chrisvoncsefalvay/vaers-outcomes huggingface dataset:
indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "hypothyroidism" (unspecified if ongoing), notes: Other medical history: hypothyroidism. Concomitant medication(s) included: LEVOTHROID, start date: 02Nov2020. Past drug history included: Keflex, reaction(s): "Allergy", notes: known allergies: Keflex; Ciproflaxin, reaction(s): "Allergy", notes: known allergies: Ciproflaxin,; Claritin, reaction(s): "Allergy", notes: known allergies: Claritin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
severe tinnitus in both ears.  Constant high pitch ringing in both ears started out of nowhere.  This is still on-going
Information has been received from a mother concerning her 6 year old son who was vaccinated with a dose of MMR II. Subsequently the pt developed autism. Unspecified medical attention was sought. It was unknown if a prescription drug was required. The pt's autism persisted. It was noted that the pt had all of the required immunizations. It was also noted that the pt's brother, 3 years old, developed signs of autism following vaccinations with diphtheria toxoid/pertussis vaccine/tetanus toxoid and poliovirus vaccine inactivated. Upon internal review, autism was determined to be an other important medical event (OMIC). The reporter indicated that her other 8 year old son had autism after receiving all of the required immunizations (WAES0305USA02785). Additional info has been requested.
Patient was given Pneumococcal 13 vaccine. It was not discovered until after the administration that the vaccine has expired in January 2023.
pt began high pitch screaming 6hr p/vax;mom had given APAP & TC MD;mom was told to bring child into the office;mom was instructed to give APAP q 4hr & next immun DT;
Magnet stuck to her arm on injection site; still has a bruise on her arm; Just plumb sick/sick as a dog; Diarrhea for 2 days; Two hours after the shot, she was on the couch with chills; Two hours after the shot, she was on the couch with fever; Two hours after the shot, she was on the couch with headache; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (still has a bruise on her arm), ILLNESS (Just plumb sick/sick as a dog), VACCINATION SITE REACTION (Magnet stuck to her arm on injection site), DIARRHOEA (Diarrhea for 2 days) and CHILLS (Two hours after the shot, she was on the couch with chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced ILLNESS (Just plumb sick/sick as a dog), DIARRHOEA (Diarrhea for 2 days), CHILLS (Two hours after the shot, she was on the couch with chills), PYREXIA (Two hours after the shot, she was on the couch with fever) and HEADACHE (Two hours after the shot, she was on the couch with headache). On 21-Sep-2021, the patient experienced CONTUSION (still has a bruise on her arm). On an unknown date, the patient experienced VACCINATION SITE REACTION (Magnet stuck to her arm on injection site). On 18-Sep-2021, DIARRHOEA (Diarrhea for 2 days) had resolved. At the time of the report, CONTUSION (still has a bruise on her arm) had not resolved and ILLNESS (Just plumb sick/sick as a dog), VACCINATION SITE REACTION (Magnet stuck to her arm on injection site), CHILLS (Two hours after the shot, she was on the couch with chills), PYREXIA (Two hours after the shot, she was on the couch with fever) and HEADACHE (Two hours after the shot, she was on the couch with headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  the patient saw a doctor who put her on antibiotics and ruled out Covid and the flu   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up include no new information.
Patient contacted pharmacy to report the apperance of "cherry angioma" or red moles on torso 7 days after vaccination. These were not previously present and no other adverse events occured. Patient was counselled to follow up with physician/dermatologist if these were troublesome and didn't resolve on there own.
No additional AEs/PQCs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This spontaneous report has been received from an office manager regarding a 10-year-old male patient. The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions, and concomitant therapies were not reported.  On 09-SEP-2022 and 16-SEP-2022, it was reported that some hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine had suffered a temperature excursion. On 01-JAN-2023, the vaccines suffered another temperature excursion and on 20-FEB-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe injection (product storage error), administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023, lot #1775827, expiration date: 27-JUN-2024, lot #U032681, expiration date: 26-OCT-2023, lot #1780876, expiration date: 09-NOV-2023, and lot #W009829, expiration date: 19-OCT-2024; however, it was not specified which one was received by the patient), (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). All temperature excursions had a total time of 25 minutes (lasting for 8, 5 and 12 minutes, respectively). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (The temperature excursion occurred as a result of a reading from a Digital Data Logger).  This is one of several reports received from the same reporter.
PAIN; 02-APR-2021-Dose 1,11-MAY-2021-Dose 2; Not feeling good; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling good), PYREXIA (Fever), PAIN (PAIN) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (02-APR-2021-Dose 1,11-MAY-2021-Dose 2) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 11-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (02-APR-2021-Dose 1,11-MAY-2021-Dose 2). In May 2021, the patient experienced MALAISE (Not feeling good) and PYREXIA (Fever). On an unknown date, the patient experienced PAIN (PAIN). At the time of the report, MALAISE (Not feeling good), PYREXIA (Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (02-APR-2021-Dose 1,11-MAY-2021-Dose 2) outcome was unknown and PAIN (PAIN) was resolving.            No concomitant and treatment medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial Reporter causality was not reported for events with Humira. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2022-621494 (Patient Link).
1-2hr p/vax pt exp chills, lethargy, recurrent 102 fever, red, swollen, tender @ site, poor coordination, vomited 2-3x (duration approx 2 days); motrin used to dec fever & comfort
Pt c/o joint pain x 10 days and palpitations then 2 days worsening chest pain.  04/18/2007 VAERS report received with MRs enclosed. Record of ER visit 3/27/2007 for 10 day c/o intermittent fatigue and joint pains, palpitations with chest pain and pressure assoc. with SOB.  (+) nausea. Clinical Impression: Chest Pain.
My facial hair is not growing; my cheeks and around on my side 'burns'; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Jan2022 (Lot number: 33075BD) at the age of 61 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "irregular heart beat and it's called PVCs" (unspecified if ongoing); "I have had a head injury" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown manufacturer), for COVID-19 immunization. The following information was reported: HYPOTRICHOSIS (non-serious) with onset Jan2022, outcome "unknown", described as "My facial hair is not growing"; SKIN BURNING SENSATION (non-serious) with onset Jan2022, outcome "unknown", described as "my cheeks and around on my side 'burns'. Therapeutic measures were not taken as a result of hypotrichosis, skin burning sensation. Additional information: It was reported that patient had a side effect from booster, it's nothing major but it's kind of weird. The patient facial hair was not growing. The patient got the shot in Jan and was starting to notice it, so patient have never had real sick beard to begin with but in the last like 4 weeks, patient mean like cheeks, there's not hair growing on parts of patient cheeks and around on side 'burns' are (not clarified further, hence not captured). It's not bothering , it's just kind of weird. Consumer was informed about role of Pfizer drug safety. Consumer stated that doctor did lab work last month. It was all okay. Patient triglycerides were little high (Further clarification unknown hence not captured), it was the 'sign'. Date of adverse event: Consumer stated adverse event date was about 4 weeks ago(further clarification unknown). The patient did not receive any other vaccine prior to vaccination.  No follow-up attempts are possible. No further information is expected.
more or less like a burn; Rash; This spontaneous case was reported by a consumer and describes the occurrence of THERMAL BURN (more or less like a burn) and RASH (Rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced THERMAL BURN (more or less like a burn) and RASH (Rash). At the time of the report, THERMAL BURN (more or less like a burn) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
SHE STARTED TO FEEL ITCHING, SORE, REDNESS, HOT, AND DIFFICULTY TO MOVE THE LEFT ARM. SHE WENT TO DOCTOR AND SHE PRESCRIBED MEDROL PACK.
This is a spontaneous report from a contactable consumer. A 71-year-old female patient received PREVNAR 13, intramuscular on 12Feb2013 at 15:30 at a single dose in the left shoulder. Medical history unspecified mycobacterium infection, unknown if ongoing; and triple bypass surgery done on an unknown date. Concomitant medications included PLAVIX, BABY ASPIRIN, LIPITOR, DIOVAN; all ongoing since unknown dates. There were no other vaccines given on the same day or within the prior four weeks. On 14Feb2013, the patient experienced terrific nose bleeding at 3:00 am due to which she went to emergency room. Therapeutic measures were taken in response to the event, terrific nose bleeding, that included treatment with cocaine. Relevant labs included unspecified blood work done on 14Feb2013, the results of which were unknown. The clinical outcome of the event, terrific nose bleeding, was recovered on an unknown date in Feb2013. As of 17Apr2013, follow-up was received from a contactable nurse reporting on behalf of the patient's physician. The nurse reported that after the administration of PREVNAR 13, the physician had not evaluated the patient. Follow-up (17Apr2013): New information from contactable nurse on behalf of a physician in response to a healthcare professional follow-up letter includes: physician had not evaluated patient after administration of PREVNAR 13. Follow-up (10-MAY-2013)): Follow-up attempts completed. No further information expected.
3 days of soreness in site of injection, muscle soreness, joint pain, chills, nausea, fever,  headaches, light headedness.
arm, red 2" circle around site;hurt, hot, itchy x 3 days;
345PM got fussy when picked up, stiffened, screamed, eyes rolled back, turned blue, quit breathing p/jerking; high pitched cry, t, drowsy, grunting, Pulse 170, resp 50; sz, resp arrest;
36 hrs after injection (~9pm Thursday night): fast heartbeat, unable to relax, up all night with fast heartrate (counts were 96-100 bpm, when rested heartrate is between 60-70).  Friday morning felt dizzy, light headed,  weak, not able to taste food (everything tasted bland), able to sleep for about 6 hours into Saturday morning.  Saturday felt more weak than previously, not able to perform simple activities without shortness of breath, dizzy, light headed, fast heartrate, no appetite, food tasted bland, very weak all day. Sunday improved a lot, more energy, no dizziness or light headed. Heartrate was still fast around 94 bpm, felt a lot better.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions, allergies or concomitant therapies was provided. On 07-May-2014, the patient was vaccinated with the first dose of GARDASIL lot # J011272, expiry date 21-APR-2016 (dose, route of administration and indication were nor reported). On 22-APR-2016, the patient received the second dose of GARDASIL 9 lot # L043213, expiry date 28-AUG-2017 (dose, route of administration and indication were not reported). No adverse effects were reported. Additional information has been requested.
PATIENT RECEIVED 3 VACINATIONS, HEPB, IPOL, AND VARIVAX IN THAT ORDER.  WHEN SHE RECEIVED THE VARIVAX SHE WENT LIMP, EYES ROLLED BACK, FAINTED, FELL OF HER CHAIR, AND HIT HER HEAD.  IT TOOK A MINUTE FOR HER EYES TO OPEN AND 4 TO 5 MINUTES TO BECOME RESPONSIVE.  MOTHER REFUSED EMS INTERVENTION OR TO GO TO AN URGENT CARE.  CALLED PATIENT THE NEXT DAY SHE IS FEELING OK BUT HAS HEADACHE AND BUMP ON HER HEAD.
Patient quickly felt nauseated after vaccination. He then fainted and remained unconscious for about 30 seconds. He convulsed for a few seconds before coming to. He then vomited and remained nauseated. Paramedics responded. Suspected low blood sugar lead to reaction.
Right arm swelled twice it size, but red, area tender to touch.  After words "hard ball" where she recd the vaccine.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Non-Significant follow up : Age group updated.
Right away I knew it felt different.  It stung more and had a  burning sensation.  At the time, I just thought to myself that this one was going to be sore. From then on I had pain that would travel back and fourth from shoulder to close to spine. It never subsided and could not lift arm without pain. Then at about 6 -7 months after,  the pain went also around to the front and I have had pain in my left side of chest. I have had shortness of breath and felt as if I may be having a heart attack at times.
Right thigh red & swollen occurred about 3 hours after the PENTACEL vaccine was administered to the right thigh.
This spontaneous report was received from a nurse refers to a patient of unknown age. On 22-APR-2013, the patient was vaccinated with dose 1 of PNEUMOVAX23 (lot number, expiry date and route was not reported). On 22-JUL-2013, the patient was vaccinated with dose 2 of PNEUMOVAX23 (lot number, expiry date and route was not reported). No adverse effect reported was reported. Additional information has been requested.
Patient was given a booster dose by contract RN. This dose was 0.5mL. This dose should have been 0.25mL. Patient had a  third dose of vaccine on 09/02/2021 of 0.5mL for being immunocompromised. This was marked on her COVID pre vaccine questionnaire on 09/02/2021. When I noticed this, I called RN to verify that this was the dose that she gave. She verified that she gave a full dose of Moderna.  She told me that she did speak to the patient about her third dose. I looked up all the records to confirm that doses were recorded correctly. I notified the patient that she received a whole dose of Moderna instead of 1/2 a dose. She reported to me that she had chills the 1st night after her vaccine and no other symptoms. She is feeling fine. I told her that this report would be made and that she may receive a call from CDC. I advised her to let her PCP know that she received a whole dose instead of 1/2. She verbalized thanks and understanding.
Patient complained of ongoing pain to injection site, area about 3 inches around site, 3 weeks after injection. Pain started day after vaccine given. Rated "4-5" (1-10 scale) at that time. Now rated "1" (1-10), mostly with movement or pressure to area.
Case received from a Healthcare Professional on 28 September 2011 under the reference number 11-0645. The reporter of this case is the same as for case 2011-09413 and 2011-09411. A female patient (date of birth not reported), with no reported medical history and concomitant therapy, had received a dose of FLUZONE (batch number, route and site of administration not reported) on an unspecified date. On an unspecified date, the patient experienced eye discharge, eye drainage and pink eye. The patient's outcome was not reported.
Fever of 100-102 starting 5 hours after vaccination. Never developed URI or other sings of infectious itiology.
red rash underneath eye and on forehead; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash underneath eye and on forehead) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red rash underneath eye and on forehead). At the time of the report, RASH ERYTHEMATOUS (red rash underneath eye and on forehead) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash underneath eye and on forehead) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red rash underneath eye and on forehead). At the time of the report, RASH ERYTHEMATOUS (red rash underneath eye and on forehead) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Roughly 12 hours after receiving the second dose of the vaccination, I began to be restless, especially when trying to sleep.  I noticed that my resting heart rate was way above normal (normal = 76-80 bpm).  My heart rate after about 10pm rose to about 115-120 bpm and stayed at that level for about 12 hours.
8 days following first dose swollen red itching arm, hard lump, hot to the touch for 5+ days, swelling and redness went away after 3-5 days but the area continues to be irritated  and hot to the touch days later. Pain and soreness in elbow arm joint has started a week after the reaction.
Injection site was sore that afternoon.  About a week later I started noticing red bumps coming up one at a time.  They are mostly on arms and torso, itchy and some puss filled.  Some are still itchy.