chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The evening after receiving the shot the patient developed hives not relieved with Benadryl, lasting 24 hrs, and he also fainted the evening after receiving the shot.  He was not taken to the ER.
Initial soreness and redness and swelling at site: site located on left arm near the front of the arm. This continued for several weeks then whole arm and shoulder, and other areas on same side of body became sore, extremely painful, and unable to move properly or without constant pain.
Sibling 2 mo had his WCC 11/04/2018-ROTARIX was given. Patient started with vomiting and diarrhea 5 days post administration of sibling's ROTARIX vaccine.
The night of the vaccination my dreams were incredibly bizarre, I had developed a headache before bed that continued for an hour or so. My shoulder hurt for four days or so and all my joints began to hurt for about a week. When I was at work my thought process was bad and verbs were difficult to think of so I resorted to pantomime at one point. My brain worked normally, maybe better than normally after a couple of days but I am still having weird dreams, albeit less and less frequently. I think it did something to my brain.
Received TD left arm on 4/23/12, called at approximately 630 pm 4/24/12 reporting "lethargy", no other symptoms.
the administration of an expired Twinrix dose to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 96-year-old female patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 09-OCT-2023, the patient received Twinrix. On 09-OCT-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: the administration of an expired Twinrix dose to a patient).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 10-OCT-2023 The pharmacist called to ask for information regarding the administration of an expired Twinrix dose to a patient. The health care professional (HCP) asked for any expected adverse reaction and if the patient had to be re-vaccinated. The patient received vaccine on 10th October 2023 which was expired on 22nd September 2023, which led to expired vaccine use. The reporter consented to follow up.
Patient states morning after vaccine, she woke up with numbness in the legs that lasted 3 to 4 days and has had continual pressure in her head and spine since receiving vaccine on 11/25. She stated she has visited multiple doctors since and they stated these conditions are not due to vaccine but patient is adamant it started only after receiving vaccination.  Patient stated symptoms are getting better slowly. Advised patient to continue to follow up with physician.
ABOUT 30 SECONDS AFTER GETTING THE COVID VACCINE, PATIENT BEGAN FEELING DIZZY AND GETTING BLURRED VISION. I HAD HER SIT DOWN AND TAKE A DEEP BREATH AND GAVE SOME WATER, THEN SHE BEGAN FEELING A LITTLE BETTER AND ABOUT 30 MINUTES LATER SHE RECOVERED AND LEFT THE PHARMACY WITH HER FATHER. I CALLED THEM ABOUT 2 HOURS LATER AND CHECKED IN AND HER FATHER TOLD ME SHE IS FEELING BETTER NOW.
Pfizer vaccine was administered outside of faclity- reported by patient- ? NO LOT NUMBER WERE SUPPLIED ---------------------------------------------------------------------------------------------------------------------------------- COAGULOPATHY, UNSPECIFIED TYPE 12/17/2022 ATRIAL FIBRILLATION, PAROXYSMAL ACUTE NON ST ELEVATION MI 12/18/2022 ATRIAL FIBRILLATION, PAROXYSMAL ACUTE MI 12/17/2022 ATRIAL FIBRILLATION, PAROXYSMAL ACUTE RESPIRATORY FAILURE 12/17/2022 ATRIAL FIBRILLATION, PAROXYSMAL COAGULOPATHY, UNSPECIFIED TYPE 12/17/2022 ACUTE NON ST ELEVATION MI    ASCENDING THORACIC AORTIC ANEURYSM ACUTE NON ST ELEVATION MI 12/18/2022 ACUTE NON ST ELEVATION MI    ASCENDING THORACIC AORTIC ANEURYSM ACUTE MI 12/17/2022 ACUTE NON ST ELEVATION MI    ASCENDING THORACIC AORTIC ANEURYSM ACUTE RESPIRATORY FAILURE 12/17/2022 ACUTE NON ST ELEVATION MI    ASCENDING THORACIC AORTIC ANEURYSM
Left arm soreness; right arm soreness (injection site) for 3-4 days; a lot of anxieties; has hypersensitivity to a lot of noise; when he hears more than one person talking - he cannot concentrate; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm soreness), ANXIETY (a lot of anxieties), HYPERACUSIS (has hypersensitivity to a lot of noise), DISTURBANCE IN ATTENTION (when he hears more than one person talking - he cannot concentrate) and VACCINATION SITE PAIN (right arm soreness (injection site) for 3-4 days) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced PAIN IN EXTREMITY (Left arm soreness) and VACCINATION SITE PAIN (right arm soreness (injection site) for 3-4 days). In May 2021, the patient experienced ANXIETY (a lot of anxieties), HYPERACUSIS (has hypersensitivity to a lot of noise) and DISTURBANCE IN ATTENTION (when he hears more than one person talking - he cannot concentrate). At the time of the report, PAIN IN EXTREMITY (Left arm soreness), ANXIETY (a lot of anxieties), HYPERACUSIS (has hypersensitivity to a lot of noise), DISTURBANCE IN ATTENTION (when he hears more than one person talking - he cannot concentrate) and VACCINATION SITE PAIN (right arm soreness (injection site) for 3-4 days) outcome was unknown.            No concomitant medications were provided. No treatment information was provided.
gray, pale appearance, lethargic, not very responsive; sx noticed approx 3 hrs p/vax given;
Client felt overly warm after second dose of Pfizer vaccine.  Was assisted to a cot by a nurse. Vital Signs taken: BP 118/78  Pulse of 74. Given water and rest. Kept for 30 minutes.  Recovered.
10:00PM - States had headache, nausea, vomiting, left arm numbness, mid-back pain.
Patient received 3 doses of Moderna. 2/13/21, 4/10/21, 5/8/21. Patient indicated that he was late in receiving the 2nd dose and on advise of his  physician he was instructed to have a 3rd does due to the late administration of the 2nd dose.
opened ipol exposed to 46.6f upto 2 minutes with no reported adverse event; opened ipol exposed to 46.6f upto 2 minutes was administered to patients with no reported adverse event; Initial information received on 31-Jul-2023  regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2023SA235015, 2023SA235023, 2023SA235246, 2023SA236046, 2023SA235058 and 2023SA235694.  This case involves a 15 years old female patient who was administered opened IPV (VERO) [IPOL] post exposure to 46.6f upto 2 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Jun-2023, the patient received 0.5 mL dose 4 of suspect IPV (VERO), suspension for injection (batch number: W1A191M; expiry date: 16-Feb-2025) via subcutaneous route in the left arm for Immunization post exposure to 46.6f upto 2 minutes with no reported adverse event (poor quality product administered) (same day latency) (product storage error) (unknown latency).  Reportedly, Reason for excursion was Fridge door opened for long; Max/Low temperature reached was 46.6F; Duration of temperature excursion was 2 minutes; human error: Yes  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events poor quality product administered and product storage error.  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.
Pt. developed a knot and erythema where HIB vaccine was given. No fever, no body rashes and no other symptoms. Area of redness and induration measured 1 x 1 cm (R) thigh.
Narrative:  70 year-old male patient was admitted on 10/08/2021 due to angina, dyspnea, headache, and fever following his third dose COVID-19 Moderna booster on 10/02/2021. Symptoms resolved with aspirin and sublingual nitrogen. EKG results were insignificant and he was diagnosed with unstable angina and atypical chest pain. No adverse events were reported following his first and second COVID-19 Moderna doses. Hospital records did not mention the correlation. However, this is being reported due to the timing of the event.
cold & dry cough x 3 wk;chest tightness & soreness;polyarthritis,chest pain;dx:sarcoidosis;chest x-ray peritracheal,hilar lymphadenopathy or rxn to MMR;trigger points dx:sarcoidosis w/ secondary fibromyalgia;pain in shoulders,elbows,wrists
Onset red, painful nodules to right calf and swelling to ankles bilat 5 days after 1st vaccine. Diagnosed as Erythema Nordosum 14 days after injection. Erythema Nordosum significantly exacerbated after 2nd vaccine
Sore arm After 2 weeks, body shake and sore arm again and left side back minor pain
Screamed, couldn't sleep, vomited, couldn't breath at times, diarrhea, fever.
Full body inflammation (mostly joints) and headache during sleep, mostly when waking. Went away completely after 3 days. Movement or ice against the back of neck eased burning.
TIA; Left upper lip is turned down/face does not look normal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA) and FACIAL PARALYSIS (Left upper lip is turned down/face does not look normal) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.  Concomitant products included METOPROLOL for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 12-Mar-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criterion hospitalization) and FACIAL PARALYSIS (Left upper lip is turned down/face does not look normal) (seriousness criterion medically significant). The patient was hospitalized for 3 days due to TRANSIENT ISCHAEMIC ATTACK. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (TIA) and FACIAL PARALYSIS (Left upper lip is turned down/face does not look normal) outcome was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments  Other concomitant medications included unspecified blood pressure medications.  No treatment information reported.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-081470 (Patient Link).; Sender's Comments: Although a temporal association exist,  the event  of Transient ischemic attack with facial paralysis is confounded by the patient's history of Blood pressure abnormal and advanced age.
Went the the lake/beach in the afternoon on 7/9/03 following immunizations. Approx 10 PM complained of headache, nausea, bilateral arm pain. To ER at 12:05 am 7/10/03 with complaints of headache, nausea, vomiting. Had Motrin 200 mg po and IV of normal saline and Phenergan 6.25 mg IV. Discharged ER 2:30 AM, 103.2 F temp.
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 20-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L016427, expiration date; 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4 C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. This is one of several reports from the same source (original report 1602USA004808). Additional information has been requested.
Immunization site post aspect RA. Round 6x6 cm slightly raised, erythemic, warm to the touch. Tender upon palpitation, it is indurated (at size of half/silver dollar coin), and local itching no SOB, CP, ETC.
Patient was inadvertently given 0.5ml of H1N1 monovalent shot instead of 0.25ml
doses administered past expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  The vial were stored in the freezer before administration.  No treatment medications was provided by the reporter.
This case was reported by a physician and described the occurrence of loss of feeling in arm in a 61-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject had no concomitant medication and no relevant medical history. Historic vaccination included influenza virus vaccine (manufacturer unspecified) given on an unspecified date without any reaction. On 6 November 2013 the subject received unspecified dose of FLULAVAL (unknown route, left arm). The lot number was reported as SKB7K04R from the reporter; however, based on a safety lot number review, the lot number was updated to 7KJ4R. In November 2013, 5 - 7 days after vaccination with FLULAVAL, the subject experienced loss of feeling in arm, upper arm and shoulder muscle twitching, tremor, numbness at the injection site, arm fasciculation and injection site tingling. The physician considered the events were clinically significant (or requiring intervention). Neurological tests were negative. At the time of reporting the events were worse.
Child was 12 yrs 0 months and received the Pfizer vaccine for 5-11 year olds.  No adverse reactions were noted.
fever-low grade temp, headache-mild, nonproductive cough, body aches, diarrhea-3-4 times a day/no blood in stool, sinus congestion, nasal congestion,.  starting 11/7/21
Persistent rash and hives.  Rash/hives appear in different parts of my body.  Arm, torso, feet, legs, etc.  They occurred daily and started the day after the vaccine.   Have persisted for almost a month.
10/7/2021 -In ED for constipation/vomiting. Underwent surgery for small bowel obstruction 10/8. Post-op leukocytes/CRP trending up - wound grew Enteroccus infections. Treated with Daptomycin, Flagyl, Cefepime. 10/14 - underwent right hemicolectomy/takedown of anastomosis.  10/17 - developed severe cough/difficult breathing. Chest XR showed bibasilar airspace disease and tested Covid +. Started on Baricitinib, Decadron, Remdisivir, and MA. Placed on BiPAP 8L. Patient in fluid overload, Troponin elevated initially 0.4 and decreased 2.3. Cardiology consulted.  10/19 - Underwent Exp Laparotomy/Ileostomy due to anastomotic leak. Daptomycin/Metronidazole/Erythromycin/Cefepime continued. CRP trending down 27-23, WBC  13.9 -14.1. Vitals WNL except BP 162/92.  10/22 - wound dehisced - culture revealed Candidae albicans. Started on Flucanozole. On O2NC - 3L. SpO2 94%. Continuing current treatments.  10/23 - Remdesivir complete. Decadron/Baricitinib continued. Midline wound dehiscence noted. Cultured candida albicans and Gram + cocci. Started Fluconazole.  10/29 - Off quarantine for Covid. Completed Decadron. Continuing Baricitinib. Continuing Cefepime, Flagyl, Dapto. On 2L O2 and starting to wean.  10/30 - Baricitinib complete. Remains on previous antibiotics for anastomotic leak. Vitals WNL 11/2 - Downgrade Covid precautions - despite continuing to test Covid positive through 11/28. Patient stay complicated by post-op wound infection/UTI. Covid status improved.  12/7 - Discharged
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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 EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
joints in the fingers have bumps on them; on each of the first joints on each of the fingers; Lots of joint stiffness and pain; Lots of joint stiffness and pain; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK9231), intramuscular in the left arm on an unspecified date in Jan2021 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. On an unspecified date in Jan2021, the patient experienced bumps on the joints in her fingers (on each of the first joints on each of the fingers), lots of joint stiffness and pain (in all the joints). The patient was treated with ibuprofen (ADVIL) for the events. The clinical outcome of bumps on the joints in her fingers (on each of the first joints on each of the fingers), lots of joint stiffness and pain (in all the joints) was unknown.
Follow-up information provided patient demographics, medical history, product details, concomitant therapy, event details, and test results. Information regarding PREVNAR was received from a healthcare professional regarding a 30-month-old male patient who experienced low titer levels. The patient received the fourth dose on 24-Sep-2007. The patient also received the fourth dose of Hib (manufacturer unknown) on 24-Sep-2007. The patient experienced low titer levels on 01-Apr-2009. The patient was reported to have recovered. No additional information was available at the time of this report. See related case(s): US-WYE-H09094309 (adverse event, expedited); US-WYE-H09220109 (adverse event, non-expedited); and US-WYE-H09220209 (adverse event, non-expedited).
scabbed wound of ¼ inch, spot near the needle was injected; scabbed wound of ¼ inch, spot near the needle was injected; really sick; This case was reported by a consumer via call center representative and described the occurrence of wound in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th January 2023, the patient received the 1st dose of Shingrix. In January 2023, unknown after receiving Shingrix, the patient experienced wound, scab and sickness. On an unknown date, the outcome of the wound and scab were recovering/resolving and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the wound, scab and sickness to be related to Shingrix.  Additional Information: GSK Receipt Date: 30-JAN-2023 Reporter's Comment: The reporter was a customer that received the Shingrix Vaccine in his left arm. The reporter reported that he was really sick over it for 2 to 3 days . It was like a popping sore, like a wound of ¼ inch or more in size (adverse event: wound).  The vaccine was provided at the customer's doctor's office.  The patient described it as a spot near the area where the needle was injected. The patient described that at some point it was swollen and red (adverse event: Swollen), (adverse event: Redness). The patient described it as a scabbed wound, and it has gotten better. Not all information was available.  The patient did not consent to follow up with healthcare professional.
Pt report normal flu like illness, fever, chills and headache for 3 days after vaccination.  About 2 week prior to her second dose scheduled she developed dyspnea on exertion, and low back pain, and shortness of breath, which she attributes to COVID vaccination.
Started getting headache within minutes of shot.   Bad body aches for about 12 hours.   Everything ached and couldn't get comfortable to sit, stand, lay down.  Stomach cramps that doubled me over lasted for a few hours.    Last 4 hours could barely walk.   Husband had to help walk me to the bathroom.  Chills and shaking and could not warm up after the 1st hour through the rest of the night! Everything started going away about 1:00 in the afternoon and felt better at 2:00.
Swelling of feet, hands,intense itch of hands, major hives, swelling in lips.
NauseaVomiting, GastricBleeding, Tachycardia, pain, severe head pressure, extreme body heat Narrative: colonoscopy
pt recvd vax 1DEC95 & hives over entire body 6DEC95; erythema multiform minor 7DEC95;
Bad Hot Flash when first getting the vx also was sweating, Now I have hot flashes every night I have to change my pajamas during the night. I also have Brain Fog. It has not gotten better. Did NOT have this issue until after the Covid vx. FYI,  I had a hysterectomy when I was 32yrs old.
pt exp temp 104.5 & sz; had 4 previous sz; EEG neg; hosp; tx w/IV ATB
Red, warm lesion 8.5 x 7.5cm - 1 cc borders marked with ink - antibiotics if increased in size.
Patient was given a dose from a vial opened for 22 hours/12 hours past stability.  Direction from CDC and Health Department obtained and patient will be revaccinated in the opposite arm asap.  She will get her true second dose 28 days after the readministration of the first.