chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received flu vaccine on 10-1-13. On 10-7-13 I had an adverse reaction from the flu vaccine which caused paralysis in my legs, feet, arms and hands. It also caused respiratory issues.
Narrative:  64-year old male patient with a PMH of HTN reported to his primary care doctor he had small chicken pox eruption on his stomach, itching and burning for 2 weeks after he received first dose of Shingrix vaccine. Denied any difficulty in breathing. He used calamine lotion to relieve symptoms. He was schedule for a second dose in December and wanted to ask his primary care doctor if he should get it. The primary care provider stated it was difficult to diagnose the rash since she did not have the change to see the rash. Additionally, Shingrix does not cause shingle-like rash. Rash may have been urticaria but she recommended the patient not get the second shot due to symptoms and the patient already got love zoster in 2017.
Significant increase in heart rate.  From my fitness watch, I had 15 hours and 50 minutes of "fat burn" that occurred  yesterday (2/2).  Today (as of 4 PM )11 hours and 40 minutes.  The only time my heart rate returns to normal is when I'm sitting still.  I also have chills and heat flashes with some body aches.
Pt suffered a pulmonary embolism 3 weeks after 2nd dose Moderna
24hrs later felt fatigued like a cold was coming on.  7 days after 2-3? red spot with slight puffiness at injection site.
Developed acute cerebellar ataxia with nystagmus approximately 8 hours after the injection, which lasted  approximately 12 hours
pt recv vax 24MAR98 & on 25MAR98 had fever 102, cough & runny nose x 2-3 days;5APR98 devel red blotchy rash on face & trunk hwich lasted 3 days;
No additional AE reported.; dose of PROQUAD was administered after a temperature excursion; This spontaneous report was received from a personnel and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 02-SEP-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot #W017570, expiration date: 29-NOV-2023 (strength, dose and route of administration were not provided) for prophylaxis (Product storage error).  On an unknown date, before the administration, vaccine underwent temperature excursion at 5.7 Fahrenheit degrees (F) for 30 minutes. Previous temperature excursion occurred on an unknown date, with 6F to 14F temperature for 1 hour and 6 minutes. Another prior temperature excursion occurred on 18-JUL-2022, with 6F to 14F temperature for 1 hour and 8 minutes. No adverse events were reported (No adverse event).
injection arm was warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection arm was warm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection arm was warm). At the time of the report, VACCINATION SITE WARMTH (injection arm was warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-318263 (Patient Link).
Student c/o dizziness after H1N1 vaccine given. Sprite given, but student continues to c/o dizziness. Mom called. Student left with mom in no apparent distress.
Feeling dizzy and headache shortly after taking the flu shot, and the symptoms lasted 4-5 days.
This initial non-serious spontaneous case, was received on 08-Aug-2017 from other non-health professional and concerns a 22-year-old female patient. The medical history of the patient was not reported. The concomitant medications included EXCEDRIN MIGRAINE, ZYRTEC and medications for birth control. On 05-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration, anatomical location, batch number, expiry date: not reported). A couple of hours after receiving the vaccine, the patient experienced blurred vision of left eye and lightheadedness. On 06-Aug-2016, the patient woke up with migraine. The treatment medication included EXCEDRIN MIGRAINE. On 07-Aug-2017, the patient again experienced blurred vision of left eye. It was reported that the events resolved on 07-Aug-2017. Significant case correction received on 05-Sep-2017: As determined causality of the event migraine was changed from unassessable to not related and case comment was updated accordingly.
Syncope reaction following second vaccination. Patient lost consciousness and fell out of chair hitting his head on the floor. Patient quickly regained consciousness. Kept him on his back with legs elevated while waiting for EMS. Took BP which was around 120/80 and gave Patient some water. Paramedics took it from there.
Symptoms started 9 hours after injections.  Symptoms included fever, chills, fatigue, nausea.  Symptoms lasted about 30 hours.  Treated with Motrin and Tylenol
doesn't have a thyroid; This is a spontaneous report from a non-contactable consumer (patient's mother). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the ER doctor told the reporter to call Pfizer Medical Information to find out if her daughter should get the second shot due to adverse reactions to the first shot. The reporter stated that her daughter doesn't have a thyroid (as reported) and her body went nuts after she received the vaccine. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
General skin irritation that began to itch and hurt. I then believed that I was having symptoms of Shingles. I went to my GP who then confirmed that it was likely shingles and began treatment with antiviral medication.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient  of unspecified age and sex, race, ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, herpes simplex, htn (hypertension), and penicillin allergy. The patient patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 201 a21 a expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855191 expiry: UNKNOWN) dose was not reported, 1 total administered on 25-JAN-2022 for prophylactic vaccination. Concomitant medications included lisinopril.  On an unspecified date, the patient experienced covid-19 infection for which patient received Pfizer drug as a treatment. The patient received non-company co-suspect pfizer drug (unspecified) (form of administration, oral route of administration, batch number, and expiry were not reported) dose was not reported, administered from 18-JUN-2022 to 22-JUN-2022 for treatment of COVID-19. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. On 28-JUN-2022, the patient experienced recurrence of covid symptoms (captured as suspected covid-19 infection.) which leds to suspected clinical vaccination failure (Dose number in series 2)  The action taken with covid-19 vaccine ad26.cov2.s, and covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint, and reference number requested.; Sender's Comments: V0- 20220716745-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
no adverse event; administered improperly stored PROQUAD; This spontaneous report was received from a medical assistant referring to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 05-SEP-2019, the patient was vaccinated with an improperly stored dose measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S009759 with expiration date on 27-SEP-2020 for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion 15°F to 46°F (17.6 F) for 56 hours and 40 minutes and a previous temperature excursion of 6°F to 14°F for 10 minutes.   There was no adverse effect reported.  This call was not because of a data logger.
Dizzy, lightheaded, nausea, emesis, smothering sensation, warm sensation over entire body, chills and decrease blood pressure.
pt recv vax 28AUG97 & 9SEP97 pt exp all flu like sx: a fever greater than 102, no energy at all, the inability to get off the couch, stomachache & pain, h/a & a sore & swollen throat;
Several hours after injection, tired, chills, body aches & fever, lasting 24 hours
swelling in upper lt arm in deltoid w/sl redness then fainting episode during the noc w/extreme pain;lt upper arm redness in lateral lt upper arm extending down elbow 6 12/" long x 3 1/2" wide;advise moist compresses, anti-inflam drug;
12 hours after the vaccine she started having chills and hot flashes. Overnight and the next day she had a fever up to 100.8, chills, hot flashes, nasal congestion, muscle aches, joint pain and headache. She took Tylenol for the symptoms.
Left thigh swelling (same site of injection) 1 day after administration of DTaP. Symptoms lasting 2 days, resolving. No treatment intervention. Counseling provided.
Maculo papular eruption started head to trunk to extremities 11 days post vaccine administration.
Narrative:  PATIENT REPORTED THAT AFTER RECEIVING FIRST VACCINE SHE DEVELOPED HIVES OF FACE AND SWELLING AND TINGLING OF LIPS. SHE WAS GIVEN DIPHENHYDRAMINE AND MONITORED FOR 1.5 HOURS. SYMPTOMS RESOLVED AND SHE WAS DISCHARGED HOME. NO ADDITIONAL INFORMATION ABOUT VACCINE AVAILABLE OTHER THAN WAS MODERNA.
pt recv vax 25NOV97 & devel stomach pain & fine rash & swelling & tenderness, near the inj site;pt states rash & swelling still present;
This case was reported by a healthcare professional and described the occurrence of hives in an infant female subject who was vaccinated with hepatitis B vaccine recombinant (hepatitis B vaccine, manufacturer unspecified).  On an unspecified date subject received 1st dose of hepatitis B vaccine (unknown).  At an unspecified time after vaccination with hepatitis B vaccine, the subject experienced hives.  At the time of reporting the event was resolved.  This report was received when subject, now 11 years of age, was refused a Tdap vaccine at her local health department because of the event above following administration of an unspecified hepatitis B vaccine.  The subject had completed her childhood Dtap vaccinations without incidence.
Information has been downloaded from data (US-EMA-20170729-rpatevhp-131840864). Information has been received from a consumer regarding to a 16 month old female patient with otitis media. Medical history included: 3 doses of TRIPEDIA at ages 2, 4, and 6 months. Patient showed signs of Autism at 7-months. At 12-months hearing was checked because she was ignoring her mom and dad. The patient's hearing was good. The patient received measles, mumps, and rubella (manufacturer unknown) dose one at 12 months of age and experienced crying, fever and listlessness which was never reported. Family history: Great grandmother with tics. On 08-JUN-2004, the patient was vaccinated with TRIPEDIA batch/lot number U1028C and with poliovirus vaccine inactivated (vero) (IPOL) batch/lot number X0554 (strengths, doses, dose numbers, and expiration dates were not reported), both by unknown administration route, as prophylactic vaccination. On 04-APR-2005, the patient had no illnesses at the physician visit. On 07-APR-2005, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (lot number reported as 11869, expiration date and strength were not reported), VARIVAX by unknown administration route, lot number reported as "0446P"; PREVNAR intramuscularly, batch/lot number A65653C; and with ACTHIB intramuscularly batch/lot number Y0404, (strengths, doses, dose numbers, and expiration dates were not reported) all for prophylactic vaccination. Concomitant therapy included amoxicillin. On 28-APR-2005, the patient experienced screaming, "may had a seizure", arching back (opisthotonos), 15 areas of bull eyes rash throughout the body and fever. On 26-AUG-2005, she received PREVNAR batch/lot number A94451K; and DAPTACEL Batch/lot number C2253A, (strengths, doses, dose numbers, and expiration dates were not reported) both intramuscularly, for prophylactic vaccination. On 27-AUG-2005 the patient experienced inconsolable crying and facial tics. On 30-AUG-2005, the patient experienced "spinning in circles"  and easily frustrated. On an unknown date, the patient experienced delayed fine motor and developmental play skills, staring spells, poor sleep, gas, hearing loss, delayed language/speech skills, seemed to loose eye contact, autism spectrum disorder, poor regulation of sensory input, diarrhea, stopped interacting with family members, delayed self care skills and grinding teeth. The outcome of screaming, seizure, rash and pyrexia was unknown. At the time of the report, the patient had not recovered from psychomotor skills impaired, opisthotonos, staring, poor quality sleep, emotional distress, tic, flatulence, deafness, speech disorder developmental, disturbance in attention, abnormal behaviour, autism spectrum disorder, crying, sensory integrative dysfunction, diarrhoea, disturbance in social behaviour, impaired self-care and bruxism. The reporter considered the aforementioned events as medically significant.; Sender's Comments: 2008-01478: 2005-01988: US-009507513-1812USA011068:
I had vomiting and diarrhea. I was really nauseous.  I hurt really bad from my toes to my head.  I could not get up and wake.  I could not eat or drink anything because it would come back up.  These lasted for about 3 days.
Disorientation, tunnel vision, blurred vision, difficulty breathing, chest tightness, severe palpitations, tachycardia, cold and clammy, tingling to extremeties, unable to verbalize thoughts and organize words. And feeling that I was going to lose consciousness.
EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a 59 year old male. The patient's weight was 155 pounds, and height was 70 inches. The patient's concurrent conditions included: drink alcohol occasionally, cannabis use occasional, and smoker, and other pre-existing medical conditions included: The patient had no illness at the time of vaccination, no past history of similar event and had no adverse event after any previous vaccination. The patient had no history of allergy to vaccine, drug, or food, no pre-existing acute illness 30 days prior to vaccination and no history of hospitalization in last 30 days, with cause. It was unknown about the family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, and expiry: 21/SEP/2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20210955823, 20211246488, 20211246559, 20211246474, 20211246517, 20211246432, 20211246471, 20210955494, 20211246439 and 20211245708.; Reporter's Comments: This spontaneous report received from a health care professional concerned a 59 year old male. The patient's weight was 155 pounds, and height was 70 inches. The patient's concurrent conditions included: drink alcohol occasionally, cannabis use occasional, and smoke 1/2 packet per day, and other pre-existing medical conditions included: The patient had no illness at the time of vaccination, no past history of similar event and had no adverse event after any previous vaccination. The patient had no history of allergy to vaccine, drug, or food, no pre-existing acute illness 30 days prior to vaccination and no history of hospitalization in last 30 days, with cause. It was unknown about the family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, and expiry: 21.SEP.2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20210955823, 20211246488, 20211246559, 20211246474, 20211246517, 20211246432, 20211246471, 20210955494, 20211245708 and 20211246439,
Soreness and a "knot" at injection site. Mild fever day after injection. Sore and warm area of redness above elbow of right arm. Mild swelling.
Severe aching pain in arm and shoulder of injection site (left arm). As the day progressed, so did the pain. Unable to sleep on left side or use arm without the pain worsening. Unable to sleep due to pain. Ibuprofen used for pain.
Adverse events: severe migraine, convulsion, incoherent speech  Treatment: Ambulance,  paramedics, had to stabilize in order to be taken to ER
Patient reports severe upper arm pain at site of reaction, without redness or swelling at injection site. Patient also reports arm weakness. Patient reports pain is unrelieved with OTC acetaminophen and ibuprofen. Patient reported severe pain starting two days after receiving vaccine and has not subsided to date.
pt recv vax;4 hrs p/ vax,exp sweating,sore throat,tender cervical glands,excessive sleepiness,fever & nausea;
High Fever (103.5), all over body aches, painful to deep breathe, nausea, sore eyes, swollen lymph glands, headache, dizzy, chills, very sore arm at injection site. I had Shingles shot on 8/30/2012.
Soreness in the right side of neck; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient).   A 71-year-old male patient (weight 102.06 kg and height 178 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL2349) on 22Jan2021, at single dose, for COVID-19 immunisation. Relevant medical history included blood pressure abnormal and blood cholesterol abnormal. Concomitant medications included lisinopril 10 mg, from an unspecified date, for blood pressure abnormal. On 22Jan2021, about an hour after the vaccination, the patient experienced soreness in the right side of his neck. The patient was treated with Tylenol. The patient did not recover from the adverse event at time of this report. The next shot will be received 12Feb2021.   No follow-up attempts are possible. No further information is expected.
he have a sudden swelling at the lower arm pit; He have a bump; Injection site is warm to touch; he is having a lump swollen like lump under the armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2022 (Lot number: SK9896) at the age of 31 years as dose number unknown (initial pfizer dose), single for covid-19 immunisation. Relevant medical history included: "one double brain condition" (unspecified if ongoing), notes: We have an 'one double brain condition' (Further not clarified) but we don't know of any medication that he is taking, he just came in here to take his booster so we don't really have much information about the patient. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown), for COVID-19 immunization. The following information was reported: SWELLING (non-serious) with onset 24Jan2022, outcome "unknown", described as "he have a sudden swelling at the lower arm pit"; VACCINATION SITE WARMTH (non-serious) with onset Jan2022, outcome "unknown", described as "Injection site is warm to touch"; AXILLARY MASS (non-serious) with onset Jan2022, outcome "unknown", described as "he is having a lump swollen like lump under the armpit"; SWELLING (non-serious) with onset 24Jan2022, outcome "unknown", described as "He have a bump".  No follow-up attempts are possible. No further information is expected.
She showed signs of shortness of breath and fatigue/ confusion less than 2 weeks after her first dose Was hospitalized and it was determined that she had an infection that was septic  She had cardiovascular damage (blood pressure issues) Fluid build up in her body Nausea Joint and muscle pain Fatigue Injection potentially entered her bloodstream or blood vessel as she received it during her chemotherapy session
no adverse event. moderna confirmed 216K22A was viable until 2/21/2023 despite beyond use date of 1/22/23
Patients arm swelled up at injection which i informed her is normal then she said the next day her entire shoulder and up to her jaw line was also swollen.
Day after was super tired with headache.  Almost 2 months after was diagnosed with Bell's Palsy.
Pt developed large area of swelling and redness on back/side of (R) arm that was very itchy and minimally uncomfortable. No fever. No respiratory sxs. Given BENADRYL at time of report.
large red mark-approx size 1/2 dollar;local tenderness;irritable;hard knot @ inj site-onset 12JUN96;