chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My daughter has seizures, adhd,and been sickly since this happened to her.  12/28/09 MR received for the following DOS:  Sick child DOS 02/28/06. Staph infection. Pt for physical, but not done due to Pt being uncooperative. RLE pustules and rash. Tx: antibiotics.  Well child visit DOS 08/11/06. Pt calmer this year.     Sick child visit DOS 01/23/07. DX: URI. Pt c/o cough, congestion. Tx: Phenergan with codeine, Dicel.  Sick child visit DOS 05/22/07. DX: purulent rhinitis. Pt sleeping difficulty, "onion breath", cough. Tx: zithromax.  Well child visit DOS 08/15/07. DX: Abnormal overweight. System review: wnl. Pt is overweight. Physician provided recommendations on decreasing carbohydrates and increasing healthy foods.  Sick child visit DOS 11/05/07. DX: Acute sinusitis. Pt c/o cough, running nose, congestion and fever. Tx: amoxicillin.  Sick child visit DOS 12/12/07. DX: Gastroenteritis. Pt c/o diarrhea, vomiting, congestion and runny nose. Tx: Pedialite.  Sick child visit DOS 01/02/08. DX: Otitis media and acute sinusitis. Pt c/o fever, runny nose, harsh cough. tx: codeine phosphate.  Sick child visit DOS 02/26/08. DX: Allergic sinusitis. Pt c/o cough/congestion, fever, headache. Tx: Claritine.  Sick child visit DOS 09/30/08. DX: Acute otitis media. Pt c/o runny nose, L ear pain, fever. Pt had yellow nasal drainage. Tx: omnicef.  Sick child visit DOS 12/03/08. DX: Acute sinusitis, head lice. Pt c/o vomiting, runny nose, congestion and mild cough. Tx: Omnicef and Ovide.  Sick child visit DOS 01/26/09. DX: URI, diarrhea.  Pt c/o diarrhea, sore throat, congestion, runny nose, cough.  Sick child visit DOS 03/30/09. DX: URI, sprayed Rankle.  Well child visit DOS 05/01/09. DX: Convulsive disorder. Pt to see neurologist. Tx: Diazepam, Topamax.  Sick child visit DOS 05/04/09. DX: Abdominal pain. Pt c/o diarrhea, stomach pain.     Sick child visit DOS 06/09/09. DX: Pharingitis. Pt c/o runny nose, sx, fever, sore throat, cranky. Tx: Amoxicillin. Sick child visit DOS 11/12/09. DX: Acute sinusitis, acute bronchitis. Pt c/o cough, stuffy nose.
rash on her neck; \This is a spontaneous report from a contactable consumer (patient herself).  A 71-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3249, Expiry Date: Unknown), via an unspecified route of administration in arm left on 15Jan2021 (at the age of 71-year-old) as single dose for COVID-19 immunization. Dosage text given as dosage amount unknown. First dose in series, via injection. The patient's medical history and concomitant medications were not reported. Consumer stated that her 1st dose of the Pfizer Covid vaccine last 15Jan2021 and then on 20Jan2021, she developed a little rash on her neck which lasted for about 4-5 days before it went away last Monday. She wanted to know if that could be a side effect of the vaccine and if it's still recommended for her to get the 2nd dose on 05Feb2021. Consumer just thought that it might be from something else, but she saw her Gynecologist on 21Jan2021, and she showed her GYN the rash and he said that he could not tell her if it was from the vaccine or not, so he thought she should call and report it to Pfizer. Consumer has previously worked as a Pharmacy Technician. She had no other vaccines on the same day. Consumer stated for history, concomitant medications, and Investigations reported as none, between that time and the time she got the rash, she had not gone and gotten any new medications or anything. She states that the medicine she was on, she has been on since prior to getting the COVID vaccine. Consumer did not provide any other details about concomitant medications. She was wondering if that rash was contraindicated for her to get the second dose, because she was due for the second dose on the 5th. On 20Jan2021, the patient experienced rash on her neck. The outcome of the event was recovered on an unspecified date.  Follow-up (28Jan2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that: patient demographic, event details and suspect product details were updated.  Follow-up attempts are completed. No further information is expected.
Fatigue, Nausea (felt but didn't vomit), muscle cramping and discomfort, joint discomfort, unable to focus, collapsed on floor of home while walking across living room floor (due to loss of muscle control, night sweats, chills, loss of energy, unable to fall asleep all night, the following night having vivid, strange dreams. The most significant event was collapsing due to the muscle problems.
Upper arm has been hurting since July 2001. Now the index finger is also hurting. An MRI was done which was negative for anything. Sometimes the pain is sharp but mostly dull.
Information has been received from a physician concerning a 6 year old male pt who on 27Mar01 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (lot635461/1246K). There was no concomitant medication. The physician reported that on 13Jan06 the pt broke out with seven varicella lesions today. He has no fever. He is being treated with diphenhydramine (Benadryl) and calamine lotion for the itching. There were no lab studies performed. The pt is not recovered. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
After 2nd dose pain intensified and spread to hands wrists and shoulders.; After 2nd dose pain intensified and spread to hands wrists and shoulders.; Very limited mobility with intense pain.; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 18Mar2021 at 13:00 (Batch/Lot number was not reported) (at the age of 72-year-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. No known allergies. The patient did no experienced COVID-19 nor tested positive pre or post vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Feb2021 (at the age of 72-year-old) and experienced intense pain in right foot and knee overall joint pain.  On an unspecified date, the patient experienced after 2nd dose, pain intensified and spread to hands, wrists and shoulders. Very limited mobility with intense pain. Both shoulders very intense pain even with nonsteroidal anti-inflammatory drug (NSAIDS). Continuing with no improvement. The patient outcome of the events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021442973 same patient, different drug dose/event
4 days after receiving flu vaccine patient reports she developed a rash in groin/genitalia  (labia) back and arms. Patient clinically stable, no signs of anaphylaxis injection site normal
Received Typhoid & Yellow Fever vaccines on 0-8/26/02. That night, developed severe headache and pruritis rash. Headache began~ 5 hours, Rash on left wrist and trunk.
Sudden onset numbness in right hand, resolved in 15 minutes.  Then recurred along with eye pain. Became very pale. Vomited.  Second episode on numbness resolved in 30 minutes, and patient recovered completely in about 3 hours.
Patient said she may have ignored issue, but she began to notice redness, swelling, and itchiness in left arm about 5 days after vaccination, and called to notify pharmacy 2 days later.  She notified pharmacy exactly 1 week post vaccination.
Pfizer 12/23/20, 2/3/21, 12/21/21. Positive on 7/5/22
1  .Shingles - topical RX cream, no symptoms other than red/purple bumps on left side  2.  Swollen lymph node under left arm - biopsy and removal - no cancer
No adverse reactions noted; HBP calling to report AE for patient that received both PROQUAD and VARIVAX.  No adverse reactions noted.  Associated AE's: 02507181//02507181 No PQC.; This spontaneous report was received from an administrator and refers to a 4-year-old male.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-OCT-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, single dose, lot #X010526, expiration date: 11-APR-2025, administered for prophylaxis (strength, and route of administration were not provided); and  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, single dose, lot #X018730, expiration date: 06-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided) (overdose). No additional adverse evenet was reported.; Sender's Comments:  US-009507513-2311USA004612:
EVENT - Minor/normal soreness at injection site for 1 day.  Post injection, day 7 - injection site swollen, red, tight, hot; 3 in diameter.  Painful, itchy, burning.  Pain scale moderate and not inhibit normal daily functions. Post injection day 9 - injection site less swollen, less pain, not as red, still 3 in diameter.  No other signs of sickness or discomfort (besides injection site). TREATMENT - Tylenol OUTCOME - TBD
This case was reported by a healthcare professional, via a GSK representative and described the occurrence of chills in a 24-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 27 August 2010 at 10:30 the subject received 1st dose of CERVARIX (1 ml, unknown route and site). On 27 August 2010, within 45 minutes after vaccination with CERVARIX, the subject experienced chills, nausea, vomiting, shortness of breath, dizziness, lightheadedness and muscular pain all over the body. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with ZOFRAN, TORADOL and Normal saline. At the time of reporting the events were resolved. The healthcare professional reported that the subject received 1st dose of CERVARIX at 10:30, and experienced all of the reported adverse events within 45 minutes of the dose. She was taken to a local Emergency Room (was not admitted to the actual hospital), received 2 doses of ZOFRAN IM, 1 dose of TORADOL IM (the mg dose of both is not known), and IV normal saline infusion (total amount not known). Admission to ER reported as 14:43, and discharge from ER at 17:00. At the time of discharge from ER the subject reported that all adverse events had resolved.
12/16/21 presents to ED for "fevers, cough, dehydration, and body aches". PMHx of "CAD s/p LAD stent, HTN, HLD"
This spontaneous report was received from a registered nurse and refers to a 12-months-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of VAQTA, lot # R018935, expiration date 05-SEP-2019 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Breakthrough case admission after three vaccines  Pfizer 3/15/21 Lot# EP7534;  PFIZER 4/5/21 lOT# EW0153;  PFIZER 10/31/21 lOT# FF8841
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "fibromyalgia" (unspecified if ongoing); "migraines" (unspecified if ongoing), notes: Has migraines from fibromyalgia. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Positive; (unspecified date) Positive; (unspecified date) Positive; Weight: (10May2020) 160 or 150. Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19. Clinical course: Caller stated she took all of the Pfizer covid 19 vaccines, she had the original, the reinforcer and got the boosters. She continually got covid virus and reported having covid 4 times. 07Sep was her last test and the antigens were negative and the proteins and peptides were positive. Patient took original vaccine then, got booster twice, both of them. Still tested positive 4 times, not 14 weeks, for 8 weeks every time, still had it. Caller stated, she still had Covid, after taking original vaccine and booster, twice. They changed name to long term Covid.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300328893 same patient, product, different dose number/event;
This spontaneous report as received from a pharmacist refers to an adult patient of unknown gender. On 22-OCT-2014, the patient was inadvertently administered a does of RECOMBIVAX HB (lot # J014312) intramuscularly which expired on 07-SEP-2014. This was supported. No adverse events were reported. Additional information has been requested.
Narrative: A 41yo, male with PMH of GERD and Dry eye syndrome was reported with a historical ADR of Pfizer Covid - 19 vaccine induced SOB, Elevated BP, Chest Pain and tingling, by the documenting NP, on September 22, 2021. Per patient's reported note, the vaccine was received at Pharmacy and after the patient developied the symptoms, he went to the Emergency Room on September 18. 2021 and got tested. Both Chest x-ray and covid test results were ok
Within a few minutes of giving the vaccine, patient reported a burning and tingling sensation down her arm and towards her fingers. She also reported a "lump" in her forearm.  There was a firm feeling area in her forearm.  There was no visible swelling or discoloration. An ice pack was applied. Symptoms gradually resolved over the rest of her office visit, approximately 20-30 minutes.
Lymphoma tumor has disappeared; appetite has increased; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization.Medical history included lymphoma from an unknown date.The patient's concomitant medications were not reported.The patient experienced lymphoma tumor had disappeared. also reported increased appetite.Caller stated she was calling to report not an adverse event, just the opposite, wanted to report an additional benefit to the Pfizer Covid vaccine, stated she was sent this article from her sister, stated the email said the article came out on 14May2021. Article said a lady was diagnosed with lymphoma in the end of 2019, that because of the Covid pandemic last year she did not go to the hospital, stated this year after the 2 injections of the Pfizer Covid vaccine, the location of the tumor it decreased and then it completely disappeared. Caller said the article stated she went to doctor for a PET scan and the tumor was gone and her appetite increased. Caller had no patient . The patient underwent lab tests and procedures which included positron emission tomogram: the tumor was gone. NDC Lot and Expiration Date unknown. Exact dates unknown. Outcome of both events was unknown.  No further information known for report.  Information on the lot/batch number has been requested.
Feeling lack of oxygen and felt faint and high, passed out later. Still feel issues including various levels of inebriation.  Prescribed potassium pills. Much better but still dealing with event. Also, had chills, heart racing, and short of breath.
Headache, Myalgia, Arthralgia, Fever, Stated fever low grade, chills. H.A. was worse in her life starting 1/7/21 into 1/8/21 Narrative:
My left bicep became swollen, red and very itchy.  It was about 6 inches below where I received an injection of the vaccine.  The area around the injection site remains sore, but not red or swollen or itchy.
shortness of breath [after first dose]; heart seemed to beat a little heavier [after first dose]; tender to the touch/felt like a real soft tissue; nickel-sized bruise/size of a golf ball or lime; injection site turned into a big red dot/had a crown on it/red streak; nauseous; little fatigued after he walked upstairs; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath [after first dose]), PALPITATIONS (heart seemed to beat a little heavier [after first dose]), TENDERNESS (tender to the touch/felt like a real soft tissue), CONTUSION (nickel-sized bruise/size of a golf ball or lime) and VACCINATION SITE ERYTHEMA (injection site turned into a big red dot/had a crown on it/red streak) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-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 DYSPNOEA (shortness of breath [after first dose]), PALPITATIONS (heart seemed to beat a little heavier [after first dose]), TENDERNESS (tender to the touch/felt like a real soft tissue), CONTUSION (nickel-sized bruise/size of a golf ball or lime), VACCINATION SITE ERYTHEMA (injection site turned into a big red dot/had a crown on it/red streak), NAUSEA (nauseous) and FATIGUE (little fatigued after he walked upstairs). At the time of the report, DYSPNOEA (shortness of breath [after first dose]), PALPITATIONS (heart seemed to beat a little heavier [after first dose]), TENDERNESS (tender to the touch/felt like a real soft tissue), CONTUSION (nickel-sized bruise/size of a golf ball or lime), VACCINATION SITE ERYTHEMA (injection site turned into a big red dot/had a crown on it/red streak), NAUSEA (nauseous) and FATIGUE (little fatigued after he walked upstairs) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported by reporter No treatment medications provided by the reporter.   This case was linked to MOD-2021-396142, MOD-2021-396143 (Patient Link).
Fever, increased resting heart rate at 165, fatigue, chills, body ache
01/27/22 presents to ED for "3rd degree heart block". PMHx of "cardiomyopathy with reduced EF, HTN, hypotestosteronism, GERD"
Expired Engerix B administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 14-year-old male patient who received HBV (Engerix B pediatric) (batch number 2h575, expiry date 12th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th October 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 17th October 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-Oct-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Engerix B pediatric formulation, which led to expired vaccine used. Suspect was coded as per narrative information.
Immediate Chest pain, Lumbar muscle spasms, Anxiety.  O2, Benadryl and Ativan administered. Transported to ER.
Pt recvd 3 Hep B vax given 26JUL89, 31AUG89, & 23JAN90; following these titer=3; Pt given a 4th dose 7AUG90 p/4th dose titer=18; 2AUG91 1 yr later titer=2;
Information has been received from a male consumer with no allergies or drug reactions, reporting on himself, who on 15-OCT-2013, was vaccinated with a dose of ZOSTAVAX. The patient reported that, on 15-OCT-2013, he experienced "burning as the her received his injection of ZOSTAVAX". The patient did not seek medical attention, no lab tests were done and no treatment was given. The patient recovered from burning on 15-OCT-2013. Relatedness between burning and ZOSTAVAX was not reported. Additional information is not expected.
This spontaneous report was received from a pharmacist and refers to a 62-year-old female patient with no drug reactions or allergies. On 15-AUG-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque-forming units (PFU), injected subcutaneously (lot # N012615 with expiration date at 16-MAR-2018, for prevention of shingles; dose and anatomical location were not reported), reconstituted with sterile diluent (STERILE DILUENT) (lot # reported as N001807 with expiration date at 31-JUL-2019). On an unspecified date in August 2017 (reported as "on an unspecified date after receiving the vaccine"), the patient began experiencing pain, redness and tenderness at the injection site. No treatment was given for the adverse events. No laboratory diagnostic studies were performed. The outcome of the aforementioned events was unknown at the time of the report. No product quality complaint (PQC) was involved. The causality assessment was not reported. Additional information has been requested.
11-4-05 C/o pain rt side rt lower lobe crackles 11-5-05 rt rib pain in morning. 5pm clammy unresponsive went to ER died at hospital. Hospital reports died from pulmonary embolism. Have not received death certificate at this time. 11/18/05 Death certificate received which revealed COD as pulmonary emboli.
This spontaneous report as received from a pharmacist refers to a 74 years old patient of unknown gender. On 06-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX (dose, strength not reported, lot # K003597, exp. date: 12-MAR-2015). No adverse effect reported (also reported that the patient did not report shingles symptoms). It was reported that the freezer temperature was -15 degrees C prior receiving the ZOSTAVAX. On 11-JUL-2014 the ZOSTAVAX was received. The temperature of the freezer was not recorded through 25-SEP-2014, when it was -9.2 degrees C. There was no power outages. The patient did not report shingles symptoms. The reporter asked what she should do. This is one of four reports from the same source. Additional information has been requested.