chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning an unspecified number of patients, who, on an unspecified dates, were vaccinated with a dose of GARDASIL vaccine (yeast). Subsequently, the patients experienced unspecified reactions. At the time of the report, the outcomes of the patients were unknown. No product quality complaint was involved. Additional information has been requested.
pt c/o feeling sleepy & was taken to the hlth room;P110, R20 3-5min later pt was found unresponsive to commands, sternal rubs & pupil checks, P80, R18 911 called;epi given;
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (318 patients received dose from vials beyond 30-day use by date) and product storage error (318 patients received dose from vials beyond 30-day use by date) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. No medical history reported. On Jun 30, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 30, 2021, patient administered expired product (318 patients received dose from vials beyond 30-day use by date) and product storage error (318 patients received dose from vials beyond 30-day use by date). On Jun 30, 2021, administered expired product (318 patients received dose from vials beyond 30-day use by date) and product storage error (318 patients received dose from vials beyond 30-day use by date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Date of refrigeration: May 7, 2021.
10-15 red papules, some w/ vesiculopapular centers, different stages, on midtrunk/lower back/buttocks.
DTaP Left thigh red, hard and tender, swollen now. 11/8 decreased redness, decreased swelling. Patient refuses to let Mom touch site no fever, not cranky.
An episode of seizure; Syncope; Unconscious; Dizziness; Fever; Nausea; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (An episode of seizure), SYNCOPE (Syncope) and LOSS OF CONSCIOUSNESS (Unconscious) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced SEIZURE (An episode of seizure) (seriousness criterion medically significant), SYNCOPE (Syncope) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Unconscious) (seriousness criterion medically significant), DIZZINESS (Dizziness), PYREXIA (Fever), NAUSEA (Nausea) and MYALGIA (Muscle aches). On 23-Mar-2021, SEIZURE (An episode of seizure) and LOSS OF CONSCIOUSNESS (Unconscious) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Chest X-ray: normal (normal) normal. On 23-Mar-2021, Computerised tomogram head: normal (normal) normal. On 23-Mar-2021, Electrocardiogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient was taken to the emergency room (ER).   Treatment included intravenous fluids.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
The vial was initially stored in the refrigerator on 24-Oct-2022 and vaccine administered on 25-Nov-2022; No adverse event; On 25Nov2022 HCP administered Moderna Monovalent to 3 patients 2 days after 30 Day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (On 25Nov2022 HCP administered Moderna Monovalent to 3 patients 2 days after 30 Day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 24-Oct-2022 and vaccine administered on 25-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (On 25Nov2022 HCP administered Moderna Monovalent to 3 patients 2 days after 30 Day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 24-Oct-2022 and vaccine administered on 25-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (On 25Nov2022 HCP administered Moderna Monovalent to 3 patients 2 days after 30 Day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 24-Oct-2022 and vaccine administered on 25-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (On 25Nov2022 HCP administered Moderna Monovalent to 3 patients 2 days after 30 Day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 24-Oct-2022 and vaccine administered on 25-Nov-2022).    No concomitant medications were reported.  It was reported that individual vails was used and vial size was 5.5ml. The vial was initially stored in the refrigerator on 24-Oct-2022. The vial did not undergo any temperature excursions.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-679103, US-MODERNATX, INC.-MOD-2022-679108 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-679103:same reporter US-MODERNATX, INC.-MOD-2022-679108:same reporter
shingrix vaccines with the adjuvant only; shingrix vaccines with the adjuvant only; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was a other health professional.  The reporter stated that, the patient received shingrix vaccines with the adjuvant only which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. They took inventory yesterday and had 3 shingrix antigens left. The reporter was not sure which patients received full dose and which patients received the adjuvant only.  The reporter stated that, all the patients that received Shingrix would have to get revaccinated. The doctor's office reported this to clinical disease centre. No other information available. This case was 1 of 5 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178145:same reporter US-GLAXOSMITHKLINE-US2021AMR178137:same reporter US-GLAXOSMITHKLINE-US2021AMR178136: US-GLAXOSMITHKLINE-US2021AMR178146:same reporter
Pt described feeling hot and feeling like she was going to faint/pass out. Pt appeared to be sweating around face/forehead, and was visibly pale. I advised her to lower her mask, so she could cool off, and offered a cold paper towel. There was visible paleness of her lips. She did NOT mention any difficulty breathing, tingling or nausea. When she looked slightly better, I offered her a water to drink. Her color started to come back, and she looked a lot better than she did when she first complained of symptoms. She said she was feeling better. I advised her to wait a few more minutes before leaving. She looked much better when leaving the store (and never did actually pass out).
Started with a tight vice like headache about 2 hours after dose, Body aches and more severe headache as the afternoon wore on. No appetite or energy to do anything my lie in be. Woke up with from a deep sleep at 2:30 am with a fever of 102.2. Took Tylenol. Headache still present and very intense. Fever came down at about 7:30am. Headache still intense, Fever is back up to 101.6 took another Tylenol. Fever came down to 100.6 and stayed steady till 11:15p.m. Slept till 6:00am Monday morning fever is gone. Head ache is almost gone. Appetite is back These are the exact same symptoms I had when I had COVID-19 in March 2020. They just lasted 2 days rather than 6 days
Pt developed fever, and pin point red rash over trunk, head, neck, and extremities.
About 5:30PM on the day of the vaccination I started feeling very sick. Body aches, chills, shivering. My temp got to 102F. I took Tylenol and it helped the fever go down but it did not totally go away. The symptoms lasted for 48 hours and then went away.
I don?t remember when the patches started forming, but it was anywhere between 3 weeks to 1 month after the 2nd dose, they started forming on my lower hips near my lymph nodes and expanded outwards. The skin was dry and slightly leathery in feel. Reddish brown color, on each hip with right being larger than the left. They continued to expand so I tried to treat with cortisone cream. Thought it would be fungal so I tried antifungal medication and that didn?t work either. It didn?t develop into scales like the psoriasis. So I went to see the dermatologist to see what it was because I wasn?t sure. Saw the dermatologist a few months later and he did a biopsy on the site and on normal tissue on my hip. And it came as granulomatous annuleri. While it was healing, I ended up with an infection on one of the sites. After it healed, I had to increase usage with my triamcinolone cream to twice a day every day and that seems to be helping. t?s lymphocyte mediated. It?ll come and go when it feels like it. Chronic
My first reaction started out as chills. I became very cold while cooking dinner. I had on an oversized hoodie, fuzzy socks, and pants and still could not stop shaking. From that point my teeth started chattering and my back started having spasms from the shaking so I laid down. I could not get warm or stop shaking even while fully dressed and covering up with two blankets. The next two days I had very bad muscle aches, was very fatigued, and had a headache, I couldn't keep my head up.  I tried reporting this at the time, but it did not work.
Rash on ankles, legs beginning about 6 hours after vaccine was administered, moderate itching and tingling in legs, treated with topical benadryl gel, rash began healing in 7 days
Swelling of left lymph node in armpit near injection site; Severe throbbing for 2.5 days and tender.; Severe throbbing for 2.5 days and tender.; joint pain concentrated in kneecaps; headache; This is a spontaneous report from a contactable consumer, the patient. A 64- years old patient of an unknown gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 16Mar2021 at 15:45 as a single dose for COVID-19 immunisation. Medical history included allergic to latex. Concomitant medications included aspirin (MANUFACTURER UNKNOWN), multi-B vitamin (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), and zinc (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received any other vaccines within four weeks, prior to the COVID-19 vaccine. On 17Mar2021 at 03:00, patient experienced swelling of left lymph node in armpit near injection site, severe throbbing for (2.5 days), tender, headache, joint pain concentrated in the kneecaps and back for 2 days. The clinical outcome for the events lymph node swollen, headache, joint pain, tenderness and throbbing pain was recovering.   No follow-up attempts are needed. No further information is expected.
patient reported experiencing pain in vaccination arm. She experienced limited mobility in left arm due to pain. She was later diagnosed with 'SIRVA'. Patient received a cortisone shot in affected arm in July 2022 and has made a full recovery with no recurring pain or medical care needed.
Patient presented to the ED with acute left-sided weakness and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Per doctor's notes: Stroke workup including MRI has been unremarkable.  Patient was evaluated by general neurology and felt that her condition was most likely consistent with her hemiplegic migraines.
Hives; Neck rash; Itchy eyes; Weakness; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS (Itchy eyes), ASTHENIA (Weakness), DIZZINESS (Dizziness), URTICARIA (Hives) and RASH (Neck rash) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, the patient experienced EYE PRURITUS (Itchy eyes), ASTHENIA (Weakness), DIZZINESS (Dizziness) and RASH (Neck rash). On an unknown date, the patient experienced URTICARIA (Hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 25 milliliter tube. At the time of the report, EYE PRURITUS (Itchy eyes), ASTHENIA (Weakness), DIZZINESS (Dizziness), URTICARIA (Hives) and RASH (Neck rash) 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.   Reporter confirmed no concomitant medication taking.
got the shot An still got the shingles/ suspected vaccination failure; still got shingles; itching; 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), shingles and pruritus. On an unknown date, the outcome of the vaccination failure, shingles and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: This case was self-reported by the patient. The age at vaccination was not reported. The patient got shingles vaccine and still got light case of shingles. The patient stated that it was itching around waist and back and was not fun. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Typical left arm soreness; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 18Mar2021 (Lot number: EP7534) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "HIV" (unspecified if ongoing); "back pain" (unspecified if ongoing). Concomitant medications included: BIKTARVY; MELOXICAM; SEROQUEL; GABAPENTIN; VIT D. Vaccination history included: BNT162B2 (Dose 1, single (Lot Number: EN6198) in the left arm at 07:00 PM), administration date: 25Feb2021, when the patient was 50 years old, for Covid-19 immunisation, reactions: "Lump on left breast", "Swollen left breast", "Nipple is sore to the touch or pushing in on it is sore", "Feel some aching in left hand / left arm soreness", "Feel some aching in left hand like arthritis", "Feel some stiffness". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "Typical left arm soreness". It was unknown if therapeutic measures were taken as a result of pain in extremity.  Additional Information: The patient did not have COVID prior vaccination, was not tested for COVID post vaccination, and had no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021314907 Same reporter, patient and drug; Different dose and events
Sinus Pain, cough, some hives, diarrhea, vomiting, aches, chills, no fever started 3/28 - peaked 3/29 - slowly decreased over 7 days.  Ending with a sinus infection.  Worth noting that i had started with a cold March 10, that progressed to strep throat the following week.  Was on antibiotics at that time.
ErythemaMultiform, UrticariaPruritus & swelling, melanoma  DIPHENHYDRAMINE 50 MG QID ,PREDNISONE 50 MG EVERY DAY ,CLINDAMYCIN 300 MG QID
Sudden severe swelling, heat, redness at injection site 1 week after injection. Joint and muscular pain in left arm (side of injection).
Immediate pain at injection site then an intense ache radiating down forearm into wrist and hand which gradually subsided over about 15 minutes.  Felt light headed and dizzy but able to walk around.    Increased "racing" heart which subsided over about 15 minutes.   At 30 minutes after injection I experienced an intense electrical shock sensation EXACTLY in the middle of the top of my head.   I can still locate the exact location and there is still a "sensation" in this location.
Swelling at site of HPV vaccination which enlarged to a 2cm x 2cm fluid filled cyst. Non-tender, no redness.  Area remained swollen at the same size for about a week then began slowly to decrease in size.
1) given subcutaneously instead of in deltoid as documented 2) localized erythema/swelling around injection site appearing AFTER  24 hours
This spontaneous report was received from a nurse to unspecified number of patients of unknown demography. Concurrent conditions and medical history were not reported. On an unknown date, the unspecified number of patients were vaccinated with RECOMBIVAX HB (dosage regimen, lot # and expiration date were not reported) that was stored improperly. No adverse effects reported. No further information was provided. This case is one of several reports from same reporter. Additional information has been requested.
Pt rcvd COVID vaccine at approx 1:30 pm and reported chest tightness at 1:45pm.  Pt used combivent inhaler and condition improved
3x5 cm red induration that occured on day 8 post vaccination. Area is tender, bright red, and hard to the touch.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced injection site pain after receiving 1st dose of SHINGRIX. For tolerance of 2nd dose, refer case US2019GSK000771.
Trumenba(Men B) was given in error instead of Prevnar 13.  Day after vaccine, parent reported the baby was very fussy, would not feed and started a fever.
Injection site turned red, began to swell. Pt said she had difficulty breathing and itching - Symptoms occurred after patient had been home for a short time.
Grade 3 diarrhea for 3 weeks; higher than normal blood pressure for over 3 weeks; intense headache for 3 weeks; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2ND DOSE SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced grade 3 diarrhea for 3 weeks, higher than normal blood pressure for over 3 weeks, intense headache for 3 weeks on an unspecified date. The patient underwent lab tests and procedures which included blood pressure: higher than normal blood pressure for over 3 weeks. The outcome of the events was recovering.  No follow up attempts are possible; information about Lot/batch number cannot be obtained.
CDC failed to notify organizations that they are officially unauthorizing bivalent until the approval announcement on the 12th, so bivalent was given on the 12th.
sick; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves female patient (age unspecified) who was sick (illness), while she received vaccine INFLUENZA VACCINE.  The patient's past vaccination(s) included INFLUENZA VACCINE for prophylactic vaccination for 8 years.  Medical history, medical treatment(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness, non-serious) (hours after) following the administration of INFLUENZA VACCINE.   Last year she just forgot to get it and did not get sick so she won't be getting them anymore.  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.