chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Cerebral thrombosis, Constipation, Contusion, Death
Clinical narrative: My mother called me when she was going to get her second vaccination. She was alive and well and living independently at her home. She could walk, talk, make her own food, wash and dry her own clothes and take her own baths.   After taking the second vaccination she went down hill. She became sicker and sicker and eventually she started coughing up blood. She decided to go to the hospital, another Hospital of facility. I don't know what the treatment was at that hospital but she was soon transferred to facility and that is where I was notified she was in the hospital and visited her there. After arriving they intubated her and said she had blood clots in her brain and heart. When I saw her after she transferred from Hospital to the Hospital I noticed one arm was swollen. Her legs were as they have been for the last 20 years and looked okay to me--no discoloration other than her regular discoloring at one right ankle and the same old same old slight swelling in the left ankle. The doctors and nurses were putting the blame on her legs but you could tell things were happening else where.  But as she got worse and worse at the hospital her right arm become more and more swollen with dark bruises appearing--the hospital staff took pictures. The left arm continued to swell and did not look normal at all. She apparently had bleeding in her left lung from a blood clot. She had three areas of her brain that add clots and some bleeding. She was constipated and gaseous when they cleaned her. They didn't treat her constipation which made being intubated worse because I feel that caused her intestines to swell, thus she also had bleeding in her intestines.  My mother died on March 17, 2021 at hospital in ICU. I was told they could not treat the blood clots because of the bleeding in her lung, intestines and brain.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Endotracheal intubation, Flatulence, Gastrointestinal oedema, General physical health deterioration, Haemoptysis
Clinical narrative: My mother called me when she was going to get her second vaccination. She was alive and well and living independently at her home. She could walk, talk, make her own food, wash and dry her own clothes and take her own baths.   After taking the second vaccination she went down hill. She became sicker and sicker and eventually she started coughing up blood. She decided to go to the hospital, another Hospital of facility. I don't know what the treatment was at that hospital but she was soon transferred to facility and that is where I was notified she was in the hospital and visited her there. After arriving they intubated her and said she had blood clots in her brain and heart. When I saw her after she transferred from Hospital to the Hospital I noticed one arm was swollen. Her legs were as they have been for the last 20 years and looked okay to me--no discoloration other than her regular discoloring at one right ankle and the same old same old slight swelling in the left ankle. The doctors and nurses were putting the blame on her legs but you could tell things were happening else where.  But as she got worse and worse at the hospital her right arm become more and more swollen with dark bruises appearing--the hospital staff took pictures. The left arm continued to swell and did not look normal at all. She apparently had bleeding in her left lung from a blood clot. She had three areas of her brain that add clots and some bleeding. She was constipated and gaseous when they cleaned her. They didn't treat her constipation which made being intubated worse because I feel that caused her intestines to swell, thus she also had bleeding in her intestines.  My mother died on March 17, 2021 at hospital in ICU. I was told they could not treat the blood clots because of the bleeding in her lung, intestines and brain.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Intensive care, Intestinal haemorrhage, Intracardiac thrombus, Malaise, Peripheral swelling
Clinical narrative: My mother called me when she was going to get her second vaccination. She was alive and well and living independently at her home. She could walk, talk, make her own food, wash and dry her own clothes and take her own baths.   After taking the second vaccination she went down hill. She became sicker and sicker and eventually she started coughing up blood. She decided to go to the hospital, another Hospital of facility. I don't know what the treatment was at that hospital but she was soon transferred to facility and that is where I was notified she was in the hospital and visited her there. After arriving they intubated her and said she had blood clots in her brain and heart. When I saw her after she transferred from Hospital to the Hospital I noticed one arm was swollen. Her legs were as they have been for the last 20 years and looked okay to me--no discoloration other than her regular discoloring at one right ankle and the same old same old slight swelling in the left ankle. The doctors and nurses were putting the blame on her legs but you could tell things were happening else where.  But as she got worse and worse at the hospital her right arm become more and more swollen with dark bruises appearing--the hospital staff took pictures. The left arm continued to swell and did not look normal at all. She apparently had bleeding in her left lung from a blood clot. She had three areas of her brain that add clots and some bleeding. She was constipated and gaseous when they cleaned her. They didn't treat her constipation which made being intubated worse because I feel that caused her intestines to swell, thus she also had bleeding in her intestines.  My mother died on March 17, 2021 at hospital in ICU. I was told they could not treat the blood clots because of the bleeding in her lung, intestines and brain.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary haemorrhage, Pulmonary thrombosis
Clinical narrative: My mother called me when she was going to get her second vaccination. She was alive and well and living independently at her home. She could walk, talk, make her own food, wash and dry her own clothes and take her own baths.   After taking the second vaccination she went down hill. She became sicker and sicker and eventually she started coughing up blood. She decided to go to the hospital, another Hospital of facility. I don't know what the treatment was at that hospital but she was soon transferred to facility and that is where I was notified she was in the hospital and visited her there. After arriving they intubated her and said she had blood clots in her brain and heart. When I saw her after she transferred from Hospital to the Hospital I noticed one arm was swollen. Her legs were as they have been for the last 20 years and looked okay to me--no discoloration other than her regular discoloring at one right ankle and the same old same old slight swelling in the left ankle. The doctors and nurses were putting the blame on her legs but you could tell things were happening else where.  But as she got worse and worse at the hospital her right arm become more and more swollen with dark bruises appearing--the hospital staff took pictures. The left arm continued to swell and did not look normal at all. She apparently had bleeding in her left lung from a blood clot. She had three areas of her brain that add clots and some bleeding. She was constipated and gaseous when they cleaned her. They didn't treat her constipation which made being intubated worse because I feel that caused her intestines to swell, thus she also had bleeding in her intestines.  My mother died on March 17, 2021 at hospital in ICU. I was told they could not treat the blood clots because of the bleeding in her lung, intestines and brain.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Facial swelling in area of filler
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, Vaccination complication
Clinical narrative: PATIENT WAS AT AT COVID-19 VACCINATION OFFSITE EVENT ON 3/18/2021 TO RECEIVE SECOND DOSE OF COVID VACCINE. PATIENT WAS SCREENED BY PHARMACIST VIA VACCINE AGENCY AND INFORMED CONSENT FORM FOR ACCURACY.  PATIENT RECEIVED FIRST DOSE OF VACCINE WITH NO ISSUES, BUT HAD AN OUTBREAK OF HIVES 20 MINUTES AFTER THE SECOND DOSE ADMINISTRATION. PATIENT WAS ATTENDED TO BY PROVIDERS WHO WERE ONSITE AND ADMINISTERED 50MG OF DIPHENHYDRAMINE LIQUID, AND WITHIN 20-25 MINUTES OF ADMINISTRATION OF DIPHENHYDRAMINE THE HIVES WENT DOWN.  FOLLOW UP CALL WAS MADE BY PPROVIDER 810PM ON 3/18/2021, TO MAKE SURE PATIENT WAS DOING WELL, WHICH HE STATED EVERYTHING WAS FINE AND REACTION STOPPED COMPLETELY.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling and itchiness at injection site.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Major tenderness in arm. Cant raise arm without feeling really tight
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: In First 24 hours itching swelling redness upper arm around injection site with superficial loss of feeling outside arm.  Area. Approx 5? in diameter.  No weakness.  Concerned about second vaccine and a worse reaction if condition has not resolved by that time.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash at injection site, with lump at injection point.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site joint pain, Injection site pain, Pyrexia
Clinical narrative: ?Pfizer-BioNTech COVID-19  Vaccine EUA?  Injection site pain Muscle pain Chills Joint pain Fever
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Dyspnoea at rest, Dyspnoea exertional
Clinical narrative: Nausea , fatigue, weakness, headache , back and Neck pain, pressure behind eyes, headache, fever, intermittent hot then chills, rapid heart rate 110s, and shortness of breath at rest & w/ exertion.  Vaccine @ 9:00am 3/13 ?> symptoms progressing at 4:00pm and lasting until next day 3/14 3:00pm
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Feeling hot, Headache, Heart rate increased
Clinical narrative: Nausea , fatigue, weakness, headache , back and Neck pain, pressure behind eyes, headache, fever, intermittent hot then chills, rapid heart rate 110s, and shortness of breath at rest & w/ exertion.  Vaccine @ 9:00am 3/13 ?> symptoms progressing at 4:00pm and lasting until next day 3/14 3:00pm
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pyrexia
Clinical narrative: Nausea , fatigue, weakness, headache , back and Neck pain, pressure behind eyes, headache, fever, intermittent hot then chills, rapid heart rate 110s, and shortness of breath at rest & w/ exertion.  Vaccine @ 9:00am 3/13 ?> symptoms progressing at 4:00pm and lasting until next day 3/14 3:00pm
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Erythema, Fatigue, Headache
Clinical narrative: 30 minutes after leaving the site, got a mild reaction where my face got tingly and red but then it subsided but then 4 hours after receiving the vaccine I began getting a low grade fever (100.6) by 5pm that same day, I began having flu like symptoms, body aches, headaches, fatigued, chills, sweating and fever had risen to 101.7. Took ibuprofen to help with the symptoms but fever kept rising. By 8pm., fever was at 102.9,  headache worsen, sweats throughout the night and felt dizzy. Next morning 3/18, fever was low grade by 7am (100.4) by 9AM, fever was gone, felt tired, with mild body aches and moderate headache and  felt exhausted the rest of the day. Symptoms are getting better with rest.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza like illness, Pain, Paraesthesia, Pyrexia
Clinical narrative: 30 minutes after leaving the site, got a mild reaction where my face got tingly and red but then it subsided but then 4 hours after receiving the vaccine I began getting a low grade fever (100.6) by 5pm that same day, I began having flu like symptoms, body aches, headaches, fatigued, chills, sweating and fever had risen to 101.7. Took ibuprofen to help with the symptoms but fever kept rising. By 8pm., fever was at 102.9,  headache worsen, sweats throughout the night and felt dizzy. Next morning 3/18, fever was low grade by 7am (100.4) by 9AM, fever was gone, felt tired, with mild body aches and moderate headache and  felt exhausted the rest of the day. Symptoms are getting better with rest.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Rash, Swollen tongue
Clinical narrative: swelling of tongue, metallic taste in mouth, instant frontal lobe headache and rash that appeared on my back 48 hours later- I took a benedryl and had my husband monitor me.  I was watched for 30 minutes at the site with my symptoms being manageable there and they got worse within the hour.  I am allergic to sulfa with mild reactions to it in small doses.  The tongue swelling, headache and metallic taste in my mouth were gone in 12 hours.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Electrocardiogram, Hyperhidrosis, Nausea, Retching
Clinical narrative: Patient felt nausea and started dry heaving.  He was sweating profusely and had tremors.  BP 140/60, HR54, O2 sat 98.  He stated that he had not had a meal today and it could be his sugar.  His glucose was evaluated and was normal.  Pt. was taken to NWMC and was accompanied by his wife.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Patient felt nausea and started dry heaving.  He was sweating profusely and had tremors.  BP 140/60, HR54, O2 sat 98.  He stated that he had not had a meal today and it could be his sugar.  His glucose was evaluated and was normal.  Pt. was taken to NWMC and was accompanied by his wife.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test
Clinical narrative: Cerebrovascular Hemorrhage (Stroke), left occipital zone; This is a spontaneous report from a contactable consumer.   A 78-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EK4176) at single dose, in the left arm, on 13Jan2021, at 15:00, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination. Relevant medical history included Sulfa allergy (Sulfonamide allergy) and drug hypersensitivity due to pethidine hydrochloride (DEMEROL) was reported as past drug event. On 03Feb2021, received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN5318) at single dose, in the left arm, for COVID-19 immunisation. Concomitant medications included levothyroxine sodium (SYNTHROID) and estrogens conjugated, medroxyprogesterone acetate (PREMPRO). On 18Jan2021, at 12:30 PM, the patient experienced cerebrovascular hemorrhage (stroke), left occipital zone. Hospitalization and treatment (stroke Center ICU care) were required (duration of hospitalization 4 days). Clinical outcome of the adverse event was recovering at time of this report. Post the vaccination, the patient has been tested for COVID-19 (Nasal Swab) on 18Jan2021 and resulted negative.
Sex: U
Vaccine: VARZOS
Symptoms: Amnesia, Cerebrovascular accident, Deafness neurosensory, Demyelination, Dizziness
Clinical narrative: stroke events; demyelinating disease of the central nervous system; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender.  Information regarding medical history, concurrent conditions and concomitant medications was not provided.  On 11-NOV-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route, and lot # not provided). Shortly after receiving zoster vaccine live (ZOSTAVAX) the patient suffered dizziness, nausea, vomiting, vertigo, facial weakness/numbness, sensorineural hearing loss and memory loss, and was diagnosed with multiple stroke events and demyelinating disease of the central nervous system. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, symptoms had resulted in physical limitations not present prior to using the product. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was not recovered.  Causality assessment was related. The reporter considered stroke events and demyelinating disease of the central nervous system  to be disabling events. Upon internal review stroke events and demyelinating disease of the central nervous system  were detemined to be medically significant events.
Sex: U
Vaccine: VARZOS
Symptoms: Facial paresis, Hypoaesthesia, Nausea, Vertigo, Vomiting
Clinical narrative: stroke events; demyelinating disease of the central nervous system; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender.  Information regarding medical history, concurrent conditions and concomitant medications was not provided.  On 11-NOV-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route, and lot # not provided). Shortly after receiving zoster vaccine live (ZOSTAVAX) the patient suffered dizziness, nausea, vomiting, vertigo, facial weakness/numbness, sensorineural hearing loss and memory loss, and was diagnosed with multiple stroke events and demyelinating disease of the central nervous system. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, symptoms had resulted in physical limitations not present prior to using the product. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was not recovered.  Causality assessment was related. The reporter considered stroke events and demyelinating disease of the central nervous system  to be disabling events. Upon internal review stroke events and demyelinating disease of the central nervous system  were detemined to be medically significant events.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Malaise
Clinical narrative: Unable to play tennis / because did not feel well; Bad headache; Soreness at injection site; This case was reported by a consumer and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 23rd February 2021, the patient received the 2nd dose of Shingrix. In February 2021, less than a week after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injection site pain. On 24th February 2021, the patient experienced headache. On 25th February 2021, the patient experienced feeling unwell. On 25th February 2021, the outcome of the headache was recovered/resolved. On 26th February 2021, the outcome of the feeling unwell was recovered/resolved. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the headache, injection site pain and feeling unwell to be related to Shingrix.  Additional details provided were as follows: Age at vaccination was not reported. The patient received 2nd dose of Shingrix on Tuesday, 23rd February 2021. The patient had a bad headache day after vaccination until morning of following day (Thursday). Also had soreness at injection site. The patient was unable to play tennis on Thursday because did not feel well. He felt better by Friday evening. Report was originally made by another family member on 27th February 2021 but then reporter spoke directly to patient on 28th February 2021.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: severe giant hives reaction on legs, thighs, chest and arms. / hives all over body; This case was reported by a consumer via call center representative and described the occurrence of hives in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2020, the patient received the 1st dose of Shingrix. In September 2020, 1 day 12 hrs after receiving Shingrix, the patient experienced hives. The patient was treated with steroids nos (Unspecified Steroids). On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows This case was reported by patient herself. The patient received the Shingrix and a day and a half later developed a severe giant hives reaction on legs, thighs, chest and arms and also severe hives all over body with allergic reaction. The patient was given steroids to counteract the reaction. The PCP advised not to get second dose but allergist recommended that patient could take the 2nd dose but with prednisone. The patient asked if she could take the 2nd dose and  could take Prednisone before and after it. It was stated that advised per PI History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of Shingrix was listed as a contraindication. The patient was referred to healthcare professional. The reporter did not consent to follow up. This case was linked with US2021014423 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021014423:Same reporter. FU3 - Deleted.
Sex: F
Vaccine: VARZOS
Symptoms: Illness, Injection site pain, Malaise
Clinical narrative: Feeling pain at the injection site on the right arm; Achy; Overall sick feeling; This case was reported by a consumer and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th August 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, pain and feeling unwell. On an unknown date, the outcome of the injection site pain, pain and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the injection site pain, pain and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the dose of Shingrix on right arm and within 1 day patient felt pain at the injection site on the right arm also achy and felt sick. The the pain at the injection site, achy and sick felt resolved in 7 days. The reporter did not consent to follow up. The caller did not willing to share patient's complete DOB and street address.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: Experienced diarrhea / has resolved; Is experiencing intermittent soft stools; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 28th July 2020).   On 16th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced soft stools. On 21st November 2020, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was recovered/resolved and the outcome of the soft stools was recovering/resolving.   It was unknown if the reporter considered the diarrhea and soft stools to be related to Shingrix.  Additional details were provided as follows: There was no events associated with dose 1 of vaccine. Patient received the 2nd dose of Shingrix and 5 to 6 days after the vaccination patient experienced diarrhea and intermittent soft stools. The formaulation for doses were not provided. It was reported that the diarrhea has resolved. The patient did not wish to provide specific demographics. The reporter did not consent to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever of 105°F after first dose; This case was reported by a physician via call center representative and described the occurrence of fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2020, the patient received the 1st dose of Shingrix. On 5th January 2021, 32 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 57 or 58 year. The patient received 1st dose of Shingrix and had fever (105 degree F). The dose was given on a local pharmacy by another HCP and not caller's location. The reporter called for information regarding the administration of a second dose of shingrix. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Atrial fibrillation, Chills, Dyspnoea
Clinical narrative: A-fib; difficulty breathing; sleeping on and off; dry heaving, feeling nauseated, not hungry; weak; chills; mild headache; Tired/fatigue; muscle pain on the arm; joint pain; Feeling nauseated; A spontaneous report was received from a consumer concerning a 77-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tiredness, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain.   The patient's medical history, as provided by the reporter, included prior COVID-19 infection. It is not clear if the patient had prior A-Fib. 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 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On 25-Jan-2021, patient was feeling fine right after first dose of the Moderna vaccine.  On 26-Jan-2021, the patient felt difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tiredness, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain.  Lab details was not provided by the reporter.  Treatment for the events included rubbing gel.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tired, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity, Retching
Clinical narrative: A-fib; difficulty breathing; sleeping on and off; dry heaving, feeling nauseated, not hungry; weak; chills; mild headache; Tired/fatigue; muscle pain on the arm; joint pain; Feeling nauseated; A spontaneous report was received from a consumer concerning a 77-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tiredness, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain.   The patient's medical history, as provided by the reporter, included prior COVID-19 infection. It is not clear if the patient had prior A-Fib. 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 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On 25-Jan-2021, patient was feeling fine right after first dose of the Moderna vaccine.  On 26-Jan-2021, the patient felt difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tiredness, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain.  Lab details was not provided by the reporter.  Treatment for the events included rubbing gel.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tired, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: A-fib; difficulty breathing; sleeping on and off; dry heaving, feeling nauseated, not hungry; weak; chills; mild headache; Tired/fatigue; muscle pain on the arm; joint pain; Feeling nauseated; A spontaneous report was received from a consumer concerning a 77-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tiredness, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain.   The patient's medical history, as provided by the reporter, included prior COVID-19 infection. It is not clear if the patient had prior A-Fib. 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 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On 25-Jan-2021, patient was feeling fine right after first dose of the Moderna vaccine.  On 26-Jan-2021, the patient felt difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tiredness, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain.  Lab details was not provided by the reporter.  Treatment for the events included rubbing gel.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tired, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Acute hepatic failure, Hepatic enzyme, Hepatic enzyme increased
Clinical narrative: ACUTE LIVER FAILURE; Hepatic enzymes increased; A spontaneous report was received from a health care professional concerning a 85-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed Acute liver failure and hepatic enzymes increased  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, was not reported.  On unknown date in Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient was hospitalized for 2-3 days (approximate date of admission on 27 February 2021 and date of discharge on 1 March 2021) . Reason for hospitalization is secondary to acute liver dysfunction with laboratory evidence of elevated liver enzymes.  Treatment for the event was not reported.  Action taken with mRNA-1273 in response to the event was not applicable  The outcome of the event's, reported  were 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.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hernia, Obstruction
Clinical narrative: throat closure three weeks after second dose; has lost the ability to swallow.; hernia; A spontaneous report was received from a consumer concerning an 88-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced throat closure three weeks after second dose/obstruction, hernia, and lost ability to swallow/dyphagia.  The patient's medical history included an aortic valve replacement. Concomitant medications were not provided by the reporter.   On 13 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 01120A) intramuscularly for prophylaxis of COVID-19 infection. On 10 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection  On an unknown date, the patient had lost the ability to swallow. Patient was taken to the ER and ER doctors thought it was a hernia and suggested a surgery. This was three weeks post dose of the vaccine. The reporter reported that the patient was taken to the hospital on 4 Mar 2021. The doctor diagnosed hernia, but they didn't explain the throat closing. They told him to take the patient to a GI doctor. The GI didn't think it was necessary to do a surgery and scheduled a colonoscopy.  The reporter disagreed with the colonoscopy because it didn't address the throat swelling. The hospital had put the patient on IV fluids but didn't have a lot of answers. On 8 Mar 2021, the hospital prescribed antibiotics and speech therapy.   Treatment activities reported by the reporter included IV fluids, antibiotics, and speech therapy .  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events, obstruction, hernia, and dysphagia were considered unknown.; Reporter's Comments: The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hiatus hernia
Clinical narrative: Hiatal hernia; Doesn't have the ability to swallow; A spontaneous report was received from a consumer concerning a 87-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  that doesn't have the ability to swallow (dysphagia) and hiatal hernia.  . The patient's medical history was not provided. Concomitant medications was not  reported.  On an undisclosed date, approximately three weeks prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown)  for prophylaxis of COVID-19 infection.  On an undisclosed date approximately three weeks after receiving mRNA-1273, the patient did not have the ability to swallow. Her doctors blamed hiatal hernia. The patient was hospitalized.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable because the patient received her second dose.  The outcome of events was unknown.; Reporter's Comments: The events were consistent with anatomical anomaly of gastrointestinal tract. Company assessed the events to be unlikely related to company product.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Ear pain, Fatigue, Inappropriate schedule of product administration, Laryngitis
Clinical narrative: Fever; Muscle ache; Fatigue; Lymph node in left armpit swollen to the size of a small; laryngitus; lips are also now swollen; earache; lingering cold symptoms/feels like a head cold; sore throat; slight cough; tongue significantly swollen; Less than 19 days between dose 1 and dose 2; Less than 19 days between dose 1 and dose 2; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself.    A 52-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation  .  Medical history included psoriasis , blood cholesterol increased . Concomitant medication(s) included citalopram (CITALOPRAM) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported.  The patient previously took amoxicillin and experienced hypersensitivity and swollen tongue. The patient received the first dose of bnt162b2 vaccine on 04Feb2021. The patient experienced tongue significantly swollen  on 23Feb2021 07:00 with outcome of recovering ,  fever on 23Feb2021 07:00 with outcome of recovering , muscle ache on 23Feb2021 07:00 with outcome of recovering , fatigue  on 23Feb2021 07:00 with outcome of recovering , lymph node in left armpit swollen to the size of a small grapefruit on 23Feb2021 07:00 with outcome of recovering , laryngitus  on 23Feb2021 07:00 with outcome of recovering , lips are also now swollen  on 23Feb2021 07:00 with outcome of recovering , feels like a head cold  on 23Feb2021 07:00 with outcome of recovering , earache  on 23Feb2021 07:00 with outcome of recovering , lingering cold symptoms  on 23Feb2021 07:00 with outcome of recovering , sore throat  on 23Feb2021 07:00 with outcome of recovering , slight cough  on 23Feb2021 07:00 with outcome of recovering.  Swollen tongue was considered an Important Medical Event. The patient received the second dose 18 days after the first dose and this is considered an off label use.  Follow up information has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Lymphadenopathy, Myalgia, Nasopharyngitis, Off label use
Clinical narrative: Fever; Muscle ache; Fatigue; Lymph node in left armpit swollen to the size of a small; laryngitus; lips are also now swollen; earache; lingering cold symptoms/feels like a head cold; sore throat; slight cough; tongue significantly swollen; Less than 19 days between dose 1 and dose 2; Less than 19 days between dose 1 and dose 2; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself.    A 52-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation  .  Medical history included psoriasis , blood cholesterol increased . Concomitant medication(s) included citalopram (CITALOPRAM) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported.  The patient previously took amoxicillin and experienced hypersensitivity and swollen tongue. The patient received the first dose of bnt162b2 vaccine on 04Feb2021. The patient experienced tongue significantly swollen  on 23Feb2021 07:00 with outcome of recovering ,  fever on 23Feb2021 07:00 with outcome of recovering , muscle ache on 23Feb2021 07:00 with outcome of recovering , fatigue  on 23Feb2021 07:00 with outcome of recovering , lymph node in left armpit swollen to the size of a small grapefruit on 23Feb2021 07:00 with outcome of recovering , laryngitus  on 23Feb2021 07:00 with outcome of recovering , lips are also now swollen  on 23Feb2021 07:00 with outcome of recovering , feels like a head cold  on 23Feb2021 07:00 with outcome of recovering , earache  on 23Feb2021 07:00 with outcome of recovering , lingering cold symptoms  on 23Feb2021 07:00 with outcome of recovering , sore throat  on 23Feb2021 07:00 with outcome of recovering , slight cough  on 23Feb2021 07:00 with outcome of recovering.  Swollen tongue was considered an Important Medical Event. The patient received the second dose 18 days after the first dose and this is considered an off label use.  Follow up information has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, Swollen tongue
Clinical narrative: Fever; Muscle ache; Fatigue; Lymph node in left armpit swollen to the size of a small; laryngitus; lips are also now swollen; earache; lingering cold symptoms/feels like a head cold; sore throat; slight cough; tongue significantly swollen; Less than 19 days between dose 1 and dose 2; Less than 19 days between dose 1 and dose 2; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself.    A 52-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation  .  Medical history included psoriasis , blood cholesterol increased . Concomitant medication(s) included citalopram (CITALOPRAM) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported.  The patient previously took amoxicillin and experienced hypersensitivity and swollen tongue. The patient received the first dose of bnt162b2 vaccine on 04Feb2021. The patient experienced tongue significantly swollen  on 23Feb2021 07:00 with outcome of recovering ,  fever on 23Feb2021 07:00 with outcome of recovering , muscle ache on 23Feb2021 07:00 with outcome of recovering , fatigue  on 23Feb2021 07:00 with outcome of recovering , lymph node in left armpit swollen to the size of a small grapefruit on 23Feb2021 07:00 with outcome of recovering , laryngitus  on 23Feb2021 07:00 with outcome of recovering , lips are also now swollen  on 23Feb2021 07:00 with outcome of recovering , feels like a head cold  on 23Feb2021 07:00 with outcome of recovering , earache  on 23Feb2021 07:00 with outcome of recovering , lingering cold symptoms  on 23Feb2021 07:00 with outcome of recovering , sore throat  on 23Feb2021 07:00 with outcome of recovering , slight cough  on 23Feb2021 07:00 with outcome of recovering.  Swollen tongue was considered an Important Medical Event. The patient received the second dose 18 days after the first dose and this is considered an off label use.  Follow up information has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Asymptomatic COVID-19, Chills, Coccidioidomycosis, Drug ineffective
Clinical narrative: positive COVID-19 test with no symptoms; Asymptomatic COVID-19; Eventually develop arrhythmia; valley fever; chills; night sweats for 1 and half week; rash looked like confetti; low grade temp; I had an irritation in my upper nose; Platelet count was found to be 90/platelet count dropped corrected with in one week; This is a spontaneous report from a contactable consumer, the patient   A 83-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on 09Feb2021 (at the age of 83-years-old) as a single dose, for COVID-19 vaccination.  The patient medical history includes Atrial Fibrillation. Concomitant medication include Eliquis, Synthroid, Pravastatin, Diltiazem and Dofetilide  The patient experienced  arrhythmia,  valley fever, chills , night sweats, rash looked like confetti,  low grade temp, asymptomatic covid-19, had an irritation in my upper nose, platelet count was found to be 90/platelet count dropped corrected with in one week. The clinical course was reported as follows On '04Mar2020'   traveled and had an irritation in my upper nose which I later came to understand was caused my asymptomatic COVID-19. Was treated for valley fever with Antifungal med, Eventually developed arrhythmia. Sought treatment at Clinic. Initial diagnosis made at urgent care where platelet count was found to be 90 '1st week in April' 2020 also reported as an event. Treatment was give for Valley Fever. No Treatment was given for Asymptomatic COVID-19 and Platelet count was found to be 90. No hospitalization was involved  The patient underwent lab tests that included Platelet count drop/found to be 90 '1st week in April' ,  Sars-cov-2 test: tested positive on 'last week in March 2020' 'Tested positive for covid 19 in the first quarter of 2020' . The clinical outcome of the event Asymptomatic COVID-19, Drug ineffective, Arrhythmia, chills, night sweats, rash, fever, nasal discomfort were unknown, while Valley fever and Platelet count low was recovered. Consumer inquired if the vaccine might trigger another platelet drop. Did not seem to but second shot next Tuesday 02Mar2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal discomfort, Night sweats, Platelet count, Platelet count decreased, Pyrexia
Clinical narrative: positive COVID-19 test with no symptoms; Asymptomatic COVID-19; Eventually develop arrhythmia; valley fever; chills; night sweats for 1 and half week; rash looked like confetti; low grade temp; I had an irritation in my upper nose; Platelet count was found to be 90/platelet count dropped corrected with in one week; This is a spontaneous report from a contactable consumer, the patient   A 83-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on 09Feb2021 (at the age of 83-years-old) as a single dose, for COVID-19 vaccination.  The patient medical history includes Atrial Fibrillation. Concomitant medication include Eliquis, Synthroid, Pravastatin, Diltiazem and Dofetilide  The patient experienced  arrhythmia,  valley fever, chills , night sweats, rash looked like confetti,  low grade temp, asymptomatic covid-19, had an irritation in my upper nose, platelet count was found to be 90/platelet count dropped corrected with in one week. The clinical course was reported as follows On '04Mar2020'   traveled and had an irritation in my upper nose which I later came to understand was caused my asymptomatic COVID-19. Was treated for valley fever with Antifungal med, Eventually developed arrhythmia. Sought treatment at Clinic. Initial diagnosis made at urgent care where platelet count was found to be 90 '1st week in April' 2020 also reported as an event. Treatment was give for Valley Fever. No Treatment was given for Asymptomatic COVID-19 and Platelet count was found to be 90. No hospitalization was involved  The patient underwent lab tests that included Platelet count drop/found to be 90 '1st week in April' ,  Sars-cov-2 test: tested positive on 'last week in March 2020' 'Tested positive for covid 19 in the first quarter of 2020' . The clinical outcome of the event Asymptomatic COVID-19, Drug ineffective, Arrhythmia, chills, night sweats, rash, fever, nasal discomfort were unknown, while Valley fever and Platelet count low was recovered. Consumer inquired if the vaccine might trigger another platelet drop. Did not seem to but second shot next Tuesday 02Mar2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.