chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 38-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). On unspecified dates the subject received 1st dose and 2nd dose of TWINRIX (details unknown). On 8 August 2011 the subject received 3rd dose of TWINRIX (unknown, left deltoid). On an unspecified date in 2011, 5 weeks after vaccination with the 3rd dose of TWINRIX, the subject experienced decreased therapeutic response. It was reported that "serologic testing 5 weeks post dose 3" showed the subject had a "low response to TWINRIX".
Four hours after the Modera booster, I experienced chills, body aches, fever. I went to bed but couldn't get to sleep. At 1:00 a.m., the fever was 102.6. I took 500 mg Acetaminophen and returned to bed. When the fever broke, I experienced severe sweating followed by nausea. I fainted and hit my face on the tile floor of my bathroom breaking the skin just above the right eyebrow. Within 30 minutes, that entire eye socket and surrounding area was dark purple. I was able to stop the bleeding and did not need to seek medical attention. There was no further nausea. The body aches and a lower fever (101.5) lasted throughout that day. By Sunday, I started feeling better and have improved each day.
1/18/2000 seizure at home; jerky onset; keep eyes rolled back 1 minute; flaccid/weak for 2 minutes; seemed ok. 911 called by mom. When ambulance arrived, started to seize again. Taken to ER.
3/31/2022 at 1335 Employee called the Nurse Vaccine Support line to report symptoms post COVID-19 booster vaccine. Vaccine Name - Pfizer Vaccine Date - 3/23/2022 Booster Dose - Yes Location - Left Deltoid Date of Symptom Onset ? 3/27/2022 Symptoms ? Runny Nose, Sneezing, Low Grade Temp (Tmax 99.8F), Hot Flashes (Face Flushed), Headache, Ear Pressure Last Day of Work and Shift ? Today, 3/31/22 (Left Work Early) / Schedule: Monday - Friday (8a-5p) / Missed Work: Not Applicable Home Remedies ? Zyrtec (Takes Nightly) Any Improvement ? Intermittent Improvement (Better During Medication Administration)
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and genders. Medical history and drug reactions/allergies were not reported. On an unknown date, the multiple unspecified patients were vaccinated with improperly stored M-M-R II (lot, dose, frequency and route not reported). Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source (1405USA001550 and 1405USA001551). Additional information is not expected.
Elevated CRP- C reactive protein; left ear pressure; loss of left upper field  of vision, in the left eye; Bilateral Ischemic Optic Neuropathy; headache; This case was reported by a nurse via call center representative and described the occurrence of ischemic optic neuropathy in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 9227H, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included HAV (Havrix) (batch number E9G4E, expiry date 29th December 2021) for prophylaxis and Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number MB9YJ, expiry date 6th June 2020) for prophylaxis.   On 30th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml, the 2nd dose of Havrix (intramuscular) 1 ml and FluLaval Tetra 2019-2020 season (intramuscular) .5 ml. On 1st October 2019, 1 days after receiving Shingrix, Havrix and FluLaval Tetra 2019-2020 season, the patient experienced ischemic optic neuropathy (serious criteria GSK medically significant) and headache. On 12th October 2019, the patient experienced sensation of pressure in ear and visual field defect. On 14th October 2019, the patient experienced c-reactive protein increased. On an unknown date, the outcome of the ischemic optic neuropathy and headache were recovering/resolving and the outcome of the sensation of pressure in ear and visual field defect were not recovered/not resolved and the outcome of the c-reactive protein increased was unknown.   It was unknown if the reporter considered the ischemic optic neuropathy, headache, sensation of pressure in ear, visual field defect and c-reactive protein increased to be related to Shingrix, Havrix and FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient received Shingrix on right deltoid. The patient experienced headache and left ear pressure. The patient experienced bilateral ischemic optic neuropathy. The patient began to have eye symptoms of loss of left upper field of vision, in the left eye.  On 14th October 2019,The patient had an elevated C reactive protein of 6.770.  On 15th October 2019, the patient was seen at the opthalmologist. The patient underwent CT angiogram of the head and neck , brain MRI which were normal. On 18th October 2019,the patient also underwent left temporal artery biopsy and was found negative for arteritis.
Pt received shingrix and fluzone in left arm 1 inch apart. Pt stated her arm is frozen or stiff with limited mobility. Pt is taking Ibuprofen (OTC) and has contacted PCP
The pt developed a 3" warm, red, tender and swollen area over the site of vaccinia vaccination. Treated with Ceftin 250mg BID X 5 days.
administered an expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 48-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 01-APR-2023) for prophylaxis.   On 03-APR-2023, the patient received Boostrix. On 03-APR-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administered an expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 03-APR-2023 The reporter consented to follow up. Healthcare professional gave consent for safety team follow up. The patient received a Boostrix vaccine which was already expired, which led to expired vaccine used.
Woke up with chills, difficulty regulating body temperature, headache, light-headedness. 100.2 degree fever. Took Tylenol to reduce fever at 8:00 AM. Fever seems to be reducing. Was 99.4 by 9:15 AM.
pt vax 6JAN95 & w/in 24 hr post vax exp joint pain, & swelling in hands, knees, feet to point of being bedridden;JAN95 exp t104;FEB95 dx rheumatoid arthritis;UTI;MAY95 lt side body paralyzed, lt foot turning inward, pain neck & back
I had symptoms like gout in my toes, but my doctor didn't think it was gout.  This began in June of 2021.  I took medication and these symptoms were gone within a year.  I had trigger in my hand at the same time.  This was in both hands, and I had it these symptoms off and on throughout all vaccines in 2021 and 2022.  In the morning I am unable to move my fingers on both hands until I exercise my fingers.  My hands still don't open all the way.  I continue to take the medications for this because my COVID-19 symptoms were much worse in the first week 2020 before we knew about COVID-19. My stamina has been less than normal since the vaccine and COVID-19.  I am unable to walk as usual, garden, hike or anything as usual.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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.  The reporter was patient. The age at vaccination was not reported. The reported that he/she was had shingles vaccine and later experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
The day of injection developed pain in left arm, side, shoulder, neck and head.  After 3 days the only pain left was in my left arm. On January 15 developed an itchy, red, hot rash about 1/2 inch below injection site.  The area was approximately 3 in by2.5 in with swelling.  Also had 5 hives break out on my body.  I took 1/2 a Benedryl and used clobetasol propionate ointment on the area until the rash went away (7 days).  The swelling took another 5 days to subside.
intermittent tingling, warm sensation and decreased grip strength after 2nd dose, persisting 2 weeks
Left axillary pain-same side as the injection; Fever; Pain at the injection site; Myalgias; Arthralgias; Moderate fatigue; I received my booster vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2, solution for injection), administration date 03Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 2), administration date: 09Mar2021, for COVID-19 immunization, reaction(s): "lymphadenopathy", "pain in my left axilla (injection in left arm) with extension into the lateral aspect of my left breast", "pain in my left axilla (injection in left arm) with extension into the lateral aspect of my left breast", "pain in my left axilla (injection in left arm) with extension into the lateral aspect of my left breast"; Bnt162b2 (Dose: 1), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset Dec2021, outcome "unknown", described as "I received my booster vaccine"; VACCINATION SITE PAIN (non-serious) with onset 03Dec2021, outcome "recovering", described as "Pain at the injection site"; MYALGIA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Myalgias"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Arthralgias"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "Moderate fatigue"; PYREXIA (non-serious) with onset 04Dec2021, outcome "recovered" (06Dec2021), described as "Fever"; AXILLARY PAIN (non-serious) with onset 06Dec2021, outcome "not recovered", described as "Left axillary pain-same side as the injection". In responded to acetaminophen returned to normal. Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt. states that after receiving the 1st dose of J&J 03/15/2021, started experiencing symptoms 04/2021 of uncontrollable hand shaking (currently lasting), chills, and sore arm. Symptoms have subsided (Hand Shaking still continuing). Primary visit 10/14/2021 no recommendations/suggestion of reporting.
This non-serious case was received on 11 March 2009 from VAERS (reference number 250118) via search of the QScan database. A 54 year old female patient received FLUZONE SV '2005-'2006 USP (lot number U1854AA) on 09 November 2005. The patient's arm became very sore following administration of FLUZONE. The next day the patient had a sore throat and was very achy. She did not have a fever. She developed a cough, bronchitis and conjuctivitis. The patient was reported as recovered.
Extensive large patches of hives on arms, legs, chest, shoulders, and neck. Most often occurring in early morning after getting up or later in evening 7 or 8 pm. Very strong itch. Most would go away after 3 to 4 days. Used topical hydrocortisone 1% and loratadine 10 mg. Problem continues to date.
Low back pain. L-S, Degeneration of lumbar or lumbasocral internal disc.  L-S, Internal degenerate of Knee (ICD 9 CM 717.9). Erectile Dysfunction (ICD 9 CM 302.72), anxiety disorder, pain in knee, Insomnia.
Temperature of 101.3 about 22 hours after shot and it got as high as 103.7 about  27 hours.  Took 2 Tylenol and went down to 102.7 at bedtime.  No fever upon waking in the morning.  Had arm pain, headache, and muscle ache in the back of my neck.  Today, still have fever and slight swelling at injection shot and pain when raising arm, but it's okay.
Within 12 hours of all three shots tinnitus in both ears - a roaring sound like a waterfall, fullness in ears, fluttering feeling in both ears
Initial report received on 31 March 2009 from a health professional.  A 16 year old male patient, with no medical history, was exposed to the saliva of a cow that died two days later; the cow's head was sent for testing but deemed an invalid specimen.  On 25 March 2009, the patient received a first intramuscular injection of IMOVAX Rabies (lot number A0484) in the left gluteal area and three intramuscular injections (two in the right gluteal area and one in the left gluteal area) of HYPERRAB (manufacturer unknown, lot number 26N97T1).  On 29 March 2009, the patient received a second left deltoid intramuscular injection of IMOVAX Rabies (lot number B0359-2).  On 31 March 2009, the patient's left arm was cold and purple with cold and tingling fingers.  The patient's outcome was reported as unknown.  No other information was reported.  Follow up information was received on 30 April 2009 from a health care professional who stated that the patient spontaneously recovered from the events on 01 April 2009.  The patient received IMOVAX on 01 April 2009, 04 April 2009, 10 April 2009, and 24 April 2009 (lot number B0359-2) in addition to the first two doses.  The patient did not experience further problems following the last four administrations.  The reporter felt that the symptoms were not related to the rabies vaccine.
Numbness and tingling on left hand and left arm. Lasted a few hours. Started in fingers of left hand, progressing up to left arm.
8 patients presented with black dots following intramuscular injection of flu vaccine (FLUZONE, lot number U1807AA). Outcomes were not reported. Follow up information received on 25/Jan/2006. Per the reporter, at the facility were the vaccines were administered, the black dots were noted by the staff nurses and medical assistants on multiple days to an unknown number of patients. During their flu shot "clinics" there is typically only one nurse giving injections. Not until later, did they realize that they were all periodically seeing the same event. The black dots were so small that none of the patients were aware of the event and there were after injection reports of pain and swelling associated with the black dots. All the patient's recovered from these events at the time of this report. No further information is expected.
Pt fainted after injection of MMR (TD was administered after MMR). Pt became pale, body rigid, diaphoretic. Pt unconscious only for a very short time and then came to complaining of ringing in 1 ear and stomachache. Had pt stay in office for approx. 1/2 hour, until feeling well enough to leave.
Developed a rash around my neck and swollen eyes (thought to be poison ivy) on 1/3/2021. Since that time, the rash has spread to my back, abdomen, chest, neck, ears. It appears to be urticaria and is extremely itchy. I completed a steroid taper early on and the rash is no loner affecting my face. I am taking daily antihistamines and using hydrocortisone cream for the itching. The rash continues to spread and is made worse with scratching.  I am unsure if this is related to the vaccine, but this has never happened before and I have no known allergies. I got the second vaccine on 1/8/2021 (at the time the rash was improving and I thought it to be poison ivy).
Below injection site of Dtap swollen redness and induration 12 cm x 5 cm
GOT GUILAIN-BARRE SYNDROME FROM THE FLU VACCINE; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   The reporter considered the guillain barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient got guillain barre syndrome from the flu vaccine. This case has been linked with US2020AMR232535 and US2020AMR232534 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR232534:same reporter US-GLAXOSMITHKLINE-US2020AMR232535:same reporter
A little fatigue; A little headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (A little fatigue) and HEADACHE (A little headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical condition reported).    On 11-Jan-2021 at 2:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021 at 4:00 PM, the patient experienced FATIGUE (A little fatigue) and HEADACHE (A little headache). On 13-Jan-2021, FATIGUE (A little fatigue) and HEADACHE (A little headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; 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.
This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 84-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included dry skin (during winter). Concomitant products included atorvastatin calcium (Lipitor) and metoprolol succinate (Toprol Xl). On 28th March 2018, the patient received the 1st dose of SHINGRIX. On 4th June 2018, 68 days after receiving SHINGRIX, the patient experienced drug eruption vesicular and blister. On an unknown date, the patient experienced pruritus, pimples and welts. The patient was treated with corticosteroid nos (Oral Corticosteroids (Nos)). On an unknown date, the outcome of the pruritus, drug eruption vesicular and welts were not recovered/not resolved and the outcome of the pimples and blister were unknown. It was unknown if the reporter considered the pruritus, drug eruption vesicular, pimples, welts and blister to be related to SHINGRIX. Additional information was reported as follows: The batch number or expiry date for SHINGRIX was not reported. On 4th June 2018, the patient visited his dermatologist after noticing the welts. At the beginning the physician just diagnosed the patient with blistering disease. The patient received one shot of corticosteroids, he was prescribed with a 10 day treatment of oral corticosteroids. The patient was later diagnosed with bullous drug eruptions after vaccination with the first dose of SHINGRIX series, but however he didn't specific the dates for receiving the diagnosis. The patient also experienced welts and itchiness. The patient couldn't exactly remember, how soon after receiving the SHINGRIX vaccine, he started experiencing itching. However the patient stated that he had itching for a while and then he started developing the welts. The patient stated that he was still developing new welts, out of which some other were not welts but they looked like hard pimples. The patient was on Lipitor and Toprol X before he visited his dermatologist on 4th June 2018. The patient's dermatologist took him off from Lipitor and kept him on Toprol XL. The patient was not on Lipitor schedule since 4th June 2018.  The patient used cream on the affected areas. Till the time of reporting, the events were not resolved yet.
BLOOD CLOT FORMED in my LEFT LEG 25 days after getting my COVID-19 Pfizer BOOSTER injection
myocarditis with troponin leak and EKG abnormalities and ectopy,  MRI scheduled
1. Within 24 hrs post vaccination 1/5/2021 severe headache, malaise symptoms.   2. 1/8/2021 onset of  severe back pain. 3. 1/13/2021 severe back pain continued, unrelieved by NSAIDS and Acetaminophen. 4. 1/14/2021  non-traumatic rhabdomyolysis possibly due to COVID-19 vaccine diagnosis. Diagnosis was made in hospital Emergency Department.
Joint pain 1st day to present, deep red skin lesions 3rd day to present, welts, head blisters4th day to present, nausea 2nd day, extreme fatigue 1-4 days,
Received vaccine, arm immediately painful, arm still painful when reported on 10/28/2012.
Within 5 minutes of receiving her Janssen Covid vaccine, the patient became dizzy and lightheaded.  We moved her to a sitting position.  She stated she really didn't feel well and we prepared to move her to a lying down position.  Before lying down patient passed out.  She continued breathing with a pulse.  We called 911.  She remained out for approximately one minute, with stimulus not waking her.  While moving patient out of the chair to a lying down position she awoke on her own.  She had no previous medical conditions or routine medications, though did say she had passed out before.  EMTs arrived and questioned patient but did not do a physical assessment.  She did not want to go to the hospital.  Patient did remain in the pharmacy for 45 minutes after.  We checked HR and BP, both were within normal limits.  We drove patient home where here daughter was present.  Patient stated she was still nauseated when she got home but seemed better an hour later
pt recv vax & reported exp a high sensation where felt rush of energy w/in 1 to 2 hrs p/vax which lasted 2hrs;
Initial unsolicited report received from pharmacist on 14-Sep-2018. This case involves a [73 years old] male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (Batch number: UI993AB, expiration date: 31-Mar-2019, route: intramuscular and site of administration: left arm on an unknown date where little amount leaked out where the needle attaches to the syringe. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to vaccine under dose. This is also a case of product complaint due to syringe leak. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Syringe had crack down the side when giving the Varicella a small bit squirt out the side.
Received a booster dose beyond the use date (beyond 30 days at 2-8C). BUD: 12/28/21 Notified manufacturer Moderna & Immunize Manager.  ADRs: Soreness and swollen armpit.