chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects; one dose of expired PNEUMOVAX23 was administered; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medication and drug reactions or allergies were not reported.  On 03-SEP-2019, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # N025656 and expiration date: 19-APR-2019) for prophylaxis (strength, dose, unit, route and anatomical location were not reported) (expired product administered). No adverse effects were reported. The outcome of expired product administered was unknown.
102 fever, chills, headache, achy, fatigue, then chest pain the entire next day.
Patient is fully vaccinated, boosted, and up to date on COVID-19 vaccinations - last dose 1/4/2023. His onset of COVID-19 symptoms was on 2/19/2023 with shortness of breath. At the hospital on 2/19/2023, patient tested positive for COVID-19 and had an abnormal chest x-ray. He was admitted to the hospital on 2/19/2023. No treatment information was provided.  Submitter does not have access to further medical information on this case including discharge date. If more information is needed, please contact the admitting hospital:
administering the patient's 2-month dose of PENTACEL at 3 months of age, with no reported adverse event; Initial information received on 25-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 months old and unknown gender patient who experienced administering the patient's 2-month dose of pentacel at 3 months of age, with no reported adverse event while receiving vaccine Diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hib vaccine conj (tet tox) (acthib) for Immunisation.  On an unknown date, the patient received  suspect Diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine Suspension for injection(strength,dose,lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the administering the patient's 2-month dose of pentacel at 3 months of age, with no reported adverse event (inappropriate schedule of product administration) (unknown latency) following the administration of Diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.     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 the guidelines. 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.
does not feel good; sore arm; aches; has no energy; tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (does not feel good), PAIN IN EXTREMITY (sore arm), PAIN (aches), ASTHENIA (has no energy) and FATIGUE (tired) in a 5-decade-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MALAISE (does not feel good), PAIN IN EXTREMITY (sore arm), PAIN (aches), ASTHENIA (has no energy) and FATIGUE (tired). At the time of the report, MALAISE (does not feel good), PAIN IN EXTREMITY (sore arm), PAIN (aches), ASTHENIA (has no energy) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. The patient was treated with antibiotics and steroids.  The patient requested for a phone call to get a response why the patient was experiencing these adverse events and whether the patient should get the second shot or not.
Information has been received from a non-pregnant 71 year old female nurse that was also the patient, concerning on herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 01-NOV-2017, a prepared dose of M-M-R II lot # M044350 (expiration date were not reported) and sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were not reported) splashed onto her face and eye while she was drawing it up. The reporting patient stated that she "flushed her eye with water and irrigated eye with ophthalmic solution for the eye wash". The patient reported that no vaccine splashed onto the unspecified patient scheduled to receive the vaccine. No adverse effect were reported.
46 hours post vaccine administration woke from nap to very painful right eye. Slightly red sclera, eye very tender to touch through eyelid, sensitive to light, deep pain with eye movements, no drainage or discharge, vision intact. After holiday weekend in to see optometrist on Monday 12/28, as symptoms still persisting, thorough eye exam with dilation and retinal optimap scan, given eye muscle paralytic and assumed to be ciliary muscle spasm, follow-up call the next morning 12/29 - light sensitivity improved but still intermittent pain with eye movements, treat with Ibuprofen for now and follow-up for increased pain or visual changes. 12/29 visit to primary care to rule other other causes, no ear or sinus infection suspected, PA believes this should be reported to VAERS due to time frame of onset and new and never experienced ailment.
Headache; Chills; full body soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 31-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 10Mar2021 (at the age of 31-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 22:00, the patient experienced headache, chills and full body soreness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the events  headache, chills and full body soreness was recovered on an unknown date of Apr2021.  No follow-up attempts are possible. No further information is expected.
TDAP ADMINISTERED (L) DELTOID 3/6/9 @ 1045.  PT NOTED HIVES & ITCH @ SITE 3/11/9.  PT CONTACTED DR 3/12/9 & WAS BROUGHT IN FOR EVAL.  EXAM REVEALED 6cmX6cm SUPERFICIAL, SLIGHTLY RAISED, RED AREA @ INJ SITE.  PT DENIED MUSCLE TENDERNESS. NO NOTED MUSCLE INVOLVEMENT.
Pt came in am received vaccine. he came around 4pm received another  Ask pt if he received before and said no. After receiving vaccine says he got it on other arm. MD contacted pt guardian.
pain & swelling @ the site of DTP inject @ lt thigh w/in 1 hr p/vax; pt was quite fussy all day crying if not held; did not want to stand or walk; sx resolved the following morning;
Following the vaccine injection which was provided by the personnel, I have developed minor fainting spells and angina for the past 10 plus days. A large dried blood clot was noted on the first day of my period which occurred on March 16th. I continue to pass large blood clots while I was having my period. I also want to point out that a personnel who gave me an injection was incorrectly injected the vaccine outside of the area of the preferred injection zone. I have reported this event to the supervisor who was on site. I have not yet contacted my health care provider at this time but plan to contact her tomorrow as these symptoms have been persisting.
Pt. c/o of feeling Light Headed. Stated "I think its  more of a mental thing" Pt . vitals as follows: @12:24 pm B/P    150/85 Hr       65 R          16 02        97% on RA.  @ 12:38 pm, vitals as follows: B/P  138/80 HR    64 R        14 02      98% Pt. stated she felt better , left at 12:56 pm in stable condition. Advised  to follow up with PCP if new or worsening symptoms occur.
Angioedema in face and arms; Strange feeling in throat and voice; Difficulty swallowing saliva/ Strange feeling in throat and voice; Swollen tongue; Lip swelling; This case was reported by a physician via call center representative and described the occurrence of angioedema in a 27-year-old male patient who received HAV (Havrix) (batch number 2AD47, expiry date 31st January 2022) for prophylaxis.   On 3rd October 2019, the patient received Havrix. On 13th October 2019, 10 days after receiving Havrix, the patient experienced throat discomfort, swallowing difficult, swollen tongue and lip swelling. On an unknown date, the patient experienced angioedema (serious criteria GSK medically significant). The patient was treated with antihistamine, epinephrine and prednisone. On 1st October 2019, the outcome of the angioedema was recovered/resolved. On an unknown date, the outcome of the throat discomfort, swallowing difficult, swollen tongue and lip swelling were unknown.   It was unknown if the reporter considered the angioedema, throat discomfort, swallowing difficult, swollen tongue and lip swelling to be related to Havrix.  Additional details were provided as follows: The physician reported that the patient was administered hepatitis A vaccine on unknown arm and had possible angioedema on two separate occasions. Approximately 48-72 hours later following vaccination, it was reported that the patient had angioedema in face and arms. The physician mentioned that the patient may not have given it much attention and reaction may started prior to patient seeking medical help and first occurrence was resolved. The physician reporter that saw the patient on 8th October 2019 and also noted first occurrence resolved. During consultation the patient reported to the physician that he was not any other medications. On 13th October 2019, the physician reports patient woke up very early in morning during sleep due to strange feeling in throat and voice, difficulty swallowing saliva, and swollen tongue. The nurse evaluation was significant for tongue and lip swelling, and the patient was given an antihistamine and subcutaneous epinephrine. The patient was then transported to an emergency room at approximately 4 AM on 13th October 2019 and then transported to a second emergency room due to physician's preference for an available ENT specialist in the event intubation was required. At the second facility, patient underwent an upper airway examination and was later discharged on a tapering dose of prednisone and antihistamines. The physician reports symptoms resolved by the time patient was returned to the detention center. The physician mentions he had requested medical records for upper airway examination and he also ordered a test for complement levels and was willing to provide this information when available during follow-up. Emergency visit was required.
The patient received the vaccine, stood up, said he felt fine, walked out of the clinic room about 20-50 feet and he fell to the floor. He hit his head, was pale, had body irregular movements and confused when he came to. If there was loss of consciousness it was less than a minute. Staff tended to him immediately, there was no apparent physical injury, he was breathing and had a pulse. called 911. took vitals and talked to patient while EMS arrived. While waiting for EMS to arrive patient was completely alert and oriented. He laid on the ground with his head and neck protected until EMS arrived. EMS evaluated him, cleared him to go home and patient agreed and declined to go to the hospital. Mom said he has passed out after a vaccine before from fear of needles.
no adverse event; administered one dose of expired pneumovax23; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On 23-DEC-2019, the patient was inadvertently administered one dose of expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route of administration and anatomical location were unknown) with lot # R006465 and expiration date 24-OCT-2019 for prophylaxis. The patient did not experience any symptoms. There was no product quality complaint associated with the case.
Temperature excursion; This spontaneous report has been received from a nurse referring to a 12 month old patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.  On an unknown date, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # T020614 (strength, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 10-FEB-2021, the vaccine was exposed to a temperature range of 35.4 °F during a time frame of 15 minutes.
Muscle soreness Fever (101°) Hot flashes Shortness of breath Increased heart rate Dizziness
pt recv vax 2JUN98 very hot, high tactile fever (2wk later);rash all over;swollen lymph nodes over inguinal areas;
Received Vaccine Monday afternoon. Fatigue, body aches,  rash behind knees and on back, and soreness at injection site Tuesday afternoon. Overnight developed fevers, chills, diarrhea, nausea, headache which gradually worsened. Discussed with Primary care physician and Hospital employee health which recommend testing for COVID-19 in the ED.
No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 13-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # 1621929, expiration date: 06-DEC-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Fever, nausea, vomiting, diarrhea , cramps, dizziness, muscle aches and fatigue.
diarrhea; cancelled his 2nd dose due to diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and PRODUCT DOSE OMISSION ISSUE (cancelled his 2nd dose due to diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced DIARRHOEA (diarrhea) and PRODUCT DOSE OMISSION ISSUE (cancelled his 2nd dose due to diarrhea). On 25-Mar-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (cancelled his 2nd dose due to diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Red, painful rash on upper left arm. Fever up to 102.0 for 2 days. Reports arm as "sore". Advised cool compress to area. No other treatment needed. Symptoms resolved.
arm being painful; chills; fever; weakness; pain moving inside of bone; very hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm being painful), CHILLS (chills), PYREXIA (fever), ASTHENIA (weakness) and BONE PAIN (pain moving inside of bone) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included TENOFOVIR ALAFENAMIDE FUMARATE (VEMLIDY) and ROSUVASTATIN for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm being painful), CHILLS (chills), PYREXIA (fever), ASTHENIA (weakness), BONE PAIN (pain moving inside of bone) and PAIN (very hurt). On 23-Mar-2021, PYREXIA (fever) had resolved. At the time of the report, PAIN IN EXTREMITY (arm being painful), CHILLS (chills), ASTHENIA (weakness), BONE PAIN (pain moving inside of bone) and PAIN (very hurt) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
After the vaccination my head starting itching really badly. After a couple of days i had burning and itchiness and bumps on my torso. I went to the urgent and they thought it was shingles they didn't do anything and then two days later it got worst and it came to my arm and back and i contacted my doctor again and she ran some blood work on me. The doctor gave me prednisone and it got a little better but it all together lasted for ten weeks. After that they had the antibiotic test done and it was positive.
brooke out in hives all on my upper legs and arms taking benadryl it stops the itching for a little while but the hive are still on me
I had realized that after taking the booster shot that was given on 1/15/22 the side-effects came on the evening of 1/26/22 with  red-skin rash [Hives] that covered my face, body,arms and legs with persistent hive itching and burning sensation.  i thought it was just a normal passing reaction, but it kepted reoccurring and i got worry . i eventually decided to go to the emergency room for treatment and was given Cetirizine HCL 10  and a referral to see a dermitologist to whom I mentioned that it has something to do with the booster shot on 1/15/2022. i was seen at the emergency room on 1/31/2022 for treatment and to my surprise this visit.
Soreness at injection site; both of her cheeks became hot; both of her cheeks became red; both of her cheeks became raised; evolved into a big circle (under her arm); a streak under her left arm; hot (red circle) at the injection site; big (red circle) at the injection site; raised red circle at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (both of her cheeks became hot), VACCINATION SITE WARMTH (hot (red circle) at the injection site), ADVERSE REACTION (a streak under her left arm), ERYTHEMA (both of her cheeks became red) and SWELLING (both of her cheeks became raised) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot (red circle) at the injection site), VACCINATION SITE ERYTHEMA (big (red circle) at the injection site) and VACCINATION SITE SWELLING (raised red circle at the injection site). On 12-Mar-2021, the patient experienced ADVERSE REACTION (a streak under her left arm) and ERYTHEMA (evolved into a big circle (under her arm)). On 25-Mar-2021, the patient experienced FEELING HOT (both of her cheeks became hot), ERYTHEMA (both of her cheeks became red) and SWELLING (both of her cheeks became raised). On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at injection site). On 14-Mar-2021, VACCINATION SITE WARMTH (hot (red circle) at the injection site), ADVERSE REACTION (a streak under her left arm), ERYTHEMA (evolved into a big circle (under her arm)), VACCINATION SITE ERYTHEMA (big (red circle) at the injection site) and VACCINATION SITE SWELLING (raised red circle at the injection site) had resolved. At the time of the report, FEELING HOT (both of her cheeks became hot), ERYTHEMA (both of her cheeks became red) and SWELLING (both of her cheeks became raised) outcome was unknown and VACCINATION SITE PAIN (Soreness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient used topical sunscreen on face on 25Mar2021.   This case was linked to MOD-2021-125983 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Outcome of event changed to Recovered/Resolved and Vaccination site pain event added.
Patient states after waiting 1/2 hour then she did shopping and left. On her way home she says she fell asleep at the wheel
Covid-19 Moderna Vaccine: Patient described getting a rash on the left arm 1 week after getting the covid 19 moderna vaccine. She said that it itched and burned but went away within 1 Week.
Began having tachycardia on 1/3/21 that continued through the night with pulse 145-180.  Went to ER on 1/4/21 and was diagnosed with Atrial Fibrillation with RVR and had to be electrocardioverted.  Have since been placed on Cardizem 180mg TID.
I had a great experience for three days! Nothing the doctor has tried really relieves my daily muscle pain but the day I got the first shot by evening I was pain free.  I was like that for three days, then pain returned.  I couldn't believe it. I waited to see what happened with my 2nd shot. I have had some relief but not as good as first time. I had to report this. I only know one person that had this experience and she also has an autoimmune disease.  I only pray that some how this means there is hope for a medical treatment for autoimmune  diseases in the future.