chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to the Medical Clinic on 8/24/06 with c/o lethargy, tiredness, elevated temperature. R frontal headache noted. No ear pain, + R eye pressure, + light yellow nasal drainage, dry sinuses, rare cough, occasional nausea, denied vomiting/diarrhea. Smallpox site without inflammation. Diagnosed as fever, fatigue, HA secondary to smallpox vaccination. Orders received for Motrin/Tylenol. Rest and fluids with quarters for the rest of the day. RTC if temp increases >102.
Left arm and leg numb and tingled, tunnel vision, disoriented, swelling of throat dizzy, headache, fatigue, sweats, body aches, muscle aches   Took benadryl, ibuprofen and Tylenol
White raised blisters on left side (was vaccinated on Left arm), inside of cheek, 3 total blisters on the cheek side only. When Pt came for his 2nd vaccine he reported he had blisters 24 hours after his 1st dose, he was unsure if it was due to something he had eaten. 1st time 5 blisters, in upper right corner of the mouth 2 on gums and 3 on the cheek side. (all inside of the mouth). Vaccine was on the right arm his first injection. Took about 3-4 days to recover the 1st time. Started gargling with salt water, after a few days and this seemed to have helped. He put his finger on the blisters the 1st time and has a strange taste and discharge from the blister.
Information has been received from a physician concerning a 36 month old female who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). "Within the last 6 months", the patient developed a breakthrough case of varicella. Unspecified medical attention was sought. Treatment included either ibuprofen (Motrin) or acetaminophen (Tylenol). No Laboratory diagnostic test were performed. There was no product quality complaint involved. Additional information has been requested.
1/6/2021 vaccination, first dose; little bit of a skin reaction to the adhesive 1/15 COVID +; sore throat, inflamed arm size of a silver dollar @ injection site, congestion, body aches
Swollen, red, baseball size or bigger, warm on her arm where she received vaccine. Stated day after-called dr 8/5 and swelling down but still red.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Patient get the 2nd dose of Pfizer shot at 7.40 pm after that around 10 mins she had felt uncomfortable. She was asked to lay down and had some sprite / water to drink. She said after laid down , did not feel like brething well. Bp was checked at 8 pm was 121/91 HR 104. At 8.10 pm BP 146/98 and HR 105 . At 8.18 pm Epipen was given ( 0.3 mg ) then at 8.22 mg Benadryl 50 mg was given. Paramedic took her to the hospital
I had a rash on the left side of my torso that kept growing. I went into the doctor; they called in a dermatologist who immediately identified it as the zoster virus. I had very mild itching, slight headache. I was given a prescription that helped to clear it up and feel that I am doing much better.
One of nine cases: An event of Expired Drug Administered occurred in a seven-year-old female. The report was received from a registered nurse . No medical or drug history was reported for the child. The child received a one-time dose of FluMist intranasally on 15-Jan-2008. On 15-Jan-2008, the child received FluMist which had an expiration date of 19-Dec-2007. The reporter stated this is one of nine children that was vaccinated on the same date. In discussing the error with two reporters from the site they both indicated that the front of the FluMist box states "For the 2007/2008 Season", there is an expiration date on the side of the box. The reporter indicated they also administer a competitor's product, which is good for that entire season and does not expire until May/June timeframe. One reporter also stated many of the vaccines they give do not have an expiration date. She also indicated they do look for expiration dates, but it was confusing to have the front of the box indicate the vaccine was "For the 2007/2008 Season". The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for pick up 1 week later, and she was unsure why the site would be supplied with product that was to expire in less than three weeks. Outcome: the child had no ill effects, the site has not had any contact from the child's family. Further dosing with FluMist is not indicated. Causality assessment is not applicable for this vaccination error. This reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
This is a spontaneous report from a contactable consumer via Pfizer. A female patient of unspecified age received BNT162B2 (TRADE NAME UNSPECIFIED; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the reporter's mother experienced rashes after the COVID-19 vaccine. The clinical outcome of rashes was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Very sore all over my body  Extremely tired Large knot in my arm Rash at injection site  Unable to use arm
soar/sore; abdominal pain; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number 7bc47, expiry date 9th June 2023) for prophylaxis.   On 19th July 2022, the patient received the 1st dose of Shingrix. On 22nd July 2022, 3 days after receiving Shingrix, the patient experienced shingles and abdominal pain. On 24th July 2022, the patient experienced pain. On an unknown date, the outcome of the shingles, pain and abdominal pain were unknown.   It was unknown if the reporter considered the shingles, pain and abdominal pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-JUL-2022 Reporter's comments: The pharmacist reported that the a patient was administered with Shingrix and had experienced abdominal pain and 5 days after had soreness and the doctor had confirmed it to be shingles. The reporter consented to follow-up.
Patient fainted and collapsed on the floor. Passed out around the 10th minute into 15 minute wait. EMS had to be alerted. Patient looked to be sweating.
patient received Janssen covid 19 vaccine. she informed me before she received it that she gets dizzy with needles and has fainted in the past with drawing blood. I gave the vaccine and pt said she was okay. a couple minutes later she said she was feeling very warm and asked for something to fan herself with. I asked another pharmacist is get her a cold compress. When she came back with it and went to give it to the patient she fainted and slumped in her chair; she did not fall out of the chair. she was unconscious for less than 30 seconds and lost bladder control. I continued to rub her wrists and neck with the cold paper towel and she regained consciousness and said she was okay. we observed her for at least 20 minutes more and then she left. she said she did not require any further medical attention.
Per pt the shot burned when he received it and arm hurt afterwards.  Pain has not gotten better and is now worse.  He said it feels like the muscle inside is bruised but there is no bruising/redness that can be seen.  He says his arm hurts slightly all the time, hurts to lay on the arm, & when he moves his neck to the side he got the vaccine on he says the muscle is more sore.
Vaccine expired on 11/7/2022. no adverse affect noted, agency informed and provided guidance to provide a redose at next visit.
Complained of dizziness on January 18,th seen by MD this date.  Passed away on 22nd.
Arm pain and muscle and joint pain within hours of the shot.  Muscle and joint pain worse at night. Over the next week progressed to pain, and stiffness in knees, hips, pelvis and shoulders.   Whenever I stayed in one position for any length of time (driving, gardening) I was incredibly stiff I could barely get out of the car or stand up.  Over the next few weeks it got worse to the point where getting out of bed and getting dressed became difficult due to stiffness.  Did not know what was going on and lived with it thinking it was related to the vaccine and would go away.  By early July, I called my doctor to see what was going on.  Taking Aleve and Tylenol to try to manage pain and stiffness.
Patient experienced tiredness, chills and felt cold. Her arm swelled up on the inside of her arm. Her arm also became red. Patient received vaccine on Wednesday and on that night and into Thursday experienced symptoms. Went to MD and got prescribed LEVAQUIN and prednisone.
Employee started to feel numbness and tingling that was shooting down the arm about an hour after her vaccine was given. Her left arm presented a different color than her right arm, then she complained of her foot on the left side feeling numb also. Employee was immediately sent to the ED for further evaluation and then followed up for continued treatment at clinic. She is currently still being treated at clinic, being referred now to a neurologist and Physiatrist for mononeuropathy and ruling out CRPS and neurotoxicity. She is on restricted duty at work and is currently being accommodated. She is being treated under a claim with insurance.
After the booster, the patient got COVID; After the booster, the patient got COVID; Sick; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 45 year-old male patient received bnt162b2 (BNT162B2), administration date 22Dec2021 (Lot number: 331308A) at the age of 45 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 22Dec2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Dec2021, outcome "unknown" and all described as "After the booster, the patient got COVID"; MALAISE (non-serious) with onset 23Dec2021, outcome "unknown", described as "Sick". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Dec2021) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, malaise. Clinical course: The nurse called because her husband (patient) received the 3rd vaccine yesterday (22Dec2021), and the husband has COVID today (23Dec2021). After the booster, the patient got COVID. The patient started developing symptoms after the vaccine yesterday and today was very sick, so he was tested positive. The nurse called to check if there were any reports of people getting actual COVID after the vaccine. No prior vaccination (within four weeks). As a treatment, the nurse stated that the patient just taken vitamin C, zinc, Tylenol, and Motrin but not treatment like medicine. The nurse further stated, "It is just confusing because he got COVID after the second shot as well and now (third dose), and that time he was tested positive and now today he was tested positive again. So, it is every time he gets the shot the second and the booster, he got the COVID." The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
HBV vaccine on 28-MAY-2011, 02-AUG-2011 and 02-MAR-2012; HBV vaccine on 28-MAY-2011, 02-AUG-2011 and 02-MAR-2012; This spontaneous report was received from a physician referring to a 9-week-old female patient. The patient's pertinent medical history, drug reactions or allergies were not provided. Concomitant vaccines included rotavirus vaccine (+) live (+) oral (+) pentavalent (ROTATEQ), diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13).  On 28-MAY-2011, 02-AUG-2011 and 02-MAR-2012, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (strength, route of administration, exact dose, lot number and expiration date were not provided) for prophylaxis, respectively (inappropriate schedule of product administration for the second and third doses).   This is one of several reports from the same reporter. This is one of two reports for the same patient.; Sender's Comments:  US-009507513-2306USA013096: US-009507513-2307USA010001:
Patient received 2 doses of AstraZeneca COVID-19 vaccination. States was a part of clinical trial 12/18/2020 and 01/19/2021. Patient then received Pfizer from different vendor 04/13/2021. Patient then received Pfizer by us as indicated in this report 12/17/2021.
Two days post vaccine I woke up and my whole upper body was itchy. I also experienced what felt like internally pmy esophagus was itchy as well. Intense burning/itching pain in my throat/chest area. Benadryl did allow the itching externally and internally to subside.
This spontaneous report as received from a licensed vocational nurse (also reported as registered nurse) refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in 2016, starting on or after 28-APR-2016, the patients were vaccinated with improperly stored doses of PROQUAD, lot # reported as M006104, expiration date 01-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 12.3 degrees Fahrenheit for 23 hours and 17 minutes. This is one of two reports received from the same reporter. Additional information has been requested.
On 9/25/00, the pt developed a maculopapular vesicular rash accompanied by a fever. The rash was located on the pt's chest, legs, tongue, and posterior pharynx.
Information has been received from a nurse practitioner concerning a 17 year old female who on 10-OCT-2007, was vaccinated with her second dose of Gardasil vaccine (lot #658282/0929U). The patient experienced chest pains and had visited the ER on 11-OCT-2007 and 12-OCT-2007. It was reported that the patient's blood work and EKG were normal. It was also reported that the patient is currently facing some issues at home and the physician believes the events could possibly be anxiety related. No further details were provided. Additional information has been requested. Follow up information has been received from an LPN concerning the 17 year old female student: chest pain during soccer game - unrelenting - transported to hospital - negative chest x-ray, negative EC. DEMEROL and ATIVAN before relief. Second epidode 24 hours later. Per medical records a chest x-ray performed 11-OCT-2006 allowed no pulmonary infiltrates. An ECG performed the same day wsa normal with normal sinus rhythm. D-dimer ws 172 ng/mL. An ECG performed 12-OCT-2007 revealed sinus bradycardia with sinus arhythmia, otherwise normal ECG. D-dimer on that date was 126 ng/mL; troponin T was low. Per a holter monitor report for 15-OCT-2007: Sinus rhythm with frequent brief episodes of sinus tachycardia. No clear correlation between heart rate or rhythm and symptoms described. Variable T-wave morphlogy of uncertain significance. " The patient's outcome remained unknown. Additional information is not expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; METOPROLOL; BUPROPION. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Erythema, induration, swelling and tenderness expanding 4" past site of injection. Patient treated for possible cellulitis.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
tested positive for COVID virus; tested positive for COVID virus; cold all day; tiny cough; chills; sweating/ woke up sweating wet; arm pain/Very sore arms; body aches; fever; some muscle aches; This is a spontaneous report from a contactable consumer(Patient's Wife).  A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 02Jan2021 13:30 at single dose for COVID-19 vaccination. There were no concomitant medications nor medical history. He did not receive any other vaccines that day or 4 weeks prior. No history of any other vaccines or events. He got his vaccine on Saturday(02Jan2021) at 1:30pm(13:30) and by 5:30pm(17:30) had very sore arms/arm pain, at 7:30pm(19:30) he had chills off and on and was sweating. He woke up soaking wet and did that on Sunday, but was feeling a little better today. He also experienced body aches and fever in Jan2021. Today is testing day at his work and he tested positive for COVID virus on 05Jan2021. Not sure if it's a coincidence. Again, he got the shot and then started having all these symptoms at 5:30 and 7:30. Now they are both on quarantine for the 10-14 days. He wanted to see if it's possible to test positive for the virus after getting the shot or is it just a coincidence. He also had some muscle aches in Jan2021. Last night (04Jan2021), he woke up again sweating, but not like on Saturday, but he got really warm and started to sweat a little, and on Sunday(03Jan2021) he was cold all day and had a tiny cough, but it wasn't significant. Ever so often she would hear him cough. All of a sudden patient would wake up sweating. Again, Saturday he soaked everything. There was no Emergency Room nor Physician Office. Outcome of Very sore arms, sweating was recovering, of pain and fever was unknown, of other events was not recovered.    Information on Lot/Batch has been requested.
heaviness on my chest; shortness of breath; This is a spontaneous report from a contactable consumer (patient) or other non HCP via Medical Information Team.  A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiration date was not provided), via an unspecified route of administration on 29May2021 as second dose single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. it was reported patient was always healthy. On an unspecified date, the patient experienced heaviness on my chest, shortness of breath. due to events patient was wondering about what my next plan of action should be because patient had no health insurance. Patient was scared and don't want to add anxiety to her symptoms. The outcome of events was unknown.  Information about lot/batch number has been requested.
HIGH INJURIES POST VACCINATION; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: 21-NOV-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced high injuries post vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of high injuries post vaccination was not reported. This report was non-serious. This case, from the same reporter is linked to 20220415256.
Fatigue, excess sleepiness,, clenching stomach pains, diarrhea
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No pertinent medical history or concomitant therapy was reported. It was reported that on 25-APR-2016, the patient was vaccinated with expired MMR II lot # K004949, expiration date 04-APR-2016, subcutaneously (dose was not provided). There was no known adverse effects. Additional information has been requested.