chrisvoncsefalvay/vaers-outcomes huggingface dataset:
AFTER 15 MINUTES; PATIENT BEGIN TO FEEL SICK.. SHE GOT UP AND LOST HER BALANCE AND FAINTED
Tinnitus- sudden onset with no prior events - 5 days after shot.; This is a spontaneous report from a contactable consumer (Patient).   A 72-year-old female (Non pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, solution for injection, Lot number: el1283), via an unspecified route at left arm on 20Jan2021, 11:30 (Age at vaccination is 72 year), at SINGLE DOSE for COVID-19 immunisation. Medical history of the patient included low thyroid and patient was allergic to penicillin and iodine. Patient not received COVID prior vaccination. Patient concomitant medication included ibuprofen (Motrin) (medications in two weeks). Patient not received other vaccine in four weeks. On 25Jan2021, 07:00 AM (5 days after the shot), the patient had sudden onset of tinnitus, with no prior events. No treatment received for the event. Patient not tested COVID post vaccination. At the time of this report event outcome was not recovered.
Vaccine received at ~830 on 12/30/20. At 1220am on 12/31, woke up shivering and freezing.  Temperature was 103.1.  Took a couple of Tylenol and retook my temp 40 mins later and it went up to 104.3.  Then took some Advil and was able to get it back down to 103.1.  was like that until about 530am and it started coming down 102, 101 and by 630 was 98.7.    Had COVID in August.  Feel perfectly fine by 0930 on 12/31.
Client given oral Typhoid 12/3/13 4 caps. Client took the last capsule 12/10/13 looked at the box which stated exp date Nov 2013. Brought back the box and CDC was called and Dr. recommending to give 2nd dose. No adverse reactions noted by client. No GI upset N/V or diarrhea noted. F/U call 12/12/13 and pt stated she was fine. To take last oral capsule 12/18/13.
02/13 symptoms of cold/flu. 02/17 cold/flu symptoms improved, decreased appetite, complained of abdominal pain. No change in bowel or bladder patterns. 02/18 rash on anterior and posterior abdomen, arms, leg, lateral face, no itching, temperature of 99-101 degrees F. Taking fluids wnl.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 15-FEB-2017 at 09:36, the patient was vaccinated with improperly stored VARIVAX injection (lot # M018436) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
12:30 AM 12/04/09 - Chills, headache, nausea, generalized pruritus and tingling. 9 AM 12/04/09 - same as above. Late PM 12/04/09 - symptoms improved with cetirizine, except pruritus/tingling. 12/05/09 - physician advised diphenhydramine.  Symptoms fully resolved by end of day.
Local reaction: Pain-discomfort. General symptoms: Headaches, joint pains, nausea, diarrhea.  Narrative:
11 patients received vaccinations beyond the refrigerated expiration date, 8 of the patient's received the expired dose 6 days past the refrigerated expiration date, 3 of the patient's received the expired dose 13 days past the refigerated expira; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 patients received vaccinations beyond the refrigerated expiration date, 8 of the patient's received the expired dose 6 days past the refrigerated expiration date, 3 of the patient's received the expired dose 13 days past the refigerated expiration) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 patients received vaccinations beyond the refrigerated expiration date, 8 of the patient's received the expired dose 6 days past the refrigerated expiration date, 3 of the patient's received the expired dose 13 days past the refigerated expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (11 patients received vaccinations beyond the refrigerated expiration date, 8 of the patient's received the expired dose 6 days past the refrigerated expiration date, 3 of the patient's received the expired dose 13 days past the refigerated expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The HCP reported there were two vials involved, that no patient has experienced any adverse events.
About 10 min into driving home I blacked out and went unconscious. I woke up in the median of the HWY with my car in the ditch. After gathering myself I got back on the road. The remainder of the morning until after lunch I had cold chills, sensitivity to sunlight for my eyes, ringing in my ears, and burning sensations through my neck.
Post vax, the pt developed a fever to 104-105F on 2/2/01 and 2/3/01. He developed "bad cough". He was dx'd with pneumonia on 2/4/01 and prescribed Biaxin BID X 10 days.
Information has been received from a physician concerning a 12 month old Asian male with HIV infected parents, a seroreverter and a history of no known adverse drug reactions or allergies and intermittent asthma with atopic dermatitis who on 16Dec1996 was vaccinated with the first dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) . On 16Dec96, immediately following vaccination, the pt developed hives. The pt sought unspecified medical attention. In follow up, the physician reported that the pt was treated with diphenhydramine (BENADRYL). Subsequently, on 16Dec96, the pt recovered from the hives. It was reported that the pt had shown no allergy to eggs. No additional information is expected.
approx 3yrs p/ vax pt presented w/breakthrough rash that was consistent w/chickenpox (mile case), treated w/calamine lotion, benadryl, tylenol
No adverse event; On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 pts received an additional 0.25 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 pts received an additional 0.25 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     It was unknown if the patient had any acute illnesses at the time of vaccination and up to one month before. It was also unknown if the patient had any chronic or long-standing health conditions.    On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 12-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On 12-May-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 pts received an additional 0.25 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 pts received an additional 0.25 ml) 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)) (Intramuscular), 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 (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 pts received an additional 0.25 ml).    This case corresponds to 20th patient out of 27 patients as described by the reporter.  The age of the patient was reported as over 65 years.  Concomitant medication of the patient was not reported as it was unknown if the patient was taking any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination or at the time of the adverse event.  It was reported that on 10-May-2023, 27 patients had received 0.25 ml of bivalent booster instead of 0.5 ml. On 11-May-2023, the patients were contacted and on 12-May-2023, 18 patients received additional 0.25 ml. Vaccine body site was reported as deltoid.  The reporter did not report any other adverse reactions.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Master case
Moderate to severe headache, "foggy" thinking - felt as though it was difficult to think or process what others were saying. I could not think clearly and made simple but yet important mistakes. I also felt moderately dizzy, especially standing up. No appetite. These symptoms lasted until Wednesday, Jan 6th, at 1730. At 1730 I suddenly felt clear headed and coherent. Duration of symptoms was 49 hrs. The sudden clarity and no longer dizzy was interesting and unexpected and noticeable.  The symptoms were fast onset and sudden termination.  Only a mild headache for an additional 24hrs.
I was monitored for 15 minutes after the shot and felt fine, so I left. Within about 5 minutes of leaving Pharmacy, my face became extremely flushed, hot and red. I thought my car was hot, so I turned on the air conditioning, but it didn't subside. No hives or any other reaction. When I got home, I called Pharmacy and was told it could be an allergic reaction and to take Benadryl and monitor for Anaphylaxis (go to ER if that happens). The Benadryl worked and I had no further symptoms. I was perfectly fine by that evening and into the next day.
Within 5 minutes of receiving the vaccine (Feb 25th), I had a strong coppery taste in my mouth, and then my lips and tip of tongue was numb and tingly.  These symptoms were gone by the evening. Then on March 8th when the injection site became inflamed looking again and was sore and itchy, my lips and tongue became numb and tingly again, this time more of my tongue and more numbness.  By the next day it was gone. I saw both my General Practitioner and my long-time OB-GYN the next day and both advised that I not take the second vaccine due to these symptoms which they viewed as unusual and potential signs of allergic reaction.
Missed his second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed his second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed his second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed his second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  No treatment information was provided.
parenthesis left upper lower body; Last booster parenthesis left upper lower body projectile vomitting developed DM type II post vaccines; Last booster parenthesis left upper lower body projectile vomitting developed DM type II post vaccines; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old male patient received bnt162b2 (COMIRNATY), on 07Jul2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: VOMITING PROJECTILE (prolonged hospitalization, life threatening), DIABETES MELLITUS (prolonged hospitalization, life threatening) all with onset 07Jul2023 at 13:00, outcome "unknown" and all described as "Last booster parenthesis left upper lower body projectile vomitting developed DM type II post vaccines"; PARAESTHESIA (prolonged hospitalization, life threatening), outcome "unknown", described as "parenthesis left upper lower body". The events "last booster parenthesis left upper lower body projectile vomitting developed dm type ii post vaccines" and "parenthesis left upper lower body" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Nov2023) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of vomiting projectile, diabetes mellitus, paraesthesia.  Additional information:  adverse event: Last booster (as reported) parenthesis (as reported) left upper lower body projectile vomitting developed DM type II post vaccines  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the close temporal relationship, the association between the life threatening events vomiting projectile, diabetes mellitus, and paresthesia with COMIRNATY can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Loss of Taste; Upper Torso Weighted Feeling; Pain in Upper Torso; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of Taste), ABDOMINAL DISTENSION (Upper Torso Weighted Feeling) and ABDOMINAL PAIN UPPER (Pain in Upper Torso) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced AGEUSIA (Loss of Taste), ABDOMINAL DISTENSION (Upper Torso Weighted Feeling) and ABDOMINAL PAIN UPPER (Pain in Upper Torso). On 20-Mar-2021, AGEUSIA (Loss of Taste), ABDOMINAL DISTENSION (Upper Torso Weighted Feeling) and ABDOMINAL PAIN UPPER (Pain in Upper Torso) had resolved. Not Provided          No Concomitant medications were reported.  No treatment medications were reported.     This case was linked to MOD-2021-054395 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: The patient stated the events reported are not true and did not want a call back again.
This spontaneous report was received from a nurse concerning an unspecified patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored Oral, ROTATEQ Lot number K005396, expiration date: 28-FEB-2016. Concomitant medications were not reproted. No adverse effects were reported and there was no product quality complaint involved. Follow up information has been received from the reporting nurse on 09-MAR-2015, who was available to provide the lot number and expiration date of the vaccine. The reporter also stated that the patient identification information was not available at the time of the call. This is one of several reports received from the same reporter. Additional information has been requested.
Ever since getting my second dose of the Pfizer vaccine, I have been nearly blacking out on a regular basis.  This happens when I stand up or move my head side-to-side.
pt recvd vax @ 11 between 1130-2 pt was shaking, shivering & very cold; no fever noted @ anytime; seen @ hosp ER dx poss immunization react;
Case number PHEH2014US015694 is an initial spontaneous report received from a medical assistant on 01 Aug 2014. This report refers to a 16 year old patient of an unspecified gender. The past medical history and concomitant medications of the patients were not reported. On 25 Jul 2014, the patient was vaccinated with MENVEO (batch number: M13030, expiry date: 30 Sep 2014) at a dose of 0.5 ml intramuscularly which had multiple temperature excursions while in storage. The temperature of the vaccine reached a maximum of 47.5 for one hour and 17 minutes on 18 Jul 2014, a maximum of 47.5 for 42 minutes on 21 Jul 2014, a maximum of 47.5 for one hour and three minutes on 24 Jul 2014 and a maximum of 47.5 for one hour and three minutes on 31 Jul 2014. No adverse events were reported following this maladministration (incorrect storage of drug).
1) Fever of 103.9. 2) Erythematous swelling of (L) upper arm. Treated with Ibuprofen and an antihistamine.
started with little red bumps that look like pimples all over his arms. Then then progressed into open sores. Took weeks an weeks to go away. Has to have heavy doses of topical antibiotics. Doctor tried to tell me it was not from the vaccine. However, they started to appear within 24 hours of his injection. He is not on any meds and is a healthy, athletic child. I know it was from the vaccine.
Feelings of unable to catch a breath; Resting pulse 38 bpm, active 38-51 bpm, unable to raise pulse above 51 bpm for 2 hours after injection with walking several times >50 ft each time; This is a spontaneous report from a contactable other hcp (the patient).     A 31-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 18Aug2021 12:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation (Age at vaccination 31 years) .  The patient medical history was not reported.  There were no concomitant medications.  The patient experienced feelings of unable to catch a breath  (medically significant) on 18Aug2021 12:30 with outcome of recovered , resting pulse 38 bpm, active 38-51 bpm, unable to raise pulse above 51 bpm for 2 hours after injection with walking several times >50 ft each time  (medically significant) on 18Aug2021 12:30 with outcome of recovered.  The patient underwent lab tests and procedures which included heart rate: 38 bpm  on 18Aug2021 Resting pulse , heart rate: 38-51 bpm  on 18Aug2021.    Information about  lot number has ben requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event Shortness of breath, Pulse decreased and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
no problems with 1st dose, the second one, she did jab me in the arm with it, under injection site there's redness, itching, hardness & tender to the touch
administered Menveo instead of Bexsero by mistake; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA467A, expiry date 31st March 2022) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details were provided are as follows: The case was reported by Medical assistant. The reporter reported that a 16 years old and 10 months old patient received 3rd dose Menveo instead of the 2nd dose of Bexsero by mistake, which led to wrong vaccine administered. The reporter consented to follow-up. The case was linked with case US2020180923 and US2021173183 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020180923:same reporter US-GLAXOSMITHKLINE-US2021173183:same reporter