonary hemorrhage approximately 4 days after the second dose of mRNA-1273 vaccine. The patient eventually died 2 days later. No causality assessment was provided by the reporter. The medical history of stage 4 renal cancer remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case refers to a male patient of unspecified age with a medical history of stage 4 renal cancer who experienced the unexpected serious event of Pulmonary hemorrhage approximately 4 days after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. stage 4 renal cancer. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Internal bleeding in the lung
Sex: F
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: Lost vision (one eye); This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Lost vision (one eye)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 BLINDNESS (Lost vision (one eye)) (seriousness criteria hospitalization and medically significant). At the time of the report, BLINDNESS (Lost vision (one eye)) outcome was unknown.            Concomitant medications were not provided. Treatment information includes steroids. Patient was hospitalized for couple of weeks and no doctors could point out the causes. They said they can do nothing and gave patient steroid and asked them to go home.  Company Comment: This case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious event of Blindness. The event occurred on an unknown date after the second dose of mRNA-1273 Vaccine which resulted in hospitalization. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-419388, MOD-2021-423152, MOD-2021-423139 (Patient Link).; Sender's Comments: This case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious event of Blindness. The event occurred on an unknown date after the second dose of mRNA-1273 Vaccine which resulted in hospitalization. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose of Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Booster). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: After the second dose, she felt tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (After the second dose, she felt tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A or 025L20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced FATIGUE (After the second dose, she felt tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 24-Feb-2021 for Tiredness, at an unspecified dose and frequency. At the time of the report, FATIGUE (After the second dose, she felt tired) outcome was unknown.            No concomitant medications reported.   This case was linked to MOD-2021-432443 (Patient Link).   Reporter did not allow further contact