chrisvoncsefalvay/vaers-outcomes huggingface dataset:
breathing trouble; chills; nausea; fever of 103.5; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 06Mar2021 16:15 (Lot number: EN6205) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: Onset date: Long ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Time: 4:15 pm, Site and route of injection:, Anatomical site of Location: Right Arm, Route of administration: Intramuscular, Lot/Batch No: EL9267, Exp 31May2021, AE Term: 5 days, Onset date: 14Feb2021, AE Outcome: Recovered, Treatment: No, ), administration date: 13Feb2021, for Covid-19 immunization, reaction(s): "chills", "nausea", "horrible fatigue", "Ill for entire week", "trouble breathing". The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "breathing trouble"; HEADACHE (non-serious) with onset 06Mar2021, outcome "unknown", described as "headache"; CHILLS (non-serious) with onset 07Mar2021, outcome "unknown", described as "chills"; NAUSEA (non-serious) with onset 07Mar2021, outcome "unknown", described as "nausea"; PYREXIA (non-serious) with onset 07Mar2021, outcome "unknown", described as "fever of 103.5". The events "breathing trouble", "headache", "chills", "nausea" and "fever of 103.5" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dyspnoea.  Additional Information: After 2 dose patient once again had breathing troubles used my inhaler and was checked by a doctor on location. Approximately 1 hour after shot patient had a headache. On 07Mar2021, patient started chills, Nausea and had a fever of 103.5. patient said work on 08Mar2021 and 09Mar2021. patient did contact her PCPs office each time either I or my husband talk to employee working their answering service.   No follow-up attempts are possible. No further information is expected.
This case was reported by a physician via sales rep and described the occurrence of lichen planus in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced lichen planus. On an unknown date, the outcome of the lichen planus was unknown.  It was unknown if the reporter considered the lichen planus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced lichen planus one to two weeks after receiving SHINGRIX. The reporter agreed to follow up from GlaxoSmithKline.
Report describes epilepsy in an 8 month old male who received Infanrix. This report was received from the vaccinee's mother and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not specified. The infant received an injection of hep B vaccine at birth. In March 1997, the infant received an injection of Infanrix; it was not known if the infant had received previous injections of Infanrix. The infant also received "routine child imunizations" although, the mother was unable to recall which vaccines had been administered. Approximately one month post-immunization, in April 1997, the infant began to experience seizures. The infant was seen by a neurologist, who made a diagnosis of epilepsy. At 2 years of age, the child "would not talk." The child was seen by another physician, who made a diagnosis of autism in 1999, when the child was 3 years old. Treatment of the events was not provided. The epilepsy and autism were ongoing as of 02/22/2002. Information was received from the child's current pediatrician on 08Oct02. The Pediatrician indicated that the child was not under his care at the time of immunization. He stated, Autism and seizures may have been underlying conditions. He indicated that immunization had been delayed, but not discontinued.  Epilepsy and autism in this report are considered medically serious.
17JUL96 devel gen rash on body t103-suggested APAP & inc fluids, w/rest & quiet, taken to family MD s/s last over 5 days;
Child developed severe rash with red welts all over. Breathing remained unlabored. BP 90/60 was given Benadryl 2.3 mg IP hip and 0.15 epinephrine SC. Transported to ER via ambulance.
had swelling under her right arm down to her breast and on the back of her arm.; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (had swelling under her right arm down to her breast and on the back of her arm.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced SWELLING (had swelling under her right arm down to her breast and on the back of her arm.). At the time of the report, SWELLING (had swelling under her right arm down to her breast and on the back of her arm.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Nine days after receiving Menactra patient developed tingling in feet and face as well as low back pain.  He presented to Hospital and was sent home.  His symptoms continued and he began to c/o weakness in his lower extrmities.  On August 10th he presented to Hospital ED and was admitted.  Subsequently he has developed dysphagia to solids, but has not had any respiratory compromise.  He remains hospitalized. Follow-up data received 12 September 2006 indicates a diagnosis of Guillain Barre Syndrome.  See attached discharge summary.
MOTHER REPORTED SWELLING AND REDNESS TO INJECTION SITE THAT STARTED 10/21/2015 EVENING.
The patient presents with tics and compulsions that began several days ago.  Pt. received his flu shot on Tuesday 10/12 am.  Four hours later, he began having head tics (moving head to right side).  He started having an arm tic as well.  They were seen by their PCP and told to monitor over the next few days but by Tuesday evening, patient was constantly moving around, feeling as though he had to continually go touch the fence, then the wall, etc.  His tics resolve when he is sleeping.  However, mother states that he has been upset and cying because he can't get the tics to stop. He has had no fevers, V/D, headache, sore throat..
DAY AFTER VAX, PT'S ARM SORE. NEXT 2 DAYS STILL SORE. 2-16-90 SHOULDER AND SHOULDER BLADE ACHING, BACK OF NECK STIFF, HEADACHE, TENDER UNDER AER.  NO REDNESS OR FEVER. ASPIRIN TREATED. SYMPTOMS RESOLVED 2-18-90.
Vaccine expired 11-21-22, bottle unlabeled. Pt notified and no adverse reactions noted by pt. Pt advised would need to be be revaccinated but refused at this moment
After the second Pfizer shot, I had no reactions until 12 hours later. After 12 hours (1am), I woke up and my skin/body was achy, which lasted about 24+ hours. I was tired and napped and slept 12 hours that next night. I didn't have a registered fever, but I was cold and had long sleeves/pants and blankets on me while it was hot outside (high 70's/low 80's).  The one symptom that I don't hear about and scared me, was when I breathed normally, I didn't notice anything, . . . but when I tried to take deep breaths, it felt like there was an elephant sitting on my chest. This breathing difficulty started at about 30 hours after the second shot (8pm). By the morning time, it was a small elephant, and by 48 hours after the second shot, it seemed to be mostly gone.  This one scared me while it was happening and I was praying hard!  I felt the pressure on my chest like COVID patients, but thankfully, it only lasted a short time.  I still haven't met someone who had the shortness of deep breath and chest pressure after the second Pfizer shot, like I did.
Wheals on face, (L) arm, (R) arm, mild swelling to (L) hand, wheals on (R) hand, chest, abdomen, (R) leg, (L) leg (erythematous wheals more pronounced on (L) thigh and (R) thigh). Appeared 24 hrs. after administration of DTaP, Hib, MMR. Prescribed MILLIPRED 10/5mL 1.25 mL po BID x 5 days. Rash resolved 3 days after appearing.
PATIENT 15 AT TIME OF IMMUNIZATION - EUA FOR 16 AND OLDER.
A few weeks after second dose I developed nausea, extreme fatigue, headache, temperature regulation issues, chest pressure and diarrhea. I thought it was food poisoning at first, but these symptoms have become recurrent at least once a month since. Slightly irregular periods as well.
Patient reported tension across the entire back in deltoid and trap muscles about 5 days post injection. Noted rigidity moved to right should area after seeing Chiropractor.
This spontaneous report was received from a registered nurse referring to 7 unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On 29-OCT-2015, the patients were vaccinated with doses of MMR II, lot # L009212 with expiration date 17-MAR-2017, (dose and route of administration were not provided); which had been exposed to a cumulative of 10.9 C for 7 hours and 28 minutes. On the same date, an excursion of 8.9 C for 1 hour and 9 minutes, brought the cumulative to 8 hours and 37 minutes. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
patient reported having mouth sores after getting the vaccine. however, patient is on chemotherapy and getting mouth sores from chemotherapy so this is unlikely to be vaccine related.
Invalid dose given as multi dose Typhoid  vial licensed for 20 doses,  dose patient received is number 22. Dose drawn exceeded dose limit for multi dose vial. Computer inventory glitch noted and now rectified.
caller had pain and swelling in her right arm from the shoulder to elbow for 5 days and since then has had pain from the shoulder all the way to fingers; physician thought this was a chemical injury to the vaccine; caller had pain and swelling in her right arm from the shoulder to elbow for 5 days and since then has had pain from the shoulder all the way to fingers; This spontaneous report as received from a 79-year-old female patient concerning herself with gastrooesophageal reflux disease.  There was no information about the patient's medical history. Concomitant therapies included famotidine (PEPCID).     On 02-AUG-2021, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 0.5 milliliter in the left arm for prophylaxis (route of administration, lot number and expiration date were not reported).  On 06-AUG-2021, after receiving the vaccine, the patient experienced had pain and swelling in her right arm from the shoulder to elbow for 5 days) and since then had had pain from the shoulder all the way to fingers(pain in extremity, and peripheral swelling). The patient stated sometimes it was bad, sometimes not so bad. The patient mentioned that her physician thought this was a chemical injury (chemical burn) to the vaccine. The patient was treated with hot/cold compress and exercises. The patient sought unspecified medical attention.  The outcome of pain in extremity, peripheral swelling and chemical burn was reported as not recovered. The causality assessment for the events was not reported.
3 DAYS AFTER 2ND DOSE OF ENGERIX-B, PT EXPERIENCED PAIN IN SHOULDER. EVENTS RESOLVED WITHOUT FURTHER TREATMENT.
Noted low grade fever (later that evening of injection) x 2 days which has entirely resolved. Since that time has noted bilateral lower extremity edema which has become pitting over the past several days---states 11 pounds of water weight since edema noted. She was assessed at a local urgent care center yesterday for work up and evaluation. No chest pain or SOB. Currently still has this condition.
At approximately 2:00 pm his arm started feeling bad, but he kept working in the yard until 7:00 pm at which time he went inside and took a shower. His arm was swollen and he started getting chills. Monday he was better, but today he still feels a headache and he can't sleep on his arm.
I experienced a blood clot in the right side of my brain and I had a stroke. I am always weak and tired easily, memory loss, confusion.
HE GOT A STOMACH ACHE AT 8:00 PM ON WED NIGHT, THEN AT 12:30 AM HE WAS HALLUCINATING AND HAD A FEVER OF 100 DEGREES AND FELT DIZZY.  THEN AT 6:00 AM HE THREW UP.  I CALLED THE DOCTOR AT 12:40 AM AND HE SAID TO WATCH HIM.
Received shot 9-19 4pm -(R) arm hurt to touch. Fever 102 degrees, sweats, chills, 2 wk off work - throwing up went to Dr. ran blood test/urine, ct scan, pelvic/rectal exam, went to hospital tested for HIV/TB all (-) - went to infectious disease - has hives Dr. states its an allergy to the flu serum. Pt allergic to red ants, latex, alcohol and bee stings. Put in hospital on Sat. now having breathing problems.
Plugged ear, hearing loss; audiologist 10/15/2014 showed mild/moderate conductive hearing loss from fluid which will require tube placement and bilateral mild sensorineural hearing loss irreversible.
Continued sensitivity & "nausea" in arms and chest similar to first dose, but more continuous.  About a week or so after, extreme fatigue and body weakness began and never stopped.  Weakness/shakiness/tremorlike tingling body/arms/legs.  It would come and go mainly in arms at first.  Now it is constant all over body and it never goes away- 2 months.  The muscle weakness is debilitating. First tingling/weakness/shakiness, followed by numbness in arms and legs, mainly right leg.  Also arms started falling fully asleep and numb at night while sleeping.  During day constant muscle and body weakness/tingling - is constant and almost unbearing.  Feels like bugs are crawling under skin all over body, fatigue, numbness, (pins and needles come and go, very "elective" kind of surges through.  Sometimes remains and fades).  Newest symptom as of only a few days ago, pain in elbows, upper arms, knees, legs, shins, lower back, shoulders, back.  Achy pain and burning pain.  Pain is new, came before the Burning pain, which is the latest.  I imagine these pains are my muscles dying.    Muscle Atrophy per ER 3/21/21 visit.
Dizziness; Patient could not stand up; Patient had no energy for 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DYSSTASIA (Patient could not stand up) and ASTHENIA (Patient had no energy for 3 weeks) 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.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced DIZZINESS (Dizziness), DYSSTASIA (Patient could not stand up) and ASTHENIA (Patient had no energy for 3 weeks). At the time of the report, DIZZINESS (Dizziness), DYSSTASIA (Patient could not stand up) and ASTHENIA (Patient had no energy for 3 weeks) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided. Patient stated that he is fine and got his 2 dose of vaccine and no longer needs a follow up.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Event outcome updated from unknown to recovered/resolved.
chills; fatigue; headache; nausea; memory brain fuzzy; appetite loss; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache), NAUSEA (nausea) and MEMORY IMPAIRMENT (memory brain fuzzy) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache), NAUSEA (nausea), MEMORY IMPAIRMENT (memory brain fuzzy) and DECREASED APPETITE (appetite loss). At the time of the report, CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache), NAUSEA (nausea), MEMORY IMPAIRMENT (memory brain fuzzy) and DECREASED APPETITE (appetite loss) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product reported, but unknown: t zone twice daily, pill  No treatment products reported
High fever (to 103) and fussy. Started about 4 hours after vaccine and lasted about 15 hours total. No treatment needed.
Post 12 hrs the site swelled, warm and red 3 1/2 inches x 2 1/4 inches encompasses deltoid area, indurated, net to tough. Continued to swell over 24 hrs no relief with cold compress, Benadryl-was given oral prelone 1 tsp qd x 3 h.
vaccine was administered around 2:35pm patient began to show signs around 2:38pm, patients face was turning red, difficulty breathing, tightness in her chest, and tightening of her muscles.   An epi pen was given at 2:40 pm in the right thigh. patient stated after epipen she felt calmer but was still feeling chest tightness. Paramedics arrived and patient was taken to hospital.
Patient reports swelling, redness, itching began night of injection (seen in afternoon for appt) with cool compresses tried
Rapid Heart Rate for 4 hours on Sunday night.  Local hospital indicated all rooms and ER was full with Covid patients, so I contacted Emergency After Hours contact through my Family Physician.  Discussed with them, and stopped my arrhythmia to normal.   I still had headache and 102 fever, but I expected those side effects for a few days.  Those side effects went away by Monday afternoon, Jan. 18th, but I did do a Covid test at the Dr. office on 1-18, and tested negative.  That is when the Dr. Office advised me to not take the 2nd vaccine, due to the rapid heart rate (arrhythmia).
Patient c/o rapid heart rate about 40 minutes after vaccination. HR was 140. No other symptoms--no CP, no SOB, no dizziness.
Fever 100.3 for 2 days, severe muscle soreness and fatigue for 36 hours, general fatigue for 48 hours.
DIED; CLOTS BLOOD; This spontaneous report received from a consumer via a company representative through media  concerned a male of unspecified age, 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 was not reported, and batch number: unknown, expiry: unknown) dose was not reported, start therapy date were not reported, 01 total was administered 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 after vaccination, the patient developed blood clots, and on an unspecified date, 04 weeks after vaccination, the patient died due to unknown cause. It was unspecified if an autopsy was performed or not.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of unknown cause on an unspecified date, and the outcome of clots blood was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0:202202239471-Covid-19 vaccine ad26.cov2.s-Died,clots blood.The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
About 24 hrs after injections, sxs started- nausea, sweats, joint aches, slowly resolved over next 48 hrs. 72 hrs later, she still has a very red, swollen, tender arm.
Chills; Lack of energy; Fever; This is a spontaneous report received from contactable health care professional (patient) works in hospital setting via company representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19, lot number not reported), on unspecified date as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced chills, lack of energy and fever. It was reported that the events took place after the use of the product. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt came to pharmacy 10/14/15. Pt's arm (right) became very red about 3.5 inch around injection site. She stated  itchy and hot.
A non-serious spontaneous report of administered expired FLUMIST was received from a health professional concerning a 11-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 04-Mar-2012. On 19-Mar-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 16-Apr-2012: No late occurring adverse events were reported.
This is a vaccine administration error. Patient previously obtained influenza FLUAD immunization 9/7/23. She received and other influenza FLUAD immunization 10/5/23. She is not experiencing any adverse effects.
episode of amnesia, occurring on 16 Feb 2021 for about 30 to 45 minutes, (no recall of memory to this time);  mild confusion/sluggish thinking lasting  about 24 - 36 hours afterwards..  No physical droopiness or paralysis; negative work-up for stroke done in ER,  TIA could not be ruled out.
Fever (100.9 degrees) started about 11pm April 9 and lasted until 8:00pm April 10