chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my husband had a massive stroke on April 30, 2 days after getting the 2nd dose of Moderna!; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (my husband had a massive stroke on April 30, 2 days after getting the 2nd dose of Moderna!) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Swine flu vaccine. Past adverse reactions to the above products included Guillain-Barre syndrome with Swine flu vaccine.    In April 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Apr-2022,  after starting mRNA-1273 (Spikevax), the patient experienced CEREBROVASCULAR ACCIDENT (my husband had a massive stroke on April 30, 2 days after getting the 2nd dose of Moderna!) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (my husband had a massive stroke on April 30, 2 days after getting the 2nd dose of Moderna!) outcome was unknown.            The patients wife reported that patient had a massive stroke on 30 Apr 2022, 2 days after getting the second dose of Moderna. She asked whether he should have the vaccine since he had Guillain-Barre after the swine flu vaccine, the family doctor as well as pharmacist said he should take.  No concomitant products reported.  No treatment products reported.  Company comment: This is a spontaneous case concerning a male patient of an unknown age, with no relevant medical history reported, who experienced the serious (medically significant) AESI of Cerebrovascular accident, which occurred two days after the second dose of mRNA-1273. The event was described as a massive stroke. The patient's wife had asked whether the patient should have had the vaccine since he had Guillain-Barre after the swine flu vaccine and the family doctor as well as pharmacist said he should take the vaccine. No further clinical information, studies performed, hospitalization, treatment details were available for review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age, with no relevant medical history reported, who experienced the serious (medically significant) AESI of Cerebrovascular accident, which occurred two days after the second dose of mRNA-1273. The event was described as a massive stroke. The patient's wife had asked whether the patient should have had the vaccine since he had Guillain-Barre after the swine flu vaccine and the family doctor as well as pharmacist said he should take the vaccine. No further clinical information, studies performed, hospitalization, treatment details were available for review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
sore arm; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9267), dose 1 intramuscular on 16Feb2021 (at the age of 76 years) as single dose for covid-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date of Feb2021 the patient experienced sore arm. Patient was calling because she got her 1st dose last Tuesday and wanted to know when she can start to see people again. She also wanted to know what the percentage rate of people that have a sore arm after injection. The Patient was due to get the second shot of the COVID-19 vaccine, and she would like to know how long will the maximum protection kick in once she receives the second vaccine? She was 76 years old and was returning to work. Patient just wanted to know when it's safer to go back. The outcome of the event was unknown.  Follow-up (19Feb2021): The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 19Feb2021, this case now contains all required information to be considered valid.  No follow-up attempts are possible. No further information is expected.
Paralysis, could not breathe, could not get out of bed, was given antibiotics at emergency room and sent home.  Died 10 days later.
Bell's Palsy; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 01:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included ADHD, depression, High Blood Pressure, high cholesterol, Allergies to medications, food, or other products:Penicillin. Concomitant medications included losartan (LOSARTAN); paroxetine hydrochloride (PAXIL CR); atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); all taken for unspecified indications, start and stop dates were not reported. On 04Apr2021 12:00, the patient experienced Bell's Palsy. The patient did not receive treatment for the event. The outcome of the event was not recovered.     Information about batch/lot number has been requested.
Pt reported a know on arm, reported back with red arm , warm to the touch.  no problems with movement.
Local site reaction: Pain-discomfort, redness, swelling. General symptoms: Chills, headaches, joint pains, muscle pains, fatigue, nausea, vomiting, swollen glands, itching. Narrative:
12x15 cm erythematous lesion of L arm. Mildly a=swollen and warm to touch.No edema
Chills (acetaminophen taken) Itchy rash on entire back, chest, abdomen and upper arms (antihistamine taken)
I had 36 hours of profound fatigue. He had pre-operative testing and the EKG results stated he had AFIB. The cardiologist said it was mild and intermittent.
Patient developed cough, fever, shortness of breath on 4/22/21. Tested positive for COVID-19 and was found to have a pulmonary emoblus in the ER on 4/27/21. She is currently admitted at Hospital, under my care. I'm also her primary care physician.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 11-JUL-2017 the patient was vaccinated with incorrect storage RECOMBIVAX HB lot # M044032 and expiration date of 03-JUL-2019 for prophylaxis. On an unknown date the patient experienced no adverse event. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA002800.
Approximately 24 hours after receiving flu vaccine (standard, adult), developed pain and swelling on right side of neck extending down to right clavicle.
I had an extremely itchy rash that started on my left shoulder blade area. A few days later it was still itchy and shocking to touch. I also developed a similar rash under my right front collar bone. I contacted my Doctor through the message system and asked if i should come in as I thought it was shingles because of the symptoms. The doctor messaged back that shingles only occurs on one side of the body at a time. I then related it to the vaccine Booster. Also in the second week after I had difficulty falling asleep sometimes still awake three hours after I had gone to bed. My joints were extremely painful . I do have mild arthritis in my finger joints that my physician was aware of and had prescribed treatment options prior to my booster shot. I had much more painful joints in hands and other parts of my body after the booster shot . This lasted for several weeks after the booster. I also had headaches causing me to take Advil.
Age-Vaccine contraindication, 17 year old patient was inoculated with Moderna brand of the COVID 19 vaccine which is approved for patients 18 years old and older.
Patient had sudden onset of headache, nausea with vomiting x 4 episodes, felt dizzy - unable to walk, hot, had itching on head (no rash). F/U on 8/15/2011 at clinic (n/v dizzy f/u).
At 21:00 patient began to experience a fever and body aches. The patient also developed a headache. The patient experienced the symptoms until they went to sleep. When awoken the next morning, symptoms were cleared.
Patient received booster dose of Pfizer, Covid-19 vaccine, before the 6 month guidelines placed by the CDC. His second dose of Pfizer being 07/06/2021, it had only been 5 and a half months.  Patient received appropriate medication for age and had no adverse reaction to the dose.
April 9, lethargic in afternoon, seeing flashing light in left eyesight. Lasted 2-3 days. Lymph node in rt groin swollen and sore. Persisting still. April 17, feverish, 101.5 F, chills, no appetite. Still persists. Difficulty breathing, slight, comes and goes.
she experienced arm soreness; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Mar2021 (Lot number: not reported) as single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced arm soreness and wanted to know if she could take Tylenol before the second dose. The patient was scheduled for the second dose on 30Apr2021. The outcome was unknown for the reported event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Myalgia Sore arm 2nd day after vaccine, fatigue during 2nd week after first dose Narrative:  Sore arm 2nd day after vaccine, fatigue during 2nd week after first dose
On 05/04/2021 I had sinus congestion, a cough, a slight runny nose,  body aches, loss of smell and taste, and fatigue. I went to urgent care and they did a Covid test, which was positive. About 4 days in I was given Dexamethasone a 7 day course due to the cough. I still have a lingering cough.
4/10/21-4:00pm left hemisphere headaches, body aches, muscles aches. Lasted through 4/11/21.  4/12/21-Went home early after eating lunch, felt the same symptoms.  As a physical education teacher, I'm noticing that each time I start to become physical the symptoms come on.  4/13/21-4/15/21, went to bed very early because I felt exhausted.  Still had random headaches.  4/18/21-4/20/21-symptoms persisted, stayed home from work Monday and Tuesday.  Today, 4/22/21, during the first hour of work had a headache along with body fatigue again and decided to fill this out.
fever; nerve pain, head, ear, throat; This case was reported by a consumer via call center representative and described the occurrence of fever in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of no adverse event the patient never had any symptoms with flu shot and the patient gets it every year.   In September 2021, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2020-2021 season. In September 2021, 10 hours after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced fever and nerve pain. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the nerve pain was not recovered/not resolved.   The reporter considered the fever and nerve pain to be possibly related to Shingrix. It was unknown if the reporter considered the fever and nerve pain to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as the patient self-reported the case. The patient received Shingrix vaccine in right arm and the flu shot in left arm (did not know which one) 2 and a half weeks ago from reporting date (did not remember exact date). The patient believed he had a reaction to Shingrix. About 10 hours after getting vaccines he reported a fever and nerve pain on the top, left side of head (scalp) that radiates down to his left ear and left side of throat. The fever went away after a day, but the nerve pain remains after 2 and a half weeks. The reporter did not consent to follow up.
Injection site moderate tenderness. Injection site moderate erythema. Mild fever with chills. Vomiting - onset at 2 hours- diarrhea onset at 2 hours lasting > 12 hours.
Severe pain in his arm, now has cough, chills, headache, and sore throat, body aches, and joint pain. States he began feeling poorly about 3 hours after the vaccine.
diarrhea; nausea; light headache; This is a spontaneous report received from a contactable other health care professional, the patient. A 63-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) as a single dose via an unspecified route of administration in her left arm on 19Mar2021 at 11:30 (at the age of 63-years-old) for COVID-19 immunisation. Medical history (reported as yes) without any specified condition. The patient had unspecified allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient received unspecified medications within 2 weeks of vaccination. The patient had not been tested COVID-19, prior to vaccination. The patient had not been tested for COVID-19, since having the vaccination. On day of injections on 19Mar2021, the patient reported as she had experienced light headache and next day on 20Mar2021 at 06:00, the patient woke-up with diarrhea and nausea, as the day progressed it got worsened and then got better today, but patient woke up again on 21Mar2021, with extreme diarrhoea and nausea, every time I try to eat, I have to go to the bathroom. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was reported that patient did not received treatments for the events headache, diarrhea and nausea. The clinical outcome for the events diarrhea, headache and nausea were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
huge shingles outbreak.  Face, neck, ear, head.  All on injection site side
Pulmonary embolism Aug 4, 2022 after having Covid-19 mid to end of Jan 2022. Short of breath; elevated heart rate for 2 weeks prior to hospital admittance. Scanned left leg for blood clots June 26th 2022 due to an ankle injury. No signs of blood clot even in June. PE affected right side of heart causing strain. Had thrombosis procedure to remove blood clots Aug 5th 2022, will remain on blood thinner medication for life.
Lymphangitis 5.5. x 7 cm at left axillary area. Tx with Naprosyn and Benadryl. PT given 48 hrs Qtrs by vax provider.
Approximately  8-10 minutes after vaccine was given, patient became very dizzy, light-headed and nearly passed out.   He was taken to clinic exam room and laid down on an exam table.   Cool compresses applied and water given.  Patient had no food for almost 8 hours prior to the vaccine.   Patient recovered in less than 30 minutes and felt fine and discharged to home with parent.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient did not experience temperature excursion previously. On 26-APR-2016 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (dose and route were unknown, lot #: L050910, expiration date: 14-JUN-2017, therapy type: digital data logger). The vaccine was exposure on 9.9 Fahrenheit for 1 hour and 20 minutes. No adverse events were reported. This case was one of several cases received from the same reporter. Additional information has been requested.
Itching; This case was reported by a pharmacist via call center representative and described the occurrence of generalized itching in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included drug allergy (Nonsteroidal anti-inflammatory drugs). Concomitant products included diclofenac sodium (Voltaren (Diclofenac Sodium)).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized itching. The patient was treated with prednisone. On an unknown date, the outcome of the generalized itching was not recovered/not resolved.   It was unknown if the reporter considered the generalized itching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The Pharmacist reported that a patient had experienced generalized itching four months in duration after receiving the first dose of Shingrix.  The patient had seen their physician who prescribed prednisone. After the prednisone therapy the itching returned. At the time of reporting, the patient was on topical Voltaren gel. Till the time of reporting, the physician and pharmacist were still monitoring and following this reaction. No additional detials were provided.
Severe flu symptoms, fainted at 5:15 am on 4/22/21, hematoma head injury
Chest Pressure; Little cough; Vccination site brusing; Vaccination site erythema; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest Pressure), COUGH (Little cough), VACCINATION SITE BRUISING (Vccination site brusing), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and FATIGUE (Fatigue) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis (Took Enbrel for Rheumatoid Arthritis). Concomitant products included PREDNISONE, WARFARIN and AMLODIPINE, METOPROLOL SUCCINATE (TOPROLOL AM) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced CHEST DISCOMFORT (Chest Pressure), COUGH (Little cough), VACCINATION SITE BRUISING (Vccination site brusing), VACCINATION SITE ERYTHEMA (Vaccination site erythema), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, CHEST DISCOMFORT (Chest Pressure), COUGH (Little cough), VACCINATION SITE BRUISING (Vccination site brusing), VACCINATION SITE ERYTHEMA (Vaccination site erythema), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
pt had vax 5MAY97 & mom had fed pt & returned to seat, pt had choking episode, turned blue & seized;rash to ER had another sz;parents requested transfer to another hosp;w/u neg;
Crying; Positive for COVID; Headache; aches; Coughing; Feels weak and powerless; Chest pain between boobs that was very heavy; Angry; Chills/shivering; cold; This is a spontaneous report from a contactable consumer. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EN6206; Expiration Date: 30Jun2021), intramuscular, administered in Arm Left on 16Mar2021 (at the age of 50-years-old) as dose number unknown, 0.3ml single for covid-19 immunisation. The medical history and concomitant medications were not reported. On 17Mar2021 the patient experienced headache, aches, coughing, feels weak and powerless, chest pain between boobs that was very heavy, angry, chills/shivering, cold. On 22Mar2021 the patient experienced positive for covid. On an unknown date the patient experienced crying. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 22Mar2021. The outcome of the events positive for covid, aches, cold and crying was unknown, for the event chest pain between boobs that was very heavy the outcome was resolved on 19Mar2021, for rest of the events the outcome was resolving.   Description of complaint: Patient received Pfizer COVID vaccine on 16Mar2021 and tested positive for COVID on 22Mar2021. Processing complaint for LOE as per verbatim not clear after first shot or second Covid positive. No correspondence as reporter information not provided. Reporter, his wife, son and daughter all received the Pfizer COVID vaccine. He did not get tested for COVID, but his wife, son and daughter did and they all tested positive after receiving the vaccine. He assumes he has COVID as well since he has the same symptoms and lives in the same household. Conclusion: The complaint for an adverse event requested by Safety with the use of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6206 was investigated. The investigation included reviewing the manufacturing and packaging batch records, retained reference samples, deviation investigations, and an analysis of the complaint history for the reported lot and product type. The final scope was expanded to the reported finished goods lot EN6206, fill lot EN5339, and the bulk formulated drug product lot EN5327. A complaint sample or photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. The complaint was not confirmed.  Follow-up attempts completed. No further information expected.
Information has been received from a physician concerning a 13 year old female patient with a history of regular menstrual cycles who on 17-JUN-2010 was vaccinated with the first dose of GARDASIL 0.5 mL IM. there was no concomitant medication. On 19-JUN-2010, the patient developed irregular menstrual bleeding. The patient's irregular menstrual bleeding persisted. The patient sought medical attention, at office visit. Follow up information has been received from a physician concerning a female patient with no pertinent medical history, no pre-existing allergies and no illness at the time of vaccination who was vaccinated with first dose of GARDASIL. Concomitant therapy included a dose of ADACEL and varicella virus vaccine live (manufacturer unspecified) (route and dose not reported). The physician reported that on 19-JUN-2010, the patient experienced abnormal vaginal bleeding and abdominal cramping that began 2 days after she received her first dose of GARDASIL. It resulting in 2 office visits. The patient started on DESOGEN, oral administration to control the bleeding. It was unknown if the patient had recovered from abdominal cramping and abnormal vaginal bleeding. There were no laboratory diagnostics tests performed. The patient sought medical attention, at office visit. No further information is available.
On 07/25/2022, I came down with low grade fever, fatigue, hoarseness, and a bit of a cough. I contacted my doctor who wanted me to test for COVID-19. I took an at home test and was positive. My doctor prescribed Paxlovid and that cleared everything up for a few weeks. In the last week or so though, I developed a cough that was persistent until around today. I took a rapid test today on 08/08/2022 which came back positive.
This spontaneous report as received from a registered nurse refers to her approximately 10 years old male son. The patient was vaccinated with (Merck) VARIVAX (dose, route and lot number not provided) some time in 1996. No other co-suspects were reported. No concomitant medications were reported. Shortly after receiving this vaccine, he had developed a minor rash in an unspecified location. The patient had 4 or 5 small blisters. It was unspecified if the patient had sought medical attention. No treatment was given for the adverse events. The patient was 16 years old and was fine at time of this report. At the time of the report the patient had recovered. Additional information is not expected.