chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm soreness; This is a spontaneous report received from a contactable reporter (other HCP). The reporter is the patient.  A 22-year-old male patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection), intramuscular, administered in deltoid right, administration date 08Jan2021 09:00 (Lot number: EL3248) at the age of 22 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021143210 same patient and event, different drug.
PAIN IN THE LEFT LEG; CONFUSION; LETHARGY; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included dust mite allergy, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced fatigue. On 19-MAR-2021, the subject experienced lethargy. On 22-MAR-2021, the subject experienced confusion. On 30-MAR-2021, the subject experienced pain in the left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confusion on 29-MAR-2021, and pain in the left leg on 10-APR-2021, had not recovered from lethargy, and the outcome of fatigue was not reported. This report was non-serious.
Red circular rash around area vaccination site.  Rash was hot to the touch. Feeling ill.  This was the varicella vaccination.
Warm, red rash around injection site. Over the past 48 hrs it has moved down left arm.
Swollen, painful node above my left collarbone; Swollen, painful node above my left collarbone; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jul2021 18:00 (Lot number: Ew0198) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 24Jul2021, outcome "not recovered" and all described as "Swollen, painful node above my left collarbone". The event "swollen, painful node above my left collarbone" and "swollen, painful node above my left collarbone" was evaluated at the physician office visit. Therapeutic measures were taken as a result of lymphadenopathy, lymph node pain.  Follow-Up (12Oct2021): Follow-up attempts are completed. No further information is expected.
Hives started on upper arms, chest. Benadryl taken and cortisone cream. Next morning, hives over neck, chest, arms, torso, thighs. Benadryl taken and cortisone applied. Went to doctor 10/11/2012, when hives extended to palms of hands and feet. Was prescribed Prednisone 80mg for 3days, 60mg for 3days, 40mg for 3 days, 20mg for 3 days. Also triamcinolone cream to affected areas. Symptoms abated finally on 10/14/12 1200pm.
Approximately 1.5 hours after receiving the vaccine, the vaccination site became red. Over the next 24-48 hours, the redness has gotten larger, is very tender to the touch and, has a hard knot. I attempted to contact the Health and Nutrition Center today. I advised the receptionist of the nature of the call. I was transferred to a nurse, had to leave a voice mail, with no callback.
Red, hot, and hard lump appeared at injection site ~2 days after receiving vaccination (COVID-19 booster). The lump grew for ~2-3 days and remained painful to the touch. The lump is still present a week after vaccination; however, seems to be getting better/smaller (less red, hot, and painful). I believe this is called ?COVID arm?.
While waiting   15 minutes after vaccination, patient approached window  stating  to Pharmacy Technician he felt light headed, dizzy. Technician went to alert Pharmacist and patient collapsed to the floor. 911 was called.  Patient was breathing but unresponsive and pale. Pharmacist administered  Epinephrine o.3mg IM.  Patient gradually became alert and was moved to chair with feet elevated and Blood Pressure of 129/74 and pulse 65.  Water was given and EMTs arrived and took  over assessment.
Administered 0.5 ml Quadrivalent Influenza vaccine to 7 month old child. Wrong age/wrong dosage.
Extreme Pain (9 out of 10) in vaccinated Arm. Unable to lift arm. Unable to sleep laying down. Had to try to sleep sitting up to support arm. Arm needed to be splinted. Required pain medication to function (First time ever after vaccination).
This case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After receiving SHINGRIX vaccine, within 2 weeks the patient was presented with Guillain Barre Syndrome. The physician did not know if the condition was related to SHINGRIX, but could not attribute it to anything else. The physician advised to the patient to not receive 2nd dose of SHINGRIX vaccine. The caller did not have any additional information to provide regarding the event.
bleeding ulcer; pneumonia; COVID infection; COVID infection (one month after he received the first covid vaccine); This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The wife called on behalf of husband who received the first dose on 16feb2021 while he was in rehab facility. The patient was not able to get the second dose as he became sick with bleeding ulcer and had to go to hospital for 2 weeks. After he was released from hospital, on 16Mar2021 he was diagnosed with pneumonia and COVID infection (one month after he received the first covid vaccine). The wife was asking if her husband has to start over with the series given it has been almost 3 months since his first dose. The patient was hospitalized for bleeding ulcer (ulcer haemorrhage) for 15 days. The outcome of the events was unknown.  Information on the batch number has been requested.
Pt received MENVEO adn Lt forearm PPD and was sittign in chair waiting x during after 5 mins patient became pale and passed out in chair, unresponsive - sweaty. Pt came to tx and laid in Trendleburg and vital signs done 9:27 am 108/60 pulse 53 resp 16 temp 97.5 po. Last vitals at 0955 BP111/5 > pulse 68 resp 14 O2 sat 99%. Pt was pinl and warm and skin dry. Seen and spoke with mom and patient felt it was a vasovagal reaction (Pt had eaten and drank that morning prior to visit) Pt left in care of mom drinking more water.
On Wednesday, 05/04/2022,  morning I had a cough. At bedtime I started to get congested and chills. Slept on the couch and stayed away from everyone. Thursday, 05/05/2022, I threw up all day, I had body aches, and the next morning I was able to drink water and kept it down and had toast. I did an at home COVID-19 test and tested positive 05/05/2022. I went to the clinic and had a PCR test on Thursday, 05/05/2022. And I kept throwing up all day Thursday. I had a lot of snot and drainage. The mucous was so thick, I could not lay down flat or I would gag on it. Friday morning, I kept food in. I received an email from the clinic and found out I tested positive for COVID-19. My doctor prescribed Paxlovid on Friday night. I still had body aches Friday night, threw up just a little bit and I have not thrown up since then. I still had a sore throat. Since taking the Paxlovid I am getting a little bit stronger.  I am still having congestion, exhaustion, not as bad as it was. I can make a meal and then I am tired. All the other symptoms have dissipated.
severe chills and body aches, then sweats, continued severe fatigue; lightheadedness  from 9 pm through the night and into the following day, gradually easing by the next evening.  85% functional 48 hrs later.
redness on arm; slight temperature; really bad body aches; body aches; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (really bad body aches), PAIN (body aches), ERYTHEMA (redness on arm), PYREXIA (slight temperature) and PYREXIA (fever) in a 65-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.     No Medical History information was reported.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (body aches), PYREXIA (fever) and CHILLS (chills). On 22-Mar-2021, the patient experienced PAIN (really bad body aches), ERYTHEMA (redness on arm) and PYREXIA (slight temperature). On 20-Mar-2021, PAIN (body aches), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, PAIN (really bad body aches), ERYTHEMA (redness on arm) and PYREXIA (slight temperature) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.
Pt. received vaccine on Friday, 05/05/23 at 4:10pm, within 2-4 hours she said she had an upset stomach, and pain. The pain got worst and she started Projectile Vomiting at 9pm. She projectile vomited a couple times, had a lot of abdominal pain. I called the on-call doctor, she said to give sips of water. During the night, pt. vomited over 7 times during the night. In the morning, she was very tired, and in pain, I called the doctor again, she said to stop all solid food for 8 hours, continue sips of water. Pt. napped most of the day, vomiting stopped. By evening she was able to have couple crackers. On Sunday 05/07/23, pt. started to feel a bit better and by the afternoon she was able to eat some solid food. On Monday morning, 05/08/23 pt. was feeling better,
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 19-NOV-2014, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the long-term prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.
Administration of powder portion with sterile solution.; Administration of powder portion with sterile solution.; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMZA521A, expiry date 30th April 2022) for prophylaxis.   On 4th August 2021, the patient received Menveo. On 4th August 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional details were reported as follows: The nurse reported that the patient received just the powder portion of Menveo reconstituted with sterile solution, adjuvanted portion was not administered, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow-up.
Given injection 4 PM, woke up midnight numbness on left side of face including eyebrow, eye or not lips. Was not droopy. Became lightheaded. Eye felt swollen like she couldn't close it but it did close. Next day also felt tingling in left arm and some on right. Mom is pregnant.  11/09/09:  OB Record received for dates of service 10/27/09:  Facial numbness. Assessment:  Had H1N1 vaccine the day before OB visit.  Presented with facial numbness.  If no improvement will refer to PCP for tx.
No other information given at this time.; Medical assistant calls to report a temperature excursion/ The product were administered; This spontaneous report as received from a medical assistant, concerning a 12 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 18-JAN-2021, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S029457 with expiration date 19-SEP-2021 (dose, frequency, route and anatomical location were not provided) for prophylaxis. The excursion date was on 25-NOV-2020 with a temperature of 47.4 and duration of 1 hour and 20 minutes. No other information given at this time.  This is one of 25 reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA005178:
Patient had acute onset post-vaccination at 10 mins of nausea, bilateral UE and LE tingling sensation, no dermatological changes. Denied SOB. Patient reported last food was 30 mins prior to vaccination with bagel. Patient vitals as stated below and given OJ and  gummies.  VITALS: T97.7, HR 75, RR 14, O2 95%, BP 150/82  After 10 mins of snacks, symptoms were improving. After 15 mins, symptoms resolved entirely. patient left site 30 mins after onset without reoccurrence.
SxS began 8/14/21: SOB, cough, fatigue, fever, chills, diarrhea
About 2 weeks after vaccine, patient began having neuropathy in right arm. It then slowly started spreading up the arm and down into the rest of the body. But seems to be slowly getting better.
MUSCLE ACHES; FATIGUE; LOW GRADE FEVER; HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once a total administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. On 16-MAR-2021, the subject experienced muscle aches. On 16-MAR-2021, the subject experienced fatigue. On 16-MAR-2021, the subject experienced low grade fever. On 16-MAR-2021, the subject experienced headaches. Laboratory data included: Body temperature (NR: not provided) 102 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever, headaches, fatigue and muscle aches was not reported. This report was non-serious.
Heart flattering fast; Her resting heart race is 54-56, but that morning was higher; Sore arm; This spontaneous report was received from a consumer (patient) and concerns a 66 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was sore, felt the heart flattering fast. Her resting heart race was 54-56, but that morning was higher.   The patient was very active, exercised every day and ate very healthy. Patient was a very healthy person and has no medical conditions, only was allergic to Sulfas.  On 09 Feb 2021, the patient received her first dose of mRNA-1273 (Lot number: 016M20A) solution for injection intramuscularly in her left arm for prophylaxis of COVID-19 infection.   On 10-Feb-2021, patient felt the heart flattering fast. This sensation lasted 2 minutes. The doctor stated that this could be a heart attack and because it happened after receiving the Covid-19 vaccine, this could be a possible side effect.   On 10 Feb 2021, the patient resting heart race was (54-56s), but in the morning it was higher.   On an unknown date the patient had laboratory test AKG.  Seriousness Criteria for the events of heart flattering fast was medically significant.  Action taken with suspect drug mRNA-1273 was unknown; Reporter's Comments: Being sent back to CP
patient was administered FLUZONE QUADRIVALENT before she got pregnant, with no reported adverse event; Initial information was received on 01-Sep-2021 regarding an unsolicited valid non-serious case from other health professional.  This case is linked to cases 2021SA294755, 2021SA293704, and 2021SA293706(CLUSTER).  This case involves a 26-year-old female patient who was vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] before she got pregnant (maternal exposure before pregnancy).   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The date of last menstrual period was 30-Apr-2021  The estimated due date is 04-feb-2022.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) concomitant medications and family history were not provided.  On 09-Jan-2021, the patient received a dose 1 of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT7325JA; expiry date: 30-Jun-2022; form: suspension for injection) via intramuscular route in unknown administration site for prophylactic vaccination.  It was the case of vaccine exposure before pregnancy (same day latency).  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were laboratory data/results available.  At time of reporting, the outcome was unknown for the reported event.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.
About 5 minutes after getting the vaccine injection my heart rate suddenly increased (My heart rate went back down to normal about 2 or 3 minutes after it initially increased), I was short of breath, and slightly dizzy. The  night of and the next morning after the injection, I have been tired, my left arm of the injection site, left shoulder, and lower back have been aching. The next day after the shot, I have been unusually tired, also.
Medical staff did not dilute Pfizer vaccine properly and inadvertently gave patient larger dose of vaccine.
atrial fibrillation; heart rate became elevated; has a defibrillator; received a shock in his chest; ill with Covid infection; Initial information received on 12-Oct-2022 regarding an unsolicited valid  serious case received from a consumer/non-health care professional.  This case is linked to cases 2022SA422349 and 2022SA425046.  This case involves a 77 years old male patient who has a defibrillator, experienced shock in his chest, atrial fibrillation and  ill with covid infection after receiving vaccines Tozinameran[ pfizer biontech covid-19 vaccine] and influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in, 2019 followed by another dose in 2021,  the patient received a  dose of suspect Influenza vaccine produced by unknown manufacturer lot number not reported at an unknown dose via an unknown route in an unknown administration site as prophylactic vaccination.  On an unknown date of 2021 followed by another dose in 2021, the patient received dose number 1  of suspect Tozinameran not produced by Sanofi Pasteur lot number not reported at an unknown dose via an unknown route in an unknown administration site for covid -19 vaccination.  On an unknown date(latency: approximately 3 years for all events), the patient had a defibrillator ( Cardiac assistance device user), and after vaccination, he received a shock in his chest (Cardioversion). His heart rate became elevated (heart rate increased), and he went into atrial fibrillation (Atrial fibrillation). The atrial fibrillation resolved and he felt good that summer. The patient stated that he reported his experience after the 2nd Pfizer vaccine dose to the Pfizer hotline. Sometime after 13Oct2021, he became ill with Covid infection (Covid 19).  Action taken: not applicable for both suspect drugs for all events.  It was not reported if the patient received a corrective treatment for the events.  Outcome: unknown for Cardioversion and Cardiac assistance device user and recovered for all other events.  Seriousness criteria: medically significant for atrial fibrillation and heart rate increased, Disability of Cardiac assistance device user; Sender's Comments: Sanofi Company comment dated 20-Oct-2022:This case involves 77 years old male patient who was vaccinated with Influenza vaccine (produced by unknown manufacturer)and Pfizer Biontech Covid-19 Vaccine (not manufactured by Sanofi) and experienced atrial fibrillation, heart rate increased and has a defibrillator . The time to onset is compatible with the role of the vaccine. The clinical course was not provided. Furthermore, additional information regarding condition at the time of vaccination, diagnostic workup would be needed for a complete assessment of the case. The case is confounded by multiple vaccines administered same time . Based upon the reported information, the role of an individual vaccine cannot be assessed.