chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: redness at injection site; swelling, and itching at the injection site; itching at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number BP3F4, expiry date 3rd September 2022) for prophylaxis.   On 10th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 10th January 2021, 2 hrs after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site itching were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site itching to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself. The patient experienced redness at the injection site approximately 2 inches in diameter, swelling, and itching at the injection site. All events lasted for two weeks and then resolved. The reporter consented to follow up.  Discrepancy : The patient's age was reported as 61 years old however as per date of birth it should be 60 years. In Argus correct age was captured.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: tingling / in her left foot; numbing in her left foot / foot is asleep; This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2020, the patient received Shingrix. On 5th December 2020, immediately after receiving Shingrix, the patient experienced tingling of extremity and numbness in feet. On an unknown date, the outcome of the tingling of extremity and numbness in feet were not recovered/not resolved.   It was unknown if the reporter considered the tingling of extremity and numbness in feet to be related to Shingrix.  Additional details were provided as follows: The patient reported case for hrself. The patient reported tingling and numbing in her left foot that presented shortly after received the vaccine. She described it as her foot was asleep No additional details provided. The reporter did not consent to follow up.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dermatitis acneiform, Ear swelling, Erythema, Fatigue
Clinical narrative: Chills; general Fatigue; developed on bump on her right cheek / near her right ear; bright red round pink growth near her ear / as the size of a pencil erasor; she broke out and a big pimply rash appeared on her right cheek; bright red round pink growth near her ear / as the size of a pencil erasor; This case was reported by a consumer via call center representative and described the occurrence of chills in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than 3 months after receiving Shingrix, the patient experienced papular rash and erythema ear. On an unknown date, the patient experienced chills, fatigue, rash and ear swelling. The patient was treated with nitrogen (Nitrogen, Liquid). On an unknown date, the outcome of the chills and fatigue were recovered/resolved and the outcome of the rash and ear swelling were unknown and the outcome of the papular rash and erythema ear were not recovered/not resolved.   It was unknown if the reporter considered the chills, fatigue, rash, papular rash, erythema ear and ear swelling to be related to Shingrix.  Additional details was reported as follows: After getting the first Shingrix injection, the patient developed on bump on her right cheek and near her right ear, she began having chills and general fatigue. The patient broke out and a big pimply rash appeared on her right cheek. She states that this had not resolved. She also reported a bright red round pink growth near her ear appeared. She described this growth as the size of a pencil erasor. She stated that her dermatologiest burned this growth off with liquid nitrogen on an unknown date. All those symptoms resolved without intervention. No further information was provided. Consented to follow up was unknown. The patient was unable to report the lot number, expiration date, or dosage of the shingrix dose she received.  For tolerance of 2nd dose, refer linked case US2021AMR063209.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063209:same reporter
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Rash, Rash papular, Swelling face
Clinical narrative: Chills; general Fatigue; developed on bump on her right cheek / near her right ear; bright red round pink growth near her ear / as the size of a pencil erasor; she broke out and a big pimply rash appeared on her right cheek; bright red round pink growth near her ear / as the size of a pencil erasor; This case was reported by a consumer via call center representative and described the occurrence of chills in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than 3 months after receiving Shingrix, the patient experienced papular rash and erythema ear. On an unknown date, the patient experienced chills, fatigue, rash and ear swelling. The patient was treated with nitrogen (Nitrogen, Liquid). On an unknown date, the outcome of the chills and fatigue were recovered/resolved and the outcome of the rash and ear swelling were unknown and the outcome of the papular rash and erythema ear were not recovered/not resolved.   It was unknown if the reporter considered the chills, fatigue, rash, papular rash, erythema ear and ear swelling to be related to Shingrix.  Additional details was reported as follows: After getting the first Shingrix injection, the patient developed on bump on her right cheek and near her right ear, she began having chills and general fatigue. The patient broke out and a big pimply rash appeared on her right cheek. She states that this had not resolved. She also reported a bright red round pink growth near her ear appeared. She described this growth as the size of a pencil erasor. She stated that her dermatologiest burned this growth off with liquid nitrogen on an unknown date. All those symptoms resolved without intervention. No further information was provided. Consented to follow up was unknown. The patient was unable to report the lot number, expiration date, or dosage of the shingrix dose she received.  For tolerance of 2nd dose, refer linked case US2021AMR063209.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063209:same reporter
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Gait inability, Insomnia, Mobility decreased, Neuralgia
Clinical narrative: cannot walk and cannot move due to the pain.; I cannot move my hip; pain is on the left hip and goes down to / left knee; severe nerve pain; I must have been sleeping wrong / has not slept; This case was reported by a consumer via call center representative and described the occurrence of unable to walk in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of neuralgia (1st dose received on an unknown date, refer case US2021AMR062577).   On 5th March 2021, the patient received the 2nd dose of Shingrix (intramuscular). In March 2021, less than a week after receiving Shingrix, the patient experienced unable to walk, mobility decreased, pain in hip, nerve pain and insomnia. The patient was treated with gabapentin. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the unable to walk, mobility decreased, pain in hip, nerve pain and insomnia were unknown.   The reporter considered the unable to walk, mobility decreased, pain in hip, nerve pain and insomnia to be possibly related to Shingrix.   Additional details were provided as follows: The case was reporter by patient's husband. The reporter wanted to know the adverse reactions of Shingrix vaccine due to her wife dealing with severe reaction with second shot. The patient was vaccinated probably last Friday from the date of reporting. The patient was experiencing severe nerve pain.  Either Monday or Sunday that the patient commented, she must have been sleeping wrong.  The patient cannot move her hip, pain was on the left hip and goes down to left knee.  The patient cannot walk and cannot move due to the pain.  The reporter does not know if the pain started on the same day of the 2nd Shingrix vaccine but did clarify that the pain started on 2nd March 2021. The patient and her husband visited healthcare provider to find out what was causing this pain.  The only thing they could think about was the second those of Shingrix vaccine.  The patient was prescribed nerve medicine that was Gabapentin on Monday from the day of reporting, which started calming the nerve down but started flaring up again.  The patient had not slept in three days and wanted to figure something out.  The patient does not want to wait a week. The reporter gave consent for healthcare provider follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: cannot walk and cannot move due to the pain.; I cannot move my hip; pain is on the left hip and goes down to / left knee; severe nerve pain; I must have been sleeping wrong / has not slept; This case was reported by a consumer via call center representative and described the occurrence of unable to walk in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of neuralgia (1st dose received on an unknown date, refer case US2021AMR062577).   On 5th March 2021, the patient received the 2nd dose of Shingrix (intramuscular). In March 2021, less than a week after receiving Shingrix, the patient experienced unable to walk, mobility decreased, pain in hip, nerve pain and insomnia. The patient was treated with gabapentin. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the unable to walk, mobility decreased, pain in hip, nerve pain and insomnia were unknown.   The reporter considered the unable to walk, mobility decreased, pain in hip, nerve pain and insomnia to be possibly related to Shingrix.   Additional details were provided as follows: The case was reporter by patient's husband. The reporter wanted to know the adverse reactions of Shingrix vaccine due to her wife dealing with severe reaction with second shot. The patient was vaccinated probably last Friday from the date of reporting. The patient was experiencing severe nerve pain.  Either Monday or Sunday that the patient commented, she must have been sleeping wrong.  The patient cannot move her hip, pain was on the left hip and goes down to left knee.  The patient cannot walk and cannot move due to the pain.  The reporter does not know if the pain started on the same day of the 2nd Shingrix vaccine but did clarify that the pain started on 2nd March 2021. The patient and her husband visited healthcare provider to find out what was causing this pain.  The only thing they could think about was the second those of Shingrix vaccine.  The patient was prescribed nerve medicine that was Gabapentin on Monday from the day of reporting, which started calming the nerve down but started flaring up again.  The patient had not slept in three days and wanted to figure something out.  The patient does not want to wait a week. The reporter gave consent for healthcare provider follow up.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: experienced a rash in her neck then in her chest and belly / new areas; This case was reported by a physician via call center representative and described the occurrence of rash zosteriform in a male patient who received Herpes zoster (Shingrix) (batch number NE49X, expiry date 23rd August 2022) for prophylaxis.   On 4th March 2021, the patient received the 1st dose of Shingrix. In March 2021, 72 hrs after receiving Shingrix, the patient experienced rash zosteriform. On an unknown date, the outcome of the rash zosteriform was not recovered/not resolved.   It was unknown if the reporter considered the rash zosteriform to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's spouse. The patient received 1st dose of Shingrix and experienced rash on back, chest and belly on 7th Mar 2021. The patient stated that, the rash was ongoing, getting in new areas and looks like shingles.  No further information reported. The reporter consented to follow up
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Dehydration, Headache, Myalgia
Clinical narrative: Headache; Fever; Joint pain; Muscle pain; Felt sick to her stomach; Threw up; Dehydration; A spontaneous report was received from a consumer concerning 71-year old, female patient who received Moderna's COVID-19 vaccine and experienced headache, fever, joint pain, muscle pain, feeling sick to her stomach, vomiting, and dehydration.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, the patient received the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 01 Jan 2021, the patient went to the emergency room for headache, fever, joint pain, and muscle pain. Patient reports feeling "sick to her stomach" and vomiting several times. She was treated for dehydration and nausea. She was discharged when her symptoms improved. Treatment for the events included IV fluids and an unspecified anti-nausea medication.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, headache, fever, joint pain, muscle pain, feeling sick to her stomach, vomiting, and dehydration, was considered recovering/resolving.; 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Headache; Fever; Joint pain; Muscle pain; Felt sick to her stomach; Threw up; Dehydration; A spontaneous report was received from a consumer concerning 71-year old, female patient who received Moderna's COVID-19 vaccine and experienced headache, fever, joint pain, muscle pain, feeling sick to her stomach, vomiting, and dehydration.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, the patient received the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 01 Jan 2021, the patient went to the emergency room for headache, fever, joint pain, and muscle pain. Patient reports feeling "sick to her stomach" and vomiting several times. She was treated for dehydration and nausea. She was discharged when her symptoms improved. Treatment for the events included IV fluids and an unspecified anti-nausea medication.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, headache, fever, joint pain, muscle pain, feeling sick to her stomach, vomiting, and dehydration, was considered recovering/resolving.; 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: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in his right arm; A spontaneous report was received from a consumer concerning a 32-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingling in his right arm/paraesthesia.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 09-MAR-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown)  intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 11-MAR-2021, The patient experienced tingling in his right arm (paraesthesia).  Laboratory details were not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 11-MAR-2021 , the outcome of the event tingling in his right arm 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.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: He past away on 28Feb2021 from a heart attack; A spontaneous report was received from a consumer concerning a 80 year old male patient who received Moderna's COVID-19 vaccine and the patient died due to heart attack.  The patient's medical history, as provided by the reporter, included diabetes, congestive heart failure, hypertension and high cholesterol. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 025L20A) intramuscularly in the right arm on 21 Jan 2021. On 26 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 024M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28 Feb 2021 the patient passed away due to heart attack. No treatment information was provided.  The seriousness criteria for the event passed away from a heart attack were death and medically significant.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome for the event, he passed away from a heart attack was fatal.; Reporter's Comments: This case concerns a 80 year old, male patient. who died due to myocardial infarction. Very limited information regarding this event has been provided at this time.  The patient's medical history of diabetes, congestive heart failure, hypertension and high cholesterol remains the risk factor for myocardial infarction. Further information has been requested. The cause of death is Myocardial infarction.; Reported Cause(s) of Death: Heart Attack
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia, Platelet count decreased
Clinical narrative: Blood on their stool was found; Patelet count has been going down; A spontaneous report was received from a healthcare professional concerning a 83-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood in his stool and platelet count decreased.  The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the event, included sacubitril valsartan sodium hydrate, ivabradine hydrochloride, sitagliptin phosphate, Isosorbide mononitrate, Clopidogrel, and Rosuvastatin.  On 11-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027720A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 8/Feb/2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  A week or two after the second dose, blood in his stool was found and happened 5 times approximately, and platelet count went down and then went slightly back up. The patient does not have any bruises, no fever,  or any other reactions. The patient was on blood thinners, but once he complained about the blood in his stool, they were stopped.  Treatment details were not provided.    Action taken with mRNA-1273 in response to the events is not applicable.  The outcome of events,  received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood in his stool and platelet count decreased, was considered recovered resolved.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, and excluding all other etiologies, a causal relationship with the event cannot be excluded
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, Myalgia, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID 19; Hallucinating; Body aches; Fever; A spontaneous report was received from a consumer concerning a 62 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed body aches (myalgia), fever (pyrexia), hallucinating (hallucination) and tested positive for covid 19 (SARS-CoV-2 test positive).  The patient's medical history was not reported. Concomitant product use was not reported.  On 04 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On 06 Mar 2021, approximately 2 days after receiving vaccine, the patient developed body aches, fever and hallucinating. On 07 Mar 2021, the patient tested positive for covid 19.  Treatment information was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events 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. However, the mRNA-1723 does not contain virus capable of causing infection and with the occurrence of SAR-COV-2 test positive after vaccination, is unlikely related to mRNA-1273.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Myelitis transverse, Nausea, Oropharyngeal pain
Clinical narrative: flare of transverse myelitis; flare of transverse myelitis; nauseous; sore throat; headache; A spontaneous report was received from a retired physical therapist who was also a 55 year-old female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed headache, sore throat (oropharyngeal pain), nauseous (nausea), and flare of transverse myelitis (myelitis transverse and condition aggravated).  The patient's medical history included transverse myelitis. Concomitant medications included mesalazine.  On 04-MAR-2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (lot# 013A21A) intramuscularly in the left arm for the prophylaxis of COVID-19 infection.  Initially, the patient reported she was fine. Then, at night on 04-MAR-2021, the patient developed headache, sore throat, then every 6 hours, she became nauseous. Early morning on 07-MAR-2021, the patient became really nauseous and went back to sleep. She reported that she had a mild flare of transverse myelitis "which doesn't happen without big insult." The flare included spasticity, weakness, and apraxia. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of events, headache, oropharyngeal pain, nausea, and transverse myelitis flare, 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.
Sex: M
Vaccine: COVID19
Symptoms: Hospice care
Clinical narrative: Patient in hospice; A spontaneous report was received from a consumer concerning a male patient of unknown age,who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, patient in hospice.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event, patient in hospice.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, patient in hospice was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Cough, Fatigue, Myalgia
Clinical narrative: Heart attack; Fatigue; Chest Pain; Cough; Fever; Muscle pain in chest area; Chills; A spontaneous report  was received from a 72 year-old female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed heart attack (myocardial infarction), fever (pyrexia), cough, fatigue, muscle pain in chest area (myalgia), chills, and chest pain.  The patient's medical history and concomitant medications were not reported.  On 25-JAN-2021, 26 hours prior to the onset of events, the patient received her second of two planned doses of mRNA-1273 (lot#: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  On 26-JAN-2021, the patient reported they have developed chills, fever, and muscle pain in the chest area. The reporter specified that it wasn't chest pain.  The patient took acetaminophen for the pain. On 27-JAN-2021, the patient reported her fever subsided but she was still having a little cough and chest pain.  On 28-JAN-2021, the patient had chest pain again during a nap and decided to call 911 because she was about to pass out. The patient was taken to the ER (emergency room) where an EKG (electrocardiogram) was performed. A few moments after the EKG, the patient had a heart attack. The cardiologist suspected the patient may have had a heart attack two days earlier because her cardiac enzymes were too high to be a result of a recent heart attack. The patient was admitted to the hospital from 28-JAN-2021 until 01-FEB-2021. Catheterization and stent placement were performed. Treatment medications included acetaminophen, clopidogrel, metoprolol, low-dose aspirin, and atorvastatin. At the time of this report, the patient was still feeling fatigued but other than that, she was feeling better.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcomes of the events, heart attack, cough, muscle pain in chest area, fever, chills, and chest pain, were resolved. The outcome of the event, fatigue, was not 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 events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Pyrexia
Clinical narrative: Heart attack; Fatigue; Chest Pain; Cough; Fever; Muscle pain in chest area; Chills; A spontaneous report  was received from a 72 year-old female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed heart attack (myocardial infarction), fever (pyrexia), cough, fatigue, muscle pain in chest area (myalgia), chills, and chest pain.  The patient's medical history and concomitant medications were not reported.  On 25-JAN-2021, 26 hours prior to the onset of events, the patient received her second of two planned doses of mRNA-1273 (lot#: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  On 26-JAN-2021, the patient reported they have developed chills, fever, and muscle pain in the chest area. The reporter specified that it wasn't chest pain.  The patient took acetaminophen for the pain. On 27-JAN-2021, the patient reported her fever subsided but she was still having a little cough and chest pain.  On 28-JAN-2021, the patient had chest pain again during a nap and decided to call 911 because she was about to pass out. The patient was taken to the ER (emergency room) where an EKG (electrocardiogram) was performed. A few moments after the EKG, the patient had a heart attack. The cardiologist suspected the patient may have had a heart attack two days earlier because her cardiac enzymes were too high to be a result of a recent heart attack. The patient was admitted to the hospital from 28-JAN-2021 until 01-FEB-2021. Catheterization and stent placement were performed. Treatment medications included acetaminophen, clopidogrel, metoprolol, low-dose aspirin, and atorvastatin. At the time of this report, the patient was still feeling fatigued but other than that, she was feeling better.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcomes of the events, heart attack, cough, muscle pain in chest area, fever, chills, and chest pain, were resolved. The outcome of the event, fatigue, was not 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 events, a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: infection; A spontaneous report was received from a 65 year-old male patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed infection (infection).   The patient's medical history was not provided. Concomitant medications included glipizide.  On 09-FEB-2021, 8 days prior to the onset of the event, the patient received his first of two planned doses of mRNA-1273 (lot#: 025L20A) intramuscularly in the left arm for the prophylaxis of COVID-19 infection.    On 16-FEB-2021, the patient developed infection and was subsequently hospitalized for three days. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event, infection, was 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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fall, Muscle spasms, Presyncope
Clinical narrative: She was hospitalized because she had an episode of shortness of breath when she was at neurologist's office; Patient experienced spasms after 11 days of receiving 2nd dose; Patient feeling she was falling to her left side after 11 days from second dose; Feels like she is going to pass out but she hasn't passed out; A spontaneous report was received from a consumer concerning a 55-year old female patient, who received Moderna's 2nd dose of COVID-19 vaccine (mRNA-1273) and experienced spasms, shortness of breath,  feeling of falling to her left side, feeling of passing out and short of breath.  The patient's medical history was not provided. Concomitant medications were not reported.  On an unmentioned date, patient received her first of the two planned doses of mRNA-1273 (Lot number: unknown) for the prophylaxis of COVID-19 infection. On 16-Feb -2021, approximately 11 days prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient received the vaccine on 16-Feb-2021. On 27-Feb -021, patient experienced spasms and  felt like she was falling to her left side, short of breath feels like she is going to pass out, but she hasn't. On 05 Mar 2021 she was hospitalized because she had an episode of shortness of breath when she was at neurologist's office. Treatment for the events included heparin, meclizine, IV fluid at hospital, Tylenol (on the day after 2nd dose on 17-Feb-2021). Also mentions that her doctor has prescribed prednisone taper dose which she will be starting on 10-Mar-2021 for 6 days.  Action taken with mRNA-1273 in response to the events was not applicable as the patient has already taken both doses of the vaccine.  The outcome of the event,  shortness of breath, was considered recovering/resolving.  The outcome of the event, spasms after 11 days of receiving 2nd dose, patient feeling she was falling to her left side, feels like she is going to pass out and short of breath, was considered 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
Sex: M
Vaccine: COVID19
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Patient passed away; Found him non-responsive; A spontaneous report was received from a consumer concerning a male patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced unresponsiveness to stimulus. The event was followed by his death.  The patient's medical history included Covid-19 and experienced dehydration prior to testing positive for Covid-19. Concomitant product use was not provided by the reporter.  The patient was diagnosed with COVID-19 at the skilled facility after becoming dehydrated. He was transported to Hospital on 23 Dec 2020 then discharged to skilled facility on 03 Jan 2021 for physical therapy.  On 02 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 02 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. The anatomical location were not reported.  On 03 Mar 2021, the patient was found non-responsive and the staff at skilled rehabilitation tried to resuscitate. Death was the outcome. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event(s) was not applicable.  The outcome of the event non responsive to stimuli was fatal. The patient died-on 03 Mar 2021 and the cause of death was not provided. It is not known whether autopsy done on this individual. No results were provided.; Reporter's Comments: This is a case of death in an unknown aged male subject with unknown medical history of recently recovered covid-19 infection before first dose, who died one day after receiving second dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Abdominal pain, Diarrhoea, Flatulence, Laboratory test
Clinical narrative: diarrhea; excessive gas; bloating; abdominal pain; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), via an unspecified route of administration in the left arm, on 26Dec2020 at 12:00 (at the age of 64-years-old) at a single dose for COVID-19 immunisation. Medical history included Hashimoto's, hypertension, osteoporosis, and sulfa allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included unspecified medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took methocarbamol (ROBAXIN) and experienced allergy. The patient experienced diarrhea, excessive gas, bloating, and abdominal pain on 27Dec2020 at 01:00. It was reported that the patient had diarrhea during the night after receiving the vaccine, which has not stopped, and also had excessive gas, bloating and abdominal pain as well. The patient underwent lab tests and procedures, all on an unspecified date, which included lab work: unknown results, stool testing: unknown results, and abdominal ultrasound: unknown results. Therapeutic measures were taken as a result of all of the events, which included unspecified treatment. The clinical outcome of diarrhea, excessive gas, bloating, and abdominal pain was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Stool analysis, Ultrasound abdomen
Clinical narrative: diarrhea; excessive gas; bloating; abdominal pain; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), via an unspecified route of administration in the left arm, on 26Dec2020 at 12:00 (at the age of 64-years-old) at a single dose for COVID-19 immunisation. Medical history included Hashimoto's, hypertension, osteoporosis, and sulfa allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included unspecified medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took methocarbamol (ROBAXIN) and experienced allergy. The patient experienced diarrhea, excessive gas, bloating, and abdominal pain on 27Dec2020 at 01:00. It was reported that the patient had diarrhea during the night after receiving the vaccine, which has not stopped, and also had excessive gas, bloating and abdominal pain as well. The patient underwent lab tests and procedures, all on an unspecified date, which included lab work: unknown results, stool testing: unknown results, and abdominal ultrasound: unknown results. Therapeutic measures were taken as a result of all of the events, which included unspecified treatment. The clinical outcome of diarrhea, excessive gas, bloating, and abdominal pain was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Allergy test, Blood test, Colitis microscopic, Colonoscopy abnormal
Clinical narrative: diarrhea; excessive gas; bloating; abdominal pain; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), via an unspecified route of administration in the left arm, on 26Dec2020 at 12:00 (at the age of 64-years-old) at a single dose for COVID-19 immunisation. Medical history included Hashimoto's, hypertension, osteoporosis, and sulfa allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included unspecified medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took methocarbamol (ROBAXIN) and experienced allergy. The patient experienced diarrhea, excessive gas, bloating, and abdominal pain on 27Dec2020 at 01:00. It was reported that the patient had diarrhea during the night after receiving the vaccine, which has not stopped, and also had excessive gas, bloating and abdominal pain as well. The patient underwent lab tests and procedures, all on an unspecified date, which included lab work: unknown results, stool testing: unknown results, and abdominal ultrasound: unknown results. Therapeutic measures were taken as a result of all of the events, which included unspecified treatment. The clinical outcome of diarrhea, excessive gas, bloating, and abdominal pain was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Stool analysis, Ultrasound abdomen
Clinical narrative: diarrhea; excessive gas; bloating; abdominal pain; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), via an unspecified route of administration in the left arm, on 26Dec2020 at 12:00 (at the age of 64-years-old) at a single dose for COVID-19 immunisation. Medical history included Hashimoto's, hypertension, osteoporosis, and sulfa allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included unspecified medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took methocarbamol (ROBAXIN) and experienced allergy. The patient experienced diarrhea, excessive gas, bloating, and abdominal pain on 27Dec2020 at 01:00. It was reported that the patient had diarrhea during the night after receiving the vaccine, which has not stopped, and also had excessive gas, bloating and abdominal pain as well. The patient underwent lab tests and procedures, all on an unspecified date, which included lab work: unknown results, stool testing: unknown results, and abdominal ultrasound: unknown results. Therapeutic measures were taken as a result of all of the events, which included unspecified treatment. The clinical outcome of diarrhea, excessive gas, bloating, and abdominal pain was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: sore arm at injection site; sore arm; fatigue; This is a spontaneous report from a non-contactable other HCP (patient). A 22-years-old non-pregnant female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL9267, via an unspecified route of administration on 09Feb2021 12:00 at SINGLE DOSE in the right arm for COVID-19 immunisation.  The patient's medical history was not reported.  Concomitant medication included levothyroxine sodium (SYNTHROID).  Other vaccine was not given in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09Feb2021 15:30, the patient experienced sore arm at injection site and same day fatigue. No treatment received. Outcome of the events was recovered in Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Postive COVID-19 test with no symptoms; Postive COVID-19 test with no symptoms; This is a spontaneous report from a contactable consumer and from a Pfizer-sponsored program. A 70-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 07Jan2021 around 10:00 to 11:00 (at the age of 70-years old) as a single dose in the left arm; and the second dose via an unknown route of administration on 28Jan2021 at 11:40 (at the age of 70-years old) as a single dose in the left arm both for COVID-19 immunization. Medical history included ongoing asthma from an unknown date. The patient had ongoing allergies to dust mites and roaches. The patient's family history included COVID-19 from the son-in-law who tested positive for COVID on 09Feb2021. Concomitant medications were not reported. The patient did not receive other vaccines within 4 weeks prior to vaccination. On 10Feb2021, the patient tested positive for COVID-19 from a Rapid test-nasal swab at 09:00. The clinical outcome of the event COVID-19 was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Decreased appetite, Fatigue, Headache
Clinical narrative: fever; nausea/intense nausea; extreme muscle pain; pain at the injection site; congestion; Couldn't eat much; headache; extreme fatigue; cold sweats; chills; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via an unspecified route of administration in the left arm on 07Feb2021 at 09:45 (at the age of 22-years-old) as a single dose for COVID-19 immunization. Medical history included depression and anxiety, both from unknown dates and unknown if ongoing. The patient had no allergies to medication, food or other products, and did not have COVID-19 prior to vaccination. Concomitant medications included duloxetine from an unknown date for an unknown indication; ethinylestradiol, ferrous fumarate, norethisterone acetate (LARIN FE) from an unknown date for an unknown indication; ibuprofen from an unknown date for an unknown indication; and acetaminophen from an unknown date for an unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported, it first started as a headache and extreme fatigue about two hours after the vaccine. She took two ibuprofen and felt better for a few hours, but the fatigue kept growing and then she started to get cold sweats and chills. The day after was the worse. She had fever, nausea, extreme muscle pain and fatigue, pain at the injection site, and congestion. She took acetaminophen through-out the day and couldn't eat much. The second day the fever and cold sweats went away but she still had intense nausea. It was the third day (as of 10Feb2021) and she felt better but still had fatigue and minor nausea. The events were reported as non-serious and did not require hospitalization. The clinical outcomes of headache, extreme fatigue, cold sweat, chills, fever, nausea, extreme muscle pain, congestion, couldn't eat much and pain at the injection site were reported as recovering. It was also reported that since vaccination, the patient had not been tested for COVID-19.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: fever; nausea/intense nausea; extreme muscle pain; pain at the injection site; congestion; Couldn't eat much; headache; extreme fatigue; cold sweats; chills; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via an unspecified route of administration in the left arm on 07Feb2021 at 09:45 (at the age of 22-years-old) as a single dose for COVID-19 immunization. Medical history included depression and anxiety, both from unknown dates and unknown if ongoing. The patient had no allergies to medication, food or other products, and did not have COVID-19 prior to vaccination. Concomitant medications included duloxetine from an unknown date for an unknown indication; ethinylestradiol, ferrous fumarate, norethisterone acetate (LARIN FE) from an unknown date for an unknown indication; ibuprofen from an unknown date for an unknown indication; and acetaminophen from an unknown date for an unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported, it first started as a headache and extreme fatigue about two hours after the vaccine. She took two ibuprofen and felt better for a few hours, but the fatigue kept growing and then she started to get cold sweats and chills. The day after was the worse. She had fever, nausea, extreme muscle pain and fatigue, pain at the injection site, and congestion. She took acetaminophen through-out the day and couldn't eat much. The second day the fever and cold sweats went away but she still had intense nausea. It was the third day (as of 10Feb2021) and she felt better but still had fatigue and minor nausea. The events were reported as non-serious and did not require hospitalization. The clinical outcomes of headache, extreme fatigue, cold sweat, chills, fever, nausea, extreme muscle pain, congestion, couldn't eat much and pain at the injection site were reported as recovering. It was also reported that since vaccination, the patient had not been tested for COVID-19.