chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant referring to a 14 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 14-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 (lot # N002720, expiration date 12-MAY-2019)  (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine was exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) which lasted for a 18 hours and 59 degrees Fahrenheit (F) which lasted for 65 hours on 13-JUN-2017. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005381: US-009507513-1707USA010591: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012729: US-009507513-1709USA012730: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA012733: US-009507513-1709USA010537: US-009507513-1709USA012777: US-009507513-1709USA012776: US-009507513-1709USA012774:
I got my first Pfizer booster for COVID-19 on 11/5/2021. On the afternoon of 6/21/2022, I began getting a sore throat. I took some throat lozenges, which helped, and I felt fine afterwards. On the afternoon of 6/22/2022, though, my throat hurt much worse. I took some TYLENOL in the hope that it would relieve it, and it did not. I went to bed with a very sore throat that night. During that afternoon, I also developed a runny nose. On 6/23/2022, I flew home after attending a class reunion. I still had the sore throat and the runny nose, and I began to have chest congestion. I thought I just had a cold. On 6/24/2022, I finally made it home. After I got home, I called a friend I had been staying with while I was in their hometown to go to my class reunion. She informed me that she and her husband were sick and that I should be tested for COVID. At about 3PM that day, I took an at-home test, and I got a positive result. I called my doctor's office, and they arranged for me to undergo a drive-thru test at the local hospital. Since the clinic was about to close, I contacted doctor on 6/25/2022 at 9:30AM, and I was prescribed PAXLOVID. I picked it up at the pharmacy and I took my first dose that day at noon. I then went home and went to bed and took the PAXLOVID on schedule. That evening, my oxygen level was 94-95, and I was told to go to the hospital if it got as low as 93, which it thankfully did not. I also had a temperature of 101.8. My worst days were 6/25/2022 and 6/26/2022, but at the time of this writing, I feel much better. My chest is still tight and hurts. I also have headache and productive cough, but no runny nose. My temperature is currently around 100.
Induration; heat; pain; pruritis, redness>3 inch diameter; swelling of approx 2 cm height at injection site; headache, itching throughout body; itchy throat, eyes, nose, sneezing, body aches - all within an hour of admin of vaccination.
Patient had his flu vaccine 9/13/23, reports he also had trigger point injections for chronic pain at cervical and lumbar spine that day. Reports that on 9/16 had severe headache and on 9/18 he developed right sided facial weakness, he went to the Emergency department and was diagnosed with Bells Palsy.
Around June 29th I started feeling nauseous, hot and cold flashes, headaches. I started throwing up around July 6th. I started feeling worse. I went to get a Covid rapid test and then went to the doctor the next day after getting the negative. They prescribed some medications, Methylprednisolone UFC 4 mg per tablet, Levothyroxine, Ondansetron 4 mg tablet, erythromycin 250 mg tablet, Prednisone, Methylprednisolone. They looked at my throat and ears and felt my lungs and my ribcage and I had inflammation in my ribcage.
24hrs after getting flu shot, pt developed a rash over her entire body except face, hands, and feet. Rash was not itchy, but face did itch. Rash was pinpoint, non-raised in size, except the inner thighs had pencil eraser, raised bumps. No breathing issues. Pt was placed on Prednisone X 3 QAM, Benadryl QPM.
Headache, neck pain, trapeze muscle pain, nausea, fever of 101.2. Lasted a few hours resolved with ibuprofen.
1. SOB 2. Flushed 3. Tremble 4. Decrease in blood pressure  EpiPen was administered. Attending physician was contacted and advised to send to ER for follow-up and monitoring.
vaccinated on 3/5/2021 with Janssen Covid vaccine.  Developed symptoms of covid (runny nose, congestion, cough, shortness of breath) on 4/17/2021 after an exposure to covid.
Bilaterally swelling of ankle and subsequently the lower legs. This was accompanied by difficulty climbing stairs--for the first two steps, his foot doesn't begin the movement correctly, but once he gets going, he's fine. Also difficult to raise foot high (est. 45-60 deg. hip flexion). No prior episodes of this condition. Note that date of vaccine is approx., per patient "three weeks ago" on 12/01/2014. Accordingly, onset of adverse event is also approximate, per patient, "two days after flu shot," problem began.
Very bad skin rash, puffiness of the face, itching, burning, hives. Also evident on arms.
All at injection site: Significant swelling, redness, itching seven days after injection.  The previous 6 days after vaccination were no symptoms.
Painful as soon as he gave it. Then after, pt's whole arm was on fire, burning.  Lasted few hours then pain started; just dizzy later. Pt. couldn't reach for anything, pain ongoing.
Got shot at 0930 am. Was very tired feeling all day... sleepy and at 1230 am that night woke up with hot and cold sweats and headache and body aches. I took some Tylenol and was able to go back to sleep. 6 hours later when Tylenol wore off same feelings hot/cold sweats but not fever, body aches and headache between temples.   About 4 days later 3/24 went to have sushi with daughter and that night got severe stomach cramps and diarrhea and headache. Next day same. 3rd day went away.
This spontaneous case, initially received on 13-Oct-2016, was reported by a health professional and concerns a female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 12-OCT-2016. Dose regimen: 0.5mL, Route of administration: Intramuscular. Batch number: WT52305. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced "Nothing is moving" (outcome: Not Reported), complained of stomach problems/Stomach did not feel good (outcome: Not Reported), Whole body is weak (outcome: Not Reported). No other information was available.
TONGUE SWELLING, DIFFICULTY SWALLOWING, METALLIC TASTE IN MOUTH, FEVER, HEADACHE, NAUSEA, MUSCLE ACHE, TIRED, LEGS SHAKY, DIARRHEA, THEN SEVERE DIARRHEA AND VOMITING, EYES BRIGHT RED AND PAINFUL, VISION BLURRED, HOT AND COLD FLASHES IN BODY. WENT TO ER.
Inadvertent administration of dose into triceps subcutaneous area, rather than IM deltoid.
Fever (102.5 F), vomiting, jaw/neck pain started 9/14/13, swelling in parotid and lymph gland and ER visit 9/15/13, hospitalized 9/15-9/18 for IV antibiotics for acute lymphadenitis.
Pt devel fever 103, purulent rhinitis, maculopapular facial rash 28JAN PM, 4 days p/vax;
16-40 hours post injection: joint pain/body aches, mid-grade fever, chills, lack of energy, tired.  38+ hours post injection: swelling lymph node in arm pit of arm where injection was administered.
This is a spontaneous report from a non contactable Nurse.   A 27-year-old male received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EL3248) via intramuscular route of administration on 03Feb2021 at 8:15 (age at the time of vaccination was 27-year-old) in right arm, as single dose for COVID-19 immunization. Medical his-tory and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (COMITNATY, Solution for injection, Batch/Lot number was EL3248) via intramuscular route in right arm on an unspecified date at 07:45 as a single dose for COVID-19 immunization. The patient did not have COVID prior to vaccination and was tested for COVID post vaccination. It was unknown if the patient had other vaccines in 4 weeks. On 21Aug2021, the patient experienced 8/23- live in daughter tested positive for COVID yesterday. The patient underwent lab test and procedure of SARS-CoV-2 test positive on 23Aug2021. Outcome of events was recovering.  No follow-up attempts are needed. No further information is expected. As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit-risk profile of the product and on the conduct of the study is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, as appropriate.
Low grade fever (99.8-100.2), headache, fatigue, and soreness at injection site
Since the shot my left arm gets stiff and doesn't have the same mobility especially if I don't move it for a while.
his headaches returned. The headaches were "quite severe"; This spontaneous report was received from a physician assistant, via a company representative, referring to a male patient in a college-aged with multiple unknown medical problems after concussion. The patient's medical history included a concussion and chronic headaches which were under control (possibly due to an unknown medical intervention). The patient's concomitant medications and drug reactions/allergies were unknown by reporter.    On an unspecified date around 3 to 4 years ago, in 2016 or 2017, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were unknown). Around the same vaccination time, after hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administration, the patient's headache returned and were quite severe. He sought medical attention and began using onabotulinumtoxinA (BOTOX) as treatment.  At reporting time, the outcome of headache was unknown. The causality assessment was not reported.
PT REPORTED FEELING DIZZY AND WEAK KEPT PT WAS KEPT IN OBERSEVATION FOR ADDITIONAL 45MINS UNTIL HE FELT BETTER
Fever, headache, nausea for 2 days. Given Bextra and placed on quarters 2 days.
Shortly after receiving the second dose Moderna vaccine, patient experienced nausea and dizziness.  Her vitals were stable.  She was alert and oriented but appeared to be weak and mildly uncomfortable.  She was observed for almost 30 minutes with resolution of the nausea but remained weak, dizzy and then started to c/o of facial numbness "like I got novocaine."  She stated it was her whole face including lips and tongue.  She remained alert talking in full sentences.  +facial symmetry, no obvious facial or tongue swelling.  Vitals remained stable.  At that time it was decided to transport her to the ED for continued evaluation.  She was brought from the outpatient vaccine clinic to the ED via wheelchair without incident.
Redeived Hep B 10am 05/10/02. Reported significant edema to left forearm and hand. Hand and forearm cool to touch with hand discolored. Symptoms began 05/11/02 while at school. Treated, Beandryl Sat/Sunday. C/O numbness in fingers, pain when lifting arm and low grade fever.
Fully vaccinated, not boosted.   COVID infection breakthrough with inpatient hospital stay.  Multiple comorbidities.
2 days fever, resolved  4 days rash, persists and increasing Also low appetite, mild pruritus, mild diarrhea days 1 2 3 4 5  1-4 BM/day mushy scratching -50% intake Rash is not morbilliform, but is very pink and clustered on trunk and body creased (neck, behind ears, axilla and inguinal) > limbs. Rapid strep test (nucleic acid) negative for G.A.S. Rash appearance scarletinkform or atopic dermalike, but more intense. No limb/digit desquamation, no oral/peri-oral lesions, no conjunctival injections, no peripheral edema or pain.
door left open, max/low temperature reached: negative 5.6 C duration out of labelled range: 8 hours due to human error with no reported adverse event; patients were administered PENTACEL after not being suitable to use post temperature excursion with no reported adverse event; Initial information received on 13-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 3 patients of unknown demographics and it was reported that door left open, max/low temperature reached: negative 5.6 c duration out of labelled range: 8 hours due to human error and patients were administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] after not being suitable to use post temperature excursion with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   On an unknown date, it was reported that door left open, max/low temperature reached: negative 5.6 c duration out of labelled range: 8 hours due to human error (product storage error) and patients were administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] suspension for injection (batch number: UJ737AAA and expiry date: 18-Sep-2023; strength, route, dose: unknown) for immunization after not being suitable to use post temperature excursion (poor quality product administered) (unknown latency).    Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01489121: 01489000: 01489121: 01489128: 01489149: 01489082:
Aches and chills 12 hours after Aches and Fever 16 hours after Aches until 36 hours after
I had a heart attack and stent inserted on 7/25/2021. Not reporting a direct adverse reaction
11/04/2021 - woke with severe vertigo, nausea, and confusion, trouble seeing clearly, photophobia, photophobia, greatly increased tinnitus. Headache began slowly, increasing in intensity to 7. Usual migraine abortant of sumatriptan 100 mg, taken twice, did not help.  Symptoms continued for 37 hours, with a visual aura of flashing lights on the second morning. Auras almost always happen for me prior to headache onset.  The second day I used hydroxyzine 50 mg, which often helps when I have neurological mastocytosis symptoms. It provided minimal help.  I assumed the vertigo was a vestibular symptom of migraine, though I had never had it before, and my migraines were in a period of minimal number per month and minimal intensity.  The headache slowly resolved, but the vertigo was present every morning through the end of February 2022.  Throughout the days I had trouble processing visual information, had severe brain fog, trouble thinking, had to hold onto things to walk without falling,  head pressure, continued increase in tinnitus such that it was constant.   I had to greatly decrease my work, often could not drive, or even leave the house.   I saw an osteopath with no diagnosis, a neurologist with no help, told to do Epley maneuver which made it worse, and finally saw an ENT who did hearing test, vestibular exam, and told me it was vestibular migraine and referred me to a new neurologist, who I have not yet seen.
No adverse event reported or observed. Vaccine indicated for patients ages 18 or older and patient 16yo at time of vaccination
a little soreness when they struck the needle in; Experienced A little Arm soreness after taking the 1st dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (the patient) reported that a 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number looks like EL3249) via an unspecified route of administration on 04Feb2021 at age of 68-year-old at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took shingles shot (Unspecified medication) which swelled her arm and she was in fever. The patient just wanted to know if she had nothing since before, she shouldn't have any more side effects. For height, patient stated she was about 5'4", she thought it might be 5'2", she couldn't remember but they'll go with about 5'4". The patient had the first one on 04Feb2021, she'd go back in 3 weeks on the 25Feb2021. The patient stated she had not shown any side effects, just a little soreness for one day in her arm/a little arm soreness after taking the 1st dose of the vaccine (Feb2021) and that was not even there bothering her. The patient also stated all she have had was one day just barely a little soreness when they struck the needle in (04Feb2021). Currently it was not even sore. For lab work, the consumer stated, "No, I had a shingles shot back, you had to wait two weeks. 'I had it done back on 09Apr, whoever the druggist was said, you would have to wait for two weeks to get one. So I waited almost a month' (not further clarified). And that was another question, I was going to ask these paper work because I go on 10th to do my blood work." The outcome of the events was unknown.
allergic reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ET6955) at the age of 28 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPERSENSITIVITY (hospitalization) with onset 29Mar2021, outcome "unknown", described as "allergic reaction". The patient was hospitalized for hypersensitivity (start date: 29Mar2021, hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: Allergy Testing: Unknown Results, notes: States he had some allergy testing, he doesn't know.  No follow-up attempts are possible. No further information is expected.
Moderate chills/sweating, slight fever from ~9PM to 3AM. Feeling completely fine now with no soreness in arm or other symptoms
Patient stated that allergic reaction started Friday night. She applied ice to the injection site. Then the rash got worst Saturday night/Sunday morning.
Horrible stomach cramping, painful with no resolution, diarrhea, some fatigue, slight disorientation.
Swelling, erythema, & pain to (L) deltoid warm to touch, decreased ROM. Sx resolved 10/28-10/29.
36 hours post va, pt was seen at ER 12/9 swelling right arm to elbow and up into neck & face. Spitting up blood, dizziness - Client prescribed Darvocet with apap client told MD she had allergic reaction, never take another.
Patient is 16. Provider ordered Moderna vaccine to be given. Nurse did not follow proper protocols and administered vaccine. Patient family notified of error.
A report has been received from a health professional concerning a 10 year old female patient. No relevant history and concomitant medications of the patient were reported. The patient who had been receiving Nasal FLUMIST (intranasal) was started on an unknown date, indication was not provided. It was reported that the pharmacist administered FLUMIST with a tiny amount of the vaccine into one nostril and then majority of the vaccine into the second nostril, a few drops of vaccine dripped out which was considered as administration error on 13-Nov-2014. Action taken with FLUMIST was unknown. The outcome of the event improper administration were unknown. The report was considered to be non-serious by reporter.
Started getting ringing in my left ear and woke me up in the middle of the night.  Cannot sleep due to loud noise.  Constant noise.  Sometimes it dulls out but in the night, the noise is very intense. I made a appointment with my primary care physicians and she said  that I did not have ear infections and referred me to ENT. I made the appointment with the ENT and they conducted a hearing test.  They did not see anything that stood out unusual.  Ears appeared fine with small amount of earing loss.  No infections to indicate why I am having this issue.  ENT prescribed a Z Pak for 6 days.  First day appear to have some relief, however the Tinnitus came back.  I have 2 days left of taking this medication
Redness, swollen, painful, warm to touch 4-5cm area on right thigh. Cellulitis of the lower limb.
A 19 year old female pt, with a history of depressions, had received an injection on Menactra, lot number U2050AA, and an injection of Adacel, lot number C2384AA, on 6/6/2006. Routes and sites of administration were reported as unknown. Twenty four hour later, the pt experienced a fever of 99.8 degrees F, nausea, and generalized body aches. No reaction was reported at the injection site. A Dr office visit did not occur. Relevant diagnostic tests were none. At the time of this report, the pt had not recovered. Follow up information received 7/3/06. Per the reporter, the pt had flu like symptoms at the time of the vaccination on 6/6/2006. No further information is expected for this case.
Covid test result=Positive; fever; coughing; lethargy; This is a spontaneous report from a non-contactable consumer. This consumer reported for a 32-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported as patient had Covid tested post vaccination. On an unknown date, patient experienced covid test result=positive, fever, coughing and lethargy. The patient underwent lab tests and procedures which included sars-cov-2 test which was positive on an unknown date. On an unknown date, patient had recovered with sequel (lasting effects) from the event fever, coughing and lethargy while outcome of the event covid test result=positive was reported as unknown.   No follow-up attempts were possible; information about lot/batch number could not be obtained. No further information was expected
Shingles vaccine 12/04/06.  Developed pain in breast an back end of 06; horrible and severe chafe like and shooting pain under arm on 01/10/07.  Dermatologist Asadi dx excema, prescribed Elidil, no help.  Internist who ordered vaccine seen on 01/31/07, couldn't rule out.  Prescribed Valtrex-but too late for Valtrex.  Dermatologist Pyring who conducted study on shingles seen 02/09/07 prescribed Lidocaine patch.  Unable to wear bra. Developed fever blister on mouth 02/07.  Pain continues.