chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INCIDENT REPORT .  A 50 year-old male walked in at 11:59am to get vaccinated ( Pfizer 2nd dose). After 6 mins in the observation area, he started complaining of lightheadedness, weakness, ?feeling funny? and short of breath?.  He admitted he hasn't had anything to eat nor drink for the day and has been working all morning with this being his first experience of such symptoms post-vaccination.  PMH-nil. Meds- Ibuprofen. Psh-nil  Precautions taken : - -the patient was instructed to lay on the yoga mat while his Bp, pulse, and HR were taken.   -the patient was also given water, apple juice, and some snacks.  -Initial Bp range was between 160/100-160/96 after consecutive checks within the first 5 mins . No rigors or chills were noted.  -After 10 mins, blood pressure reading went down to 140/84 and finally 137/82 with a pulse ox  reading of 98%.  - He admitted to feeling better and resumed his duty at work. Patient was advised to see his Primary Care Physician for better health evaluation as well.   - Aprroximately , 4hours later , the patient came back in to the discharge unit and complained of extreme weakness, and dyspnea. Blood pressure reading stands at 160/104 mmhg and patient admitted to feeling worse.   -911 was called , on arrival they also got detailed history form the patient and checked his Bp, pulse and blood sugar which turned out to be 162/100, 98%, and 67 respectively.  - However, on request patient refused to go to the hospital despite pertinent findings. He was signed the refusal form and advised to go home and rest.  P.S- I got his contact for subsequent checking in.
Pt received pfizer vaccines on 4/14/21 and 5/5/21. Pt presented to the ED on 01/03/2022 with complaints of nausea, vomiting, and chest pain. Pt was found to be COVID positive.
Patient reports an increase in her migraines after her first dose. She reports an even higher incidence of migraines after her second dose. Since her second dose she has been having migraines daily.
I had a fever for about 4 days after the vaccine. About 2 days after that, I felt really tired. About a week after, I started to have abdominal pain and cramping. After that I had this dull ache under my right ribs where my liver would be. This lasted for a couple weeks, and I went to the doctor, and they suggested an abdominal ultrasound. They looked at it and didn't see anything there. So, I continued to have abdominal aches and something that seemed like menstrual cramps, but I knew it wasn't that. They ordered a vaginal ultrasound. They noted that the endometrium was thicker than it should be. We did a biopsy and that came back negative. I lived with that and then it faded away within a few months. During this same time, my toenail was blue on my left foot the big toenail. Especially in the morning I'd notice it. I was making sure I was hydrated, and every now and then the toe would be achy, and I'd take a walk to promote circulation. I mentioned this to the doctor, and they didn't say much. It would ache every now and then. By the time I got my booster, it was starting to go away, and it wasn't as noticeable. After the booster, it came back but faded again pretty quickly. When I had the abdominal pain, I also had GI problems. My stomach was upset, I had reflux which I've never had before. Heart burn which I've never had before. That has also gone away.
Lightheaded, BP, HR & SPO2 Taken 2 4:13p 132/92, 98%, 78, Reports being easily lighteaded, relieved after a fewww mins-hour. Pt stated that he has not eaten today. Advised Pt stated to eat. V/S taken @ 4:25p 120/75, 71, 98%.
SINCE THE DAY OF HER SHOT SHE STARTED HAVING STOMACH PAIN, NOT FEELING WELL, I THOUGHT SHE HAD THE FLU, ON THE 21ST, HOWEVER, SHE WAS TURNING GRAY, COULD BARELY RESPOND SO I TOOK HER TO THE ER, WHERE THEY SAID SHE HAD A GLUCOSE OF OVER 800 AND WAS CLOSE TO A DIABETIC COMA, SHE NOW HAS TYPE 1 DIABETES, 4 FINGER POKES AND 4 SHOTS EVERYDAY
BP 154/97; PO2 lowest 87%; body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch); Fever up to 102.5 F; pulse up to 136; body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch); body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch); headache; pain and mild swelling at injection site; pain and mild swelling at injection site; This is a spontaneous report from a contactable nurse (patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) Dose 1 via an unspecified route of administration, administered in the right arm on 09Sep2021 at 13:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included seizure disorder from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing (penicillin). Concomitant medications included levetiracetam (KEPPRA) for an unspecified indication, start and stop date were not reported; alprazolam (XANAX) taken for an unspecified indication, start and stop date were not reported; prn 1371 (PRN 1371) taken for an unspecified indication, start and stop date were not reported; torsemide for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Sep2021 at 03:00, the patient experienced fever up to 102.5 F, pulse up to 136, BP 154/97, PO2 lowest 87, body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch), headache, and pain and mild swelling at injection site. The patient was recovering from the events.; Sender's Comments: Based on available information and the close drug event temporal association, a possible contributory role of suspect product BNT162B2 to the development of events blood pressure increased, oxygen saturation decreased and weight bearing difficulty cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
improperly stored dose os PEDVAX; no adverse effects; This spontaneous report was received from a medical assistant concerning to an patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number N024570 with expiration date on 01-MAY-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis.  Administered doses of vaccine experienced temperature excursion below 36 degrees Fahrenheit (F) (32.1 F)  for 8 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Patient developed fever, chest pain, shortness of breath.  EKG demonstrates diffuse ST elevation and PR depressions suggestive of pericarditis.  Treated with IV hydration, NSAIDS, required medevac to definitive care. No additional terms added from Other Document rec'd 11/10/2005.
HIB dilute with wrong solution. No adverse reaction. DOB was listed on hardcopy form as 07/10/1980 for a child with a patient age of 2 years.
stomach was very upset , stomach is so bad; patient reported to be burping a lot and burped during the call, nothing is helping; hand started hurting; nauseated, I feels like vomiting but can't vomit; feverish after the booster too; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach was very upset , stomach is so bad), ERUCTATION (patient reported to be burping a lot and burped during the call, nothing is helping), PAIN IN EXTREMITY (hand started hurting), NAUSEA (nauseated, I feels like vomiting but can't vomit) and PYREXIA (feverish after the booster too) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011520A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal), Gas and Anxiety. Concomitant products included PANTOPRAZOLE for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 ABDOMINAL DISCOMFORT (stomach was very upset , stomach is so bad), ERUCTATION (patient reported to be burping a lot and burped during the call, nothing is helping), PAIN IN EXTREMITY (hand started hurting), NAUSEA (nauseated, I feels like vomiting but can't vomit) and PYREXIA (feverish after the booster too). The patient was treated with FAMOTIDINE for Nausea, at a dose of 20 mg. At the time of the report, ABDOMINAL DISCOMFORT (stomach was very upset , stomach is so bad), ERUCTATION (patient reported to be burping a lot and burped during the call, nothing is helping), PAIN IN EXTREMITY (hand started hurting), NAUSEA (nauseated, I feels like vomiting but can't vomit) and PYREXIA (feverish after the booster too) outcome was unknown.            This case was linked to MOD-2021-403284 (Patient Link).
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions and medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # reported as M044030 with expiration date on 13-JUN-2018 (dose was not reported). There was no adverse effect reported. Administered doses of the vaccine experienced the temperature excursion of 70 degrees Fahrenheit for 1 hour. Data logger was not involved in recording of the temperature excursion. There were no previous excursions reported. This is one of the several reports received from the same reporter. Additional information is not expected as there was no permission for further contact. Sender's Comments: US-009507513-1706USA010617: US-009507513-1706USA010618.
On Sunday, 10/16/2022 I started with a cough, head congestion, low fever and fatigue. I did a home test on Thursday, 10/20/2022 in the morning and the results were positive. My symptoms were a little worse at this time. I called my doctor on 10/20/2022 and she prescribed a cough medicine, and recommended MUCINEX. I am still recovering, but I will probably start feeling better over the weekend.
Information has been received from a physician concerning a 3 year old patient (gender unknown) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The patient experienced a mild case of chicken pox. Attempts made to obtain additional identifying information to distinguish the individual patients mentioned in this report were unsuccessful. This is one of several reports received from the same source. The patient's sibling (WAES# 0705USA001188) had a similar experience following vaccination with varicella virus vaccine live (Oka/Merck). No additional information is expected.
About 3-4 weeks after injection I have had  my eyes water without infection so bad it would leave sores on my eye lids. They were red and swollen. I now have eczema on both my palms . I have red bumps with pus that come and go. Also a fungal / yeast infection  in my pits. Inner thigh, under breasts.
Pain/swelling of left deltoid after 3rd Hep B vaccine on 5-20-15. Swelling, dizziness, SOB.
4 hrs after vaccine -had diarrhea, then vomiting; headache and some dizziness. No fever. No localized reaction.
Initial unsolicited report received from a nurse on 28-Nov-2017. This case involves a male patient of unknown age, who was vaccinated with 0.5 ml dose of FLUZONE QIV (batch number: U589DA, expiry date, dose, dose in series, route, site of administration were not reported), on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following vaccination the patient developed large red rash. Laboratory tests and corrective treatment were not reported. The event's outcome was not reported. List of documents held by sender: none.
No reaction after 15 min. of administration of vaccine. Patient returned to clinic approx 1.5 hrs. after presenting with red splotches on face and back of neck. Patient stated no other symptoms, i.e. no SOB, no itching, no fever, no pain. Patient reports no redness 10/23/2013 09:00.
Initially pain in arm severe and last a few weeks 06/19/2021 got sick with diarrhea, sore throat, earache, nausea felt like had the flu for several days was on a liquid diet of broth no medicines. 07/07/2021 started feel better with still scratchy though, no nausea or diarrhea.
Possible COVID breakthrough infection. The patient received COVID vaccines (Pfizer) on 3/7/2021 and 3/28/2021. He was tested positive for COVID on 5/1/2021 but is asymptomatic.
Redness in his arm; Pain / in his arm; Red papule on his arm; This case was reported by a consumer and described the occurrence of erythema of extremities in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced erythema of extremities, pain in arm and papule. On 18th December 2020, the outcome of the papule was recovered/resolved. On an unknown date, the outcome of the erythema of extremities and pain in arm were recovered/resolved.   The reporter considered the erythema of extremities, pain in arm and papule to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on left arm. The patient does not recall the specific day but he mentioned that vaccination was done at the beginning of November 2020. The patient experienced pain and redness in his arm and 3 weeks later developed a red papule on his arm. The patient wanted to know if red papule was a side effect or not. The reporter consented to follow up.
Shortness of breath with sudden onset. Seen at physican office .  Chest CT, Echo, PFT ordered.  Bilateral pulmonary emboli discovered . Eloquis started. Improvement seen. Sats and increased HR improved. Persistent coughing still remains. Patient to remain on Eloquis for 6 mon minimum .
Patient has a red raised rash in the shape of a circle near the tricep region of her left arm. It was confirmed that the injection was given in the deltoid muscle. She states her arm is very sore and the area is tender. She has been treating with ibuprofen and will be applying hydrocortisone cream.
Noticed right arm was sore in the night. In the AM of 11/7/00, arm was red at the injection site and to elbow. Also, was swollen, hot and painful. To Urgent Care for treatment with hydroxylzine HCI, Prednisone and diclofenac.
Became very dizzy in the morning after standing up, patient was not able to eat anything resulted to vomiting.
Dizziness, Headache, Fever, SORE ARM, CHILLS Narrative:
After administering Pfizer Bivalent 0.3mcgs. RN realized last dose of monovalent vaccine was administered on 08/11/2022. #rd dose administered too early. Asymptomatic at time of vaccination. Pt. was notified immediately.
pt recv vax 21OCT97 & c/o tingling feeling @ site;c/o soreness to lt deltoid area; 22OCT97 noticed redness & heat to area; 7x8x4cm redness & sl elevation;
Two days after receiving the vaccine, I experienced a sudden onset of fever of 100.3 degrees, chills and hot flashes, muscle aches and I also began vomiting until I no longer had any food or fluid in my stomach. I felt lethargic for about 5 days, and then begin feeling itchy and breaking out into hives that appear on my skin like scribbles, that I would later find out are a condition called urticaria that would appear on different areas of my body, and feel warm to the touch. My hands and feet also began to swell. I tried Benadryl (Diphenhydramine) 25mg OTC tablets twice daily for about a week but felt too exhausted to work so I ended that treatment. I would later try Cetirizine OTC tablets 10mg once a day and this has solution has stopped the symptoms but they are still present if I do not take the pill once a day. The symptoms have gotten better overall, but are still present if I do not take a daily Cetirizine tablet.
Patient received flu shot, was sitting on the bench and fainted. She was out for maybe 10 seconds.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 20Nov2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jul2022) Negative, notes: COVID test (PCR and home kit) tested negative on 29Jul2022; (30Jul2022) Positive, notes: But 30Jul2022, the home kit shows positive; (31Jul2022) Positive, notes: 31Jul2022 still shows positive with darker positive line. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course was reported as patient had COVID test (PCR and home kit) tested negative on 29Jul2022. But 30Jul2022, the home kit showed positive and on 31Jul2022 still showed positive with darker positive line. On 31Jul2022, patient started to have running nose and coarse throat and treatment of COVID-19 was given with Paxlovid. treatment start date=22Jul2022, treatment stop date=26Jul2022, lot number=1916517A.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Unexplained pain in leg/leg still hurts; NOse bleed; Severe headache/pressure headache; Shortness of breath; Felt like heart was racing/racing heartrate; Felt out of it/felt bad/feel horrible/I don't feel normal/this is worse than COVID; Congested; I am easily winded/couldn't walk long distances; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (NOse bleed), HEADACHE (Severe headache/pressure headache), DYSPNOEA (Shortness of breath), HEART RATE INCREASED (Felt like heart was racing/racing heartrate) and VACCINATION COMPLICATION (Felt out of it/felt bad/feel horrible/I don't feel normal/this is worse than COVID) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced FATIGUE (I am easily winded/couldn't walk long distances). On 22-Apr-2021, the patient experienced EPISTAXIS (NOse bleed), HEADACHE (Severe headache/pressure headache), DYSPNOEA (Shortness of breath), HEART RATE INCREASED (Felt like heart was racing/racing heartrate), VACCINATION COMPLICATION (Felt out of it/felt bad/feel horrible/I don't feel normal/this is worse than COVID) and NASAL CONGESTION (Congested). On 24-Apr-2021, the patient experienced PAIN IN EXTREMITY (Unexplained pain in leg/leg still hurts). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. At the time of the report, EPISTAXIS (NOse bleed), HEADACHE (Severe headache/pressure headache), DYSPNOEA (Shortness of breath), HEART RATE INCREASED (Felt like heart was racing/racing heartrate), VACCINATION COMPLICATION (Felt out of it/felt bad/feel horrible/I don't feel normal/this is worse than COVID), NASAL CONGESTION (Congested), FATIGUE (I am easily winded/couldn't walk long distances) and PAIN IN EXTREMITY (Unexplained pain in leg/leg still hurts) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
she has experienced pain in the arm when she raises her arm parallel to the floor; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Lot number: erh733) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid 19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she has experienced pain in the arm when she raises her arm parallel to the floor". No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. The nurse reported that on 04-FEB-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender from which their concurrent condition, medical history or concomitant medications were unknown. On an unknown date, the patients were vaccinated with M-M-R II (dose, route and dose number not provided) (lot no: K004949 with expiration date of: 04-APR-2016), the reporter also stated that the aforementioned vaccine was inappropriately stored. At the time of this report, no adverse events were reported and the outcome of the patients was unknown. The physician also reported that another unspecified number of patients were vaccinated with inappropriately stored VARIVAX (Merck) and PROQUAD (Merck) (please refer to MARRS No. 1503USA012150 and MARRS No. 1504USA005043). The physician reported that the earliest dose administered was on 21-FEB-2014, however it was unknown which vaccine was administered in this date. Additional information has been requested.
Well I had been diagnosed with microscopic hematuria prior to receiving the vaccine and after receiving the vaccine, I had to go into the hospital. While in the hospital I was diagnosed with kidney disease. I was diagnosed by a kidney biopsy while in the hospital. This was about ten days after my second dose of the Moderna vaccine. I have been on medications since then - Atorvastatin, Lisinopril, Prednisone, and prescription strength fish oil.