chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of rotavirus infection in a 2-month-old male patient who received ROTARIX lyophilized formulation (batch number 2ZX4M, expiry date unknown) for prophylaxis. On 18th March 2019, the patient received the 1st dose of ROTARIX lyophilized formulation (oral) 1 ml. On 20th March 2019, 2 days after receiving ROTARIX lyophilized formulation, the patient experienced rotavirus infection (serious criteria hospitalization). On an unknown date, the outcome of the rotavirus infection was recovered/resolved.  It was unknown if the reporter considered the rotavirus infection to be related to ROTARIX lyophilized formulation. Additional details were provided as follows: The patient was admitted to the hospital. The patient initially came to the emergency room at the facility where the pharmacist works and then transferred to the hospital downtown. The reporter did not provide dates or number of days that patient stayed at the hospital.
Terrible taste; patient tested positive for Covid19; salty taste in her mouth; lost sense of smell; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (lost sense of smell), DYSGEUSIA (salty taste in her mouth), TASTE DISORDER (Terrible taste) and COVID-19 (patient tested positive for Covid19) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ANOSMIA (lost sense of smell). On 05-Mar-2021, the patient experienced DYSGEUSIA (salty taste in her mouth). On 11-Mar-2021, the patient experienced COVID-19 (patient tested positive for Covid19). On an unknown date, the patient experienced TASTE DISORDER (Terrible taste). At the time of the report, ANOSMIA (lost sense of smell), DYSGEUSIA (salty taste in her mouth), TASTE DISORDER (Terrible taste) and COVID-19 (patient tested positive for Covid19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.       Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Significant Follow up appended for Event update
7/30/22 2200:  Felt slight itching to skin and noted large very red rash to upper abdomen. Next morning very faint rash to abdomen but increased rash returned evening of 7/31 to upper abdomen, sides of breast with welts noted. 1 hive noted to lower neck area. Morning of 8/1 no rash but approximately 45min after shower rash/welts to L. breast area, lower abdomen. Went away in 1-2hrs. The evening of 8/1 rash/welts to L. breast area and abdomen returned. Rash had more welts present. 8/2 no rash when awaken, them couple hours later scattered welts to lower abdomen and medium size rash to R. posterior neck area.  Rash/welts have very little itching but can tell they are there.
Patient received injection at about 3 pm and between 5-6 pm started getting fever, scratchy throat. Between 6-7 pm sx of throat closing and vomiting. Patient seen and treated.
Initially, post vax, pt was given Tylenol for 24 hours, as is recommended. At approximately 30 hours, post vax, pt became lethargic and hard to arouse. For 5 minutes, she seemed unable to answer me and unaware of my attempts to awaken her. Her eyes were open but they moved very rapidly, back and forth and she seemed unable to hold her arms still. Her temperature was 103.2F. With Tylenol, temperature went down but on 2nd afternoon, post vax, her temperature spiked to 104.5 and on 3rd afternoon, temperature spiked to 103.7F. There was only 1 incident of seizure-like activity.
Fever; Chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were unknown.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix years ago. The patient stated that, shed had every reaction that she could read online with the first dose of Shingrix vaccine. The patient had fever and chills that lasted for about 2 to 3 days. The patient did not want to answer any questions in regards to the adverse event and did not want to provide any demographic information.
mom said about 2 hrs /p shot, pt broke out /w rash, thigh was red to knee. Rash lasted about 1 hr then subsided except under nose & chin, low grade T, Next day T 100.8(R) & lethargic,called MD went in,TX push Pedialyte give Tylenol observe
See attached forms: DD Form 2766 C vaccine administration record form 600 health record chronological record of medical care.
A-fib; Rapid heart beat; A spontaneous report was received from a consumer concerning a 79 year old, female patient who experienced rapid heartbeat and atrial fibrillation (A-fib).  The patient's medical history included hypertension and renal disease. Concomitant product used were losartan potassium ,levothyroxine,  fluorseminde ,levotiroxine, multivitamin, zinc , vitamin for knee joint movement,  vit D3 , alpha lipoic acid, rosuvastatin calcium ,  elequis,  milatonin , probtotic 10.   On 27 JAN 2021, approximately 30 minutes prior to the onset of the symptoms, the patient received her first of two planned doses of mrna-1273, batch number was not provided, intramuscularly in an unknown injection site  for the prophylaxis of COVID-19 infection.  On 27th  JAN 2021,  after receiving the vaccine she experienced rapid heartbeat and she reached out to the pharmacy where she took the vaccine. From there the pharmacist called 911.   On 27th JAN 2021 she was hospitalized, and the hospitalization prolonged for four days and discharged on 31 JAN 2021.  Treatment for the event included Eliquis 5 milligrams (mg) and Metoprolol Succinate ER 25mg.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events rapid heart beat and A-fib were unknown.; Reporter's Comments: This case concerns a 79-year-old female, with medical history of hypertension, who was hospitalized with serious unexpected events of atrial fibrillation and heart rate increased. The events occurred the same day as the first dose of mRNA-1273 and were treated with Eliquis and Metoprolol. Event outcomes unknown. 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.
felt like a metallic taste in her mouth.; sinus headache; felt faint; I felt really bad; a bit anxious; little bump area was still there 2 weeks later and she was quite surprised; didn't have very much pain in her arm; This is a spontaneous report from a contactable consumer (patient). A 64-years and 5 months old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6204, expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 14Mar2021 11:48 as dose 1, 0.3 ml single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included Cefalexin from 08Mar2021 to around 15Mar2021 or 16Mar2021, Differin face gel (stated this was over the counter), Centrum Silver for women over 50 (takes with a glass of water) and multivitamin. The patient previously took excedrin aspirin free possibly around 2008-2009 and experienced feeling abnormal and she feels like she is going to pass out and in Oct2020, when she was going back for her 2nd part of the Shingles vaccine and she thinks she also received a flu shot and the next day she had a reaction where she felt bad like she almost had the flu, but it was gone in 4-6 hours. It was reported that patient was taking Covid 19 vaccine so that she would not have a severe reaction to the Covid 19. On 15Mar2021, the patient experienced sinus headache, felt really bad it was like when she did not do well when she takes Excedrin which patient stated it did not last long, like 45 minutes, faint, a bit anxiousPatient stated that after she felt bad, she was going to pass out stopped after about 45 minutes and has been gone. She felt really bad and went to go take a shower and get ready to go to the ER and after the shower she had water and felt a lot better and did not feel like she needed to go to the ER and longer and it had not happened again and she did not go to the ER. On 16Mar2021, she felt like a metallic taste in her mouth. In Mar2021, she had little bump area was still there 2 weeks later and she was quite surprised as it was much smaller 26Mar2021 and yesterday she did not feel a bump at all at the shot site and did not have very much pain in her arm. On 15Mar2021, patient recovered from the events sinus headache started the same day in that 45 minute time frame and lasted that 45 minutes and was the same for the anxious feeling, felt faint and really bad. On 18Mar2021, patient recovered from the event metallic taste which was lasted for 2 days. On 29Mar2021, patient recovered from little bump area was still there 2 weeks later and she was quite surprised and in Mar2021, she had recovered from the event did not have very much pain in her arm  No follow-up attempts were needed; information about lot/batch number could not be obtained.
Information has been received from a registered nurse concerning a 22 month old white female with an amoxicillin allergy who on 10/11/02, was vaccinated SC in the left thigh with the first dose of varicella virus vaccine live (lot # 638816/1236L). Concomitant vaccinations on that same day included MMR. There was no illness at the time of vaccination. The RN reported that on 8/25/03, the patient developed a mild breakthrough varicella rash and a low grade fever. No other symptoms were reported. Unspecified medical attention was sought and no laboratory/diagnostic tests were performed. In 2003, the patient recovered from the breakthrough varicella rash and low grade fever. Additional information has been requested.
Severe flu like  symptoms. Fever of 102, aching body, chills, severe exhaustion.
sore arm, 2 inch red circle, itchy and warm to touch but not as bad as yesterday (day of shot).  Onset within an hour of vaccine
Full body aches, chills, sweats, low fever 99.8, headache, fatigue, and soreness at injection site
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 8.3 degree Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Patient was given PREVNAR 13 at a morning appt. That evening developed shortness of breath and went to the ED. Subsequent had 2 more ED visits for SOB. The last one was admitted to hospital with mild CHF. Echo showed 45-50% global hypokinesis.
9/19/18 at 7:49 PM - received call from pt mother. Child received vaccine 2 days ago and today both thighs are swollen with multiple hives. Child scratching and causing some bleeding. No meds given. Provider discussed with mom, could be a vaccine reaction. Suggested giving BENADRYL/MOTRIN as needed for comfort. If more symptoms present or worsen come to office.
I suffered a mini stroke on 02/17/2021.; Increase in atrial fibrillation; Sleep Apnea; I had a cardiac ablation procedure done on 06/09/2021  to treat the atrial fibrillation.
Fever of 102 on 5/17 with rash starting on forehead on 5/19 and progressing down body.
His GFR was 42 in March of 2021 after getting the  2nd dose/ his kidney function was in the toilet; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC KIDNEY DISEASE (His GFR was 42 in March of 2021 after getting the  2nd dose/ his kidney function was in the toilet) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 038K20A) for COVID-19 vaccination.     The patient's past medical history included Hospitalization (For kidney problems.) in November 2020. Concurrent medical conditions included Chronic kidney disease stage 3 (He was diagnosed with Stage 3 Kidney Failure).   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced CHRONIC KIDNEY DISEASE (His GFR was 42 in March of 2021 after getting the  2nd dose/ his kidney function was in the toilet) (seriousness criterion medically significant). At the time of the report, CHRONIC KIDNEY DISEASE (His GFR was 42 in March of 2021 after getting the  2nd dose/ his kidney function was in the toilet) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Glomerular filtration rate: 40s (Low) It is recommended to be in the 60s based on his age. In March 2021, Glomerular filtration rate: 42s (Low) 42s. In July 2021, Glomerular filtration rate: 40s (Low) 40s. In December 2021, Glomerular filtration rate: 38s (Low) 40s. On an unknown date, Glomerular filtration rate: 53s (Low) A month after hospitalization it was 53.         Concomitant medications were not reported. No treatment information was provided by the reporter.  In November of 2020, patient  was hospitalized, it was discovered that he had kidney problems, he was diagnosed with Stage 3 kidney failure and his GFR was in the 40s.   A month after he was hospitalized it was 53 and everyone was pleased with the improvement. Patient was been on a low fat, low sodium diet and increased water intake since November of 2020 which helped until he got the shots.  Company comment This is a spontaneous case concerning a 75-year-old malepatient with medical history of Chronic kidney disease stage 3 and was hospitalized in November 2020, who experienced the serious unexpected event of Chronic kidney disease. The event occurred on an unknown date on the same month after the second dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 75-year-old malepatient with medical history of Chronic kidney disease stage 3 and was hospitalized in November 2020, who experienced the serious unexpected event of Chronic kidney disease. The event occurred on an unknown date on the same month after the second dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Chills, Fever, Nausea, bodyaches, Headache, cramping, diarrhea,
Administered in left deltoid - unable to use arm 2 wks post vaccine. Has had flu vaccine previous years.
A 75 year old patient was administered Adacel, no AE.; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00612908) and transmitted to Sanofi on 24-May-2021.  This case involves a 75 years old male patient who was administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] VACCINE (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination on 21-MAY-2021 (Product administered to patient of inappropriate age)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day).  The caller wanted to know if it was okay for his in-laws to be administered Adacel based on their age (70's). The family members were 73 and 75 years of age and were administered Adacel last week. He asks if it was ok.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
DTaP, PREV. given on 9/12/10, (R) bicep. Erythema, warm area on (R) bicep area developed. 7/15/10 Afeb, full ROM with (R) arm. TX' cool compresses, MOTRIN PRN.
Patient given Td booster on 08/15 in left upper arm; reports today 08/25/2003 that she developed pain at "4" (1-10 scale) near injection site; denies fever, drainage but feels a "know" at injection site about the "size of an egg; will consult MD as well.  Encouraged gentle range of motion, apply ice or heat as needed for (^) comfort; analgesics as needed.
received the second Shingrix shot in April. Got three cases of shingles in at 6 week intervals. Hope I don't continue to sffer from these recurrences.
Patient complains of severe fatigue, loss of strength to injection site. Arm was heavy. Inability to focus. Patient stated she left home early due to severe fatigue. Patient complains of pressure to head on following day. Patient states fatigued. Patiend denied fever. Extremely fatigued for a few days.
administered a dose after improper storage and handling; Dose administered more than 12(US) post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12(US) post puncture) and PRODUCT STORAGE ERROR (administered a dose after improper storage and handling) in a 74-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 011B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jul-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12(US) post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered a dose after improper storage and handling). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12(US) post puncture) and PRODUCT STORAGE ERROR (administered a dose after improper storage and handling) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported. The number of doses in the vial was 3 doses. The vial was never in the fridge. They moved the vial from the freezer to room temperature 25-Jul-2022. The date and time the vial was first punctured was on 25-Jul-2022 around 10 AM. The vial stored post puncture at room temperature. Total amount of time the vial was exposed to room temperature range was 23 hours. The vial did not underwent any temperature excursions. No treatment were reported.
Initially, itchy scalp.  Visit to doctor on 3/1/2010 made diagnosis of Shingles.  As indicated, Zostavax vaccination was given on 02/22/2010.  Shingles redness and swelling on right side of face and forehead.  Painful!
Extreme fatigue; sore throat; stomach pain; sore arm; chills; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself.  A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 15:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  Medical history included rheumatoid arthritis  , covid-19 from an unknown date prior vaccination.     The patient's concomitant medications were not reported.  The patient previously took amoxicillin and experienced hypersensitivity.  The patient experienced extreme fatigue  on 11Mar2021 14:30 with outcome of recovering , sore throat  on 11Mar2021 14:30 with outcome of recovering , stomach pain  on 11Mar2021 14:30 with outcome of recovering , sore arm  on 11Mar2021 14:30 with outcome of recovering , chills on 11Mar2021 14:30 with outcome of recovering.  The patient underwent lab tests and procedures which included blood test: negative   on 26Aug2020   , sars-cov-2 test: negative   on 10Mar2021  .    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Note: dates for vaccines are estimated - don't have card with me right now on this original completion of report. So I got my period and haven't stopped bleeding. It's been changing from spotting, to heavy bleeding to severely heavy bleeding and back  to spotting. It varies in how much.
Approximately 24hrs. after vaccine I developed muscle twitching and muscle spasms. This has lasted since the vaccine for approximately 1- 1/2 months now.
Individual presented for vaccination for Covid-19. Right after the vaccinator administered the Janssen vaccine without issue the data collector realized he had completed a series of vaccination with the Moderna product on 3/27/2021.   He was observed for about 30 minutes post-vaccination without issue. He was informed that he had received a dose of Janssen but was already vaccinated with the Moderna series and should not seek further vaccination.
Day 1 and day 2 severe diarrhea. Day 3 broke out in hives on hands, neck, behind ears, and buttocks.   I did go to the doctor after the hives appeared and was given a shot of antihistamine and meds to help the itch from the hives.
In early February 2023, I had a rash on my knees, elbows, lower spine, across my shoulders, that developed into hives, it caused my lymph glands to swell under my arms. This lasted until April of 2023, there has been no cause found for this. After this resolved, my mid back and hips had a rash that came up but does not really have the hive. I have bloodwork to try and determine if I have lupus, allergies to medication, etc. I have had biopsies that also came back inconclusive.
This spontaneous report as received from a medical assistant and refers to approximately 4 patients of unknown demographics. On an unknown date(s), the patients were vaccinated with improperly stored PROQUAD lot # M042497, expiry: 17-APR-2018 for prophylaxis (incorrect product storage). The sterile diluent used to reconstitute the PROQUAD was properly stored. No symptoms reported. Temperature excursion details were as follows: Temperature: -13 degree Centigrade Time frame: 3 hours and 20 minutes (cumulative total). The call was due to a data logger. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved.