chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Glomerular filtration rate, Swollen tongue
Clinical narrative: tongue swelling and shortness of breath
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Cellulitis, Drainage
Clinical narrative: Cellullitis with large blisters & orange draining watery fluid
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased
Clinical narrative: Pfizer -BioNTech COVID-19Vaccine EUA  About 10 minutes after having the shot, I had a rush to my head and a feeling of being faint, followed by a rapid heartbeat.  This subsided after a few minutes, but the rapid heartbeat seemed to remain for hours.  It felt like a low blood sugar attack.  I had not eaten a proper breakfast before having this shot and I am wondering if that had something to do with it.  I want to make sure I can have the second shot if I eat well before I go and have hydration with me.  I waited an extra 10 minutes and got out to my car and ate some nuts and drank water.  Felt like I had too much caffeine the rest of the day.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Mental status changes, SARS-CoV-2 test positive, Urinary tract infection
Clinical narrative: Patient reportedly recevied COVID vaccine on 2/25/21 but unsure of manufacterer or lot number.  Patient admitted to hospital on 3/17 for altered mental status and suspected UTI.  COVID screen test on 3/17 resulted positive.  Patient was asymptomatic for COVID.  Patient was discharged on 3/21/21 with no clinical deterioration from COVID.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Pain, Vomiting
Clinical narrative: vomiting, temperature over 101, chills, extreme body aches, vomiting stopped after 12 hours, other symptoms took longer and were slower to stop. It took 48 hours for temperature to return to normal, and body aches to stop
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tremor
Clinical narrative: C/O HEART RACING; SHAKING EPISODE X  3 ;  AFTER THIRD EPISODE AGREED TO GO TO ER;  AMBULANCE TRANSPORTED TO HOSPITAL..   SPOKE WITH CASE @0803 ON 3/26/2021;  STATES THEY DID NOT KEEP HER.  OBSERVED HER IN ER FOR A WHILE THEN DISCHARGED HER.  NO FURTHER PROBLEMS.  FINE TODAY
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Pruritus, Swelling
Clinical narrative: Bruising and redness following day of shot. Redness/swelling subsided after 3-4 days, however 8 days following the shot started up again. Red and itchy.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Immediate post-injection reaction, Taste disorder
Clinical narrative: Immediately after vaccination patient felt flushed and had "a funny taste in her mouth". She was evaluated by an on-site EMT and symptoms resolved within 30 minutes.  Patient has a history of panic attacks.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received a Pfizer dose on 3/5/21 and was accidentally given a Moderna dose on 3/25/21.  He didn't experience any adverse effects at the time of vaccination.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Dementia
Clinical narrative: 92 y/o - Severe dementia. Hospice
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Headache, fatigue, and local pain in Left Arm lingering for longer than 48 hours.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: Very painful sore arm, shoulder and neck.  Slight Headache Taking Tylenol
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in face and hands.  This lasted off and on for the 21 days between shots
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Lethargy, Pyrexia, Vomiting
Clinical narrative: Chills, fever, extremely  lethargic , vomiting for about 3 hours  Lethargic for over a week. Fever for 2 days
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: HEAD TO FOOT TOTAL BODY RASH......
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Skin warm, Swelling
Clinical narrative: on day 8th after vaccine, itching and painful circular area noted at the site (left arm) about 5inch in diameter, swollen and warm to touch, called primary physician who contacted allergist and 5 day course of Prednisolone was prescribed
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pruritus, Urticaria, Vomiting
Clinical narrative: Pt received 2nd Moderna vaccine 3/22/2021. On 3/23/21 she experienced a headache, nausea, vomited 1 time and had fatigue. Awoke on 3/24/2021 with hives from neck down. States included back, abdomen, arms and legs but did not involve face .Complained of severe itching. Took Benadryl and rested that day at home. Saw primary care doctor 03/25/2021 because rash was more severe. Was given steroid injection and oral steroids for 5 days.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Lymphadenopathy
Clinical narrative: Extreme breast pain, both right and left for six days. Swollen lymph glands in both arm pits.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Swelling, Tenderness
Clinical narrative: Circular patch that was red and itchy.   Somewhat swollen and tender with a slight rash.    2 days later the swelling and tenderness had gone away but the rash remained and the redness spread as if disipating.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red rash  at injection site developed ~8 days after vaccination. Approximately 3" diameter. No itching or pain, no systemic symptoms.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore arm got significantly worse overnight. Pain is severe. Painful to move arm. Ice is not helping.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dysphagia, Panic attack
Clinical narrative: On 3/25/2021.  Within about 10 minutes after taking the covid vax the pt started saying she could not swallow.  BP was little elevated, her O2 was 94, Pulse rate 88.  Pt started to panic and then given Epi injection which did not help.  911 was called.  Pt was talking and able to walk to the gurney.  She was transported by ambulance to ER .
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain
Clinical narrative: Fatigue, moderate body aches, throbbing headache, moderate joint pain
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No other AE/PQC reported at this time; a pediatric patient received an adult dose of VAQTA; Dr. ordered an adult dose for a 16-year-old; This spontaneous report as received from a medical assistant referring to 16-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported.    On 22-DEC-2020, the patient had a well-child visit with the physician, who ordered the patient with the first dose of hepatitis A vaccine, inactivated (VAQTA) at the adult dose (product prescribing issue). On that day, the patient was vaccinated with the first dose of hepatitis A vaccine, inactivated (VAQTA) (lot# T014590 has been verified to be a valid lot number, expiration date15-APR-2021; route not reported) at an adult dose instead of the pediatric dose in the right arm for prophylaxis at the private doctor's office/hospital (incorrect dose administered). It was reported there was no temperature excursion occurred as a result of a reading from a digital data logger. No other adverse event or symptom was reported at this time (no adverse event) and no drug treatment was prescribed for the experience. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARZOS
Symptoms: Autopsy, Death
Clinical narrative: Patient passed away; This case was reported by a consumer via patient support programs and described the occurrence of unknown cause of death in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   The reporter considered the unknown cause of death to be unrelated to Shingrix.  Additional details were as follows: The age at vaccination was not reported. The patient's history was unknown. The patient received Shingrix and died. The cause of death was unknown and autopsy performed was unknown.; Reported Cause(s) of Death: unknown cause of death
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis
Clinical narrative: I have arthritis; This case was reported by a consumer via call center representative and described the occurrence of arthritis in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced arthritis. On an unknown date, the outcome of the arthritis was unknown.   It was unknown if the reporter considered the arthritis to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient had arthritis but was not clear if it occurred after getting 1st shot of Shingrix or if it was patient's current condition. No further information was provided. The consented to follow up was unknown. The case been linked with the case US2021AMR066208, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR066208:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had an allergic reaction to the shingles vaccine.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient was fed up with these shots. The patient got sick after the flu shot. The consent to follow-up was not asked.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR062659:same reporter US-GLAXOSMITHKLINE-US2021AMR069219:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: After the first / arm itched at the injection site; This case was reported by a other health professional and described the occurrence of injection site itching in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was recovered/resolved.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for herself. The age at vaccination was not reported. After the first dose of Shingrix vaccine patient's arm itched at the injection site for several weeks, but that was all. For tolerance of 2nd dose refer case US2021AMR069511. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR069511:Same patient. Same reporter., 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Syncopal event after first dose; This case was reported by a other health professional via sales rep and described the occurrence of syncope in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced syncope (serious criteria GSK medically significant). On an unknown date, the outcome of the syncope was unknown.   It was unknown if the reporter considered the syncope to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient experienced syncopal event after first dose and was concerned that it might exclude from future vaccination. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Ear swelling, Swelling face, Swollen tongue, Urticaria
Clinical narrative: covered with hives; metal taste in her mouth; allergic reaction within 30 minutes following the administration of the vaccine; tongue /started to swell; her face, /started to swell; ears started to swell; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 54-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2011-12 season) for prophylaxis.   Concurrent medical conditions included drug allergy (allergic reaction to calcium pills).   On 25th October 2011, the patient received FluLaval 2011-12 season. On 25th October 2011, less than an hour after receiving FluLaval 2011-12 season, the patient experienced allergic reaction, swollen tongue, facial swelling, ear swelling and taste metallic. In November 2011, the patient experienced hives. The patient was treated with benadryl (nos) (Benadryl) and prednisone. On an unknown date, the outcome of the allergic reaction, swollen tongue, facial swelling, ear swelling, hives and taste metallic were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, swollen tongue, facial swelling, ear swelling, hives and taste metallic to be related to FluLaval 2011-12 season.  Additional details were provided as follows: The patient had an allergic reaction within 30 minutes following the administration of the vaccine.  She had a metal taste in her mouth and her face, tongue and ears started to swell. She took benadryl immediately and then was given prednisone for a month.  When prednisone ran out, the patient was covered with hives. She took 2 more prednisone pills to resolve the hives. The reporter did not consent to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Shingles; Pain; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number EZ4TD, expiry date 4th November 2022) for prophylaxis.   On 22nd January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the pain was recovering/resolving.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced an active case of Shingles after receiving Shingrix.  The patient had a pain for 3 days, but she was better and there were no active shingles at the time of reporting.  The reporter inquired if they could give the 2nd dose to the patient. The consent to follow up was provided.  The batch number of Shingrix was reported as E24TD, which was corrected to EZ4TD as per sales data sheet.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: First dose / 11/5/2020 / she developed shingles and has had it for 2 weeks; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but was selected adult as per vaccine indication. The patient had received first dose of shingrix on 5th November 2020 and experienced shingles for 2 weeks. Patient was scheduled for second dose in March 2021, but now she will confirm  with HCP, when she can get it. No other information was reported. The reporter did not consented to follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Choking, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: annoying choking all day long; extremely hot to the touch; red patch on my arm; chills; The arm was extremely sore, not the usual pain; A spontaneous report was received from a consumer concerning a female patient of 65 year old, who was received Moderna's COVID-19 vaccine(Mrna-1273) and experienced redness, pain and hotness in arm, chills and choking.  The patients medical history included high cholesterol and blood pressure. Concomitant medications reported included Lipitor, Hydrochlorothiazide, baby aspirin and vitamins.  On 05 Feb 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 030M20A ) vaccine intramuscularly in the left non-dominant arm for prophylaxis of COVID-19 infection.  On 05 Feb 2021, couple of hours later patient experienced soreness in arm.  On an unknown date, six days after the vaccination, patient experienced redness in arm and extremely hot to the touch.  On an unknown date, 1 to 2 days later after vaccination, patient started choking all day long and patient also got the chills.  Treatment for the event included Advil once or twice.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for unknown for redness and pain, recovered for feeling hot, not recovered for chills and choking.; 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: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose of Moderna on day 19; A spontaneous report was received from a pharmacist concerning a patient of unknown age and gender, who received second dose of Moderna's COVID-19 vaccine (mRNA-1273) on day 19 from their first dose.  The patient's medical history and products known to have been used by the patient were not reported.  The patient received their first of two planned doses of mRNA-1273 (Batch number: Batch number not provided) on 28 Jan 2021, and after 19 days from the first dose on 16 Feb 2021 patient received their second of two planned doses of mRNA-1273 (Batch number: Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  No treatment information was provided.    No relevant laboratory details were included.  Action taken with the drug in response to the events was not applicaple.  The event was considered as recovered/resolved.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their third dose of mRNA-1273 (Lot unknown), reporting Inappropriate schedule of product administration without any associated adverse events.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Electrocardiogram, Erythema, Hyperhidrosis
Clinical narrative: felt like passes out; face turned bright red; sweating; shivering; A spontaneous report was received from a consumer concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, face turned bright red/erythema, sweating/ hyperhidrosis, shivering/shivering, felt like she would pass out/loss of consciousness, blood pressure was 88/66/ hypotension.  The patient's medical history was not provided. Concomitant medications reported was valsartan.  On 4 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010AZIA) in the left arm intramuscularly for prophylaxis of COVID-19 infection.  On 4 Mar 2021, the patient after she received mRNA-1273, she waited for 30 minutes and was okay. She drove about half an hour, and her face turned bright red, sweating, shivering, felt like she would pass out. The event felt like she would pass out was assessed as serious as per IME list. She pulled to the side of the highway to wait, it got worse. She called 911 and they transported her to the hospital. She went to the ER from 2:30 to 5:30pm. They did a lot of tests; blood test, heart test, EKG, everything was normal. They put her on saline bags. When the ambulance first got there her blood pressure was 88/66, when she left the hospital it was back to normal.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events face turned bright red, sweating, shivering, felt like she would pass out/loss of consciousness was not reported whereas event blood pressure was 88/66 was resolved on 4 Mar 2021.; Reporter's Comments: This case concerns a 63-year-old female who had a serious unexpected event of loss of consciousness along with nonserious unexpected hypotension, erythema, hyperhidrosis, and expected chills.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: felt like passes out; face turned bright red; sweating; shivering; A spontaneous report was received from a consumer concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, face turned bright red/erythema, sweating/ hyperhidrosis, shivering/shivering, felt like she would pass out/loss of consciousness, blood pressure was 88/66/ hypotension.  The patient's medical history was not provided. Concomitant medications reported was valsartan.  On 4 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010AZIA) in the left arm intramuscularly for prophylaxis of COVID-19 infection.  On 4 Mar 2021, the patient after she received mRNA-1273, she waited for 30 minutes and was okay. She drove about half an hour, and her face turned bright red, sweating, shivering, felt like she would pass out. The event felt like she would pass out was assessed as serious as per IME list. She pulled to the side of the highway to wait, it got worse. She called 911 and they transported her to the hospital. She went to the ER from 2:30 to 5:30pm. They did a lot of tests; blood test, heart test, EKG, everything was normal. They put her on saline bags. When the ambulance first got there her blood pressure was 88/66, when she left the hospital it was back to normal.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events face turned bright red, sweating, shivering, felt like she would pass out/loss of consciousness was not reported whereas event blood pressure was 88/66 was resolved on 4 Mar 2021.; Reporter's Comments: This case concerns a 63-year-old female who had a serious unexpected event of loss of consciousness along with nonserious unexpected hypotension, erythema, hyperhidrosis, and expected chills.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Oropharyngeal blistering, Pharyngeal swelling, Swelling face
Clinical narrative: rash in his throat; boils in his tongue; swelling in his face and throat; swelling in his face and throat; headache; joint pain; A Spontaneous report was received from a consumer(patient) concerning himself a 63 year old male patient, who received dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, joint pain/arthralgia, swelling in face and throat, rash in the throat/oropharyngeal blister and boils in tongue/tongue blistering.  The patient's medical history was not provided. Concomitant medications included blood thinner and meloxicam.   On 25 Feb 2021 prior to the onset of events the patients received first dose of their two planned doses of mRNA-1273 (Batch N0:001A21A) intramuscularly in the left arm for prophylaxis of covid 19 infection.  On 25 Feb 2021, within the first 24 hours he had a headache and joint pain. Then, a couple of days after he experienced swelling in his face and throat, a rash in his throat, and boils on his tongue. Rash in the throat/oropharyngeal blister was considered medically significant and serious. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, headache, joint pain/arthralgia, swelling in face and throat, rash in the throat/oropharyngeal blister were unknown. The outcome of the event boils in tongue/tongue blistering  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 event, a causal relationship cannot be excluded.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Tongue blistering
Clinical narrative: rash in his throat; boils in his tongue; swelling in his face and throat; swelling in his face and throat; headache; joint pain; A Spontaneous report was received from a consumer(patient) concerning himself a 63 year old male patient, who received dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, joint pain/arthralgia, swelling in face and throat, rash in the throat/oropharyngeal blister and boils in tongue/tongue blistering.  The patient's medical history was not provided. Concomitant medications included blood thinner and meloxicam.   On 25 Feb 2021 prior to the onset of events the patients received first dose of their two planned doses of mRNA-1273 (Batch N0:001A21A) intramuscularly in the left arm for prophylaxis of covid 19 infection.  On 25 Feb 2021, within the first 24 hours he had a headache and joint pain. Then, a couple of days after he experienced swelling in his face and throat, a rash in his throat, and boils on his tongue. Rash in the throat/oropharyngeal blister was considered medically significant and serious. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, headache, joint pain/arthralgia, swelling in face and throat, rash in the throat/oropharyngeal blister were unknown. The outcome of the event boils in tongue/tongue blistering  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 event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Heart rate
Clinical narrative: Atrial Fibrillation (AFib) episode that lasted about 3 hours; A spontaneous report was received from a consumer who was also a 73-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced atrial fibrillation (Atrial Fibrillation).  The patient's medical history included acid reflux, atrial fibrillation and high cholesterol. Products known to have been used by patient with in last two weeks included omeprazole, simvastatin, amlodipine, apixaban, famotidine, multivitamin, and probiotics.  On 04 Feb 2021, patient received his first of the two planned vaccine doses of mRNA-1273 (Lot number: 10N20A) intramuscularly.   On 08 Mar 2021, approximately one day prior to the event, the patient received his second of two planned doses of mRNA-1273 (Lot number: 032N20A) intramuscularly for prophylaxis of COVID-19 infection.   On 09 Mar 2021, the patient experienced the event atrial fibrillation episode that lasted about 3 hours and heart rate reached 160 BPM at rest, and continued to fluctuate up and down. It was reported that the patient had cardiac conditions that periodically caused him to experience Afibs, but those usually only last for about 2 minutes.   The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, atrial fibrillation, was considered resolved on 10 Mar 2021.; Reporter's Comments: Based on the current available information and the subject's underlying history of recurrent Afib, the event was assessed as Unlikely Related to study drug. The case is confounded by the subject's underlying history of Afib, which was reported to occur periodically and subsiding on its own.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Seizure, Vaccination site pain
Clinical narrative: Headache; Serious convulsion; Slight tenderness at the injection site; A spontaneous report was received from a consumer concerning an 81-years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced serious convulsion/seizure, slight tenderness at the injection site/vaccination site pain and headache.   The patient's medical history included blood pressure high, diabetes and rheumatoid arthritis. Concomitant medications included methotrexate.  The patient received their first of two planned doses of mRNA-1273 (lot/batch number: unknown) on 04 Feb 2021. On 08 Mar 2021, prior to the onset of the event, the patient received the second of two planned doses of mRNA-1273 (batch number: 027A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 08 Mar 2021, the patient experienced slight tenderness at the injection site. On 09 Mar 2021, at 12.30 and 1.30 AM the patient experienced medically significant event of serious convulsion with no previous history of seizures. Since patient has a disabled husband, she didn't call ER (emergency room) and went to the neurologist next morning who told her to report it. On 10 Mar 2021, the patient experienced headache attributed to migraines. Treatment for the event headache included paracetamol. Treatment information for the events serious convulsion and slight tenderness at the injection site was not reported.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.  The outcome of the event slight tenderness at the injection site was resolved on 08 Mar 2021. The outcome of the event serious convulsion was resolved on 09 Mar 2021. The outcome of the event headache was resolved on 10 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; A spontaneous report was received from a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's Palsy.  The patient's medical history and concomitant medications were not provided.     On an unknown date, the patient received a dose of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date after receiving the Moderna's COVID-19 vaccine, the patient experienced Bell's Palsy.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke following administration; A spontaneous report was received from a consumer concerning a 78 year old ,female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a stroke/cerebrovascular accident.  The patient's medical history was reported as previous stroke two years ago. Concomitant medications taken by the patient included losartan, glipizide, lintas, metformin, blood thinners, hydrochlorothiazide.   On 26 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 023M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Feb 2021, the patient experienced a stroke which needed emergency treatment. She received treatment for this condition and was back at home at the time of reporting and at that point she had no other side effects.  Treatment activities for event was received but not provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of event, stroke  was recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. However, patient's elderly age along with prior history of stroke are considered significant risk factors.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Exposure via eye contact, SARS-CoV-2 test
Clinical narrative: splashing some of the vaccine into his eyes; COVID-19; A spontaneous report was received from a pharmacist concerning himself (male patient  of 42 years age) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced COVID-19 in that week of vaccination and splashed some of the vaccine into his eyes.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 13 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.   The patient was diagnosed with COVID-19 by COVID-19 test performed on an unknown date in Feb 2021 within the week of first dose Covid vaccination.  The patient splashed some of the vaccine into his eyes on 13 Feb 2021. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event(s) was unknown.  The events COVID-19 was recovered on unknown date and outcome of event splashing some of the vaccine into his eyes was unknown.; Reporter's Comments: This report refers to a case of Exposure via eye contact and for mRNA-1273, lot #   unknown with  Event of COVID-19 positive. Based on mechanism of action of mRNA -1273 vaccine, the event COVID-19 is assessed as unlikely related to mRNA-1273.
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: erectile dysfunction; A spontaneous report was received from consumer who was a 66-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced erectile dysfunction.    The patient's medical history was not reported.  Concomitant medications included atorvastatin.   On 11 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 042L20A) through intramuscular route at left arm for prophylaxis of COVID-19 infection.  Since 14 Feb 2021, patient felt the issue of erectile dysfunction.  Treatment activities for event was not provided.  On 11 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 040A21A) through intramuscular route at left arm for prophylaxis of COVID-19 infection.  Action taken with mRNA-1273 in response to the events was not applicable as the patient received both scheduled doses of the vaccine.   The event of erectile dysfunction was considered 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 event, a causal relationship cannot be excluded.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Syncope
Clinical narrative: started to faint & passed out; I was sweating; had the chills; A spontaneous report was received from a consumer  concerning a 34-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced faint, passed out ,sweating,and chills..   The patient's medical history, was not provided. Concomitant medications was not reported. On 13 Mar 2021 prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: 040A21A)  in the left arm for prophylaxis of COVID-19 infection.   On 13 Mar 2021, prior to receiving mRNA-1273, the patient felt faint, passed out ,sweating,and chills.Treatment for the events  was unknown.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of  events, faint, passed out ,sweating,and chills, were considered resolved  on 13 Mar 2021.; 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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Pneumothorax
Clinical narrative: Pneumonia with collapsed lung; Pneumonia with collapsed lung; Scheduled to take 2nd dose of vaccine on 26 Mar 2021, 6 weeks after; A spontaneous report was received from a consumer concerning a 80-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pneumonia with collapsed lung/pneumonia and scheduled to take second dose of vaccine on 26 Mar 2021/inappropriate schedule of vaccine administration.  The patient's medical history was not provided by the reporter. No concomitant medications were reported.  On 06 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 61016308) in the right arm for prophylaxis of COVID-19 infection.   On 06 Mar 2021, the patient experienced pneumonia with collapsed lung and was hospitalized.  She was scheduled to take second dose of vaccine on 26 Mar 2021.  Treatment for the event included hospitalization for pneumonia with collapsed lung.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, pneumonia with collapsed lung was unknown.  The outcome of the event, inappropriate schedule of vaccine administered was considered to be resolved.; Reporter's Comments: This case concerns an 80-year-old who had second dose scheduled 6 weeks after first dose (inappropriate schedule of product administration) and also experienced collapsed lung/pneumonia. Although a temporal association exist, based on the information provided, the event of collapsed lung/pneumonia is assessed as unlikely related.  Pneumonia is due to an infective etiology.  The event of inappropriate schedule of product administration is assessed as not applicable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Eyelid ptosis, Hypoaesthesia, Pain in jaw
Clinical narrative: Related it to a bells palsy feeling; Numbness in her face; Jaw pain; Eye lid drooping; A spontaneous report (United States) was received from a consumer concerning a 64-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced numbness in her face, jaw pain, eye lid drooping, related it to a bells palsy feeling.  The patient's medical history was not provided by the reporter. Concomitant medication reported included atorvastatin.  On 11 Mar 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: 038A21A) for prophylaxis of COVID-19 infection.   On 11 Mar 2021, about 15 minutes after the vaccination, the patient experienced numbness in her face, jaw pain, eye lid drooping related it to a bells palsy feeling.These symptoms subsided within the day.  Treatment for the events were not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events experienced numbness in her face, jaw pain, eye lid drooping related it to a bells palsy feeling are reported to be resolved on 11 Mar 2021.; 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: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Fear, Feeling cold, Hypertension
Clinical narrative: blood pressure was 200/120; felt like it was hard to breathe; felt dread; felt a strange cold rush over his system; A spontaneous report was received from consumer concerning a 41 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt a strange cold rush over his system/ feeling cold, felt like it was hard to breathe/dyspnoea,  felt dread/fear,  blood pressure was 200/120/hypertension.  The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient were not provided.   On 8 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) through intramuscular route at left arm for prophylaxis of COVID-19 infection.   On 8 Feb 2021, less than a minute after receiving vaccine, patient felt a strange cold rush over hissystem felt like it was hard to breathe, he felt dread. Patient reported that the facility had checked and his blood pressure was 200/120. Patient was not sure if it was a panic attack, but he took antianxiety medicine.  Treatment activities for event was done with antianxiety medicine.  The seriousness criteria for the event hypertension was assessed as medically significant.  The seriousness criteria for other event was not reported.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, and felt a strange cold rush over his system, felt like it was hard to breathe, felt dread, blood pressure was 200/120 were unknown.; Reporter's Comments: Based on the information provided which includes a STRONG temporal association between the reported events, administration of mRNA-1273 vaccine and excluded all other etiologies, a causal association cannot be excluded
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Kidney infection, Product dose omission issue, Urinary tract infection
Clinical narrative: Urinary tract Infection; Kidney Infection; did not receive second dose; A spontaneous report was received from a consumer, who was also a 60-years-old Female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who had Urinary tract Infection, did not receive second dose (Product omission issue) and Kidney Infection.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 04 Feb 2021, prior to the onset of the symptoms, the patient received her first of the two planned vaccine doses of mRNA-1273 (Batch number: 010M20A) via an unknown route in the left arm for prophylaxis of COVID-19 infection.  On 01 Mar 2021, the patient was admitted to hospital for two days for urinary tract infection and kidney infection.   On an unknown date, the patient was discharged, and treatment for the events included higher antibiotics and other treatment during hospitalization and post discharge from hospital. Higher antibiotics was continuing at the time of report.  It was reported that the patient was due for her second of the two vaccine doses on 03 Mar 2021, however, she did not receive the second dose.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, Urinary tract infection, Kidney Infection, and did not receive the second dose, was not reported.; Reporter's Comments: This report refers to a case of Product omission issue for mRNA-1273, lot # 010M20A. Additionally, patient experienced Urinary tract infection and Kidney infection and was hospitalized.  Based on the current available information and infectious nature of reported event both events were assessed as unlikely related. The subject's gender can be a confounding factor in leading to increased risk of UTI.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Dyspnoea, Hypoaesthesia oral, Movement disorder
Clinical narrative: Dizziness; numb tongue; difficulty swallowing; difficulty breathing; inability to move arms and legs; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6199 and expiration date unknown), via an unspecified route of administration in the left arm on 09Mar2021 at 15:00 as a single dose for COVID-19 immunization. Medical history included depression, pre-diabetes and known allergies: bee stings. Concomitant medications included loratadine (LORATADINE), metformin (METFORMIN), paroxetine (PAROXETINE), and bupropion hydrochloride (WELLBUTRIN), and "Mul". The patient had no other vaccine in four weeks. On 09Mar2021 at 15:15, The patient experienced dizziness, numb tongue, difficulty swallowing, difficulty breathing, and inability to move arms and legs. The patient had no COVID prior vaccination and had not tested post vaccination. Therapeutic measures were taken as a result of the events which included Epinephrine, ER treatment, and Prednisone. The outcome of the events was resolving. The events resulted in: Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event).