chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via sales rep and described the occurrence of rotator cuff tear in a female patient who received Shingrix for prophylaxis. In July 2018, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced rotator cuff tear and injection site pain. On an unknown date, the outcome of the rotator cuff tear and injection site pain were unknown. The reporter considered the rotator cuff tear and injection site pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and the day following injection, pain at the injection site was so severe that she went to the emergency room. The patient continued to have pain in her shoulder area since July 2018 injection and she was referred to an orthopedic physicians after an appointment with her primary care provider (PCP). The orthopedic surgeon informed the patient that it was the Shingrix vaccination that caused her rotator cuff to be torn (shortly after vaccination). The patient was threatening litigation against GlaxoSmithKline and the reporting pharmacist.
Left facial tingling sensation and itching s/p vaccination and progressively worsen over the subsequent several days.  Tx:  Benadryl po w/o improvement:  Pt return to ER for further care including CT of brain and IV Benadryl.
Left arm swelling; Left arm swelling/ hot/dark pink to the elbow.; Left arm swelling/ hot/dark pink to the elbow.; This is a spontaneous report from a contactable consumer, the patient. A 70-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727) via unspecified route of administration in left arm on 28Mar2021, at 13:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not have any allergies to medications, food, or other products. Concomitant medications included pravastatin (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was diagnosed with COVID-19 on unspecified date. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 31Mar2021, the patient experienced left arm swelling, hot and dark pink to the elbow. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit. The patient was advised by the nurse to take BENADRYL (patient took BENADRYL and swelling sent down in 3 days) and warm compression as treatment for the events. The clinical outcome of events left arm swelling, hot and dark pink to the elbow was resolved on 03April2021.   No follow-up attempts are needed. No further information is expected.
PT REPORTED SEVERE HEADACHE THE AFTERNOON OF THE VACCINE. THE HEADACHE WAS WORSE THE FOLLOWING MORNING, ALONG WITH RED RASH AT INJECTION SITE AND ABDOMINAL PAIN. PT. REPORTS "PASSING OUT" AND FALLING, RESULTING IN CONTUSIONS TO KNEE, ARM, SHOULDER AND FACE.
Headache, injection site swelling, all over body pain, swollen lymph nodes all over, stiff neck, chills, brief running nose, brief difficulty getting a deep breath, hives on abdomen, bilateral abdominal rash
The day I got it, I was fine. That night I had chills, nausea, pain in my lymph nodes under my arm and swollen, and I had a fever of over 100. Extremely tired. I have previously had breast cancer in my left breast and have had 5 lymph nodes removed on that side, but after the vaccine both sides were swollen. Started feeling better after a few days. On 17th of April I started getting rashes, it started on my scalp, then my neck and both arms and down in my hands. At that point, I was on daily low dose aspirin and metoprolol tartrate 25mg. Called cardiologists because when I was on metoprolol I couldn't take a decongestant, he suggested Benadryl without decongestant and that helped. It lasted about a week, but was tolerable. About 3 ½ weeks after vaccine are when the blood clots started. I saw my PCP on 5/21/21, diagnosed small blood clot below my knee. Told me to continue with aspirin and put heat on it. It was very painful, I had that about a month. I did develop COVID on 12/29/21. After that I started having issues breathing in January 2022. Was diagnosed with SVT by the doctor.
Immediately felt sore in arm then felt hot and sweaty in post vaccine waiting room dizzy blurred and blacked out vision... Vasovagal syncope episode  Emt and nurses came right over gave me oxygen and water.....felt better after approximately 25 minutes of treatment....drank 3 bottles of water was able to walk and leave without going  to hospital around 12:15pm  Arm severely sore for 48 hours.
This initial report was received from a medical assistant concerning unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VAQTA, , lot number M009377 with expiration date 17-JUN-2017, lot number L009445 with expiration date 01-JUN-2017 and lot number L023936 with expiration date 15-MAR-2017 (dose, strength, route of administration and anatomical location were not reported. According to reporter, the vaccine experienced temperature excursion of up to 45.5 F for 362 hours and 12 minutes. No adverse effects were reported in any patients. This is one of several reported from the same source (1611USA012962 and 1611USA007125). Additional information is not expected since reporter did not give consent for follow up.
Patient had extreme redness, itching, and redness spread down half of her arm to her elbow, and spread all around her arm. The rash worsened for several days after the vaccine and began to recede on Sunday 8/11/19.  Patient was advised by her MD to start loratadine 10mg tabs and ranitidine 150mg tabs. MD advised patient to wait full 6 months to obtain second dose of Shingrix, and to pre dose for several days prior to injection with loratadine and ranitidine.
Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022; Patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2022 at 9:49 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Feb-2022 at 9:49 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Patient received booster dose vaccination time was reported as 09:49:26. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  Treatment medications were not reported.
neck/upper thoracic pain radiating to left shoulder blade, difficult to turn head. 50% better the second day, then fine by third day.
Tingling in feet and hands, numbness in feet, loss of balance 2-3 weeks prior to ER visit on 6/12, was admitted  to hospital Guillame Barre Syndrome was diagnosis MRI of brain and lumbar Lumbar puncture to confirm high protein IVIG infusion for 5 days
A cluster of over 100 patients out of an unspecified number of vaccinees from a hospital, who received Fluzone (lot number U2199AA) and experienced black dots at injection site.  Initial report received from a nurse at a hospital on 02-Nov-2006.  Over 100 unidentifiable patients received on an unspecified date, Fluzone (U2199AA) (multidose vial) into the deltoid (dose, side and route of administration were not reported) and experienced black dots at injection site immediately after the dose of was administered.  No corrective treatment was reported.  Patients outcome was not reported.  SafetyGlide 23g, 1", 25g 5/8 needles were used with Safety Glide syringe system (lot number for the needle used was not reported).  The alcohol brand was unknown, but the reporter said it was a generic brand, started with "M".  The black mark appeared all the way through using the vial, with no difference of the dose number.  The black spot appeared immediately after vaccination, it was unknown if it disappeared or how long it lasted.  The reporter had not ever seen this happen with any other product vial.  The black dots were noticed by all five nurses that administered the vaccines.  The reporter had not ever seen this happen in the past year.  The reporter did not track the incident, but was willing to do so if the event continued.  112 vials were purchased and 15 were used so far.  The event had been occurring routinely, but it was most noticeable on higher skinned people.  The reporter was not sure if it happened with every dose.  The reporter did not have any empty vials (all had been discarded), but stated they were doing many immunizations so they would have more empty vials by the end of the day (02 November 2006).  Concomitant vaccinations, medical history and prior exposure to Fluzone were not reported for the patients.
Headache on the following day; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 50-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; #lot: EL3247) via an unspecified route of administration, administered in left arm on 19Feb2021 09:30 AM (at the age of 50-years-old) as dose 2, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccine administered within 4 weeks from vaccination. Patient not diagnosed with covid prior vaccination and not tested for covid post vaccination. On 20Feb2021, the patient experienced headache on the following day. No treatment received for the event. The outcome of the event was recovered on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
Extremely swollen and painful axillary lymph nodes, headache, chills, breast tenderness, fatigue, irregular period
530PM woke up from nap w/swollen face & macular rash on face & chest;mom had reported systemic wheals & swelling but this is not documented on ER report;pt ER visit states visit no urgent;given DPH & discharged;
Bells palsy to right of face and numbness to left side of face.  Pain at injection site.
Tachycardia, hyperventilation, myalgias. Received ATIVAN and TORADOL in ER.
Pt received Fluzone HD Quad on 09/04/20. He reported to the pharmacy on 9/25/20 stating that he is still experiencing pain at the site of injection
Patient received a tdap on 5/23/2012 left deltoid. Patient seen on 5/25/2012 for c/o warmth, redness to left deltoid with fever. 5cm red swelling with streaking toward axilla. Cold compress to arm. F/U if.
Patient is in the hospital with walking pneumonia.  The patient's wife called to report that she believed it was from the Prevnar 20 vaccine
After 10 days of receiving vaccine, patient experienced red, zit like bumps on abdomen. The bumps were itchy and bled when scratched. It spread to her arms and legs and is still reoccurring in random spots throughout her abdomen, arms, and legs.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Oct2021 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Treatment: Paxlovid. Treatment start date: 05May2022 and stop date: 09May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
seizure; This case was reported by a pharmacist via call center representative and described the occurrence of seizure in a 1-month-old female patient who received HBV (Engerix B) (batch number HN5BE, expiry date unknown) for prophylaxis.   On 8th October 2019, the patient received Engerix B 10 µg. On 8th October 2019, less than a day after receiving Engerix B, the patient experienced seizure (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the seizure was not recovered/not resolved.   It was unknown if the reporter considered the seizure to be related to Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. Shortly after getting the vaccine, they were putting her in the care to go home, the patient started having a seizure. The patient was taken to the emergency room (ER) and later admitted to the hospital. On 10th October 2019, she was on anti-seizure medication in the hospital, but was still experiencing seizures. She did not have any seizures prior to getting Engerix-B. The Engerix B batch number was reported as HN5B3, however based on a batch number review, the batch number was corrected to HN5BE.
pt reported fatigue; This is a spontaneous report from pharmacy received from a contactable Healthcare Professional. A 74-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on an unspecified date, at 74 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization and palbociclib (IBRANCE), oral from 13Apr2021 and ongoing (Batch/Lot number was not reported), at 125 mg daily day 1-21 of 28 day cycle for breast cancer. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced fatigue. Palbociclib dose was not changed in response to the event. The event outcome was unknown at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a healthcare provider at a physician's medical office for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at care centers for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Moderna COVID-19 Vaccine EUA.   30 hours of aches, extreme tiredness, and fever.
Breakthrough case admission after 4 vaccines Pfizer 3/10821 Lot# En6199;  Pfizer 3/31/21 Lot# ER8733;  Pfizer 10/11/21 Lot# FF2589;  Pfizer 11/2/22 Lot# GJ3277
Patient was given a first dose Pfizer vaccine on 03/25/2021 and then received a second dose vaccine of Moderna on 04/15/2021.  At the time this document is submitted, the patient's medical record does not report any AEs.
Myocarditis/pericarditis; Myocarditis/pericarditis; Chest pain; Heart burn; This is a spontaneous report from a non-contactable consumer received from a Pfizer sponsored program.   An 18-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date (1 or 2 days after receiving the first dose) the patient experienced chest pain and heart burn. The patient was not evaluated by a doctor at the time of the chest pains so was unclear if it was myocarditis/pericarditis. The patient 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.
Patient vaccinated 8/30/2021, 4/8/2021, 3/18/2021. Patient hospitalized and COVID positive 1/12/22.
Body so weak he can't get up; Going to the bathroom every hour to urinate; Equilibrium is off; Knot at the injection site; Fever 101.0; Hurt likes hell; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Body so weak he can't get up), POLLAKIURIA (Going to the bathroom every hour to urinate), BALANCE DISORDER (Equilibrium is off), VACCINATION SITE INDURATION (Knot at the injection site) and PYREXIA (Fever 101.0) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Body so weak he can't get up), POLLAKIURIA (Going to the bathroom every hour to urinate), BALANCE DISORDER (Equilibrium is off), VACCINATION SITE INDURATION (Knot at the injection site), PYREXIA (Fever 101.0) and MYALGIA (Hurt likes hell). At the time of the report, ASTHENIA (Body so weak he can't get up), POLLAKIURIA (Going to the bathroom every hour to urinate), BALANCE DISORDER (Equilibrium is off), VACCINATION SITE INDURATION (Knot at the injection site), PYREXIA (Fever 101.0) and MYALGIA (Hurt likes hell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) Fever 101.0.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Pt had a 6 cm  in diameter area of swelling and redness to arm where vaccine was given. Also with a knot under the skin and a small bruise at the injection site.  Dad called our office 4 days afterwards asking if we would look at it as he was concerned. He brought pt to our office.  I advised him to use Ibuprofen for pain, take a Benadryl before bedtime for redness/swelling, and apply a cold compress to it. Dad verbalized understanding.
I will attach DD Form 2766 and copy of certificates of vaccination and sign and symptoms. Memory loss with dizziness, trouble remembering recent information, disorientation, insomnia, sleep problems, joint & muscle aches, anxiety, angry, irritable, depression, diabetes mellitus, loss of energy,eye disease, vision problems, hypertension, coordination problems, blood pressure varies, sneezing, weakness, weight loss, joint swelling, lower back pain, back pain, respiratory problems, muscle & joint pain, rib cage pain, eye pain, chest pain, skin itching, Charlie horse,
PATIENT HAD PFIZER VACCINE  Dose 1 date: 01/6/2021, Dose 2 date: 01/27/2021, AND TESTED POSITIVE TEST RESULTS.
Patient received Pfizer COVID vaccine on 3/18/21 and 4/13/21. On 1/24/22, patient admitted to our CCU with BiPAP for acute hypoxic respiratory failure due to severe COVID PNA and possible superimposed bacterial PNA. As of today (1/26/22), patient is still admitted in CCU with BiPAP.
I experienced a severe headache. Even though I didn't take my temperature I am sure I had a fever. I also had aches, chills, and itchy dry eyes and skin. This lasted at least two days (the two days after receiving the vaccine). Never had this happen before.
Tachycardia day of injection. Hallucinations following day. Hives noted two days after injection in a semi-circle around the injection site.
Patient was administered the COVID booster to patient. Employees were to complete this training before giving Booster Doses at the site. Patient being made  aware.
102 temperature, fluctuating down to 95.6 and then back up to 101.6,  headaches, chills and shakes, bodyaches and severe neck pain that lasted for five days ended up in the emergency room to rule out meningitis.
Nurse reported 4-month-old twins received first dose of ROTATEQ on 10/05/2023.; This spontaneous report was received from an Other Health Professional and referred to a 4-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 05-OCT-2023, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, expiration date: 01-NOV-2024, administered orally for prophylaxis (lot# X001085 was an invalid lot# for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) rotavirus vaccine, live, oral, pentavalent (ROTATEQ), strength was not provided) (Product administered to patient of inappropriate age).  This is one of the 2 reports reported by same reporter (referred to twins).
At 23:00, pt experienced shortness of breath, erythema, and a knot had developed. Pt given Benadryl from ER. Upon follow up, erythema was resolved but knot in left deltoid still present.
I had a warm rush come from my left chest up through the left side of my neck about 12 minutes after the shot. I did not report it at the time because I didn't know it was possibly from the shot. The feeling continued to come and go through the left side of my chest and neck area. I also began feeling a tingling sensation in my left jaw, arm, hand. The tingling sensation has remained fairly consistent. The heat rush comes and goes and varies in intensity from a warm feeling to very hot and uncomfortable like there was a tube of hot lava inside my body causing quite a bit of pain.
PATIENT RECIEVED A HEP A AND A VARICELLA VACCINE AND WAS OBSERVED FOR 15 MINUTES. AFTER THE 15 MINUTES SHE STOOD UP TO LEAVE AND FAINTED. SHE WAS HELPED TO THE FLOOR AND CAME TO A FEW SECONDS LATER.