chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu-like symptoms; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: The field representative called and stated a doctor mentioned to him that his (the doctor's) partner had flu-like symptoms for a week after receiving Shingrix.  This occurred during a casual conversation and no other information was collected by the field representative. The reporter did not give consent to follow up. The name of the doctor that reported the event was provided but (no contact information provided).
had the shot but still got the shingles/ Suspected Vaccination Failure; had the shot but still got the shingles; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 10-Aug-2022 Reporter's comment: The case was received from the patient's friend via interactive digital media. The reporter reported that the patient had the shot but still got the shingles. The reporter stated that so there not preventable from shingles. The reporter had the shingles and physician said that you can still get the shingles. The reporter mentioned that her husband got the shot hoping he never get them. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
had got sick; had a knot in my arm that I got the injection in/knot in left arm was reported as worsened; If she touches it, it hurts; The knot was hot and if she touched it, it hurt; This is a spontaneous report from a contactable consumer, the patient.  A 57-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: FC3183), via an unspecified route of administration, in arm left on 20Aug2021 at 12:30 as dose 1, single (age at vaccination 57 years) for covid-19 immunisation. Medical history was diabetic, diagnosed about 8 months ago and ongoing and had bad sinuses since an unknown date and she kept an epi pen, she took covid test and did not have covid, this was prior to the vaccine. The history of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient's concomitant medications were not reported. She got her first dose on 20Aug2021, Friday, and the following day she had a knot in her arm that she got the injection in and it had gotten worse on 21Aug2021. The knot was hot and if she touched it, it hurt in 2021. Someone said put some pressure on it but she was scared to do that. She was asking if her left arm was supposed to feel like a knot. She started feeling the knot on Saturday and it started getting bigger and bigger. People told her she may have a blood clot and they were driving her nuts. She reported she had got sick and thought she had it and it was instead an upper sinus infection. The patient did not take any therapeutic treatment for the events. The patient underwent lab tests which included sars-cov-2 test: did not have covid on an unknown date and this was prior to the vaccine. There were no relevant tests. No additional vaccines were administered on same date as that of the pfizer suspect. The events did not require a visit to emergency room or the physician office. There were no prior vaccinations (within 4 weeks). There were no adverse events following prior vaccinations. The patients relevant family medical history was none. The outcome of the event had a knot in my arm that i got the injection in was not recovered and rest of all event outcome was unknown.  Follow-up attempts are completed. No further information is expected.
2 days after vaccines given child had symptoms of erythema, swelling and blistering of right upper arm, and fever. Seen at Center Care and given injected antibiotics and oral antibiotics.
Swollen lymph nodes left armpit; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Mar2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On 09Mar2021 at 12:00, the patient experienced swollen lymph nodes left armpit. The event did not result in doctor or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes left armpit was not resolved at the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a licensed practical nurse regarding a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 30-SEP-2014, the patient was vaccinated with first dose of PNEUMOVAX 23 (lot number and expiry date unknown). On 23-NOV-2015, the patient was again vaccinated with of second dose of PNEUMOVAX 23 (lot no. # K020214, expiry date: 25-MAR-2016) which was shorter than the recommended dosing interval. No concomitant medications were reported. No other adverse events were reported. No product quality complaint was reported. Additional information has been requested.
Discomfort deep with initial vaccine, typical tenderness after vaccine administration.  On day 2 noted redness and heat to site.   Continues to be more painful than any previous vaccine received.
One day after vaccination, patient had a rapid change of mental status, became disoriented, confused, and had difficulty talking and was unable to dress herself admitted to Hospital with MRI evidence of new right subparietal  thrombotic stroke.   Pt treated with aspirin and also had an elevated D-Dimer with no evidence of pulmonary embolus or DVT .  Pt was NOT hypoglycemic and was not hypoxic.  Improved spontaneously over 3 days  10/30/2021, was able to return home, but had not returned to baseline at the time of discharge
Right & left arms to shoulder pain. Neck pain. This is still painfull more then a month later. Must have a pillow under my arm. Taking advil. Haven't slept more then 2 hours at a time.
Dizziness; Red and warm at the injection site; Red and warm at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), VACCINATION SITE WARMTH (Red and warm at the injection site) and VACCINATION SITE ERYTHEMA (Red and warm at the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and AMLODIPINE for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced DIZZINESS (Dizziness), VACCINATION SITE WARMTH (Red and warm at the injection site) and VACCINATION SITE ERYTHEMA (Red and warm at the injection site). The patient was treated with HYDROCORTISONE for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), VACCINATION SITE WARMTH (Red and warm at the injection site) and VACCINATION SITE ERYTHEMA (Red and warm at the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications Lisinopril, Amlodipine.
allergy; cold; heart rate went up to 127, then stayed in the mid 80's; This is a spontaneous report from a contactable consumer (patient). This a 72-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date: not reported), via an unspecified route of administration, on 22Jan2021 03:45 PM at a single dose on the right arm for COVID-19 immunization. The patient was not pregnant. The patient had not received other vaccines in four weeks prior to receiving bnt162b2. Medical history included Hashimoto's, and allergy to statins and fluoroquinolones. The patient had no covid prior to vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) and liothyronine sodium (CYTOMEL). The patient also received another vaccine (unspecified), first dose on 22Jan2021 on the right arm. At about 12:30 or 1:00 pm on Saturday, 23Jan2021, the patient's heart rate went up to 127, then stayed in the mid 80's. She felt like she had an allergy or a cold all of a sudden. She had to rest for a few hours. By 4 pm she felt better. The patient was not tested for covid post vaccination. The patient did not receive any treatment. Outcome of the events was recovered on an unspecified date in Jan2021.   Information on the Batch/Lot number has been requested.
Immediately post injection  ( 3:15 pm  08/04/2021)  , Ms Strauss felt "funny", and simultaneously  lips numb and head feeling "woozy .    Given Benadryl po 12.5 mg X2       911 called, AAPD police arrived 3:29 pm. .  Transported by Huron Valley Ambulance to  Hospital Emergency Department. shortly after.  VS:  145/96  P 94 at 3:18 pm. 158/119 P 101 at 3: 26 pm
At facility, I was put on call-out to receive a RECOMBIVAX on 01/07/2008. RN injected the RECOMBIVAX into the wrong area of my arm causing discharge, leakage from the RECOMBIVAX to burn my skin to the flesh, leaving me scarred: scarred for life.
This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (COVID-19 VACCINE NOS-MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown".; Sender's Comments: Based on the  information provided, a causal association between reported event thrombosis and suspect BNT162B2 cannot be excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300137572 Same article/drug/event or different patient;
An adult presented as a walk-in client for a Pfizer second dose. Vaccinator gave Pfizer (5-11) pediatric dose instead of the adult Pfizer second dose. CDC guidelines were reviewed. A second dose of Pfizer pediatric vaccine was given per CDC guidelines. Upon further review it was determined that the second dose should have been the Pfizer adult dose. CDC guidelines were vague regarding this point. The patient was immediately notified. She waited the appropriate amount of time after receiving the vaccine. No treatment was necessary. No adverse effects were noted.
Fever 100.5 degrees, severe "sick feeling", redness & warmth on arm at injection site, stayed in bed for 2 days before feeling well enough to get up. Took TYLENOL & fluids & rested.
Customer c/o pain in her left arm right after receiving the shot.  Customer stated it was very bad pain that just hit at once.  Code Red called and EMS and Nurse responded.  Vitals taken.  BP 104/72, O2 99, HR 94.
Itchiess all over, as if I were reacting to sun positioning. Itching was noticeable to me by the next morning and become progressively worse towards the end of the day. I began scratching very hard by the end of the day. I took a benedryl to help me sleep through it. Itching resumed through the night and still persists, however, not as intense as day two. Day 2 evening I had fine bumps all over my body and some red welps on my torso, thighs, lower legs, and chest ( I think from scratching so hard).
After receiving the vaccine the pt walked over to the Recovery area and  Pt verbalized becoming lightheaded, dizzy, and having spotty vision. Pt says she has a history of lightheaded and dizziness , so she knows to lay down when that occurs and that's  what she did.
3 d after vaccination developed significant abd pain and n/v/d. Stools were loose and floated w/ foul smell. No fever noted. With headache. 2 nights after that noted nuchal rigidity, which lasted ~ 2 days. With fatigue,  body aches, weight loss of 6 lbs w/ poor po intake.  On 1/24 (~5 days after vaccine)  developed a vesicular rash on his L thigh, and later on the L sacrum, itchy but not painful. Diagnosed as herpes zoster.
Patient had wrist fracture in May 2017. She was given Pneumovax in same arm 7/5/2017. She was no longer wearing a cast. Patient had no pain until a few days later. The doctor diagnosed her with complex regional pain syndrome caused by introducing pain or trauma (including drawing blood or vaccination) into a patient who has suffered from a fracture recently.
Typical adverse effects after the vaccine (fever, chills muscle aches) but low grade fever persisted for almost one week.   Platelets in labs drawn on 3/9/21 were 100K. ITP suspected.  No bleeding as of 3/15/21.
increasing hives and itching/Small itchy red raised dots hands feet and torso; itching; site swollen; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (increasing hives and itching/Small itchy red raised dots hands feet and torso), PRURITUS (itching) and SWELLING (site swollen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced URTICARIA (increasing hives and itching/Small itchy red raised dots hands feet and torso), PRURITUS (itching) and SWELLING (site swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (increasing hives and itching/Small itchy red raised dots hands feet and torso), PRURITUS (itching) and SWELLING (site swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided.   Reporter did not allow further contact
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Patient was shaking upon initial injection of the Pfizer bivalent (but vaccine was not pushed through yet). After the vaccine was given, patient said she felt light-headed and felt like she was going to faint. Patient later was disoriented and and passing in and out. Patient soiled herself as well. Firefighters reported that she most likely had low blood sugar levels. She ultimately came back and a checkup at the hospital. Her other vaccine was not given that day.
Case number PHEH2012US020672, is an initial spontaneous report received from a health care professional on 10 Oct 2012 with a follow-up received on 06 Nov 2012: This report refers to a 6 month old male child. He was vaccinated with MENVEO (batch number: A12012, expiry date: May 2013) at a dose of 0.5 ml intramuscularly in to the left anterior thigh on 09 Oct 2012. No adverse event was reported. Follow-up received from the health care professional on 06 Nov 2012: Updated patient demographics, batch number of MENVEO, dose, route and site of administration.
It was reported "A physician called her (the reporter) stating a pt developed local reaction and dx'd it as cellulitis." From follow-up #1 correspondence returned on 7-May-2001, it was reported that the patient's recovery status is unknown. 'The MD's office filed a VAERS also.'
Pt received the first dose of the Moderna COVID vaccine on 3/6/21. The following morning, she had moderately swollen eyes and mild dizziness. Eyes swollen since Friday after covid vaccine, BP noted to be low after taken twice. Pt went to ED and was put on Pepcid, Benadryl, and Prednisone. Pt feels the same, no improvement in the eye swelling. The dizziness is gone now. No fever, redness or pain at the injection site. Pt is swallowing and breathing without difficulty.                      Any treatment So Far: prednisone, benadryl, pepcid
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 11-JUL-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 05-MAR-2018, the patient was treated by a nurse practitioner for a blistering vesicular outbreak which was then diagnosed as severe herpes zoster. The patient has been prescribed valacyclovir and oxycodone-acetaminophen for management of her painful symptoms and chronic pain. 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. Additional information has been requested.
About 2 hours after the shot, the injection area started to hurt. By the end of the first day, my left shoulder muscles were painful (pain grade: 2~3 out of 10).  This pain subsided in about 3 days.  Starting from 1/2/2021, a red, warm, and itchy papule is visible around the injection site, measuring up to 4 cm.  Meanwhile, a mildly painful (2-3/10) lymph node could be palpated in my left axilla.  The pain exacerbates upon pressure (4/10).  The swelling and mild pain persist until today.  Only occasional tylenol and topical anti-itch cortisol cream were used.
Case number PHEH2016US030914, is an initial spontaneous report received from a nurse on 22 Nov 2016. This report refers to a 56 years old female patient (non-pregnant). Past medical history and concomitant medication were not reported. The vaccine was well tolerated in the past (unspecified details). The patient was vaccinated with an expired dose of FLUVIRIN (batch number: 1516401, expiration date: Jun 2016) at 2:30 PM on 22 Nov 2016 at a dose of 0.5 ml, intramuscularly in right deltoid. On the same day at 2:45 PM the patient was revaccinated with FLUVIRIN in left deltoid. It was reported that the patient did not have an adverse reaction from outdated vial of FLUVIRIN. No adverse event was reported following this medication error. Follow up report received on 23 Dec 2016: added patient demographics (height and weight) and vaccination details.
Patient tested positive for COVID 4/16/21. Completed COVID vaccine series 2/2/21. Asymptomatic. Recently returned from trip on 4/13/21. Traveled by plane.
Pt. received 1st dose of Moderna vaccine on 4/1/21, and was subsequently admitted to the hospital on 4/4/21 with COVID19
Patient contacted my office yesterday to report this event which occurred several months ago, approximately 6 days after vaccination with Havrix (of which she had previous a dose) and Typhim Vi (first dose). Reports "rash", itching, hives, and erythema of lower extremities, trunk and palms intermittently, but at least once daily, usually in the evening. She has seen her primary physician and an allergist. Allergy testing reported as inconclusive. Current treatment with Zyrtec po and Doxepin topical seem to be giving her some recent relief. She reports symptoms are improving. She also takes Timolol and HCTZ for her hypertension. Unknown if related to vaccination.
The next day I had a severe sore throat. I could barely speak or swallow. It cleared up in two days.  However, in the weeks after the second dose, I tested positive for the first time for rheumatoid factor and ANA. I also had a first-ever outbreak of psoriasis.
Headache, NauseaVomiting, HA, MUSCLE ACHES, NAUSEA, FATIGUE Narrative:
On 4/25/2021 I experienced a sever case of Vertigo.  In trying to fix a loose tank on a toilet I proceeded to lay flat on the gound to tighten some bolts on the underside of the take.  As soon as I rolled from my back to my left side I felt as though the entire room was spinning and I was unable to move or control myself.  A friend witnessed it.  For the next several days I was unable to walk straight and felt as though I was always drunk.  I had to call into work for several days and once I felt a little better I had my wife drive me to my office.   I still have minor events of dizzyness from time to time.  Also to add to the issues my ears (yes both) have not stopped ringing since.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 06-DEC-2018, the patient was vaccinated with improperly stored dose of VARIVAX (strength and dose were not reported) (lot # R018931 and expiry date: 02-JUL-2020), via subcutaneous for prophylaxis (product storage error). The vaccine vas reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccine was stored in between -14 degree Celsius (C) to -10 C (-14 C) for 27 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This report is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1812USA005671.
1 Week after MMR and DTaP , Hib fevers 100-103 vomited frequently. No local reaction or rash Day 8-9 fever 103.8, vomiting x 6.