chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine was clear, not re-suspended; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong technique in product usage process in a 43-year-old female patient who received HAB (Twinrix) for prophylaxis.   On 04-MAY-2023, the patient received the 1st dose of Twinrix (injection, left deltoid). On 04-MAY-2023, an unknown time after receiving Twinrix, the patient experienced wrong technique in product usage process (Verbatim: vaccine was clear, not re-suspended). The outcome of the wrong technique in product usage process 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: 04-MAY-2023 Reporter was the patient that received her first dose of Twinrix in her upper left arm and reported that when the pharmacist administered the vaccine, the vaccine was clear and not cloudy.  The patient went back to the pharmacy and spoke to the pharmacist and told the pharmacist that the vaccine was supposed to be shaken so it was a cloudy, white color and not clear.  The patient reported that the pharmacist read the directions in front of her, and the patient reported that the pharmacist stated that he did not know it had to be shaken up. The reporter consented to follow up with her and healthcare professional. The patient received Twinrix dose without shaking it prior to the administration as was indicated on the prescribing information, which led to wrong technique in product usage process.
This spontaneous report as received from a pharmacist via Publicist representative refers to an 81 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX vial dose and route unspecified, lot # J000492 and expiry date 19-JAN-2014, in the right arm. The patient experienced a swollen right arm from her shoulder to the wrist after receiving the vaccine. Pharmacist stated this was the same arm that patient received the injection. Patient saw her physician who recommended BENADRYL. Pharmacist reported that the patient stated this settled down two weeks later. The outcome of a swollen right arm from her shoulder to the wrist after receiving the vaccine was reported as recovered/resolved. Additional information has been requested.
Pain in side and pelvic area at around 5:00 p.m.   Eventually she got a bad headache and was very fatigued.  By 10 p.m. that night she had numbness in her hands and feet.  The next day at school she fell asleep and now 29 hours after the shot she is so tired she is slurring her words and still has numbness.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date approximately in 2016 (also reported as unspecified dates since 01-FEB-2016) the patient was vaccinated with ROTATEQ (lot # L010837, expiry date 16-FEB-2017) (Lot # L027070, expiry date 30-APR-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that the vaccines were exposed to a temperature of 33.4 degrees Fahrenheit for 2 hours and 51.4 degrees Fahrenheit for 1.5 hours (incorrect product storage). No adverse effects were reported. The action taken with the therapy with ROTATEQ was unknown. The outcome of the events was unknown. It was reported that the vaccines that underwent temperature excursion were administered. It was reported that there was no previous temperature excursion. It was also reported that this case was being reported due to a data logger. This case is linked to case numbers 1603USA002167, 1603USA007489, 1603USA007491 via same reporter link. Additional information has been requested.
Possible overdose.  Needle retracted into syringe while plunger was being depressed during injection.  Healthcare tech pulled out a second syringe and injected a full dose.  Tech wouldn't say whether any vaccine was injected during first attempt, however vaccine was spilling down the arm of the patient. This tech should not be injecting, shakes patient arms aggressively and then very aggressively plunges needle into arm.  We've had 5 COVID injections among our family and haven't seen anything like this.
02/13/03- received anthrax #1 02/15/03- painful swelling of the injection site x couple of weeks- became a thick quarter sized painful knot in the following two months- still palpable. 03/19/03- received anthrax #2 03/20/03- Painfully swollen and red upper right arm x1wk 03/27/03- right elbow/shoulder joint pain, painful soft lump under her right arm, constant lower neck pain, constant pressure-like headache, constant dull pressure over her left chest muscle, and muscle spasm around the left chest area. Will mail patient's clinical summary via Fed-Ex.
he had nonprotective titers to S. pneumoniae despite vaccination with pneumococcal polysaccharide vaccine-23; he had nonprotective titers to S. pneumoniae despite vaccination with pneumococcal polysaccharide vaccine-23; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a currently 62-year-old male patient. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis (exact dose, dose #, route of administration, anatomical location, lot # and expiration date were not reported).  Since an unknown date, reported as 17 years ago, he was experiencing recurrent sinopulmonary infections. He was found to have low immunoglobulin (Ig) levels: IgG was 296 mg/dL, IgA was 6 mg/dL, and IgM was 76 mg/dL. He had nonprotective titers to S. pneumoniae despite vaccination with pneumococcal polysaccharide vaccine-23 (vaccination failure, antibody test negative). Immune workup was also notable for T cell lymphopenia requiring prophylactic trimethoprim/sulfamethoxazole. He was diagnosed with common variable immunodeficiency and Hennekam syndrome. He was placed on immunoglobulin replacement therapy (IGRT) but even therapy serum IgG remained in the 400500 mg/dL range, likely due to "thirdspacing" from his lymphatic disorder. However he did not have any significant infections while on IGRT. On an unknown date, reported as past year, the patient was diagnosed with cirrhosis secondary to non-alcoholic steatohepatitis, and was undergoing liver transplant evaluation. He self-discontinued IGRT at the time of diagnosis. Six months after stopping IGRT the patient remained infection-free. Immunoglobulin panel revealed a serum IgG of 819 mg/dL, the patient's highest recorded value. Interestingly, at follow up the patient was found to have protective titers to S. pneumoniae, likely reflecting lingering antibodies from his infusions months prior.  The outcome of the event of vaccination failure was unknown. The outcome of the event of antibody test negative was considered as resolved.   Literature report.  A copy of the published article is attached as further documentation of the patient's experience.
This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Moderna product on 05/05/2021 and 06/02/2021. They tested positive for COVID-19 via antigen text x2 on 09/12/2021. They presented to emergency department via ambulance on 09/20/2021 and were admitted to hospital. The individual experienced complications of COVID-19 pneumonia, a secondary bacterial pneumonia, hypoxia, and a UTI. Their condition continued to decline despite treatment. They remained hospitalized until their death on 09/23/2021.
On 8/4/01, parents noticed red spots on pt's buttocks and genital area. Assuming it was diaper rash, parents treated this with triple antibiotic ointment. On 8/5/01, the pt's rash spread to face, belly and eyes. Pt has a low-grade fever and itching. On 8/6/01, pt's fever increased to 101F-103F; given Motrin and Tylenol, alternating. Pt brought to ER/hospital per dermatologist referral. Upon admission, exam revealed multiple dry, crusted erythematous papules, right axillary lymphadenopathy, ill appearing, toxic, right eye swollen shut. Pt started on acyclovir, oxacillin, Atarax and Tylenol. Pt had staph aureus sepsis, confirmed with blood culture.
Diarrhea, NauseaVomiting, Fatigue, nausea, occasional diarrhea, itching and swelling at injection site. Narrative: Fatigue, nausea, occasional diarrhea, itching and swelling at injection site.
This spontaneous report as received from a health care worker refers to a 60 year old female patient with intervertebral disc disorder and unspecified drug reactions/allergies to OXYCONTIN, morphine and COMPAZINE. On 11-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneous (lot # K014834, expiration date 14-DEC-2015). There was not concomitant therapy reported. On an unknown date after ZOSTAVAX administration, the patient developed bilateral weakness of her upper extremities, bilateral hand tremors, swelling and redness in her upper chest and was diagnosed with reflex sympathetic dystrophy. On 20-DEC-2014, the patient had scheduled a back surgery for intervertebral disc disorder and was discharged from hospital on 21-DEC-2014. On 14-MAY-2015, the patient fell down and injured her knee, she had swelling and arthralgia reported as "she had an unresolved knee pain and swelling after the fall." On an unknown date, blood work laboratory test was performed but not result was provided. It was also reported that the patient sought medical attention, she visited the office. The patient received treatment with prednisone (manufacturer unknown) and with TYLENOL for the adverse events. The outcome of complex regional pain syndrome, intervertebral disc disorder, arthralgia, fall, joint swelling and joint injury was reported as not recovered/not resolved. Action taken with ZOSTAVAX was not applicable. Additional information has been requested.
This patient received his first COVID-19 vaccine on 12/23/2020 and was vaccinated with the Moderna vaccine. He returned on 1/14/2020 and received the Pfizer vaccine on this day. Per Moderna protocol he was a week early and received the wrong vaccine.
2 days after vaccination in left deltoid, patient developed erythema, swelling, and firmness circumferentially proximal to elbow and distal to, but sparing, the injection site.  She felt mild pruritis and tingling sensation.  4 days after vaccine, she felt nausea without emesis. No throat closing, shortness of breath, chest pain, fevers  change in arm's range of motion or strength.   Likely represents hematoma (patient is on anticoagulation) vs local injection site reaction.
This spontaneous report as received from a Licensed Practical nurse refers to a patient aged "15 to 18 months". The patient was vaccinated with dose 1, 0.5 ml PROQUAD (merck), SC (site of administration and lot # not reported) in 2011 ("about a year ago"). No other co-suspects were reported. No concomitant medications were reported. It was reported that about a week after immunization, the patient experienced febrile seizure. It was reported that the children had to go to the hospital (name/location unspecified) but the patient duration at the hospital was unknown by the reporter. No treatment information was reported. The outcome of febrile seizure was reported as recovered/resolved. The relatedness for febrile seizure is unknown for PROQUAD (Merck). This is one of several reports from the same source (MARRS# 1210USA000981). Additional information is not expected.
may have had a full course/ was given a dose of Engerix-B; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a male patient who received HBV (Engerix B) for prophylaxis.   The patient's past medical history included hospitalization (had prior hospitalization for acute kidney failure). Previously administered products included Engerix B (may had received full course of Engerix B vaccination during a prior hospitalization for acute kidney failure).   In September 2021, the patient received Engerix B. In September 2021, unknown after receiving Engerix B, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided are as follows: The age at vaccination was not reported. The nurse thought that the patient might have had a full course of Engerix-B vaccination during a prior hospitalization for acute kidney failure. The patient received a dose of Engerix- B, who had protective anti HBs antibody levels, which led to extra dose administered. No more information were provided. The reporter consented to follow-up. The case was linked with case US2021AMR202062 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202062:same reporter
Expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patients) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patients). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information were reported.  HCP stated that some patients had reported flu like symptoms after receiving the vaccination but did not have details on that.
About 5 minutes post vaccine, patient experienced an adverse reaction, including right sided weakness, altered mental status, slurring of speech, diaphoresis, and slowed breathing. Patient was oriented to person, but was unable to follow simple commands and did not regain full consciousness. Vital signs at 0917: BP- 118/72, HR-47, O2- 99%, and diminished breath sounds.  Emergency services, 911, called at 0920 . EpiPen given per emergency service dispatch instructions. Post epi, patient with increased LOC but still unable to move right side fully. At 9:23am O2 was 99% and HR was 73. Ambulance arrived at 0929 and report was given to paramedic. Pt taken to hospital via ambulance at 0931.
This spontaneous report as received from a medical assistant refers to an unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with ROTATEQ, oral (dose and frequency not provided). Medical assistant reported that unknown number of improperly stored ROTATEQ doses were administered to unspecified number of patients. ROTATEQ have been exposed to temperature below 36 F for total of 2 hours and 30 minutes. No adverse effects reported. No additional information provided. This is one of several reports from same source. Additional information has been requested.
Within minutes of administering DTaP/Hib into R thigh pt developed large erythematous wheal of entire upper thigh.
Had Hives X 5 days covered body except for face and neck.  Hives did come and go with Benadryl.
BACK ACHE; TINGLING ON BOTH HANDS / TINGLING SENSATION; NUMBNESS IN THE JOINTS; LEFT KNEE SWELLING; LEFT LEG MUSCLE ACHE; LEFT KNEE ACHE; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-MAR-2021 08:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced back ache. On 06-MAR-2021, the subject experienced tingling on both hands / tingling sensation. On 06-MAR-2021, the subject experienced numbness in the joints. On 06-MAR-2021, the subject experienced left knee swelling. On 06-MAR-2021, the subject experienced left leg muscle ache. On 06-MAR-2021, the subject experienced left knee ache. On 06-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 06-MAR-2021, and had not recovered from left knee ache, back ache, numbness in the joints, left knee swelling, left leg muscle ache, and tingling on both hands / tingling sensation. This report was non-serious.
Pt recv vax on 1/19/99; 20 min post vax pt exp itching of upper body, face & lips; sensitive skin w/ dermatographism
injection site was red, reaction; injection site was sore, reaction; injection site was warm to the touch, reaction; swelling at the injection site, reaction; hives on face; itchy hives; fever; shivers; swelling down her arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-MAR-2023 11:00, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 06-MAR-2023, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: fever) and shivers (Verbatim: shivers). On 07-MAR-2023, the patient experienced injection site erythema (Verbatim: injection site was red, reaction), injection site pain (Verbatim: injection site was sore, reaction), injection site warmth (Verbatim: injection site was warm to the touch, reaction), injection site swelling (Verbatim: swelling at the injection site, reaction), hives (Verbatim: hives on face) and pruritus (Verbatim: itchy hives). In MAR-2023, the patient experienced swelling arm (Verbatim: swelling down her arm). The outcome of the injection site erythema, injection site pain, injection site warmth, injection site swelling, hives and pruritus were not recovered/not resolved and the outcome of the fever and shivers were recovered/resolved and the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site warmth, injection site swelling, fever, shivers, hives, swelling arm and pruritus to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site pain, injection site warmth, injection site swelling, fever, shivers, hives, swelling arm and pruritus to be related to Shingrix.   Additional Information: GSK Receipt date: 09-Mar-2023 The reporter was the patient and states that she got her first Shingrix vaccine. She states that by that evening, she had shivers and a fever that lasted for about 3 days. The day following her vaccine, the injection site was red, sore, and warm to the touch.   She also had swelling at the injection site that traveled down her arm.  In addition, the day following her shot she started with a few itchy hives on both sides of her face.  The hives on the left are more pronounced and itchier than on the right.  Her fever and shivers have gone away, but she still had the hives on her face and the injection site reaction.   The patient did not have a lot or exp for the vaccine. The reporter consented to follow up. As per narrative, it seems that swelling extended and it reached to whole arm therefore both arm swelling and injection site swelling was coded.
Diarrhea and vomiting going on still for the last 4 days. Took to doctor he said it was a bad reaction to the Rotavirus vaccine. Giving fluids, and trying to keep him well hydrated. Advised to go to ER if continues through end of week, or gets worse.
24 hours following administration patient developed body aches, fever (101), sore throat and nausea.  72 hours after receiving the shot he developed sudden onset substernal chest pain described as sharp and burning with radiation to his bilateral arms.
Patient is a 64 year old woman but was given a Fluzone HD that is indicated for 65+
weakness, runny nose, diarrhea, inflammation, chest pains, anxiety, swollen face, fingers, brain fog,
Severe thrombocytopenia with epistaxis requiring hematology consultation, IVIG, and ultimately daily eltrombopag therapy to correct.
developed red rash and itching around injection site.  used heat to site and sx were almost gone in the morning
This spontaneous prospective pregnancy report as received from registered nurse, refers to a female patient of unknown age. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that, on 04-OCT-2013, the patient, who was 4 weeks pregnant at the time, was vaccinated with GARDASIL INJ (dose, route and lot number not provided), and with VARIVAX (Merck) (dose, route and lot number not provided). Concomitant therapies included BOOSTRIX (also reported as BOOSTERIX, administered on 04-OCT-2014). The patient became pregnant with Last Menstrual Period (LMP) of 06-SEP-2013 and Estimated Date of Delivery (EDD) of 13-JUN-2014. The pregnancy outcome was unknown. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 46 year old patient of unknown gender. On 12-JUL-2014 the patient ws vaccinated with a first dose of (Oka/Merck) VARIVAX (dose, route of administration not provided, lot # 0609AE) which expired on 23-MAR-2014. No adverse reactions were reported. Additional information has been requested.
pt recv vax; high pitched cry, fever; then limp; unresponsive;CT Scan shows brain damage, loss of sight; suspected neonatal sepsis;visual impairment,motor delay;hypothermia hemoglobin: 8.4;abn in distal lt radius;hearing affected;
After receiving my 1st dose of Pfizer I unexpectedly got my period 2 days later.  It was about  10 days early, and I?m normally very regular.  At the time I chalked it up to pre menapausal symptoms . But it was definitely out of the norm.   If I go back to 30 days normal cycle I?ll be more convinced it was due to vaccine.
Pt started itching around inject site 30 minutes post vax. Over the weekend, developed scattered fine rash on left arm, scattered areas of redness on left arm and redness on chest shaped like a butterfly; right post neck and back. Saw family MD and was given Vistaril on 2/28/00.
Patient contacted pharmacy concerning a red welt the size of a half dollar that started to develop aprroximately 24 hours after her vaccination. The deltiod muscle is tender. Recommended ice and diphenhydramine to the patient. If continues to worsen to contact her PCP.
Hi frequency Noise in head. Doesn't stop when covering ears. Doctor appointment scheduled to evaluate.
1hr p/vax pt noted swelling & redness of lips & face;no other rash, no SOB, no diff breathing;no vomiting,no nausea;tx w/DPH
No additional AE.; Caller stated a 62 year old patient had a first dose of VAQTA in January 2019, but did not come back for the second dose until today, 13JUL2022.; This spontaneous report was received from a pharmacist and refers to a 62-year-old patient of unknown gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On an unknown date in January 2019, the patient was vaccinated with a first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (dose, strength, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 13-JUL-2022, the patient was vaccinated with a second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, 0.5 milliliter, lot # U036184, expiration date 02-MAR-2023 (strength, route of administration and anatomical location were not provided) for prophylaxis (inappropriate schedule of product administration). No additional adverse event was reported (no adverse event).