chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer. A 73-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581), via an unspecified route of administration in left arm on 10Feb2021 (Batch/Lot Number: EN9581) as a single dose for COVID-19 immunisation. Medical history included hypertension, prolactinoma, hyper cholesterol, and allergies to penicillin. Concomitant medications received within 2 weeks of vaccination included verapamil, lisinopril, atorvastatin, and omeprazole. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) in the left arm on 20Jan2021 01:00 PM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He was not diagnosed with COVID-19 prior to vaccination. The patient experienced stroke due to blood clot at superior sagittal sinus of brain on 11Mar2021 13:00. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Hospitalization for 6 days. Treatment received for the adverse event included Enoxaparin injections and warfarin. Outcome of events was not recovered. The patient had not been tested for COVID-19 since the vaccination.
Patient came to get the vaccine on 6/13/21 and she was sitting down for 15 minutes but after a few minutes she waved me over and said she was feeling really weak for no appearent reason. I asked her to take a few deep breaths and she did and calm her down. She had a water bottle with her and I asked her to drink some water and she did. After a few minutes she felt a little better. I checked her blood pressure and it was 174/105 and I asked her to sit for a few minutes, deep breaths, and for her to relax as much as she can. I took her blood pressure a few more times. After about 15 mintes she felt a lot better and her blood pressure was 140/88. I asked if she needs me to call someone or if she needs to go to the hospital. She said she was a lot better andwent back to work. I saw the patient a few days later and the patient said she had to go to the hospital but she is ok now. Apologize to the patient that she had to go to the hospital. the patient was fine and said she was glad to get her second dose of moderna. scrt and vaers entered
One week later, injection site looked and felt like a hive. Muscle also was knotted up around injection site. 3 days later, it's still knotted,  now sore, and still itchy.
Generalized urticaria, twitching/shaking, fever, swelling of bilateral knee joints; treated w/ PO benadryl, topical hydrocortisone, SQ epi, PO prednisolone, and PO ibuprofen
Chickenpox Outbreak that presented with fewer than ten blisters and expanded to cover areas of face, arms, chest, feet, and legs. Also has passed it on to father.
Woke up with swollen armpit and painful..like fluid buildup in my right arm. Still painful today the 4th day after shot. Red spot at injection site.  Can't close arm all the way down without pain/discomfort.  Headache Malaise  Mild tooth pain upper and lower on right site.
Rcv'd DTap and IPV to L delt 7/13/04. No reaction 7/13/04 or on 7/14/04. Mom called 7/15/04, AM to advise pt. was having a local reaction; redness, warmth, slightly swollen 3-4 inches long on L delt. No fever, pain, nausea, vomiting, otherwise normal.
Evening of April 8th - Fever, chills, fatigue, sore arm April 9th - Continued chills, fatigue, sore arm, fever in the evening Evening April 10th and April 11th - heart palpitations and trouble breathing about 1-2 hours after falling asleep
It's painful but no worse than other pain I already have; Suspected vaccination failure/I had the vaccine and I have shingles now; I have shingles now; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included pain (have had other pain).   On an unknown date, the patient received Shingles vaccine. In August 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the vaccine and have had shingles right now. The patient stated that they were painful but no worse than other pain that he/she already had. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
pt's wife called back to the pharmacy and said pt had a seizure/tremors and lasted 15 to 20 minutes. the pt had stayed in the pharmacy for 15 minutes with no issues.i asked the wife did they call 911 or go to the er. she said it stopped after about 15 minutes.
fever ~103 for 6 hours, chills, muscle aches, major fatigue  acetaminophen, every 6 hours
Pt c/o dizziness, warm feeling to face, headache 10 min. after recieving vaccine. Pt observed rechecked BP. Crackers, Gatorade and Tylenol given to pt. Pt examined by MD prior to D/C. Pt observed by RN gait assesed pain reassesed pt d/c'd home with mom 1 hour after vaccine administered  ER warnings given.
pt recvd vax 25JAN94 PM; APAP given prior to vax; @ 5 pt fussy, 8:00 pale, no responsive, limp; 9:30 t101, spitting up;
drastically declined in health/eventually died last year; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Grandmother of nurse had a heart condition" (unspecified if ongoing). The patient's concomitant medications were not reported. No other vaccine in four weeks. Vaccination history included: Covid19 vaccine (DOSE 1, SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid19 vaccine (DOSE 2, SINGLE, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: GENERAL PHYSICAL HEALTH DETERIORATION (death) with onset Sep2021, outcome "fatal", described as "drastically declined in health/eventually died last year". Nurse talked about her grandmother having heart issues and did not do well from a Covid shot and wasn't going to receive another one and a pharmacy talked her getting one. The nurse felt her grandmother drastically declined in health after her vaccine and eventually died last year. Neither nurse mentioned the brand of Covid vaccine but thought I should report and neither wanted to be contacted. Not sure of the month her grandmother died.It was unknown if therapeutic measures were taken as a result of general physical health deterioration. The patient date of death was Sep2021. Reported cause of death: "drastically declined in health/eventually died last year". It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccine cannot be excluded for the reported event due to temporal relationship. However, the reported event may likely represent intercurrent medical condition in this patient with history of underlying cardiac conditions. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including autopsy results, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  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.; Reported Cause(s) of Death: drastically declined in health/eventually died last year
2 weeks post vaccine, 11/01/2021- I had a small pain in my upper back, rib cage area I did not pay much mind to it, I thought I twisted wrong. In the coming days the pain was so intense I could not walk. I took ibuprofen. The pain went away momentarily, and it came right back, and the pain has been here since. I went to the Urgent Care 2 weeks after. They did a whole physical. The doctor felt it was a kidney problem. They did an ultrasound of my kidney and found a small cyst on my kidney. They prescribed ibuprofen 600 mg. I took the 30 pills I was given. Now I am taking Advil as needed. I followed up with a urologist. He did not think it was my kidney. He thought it was muscular skeletal. I have an appointment with my PCP on 12/02/2021. I have an appointment with my pulmonologist 12/22/2021. I have not recovered from my adverse event. I am still seeking treatment. I have followed ups with doctors, and I would like to figure out what is causing the pain. I have been going to work. I work remotely, so I can do my job. I have no days off.
Diagnosed w/cellulitis - treated w/docycycline and Mupirocin.
pt recv vax 8NOV94 & MD visit 9NOV in the late morning, parent reported to MD that 5AM that morning pt had fever & a sz was taken to Er; appeared fine; CBC & UA nl; pt also appeared fine @ ofc visit; no tx; pt recovered;
One day after immunization patient experienced severe swelling in left deltoid muscle as well as lymph nodes under her arm and down her entire side (ipsilateral to injection site). Her armpit was swollen up to roughly grapefruit-sized. Her breast was swollen and she was unable to lower her left arm due to severe pain. She is still having some residual swelling and pain from the injection.
Reports dead arm sensation and soreness that started ~3 weeks following vaccination with new initial cramping/nerve pain sensation this morning while working.
Sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 (Lot number: EW0158) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 10May2021, outcome "unknown", described as "Sore throat". The action taken for bnt162b2 was unknown.  Additional Information: Expiry Date of Covid-19 vaccine: Unknown.Other Products: No.Investigation Assessment: No.Caller is asking if her mother can get the second dose since she has a sore throat. Caller states her mother takes a lot of medications. Declines to provide medication details.  No follow-up attempts are possible. No further information is expected.
A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400068, PJP200069, PJP200400070, PJP200400071, PJP200400072, PJP200400073, PJP200400074, PJP20040075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.
Received DTAP, Hib, Hep B, PCV 12, IPV and afterwards developed fever, and it was 104 to 105 degrees with non-stop crying per mom on 3-1-13. Referred to take to MD. F/U on 3/14/13 didn't take to MD fever broke turned around after talking with nurse per mom.
After having that 1st pfizer vaccine I have experienced changes in my period (very dark brown blood with clotting in the beginning) , twitching & trimmers in both of my arms, and grinding my teeth.
2 days post vax pt rash became much more severe;pt had to be treated w/oral topical corticosteroids;either guttate psoriasis or a lichenoid drug reaction were suspected;a strep cult & an anti-streptolysin o cult was taken both negative;
Discharge Provider:  DO Primary Care Provider: DO Admission Date: 6/20/2022 Discharge Date: 06/23/2022  PRESENTING PROBLEM: Bronchiolitis obliterans syndrome, grade 0P (HCC) [J42] COVID [U07.1] AKI (acute kidney injury) (HCC) [N17.9]   HOSPITAL COURSE:   This is a 78 y.o. who has a past medical history significant for IPF s/p Left single lung transplant in 2014, on Fluconazole for disseminated Cryptococcal infection, CAD, Aflutter s/p ablation, CKD, GERD , DM. He was admitted for observation today after a few days of poor appetite, nausea, and emesis in the last day. Hospital course was significant for positive COVID PCR test.  He is not hypoxic, does endorse mild dyspnea and baseline congestions. Admitted for AKI   6/21: Renal function improved. Needs to be assess by PT/OT. Feeling better.  6/22: Still with fatigue, nausea, headache, and now poor PO intake--- > worsening kidney function. Will need another day at least in hospital. PT/OT planned today   Plan Today - IVF on 6/20 with improvement in renal function, Since then not drinking water since it is not filtered and renal function worse. He is eager for discharge and will give more IV fluids, recheck and discahrge if improved. Plan for Labs 6/24 and possibly next week. - Due to frequent infections will reduce tacro goal to 4-6, continue pred 5mg - Nausea: prn zofran - Headache: prn tylenol  - Tacro repeat tomorrow in AM after discharge  - PT/OT ---- > Home health and PT
ONSET 3/16/2021 FEELING TINGLING ON HER TONGUE; 3/17/021 NOTED RIGHT SIDE FACIAL NUMBNESS WHEN PATIENT WOKE UP.
This case was reported by a healthcare professional and described the occurrence of pain in a female subject aged 30-40's who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On 9 October 2007 the subject received 1st dose of Fluarix 0.5 ml in the right arm.  On 9 October 2007, at an unspecified time after vaccination with Fluarix, the subject experienced pain.  At the time of reporting the outcome of the event was unspecified.  The event occurred in five different female subjects.
fevers, tmax 100.6 within 12 hrs of administration responding to tylenol diarrhea, vomiting within 24hrs
Red rash, about 2 inches starting about 8 hours after injection. Hard hot lump. Faded into a bruise on day 5.   Returned as a large, red, hot rash on day 7 with lymph node pain in left armpit. Rash has increased in size daily.   Is now about 6 inches in size.
Swelling in left arm, chills, breathing difficulties, left arm hot to touch. These are still persisting.
Swelling of left thigh and skin around upper left knee.  Mild pink rash on left medial thigh.  Mild limping, resolved with ibuprofen
8 days after first shot the injection site and upper arm swelled, red rash and pain. Has continued for the past three days.
I started having redness and itchiness at the injection site. It started off about the size of a nickel but is now the size of a half dollar if not bigger. I always started having aching in my shoulder where I got the vaccine that made it uncomfortable to go to sleep.
Some flat hives developed that night. The next day more hives appeared on his chest and back. 2 days after shot hives were on forehead, chest, back, neck, forearms, legs. Some were flat and some were raised and blister like (some appeared like chicken pox). 3 days after shot hives (flat and blister like) covered his body including face except the groin area. He also had some redness to the whites of his eyes-he went to the emergency room. The hives were itchy, not painful. He did not experience any difficulty breathing. As of today he no longer has any blister like hives but does still have many red splotches left on his back and chest and arms-they are fainter but still present.
Injection site became raised, red, warm to touch for a couple days, Then on the third day began to itch. itches for about 5 days, seemed better. Day 8 itchy, skin feels slightly thickened, definite  red area defined.
Swelling red hot area about 4" around below the injection site. Day 4 now shows slight decrease in swelling and size of red area.
#2 shot given a week early. no symptoms  reported by patient at the time of vaccination.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium
Patient stated that they began to have redness around the injection site the following day after vaccination.  They came to the pharmacy two days out and had redness the size of a piece of bread on their upper arm in the area of their vaccination.  Patient stated it was hot to the touch and obviously red.
No adverse reaction to patient noted.  Vaccine was administered 12 hrs after vial was punctured.
Cardiac symptoms: arrhythmias, tachycardia. Treated with beta blockers with little success. I'm still experiencing the symptoms.
pt recv vax 25NOV98 & 1DEC98 pt devel diarrhea w/bloody mucous & irritability;
pt recv vax 19JUN95 & 23APR97 pt devel a mild case of chickenpox;
EE woke up on 12/22/2020 experiencing diarrhea, facial flushing and swelling, lip/brow swelling, hands started swelling, edema, redness/rash. Patient was evaluated at local EC and was found to have low BP. EE was treated with Solumedrol, Benadryl, and Pepcid. Patient was discharged home from EC  after 2 hours with PO steroids x4 days.
Lightheadedness on 3/5/21 Soreness at vaccine site  Shortness of Breath Body Chills Fatigue Weakness Headache
Tested positive for Covid-19 had a runny nose; Drug ineffective; This is a spontaneous report from a contactable physician received via a sales representative. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first and second dose both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus. Concomitant medications were not reported. Physician's mother-in-law was visiting  and was able to get her the Pfizer Covid vaccine while here. She traveled back home to her country. She was exposed to her daughter who then tested positive for Covid. Mother, had a runny nose and felt fine. She tested positive for Covid-19 as well. The reporter was not sure how many days or weeks post 2nd dose she was until she was exposed, but she had a super mild breakthrough case. The mother-in-law is high risk for Covid. She had only Covid symptom and felt fine. The outcome of the event was unknown.   The event occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the reported events drug ineffective and COVID 19 are possibly related to PFIZER-BIONTECH COVID-19 VACCINE.
Information has been received from a physician concerning a patient who was vaccinated with a dose of ROTATEQ (date, dose number and dose not provided).  The physician reported he suspected that a patient developed intussusception after receiving ROTATEQ.  The outcome is unknown.  No other information was provided at the time of this report.  Upon internal review intussusception was considered an other important medical event.  Additional information has been requested. 10/15/09 Hospital records received for dates 6/22/08 to 6/25/08. DC DX: Ileocolonic intussusception. Presenting SX:Pt received  rotateq vaccine 6/13/08 on 6/22/08 presented to hospital with lethargy.  Decreased appetite, fussy, emesis x2. Testing revealed ileocolonic intussusception with a failed barium enema attempt. Pt underwent laparotomy reduction of ileocolonic intussusception plus appendectomy successfully. 10/28/09 Vaccination records received. Medical records received for dates 5/08-10/09. OV 5/13/08 well child exam WNL. Received total of 6 vaccines. OV 6/20/08 parent c/o pt. acting sick, irritable, decrease PO, distended stomach. OV: 6/27/08 f/u intussusception surgery. Pt. eating well, playing. OV 6/28/08 parents c/o pt. has fever, having trouble with BM. BM was hard prev day. Struggling this AM with BM. Fever noted by parents 6/29/08 pt. to f/u with specialist 6/30/08. OV 8/14/08 wellness exam. Parent c/o pt. has fever past 3 nights. CBC drawn. OV 9/3/08 parent c/o pt. fever 2 days, diarrhea since x3 days ago, no blood in stool, vomit x1, 3 days ago, decreased appetite.  Per parents went to ER. OV 10/31/08 wellness exam WNL.
Large erythematous area surrounded by larger, hard, circumscribed area Tender to touch + pain
On or about May 16th, noticed a lesion similar to that of the vaccine on the anterior aspect of this R foot. It was a raised, pus filled lesion NOT associated with any trauma to his foot. He then noted he had 3 other similar lesions 2 on his R leg (shin) and one on his R forearm, none of these lesions could be associated with trauma/bug bites etc, however the lesions on his legs were several days old and had been scratched during the work day and were not intact. We really didn't associate the lesions with the vaccine until the lesion on his foot appeared. He is meticulous about his hygiene and especially careful about his feet due to health issues as a child. Once we noticed the lesions we did contact the proper people and an ER doc friend of mine. No fever was associated with this. No malaise, some slight body aches. We did not seek treatment other than to observe and be mindful.