chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TYP
Symptoms: Influenza, Pyrexia
Clinical narrative: Diagnosed with influenza A; Spontaneous report received on 28FEB2020.   A physician (consumer's mother) reported that her 9-year-old child was diagnosed with influenza A (PT: Influenza) while being on Vivotif for immunisation. The child received first, second and third dose of Vivotif on 22FEB2020, 24FEB2020 and 26FEB2020 respectively. On 26FEB2020, the child developed symptoms and was diagnosed with influenza A on 27FEB2020. The physician stated that the fever was coming down on 28FEB2020. The child did not receive the last dose of Vivotif on 28FEB2020. Action taken with Vivotif with respect to the reported event was vaccine withdrawn. The outcome of the reported event was resolving at the time of report.  Company Comment: A consumer was diagnosed with influenza A (Influenza) a day after taking third dose of Vivotif. In response to the event, fourth dose of Vivotif was not given and the fever came down a day later. Considering the infectious pathogenesis of influenza (a viral infection), the causality of the event is assessed as unlikely with Vivotif.; Sender's Comments: A consumer was diagnosed with influenza A (Influenza) a day after taking third dose of Vivotif. In response to the event, fourth dose of Vivotif was not given and the fever came down a day later. Considering the infectious pathogenesis of influenza (a viral infection), the causality of the event is assessed as unlikely with Vivotif.
Age: 12.0
Sex: F
Vaccine: TYP
Symptoms: Ear infection
Clinical narrative: Ear infection; Spontaneous report received on 28FEB2020.   A caregiver (consumer's mother) reported that her 12-year-old daughter was diagnosed with an ear infection (PT: Ear infection) while being on Vivotif for immunisation. The consumer took her first of Vivotif on 27FEB2020. On 28FEB2020, she was diagnosed with an ear infection. Thus, she was prescribed amoxicillin of unknown strength (12 ml; twice a day for 10 days). She was not planning to take remaining doses of Vivotif until the end of her antibiotics course. Action taken with Vivotif with respect to the reported event was vaccine withdrawn. The outcome of the reported event was unknown at the time of report.  Company Comment: A consumer was diagnosed with ear infection a day after taking first dose of Vivotif. In response to the event, she was prescribed with amoxicillin and consumer did not plan to take the remaining Vivotif doses. Considering the infectious pathogenesis of ear infection, the causality of ear infection is assessed as not related to Vivotif.; Sender's Comments: A consumer was diagnosed with ear infection a day after taking first dose of Vivotif. In response to the event, she was prescribed with amoxicillin and consumer did not plan to take the remaining Vivotif doses. Considering the infectious pathogenesis of ear infection, the causality of ear infection is assessed as not related to Vivotif.
Age: 27.0
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took second dose on day 2; Spontaneous report received on 27FEB2020.   A pharmacist reported that a consumer "took second dose on day 2" (PT: Inappropriate schedule of product administration) while being on Vivotif for immunisation. The consumer took the first and second dose of Vivotif on 26FEB2020 and 27FEB2020 respectively. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took second dose of Vivotif on day 2 (Inappropriate schedule of product administration). Vivotif should be taken every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took second dose of Vivotif on day 2 (Inappropriate schedule of product administration). Vivotif should be taken every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Age: 53.0
Sex: F
Vaccine: TYP
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives with itchiness; Spontaneous report received on 03MAR2020.   A healthcare professional and consumer collaboratively reported that a female consumer had hives with itchiness (PT: Urticaria) while being on Vivotif for immunisation. The consumer started taking Vivotif on 11FEB2020. On an unknown date, she took the third dose of Vivotif in the morning and developed hives in the afternoon. She had hives on her upper back, chest, wrist, legs, belly, face and neck. Thus, she took Benadryl (diphenhydramine) to help with the hives and itchiness, and she got relief. Afterward, she took her fourth dose of Vivotif as per the schedule. Still, she experienced itchiness mostly at the nighttime, so she took Benadryl for it. Then, her physician started her on levocetirizine (5 mg; twice daily) on 03MAR2020 for hives and itchiness and she did not experience hives or itchiness since last night (03MAR2020), but she also stated that she could not tell if the itchiness had completely resolved. Action taken with Vivotif with respect to the reported event was dose not changed. Her symptoms were resolving at the time of report.  Moreover, it was reported that the consumer did not have any true allergy. However, tetracycline had caused her stomach to hurt and shrimp caused her extreme stomach symptoms in the past.  Additionally, it was reported that the consumer did not take any concomitant medication.  Company Comment: A consumer had hives with itchiness (urticaria) on the same day of taking third dose of Vivotif. In response to the event, she took Benadryl and continued to take fourth dose of Vivotif but she still had itchiness in the night. The consumer then took levocetirizine and the event was resolving. Considering the case information and the potential of Vivotif to cause urticaria, the causality of the event is assessed as possible with Vivotif.; Sender's Comments: A consumer had hives with itchiness (urticaria) on the same day of taking third dose of Vivotif. In response to the event, she took Benadryl and continued to take fourth dose of Vivotif but she still had itchiness in the night. The consumer then took levocetirizine and the event was resolving. Considering the case information and the potential of Vivotif to cause urticaria, the causality of the event is assessed as possible with Vivotif.
Sex: M
Vaccine: TYP, UNK
Symptoms: Inappropriate schedule of product administration, Labelled drug-drug interaction medication error
Clinical narrative: Took fourth dose of Vivotif a day late; Took bactrim while taking Vivotif doses; Spontaneous report received on 03MAR2020.   A male consumer reported that he "took bactrim while taking Vivotif doses" (PT: Labelled drug-drug interaction medication error) and "took fourth dose of Vivotif a day late" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif for immunization and Bactrim (sulfamethoxazole and trimethoprim) for prophylaxis for cystoscopy. The consumer took three doses of Vivotif according to the schedule on 25FEB2020, 27FEB2020, and 29FEB2020 respectively. However, the consumer forgot to take the fourth dose of Viviotif on 02MAR2020 and took it on 03MAR2020 (01:00 AM). It was also reported that the consumer took the Bactrim on 02MAR2020 for prophylaxis for his cystoscopy. Action taken with Vivotif and Bactrim with respect to the reported events was not applicable. The outcome of the reported events was unknown.  Company Comment: A consumer took bactrim while taking Vivotif doses (Labelled drug-drug interaction medication error) and also took fourth dose of Vivotif a day late (Inappropriate schedule of product administration). Vivotif doses should be taken every other day and there should be a gap of at least three days between Vivotif and antibiotic doses. Considering the nature of the events, the causality of both the events is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took bactrim while taking Vivotif doses (Labelled drug-drug interaction medication error) and also took fourth dose of Vivotif a day late (Inappropriate schedule of product administration). Vivotif doses should be taken every other day and there should be a gap of at least three days between Vivotif and antibiotic doses. Considering the nature of the events, the causality of both the events is assessed as not applicable to Vivotif.
Age: 14.0
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took Vivotif doses in an inappropriate way; Spontaneous report received on 03MAR2020.   A non-healthcare professional reported that a 14-year-old male consumer "took Vivotif doses in an inappropriate way" (PT: Inappropriate schedule of product administration) while being on Vivotif for immunisation. The consumer did not take Vivotif doses according to the schedule. The doses were taken on 25FEB2020, 29FEB2020 and 02MAR2020 respectively. It was reported that he forgot to take his second dose on 27FEB2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif doses in an inappropriate way (Inappropriate schedule of product administration). This consumer took vivotif doses on day 1, 5 and 7 as he missed his second dose on day 3. Vivotif doses should be taken every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took Vivotif doses in an inappropriate way (Inappropriate schedule of product administration). This consumer took vivotif doses on day 1, 5 and 7 as he missed his second dose on day 3. Vivotif doses should be taken every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took two unrefrigerated doses of Vivotif; Spontaneous report received on 05MAR2020.   A pharmacist reported that a consumer "took two unrefrigerated doses of Vivotif" (PT: Product storage error) for immunisation. The consumer took first and second dose of Vivotif on 28FEB2020 and 01MAR2020 respectively which were not refrigerated. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took first two doses of Vivotif which were unrefrigerated (Product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of Product storage error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took first two doses of Vivotif which were unrefrigerated (Product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of Product storage error is assessed as not applicable to Vivotif.
Sex: U
Vaccine: VARZOS
Symptoms: Ocular discomfort
Clinical narrative: my eyes have been bothering me since then; This case was reported by a consumer via interactive digital media and described the occurrence of eye discomfort in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received Shingrix. In November 2020, immediately after receiving Shingrix, the patient experienced eye discomfort. On an unknown date, the outcome of the eye discomfort was not recovered/not resolved.   It was unknown if the reporter considered the eye discomfort to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. Since receiving Shingrix, the patient's eyes had been bothering to the patient. The patient was asking, if this was related to Shingrix vaccination.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster, Laboratory test normal, Pain in extremity, Rash
Clinical narrative: Was diagnosed with shingles; Got leg pain; A rash developed on the leg; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   In November 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. In November 2020, less than a day after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced shingles, leg pain and rash. On an unknown date, the outcome of the shingles, leg pain and rash were unknown.   It was unknown if the reporter considered the shingles, leg pain and rash to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient's daughter reported the case. The patient never had chicken pox. The reporter stated that, the patient received flu shot in November 2020 and very night had leg pain, rash developed on the leg and was diagnosed with shingles. The reporter did not know the name of Flu shot but thought that it was one of the 65 year old shots. GSK note- GSK does not make any of that type of Flu vaccine but conservatively case created since the patient was not 100 percent positive.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: First dose administered 21 days before; Headaches; Nausea; Fever; Body aches; Chills; Joint pain; Throwing up; Extreme exhaustion; A spontaneous report was received from a pharmacist concerning a 59 years old female patient who received Modern's COVID-19 vaccine (mRNA-1273) who experienced headaches, nausea, fever, body aches, chills, joint pain, throwing up, extreme exhaustion, and inappropriate schedule of vaccine administration.  The patients medical history was not provided. Concomitant medication included vitamins and female hormones.  On 25 Jan 2021 prior to the onset of the events, the patient received their second dose of mRNA-1273 (lot/batch: 025520-2A) for prophylaxis of COVID-19 infection. First dose might have been administered 21 days before.  On 25 Feb 2021, after 12 hours of receiving the vaccine, the patient experienced headaches nausea, fever, chills, joint pain, throwing up, extreme exhaustion. No Laboratory details provided.   Treatment for the events include paracetamol and antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, headaches, nausea, fever, body aches, chills, joint pain, throwing up, extreme exhaustion, were not reported. The outcome of the event, inappropriate schedule of vaccine administration, was resolved on 25 Jan 2021.; Reporter's Comments: This case concerns a 59 Y/O F who had a nonserious unexpected event of Inappropriate schedule of product administration with mRNA-1273 (lot # 025520-2A) with nonserious expected fatigue, fever, chills, nausea, vomiting, headache, pain, arthralgia.  Event onset the same day as the second dose, which was 21 days after the first dose. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: First dose administered 21 days before; Headaches; Nausea; Fever; Body aches; Chills; Joint pain; Throwing up; Extreme exhaustion; A spontaneous report was received from a pharmacist concerning a 59 years old female patient who received Modern's COVID-19 vaccine (mRNA-1273) who experienced headaches, nausea, fever, body aches, chills, joint pain, throwing up, extreme exhaustion, and inappropriate schedule of vaccine administration.  The patients medical history was not provided. Concomitant medication included vitamins and female hormones.  On 25 Jan 2021 prior to the onset of the events, the patient received their second dose of mRNA-1273 (lot/batch: 025520-2A) for prophylaxis of COVID-19 infection. First dose might have been administered 21 days before.  On 25 Feb 2021, after 12 hours of receiving the vaccine, the patient experienced headaches nausea, fever, chills, joint pain, throwing up, extreme exhaustion. No Laboratory details provided.   Treatment for the events include paracetamol and antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, headaches, nausea, fever, body aches, chills, joint pain, throwing up, extreme exhaustion, were not reported. The outcome of the event, inappropriate schedule of vaccine administration, was resolved on 25 Jan 2021.; Reporter's Comments: This case concerns a 59 Y/O F who had a nonserious unexpected event of Inappropriate schedule of product administration with mRNA-1273 (lot # 025520-2A) with nonserious expected fatigue, fever, chills, nausea, vomiting, headache, pain, arthralgia.  Event onset the same day as the second dose, which was 21 days after the first dose. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Angioedema both times; A spontaneous report was received from a health care provider concerning a patient (him/herself), age and gender not reported, who experienced angioedema.   The patient's medical history was not reported.    Concomitant product use was not provided by reporter.   On unknown date, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.  Per voicemail, an adverse event was reported on both the first and second dose of Moderna vaccine. Angioedema both times, the second time was a little bit worse. The second dose lasted three days.   Treatment for the event included prednisolone, famotidine, and diphenhydramine.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   The outcome for the event was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Treatment for the event included prednisolone, famotidine, and diphenhydramine. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Swollen tongue
Clinical narrative: Allergic Reaction, tongue swelled; Allergic reaction; A spontaneous report was received by a consumer concerning a 20-30-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced allergic reaction, tongue swelled (swollen tongue).  The patient's medical history was not provided by the reporter. Concomitant product use was unknown.  On an unknown date, prior to the onset of the events, the patient received a dose of mRNA-1273 (Lot number unknown) for prophylaxis of COVID-19 infection.  The reporter stated that on 23 Jan 2021 at 5:30 PM he was informed that his friends fiance had an allergic reaction shortly after receiving a dose of Moderna's vaccine (mRNA-1273). The patient's tongue swelled, and an EpiPen was administered.  The patient was then taken to the emergency room (ER) for monitoring.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, allergic reaction, tongue swelled, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease
Clinical narrative: progressively worsening symptoms of COPD; A spontaneous report was received from a consumer who was also a male patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced progressively worsening symptoms of chronic obstructive pulmonary disease (COPD)/COPD exacerbation.  The patient's medical history included COPD, which the patient admitted was worsening before the vaccine. Relevant concomitant medications included simvastatin, lisinopril, and allopurinol.  On 04 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 11 Feb 2021, the patient was hospitalized for progressively worsening symptoms of his COPD.    Treatment included a prednisone injection in the hospital and prednisone 60 mg orally after discharge from the hospital (date unknown) for more than a week.    Action taken with mRNA-1273 in response to the event was not reported.    The outcome of the event progressively worsening symptoms of COPD was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: light headed, caused him to pass out; dizzy; A spontaneous report was received from a consumer concerning, a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced light headed caused him to pass out and dizzy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   It was also reported that after receiving his first dose, the patient reported symptoms of fatigue, headache and chills.  On 11 Feb 2021, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  After receiving the second dose, the patient reported feeling dizzy and lightheaded when he woke up the next morning. He then passed out and hit his head. No treatment information was provided.  Action taken with study drug was not applicable as the subject had already received both scheduled doses  The outcome of the events, light headed caused him to pass out and dizzy were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dyspnoea
Clinical narrative: Atrial fibrillation; Hard to breathe; A spontaneous report was received from a consumer (patient's wife), regarding a 37 years-old white male patient, unknown ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced, atrial fibrillation, uncomfortable (discomfort), and hard to breathe (dyspnoea).  Current medical conditions reported as controlled atrial fibrillation and cardiomyopathy. Past medical history includes atrial fibrillation diagnosis (May 2018) and stroke (May2018/hospitalized). Weight reported as 180 lbs.The patient's medication allergy included albuterol inhaler. Concomitant medications reported included are rivaroxaban, levetiracetam, bisoprolol and flecainide.  On 15 JAN 2021, one day prior to the onset of events, the patient received their first of planned doses of mRNA-1273 (batch number: 029L20A), at a dose of 0.5 ml, intramuscular in the left arm for the prophylaxis of COVID-19 infection.  The consumer reported that the patient became uncomfortable and it was hard to breathe on 16 JAN 2021. On 17 JAN 2021, in the morning, the patient went into atrial fibrillation. The patient received treatment medication with a double dose of flecainide and went back into normal sinus rhythm about 2 hours later. On 18 JAN 2021, in the morning, the patient had a second occurrence of atrial fibrillation, for which he received treatment with a double dose of flecainide and went back into normal sinus rhythm. On 21 JAN 2021, the patient again developed atrial fibrillation third occurrence, for which he received treatment with a double dose of flecainide and went back into normal sinus rhythm. On 27 JAN 2021, the patient had a fourth occurrence of atrial fibrillation, for which he received treatment with a double dose of flecainide and went back into normal sinus rhythm. These adverse events were reported to his physician. The consumer stated that she can be further contacted if the safety department follows up for any additional information.  Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of the events, atrial fibrillation, uncomfortable, and hard to breathe, were reported as not recovered.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  The patient's medical history of atrial fibrillation and cardiomyopathy remains a confounding factor. Further information has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diplopia, Pyrexia
Clinical narrative: Double vision; Chills; Low graded fever (99.8); A spontaneous report  was received from a consumer, concerning a 75-year-old male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced double vision, chills and low graded fever (99.8).   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 30 JAN 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number 012M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 31JAN2021, after the vaccine administration, the patient developed chills and low-grade fever of 99.8, hence he was given with acetaminophen to alleviate these symptoms. On 01 FEB 2021, the patient started experiencing double vision, hence, on 05 FEB 2021, the patient went to their eye doctor who instructed the patient to go to the emergency room (ER). The ER doctor admitted the patient to the hospital to run some tests and labs.  The patient was tested for stroke, tumor, and bell palsy and all these tests were negative. The hospital conducted several CT and MRI and they were all negative. The neurologists did not know what was going on with the patient. Hence, he was discharged from the hospital on 07 FEB 2021. The patient was still having symptoms. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events were not applicable.  The outcome of the events double vision, chills and low graded fever (99.8) were considered not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Blood test, Chills, Dizziness, Electrocardiogram
Clinical narrative: Fainting twice; Low blood pressure; Sweating like hell; Dizziness; Significant chill; Body was feeling hot; A spontaneous report was received from a consumer, a 52 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine, who experienced fainting twice (syncope), low blood pressure (hypotension), sweating like hell (hyperhidrosis), dizziness, significant chills (chill), and body was feeling hot (pyrexia).   The patient's current conditions included epilepsy and slight cholesterol. Historical condition was not reported.  Products known to have been used by the patient, within two weeks prior to the event, included eslicarbazepine acetate, simvastatin, atorvastatin, sertraline hydrochloride, acetylsalicylic acid, ubidecarenone, vitamins nos, fish oil and cyanocobalamin.  On 13 Feb 2021, prior to the onset of symptoms, the patient received their second planned dose of mRNA-1273, (lot number: 030M20A), intramuscularly into right upper arm for prophylaxis of COVID-19 infection.   On 13 Feb 2021, after administering the vaccine, patient stated that everything was normal. The patient stated that he went to bed at 9 pm and at 11 pm, he started feeling significant chill and body was feeling hot. On 14 Feb 2021, at 2 am, the patient woke up to go restroom because he was sweating like hell and felt dizziness. The patient's wife noticed that the patient had fainted, and she stood him up and fainted again. His wife made him sat down on the bed and called 911. Once the paramedics arrived, the patient underwent electrocardiogram (EKG) that was normal and checked his blood pressure (BP) that was at 95/82 (unknow units). The patient stated that his BP was usually normal at 120/80 or 85. The paramedics took him to hospital. In the ambulance, they performed another EKG and BG which came out to be normal. The patient was taken to the hospital and they performed multiple blood test that came out to be normal. The patient stated that the nurse gave him unspecified intravenous (IV) liquid as treatment medication for the events which he does not remember. The patient also informed that the doctors concluded that this may happen due to Moderna COVID-19 vaccine. The patient was discharge from the hospital at 4:14 am of 14 Feb 2021. The patient does have light dizziness but not heavy and no other symptoms.  The outcome for the event(s), fainting twice, low blood pressure, sweating like hell, significant chills, and body was feeling hot were considered as resolved/recovered on 14 Feb 2021 and that of event, dizziness, was reported as not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Hypotension, Pyrexia, Syncope
Clinical narrative: Fainting twice; Low blood pressure; Sweating like hell; Dizziness; Significant chill; Body was feeling hot; A spontaneous report was received from a consumer, a 52 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine, who experienced fainting twice (syncope), low blood pressure (hypotension), sweating like hell (hyperhidrosis), dizziness, significant chills (chill), and body was feeling hot (pyrexia).   The patient's current conditions included epilepsy and slight cholesterol. Historical condition was not reported.  Products known to have been used by the patient, within two weeks prior to the event, included eslicarbazepine acetate, simvastatin, atorvastatin, sertraline hydrochloride, acetylsalicylic acid, ubidecarenone, vitamins nos, fish oil and cyanocobalamin.  On 13 Feb 2021, prior to the onset of symptoms, the patient received their second planned dose of mRNA-1273, (lot number: 030M20A), intramuscularly into right upper arm for prophylaxis of COVID-19 infection.   On 13 Feb 2021, after administering the vaccine, patient stated that everything was normal. The patient stated that he went to bed at 9 pm and at 11 pm, he started feeling significant chill and body was feeling hot. On 14 Feb 2021, at 2 am, the patient woke up to go restroom because he was sweating like hell and felt dizziness. The patient's wife noticed that the patient had fainted, and she stood him up and fainted again. His wife made him sat down on the bed and called 911. Once the paramedics arrived, the patient underwent electrocardiogram (EKG) that was normal and checked his blood pressure (BP) that was at 95/82 (unknow units). The patient stated that his BP was usually normal at 120/80 or 85. The paramedics took him to hospital. In the ambulance, they performed another EKG and BG which came out to be normal. The patient was taken to the hospital and they performed multiple blood test that came out to be normal. The patient stated that the nurse gave him unspecified intravenous (IV) liquid as treatment medication for the events which he does not remember. The patient also informed that the doctors concluded that this may happen due to Moderna COVID-19 vaccine. The patient was discharge from the hospital at 4:14 am of 14 Feb 2021. The patient does have light dizziness but not heavy and no other symptoms.  The outcome for the event(s), fainting twice, low blood pressure, sweating like hell, significant chills, and body was feeling hot were considered as resolved/recovered on 14 Feb 2021 and that of event, dizziness, was reported as not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Feeling abnormal, Hyperhidrosis, Syncope
Clinical narrative: Fainting twice; Low blood pressure; Sweating like hell; Dizziness; Significant chill; Body was feeling hot; A spontaneous report was received from a consumer, a 52 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine, who experienced fainting twice (syncope), low blood pressure (hypotension), sweating like hell (hyperhidrosis), dizziness, significant chills (chill), and body was feeling hot (pyrexia).   The patient's current conditions included epilepsy and slight cholesterol. Historical condition was not reported.  Products known to have been used by the patient, within two weeks prior to the event, included eslicarbazepine acetate, simvastatin, atorvastatin, sertraline hydrochloride, acetylsalicylic acid, ubidecarenone, vitamins nos, fish oil and cyanocobalamin.  On 13 Feb 2021, prior to the onset of symptoms, the patient received their second planned dose of mRNA-1273, (lot number: 030M20A), intramuscularly into right upper arm for prophylaxis of COVID-19 infection.   On 13 Feb 2021, after administering the vaccine, patient stated that everything was normal. The patient stated that he went to bed at 9 pm and at 11 pm, he started feeling significant chill and body was feeling hot. On 14 Feb 2021, at 2 am, the patient woke up to go restroom because he was sweating like hell and felt dizziness. The patient's wife noticed that the patient had fainted, and she stood him up and fainted again. His wife made him sat down on the bed and called 911. Once the paramedics arrived, the patient underwent electrocardiogram (EKG) that was normal and checked his blood pressure (BP) that was at 95/82 (unknow units). The patient stated that his BP was usually normal at 120/80 or 85. The paramedics took him to hospital. In the ambulance, they performed another EKG and BG which came out to be normal. The patient was taken to the hospital and they performed multiple blood test that came out to be normal. The patient stated that the nurse gave him unspecified intravenous (IV) liquid as treatment medication for the events which he does not remember. The patient also informed that the doctors concluded that this may happen due to Moderna COVID-19 vaccine. The patient was discharge from the hospital at 4:14 am of 14 Feb 2021. The patient does have light dizziness but not heavy and no other symptoms.  The outcome for the event(s), fainting twice, low blood pressure, sweating like hell, significant chills, and body was feeling hot were considered as resolved/recovered on 14 Feb 2021 and that of event, dizziness, was reported as not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Massive stroke; A spontaneous report was received from a consumer (patient's daughter), concerning an 85-year-old female patient, who received Moderna COVID-19 vaccine and death occurred in two days.  The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies. She states that her mother was physically and mentally healthy before vaccination.   On 29-JAN-2021, prior to the onset of events, the patient received her first of two planned doses of covid-19 vaccine for the prophylaxis of Covid-19 infection. There were no complaints on any side effects from the patient for 6 hours after vaccination. Next day, she was found unresponsive on her bed by her neighbor after they were sent to check on her by her daughter. Her heart was beating, and she was breathing at that time, but did not have consciousness. According to her daughter, the patient had a massive stroke in her sleep sometime between 8:pm on 29-JAN-2021 and 9:30 am on 30-JAN-2021. Her life saving measures were taken out at 1:15 am on 31-JAN-2021 and she died approximately at 1:45am.  No information available on hospitalization and treatment received with this event. It is not known whether autopsy was done.  Action taken with 2nd dose of Moderna Covid-19 vaccine was not applicable.  The outcome of the event stroke is fatal.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of stoke, a causal relationship cannot be excluded. Patient's elderly age is considered a risk factor.; Reported Cause(s) of Death: Massive stroke
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away; A spontaneous report was received from a Pharmacist concerning a 65 years-old, male patient who passed away/MedDRA PT: death, days after receiving the second dose of the Moderna COVID-19 vaccine.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Lot #012L20A) on 12 Jan 2021. On 11 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot # 030M20A) (route of administration and injection site not provided) for prophylaxis of COVID-19 infection.  On an unknown date, days after receiving the second dose of the Moderna COVID-19 vaccine, the patient passed away. The patient did not come to the hospital; therefore the Pharmacist had very little detail of the situation but believed it was due to aspiration based on report received from the patient's boss. The Pharmacist reported there was no report of any issues from the first vaccine. The patient was found at home by spouse and had yellow stuff on face and chest.   Action taken with mRNA-1273 was not applicable as the patient deceased.  The patient died on an unknown date. The cause of death was reported as unknown. Plans for autopsy were not provided.; Reporter's Comments: Very limited information regarding the event of death has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Death days after receiving the second dose of the Moderna Covid-19 Vaccine
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Dyspnoea, Pain
Clinical narrative: Died at home; Gasping for air/difficulty breathing; Soreness; A spontaneous report was received from a physician concerning a 45 years-old, female patient who experienced soreness/MedDRA PT: pain, gasping for air/difficulty breathing/MedDRA PT: dyspnoea and subsequently died/MedDRA PT: death.  The patient's medical history included blood pressure (disorder not specified), thyroid disorder, depression and anxiety. Concomitant product use included blood pressure medication, thyroid medication and possibly depression and anxiety medication.  On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot #007M20A) (route of administration and injection site not provided) for prophylaxis of COVID-19 infection.  On 28 Jan 2021, following the vaccination, the patient was fine but had experienced some soreness.  Per patient's coworker, the patient did not take any medication as it made the patient sick. The physician was not aware of any complaints from the vaccine.  On 13 Feb 2021 at 3:31am, the patient called 911. Per the 911 call, the patient was gasping for air on the call and having difficulty breathing. The patient subsequently died on 13 Feb 2021 at home. The physician inquired whether Moderna gets involved with the autopsy and logistics of the death of patients and wanted to know the time frame for reporting a death of a patient who received the vaccine. The physician did not know who administered the patient's vaccine.  Action taken with mRNA-1273 in response to the events was not applicable as the patient deceased.  The event died was fatal. The outcome for the events soreness and gasping for air/difficulty breathing was unknown.  The patient died on 13 Feb 2021. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding the event of dyspnea and death has been provided at this time. Further information has been requested. Patient's medical history of blood pressure is considered a risk factor. Based on the current available information and temporal association between the use of the product and the onset of the pain, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Died at home
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: accidental vaccination of a 16 year old; A spontaneous report  was received from a consumer concerning a 16 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 14 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. The route of administration was unknown. The patient got the first dose of the Moderna vaccine on 14Jan2021.  On 11 FEB 2021, the patient was turned away for their second dose because of their age.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event experiencing accidental vaccination was resolved; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Exposure via skin contact, Underdose, Vaccination site discharge
Clinical narrative: some vaccine leaked out; some of the vaccine leaked out the arm; vaccine leaked out the arm; A spontaneous report was received from a 71-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and some of the vaccine leaked out of arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The patient reported he was given his first dose of the Moderna vaccine and some of the vaccine leaked out of his arm. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events were considered recovered on 10 Feb 2021.; Reporter's Comments: This report refers to a case of underdose and exposure via skin contact for mRNA-1273 (lot # unknown) with no associated AEs reported.
Sex: U
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; A spontaneous report  was received from a health care professional (HCP) concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's Palsy/facial paralysis.  The patient's medical history was not provided. Concomitant medication history was not provided.  On 30 DEC 2020, the patients received their first of two doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   The HCP stated that on 25 JAN 2021 the patient developed Bell's Palsy.    Treatment for this event was not provided.  The outcome of the event, facial paralysis was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Erythema, Eye pruritus, Eye swelling, Lip swelling
Clinical narrative: Anaphylactic reaction; swollen throat; eyes itching; eyes swollen; swollen lips; She had hives all around her waistband, back, arms, chest, and her hair; Palms were red; palms were very itchy; her arm was tender; A spontaneous report  was received from a consumer concerning a 71-Year-Old female patient, who was administered Moderna's COVID-19 vaccine second dose and her arm was tender, palms were itchy, palms were very red, hives all around waistband, back, arms, chest and hair, swollen throat, swollen lips, eyes swollen and eyes itching and anaphylactic reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13-Jan-2021 the patient received their first of two planned doses of mRNA-1273 (Lot Number:012L20A) Intramuscularly in the left arm. On 11-Feb-2021 prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 11-Feb-2021, patient stated her arm was tender, but she was able to sleep on her side. On 12-Feb-2021 night, her palms were very itchy. On 13-Feb-2021, approximately at 04:30 am patient stated it was like someone had a blowtorched on her palms. Her palms were very red, "as red can be" and itching tremendously. When she used the bathroom, she had hives all around her waistband, back, arms, chest and her hair. Patient went to ER. Since her ER visit, patient stated some of her spots on her chest lighten up and her hands were not as bad. Patient denies ever having trouble of difficulty breathing. Patient called again and reported new adverse events from previous one. Patient went to ER for second time on 13 Feb 2021 night and experienced unbearable itching and burning. Patient felt okay until 15-Feb-2021 and went bed and woke up 1:30 am in the morning with swollen throat and lips and she thought she was experiencing anaphylactic reaction. Her eyes were swollen, itchy and needed help.  Treatment for the event included patient put an ice pack between her hands for an hour on 13-Feb-2021. The ER gave her diphenhydramine and famotidine and patient was sent home with same medications. Patient also used arnicare gel for her whole waistband, which she stated was very cooling and helped with the burning and itching. Patient received 5 doses of steroids, diphenhydramine and famotidine after second ER visit.  The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The events, arm was tender, palms were itchy, palms were very red, hives all around waistband, back, arms, chest and hair, swollen throat, swollen lips, eyes swollen and eyes itching and anaphylactic reaction, were considered unknow.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.