chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT STATES THAT SHE WAS ITCHING TODAY WHILE IN CLASS AT SCHOOL. ON HER WAY HOME TODAY AT APPX 4:00PM SHE NOTICED HIVES. WHEN SHE GOT HOME SHE NOTICED HIVES ALL OVER BODY BUT NOT FACE. MOSTLY ON HER BACK AND STOMACH AREAS. I ADVISED THAT SHE TAKE BENADRYL OTC AND TO CONTACT HER PRIMARY CARE PHYSICIAN. PT ASKED HOW LONG TO EXPECT HIVES I SAID I'M NOT CERTAIN, BUT WOULD EXPECT 24-48 HOURS. CONTACT HER MD TO BE SURE. PT DENIED ANY DIFFICULTY BREATHING. STATED RASH NOT ON FACE. DENIED ALLERGY TO EGGS. STATED HAS HAD PREVIOUS FLU SHOTS AND RECALLS HAVING THE H1N1 VACCINE A FEW YEARS AGO WITH NO ADVERSE EVENTS.
Patient noticed, pain swelling, and redness the day following vaccine. Area grew larger over time and was warm to the touch.
Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife.  The age at vaccination was not reported. She asked questions regarding Shingrix because she was thinking about getting it.  She stated that, the patient had Shingrix in the past and he only had a sore arm.  She spoke per content, sending PI, referred to her healthcare, MI phone number was given. Limited information was provided.
patient was in the shower at a warm temperature and patient passed out and went down. He hit his tooth, his eyes, and head, and bleeding profusely. Tried to get up but fell back down and hit knee and right shoulder and went back down. After being found by housekeeper, patient was led to his bed and slept most of the day. Decided not to go to seek urgent care. Next day, went to emergency room, running blood test and MRI. Pending doctor appointments coming up, such as dental, cosmetic plastic surgeon for eyes and head, waiting on MRI for rotator cuff, may need to run an MRI on knee.
A vial of Moderna was opened 30 days prior to administration of the vaccine on the date of 8 August 2021.    The vaccination was given outside  the 12-hour use limit on punctured vials per the manufactures recommendations.   Moderna was contacted and the clinic has been informed that the members that received the vaccination is considered vaccinated since the members had the usual reactions to the vaccination.    There was no additional testing or treatment provided.  This is being reported since there was an error in the administration process.  There were no adverse reactions.
This spontaneous report was received from an office manager and refers to a 4-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 18-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517.
PT NOTICED A WARM AND RED SPOT ABOUT THE SIZE OF A SILVER DOLLAR BUT HAD NOT SEEKED ANY MEDICAL ATTENTION.  I ADVISED HER TO TRY BENADRYL AND TO HAVE IT CHECKED OUT IF IT DOES NOT IMPROVE.
This spontaneous report as received from a registered nurse refers to a 38 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date the 38 year old patient was vaccinated with first dose of GARDASIL 9 (lot number and expiry date unknown) (dosing regimen and frequency unknown) for prophylaxis. No adverse events were reported. There was no product quality complaint reported.
Primary smallpox vaccinee who reports normal progression of the smallpox vaccination site on his left upper arm. He received the H1N1 vaccine IM and denies and unusual or prolonged symptoms at the vaccination site. On the evening of vaccine receipt, patient reported shortness of breath with exertion. (This was following a 6-mile run that afternoon.) He also experienced a headache. The next a.m. (1/7/2010), after patient had been awake for a little while, he noted non-exertlonal chest tightness and non-radiating pain on the right side of his chest. He notes the pain was worse with deep breaths, but did not note any change it the chest pain with positional changes. He noted some lightheadedness with position changes and his headache continued. He mentioned this to his supervisor and was told to rest, so he engaged in minimal activity for most of that day. On the a.m. of 1/8/2010, patient noted chest pain and tightness and continued to experience a headache after he awoke, so he sought evaluation of his symptoms. His headache was treated with VICODIN and a Medrol-pack and he was also given BENADRYL and placed on 24 hour quarters. He returned for evaluation on 1/12/2010, and he was still having some chest tightness and pressure (3/10), but his headache was resolved. He had an abnormal ECG (incidental finding of WPW), so he was instructed to return on 15 Jan and INDOCIN was prescribed. When he returned on 15 Jan, his symptoms had significantly improved, but he still reported mild chest tightness with deep breaths and his repeat ECG showed WPW. Cardiology was consulted and patient was given a profile and scheduled for an ECHO with subsequent Cardiology follow-up in early February. (pending) When I spoke to patient on 22 Jan 2010, patient denied any chest pain or tightness, but was experiencing some mild shortness of breath and fatigue. He reported that he had been experiencing headaches daily over the past 10 days. He reports a history of migraine headaches which started when he was in 10th grade. His migraine headaches were often preceded by visual changes in his right eye ("see squiggly line") and were usually accompanied by nausea and photophobia. He had treated these headaches with IMITREX in high school, but more recently, if recognized early, he would usually treat with EXCEDRIN migraine and rest in a cool, dark room. He had a period of about 1 year following high school where had had no migraine headache, but then they gradually returned. Over the past year, he usually experienced 1 headache per month. He describes the headaches that he experienced after his recent vaccine receipt as being similar in character to his migraine headaches and respond to Excedrin Migraine, but return the following morning. Patient denies previously experiencing prolonged headache syndromes or exacerbation of migraines following previous vaccinations.
pt recvd vax 7NOV95 & 16NOV95 returned to clinic w/ Fifty cent (2cm) induration, hot to touch;adm to hosp poss I&D but w/ATB improved well
I had a horrible, lengthy Charley Horse cramp (on my right leg), followed by stomach pains, dizziness, diarrhea, fever, sweats, blurry vision, nausea, then I fainted/collapsed. When I came to, I was disoriented, had more diarrhea, chills, followed by my second Charley Horse cramp, this time on my left leg.  When I woke after a few hours of sleep, I was tired, weak and had a slight headache but generally felt ok. By Tuesday, other than little/mild muscle aches, I'm back to normal.
RECEIVED THE JANSSEN VACCINE TODAY AFTER HAVING THE MODERNA (POTENTIAL MEDICATION ERROR); This spontaneous report received from a health care professional concerned a 38 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had everything normal after getting vaccine. The patient was previously treated with mrna 1273 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-SEP-2021, the patient experienced received the janssen vaccine today after having the moderna (potential medication error). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received the janssen vaccine today after having the moderna (potential medication error) was not reported. This report was non-serious.
Dizziness started 12 hours post vaccine and has continued for 2 days all day, then 2 days on and off, still experiencing on and off dizziness on day 5 though less frequently.  Even occurs at night while laying in bed asleep
Approximately 11hours after receiving vaccine on 1/8/21, terrible chills and shaking began. The next morning 1/9/21 around 6am temperature rose to 100.4F. At 3pm on that same day, temperature went up to 102.6F. Took Tylenol 1000mg at that time. Continued to have terrible shaking and chills, also experienced a severe headache, eye pain, and body aches. Had diarrhea once on 1/9. Fever broke this am on 1/10/21, still feeling slightly fatigued with discomfort behind my eyes but improving from yesterday.
About a week and a half after being vaccinated,  I passed out at the gym prior to exercising.  I was admitted to the hospital for leaking triponin and dizziness.  I was released from the hospital and proceeded to be dizzy.  I could not drive for almost 2 months, all I could do was walk and even then i couldn't walk a straight line.  Was admitted again on 4/11/2021 for dizziness and triponin issues.  I was again released.  Did testing with Cardiology....angiogram, cardiac MRI and all came back clear.  Did extensive testing with Neurology....check for crystals, vertigo testing and MRI of Head and all came back clear.  About 2 months from when I was vaccinated I finally started feeling better and was cleared to exercise and drive a car again.  Occasionally I will have dizzy spells driving but nothing debilitating.
pain, redness and swelling approximately silver dollar size at injection site.  4.5 by 7cm erythemia and induration
Bivalent administered as Third Dose (Immunocompromised Individuals); No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent administered as Third Dose (Immunocompromised Individuals)) and NO ADVERSE EVENT (No adverse event) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.   Concurrent medical conditions included COPD, Obesity and Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent administered as Third Dose (Immunocompromised Individuals)) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent administered as Third Dose (Immunocompromised Individuals)) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent administered as Third Dose (Immunocompromised Individuals)).    No concomitant medications were reported.  Patient was recommended by pulmonologist to have fourth vaccine.   No treatment information was provided.
I had my 1st vaccine on March 30,2021 and the next day I started my period.  This was unplanned since I am on birth control pills that are a 3 month package.  My period lasted until April 17, 2021. It stopped for a day and then I started spotting again.
No event so far but Child was given MMR and MMRV along with Hep A at the same time (MMRV was administered instead of Varicella)
possible doses administered after expiration date of Moderna vial; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (possible doses administered after expiration date of Moderna vial) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (possible doses administered after expiration date of Moderna vial). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (possible doses administered after expiration date of Moderna vial) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.
Lump on her arm; hot; red; itchy; it was like the flu shot; A spontaneous report was received from a healthcare professional concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events it was like the flu shot/influenza like illness, lump/vaccination site lump, red/vaccination site erythema, itchy/vaccination site pruritus, hot/vaccination site warmth.  The patient's medical history was not provided. Concomitant medications reported were calcium carbonate, potassium chloride, dibasic calcium phosphate, magnesium oxide, ascorbic acid , microcrystalline cellulose, dl-alpha tocopheryl acetate, modified corn starch, corn starch, maltodextrin(Centrum Silver), vitamin D3 for unknown indication.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 29 Jan 2021, after receiving the vaccine, the patient experienced the events it was like the flu shot. On 1 Feb 2021, three days after receiving the vaccine,  she had a lump on her arm. It was red, hot and itchy. Treatment details included unspecified antihistamine.  Action taken with mRNA-1273 in response to the events was not reported.   On 6 Feb 2021 the outcome of event it was like the flu shot was resolved.  On 8 Feb 2021 the outcome of events lump, red, itchy was resolved.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received a third dose of the Moderna COVID-19 Vaccine) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.  No Medical History information was reported.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, received third 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) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient received a third dose of the Moderna COVID-19 Vaccine). On 13-May-2021, EXTRA DOSE ADMINISTERED (Patient received a third dose of the Moderna COVID-19 Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not reported. Concomitant medications were not reported.  The patient mentioned that he received a letter stating that one of his doses may have been invalid due to temperature and would need another dose.  Patient had no symptoms afterwards.
Initial report was received on 15 September 2011 from a health care professional. A female patient with reported allergies of PCN, ADVICORE and niacin, had received an intramuscular left deltoid injection of FLUZONE HIGH-DOSE, lot number UH458AA (date of administration not reported) and an unspecified amount of time later, experienced swelling and inflammation from the shoulder to the elbow. The patient was evaluated by a physician. Treatments were not reported. The patient has had FLUVIRIN in the past years. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Shallow breathing, chest felt tight, dizziness, eyes had trouble focusing. It lasted around half an hour.
This spontaneous report was received from a 73-year-old male patient regarding himself with no drug reactions/allergies. The patient's medical history included heart surgery. On an unknown date in August 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot# and expiration not reported) subcutaneously in his left arm. Concomitant medications included tamsulosin hydrochloride, gabapentin, omeprazole and LUNESTA. The patient stated he had pain in his left arm and shoulder on an unknown date in August 2012. He described the pain, especially in the shoulder being extreme and he had to lift the arm up with his right arm due to the pain. He also stated there was redness on the arm and shoulder. He was being treated by a physician. Treatment was rendered for the events, pain medications, ZOVIRAX salve, lidocaine ointment and a bandage he wears for 12 times. The patient sought medical attention for the events. Additional information has been requested.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756521A, A0756523A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUACA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Chief Complaint  COVID pos friday. Increasing SOA, cough, dizziness since. Hx HHT- feels like this when she needs transfusion. Last transfusion 1 month ago  History of Present Illness  44-year-old female with an interesting history of Osler-Rendu-Weber syndrome who presents with increasing shortness of breath and some dizziness.  She apparently has these exact symptoms sporadically when she becomes symptomatically anemic.  Her last transfusion was 1 month ago.  She follows closely in the hematology clinic with Dr.  Also incidentally, she was tested positive for Covid this past Friday, October 22.  She received a Johnson & Johnson vaccine in May of this year.  She has not had to her knowledge in the  associated symptoms and feels that the shortness of breath and dizziness is probably due to her anemia.    Indeed in the ER this evening, she was found to be anemic with a hemoglobin of 4.8 g/dL.  Her baseline is around 7.2-7.3 g/dL.  3 units of blood have been ordered by the ER physician.  She now arrives to the third medical floor in stable condition.   Patient will now be admitted to the hospitalist service for continued evaluation and management of presenting conditions.