chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old male patient who received Influenza vaccine Quadrivalent. Co-suspect products included ADVAIR DISKUS inhalation powder (batch number 6ZP7785, expiry date 31st January 2018) for chronic obstructive pulmonary disease. In September 2016, the patient received Influenza vaccine Quadrivalent. On an unknown date, the patient started ADVAIR DISKUS (inhaled) 1 puff(s) twice daily (2 puff(s) daily). In December 2016, 91 days after receiving Influenza vaccine Quadrivalent and not applicable after starting ADVAIR DISKUS, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza (serious criteria hospitalization), methicillin-resistant staphylococcus aureus infection (serious criteria hospitalization and GSK medically significant), dehydration (serious criteria hospitalization) and dizziness (serious criteria hospitalization). On an unknown date, the patient experienced weakness. ADVAIR DISKUS was continued with no change. On an unknown date, the outcome of the vaccination failure and weakness were unknown and the outcome of the influenza, dehydration and dizziness were recovered/resolved and the outcome of the methicillin-resistant staphylococcus aureus infection was recovering/resolving. The reporter considered the vaccination failure and influenza to be possibly related to Influenza vaccine Quadrivalent. The reporter considered the methicillin-resistant staphylococcus aureus infection, dehydration and dizziness to be unrelated to Influenza vaccine Quadrivalent and ADVAIR DISKUS. It was unknown if the reporter considered the weakness to be related to Influenza vaccine Quadrivalent. and ADVAIR DISKUS. The reporter considered the influenza to be unrelated to ADVAIR DISKUS. Additional details were provided as follows: The case was previously reported to the physician. In 2012, the patient received ADVAIR DISKUS. The manufacturer for influenza injection was unknown. In December 2016, approximately 4 years after receiving ADVAIR DISKUS and approximately 3 months after receiving Influenza vaccine Quadrivalent, the patient experienced influenza, methicillin-resistant staphylococcus aureus infection, dehydration and dizziness. The patient was hospitalized for a day and a half. The patient was discharged, but went back in the hospital one week later. On his previous hospital stay, he contracted methicillin-resistant staphylococcus aureus infection (MRSA). The patient was transferred to a different hospital for several days. The patient reported that the methicillin-resistant staphylococcus aureus infection (MRSA) was finally killed off, but it left him weak. The patient did not recall the name of the physician, he had, but said fine to receive a letter asking for that information. He had the paperwork somewhere. This case was considered as suspected vaccination failure as the lab test confirmation was unknown at the time of reporting.
This spontaneous report was received from a Registered nurse regarding a 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
No adverse effect; Improperly stored VARIVAX; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant therapy were not reported.   On 26-FEB-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency and route were not reported) (lot # R018143 and expiry date: 25-JUN-2020, lot # R026715 and expiry date: 18-SEP-2020) for prophylaxis. The varicella virus vaccine live (oka/merck)(VARIVAX) was reconstituted with properly stored diluent(DILUENT MRK INJ). It was reported that, the nurse did not know which lot number was administered to the patient therefore 2 lot numbers are documented.  The vaccines were stored in temperature 47 degree Fahrenheit (F) to 77 F (66.5 F) for 943 Minutes. No previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.  This is one of two reports received from the same reporter.
Swelling 6 inches around site. Significant itching. Pain from the elbow to hand.
Information has been received from a literature article, concerning a 2 year old patient who was vaccinated with hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown). Subsequently the patient experienced autistic symptoms, fever 106F and convulsions. Autistic symptoms and convulsions were considered to be other medical events (OMIC). It was also reported that another patient had the same symptoms (WAES0510USA09342). No further information is available. The literature article is attached as further documentation of the patients experience.
It started with massive bilateral leg pain, couldn't stand, walk, sit, sleep and drive car, I had to take Advil 400mg daily to reduce the pain, I worked for 3 months, finally stopped working and went on temporary disability and started going to multiple doctors for treatments. I paid all from my own pocket and used my health Insurance. continued;
My 14 month old was given a 3rd dose of rotavirus vaccine, when he should not have been.
5 days post injection pt. continues to have 170 x 160 area of redness surrounding injection site. Slightly swollen and warm to touch. (Began morning after injection).
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 at 12:00 as dose 1, single (Lot number: En6202), in left arm, on 03Apr2021 at 12:00 as dose 2, single (Lot number: Ew0151), in left arm and on 17Nov2021 at 12:00 as dose 3 (booster), single (Lot number: Fh8028) at the age of 63 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Other medical history: Diabetes high blood pressure anxiety; "high blood pressure" (unspecified if ongoing), notes: Other medical history: Diabetes high blood pressure anxiety; "anxiety" (unspecified if ongoing), notes: Other medical history: Diabetes high blood pressure anxiety; "Known allergies: Bee sting" (unspecified if ongoing), notes: Known allergies: Bee sting. Concomitant medication(s) included: BYSTOLIC, start date: 01Nov2021; ZOLOFT, start date: 01Nov2021; ATIVAN, start date: 01Nov2021; NATUREMADE, start date: 01Nov2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Anti-viral details: product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 14Apr2022, Treatment stop date: 15Apr2022. Therapeutic measures were taken as a result of vaccination failure, Covid-19.
Started with vomiting, diarrhea, fever, chills, sweats, head, chest, congestion, headaches, throat soreness, loss of taste and smell, im currently taking  Paxlovid antiviral medication that was prescribed by my Dr.
Information has been received from a nurse four patients who on unspecified dates was vaccinated with a dose of VARIVAX (Merck) (LOT# not reported).  On unreported dates, after vaccination, the patients experienced local injection site reactions.  No further information was available at the time of this report.  Follow-up information has been received from a nurse concerning a 14 year old female who in the week or so of 24-JUL-2009 was vaccinated with a dose of VARIVAX (Merck) (LOT# 664620/0797Y).  "During the week or so of 24-JUL-2009", the patient experienced injection site reactions.  She had recovered at the time of this report.  Follow-up information has been received from a registered nurse concerning the 14 year old female who on 29-JUL-2009 was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (LOT# 664620/0797Y).  On 31-JUL-2009, the patient experienced local injection site reaction described as swelling and erythema.  The patient had responded to icing and observation.  On an unknown date, the patient recovered.  A lot check has been initiated.  This is one of several reports from the same source.  Additional information has been requested.
I had no symptoms within the first 24 hours of the vaccine. The joint pain started about a day or two after the vaccine.  It was intermediate and the lack of range of motion was about 2 weeks after the vaccine.  I went the doctor July 26th, and they prescribed physical therapy.  I have not had my first appointment for physical therapy yet.
My husband got a headache and a rash on his temple, starting the Wednesday after his second shot. His headache and the rash got worse, along with swollen lymph nosed on his neck and head. He went to an urgent care clinic on Saturday, a week after his second Moderna shot, and was diagnosed with shingles. He was given gabapentin, a generic of Valtrex and prednisone.
chills ("freezing"); freezing hands and toes; This case was reported by a consumer via call center representative and described the occurrence of chills in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included raynaud's disease.   On 8th September 2020, the patient received the 2nd dose of Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced chills and cold hands & feet. In September 2020, the outcome of the chills and cold hands & feet were recovered/resolved.   It was unknown if the reporter considered the chills and cold hands & feet to be related to Shingrix.  Additional details were provided as follows: The patient received shingrix on left arm. The patient stated, she had freezing hands and toes for about one and half hour. The reporter was not sure if the chills (freezing) to her hands and toes might not have been from that disease. The reaction was gone the next day. The reporter consented to follow up.
"Covid arm" - 8 days post-vaccine (1st dose), I had a reaction on my upper arm, near the vaccine site.  Reaction was red, swollen, feverish, itchy - approx 2" x 3" oval.  24 hours later & it's still present, however all reactions while still present have lessened somewhat.  I'm using an antihistamine topically (day) and orally (night).
Developed joint pain in right hip. Pain progressed to other joints and muscles. Diagnosed with fibromyalgia finally in 2008.
Metal Taste in mouth; Skin was Tingling; Swollen on injection; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metal Taste in mouth), PARAESTHESIA (Skin was Tingling) and VACCINATION SITE SWELLING (Swollen on injection) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L204) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Metal Taste in mouth), PARAESTHESIA (Skin was Tingling) and VACCINATION SITE SWELLING (Swollen on injection). At the time of the report, DYSGEUSIA (Metal Taste in mouth), PARAESTHESIA (Skin was Tingling) and VACCINATION SITE SWELLING (Swollen on injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events was not reported by reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-080885 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up received on 24 May 2021 included no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Had varivax on 10/8/99. Today presented with varicella rash with about 8 lesions. No other symptoms. Has it presently.
pt recv vax & it was noted that pt may have had rubella as a child & recv 2 doses of rubella vax p/each pregnancy;according to reporter pt MD felt pt had not seroconverted;
10/7/2019 Patient is a 35 y.o. male evaluated with a video visit on Currently he complains of rash over his whole body. He get a vaccine- flu and Tdap at that time. It is itchy, it started on wrists then moved to armpit, then on upper body.    The symptoms have been present for 1 day(s).  He denies a history of fever, chills, difficulty breathing.  He has tried over-the-counter agents for his symptoms. Zyrtec. ? predniSONE (DELTASONE) 20 MG tablet likely reaction to vaccines. advised if having difficulty breathing, tongue swelling, fever to be seen in person.   Addendum: will cancel prednisone and use vistaril instaed due to recent vaccine
Initially bilateral wrist pain, swelling and decreased range of motion.  Progressed over next 6 months prompting further evaluation and diagnosed with tenosynovitis in wrists b/l.  Continued to progress over following year affecting knees, elbows, ankles, shoulders, fingers and feet.  Diagnosed with presumptive Unspecified Connective Tissue Disease.  Treated with PO NSAIDS, steroids, steroid injections in wrists b/l, braces, hand OT, PT all with transient relief.  Vaccination is suspected to have triggered autoimmune response (UCTD vs seronegative RA) vs reactive arthritis.
at 1:36pm client started c/o heaviness in chest, denies SOB.Client had taken Benadryl 50mg po and 2 Zyrtec at 12:30pm to offset a reaction. Bp was elevated. Taken to triage area. no medications given. 2:35 pm client reports improvement is chest heaviness. Her husband was with her to drive her home.
Swelling on the right arm on the lower part of his armpit; This is a spontaneous report from a contactable consumer (patient, reported for himself).  A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch/lot: Not provided), via an unspecified route of administration on unspecified date as dose number unknown, single for COVID-19 immunization. The patients Medical history and Concomitant medication were not reported. On unspecified date patient took COVID-19 Vaccine last Saturday. Sunday, he experienced swelling underneath right arm on the lower part of his armpit on unspecified date. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
L upper arm red and swollen, no fever-seen 2 days later-still tender but improved. No cellulitis-use cool compress and MOTRIN prn-most probably from DTAP (KINRIX).
I have MS and I was having some stomach issues and they said it wouldn't be a problem but I ended up in the hospital for 5 days then in rehab. I woke up about 2am after vaccine and when trying to go to bathroom my legs gave out and I hit the floor, we called EMS to get me up and I was really weak. My legs were gone the rest of the night and I couldn't stand my husband had to help me . On the 24th, we called the EMS to take me to the hospital and they sent me to rehab and I got out of there on the 28th to home but I do not have my strength back.
left shoulder and upper arm pain; left shoulder and upper arm pain; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left (left shoulder) on 29Mar2021 (Batch/Lot Number: ER8730) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 01Mar2021, with lot number EL3302, in his left shoulder and experienced pain in his left shoulder. The patient received the second dose at the end of Mar 2021, on 29Mar2021. Since the second dose (29Mar2021), he experienced left shoulder and upper arm pain for two months and the pain has not gone away. Caller states that he received the injection in his left arm. He had consulted with his HCP in which they advised him to perform stretching exercises and states that the exercises have not helped. Caller states his doctor said the pain must be from him having a strong immune system. It was reported that after the second dose, he had less pain in his shoulder, but it hasn't gone away. He did not have a prescribing doctor. He had not received treatment. He didn't go to the doctor or ER. He did talk to his doctor, and his doctor said people are reporting all kinds of weird stuff. He did ask him if he was working it out. The caller was stretching every morning, and that was when he felt it. Patient wanted to know if he should be concerned about this side effect, what he should do and there is any treatment recommendations to provide. He also asked if anyone else has experienced this side effect and what could cause this pain in his arm and shoulder. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Information has been received from a female patient of unknown age via company representative, referring to herself. No relevant medical history or concurrent conditions were reported. In 2005 (reported as 10 years ago) the patient was vaccinated with three shots of GARDASIL (dose, frequency, lot# and expiration date not reported). In 2014 (reported as last year) the patient received a booster shot with the GARDASIL (dose, frequency, lot# and expiration date not reported) (Extra dose administered). The patient asked if she was able to booster again with GARDASIL 9 or if she was required to take the full 3-dose series of GARDASIL 9. Additional information has been requested.
1st dose 4Nov2021, 3rd dose 3Jan2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 24-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX) and HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 3rd January 2022, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 3rd January 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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: 19-MAY-2022  Reporter's Comments: Pharmacist reported a patient received three doses of Twinrix. Did not consent to follow-up. Additional Supportive Information: The patient received 3rd dose of Twinrix, earlier than recommended interval, which led to shortening of vaccination schedule.
A nurse reported the occurrence of headache in an adult male of unspecified age who was vaccinated with Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the subject received his first injection of Engerix-B. At an unspecified time post-immunization, he experienced headache and nausea. As of 10/10/02, the outcomes of the events were unknown. Comment: This report has been linked to report A0383039A due to same reporter.
Bells-Palsy after 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of BELL'S PALSY (Bells-Palsy after 1st dose) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bells-Palsy after 1st dose) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bells-Palsy after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
She states that her "friend's mom started losing her hair in clumps since the vaccine"; This is a spontaneous report from a Non-contactable Consumer. This Non-contactable Consumer reporting for a female patient.   A female patient with an unspecified age received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number: unknown) via unknown route of administration on an unknown date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. On an unknown date, it was reported that, her friend's mom started losing her hair in clumps since the vaccine. At the time of this report the outcome of the event was unknown.  No follow-up attempts were possible, information about lot/batch number cannot be obtained.
Intense itching and redness at site approx 3 hours after injection .  Redness remains 16 hours later
Patient receive the vaccine Tuesday afternoon and by Wednesday morning had red streaks down his arm. Report to primary care provider and was told that if it did not apporoved by Friday report to urgent care. Urgent Care Nurse report localized redness and swelling at the injection site and the patient expressed his arm was aching at a 3 pain level.
Within 48 hrs of 12/6/04 vaccines, patient presented with staring spells w/eye deviation to left and arm (L) trembling. Nine days later (12/17/04), patient had a grand mal type seizure and stopped breathing. Patient seizures have failed to stop without medication. This had led to numerous hospitalizations, life threatening illness and currently, hearing loss due to a drug reaction in the hospital. Records rec'd 11/17/05 -- no additional terms/sr
redness rt arm x 1-2day;tender to touch x 1-2 days;fever not quantified x 1 day;golf ball induration x 1 day;
Patient stated her arm was a little red and itchy right away, then the redness and a lot of itchiness occurred again 3 weeks later.
Headache, Myalgia, Fever, Angina, Fatigue Narrative: