chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccines exposed to high temperature, later administrated; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received HBV (Engerix B) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis, flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Engerix B, Boostrix, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device and Fluarix Quadrivalent 2019-2020 season. On an unknown date, unknown after receiving Engerix B, Boostrix, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device and Fluarix Quadrivalent 2019-2020 season, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 details were provided as follows: The age at vaccination was not applicable to this report. The pharmacist reported that, the administration of Engerix-B, Boostrix, FuLaval, and Fluarix after the vaccines were inappropriately stored.  The health care professional worked in a nursing home were the vaccines were exposed to a high temperature for the course of 2 months and later administrated to the patients of the facility, which led to incorrect storage of drug. There was no information regarding how many patients, age, gender or which vaccine was given to each of them at the time of reporting. There was no information regarding the expiration date or lot number.  The health care professional did not know the date of the administration. It was only known that the vaccines were used after the temperature excursion. The reporter agreed to be contacted for follow-up.
Day 0:  Patient developed fatigue, headache, weakness, muscle aches.  Describes muscle weakness as mostly in her legs, feeling like they are going to give out.  Grip strength normal.  No difficulty breathing.  Pain in neck and back similar to pain she experiences with ankylosing spondalitis.  No numbness or tingling in hands and feet.  Day 8: COVID test done - negative.  No other tests run.  Day 10: COVID PCR test done - also negative.  No other tests run.  Spoke with rheumatologist who believes it could be related to AS. Day 15: Still experiencing side effects - very fatigued.  This is the first day she has been out of bed for more than a few hours at a time.  Planned visit with PCP tomorrow.
patient fainted when she was at the register being released after receiving the vaccines Flublok Quad and the Shingrix.  EMT's were called since she hit her head; they took her to hospital because when they were evaluating they asked her to stand and she became dizzy again and had really low blood pressure...Patient came back later today and states that she is fine her blood pressure, heart and blood work up all came back normal
12 year old client presented to vaccination site with guardian to receive first dose Pfizer vaccine. After client and guardian left vaccination site, nurse lead discovered discrepancy with administered dose count and found that the client received a pediatric 0.2ml dose by mistake. Nurse lead attempted to notify guardian of vaccination misdose and educate on CDC guidance for second dose Pfizer. Guardian unavailable, but lead nurse left voicemail requesting call back. Lead nurse attempt contacting client again.  All safety checks reviewed, and lead nurse to provide all vaccinators with additional resources to ensure proper review of client personal information. Additionally, we are aware that the client had just turned 12 years old, 5 days prior to vaccine appointment.  VERP submitted. Lead RN counseled Vaccinator  on verifying age of minors prior to vaccinating. Vaccinator verbalized understanding and stated that she thought Pfizer pediatric dose was indicated for 12 years and under and guardian specifically requested Pfizer pediatric dosage. Lead RN provided clarification and stated client will need to receive adult Pfizer (12 and up) dose for 2nd dose and advised Vaccinatior to elevate request to Lead RN, if guardian is requesting a change in dosage of any vaccine.
This case was reported by a consumer and described the occurrence of autism-like symptoms in a 17 month old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed for prophylaxis. A physician or other health care professional has not verified this report. The pt's medical history, concurrent conditions, and concurrent medications were not reported. Reportedly, the pt's two brothers, "ages eight and six," are both autistic. On an unspecified date, at 18 months of age, the pt received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed. The mother reported that the pt subsequently developed "autism-like symptoms"; he "started to lose eye contact and stopped talking." The outcomes of the events were unknown. The autism-like symptoms in this report are considered medically serious (OMIC).  A 15-day follow up report received 8/7/2003 adds: Additional info was received from the vaccine provider on 08/01/2003. He indicated that symptom onset was 12/04/2001; the pt was 17 months of age at symptom onset. The events persisted as of 07/28/2003. The vaccine provider considered the events to be unrelated to vaccine administration.
After the first shot on 4/4/21 i felt a little sick for a day and after 3 weeks i got a bump on my neck above my collarbone on the same side where i got my shot. After the second dose on 4/25/21 i felt very sick for about a week and the lump is still there
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. Initial information was processed along with the additional information received on 05-OCT-2021 The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced suspected immunological vaccine failure. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000196118.; Sender's Comments: V0: 20211007061-covid-19 vaccine ad26.cov2. s-suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Hives type of raised welt that kept enlarging. Started about size of  a quarter   Then enlarged to size of a pork chop.  Did not itch. Began about a week after injection
Received ZOSTAVAX on 6/11/08. 6/13/08 upper arms itchy. 6/14/08-6/16/08- lg. hives arms, leg and back
could not get out of bed; whole body aches; shaking; significant nausea; significant dizziness; headaches; immediate reaction up to jaw, ear and shoulder/ she felt it on the left side of her jaw and her left ear, and down her arm and it was tingling down her hands; not feeling well; very stressful; This is a spontaneous report from a contactable consumer for herself. A 53-year-old female patient received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) intramuscularly at upper left arm, 12:45PM on 08Jan2021 to prevent Covid. The patient had no medical history. She did not get sick and had not taken a sick day in 5 years. Patient had not received other vaccines within four weeks. Patient had no concomitant medications.  The patient had an immediate reaction up to jaw, ear and shoulder following first dose on 08Jan2021. When she got the injection, she could feel the stuff going in and something on the left side of her jaw, and she brought her right hand up to rub her jaw. She was not sure if a nerve may have been hit, but she felt it on the left side of her jaw and her left ear, and down her arm and it was tingling down her hands. This has recovered completely at the time of reporting. She had not been feeling well since that day and got worse. On Wednesday (13Jan2021), it started with significant dizziness and her headaches started toward the end of day. By Thursday (14Jan2021) she had the headache and significant nausea. The body aches started on Thursday. Her whole body ached so much that she was shaking. On Friday (15Jan2021) she could not get out of bed since the headache was intense along with the dizziness and nausea. She received Advil and Tylenol as treatment and was also taking clonazepam since it had been very stressful. She was worried since she felt safe going in to get the vaccine and she did not feel so safe now. At the time of reporting, she improved but not recovered. She would like to know what she is experiencing is a side effect or if she should be tested for Covid. The outcome of tingling feeling resolved, stressful was unknown and outcome of other events was resolving.   Information on the lot/batch number has been requested.
pt seen 27MAR98 w/12 lesions in various stages from red papules to vesicles on erythematous bases on back, trunk, diaper area, behind lt ear; no fever;no cough;exposed @ daycare 2wk ago;
Patient quickly began exhibiting symptoms of type 1 diabetes... polyuria, polydypsia, polyphagia, yeast infection, irritability, lethargy, bed wetting.
He has severe headaches  I had pericarditis and spotting and menstrual pain/clots and heavy bleeding.
Pt received anthrax, typhoid, and SPV vaccinations on 2/20/08.  On 2/24/08 pt took 5 home pregnancy tests which were positive.  LMP (normal) on 18Jan08.  Pt had spotting on 16 Feb08.  Pt had unprotected sexual activity on Feb 2-3, 2008.
Around 10 am after receiving the vaccine, I was extremely tired, had a severe headache, fever (101) and had body aches. I took Tylenol 650 mg every 4 hours throughout that day. I did fall asleep that afternoon for over 3 hrs, which is very unusual for me. I wasn't quite aware of what was happening around me. My son stated that I had asked questions and seemed to be confused that it was Saturday evening and not Sunday morning.  I also developed a red rash and swelling to my left upper arm, where I was injected. It began to itch on Monday. I took Tylenol for the pain. The rash lasted until Thursday, 6 days after the injection.
Prolonged menstrual bleeding; This spontaneous case was reported by a consumer and describes the occurrence of OLIGOMENORRHOEA (Prolonged menstrual bleeding) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Concurrent medical conditions included Hypertension, Irritable bowel syndrome, Anxiety and Food allergy.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OLIGOMENORRHOEA (Prolonged menstrual bleeding). At the time of the report, OLIGOMENORRHOEA (Prolonged menstrual bleeding) had not resolved.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was provided.  The patient started a menstrual cycle and had not stopped bleeding since. Prior to being vaccinated, the patient had a period every 3-5 months.  On an unknown date, the patient had multiple tests done (unspecified) and possibly an ablation procedure or IUD (intrauterine device) inserted to stop the bleeding.  No treatment information was provided.
Pt vaccinated at 8:40 Am. Pt reported feelings of warmth, dizziness, and lightheadness 5 minutes post vaccination. Pt assisted to stretcher, B/P 129/95 HR 65 RR 20 O2 Sat 99% RA. Pt hydrated with electrolytes/water. Pt reports prior episodes of same symptoms outside of vaccinations. Pt reported resolution of symptoms  after prolonged monitoring. d/c'cd at 10:08 Am.
At 4:27 pm client stated she was developing a rash on face.  BP 220/110, P 80, R16.  Epinephrine .5ml given IM at 4:31pm.  Reported tongue felt thick and difficulty breathing, BP 210/100, P 64, R 18. Benadryl 50mg given at 4:34pm, rash on face less, BP 178/88, P 60, R 18.  Transferred by private vehicle to Hospital at 4:45pm.
Information has been received from a health professional and a physician concerning an approximately 18 month old female child with no allergies an no history of chickenpox or recent chickenpox exposure who on 11JUL202 was vaccinated in the left thigh with a first dose of varicella virus vaccine live (lot 642632/0324M). There was no concomitant medication. It was also noted that no rash occurred at the site of injection post-vaccination. In December 2002 a "first episode" of "manylesions" occurred. The patient subsequently recovered. On 19APR2003 the child developed a rash with two coalescent lesions on the right heel. A specimen form the rash was sent for a direct fluorescent antibody test and a culture and both were negative. The reporter noted that se did not know what type of rash the child had. Additionally, it was noted that on 19APR2003 the patient developed herpes zoster. A specimen was obtained on 22APR2003 from a papule lesion for varicella zoster virus (VZV) analysis at Columbia University. Information was received from the VZV Identification Program at Columbia University which indicated that the specimen was insufficient to properly analyze, no VZV DNA was amplified and was "negative for b-globin, no strain ID". It was noted that the patient recovered. Additional information was received from a woman in the physician's office who stated that "this was the second occurrence of these lesions/rash on the same site, the right heel." The reporter did not have a definitive diagnosis related to the rash and did not think herpes zoster was the definitive diagnosis. She also stated that the direct fluorescent antibody was negative but there were too few cells to interpret the data, therefore it was more likely to be an inadequate specimen. No  further information is expected.
No significant adverse effects from initial vaccines.  **6 months post-vaccine-- Bell's Palsy diagnosis Evidence of earlier stroke
My last menstrual period was mid-December 2020.  I received my first COVID vaccine on 1/8/21 and my second on 1/25/21.  I did not have a period until 3/8/21.  I had bloodwork drawn on 3/3/21, which included FSH, LH, beta-HCG, free and total testosterone, prolactin, estradiol, and progesterone were all within normal limits (beta-HCG was <1).  Prior to that, I took several at-home pregnancy tests which were also negative.  Other than when I was pregnant (with my two children), I have never missed a period.
Patient awoke writhing and grunting in apparent extreme pain; she thrashed in bed and indicated arm pain. This behavior has never before been seen in the patient. No fever. Was given 5mg acetaminophen in liquid suspension ("Little Remedies" brand) and was moved into parent's bed for comfort and overnight observation. Patient showed improvement with some apparent discomfort through the night; she awoke markedly improved the following morning, though tired and sluggish, and had no appetite until 5PM that evening. Now, 24 hours later, she appears back to normal.
Pt recvd vax & the day of 2nd inject exp dizziness, general malaise, fatigue, joint pain & arthralgia;
Flu like systwms 9hrs post vaccination, itching at injection site 11hrs post vaccination. Swelling, redness, itching, blister, hardness at injection site 24 hrs post vaccination, continuing to worsen still at 36hrs post vaccination. Increased pain on lymph nodes and joints, nausea, dizziness fatigue. Symptoms persist and worsen despite advil/tylenol, zyrtec/benadryl, hot cold compress. Tramadol prescribed for fibromyalgia pain has no effect on symptoms as well.  Orginal series of moderna covid injection resulted in no injection site pain, swelling, itching or hardness.  First vaccination caused mild fever. Both injections of first series caused flu like symptoms 7-10 post both injections(3/11/21 and 4/7/21).  Moderna booster 10/30/21 did not cause fever but did cause flu like symptoms as well but getting worse as opposed to better in subsequent days following vaccination.  Flu like symptoms approx 7 days post vaccination is common with any vaccination I have ever recieved.
administered after expiration date but Moderna tested lot and said it provided the necessary protection and did not need to be repeated
A report has been received from a Pharmacist concerning a 38 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 31-Dec-2013. The pharmacist reported that the patient received expired FLUMIST QUADRIVALENT which started on 31-Dec-2013. The outcome of the event of patient received expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
I cannot stand for 10 minutes; Pain from my hips to feet; Pain from my hips; Had extensive body aches; This spontaneous case was reported by a nurse and describes the occurrence of DYSSTASIA (I cannot stand for 10 minutes), PAIN IN EXTREMITY (Pain from my hips to feet), ARTHRALGIA (Pain from my hips) and MYALGIA (Had extensive body aches) 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.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced ARTHRALGIA and MYALGIA. On an unknown date, the patient experienced DYSSTASIA and PAIN IN EXTREMITY. In November 2021, MYALGIA had resolved. At the time of the report, DYSSTASIA, PAIN IN EXTREMITY and ARTHRALGIA outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.                             Treatment information was not provided by the reporter.  2 weeks before reporting patient received Moderna booster vaccine. and the following week patient experienced pain from my hips to feet and was not able to stand for 10 minutes was always in pain.
Pain below right ankle, what appeared to be a growth in the vein, complained to doctor, nothing was done, no tests, no treatment, have not recovered, growth has grown into quarter-size and is extremely painful. No vaccines prior to COVID have led to any adverse reactions.
Onsets all began around 6am 2/14/2022 the morning following the injection Naseau and Dizzyness when standing for 3-4 days. Over tired and slept 12+ hours a day for 3-4 days  Headache for 2 days, Low grade Fever 99.4 to 99.9 with sweats 3 days,   Severe Diahrea uncontrolled liquid unable to hold.  Remained in Bed for 5 days with only diet intake of Ginger Ale, Water, Bananas, Apple Sauce, Plain Untoastsc and Toasted White Bread, Plain White Rice. First normal bowel movement on Sunday 2/20/2022. Also was taking Immodium 4x day with No Relief x 3 days. Finally seemed to start improving on 2/17/2022.
Immediate pain at injection site on 10/28/20, extremely sore arm (upper/bicep) that progressively got worse with debilitating pain. Not able to extend or lift arm fully. Went to doctor on 1/13/21 after I couldn't take the pain any longer, was prescribed a steroid (methylPREDNISolone 4MG Oral Tablet Therapy Pack- 1 1/2 packs) to help with inflammation. Didn't improve, so doctor then suggested physical therapy on 2/11/21 and I have been doing PT twice a week for over 3 months now (since 2/21/21) and was diagnosed with frozen shoulder.  Saw an orthopedic specialist on 4/29/21 to confirm frozen shoulder and will follow up after more PT in 6 weeks.
Fever spiking at 103.2 that has lasted three days and now we're on to day 4. Baby is not eating as well as normal, and he seems to be feeling very sick: clingy, tired eyes, crying randomly.
pt received incorrect dosage of covid vaccine. Received 6m-4y dosage instead of 5y-11y dosage. Incorrect vial chosen in med room by RN.
pt recvd vax 17NOV92 in rt thigh; stated pt cries alot & redness @ site; now area feels hard w/some warmness to site;
second dose 37 days apart form first dose. First dose was 3/16/2021 / second dose was 4/22/2021; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number AP545, expiry date 25th January 2023) for prophylaxis.   Concurrent medical conditions included blood pressure. Concomitant products included Herpes zoster (Shingrix).   On 22nd April 2021, the patient received the 2nd dose of Shingrix. On 22nd April 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, 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.  Additional details were reported as follows: The nurse was looking for guidance because there was a patient that received Shingrix second dose 37 days apart form first dose. The patient received 2nd dose of Shingrix, before than the recommended interval, which led to shortening of vaccination schedule. The patient was not immunocompromised and he was taking 3 different medications for blood pressure. The reporter did not consent to follow up.
adult dose of Engerix-B was administered to a 5 week old; Adult product administered to child; Engerix-B was administered, was supposed to receive Recombivax; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 5-week-old male patient who received HBV (Engerix B adult) (batch number 9P9B5, expiry date 7th February 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th November 2021, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 9th November 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced accidental overdose, adult product administered to child and wrong vaccine administered. On an unknown date, the outcome of the accidental overdose, adult product administered to child and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse stated that, an adult dose of Engerix-B was administered to a 5 week old patient, which led to accidental overdose and adult product administered to child. The patient was supposed to receive Recombivax but received engerix b adult, which led and wrong vaccine administered. The reporter consented to follow up. This case has been linked to US2021158186, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021158186:same reporter
Medical Provider ordered Hepatitis B vaccine, Nurse administered Meningococcal B vaccine.