chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in or around 2018, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine adult health maintenance and for its intended purpose: the prevention of shingles (dose, dose number, route, anatomical site of vaccination, lot # and expiration date were not provided). On an unknown date (reported as shortly after receiving the vaccine), the patient suffered shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient condition. In addition, the patient sustained severe and permanent personal injuries. Further, the patient had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of herpes zoster was not recovered. The causal relationship between the event and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster was considered a disabling event by the reporter.
Information has been received from a nurse practitioner referring to a patient of unknown age and gender. There was no concurrent condition or medical history reported. On 23-JAN-2016 the patient was administered improperly stored GARDASIL (lot # K011562, expiration date 08-APR-2017) (dosage, strength and route unknown) (temperature 30 degree Fahrenheit, time frame 4 hours). There was no concomitant medication reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
No additional AE reported; excursion of 72 hours 0 minutes 0 seconds at 46.7F (47F); This spontaneous report was received from a healthcare professional (HCP) referring to a 73-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.  On 03-MAR-2023, per data logs, the temperature of the stored vaccines was up to 46.7 F (product storage error). On 03-MAR-2023, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection (0.5 mL, lot#: W027449, expiration date: 25-SEP-2024; route of administration, and anatomical location were not reported) for prophylaxis. No additional adverse event (AE) was reported (no adverse event).   This is one of the 12 reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002746: US-009507513-2304USA002750:
This patient complained of upper respiratory infection since 11/23/00 and felt better. She had flu shot on 11/28/00. Complained of headache, sore throat, body ache, cough, nausea, vomiting, diarrhea, and a fever of 100.6. This patient had sickness for 5 days, she's feeling better today.
No adverse event. vaccine administration error Inadvertently gave a 1st dose of Moderna that had expired two weeks prior. The Medical director was called, he looked it up and gave orders that the dose was invective- no adverse effects, and the staff could receive another dose after two weeks. Staff was notified. The subsequent dose was given 10/18/2021  How to prevent in the future: 1. 09/20/2021  2. When I still hadn?t received an email with the expiration ? I should have looked it up. 3. Nurse in charge of COVID Vaccines, should use the storage and handling tool kits from Moderna as well as, frequent checks for expired doses.  4. When the Nurse delivering the vial to the Nurse giving the dose-   a two person check to confirm that the vaccine had not expired and that the lot and dose were correct.
Patient was experiencing shortness of breath, increasing heart rate and respirations, facial numbness (mouth) and sweaty palms. Patients vitals were taken and blood pressure (150/90) and heart rate changed frequently. Emergency services were called and patient agreed to transport to hospital for further evaluation. Pt has a hx of anemia. EMS transported pt by walking.
Ear infection and throbbing in the ear. Began about 1.5 days after vaccination. Originally thought was just wax, but still ongoing 10 days later. Possibly slight improvement.
EXTRA DOSES OF DTAP-IPV AND MMRV GIVEN BY ERROR PATIENT COMPLAINED OF SORENESS TO LEFT THIGH NO SWELLING OR FEVER PER FATHER
the patient received the vaccine on 12/10/2001. One day later, the area around the injection site was firm, tender, erythematous. Two days later, the arm was less tender, the swelling had decreased and there was minimal redness.
On 1/7/21 I noticed a slightly enlarged left supraclavicular lymph node. There was a small amount of edema in the area surrounding it. I applied heat to it and this seemed to relieve some of the swelling. Around noon on 1/8/21 the lymph node and the tissue sounding it had approximately doubled in size from the night before. I went to my local urgent care center. The doctor seemed to think that there is a very high probability that it is my body reacting to the vaccine, especially since I still currently have a visible bruise on my arm from the injection.  The injection was on the same side as the swelling. She couldn't confirm that it is a reaction with 100% certainty, I was prescribed Keflex 500mg tabs TID for a week just in case there is an infection present.  I am supposed to monitor the size of the swelling and follow up with a PCP.
Approximately 12 hours after injection: urgent need to urinate repeatedly (about 12-15 times), significant  dizziness when getting out of bed to use the restroom (not evident while in bed). Gassy stomach prior to bedtime.
Fever; Throwing up a lot of phlegm; throwing up; This is a spontaneous report from a contactable consumer (patient's wife) reported for a 67-Year-old male patient (husband). A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0198, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 21Jul2021 at 10:30 (at the age of 67-year-old) as a single dose for covid-19 immunisation at pharmacy. Medical history included ongoing asthma, blood pressure high and sinuses. Patient's family history included high blood pressure of dad (family history). Concomitant medications included ongoing fluticasone propionate, salmeterol xinafoate (ADVAIR) 250/50, 1 puff once a day for lung function; ongoing montelukast 10mg once daily taken for sinuses; ongoing hydrochlorothiazide, losartan potassium 50/12.5mg, once a day taken for blood pressure high and low dose acetylsalicylic acid (ASPIRIN) 81mg once daily, heart doctor told him to take it, may be a blood thinner. No additional vaccine was administered on same date of the Pfizer Suspect. No adverse events prior vaccination. No prior vaccination within 4 weeks of Pfizer vaccine. Patient's wife reported, her husband has been throwing up a lot of phlegm and has also had a fever since the 22Jul2021. Patient had a mild fever the evening of 22Jul2021, but the fever didn't really get bad until Friday. The fever has been going up and down, from 102.9 to 99. Stated that the fever was persisting and throwing up is about the same. Patient went to the doctor yesterday, and the doctor said that everything was okay. Events leads to physician office visits. The patient underwent lab tests and procedures which included body temperature resulting mild on 22Jul2021, going up and down and ranging in 102.9 to 99 on 23Jul2021. Tylenol was taken as a treatment for the events. Patient's wife's Oncologist does want him to have a covid test. The clinical outcome of the events was not recovered at the time of reporting.  Follow-up attempts are completed. No further information is expected.
Person reporting her adverse event c/o approximately 10 hours after taking her moderna booster shot, she started having severe muscle pain which made it difficult for her to move. She states that she took a dose of aspirin and got some relief within an hour from that. She also states she took aspirin periodically for 24 hours and gained full relief.
ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE DVT, UNSPECIFIED VEIN 2/1/2023 &  3/13/2023  -- PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE
2/5/2023  I woke up with tingling across my left cheek, sort of a pins and needles feeling. Over the next couple of weeks, the duration of the tingling lasted longer, and it spread down towards my jaw.      Last week it lasted for a couple of hours. It also began to start on my right cheek. On 2/17/23 I went to the ER. They were ruling out a stroke. They did a CT, bloodwork and consulted with Neurology.  I was discharged and Neurology said to treat it like I had a TIA. I had a follow up appointment on 2/21/23 with the nurse practitioner. She wanted to hold off on having an MRI. She diagnosed me with Trigeminal Neuralgia.  I was started on prednisone.  That same day the tingling began going down my jaw and down my neck. It had worsened.  When I saw a picture of the nerves involved with Trigeminal Neuralgia, I realized it was exactly where I was experiencing these symptoms. I am on Day 3 of the Prednisone, and it appears to be relieving some of the symptoms. The APN told me a virus could have triggered it. I did have a virus after my vaccine I got from my grandson.
Member reported to medical for a bandage change when it was noted that there were five(5) (1-2mm) inadvertent inoculation on the left deltoid. Member was afebrile and had no pertinent s/s. Member provided re-educated on proper site care and bandage applied to site. Member instructed to follow up if sign/symptoms occurred per smallpox tri-fold.
Symptoms began following injection which has worsened. Symptoms so far include red raised area where injection was given, 5" x 3" which is warm/hot to touch. Employee states this happens every time she takes flu shot. Has not yet resolved (visited employee health 10/13/2016).
One hour later developed a headache. The next day, my muscles felt like a ran a marathon. Two days later developed a yeast infection ( I had no sex one week before and after this event). That weekend I developed a thrombosed external hemorrhoid. At the doctor's office on Monday, it was removed.
Fingers tingling and flushing. Benadryl 25 mg PO offered and taken.  Stated felt much better.  BP initially was 194/82, on recheck was 177/86.  Does have history of hypertension.  No issues with first dose, released after 30 minutes.
Vomiting and bloody diarrhea and not wanting to eat starting 10/24/17.
RINGING IN THE EARS/TINNITUS  BILATERALLY; This spontaneous report received from a patient concerned a 49 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced ringing in the ears/tinnitus bilaterally. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of ringing in the ears/tinnitus bilaterally was not reported. This report was non-serious.
patient with rash/welts and urticaria over entire body, esp torso. administered own epipen and benadryl. no respiratory sx. Zyrtec daily x 1 wk.
During vaccine administration, vaccine leaked from  the syringe. Patient did not receive full vaccine and it is unclear how much of the dose the patient received.
A report has been received from a Pharmacist (mother of the patient) concerning a 7 year old, Male subject, who had been receiving FLUMIST (intranasal). FLUMIST was administered on 02-Nov-2015. The patient got large raised bumps on legs and hips which started on 03-Nov-2015. At the time of reporting, the event of large raised bumps on legs and hips was ongoing. The report was considered to be non-serious by the reporter. The reporter considered that there was no causal relationship between large raised bumps on legs and hips and FLUMIST and the company physician agreed.
Large local reactive manifestation, no erythema, increased warmth of 14 x 19 cm (R) ant thigh.
had the shot and still got it / Suspected vaccination failure; still got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the shot and still got it/ Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 05-MAR-2023 This case was reported by a patient's friend via interactive digital media. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Moderna Monovalent was given as dose #3, instead of bivalent dose. As of today, 02/08/23, there have been no reports of adverse reaction.
No adverse reactions reported. The patient's doctors office called our pharmacy on 10/21/2021 to let us know that we administered a flu shot to the patient on 10/13/2021. They also gave the patient a flu shot that same day at the office, about 30 minutes prior.  The patient came to our pharmacy and stated he needed to get a flu shot and his shingrix shot.  The patient selected the option "no" when filling out our consent form as to getting any previous shots in the last month.  We did both shingrix and flu shot for the patient. When following up with the patient on the phone on 10/21/21, he states that he never received a flu shot from his doctors office on 10/13/21or at all.  I verified with the doctors office twice that he indeed got his shot there.  The doctor has not initially reported concerns for memory loss but are looking into it further.
Patients eyes rolled back, turned very red, and his arms became rigid for about 30 seconds, then he passed out. He came to about 30 seconds later. We called 911 - paramedics assessed the patient and concluded that he was feeling ok.
vertigo-like symptoms (extremely dizzy) appearing in early morning week later after shot-lasted into next morning. Extreme dizziness then lessened...experienced fatigue next several days.
Severe fatigue Weakness Runny nose  Low grade temp All occurred within 24 hours and continue today
Hypersensitivity reaction; Mild metallic taste; Flushing; Heart palpitations; Tightness in chest; Lightheadedness; Weakness; A spontaneous report was received from a consumer who is a physician concerning herself, a 50 year old female patient who recived Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypersensitivity reaction, dysgeusia, flushing, palpitations, chest discomfort, dizziness and asthenia.  The patient's medical history was not provided.  No relevant concomitant medication was reported.  On 26Dec2020, the patient received the first of their first of two planned doses of mRNA-1273 (lot number 025H20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 26Dec2020, shortly after receiving the injection, the patient experienced a hypersensitivity reaction with a mild metallic taste, flushing heart palpitations, tightness in chest, lightheadedness, and weakness.  No treatment was reported and the symptoms did not last past the day.  Action taken with the mRNA-1273 in response to the events was not reported.  The outcome of the events of hypersensitivity reaction, dysgeusia, flushing, palpitations, chest discomfort, dizziness and asthenia  was considered resolved.; Reporter's Comments: This case concerns a 50 year old, female patient, who experienced a serious unexpected event of Hypersensitivity after receiving first dose of mRNA-1273.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Woke up next day, March 4, 2021, with nausea, weakness, and unclear mind. Lasted 1 day.
Patient presented to the ED on 1/24/2021. She then presented to the ED and subsequently hospitalized for 2 days on 2/4/2021 with chest pain.
Polyarticular Joint Pain; Costal margin pain; Knee buckling; Left flank pain; This case was reported by a lawyer and described the occurrence of polyarthralgia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced polyarthralgia (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the polyarthralgia was unknown.   It was unknown if the reporter considered the polyarthralgia to be related to Shingrix.  Additional information: The initial information received on 31 March 2021 through medical records (case is now medically confirmed). The plaintiff was a male patient. His concurrent condition included he was a nonsmoker. His historical condition includes Bursitis and Olecranon bursitis. He had used the Shingrix vaccine 0.5 ml intramuscularly on 12 February 2019 for prophylaxis. He was diagnosed with Costal margin pain on 06 November 2020, left Knee buckling on 13 October 2020, Left Flank Pain on 10 July 2020 and the out come was unknown.
05/25/2019 06:00pm patient had fever, given tylenole: 05/27/2019 7:00am developed skin lesions-papules and some are vesicles, not itchy in the skin, buttocks and lower extremities
BODY ACHES; CHILLS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and body aches was not reported. This report was non-serious.
Local reaction with swelling, erythema and warmth on (R) upper arm 3 x 4 cm at the site of varicella vaccine administered.
Muscle soreness at injection site, fever (up to 100.3) & joint pain beginning approximately 6 hours after injection and lasting approximately 36 hours.  Fever and joint pain treated with ibuprofen.  All events self-resolved after the 36 hour time period.
Dime size  inducation on injection site, left deltoid.  Edema and redness to surrounding injection  site.
Pfizer / BioNTech: 09Oct2021; Paxlovid: COVID 19 Treatment; Pfizer / BioNTech: 09Oct2021; Paxlovid: COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Oct2021 as dose number unknown, single (Lot number: FF8841) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (unspecified if ongoing); "Known allergies: antibiotics" (unspecified if ongoing), notes: Known allergies: antibiotics; "Known allergies: sulfur" (unspecified if ongoing), notes: Known allergies: sulfur; "high blood pressure" (unspecified if ongoing); "high BMI" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Lisinopril, reaction(s): "Allergy". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 03May2022, outcome "unknown" and all described as "Pfizer / BioNTech: 09Oct2021; Paxlovid: COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible. No further information is expected.
Start to shows like a red part; itching; This is a spontaneous report received from a contactable consumer (patient). A 78-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 25Feb2021 (at the age of 77-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that everything worked okay and patient did not have any reaction nothing, but on an unspecified date in Mar2021 (reported as 9 or 10 days later), the patient experienced started to showed like a red part and it was itching. The patient called the pharmacy and they don't have any information about that. They refer to her primary doctor and he does not know anything about that also. It was reported that the patient was supposed to go back there on 18th for the second one but doesn't know if she should get it or not as she was really afraid; she doesn't know what was going on. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt was given 0.3 ml  instead of the 0.5 ml dosage.
Developed Dizziness / lightheadedness immediately following the injection . Remained alert and lucid. Blood Pressure rose to 248/124. Pulse Approx. 92 min Sent to Emergency Room via EMS for complete assessment Patient mentioned that she developed localized cervical adenitis following the 1st dose of vaccine Impression: Hypertensive Reaction to COVID vaccine. Hypertensive emergency .
Within one hour of vax, the pt developed a raised rash and joint pain. He did not seek medical attention, and recovered without treatment. The pt received his third dose on 11/13/00. Within one hour of vax, he experienced sharp pain in his fingertips and became lethargic. At some time post vax, he developed redness (site not specified). The pt did not seek medical attention and did not treat himself for the fingertip pain, lethargy or redness. As of 11/15/00 only slight redness remained.
Sores in mouth, welch on arm, pain at injection site on the evening after receiving the vaccine. Patient states that she feels off.