chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received Shingrix / on November 2019 and did not receive 2nd dose yet.; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows:  The age at vaccination was not applicable for this report. Till the time of reporting, the patient received 2nd dose of Shingrix, which led to incomplete course of vaccination. All patient identifiers were reported. No batch number or expiration date were available when asked. No more clarification was performed by HCP. The reporter consented to follow up.
Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022; Doses administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No known drug allergy was reported.  Concurrent medical conditions included Hypertension. Concomitant products included HYDROCHLOROTHIAZIDE, IRBESARTAN (IRBESART AND HYDROCHLOROTHIAZIDE), AMLODIPINE, METOPROLOL, FAMOTIDINE (PEPCID [FAMOTIDINE]) and CETIRIZINE HYDROCHLORIDE (CITIRIZINE [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 30-Mar-2022 at 9:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator: 25-FEB-2022 Vial didn't undergo any temperature excursions. Patient had not experienced any side effects yet. No treatment details were provided.
I woke up one day and started to feel chest pain and tightness that continued to get worse through out the day. I was getting very easily out of breathe, feeling like I might faint or fall over, weak. When my arm got tingly and I had to urinate every few minutes, I went to the hospital. They ran every test possible and nothing looked like an emergency. They told me to see my general practitioner, she was out of office so I saw her nurse practitioner. He ran more tests which didn?t turn up  anything and recommended I see a cardiologist. The cardiologist checked my heart and had me wear a monitor for 24 hours. The monitor showed sudden spikes in my heart rate up around 160. He said I likely have POTS and must?ve gotten covid but didn?t know it but I didn?t. I didn?t have covid or any other sickness at any point.   The symptoms persist on a random but consistent basis.  I feel chest pain, out of breathe, weak, fast heart rate when doing normal activities like laundry or when walking uphill/stairs,  carrying things, etc. This isn?t like normal being out of shape and getting winded, it?s very different.
death is reported in a pt who recvd 1 dose of flu vax 2OCT; pt died in sleep on 3OCT; coroner stated that there was no evidence of swelling or anaphylaxis & believed that pt died in sleep of natural causes or a coronary;
Patient developed purpuric rash on face, neck, arms and right foot 4 days after immunization.  He was seen at ER and prescribed antibiotics.  On my clinic visit rash most consistent with henoch shonlein purpura or similar vasculitis.  Started on Oral steroids and referred to dermatology.
I am having rash, the rash started just little bit on my stomach, I can feel it all over my body, it's not coming down; Really hard for me to sleep at night time; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EW0199) via an unspecified route of administration in arm left on 13May2021 as single dose for COVID-19 immunization. Medical history included diabetic. Concomitant medications included metformin hydrochloride, saxagliptin hydrochloride (KOMBIGLYZE) for Diabetes. The patient stated that she took the first dose of vaccine on 13May and on an unspecified date in 2021 she is having rash, the rash started just little bit on her stomach and now she can feel it all over my body, it's not coming down and she said that this is more than a one month now and she is still suffering from this rash she said that it's started just little bit and spreading all over and it's really hard for her to sleep at night time also. The patient underwent lab tests and procedures which included blood test, result was unknown. Patient received Cetirizine Hydrochloride as treatment for events. The seriousness of the events was not serious. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts are completed. No further information is expected.
Persisting stomach pain; Nausea and vomiting; Nausea and vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Persisting stomach pain), NAUSEA (Nausea and vomiting) and VOMITING (Nausea and vomiting) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Persisting stomach pain), NAUSEA (Nausea and vomiting) and VOMITING (Nausea and vomiting). The patient was treated with BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) at a dose of UNK dosage form. At the time of the report, ABDOMINAL PAIN UPPER (Persisting stomach pain), NAUSEA (Nausea and vomiting) and VOMITING (Nausea and vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter.
MODERNA COVID VACCINE #3 GIVEN 12/20/21, LOT #033H21A; pt brought to ED after testing positive for COVID at clinic; c/o increasing SOB, cough, fever, diarrhea, chills, chest congestion x 5 days; in ED O2 saturation was 70% on RA; started on Optiflow; steroids, Remdesivir, Vitamins C, D, and zinc, empiric ABX; later required intubation; worsening metabolic acidosis; shock requiring vasopressors; CRRT with improved acidosis but condition continued to worsen; family transitioned pt to DNR and pt passed away in the hospital
Patient was administered 12+ Pfizer Bivalent dose; however, the patient is only 10 years old.
4 HOURS AFTER VACCINE PT STARTED FEELING ILL. SHE THREW UP, WAS SHAKY AND SWEATY, FEVERISH FATIGUED.  THEN STARTED HAVING SOME DIFFICULTY BREATHING AND DRY HEAVED A FEW TIMES.  USED ALBUTERAL AND AFTER AN HOURS THINGS SETTLED AND SHE SLEPT A COUPLE HOURS.  FELT BETTER AFTER 3 DAYS.
I just notice my teeth gotten to rot after my second shot but I also haven't brush in two years; I just feel like ever since I got the vaccine my life is actually gone down hell; I just feel like ever since I got the vaccine my life is actually gone down hell; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 56-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included none. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 administered on an unspecified date for COVID-19 immunization. On an unspecified date the patient just noticed patient's teeth gotten to rot after the second shot, but patient also haven't brush in two years; the patient just feels like ever since got the vaccine patient's life was actually gone down hell. Consumer stated, "I just notice my teeth gotten to rot after my second shot, but I also have not brush in two years so, I am not really sure I was just wondering if it is like a co-relation that you aware of. Oh, my teeth just rotted kind of rot, but I also have not brush my teeth in two years; I just feel like ever since I got the vaccine my life is actually gone down hell." The clinical outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow up (23Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
The day after the 2nd dose I was knocked out with standard side effects, such as chills, headache, fatigue, and could not do much.  The headache passed by 9/11 at night, but chest pain started to take over.  Right now, in the morning, I still feel tightness in my chest, and my resting heart rate is faster than normal.
pt states approx 4hr p/vax devel swelling of lips progressed 1hr later to devel hives-chest/abd/legs;no change overnight;saw PMD dx allerg eggs;
Headache; Has no taste; Bitter metallic taste on her lips and fingers; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), AGEUSIA (Has no taste) and DYSGEUSIA (Bitter metallic taste on her lips and fingers) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), AGEUSIA (Has no taste) and DYSGEUSIA (Bitter metallic taste on her lips and fingers). At the time of the report, HEADACHE (Headache), AGEUSIA (Has no taste) and DYSGEUSIA (Bitter metallic taste on her lips and fingers) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment medications were not reported.
Total loss of libido for 3 days. Severe Headache and body aches. left arm really hurt form the injection. all pain was gone within 2 days. 6 days later I developed a sty in my left eye. I also had a sty in my left eye a week before I tested positive for Covid on Sept 20 2020.
7 hrs after injection redness and warmth developed, no pain, redness is 8 x 9 cm oral on (L) upper/outer arm on day.
itchy; migraine; fever; This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in the left arm on 30Aug2021 11:00 (at the age of 49-year-old) (Batch/Lot Number: FC3184) as single dose for COVID-19 immunisation. Relevant medical history included hypertension, COVID-19 from 22Jun2020 to an unknown date and ongoing migraine. It was unknown if the patient was pregnant. Concomitant medications included olmesartan taken for high blood pressure from 2020 and ongoing; hydrochlorothiazide taken as water pill from 2020 to an unspecified stop date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Aug2021 (at the age of 49-year-old) (Batch/Lot number FA7484) for COVID-19 immunisation and experienced itching, migraine aggravated, eyeball soreness, fever, myalgia, sensitivity of teeth, sweating, vomiting, nauseous, blurry vision, headache, rash and foggy feeling in head. In Aug2021, after the second dose of the vaccine, the patient experienced itchy (medically significant), migraine (non-serious) and fever (non-serious). Corrective treatments taken as a result of the events included: paracetamol (TYLENOL) for fever, "EXCEDRIN" for migraine and diphenhydramine hydrochloride (BENADRYL) for itching. The patient recovered from the events in 2021. Duration of itchy and migraine was 3 days; duration of fever was 4 days.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101043898 same patient, different events after different doses of the vaccine
serious and more headaches which are not normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "serious and more headaches which are not normal".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received PPSV23 vaccine in right deltoid 9/6/17. Patient reported soreness after injection. Soreness continued into the following day, 9/7/17. Patient given prescription of ibuprofen 800 mg tablets (30 tablets) to take for pain. Injection muscle was inflamed and tender.
Approximately 1 minute after getting varicella vaccine, patients arm at the site (right arm) turned red and started itching.  Administered Benadryl 50mg per mouth.  Complained of shortness of breath.  No other rashes noted.  Patient remained in health department for 20 min. after medication.  Redness was almost gone.  Patient stated it was not itching as bad.  Advised to go to ER if symptoms return or worsen.
Pt presented at 16:35 to clinic on 2/3/23 c/o chest pain.  Clinic was closed.  Nurse talked to pt - pt assessed, no acute distress, speaking full sentences, advised to drive to ER pov.  Pt presented to ER at 16:46 with chest pain ,EKG showed inferior ST elevation MI with elevation in leads 2, 3,F, V2-V6.  Given thrombolytics.  At approx 18:30 pt became unresponsive, suffered cardiac arrest with PEA, unable to be resuscitated.  Time of death 18:50
Raised, red rash on tricep area. Approximately 1inx 2 in. Warm to touch. No pain noted.
Breakthrough Case  Patient received Booster on 10/19/2021  Lot #FC3182  Admitted by Pharmacy
Patient was vaccinated without incident at 08:59 AM.  We later received a report from his spouse that he expired on the same day at 9:00pm . According to his wife an autopsy was performed and the cause of death was an acute myocardial infarction.
I experienced mostly body aches, congestion and extreme tiredness I am now sleeping 8-10 hours which is much more than I usually sleep.
onset of patch of macular erythema lt side of abd, painful, not itchy, 2 days p/vax; felt achy & feverish 12AUg also; seen by MD 14AUg94, dx as probable shingles no vesicles seen, given gastrix cream & Ibuprofen;
Extreme shoulder pain (felt like when I had shoulder surgery, which was on the other arm, but same effects). Could not lift arm due to extreme pain and stiffness in tendons, extremely tender to touch. The mobility is back after 3 days, but as if trying to regain motion in the joint (tenderness duller but existent). Shooting pulses down the neck through the shoulder that I am still encountering.
I was exposed by two unvaccinated adults who live in my house. I woke up felt like I had a sinus infection, massive headache pressure and congested. It was ragweed season so just thinking Sinus infection. I started feeling worse took a rapid test and went to ER got a PCR test. I started having fever and chills. I had rattily feeling in my chest. I stomachache and diarrhea and sore throat at times. I was supposed to be out of isolation but the health department recommended I stay home until I feel better. I have been to Urgent care twice, I have been taking Mucinex DM, Tessalon pearls cough suppressant pill. My lungs showed I had pneumonia in my left lung and bronchitis, The first chest x-ray showed I had ground glass opacity in my lungs. The Dr. prescribed antibiotics and prednisone. My oxygen dipped into 80s so I went to ER they checked for blood clot, EKG, XRAYS. and other test sent me home my oxygen went up to 93. I'm still sick with fevers and in isolation.
1/11 woke at 0400 with extreme shivering, vomiting, fever 101.8, headache. Previously COVID + 11/17/2020.
Immunocompromised patient received Moderna booster dose as third dose in series; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received Moderna booster dose as third dose in series) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received Moderna booster dose as third dose in series). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received Moderna booster dose as third dose in series) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  It was reported that the patient got her first two doses of Moderna booster. Instead of signing-up for immunocompromise, instead of getting the full dose the patient got the half dose. Reporter stated that they are the pharmacy that gave patient's first, second and booster dose.  No treatment information was provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2022: Follow-up received and included no new information.
Information has been received from a published article. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received RECOMBIVAX HB vaccine, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient # 25 of 32, a 17 year old female. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second dose of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 17 year old female on an unspecified date was vaccinated with the second dose of RECOMBIVAX HB vaccine (lot number, route and site not reported). There was no concomitant medication. One day after vaccination, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The patient also experienced symptoms of autoimmune disorder. The authors stated the RECOMBIVAX HB vaccine may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB vaccine (WAES #1004USA01716, WAES # 1004USA02327 to WAES # 1004USA02349, WAES # 1004USA02351 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (passed away) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported. Company comment: This spontaneous case concerns a 17-year-old patient of an unknown gender, with no medical history reported, who died an unknown time after a dose of mRNA-1273 (Moderna COVID-19 Vaccine) (seriousness assessment reported as fatal and medically significant). Cause of death was not reported. Information regarding clinical evaluation, diagnostic tests, autopsy report, and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-750558, US-MODERNATX, INC.-MOD-2023-750508 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750558:Same Reporter Patient US-MODERNATX, INC.-MOD-2023-750508:Same Reporter Patient; Reported Cause(s) of Death: Unknown cause of death
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 15-MAR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number L024129; expiration date 21-JAN-2017) "10 PK 0.5 ml SD-PFS LLok w tip" (route of administration and anatomical location were not reported). On an unspecified dates, the PNEUMOVAX 23 had one temperature excursion of 28 hours. The highest recorded temperature was 49 F (9.444444444 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
9 Days after administration of varicella vaccine and MMR vaccine, pt developed ~200 erythematous macules involving scalp, face, arms, chest, back, legs, sparing palms and soles. 3 lesions one longer than .5 cm with ? vesicle formation in center.