chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 nights having nightmares; waking with rapid heart rate; This is a spontaneous report from a non-contactable consumer (patient). A70-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the left arm on 30Jan2021, at 14:30 (age at vaccination: 70 years) as a single dose for COVID-19 immunisation. The patient medical history included IgA blood deficiency, hypothyroidism and allergy to horse serum. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The concomitant medication included levothyroxine sodium (LEVOTHYROXIN) at 88ug daily, monascus purpureus (RED YEAST RICE), glucosamine hcl + msm (glucosamine hydrochloride;methylsulfonylmethane), calcium, fish oil, loratadine (CLARITIN), minerals nos, vitamins nos (ONE A DAY). The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that during the 2 weeks after the first dose, the patient experienced 5 nights having nightmares and waking with rapid heart rate on 05Feb2021. The patient did not receive any treatment for the events. The events were reported as non-serious by the reporter. The outcome of the events 5 nights having nightmares and waking with rapid heart rate was unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient was vaccinated with the first dose GARDASIL on 17-AUG-2007, the second dose on 19-DEC-2007, and would receive 3rd dose on 09-AUG-2012. Vaccine lot # and route were unspecified. No adverse effect was reported. Additional information has been requested.
Hospitalization Patient admitted here transitional care following testing positive prior to proposed d/c to SNF.
COVID-19 Pfizer BioNTech EUA Felt light headed, dizzy, parent helped him sit on ground, laid down, drank water BP 126/76 P 80
This case was reported by a healthcare professional and described the occurrence of hives in a 7-year-old female subject who was vaccinated with Havrix, for prophylaxis. The subject has no significant medical history, no concurrent conditions and no history of drug allergies. The subject was not receiving concurrent medication. On 23 August 2006 the subject received 1st dose of Havrix at 720 elisa units, intramuscularly, in the left thigh. An unspecified amount of time following administration of Havrix, on 23 August 2006 (same day of vaccination), the subject developed hives on her left leg only. At the time of reporting the event was unresolved. Follow-up information was received on 18 September 2006. According to the vaccinating physician, the subject experienced hives and urticaria on 28 August 2006, five days after vaccination with Havrix. The events resolved on 04 September 2006. As a result of the events, the immunization series with Havrix was discontinued. The reporting physician considered the hives and urticaria were related to vaccination with Havrix.
systemic manifestations including orthostatic hypotension; malaise & elevated temp 102.1; had preceding viral synd w/dehydration;
Large injection site welt; Large injection site welt, very red; Large injection site welt, very red with heat and pain.; Large injection site welt, very red with heat; Small slight discoloration on arm.; Dose received: 3; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 23Nov2021 at 09:30 (Lot number: FH8020) at the age of 55 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Breast cancer metastatic" (unspecified if ongoing), notes: Breast Cancer metastasized to the bone. Concomitant medications included: XGEVA, start date: 12Nov2021, stop date: 12Nov2021; ALEVE; LETROZOL and CLARITIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EN6205, Route of Administration: Unspecified, Anatomical Location: Right arm, Time of Administration: 14:00), administration date: 02Mar2021, when the patient was 54 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE, Lot Number: EN8733, Route of Administration: Unspecified, Anatomical Location: Right arm, Time of Administration: 14:00), administration date: 23Mar2021, when the patient was 54 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021 at 09:30, outcome "unknown", described as "Dose received: 3"; VACCINATION SITE REACTION (non-serious) with onset 23Nov2021 at 16:00, outcome "recovering", described as "Large injection site welt"; VACCINATION SITE ERYTHEMA (non-serious) with onset 23Nov2021 at 16:00, outcome "recovering", described as "Large injection site welt, very red"; VACCINATION SITE PAIN (non-serious) with onset 23Nov2021 at 16:00, outcome "recovered" (an unknown date in Dec2021), described as "Large injection site welt, very red with heat and pain"; VACCINATION SITE WARMTH (non-serious) with onset 23Nov2021 at 16:00, outcome "recovered" (an unknown date in Dec2021), described as "Large injection site welt, very red with heat"; SKIN DISCOLOURATION (non-serious) with onset 23Nov2021 at 16:00, outcome "recovering", described as "Small slight discoloration on arm". Therapeutic measures were not taken as a result of vaccination site reaction, vaccination site pain, vaccination site warmth, vaccination site erythema and skin discolouration.  Additional Information: The patient did not have any physical allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The large injection site welt, very red with heat and pain expanded to 3 inch diameter. Three weeks later, the heat and pain went away. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Pt was administered the MCV4 vaccine @ 1000 on 7/8/2021, about 2000 on 7/8/21, pt complained about low grade fever of 100, and b/l UE and b/l LE pain. pt went to sleep, woke up about 2200 and then could not sleep well the rest of the night. Was up on 7/9/21 about 0630 with sxs of Diarrhea and still having b/l UE and LE pain still with a low grade fever. Advised mother to take pt to the ER to be evaluated.
patient felt tired (worse with 1st) after 1st and 2nd doses of anthrax-after second patient developed erythematous rash on trunk along with itching 1-2 days after 2nd dose-no other systemic symptoms.
pt recv vax;6cm area of hyperenia & warmth;tx w/ moist heat;
101.4 fever swelling at injection sight vomiting diareah chills headache sore joints.
Left thigh with erythema, tender to touch visible puncture wound from PREVNAR 13 with small knot under puncture site.
At 4 hrs post Prevnar and HIB R thigh developed swelling 21cm R thigh vs. 18.5 on left with screaming, hard to console.
Patient returned to pharmacy on 12/14/21 due to arm. Vaccine was on 12/01, patient states had arm soreness for a few days which resolved then noticed on 12/11/21 that arm had rash/sore/scabs. Patient reports no changes over the last 3 days. Patient has area around injection site that is red, scabbed over, with scarring in some areas. Patient denied any itching, fever, swelling, pain at the site.
Shortly after receiving the vaccine, patient fainted, became hypotensive and bradycardic. Additionally he vomited and urinated. On recheck his blood pressure and HR had returned to a normal value. He declined going to the ED and left after feeling better NauseaVomiting, HYPOtension, Syncope, Bradycardia & urination
Seizures; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a female patient who received DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown.   The reporter considered the seizure to be related to DTaP vaccine.  Additional details were provided as follows: The age at vaccination was not reported Reporter daughter reacted to DTaP, when she was a baby. Seizures abd the like. However, when reporters daughter was older, reporter went back and got her vaccinated. She didn't react that time.
This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feel pretty ill), PYREXIA (I ran a fever of 101) and PYREXIA (Have a fever of 101.5) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PYREXIA (I ran a fever of 101). On an unknown date, the patient experienced MALAISE (Feel pretty ill) and PYREXIA (Have a fever of 101.5). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (Feel pretty ill), PYREXIA (I ran a fever of 101) and PYREXIA (Have a fever of 101.5) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 101 (High) High. On an unknown date, Body temperature: 101.5 (High) High. No Concomitant medication was reported.
Shot was put in the very top of my arm, in my shoulder.  Excruciating pain when given and for some time thereafter.  Able to drive home one-handed.  Taking extra celecoxib, heat, resting has provided some improvement but still having problems 3 weeks later.
Shoulder pain and swelling down near elbow, muscular (all body) pain , shivering, mild headache, mild nausea all effects lasting 4-5 days (same effects as 1st shot 2 months previous)
Prior to the tetanus shot, the patient was very active and alert, doing word searches, Bible study and reading, watching TV, going out to eat with family and friends, etc.  Since the shot was given, she has become confused and keeps falling asleep more often while eating at the table, reading the newspaper, watching TV, etc.  She fell asleep in church two Sundays in a row with her head on her lap and has fallen asleep at home while sitting in her chair quite often.  She fell asleep while folding clothes, fell to the floor, and bruised her legs.  She was admitted to the hospital and everyone was informed that she had received the tetanus shot.  It was not as noticeable at first but has progressively become worse.
Sugar taste in mouth with injection, sore arm. 10 hours later, onset of fever (104 degrees). Severe headache, body aches, brain fog. Taking advil and tylonol.
This spontaneous report was received from a physician via company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 28-JUN-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. "10 PK 0.5 mcg/0.5ml SDLLolCap Ped" and lot number L023387 with expiration date of 22-JUN-2017 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 88 hours with a lowest recorded temperature of 33 Fahrenheit (F) (0.555555556 Celsius (C)) and other one of 80 hours with a lowest recorded temperature of 34 F (1.111111111 C). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
19-year-old male presents with headache, body aches and subjective fever following second COVID vaccination.  She received a vaccination 2 days ago, and yesterday developed acute onset of generalized body aches, mild, constant with gradual onset of bitemporal frontal pressure headache, similar to priors.  He also reports subjective fevers but has not checked his temperature.  He took Motrin yesterday with some improvement.
A 45 year old male patient received an intramuscular right deltoid injection of FLUZONE (lot number U2847AA) on 21 October 2008 at 8:40 pm. Approximately four hours post vaccination at 8:00 PM, the patient developed chest tightness which lasted about an hour and also complained of a sore throat. The patient did not report any shortness of breath. The patient was not recovered at the time of the report. List of documents held by Sender: None.
This spontaneous report has been received from a nurse referring to a 23 month old male patient. The patient's medical history, concurrent conditions or concomitant medication were not reported. On 22-MAR-2017, the patient was vaccinated with an expired dose of M-M-R II (which had the lot number reported as L0939213, expiration date 17-MAR-2017) (dosage information, route or anatomical site of vaccination were not informed) for prophylaxis. No adverse effects were noted. And there was no product quality complaint involved. This is one of two cases from the same reporter. Additional information is not expected, since the physician cannot be contacted.; Sender's Comments:  US-009507513-1703USA011903:
cramps; possible bacterial or yeast infection; discharge; arm itching; arm feeling like fire; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm itching), FEELING HOT (arm feeling like fire), MUSCLE SPASMS (cramps), INFECTION (possible bacterial or yeast infection) and DISCHARGE (discharge) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PRURITUS (arm itching) and FEELING HOT (arm feeling like fire). In May 2021, the patient experienced MUSCLE SPASMS (cramps), INFECTION (possible bacterial or yeast infection) and DISCHARGE (discharge). At the time of the report, PRURITUS (arm itching), FEELING HOT (arm feeling like fire), MUSCLE SPASMS (cramps), INFECTION (possible bacterial or yeast infection) and DISCHARGE (discharge) outcome was unknown.            Concomitant medications were not provided. Treatment medication includes Vaginal gel as treatment.  After the second dose, the patient reported her arm itching and feeling like fire. Patient reports in May experiencing cramps, discharge and possible bacterial or yeast infection still waiting for results from her doctor.No concomitant medication were given by reporter.
TC 1/30/2023 from client to PHN cell number. Client reports that R arm is slightly swollen, red, and slightly warm to touch. It is 'crazy itchy' On inquiry, client reports no lesions or rash. Client reported applying 'after bite' cream 1/30/23 am but that it did not seem to help and wondered if she should wash it off.  A: Local reaction that can be expected of Shinrix. Discussed the typical side effects of the vaccine. Encouraged that if worsens (more swelling, rash or sores, increased discomfort) to call back to PHN and/or primary care. Always an option to checkinwith primary care and let them know reaction for their advice and to have on medical file at clinic. Supportive care: acetaminophen/ibuprofen/apply ice as needed for discomfort. Discussed safe ice pack use. Encouraged to try 'not to' itch to avoid increased irritation and not apply further creams or ointments unless primary care advises. Option to try benadryl/diphenhydramine OTC for relief of itchiness. If worsened client to call PH and/or primary care. Informed about VAERS and option to self-report. PHN let supervisor and clinic lead know of call & documentation in progress.
At time of vaccine (04/07 11:45 AM) was light-headed and had shoulder pain at injection site but no other adverse effects during observation period.  While driving home, had some tingling/numbness in left arm and knees with persistent pain in shoulder.   Felt fine other than shoulder pain and slight headache until that night. I went running after finishing work (around 7 pm) and started experiencing intense tingling/numbness all down left arm to hand as well as intense knee pain not typical during running, at which point I stopped running and went home. When I got home I noticed my left index finger had lost circulation (was white).   That night I experienced moderate but increasing fatigue as well as chest pain and tightness. My hands both felt numb like they fell asleep/lost circulation, as well as my left arm and feet.   The next morning I felt better but the fatigue and numbness in my hands and feet started up again around 10 am and lasted for several hours. I had some chest pain that night (around 11 pm) and a headache on and off throughout the day.   Today (04/09) I felt completely fine. I did start my period the day before my vaccine (04/06) and was having heavy bleeding/cramps that day and a bit throughout the time described above.
Case number PHEH2016US033492, is an initial spontaneous report received from a consumer on 15 Dec 2016. This report refers to a male patient. Historical condition included stroke. Current condition included cancer. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) on an unknown date. On an unknown date after vaccination, the patient experienced dizziness and muscle aches. The patient went to emergency room on an unknown date. The outcome, seriousness and causality of the events were not reported. Seriousness assessment of the event dizziness was upgraded based on information available in the source document.
local erythema, edema-both encompassing lt thigh 10-12cm radius;
Janssen COVID-19 Vaccine EUA .. Super sore for over 24 hours. Lost sense of smell and taste for a short period of time. Cotton mouth and wasn't dizzy but had a weird feeling in my head I never felt before.
TWELVE HOURS AFTER VACCINE ADMINISTRATION, PT REPORTED EXTREME CHILLS AND TREMORS THAT LAST 3 TO 4 HOURS IN DURATION
Moderna COVID?19 Vaccine EUA.  After my second dose of the Moderna COVID19 vaccine I started with the same reaction as the first, a mildly sore arm.  After showering at the end of my day I was hit by fever and chills, this is around 12:30 am, not an unusual time for me to be up.  Fever broke around 5am, shortly after I was feeling better and ready for food.  My girlfriend and I then set out on a long drive (we had been visiting family and were now heading home), I was fatigued but who wouldn't be after a feverish night.  Due to a stressful driving experience (she was driving not me for obvious reasons) we decided not to do the 10hr drive in one shot.  We checked into a hotel around 8:30pm and I got hit with a fever and chills again.  Why I'm making this report:  My girlfriend (who had not just gotten a vaccination) agrees with me that the locations where I got worse were cold (at least to us).  We are accustomed to this heat and our home is set at 78 degrees F.  The Hotels we stayed in were set a 72; I don't have a lot of fat, not ill I still shiver at 72.  IS IT POSSIBLE COLD ENVIRONS CAN EXACERBATE SIDE EFFECTS?
Patient was given inital dose of Tdap on 06/04/09 and was give a 2nd dose on 06/29/09.
I got my shot on the 19th and that evening it was like a light switch and I was so tired I went to sleep at 730pm I had severe chills and fever and had to go to bed. The next day I still wasn't feeling well and I was called in to get covid tested and I went to the ER on the 21st and took a rapid covid test that was positive. I was stable and had good oxygenation and was discharged. I have fever nausea vomiting  I also had problems with O2 stat i was in the 80s and realized I was having respiratory failure so I was admitted on the 27th and I've been here ever since. I had kinetic storm and infusions my O2 stats were bad and I was sent to the covid unit and put on high flow oxygen and negative for a PE, I'm still on the covid unit but I feel much better today
Patient became anxious, dizzy, and SOB. Pt was found to have 02 saturations that dropped in the 80s momentarily, but resolved after zyrtec was given and was observed for an additional 45 minutes.
Sharp pain radiating down upper arm when administered. Severe upper arm pain later that day. Periodic jolt of pain down entire arm with movement and then numbness. After 6 months went for Dr. visit. Physical Therapy authorized. Received 12 weeks. Improved ROM but still have pain.
Fever, body ache, swollen lymph nodes, nausea, red bumps all over body, cold sweats, chest aching.
Information has been received from a registered nurse concerning a 12 month old Caucasian female with no known allergies who on 14JUL2003 (also reported as 13JUL2003) at 9:00 AM was vaccinated SC in the left thigh with a 0.5ml first dose of varicella virus vaccine live. Concomitant vaccination on the same day at 9:00 AM included a fourth dose IM in the right thigh of Streptococcus peneumoniae vaccine (PREVNAR). Other concomitant medication started on 14JUL2003 included ferrous sulfate (Fer-in-sol) (previously reported as there was no other concomitant medication). On 21JUL2003 at 14:15, the mother called the doctor's office to report that  her child developed 4 to 5 vesicles on the trunk and extremities which were "non-itchy, "had a temperature of "99 axillary" and crankiness. The reporter also indicated that the patient had been seen at the office on 25JUN2003 for "atypical varicella." The patient was not hospitalized. Unspecified medical attention was sought and no prescription drug treatment was required. There were no laboratory results or diagnostic tests. It was noted that the patient and her siblings had no known adverse events following prior vaccination.  A product quality complaint was not involved.  Follow up information was received from the registered nurse which indicated that on 24JUL2003 the mother reported that all the vesicles scabbed expect for one on the lower leg. The mother will monitor for signs and symptoms of increased inflammation and pain and follow up as needed. Additional follow up information that the patient had recovered. No further information is expected.
This spontaneous report was received from a pharmacist concerning a patient of unknown gender and age. On 06-MAR-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K00726, expiration date: 09-JAN-2015), 0.65 ml, subcutaneous. No adverse effects was reported. Additional information has been requested.