chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blood in stool; Loose stools; Mucus stools; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4308149-00 (Same patient).  A 70 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at cf for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HAEMATOCHEZIA (medically significant), outcome "unknown", described as "Blood in stool"; DIARRHOEA (non-serious), outcome "unknown", described as "Loose stools"; MUCOUS STOOLS (non-serious), outcome "unknown", described as "Mucus stools". The action taken for adalimumab was unknown.  Causality for Humira (Adalimumab) : The reporter's causality for the event(s) of loose stool, blood in stool and mucus in stool was not provided.  Causality for Pfizer BioNTech COVID-19 Vaccine (Tozinameran) (Tozinameran) Unknown : The reporter's causality for the event(s) of loose stool, blood in stool and mucus in stool was Possible.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot 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.
Patient had raised rash, sensitive, slightly red and elevated. Advised patient to active to apply 1 CC to area to reduce swelling, take OTC pain relievers. OTC BENADRYL.
Achy Joints; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6204), via an unspecified route of administration on 03Mar2021 11:00 (at the age of 40-years-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing hypothalesemia, asthma and allergy to Percocet. Concomitant medications included cetirizine hydrochloride (ZYRTEC), beclometasone dipropionate (QVAR) and lorazepam (ATIVAN). The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced achy joints in Mar2021. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for this event. The clinical outcome of achy joints was recovered in Mar2021.  No follow-up attempts are possible. No further information is expected.
Patient was given a Zostavax vaccination in the deltoid muscle (IM) instead of subcutaneous (SQ).
Felt fine other than soreness in arm before sleep. Woke up around 11 with fever nausea and stomach discomfort all night
I woke up in the middle of the night around 4am in extreme pain (vaccination was yesterday at 12:40pm).  I cannot lift my left arm, pain shooting down my side and through my lower back.  This has continued throughout the day and I've struggled to get out of bed because of the pain.  I've taken Advil which has provided slight relief.  It is now 7:00pm and although slightly better, I am still in a lot of pain.  I am a very active and fit 51 year old.
Pfizer Covid Bivalent vaccine given as first dose in the series. Patient has not had primary dosing series.
Diarrhea; Stomach rolling; Total loss of bladder control; Fatigue was really bad; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Stomach rolling), URINARY INCONTINENCE (Total loss of bladder control), FATIGUE (Fatigue was really bad) and NAUSEA (Nauseated) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, OLMESARTAN and ALPRAZOLAM for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Stomach rolling), URINARY INCONTINENCE (Total loss of bladder control), FATIGUE (Fatigue was really bad) and NAUSEA (Nauseated). On 19-Mar-2021, URINARY INCONTINENCE (Total loss of bladder control) had resolved. On 24-Mar-2021, ABDOMINAL DISCOMFORT (Stomach rolling) and NAUSEA (Nauseated) had resolved. At the time of the report, DIARRHOEA (Diarrhea) and FATIGUE (Fatigue was really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included omeprazole.
Two or three hrs after injection, pain began in entire left arm, continue to get worse until arm couldn't be in use. Got home, pain was in whole body. Throbbing pain in shoulders, and wrists, even down to ankles. Became disoriented, had problems getting up using the bathroom. Same night, no sleep, in extreme pain. Was really disoriented and had no clue of what was going on. Lasted until 8am the next morning. Symptoms were improving as next day came along. Still have mild pain in joints.
Extreme vomiting, extreme chills and hot flashes, stabbing jaw pain, all for 24 hours, then body aches, fatigue and feeling crummy for the next week.
shingles 2 weeks later; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Covid 19 vaccine (fully vaccinated and booster), Influenza vaccine (annually), pneumonia vaccine and polio vaccine (as a child).   On an unknown date, the patient received Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles (Verbatim: shingles 2 weeks later). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-Mar-2023 This case was reported by a patient via  interactive digital media. The patient was a firm believer in vaccines. The patient was fully vaccinated and boosted against Covid. He or she took the flu vaccine annually. The patient had the pneumonia vaccine and a multitude of vaccines and polio vaccines as a child. He or she recently had the Shingrix vaccine and ended up breaking out with the shingles 2 weeks later.  Follow-up was not possible, as no contact details were available.
Within Minutes of receiving HPV vaccines, became light headed pale, nauseated, weak, vomited, had muscle weakness until next day. Mother refused to let patient have 3rd dose but never informed us of above until today, 3-10-09.
This spontaneous report as received from a pharmacist refers to an unspecified amount of patients. On unknown dates, the patients were vaccinated with ZOSTAVAX that was stored at -10C for an unspecified amount of time. Pharmacist stated that the overall temperature might not have been at or below -15C. No adverse effect reported. Additional information has been requested.
Received first Moderna vaccination on 06/07/2021.  On 06/23/2021- at approximately 9:00 pm patient developed a fever of 102* accompanied by  muscle &  body aches, chills, headache and fatigue.  On 96/24/2021- 10:15 am- I I gave patient 2 Tylenol and liquids. Patient is now sleeping and I will  watch his symptoms carefully.
Fatigue at 11:30  and continued thoughout next 48 hours. Chills so severe I was shaking at 7 :30 pm -  10:00pm.  Achy ness and horrible headache at 1:00pm and continued throughout next day. High fever at 8:00pm -2:00am and slight fever continued for next day.
This spontaneous report as received from a 67 year old male consumer refers to himself. Patient had drug reaction/allergy to sulfa based antibiotic. The patient's medical history included stroke(dates not provided). Approximately in August 2013 (reported as about 3 months ago) the patient was vaccinated with pneumococcal vaccine, polyvalent (manufacturer unknown) one dose, injection (lot# not reported)) (dose, strength, route and site of administration not reported). Concomitant therapies included PLAVIX and FLOMAX. Approximately in August 2013 (reported as about 3 months ago) the patient developed pain his arm and the muscle over his shoulder was swollen and the patient stated he did not feel like himself and he felt crummy. No treatment for events was given. No lab test performed. Approximately in September 2013 (reported as about 2 months ago) the patient recovered from the events. The relatedness between pneumococcal vaccine, polyvalent (manufacturer unknown) and the events was not reported. The patient sought medical attention via phone call to physician. This is one the two reports from the same reporter and patient (Same patient link # 1311USA006205). Additional information is not expected.
Fever. Rash and inflammation on entire torso, arms, forehead, partial legs. Inconsolable crying.
COLD SWEATS; CHILLS; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced cold sweats, chills, fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, headache, chills and cold sweats was not reported. This report was non-serious.
Around 4pm I started experience hives my my legs, and arm where I was vaccinated and some on my back. I also got my period earlier than I was suppose to by two weeks and have been experiencing really intense cramps that I have never experienced before. My period is heavier than usually
around 6pm I had a bad headache and nausea and through the night I felt like I had a cold chills fever that lasted through the morning. The next day I felt tired and weak. That evening I started feeling fever chills and sore throat. I called the urgent care and I went in for a covid test and 2 days later it came back negative. By the weekend I felt better
Scribe informed patient was "ready to receive vaccine." Patient was nervous and RN was consoling patient at time.  She injected vaccine without verifying which type of vaccine was administered for the first dose.
SUSPECTED CLINICAL VACCINATION FAILURE; SICK WITH COVID/ SUSPECTED COVID 19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a 91 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in AUG-2021, the patient experienced suspected clinical vaccination failure. The patient was sick with suspected covid-19 infection.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick with covid/ suspected covid 19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint. This case, from the same reporter is linked to 20210854979 and 20210855235.; Sender's Comments: V0: 20210855254-covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
My COVID-19 symptoms started on 12/07/2022 in the morning as soon as I woke up. I had a head congestions.  I had a moderate cough. I got sick when I was on a cruise ship. I called my doctor on 12/09/2022. We discussed about the medication but  since I received the vaccine most recent she didn't prescribe me any. On 12/11/2022 I tested positive for COVID-19 infection.  On 12/12/2022 or 12/13/2022 I called my doctor again we discussed about Paxlovid since I wasn't really sick she didn't prescribe medication. I took over the counter Tylenol and Cough drops.
Began experiencing chills and fever around 2am on Thurs, Jan 28th. Chills, headache, fever, body aches all lasted from 2am on Thurs, 28th until approx. 7pm on Thurs, Jan 28th. Impacted daily activities. Could not go to work.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.  No vial went any temperature excursions.  there was no adverse reactions to the patient   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up added second reporter details
Left cheek got tingly and numb with slight droop about 20 minutes after vaccine. Continue to have symptoms one day later.
Change in mental status giddy, confused, pain in both arms tingling in left arm, weak hand grasp both hands.
Information has been received from a registered nurse referring to a 13 years old patient of unknown gender. Pertinent medical history and drug reactions/allergies were not reported. On 27-AUG-2015 the patient received PROQUAD (Merck) lot # L009210, expiration date 17-SEP-2016 (route and dose were not reported) (inappropriate schedule of drug administration). Concomitant drug was not reported. The patient did not experience an adverse event. This is one of two reports from the same reporter. Additional information has been requested.
Arm was somewhat sore the following day after injection. Then extremely sore two days after injection. Less sore day three after. Eighth day after injection, I was dizzy while at the park with my child. The morning of the 9th day after injection, I woke up with a circular rash, slightly itchy and my arm sore again. It is currently the end of ninth day and still have rash.
Next day following vaccine, I developed a very itchy rash on upper body parts - arms, around armpits, side and upper torso chest and back, developed sores from intense scratching and scabbing.  Still lightly itchy as of this date.
redness & swelling @ site of inject x 1 wk; area broke open & whitish discharge x 1wk; now small area w/scar; on rt deltoid area;
Extreme abdominal pain/cramping. We ended up taking her to the ER department at the Hospital because the pain was so extreme. In the course of the visit to the ER, they took a CT scan of the abdomen, and there saw evidence of Covid in the lungs. They did a nose swab test, and she tested positive. She had some mild symptoms (stuffy head, headache, mild sore throat) earlier in the week (May 8 - May 9), but we thought it was possibly allergies. Turns out it was Covid and we didn't know it.  It seems that with the Covid virus already in the system, the shot caused an extreme reaction.
Myalgia, Fever & NauseaVomiting Narrative:  dose 1 DAY 1-4 PAIN AT INJECTION SITE; DAY 5 ITCHING AT INJECTION SITE;DAY 2: CHILLS; FEVEr; NAUSEA;DAY 3: MYALGIA; NAUSEA;DAY 4-5 NAUSEA dose 2: day 1-3-sorearm;day2-fever/chill/fatigue;day3ache/fatigue/nausea;day4-fatigue/n;day 5-6-nausea
Patient had a circular rash at injection site that was red and slightly swollen. Slightly warm to the touch. Patient stated they have not noticed any change in size or color.
Local rash about 1 inch square at injection site.  Patient showed it to her doctor who recommended no treatment necessary.
Pt called to report that her left arm because red, swollen and hot. The size of swelling she reported the size of golf ball. She reported she went to ER and received Rx for Keflex 500 mg every six hours x 10 day. Dx; Cellulitis
pt recvd vax SEP92 & w/in 8 hrs following vax pt exp body aches, neck pain, neck stiffness, moderate chills & a warm sensation; w/in 48 hrs pt exp severe epigastric pain & a dec appetite; w/in 72 hrs exp severe pain in rt upper quad area;
Patient reported having history of syncopal episodes After vaccination patient had syncopal episode, was pale, clammy and diaphoretic Patient seen by medical team, refused medical transport and signed AMA form Patient stated symptoms resolved
Information has been received from a registered nurse referring to 6 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 21-SEP-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot #L024997, expiration date: 06-OCT-2016), which were improperly stored for 13 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Still afflicted, face upper right quadrant; Started numb; rash; Piercing crusty scabs; Ugly tingly; Itching; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of facial discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced facial discomfort (Verbatim: Still afflicted, face upper right quadrant), numbness (Verbatim: Started numb), rash (Verbatim: rash), scab (Verbatim: Piercing crusty scabs), tingling (Verbatim: Ugly tingly) and pruritus (Verbatim: Itching). The outcome of the facial discomfort, numbness, rash, scab, tingling and pruritus were not reported.   It was unknown if the reporter considered the facial discomfort, numbness, rash, scab, tingling and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the facial discomfort, numbness, rash, scab, tingling and pruritus to be related to Shingles vaccine.   Additional Information: GSK receipt date: 18-MAR-2023 The case was received from the patient interactive digital media. The patient had the shot and still afflicted the upper right quadrant of his/her face. The patient stated that it started numb, then rash, then crusty scabs, ugly, tingly, itching, piercing. The physician said imagine how it worked be of you had not received the shot. The follow-up could not be possible as no contact details were available.
Patient to clinic for varicella vaccine 1st of two. Nurse chose Zostavax instead of varicella vaccine
Patient called today and said she was vomiting and couldn't get out of bed on Monday and today she is able to eat but the left arm where the shot was given is highly sensitive below the injection site on both areas. Patient received both the Pneumonia 23 and Flu shot in the same arm. I asked her if she would keep calling each day so we can just make sure she is getting better.
the rash is hot, sweaty, stinging and covers her entire body; upset; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 26Mar2021, as single dose for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis. The patient previously took first dose of BNT162B2 on 05Mar2021 and 10 days later she reported rash. The patient's past medication included prednisone for 5 days, taken for rash and when that was completed she was encouraged to get her second dose. On 31Mar2021, 5 days after second dose, the rash came back again. She had been to Urgent care, 4 different doctors at 3 different facilities and had been prescribed prednisone 3 times, which helped for a bit, made the rash fade, but the when the prescription ran out the rash returned in the exact same spots. Patient informed that the rash was hot, sweaty, stinging and covers her entire body, "I look like I've been burned". Patient had been to multiple doctors, and referred to Dermatologist. Patient stated that this was not a skin problem, it was an immune system problem. Patient reported to have a history of rheumatoid arthritis and stated that she believed event was an autoimmune response to the vaccine. Patient was audibly upset. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
Felt nauseous and broke out into a sweat.  Reported lightheadedness and dizzy.  Felt like she would pass out. Reported tingling in fingertips.  Laid down for an hour. Tingling subsided and felt lightheadedness subsided; however, continued to feel nauseous.  Denies vomiting, chest pain, SOB, et.c
Chills, shaking, body aches, tired, sore neck, head ache for 36 hours.
Starting approximately 45 minutes to an hour after my first dose of COVID-19 Vaccine by Pfizer I experienced a metallic taste in my mouth. This taste was present for the next 48 hours and would be less noticeable when eating, but would return after eating. After 48 hours it was less persistent and by 72 hours the metallic taste was gone.