chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TYP
Symptoms: Expired product administered
Clinical narrative: Ingested all four doses of expired Vivotif; Spontaneous report received on 03FEB2021.  A pharmacist reported that a consumer "ingested all four doses of expired Vivotif" (PT: Expired product administered). The consumer was receiving oral Vivotif (expiry date: JUN2020) for immunisation. The consumer took all four doses of expired Vivotif on unknown dates. The pharmacist did not mention any adverse event experienced by the consumer. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown at the time of report.  Company Comment: It was reported that a consumer ingested all four doses of expired Vivotif (expired product administered) and then the consumer did not experience any adverse events. Further details of the event is limited. Considering the nature of the event, the causality of expired product administered is not applicable with Vivotif.; Sender's Comments: It was reported that a consumer ingested all four doses of expired Vivotif (expired product administered) and then the consumer did not experience any adverse events. Further details of the event is limited. Considering the nature of the event, the causality of expired product administered is not applicable with Vivotif.
Age: 36.0
Sex: U
Vaccine: TYP
Symptoms: Expired product administered
Clinical narrative: Took one dose of expired Vivotif; Spontaneous report received on 08FEB2021.  A pharmacist reported that a consumer "took one dose of expired Vivotif" (PT: Expired product administered). The consumer was receiving Vivotif (expiry date: Jun 2020) for immunisation. In Jan 2021, the consumer took one dose of expired Vivotif. The pharmacist stated that the consumer was doing just fine and had not experienced any side effects. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: It was reported that a consumer took one dose of expired Vivotif (expired product administered) and was doing well. Considering the nature of the event, the causality of expired product administered is assessed as not applicable to Vivotif.; Sender's Comments: It was reported that a consumer took one dose of expired Vivotif (expired product administered) and was doing well. Considering the nature of the event, the causality of expired product administered is assessed as not applicable to Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: Hives on upper lip; Spontaneous report received on 16FEB2021. Additional information received on 24FEB2021 and 25FEB2021.  A male consumer reported that he had "hives on upper lip" (PT: Urticaria) while being on Vivotif for immunisation. On 16NOV2019, he took first dose of Vivotif. On the same day, he had hives on his upper lip. He took Benadryl (diphenhydramine) as treatment for hives that resolved the symptoms. Action taken with Vivotif with respect to the reported event was drug withdrawn. At the time of report, he had recovered from the reported event.  It was reported that consumer was eligible for coronavirus disease (COVID) vaccine and he was eager to get one but he had an allergic (hives) reaction to Vivotif. He was trying to find out if there are any overlapping components of the Vivotif and COVID vaccine in other to see if he would be allergic to the COVID vaccine.  His medical history included haemorrhage, no allergies however, sometimes bloody nose due to dryness in air, and had no other major medical condition.  He was not taking any concomitant medication.  Company Comment: A consumer developed hives on his upper lip (urticaria) on the same day of taking first dose of Vivotif. In response to the event, he took benadryl which resolved urticaria, and he did not continue taking the remaining doses of Vivotif. Considering the case information, and potential of Vivotif to cause urticaria, the causality of urticaria is assessed as possible with Vivotif.; Sender's Comments: A consumer developed hives on his upper lip (urticaria) on the same day of taking first dose of Vivotif. In response to the event, he took benadryl which resolved urticaria, and he did not continue taking the remaining doses of Vivotif. Considering the case information, and potential of Vivotif to cause urticaria, the causality of urticaria is assessed as possible with Vivotif.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Tenderness
Clinical narrative: tenderness and redness on injected arm; tenderness and redness on injected arm; This case was reported by a consumer via call center representative and described the occurrence of tenderness in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced tenderness and erythema of extremities. On an unknown date, the outcome of the tenderness and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the tenderness and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's boyfriend. The lot and expiry date were unknown. The patient experienced tenderness and redness on injected arm for 1 day after getting Shingrix. The reporter did not consent to follow-up. This case has been linked with US2021029245, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021029245:same reporter
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site warmth, Urticaria, Vaccination site cellulitis
Clinical narrative: Cellulitis reaction at injection site; Hives all over body; Her arm was sore, warm and tender; Her arm was sore, warm and tender; A spontaneous report was received from a nurse concerning herself, a 44-year-old white female patient who developed a cellulitis reaction at injection site her arm was sore, warm and tender and hives all over body.  The patient's medical history included rheumatoid arthritis and allergy to Demerol. Products known to be used by the patient within two weeks prior to the event included methotrexate, sertraline hydrochloride and multivitamin.  On 08 Jan 2021, two days prior to the onset of event her arm was sore, warm and tender, the patient received the first of two planned doses of mRNA-1273 (Batch number 037K20A) intramuscularly into left arm for prophylaxis of Covid-19 infection.  On 09 Jan 2021, the patient's reported that her arm was sore, warm, and tender. On 13 Jan 2021, the patient reported a cellulitis reaction at the injection site (medically significant) and hives all over her body (under both armpits, back of knees, ankles, wrists, and fingers). Treatment for the event included cefalexin and prednisone. On 20 Jan 2021, the cellulitis is improving and was not red anymore and the hives were starting to go away.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events a cellulitis reaction at injection site her arm was sore, warm and tender and hives all over body was recovering.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Dementia
Clinical narrative: Vaccine has made dementia worse; A spontaneous report was received from a consumer (patient's husband), concerning a 91-years-old, female patient who experienced vaccine has made dementia worse.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 28JAN2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 032L20A] intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 29JAN2021, the reporter claims after his wife was vaccinated her dementia has got worse and she is in fantasy world. Treatment information was not provided. The event worsening dementia due to vaccine was assessed as medically significant.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event worsening dementia due to vaccine 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 event, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Fatigue, Nausea
Clinical narrative: Chest pain; Joint aches; Body aches; Fever; Chills; Fatigue; Nausea; A spontaneous report was received from a 66 year old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced chest pain, body and joint aches, fever, chills, fatigue, and nausea.  The patient's medical history was not provided.  No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 on 10-Jan-2021.  On 11-Feb-2021, approximately 2 days prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 intramuscularly for the prophylaxis of COVID-19 infection.   On 11-Feb-2021, the patient developed body and joint aches, chest pains, fever, chills, fatigue, nausea, and just hurt all over and felt terrible. On 12-Feb-2021, the patient's symptoms persisted, and she was in the emergency room (ER) to be treated.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable.  The outcome of the events, chest pain, body and joint aches, fever, chills, fatigue, and nausea, 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 event, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Chest pain; Joint aches; Body aches; Fever; Chills; Fatigue; Nausea; A spontaneous report was received from a 66 year old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced chest pain, body and joint aches, fever, chills, fatigue, and nausea.  The patient's medical history was not provided.  No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 on 10-Jan-2021.  On 11-Feb-2021, approximately 2 days prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 intramuscularly for the prophylaxis of COVID-19 infection.   On 11-Feb-2021, the patient developed body and joint aches, chest pains, fever, chills, fatigue, nausea, and just hurt all over and felt terrible. On 12-Feb-2021, the patient's symptoms persisted, and she was in the emergency room (ER) to be treated.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable.  The outcome of the events, chest pain, body and joint aches, fever, chills, fatigue, and nausea, 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 event, a causal relationship cannot be excluded.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Renal failure
Clinical narrative: Renal failure; Horrible Headaches; Body ache; A spontaneous report  was received from a consumer concerning an 83-year-old male patient, who was administered Moderna's COVID-19 vaccine and one week later, he had horrible headaches, body ache and hospitalized for kidney problem (Renal failure).  The patient's medical history included diabetes and high blood pressure. Products known to have been used by patient, with in two weeks prior to the event, included apixaban, sitagliptin, carvedilol, furosemide, glipizide.  Patient became COVID positive on 14-DEC-2020 while in the hospital and survived.  On 02-Feb-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 09-Feb-2021, approximately one week later, patient had horrible headache and body ache. Patient is better now but he is in the hospital because he has kidney problems (Renal failure) started on 14-Feb-2021. Patient's wife mentioned in call that this has never happened in past and she already asked MD not to give him the second dose. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was discontinued.  The outcome of the events, he had horrible headaches, body ache, were considered resolved. The outcome of the event hospitalized for kidney problem (Renal failure) was considered 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 reported events, a causal relationship cannot be excluded. Patient's elderly age and medical history of diabetes and high blood pressure may have been contributory for the event of renal failure.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Asthenia, Dysstasia, Feeling abnormal, Hallucination
Clinical narrative: hallucinating; seeing spots; dreaming is unbelivable; pain; buzzing on her neck; body has no strength; could not stand straight; nausea; vomiting; A spontaneous report  was received from a female consumer regarding herself who received first dose of Moderna Covid-19 vaccine (mRNA-1273)and have experienced hallucinations, excessive dreaming, loss of strength, inability to stand up, feeling abnormal, pain, nausea and vomiting.  The patient's medical history was not provided. Her concomitant medications were not provided. No information on allergies.   On 14-FEB-2021, prior to the onset of events, the patient received her first of two planned doses of Covid-19 vaccine (mRNA-1273) for the prophylaxis of Covid-19 infection at noon time.   On 15-FEB-2021, she said, she still feeling it in her brain, her head and her body. She has no energy, could not even get up, she has buzzing on her neck and her body has no strength. She is hallucinating, seeing spots, seeing all kinds of things and her dreaming is unbelievable. She had so much pain, nausea and vomiting. She hung up the phone saying no time for this. It is not known whether the patient has any psychiatric history in the past. Treatment information was not provided.  Action taken with the 2nd dose of mRNA-1273 in response to the events was not reported.  The outcome of the events was unknown at the time of report. Follow up information is expected.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, visual, Nausea, Pain, Vomiting
Clinical narrative: hallucinating; seeing spots; dreaming is unbelivable; pain; buzzing on her neck; body has no strength; could not stand straight; nausea; vomiting; A spontaneous report  was received from a female consumer regarding herself who received first dose of Moderna Covid-19 vaccine (mRNA-1273)and have experienced hallucinations, excessive dreaming, loss of strength, inability to stand up, feeling abnormal, pain, nausea and vomiting.  The patient's medical history was not provided. Her concomitant medications were not provided. No information on allergies.   On 14-FEB-2021, prior to the onset of events, the patient received her first of two planned doses of Covid-19 vaccine (mRNA-1273) for the prophylaxis of Covid-19 infection at noon time.   On 15-FEB-2021, she said, she still feeling it in her brain, her head and her body. She has no energy, could not even get up, she has buzzing on her neck and her body has no strength. She is hallucinating, seeing spots, seeing all kinds of things and her dreaming is unbelievable. She had so much pain, nausea and vomiting. She hung up the phone saying no time for this. It is not known whether the patient has any psychiatric history in the past. Treatment information was not provided.  Action taken with the 2nd dose of mRNA-1273 in response to the events was not reported.  The outcome of the events was unknown at the time of report. Follow up information is expected.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Diarrhoea
Clinical narrative: AFIB reaction; diarrhea; A spontaneous report was received from a consumer concerning a 70-year-old male patient, who experienced AFib/ MedDRA PT: atrial fibrillation and diarrhea/ MedDRA PT: diarrhoea.  The patient's medical history included atrial fibrillation (AFib). No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of Covid-19 infection.   The patient stated that about a day and a half later following vaccination, he started experiencing AFib and diarrhea. He also reported that on the day of his vaccine, he took an echocardiogram and his heart was doing well. Patient was originally diagnosed with AFib in 2011. The patient stated that he is doing better today.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the events was not reported.  The events, atrial fibrillation and diarrhea, were considered recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event,s a causal relationship cannot be excluded. Patient's medical history of atrial fibrillation is considered a confounder for the event of atrial fibrillation.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Renal failure
Clinical narrative: Stage 4 kidney failure; A spontaneous report was received from a consumer concerning an 83-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stage four renal failure.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 18 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 011L20A) intramuscularly on her right arm for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient was diagnosed with Stage-4 Kidney Failure.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The relatedness of the event (Kidney Failure) to the suspect drug is unknown.  At the time of this report, the outcome of the event reported (Stage-4 Kidney Failure) was not resolved.; Reporter's Comments: This case concerns a 83-year-old, female patient, who experienced stage four renal failure. Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fall, SARS-CoV-2 test positive
Clinical narrative: Multiple falls; A spontaneous report was received from a healthcare facility staff memberconcerning a male patient of unknown age who received Moderna's COVID-19 vaccination (mRNA-1273) and experienced multiple falls.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 23 Jan 2021, approximately 18 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient was hospitalized for multiple falls.  The patient's wife stated that while in the hospital he tested positive for COVID.  Moreover, the patient's wife also tested positive for COVID-19 infection.   The patient was still in the hospital as of 17 Feb 2021.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event was unknown.; Reporter's Comments: This case concerns a male patient of unknown age, who was hospitalized for multiple falls, 18 days after the administration of first dose of mRNA-1273. The patient tested positive for COVID-19 while in the hospital. Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Death, Haemorrhage, International normalised ratio, Urinary tract infection, Urine analysis
Clinical narrative: Passed away; UTI; Abnormal bleeding; A spontaneous report was received  from a healthcare professional concerning a patient who received the Moderna COVID-19 Vaccine (mRNA-1273) and experienced abnormal bleeding, UTI, and passed away.   The patient's medical history included a long term history of anticoagulation therapy. Concomitant product use included anticoagulation therapy.  On 31Jan2021 prior to the onset of the events the patient recieved their first dose of mRNA-1273 (Lot number:not reported) intramuscularly for prophylaxis of COVID-19 infection.  On 07Feb2021, the patient complained of abnormal bleeding. Patient was seen at clinic on 10Feb2021 and was diagnosed with a UTI and given antibiotics. An INR was also completed that day due to patient having a long term history of anticoagulation therapy. Results of that showed the INR to be 12. Prior to vaccination, patient's INR was normal and no changes to medications and diet were made after vaccination and prior to complaint starting.   On 12Feb2021 the patient passed away.  Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 12Feb2021. The cause of death was unknown. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns an 82 year old male patient, with history of long term anticoagulation therapy (unknown indication), who experienced a fatal event of death and abnormal hemorrhage, 13 days after receiving second dose of mRNA- 1273 (Lot# Unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for COVID-19; A spontaneous report was received from a consumer  regarding himself, an 88-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was diagnosed and hospitalized with COVID-19.  The patient's medical history was not included. It was stated that the patient takes other medications, however they were not identified.  On 21 January 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.    On an unspecified date, the patient reported that he went to the hospital and was admitted for COVID-19. Medications were given as treatment, but not identified. He states that he has no clue what it is, it was given to him at the hospital.   Consent to contact was provided.  Action taken with mRNA-1273 was not reported.  The outcome of the event, diagnosed COVID-19 positive after receiving the vaccine was considered unknown.; Reporter's Comments: This case concerns an 88-year-old male who was hospitalized with a serious unexpected event of COVID-19.  The event occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on 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.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Dyspnoea, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; he wasn't breathing right; loss of sense of taste; loss of sense of smell; A spontaneous report was received from a consumer concerning a 70-year-old male patient, tested positive for COVID-19, had loss of sense of smell and taste, and was hospitalized because he was not breathing right/COVID-19.   The patient's medical history included blood pressure, cholesterol and unspecified prostate. Concomitant medications included unknown medication for his blood pressure, unknown cholesterol medication, and unknown prostate medication.    On 30 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) for prophylaxis of COVID-19 infection.  On 02 Feb 2021, the patient had loss of sense of smell and taste. On 05 Feb 2021, he tested positive for COVID-19 and was hospitalized because he wasn't breathing right. He returned home on 08 Feb 2021.   Treatment for the event included vitamins, dexamethasone, pantoprazole, steroids, and remdesivir.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome for the event wasn't breathing right was resolve don 08 Feb 2021.   The outcome for the events tested positive for COVID-19, had loss of sense of smell and taste was considered as 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 event, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Atrial flutter, Heart rate increased
Clinical narrative: Atrial fibrillation; Feeling fluttery; Heart rate was racing and was increasing, went up to 175 just sitting; A spontaneous report was received from a consumer concerning a 64-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced atrial fibrillation, feeling fluttery, and heart rate was racing and was increasing, went up to 175 just sitting.  The patient's medical history was not provided. Concomitant medications included Travatan for glaucoma.    On 12 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, five hours after vaccination, the patient experienced a fluttery feeling, heart rate was racing and was increasing, heart rate went up to 175 just sitting. She took an EKG on her watch and it was atrial fibrillation. When she was sleeping, her heart rate was at 102 or the 90s, normally it would be in the 60s.    No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events, atrial fibrillation, feeling fluttery, and heart rate was racing and was increasing, went up to 175 just sitting, was unknown.; Reporter's Comments: This case concerns a 64 year old female patient, who was on hospice care experienced a fatal event of death, 1 day after receiving second dose of mRNA- 1273 (Lot# 030M20A). Very limited information regarding this event has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: patient who has atrial fibrillation who needed special care after getting the vaccine; A spontaneous report was received from a Consumer reporting a patient who received Moderna's COVID-19 Vaccine and who has atrial fibrillation who needed special care (supportive care).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On unknown date, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the reporter contacted the Safety Department and enquired regarding a patient who has atrial fibrillation on an unknown date and needed special care after getting the vaccine.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  At the time of this report, the outcome of the event, patient who has atrial fibrillation who needed special care after getting the vaccine, was unknown.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Injection site pain
Clinical narrative: Mild bell's palsy; Sore arm; A spontaneous report( was received from a 72 years old, female patient who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced events of sore arm and mild bell's palsy(facial palsy).  The patient's medical history was not provide .No relevant concomitant medications were reported.  ON 02-Feb-2021, prior to the onset of the events, the patient received their first dose of mRNA-1273 (lot: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 02-Feb-2021, post vaccination, the patient reported that her right arm was sore for a few days. No treatment information was provided.  On 09 Feb 2021, the patient has extensive dental work in one side as the dentist tried to put an implant in and was unable to.   On an undisclosed date, days following dental work, her lips on the left and right of her face were not matching. She stated that the rest of her face was fine.   On an undisclosed date, her dentist and primary care physician diagnosed her with an extremely mild case of Bell's Palsy caused by the extensive dental work.  The treatment received for the event included steroid injection.  The outcome of the events was unknown.; Reporter's Comments: Patient's dentist and primary care physician diagnosed her with an extremely mild case of Bell's Palsy caused by the extensive dental work.   Based on reporter's causality provided, the event is assessed as unlikely related to mRNA-1273.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Stent placement
Clinical narrative: minor heart attack; stent put in; A spontaneous report was received from a consumer who was also a 75 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a minor heart attack / myocardial infarction and stent was put in / stent placement.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 25-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in the left arm for prophylaxis of COVID-19 infection.  On 13-Feb-2021, the patient experienced a minor heart attack and had a  stent placement.    Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, minor heart attack and stent was put in, was not provided.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Food aversion, Malaise, Pneumonia, SARS-CoV-2 test negative
Clinical narrative: Pneumonia; coughing with bubble spit; STOPPED EATING AND WOULD NOT SWALLOW PILLS; PAIN IN ARM; NOT FEELING WELL; A spontaneous report was received from a consumer concerning a male patient of 94 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced pain in arm,felt unwell, coughing with bubble spit,stopped eating, would not swallow pills and pneumonia.  The patients medical history was not provided.No relevant Concomitant medications were reported.   On 08 Feb 2021,prior to the onset of events, the Patient received their second of two planned dose of mRNA-1273(Lot number: 031L20A) vaccine for prophylaxis of COVID-19 infection.  On 09 feb 2021,patient experienced pain in arm and felt unwell. On 13 Feb 2021,patient experienced coughing with bubble spit,stopped eating and would not swallow pills. On 15 feb 2021,patient went to the hospital and was diagnosed with pneumonia and patient was hospitalized and received a negative covid test in the hospital. Treatment information for the event included IV and oxygen.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the event pain in arm and felt unwell were considered resolved on 10 feb 2021. The outcome for the event coughing with bubble spit were considered resolved on 14 feb 2021. The outcome for the event stopped eating and would not swallow pills were considered resolved on 15 feb 2021.The outcome for the event pneumonia was not provided.; Reporter's Comments: This case concerns a 94-year-old male who was hospitalized with a serious unexpected event of pneumonia along with NS unexpected malaise, cough, aversion to food and NS expected vaccination site pain. COVID-19 test negative. Event onset 30 days after the first dose of mRNA-1273. Treated with O2 and IV. Pneumonia outcome unknown. Based on 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.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pneumonia; coughing with bubble spit; STOPPED EATING AND WOULD NOT SWALLOW PILLS; PAIN IN ARM; NOT FEELING WELL; A spontaneous report was received from a consumer concerning a male patient of 94 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced pain in arm,felt unwell, coughing with bubble spit,stopped eating, would not swallow pills and pneumonia.  The patients medical history was not provided.No relevant Concomitant medications were reported.   On 08 Feb 2021,prior to the onset of events, the Patient received their second of two planned dose of mRNA-1273(Lot number: 031L20A) vaccine for prophylaxis of COVID-19 infection.  On 09 feb 2021,patient experienced pain in arm and felt unwell. On 13 Feb 2021,patient experienced coughing with bubble spit,stopped eating and would not swallow pills. On 15 feb 2021,patient went to the hospital and was diagnosed with pneumonia and patient was hospitalized and received a negative covid test in the hospital. Treatment information for the event included IV and oxygen.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the event pain in arm and felt unwell were considered resolved on 10 feb 2021. The outcome for the event coughing with bubble spit were considered resolved on 14 feb 2021. The outcome for the event stopped eating and would not swallow pills were considered resolved on 15 feb 2021.The outcome for the event pneumonia was not provided.; Reporter's Comments: This case concerns a 94-year-old male who was hospitalized with a serious unexpected event of pneumonia along with NS unexpected malaise, cough, aversion to food and NS expected vaccination site pain. COVID-19 test negative. Event onset 30 days after the first dose of mRNA-1273. Treated with O2 and IV. Pneumonia outcome unknown. Based on 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.
Sex: M
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: Complete hearing loss; A spontaneous report  was received from a physician concerning a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced complete hearing loss.  The patient's medical history was not provided by reporter. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced complete hearing loss after receiving COVID-19 vaccine. Laboratory details were not provided. Treatment information was not reported.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, complete hearing loss, was unknown.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of Deafness, after receiving 1st dose of mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Unspecified side effects; A spontaneous report  was received from a consumer, concerning a male patient (age unspecified) who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced unspecified side effects ( Vaccination Complications)    The patient's medical history was not provided. No relevant concomitant medications were reported.    On unspecified day in JAN-2021 (two weeks ago from the reporting date), approximately 20 hours, prior to the onset of the symptoms, the patient received his first of two planned doses of mRNA-1273 (batch number not provided) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.  On an unspecified day in JAN-2021, the patient had experienced unspecified side effects and was hospitalized.   Treatment information was not provided.  The outcome of the event unspecified side effects 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 event, a causal relationship cannot be excluded.  Very limited information  has been provided at this time and further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Oral herpes, Psoriasis, Stevens-Johnson syndrome
Clinical narrative: Stevens Johnson syndrome; 1 blister on lip looks like outbreak of herpes; horrible outbreak of psoriasis; A spontaneous report was received from a healthcare professional concerning a 73-year-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced steven-johnson syndrome, oral herpes(blister on the lip which looks like an outbreak of herpes), psoriasis (bolus lesion on right arm, two bolus lesions on back, and legs).  The patient's medical history included bad psoriasis.  Products known to have been used by the patient, within two weeks prior to the event, included secukinumab for psoriasis, which the patient took on 21 JAN 2021 as per the reporter.  No other relevant concomitant medications  was reported.   On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On 04-Feb-2021, it was reported that the patient had blister on the lip which looked like an outbreak of herpes. It was also reported that the patient had a bolus lesion on right arm, two bolus lesions on back, and legs, had a horrible outbreak of psoriasis. The physician mentioned that it appeared as Stevens Johnsons syndrome. Treatment included secukinumab for psoriasis.   Action taken with mRNA-1273 was unknown.  The outcome of the events, steven-johnson syndrome, oral herpes (blister on the lip which looks like an outbreak of herpes), psoriasis (bolus lesion on right arm, two bolus lesions on back, and legs), were unknown.; Reporter's Comments: This case concerns a 73-year-old  patient, who experienced Stevens-Johnson syndrome, oral herpes outbreak and outbreak of psoriasis. The patient's medical history included bad psoriasis and patient is on cosentyx for psoriasis. Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Unresponsive; A spontaneous report was received from Pfizer concerning a 32-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 28 DEC 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown)  for prophylaxis of COVID-19 infection.  On 04 JAN 2021, at 7:20 am, the patient died. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 04 Jan 2021. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: This case concerns a 32-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death. The cause of death was unknown. Plans for an autopsy were not provided. Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Unresponsive; A spontaneous report was received from Pfizer concerning a 43-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 08 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown)  for prophylaxis of COVID-19 infection.  On 09 JAN 2021, the patient died. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 08 Jan 2021. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Unresponsive; A spontaneous report was received from Pfizer concerning a 45-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 28 Dec 2020, approximately 24 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown)  for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient was found deceased at home. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 29 Dec 2020. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.; Reported Cause(s) of Death: unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Unresponsive; A spontaneous report was received from Pfizer concerning a 50-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown)  intramuscular for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient died. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 31 Dec 2020. The cause of death was unknown. Plans for an autopsy were unknown.; Reporter's Comments: This case concerns a 51 year old, female patient, who experienced an unexpected event of Death, after receiving 1st dose of mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. There is no contact information and no further follow up information is expected.; Reported Cause(s) of Death: unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Death
Clinical narrative: chronic hypoxia respiratory failure; Unresponsive; A spontaneous report was received from Pfizer concerning a 51-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had developed hypoxia a sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown)  for prophylaxis of COVID-19 infection.  On 07 Jan 2021, around 6:00 pm, the patient became increasingly hypoxic. He was transported to the hospital for acute on chronic hypoxia respiratory failure. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 12 Jan 2021 at 11:25pm. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Unresponsive; A spontaneous report was received from Pfizer concerning a 52-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 08 Jan 2021, approximately 2 hours prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown)  for prophylaxis of COVID-19 infection.  On 08 Jan 2021, the patient was monitored for the appropriate amount of time by nursing staff, following vaccination. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 08 Jan 2021 at 2:15pm. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: This case concerns a 52-year old, female patient, who experienced a sudden death 1 day after administration of first dose of mRNA-1273. The cause of death was not provided. Plans for an autopsy were unknown. Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; A spontaneous report was received from a reporter concerning a 56-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and had experienced death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 23 Dec 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown) for prophylaxis of COVID-19 infection.  On 08 Jan 2021, the patient died. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 08 Jan 2021. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Unresponsive; A spontaneous report was received from Pfizer concerning a 56-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 08 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown)  for prophylaxis of COVID-19 infection.  On 09 Jan 2021, the patient was found deceased in her home. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 09 Jan 2021. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death