chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Quadracel given in error. Patient was due for DTap. No adverse signs/symptoms noted. MD discussed with family.
Minutes after being given the vaccines he had eruption of rashes on arms, body and face, no fever, no swelling of eyes and lips. But subsided after 30 mins.
Information has been received from a healthcare worker (medical assistant) concerning multiple unspecified patients of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On multiple unspecified dates, unspecified doses of PROQUAD (Merck) (lot # L030591 with expiration date 10-FEB-2017, dosage and route not reported) which were improperly stored under 12.5 F for 20 hours were administered to multiple unspecified patients. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of injection site rash in a 42 year old male subject who was vaccainted with FluLaval for prophylaxis. On 11/17/06 the subject received a dose of FluLaval in an unspecified arm. On 11/17/06, the subject also received hepatitis A vaccine (Havrix), Typhim VI and and unspecified vaccine. The healthcare professional noted that at the site of the Flulaval injection, on 11/17/06, 0 days after vaccination with FluLaval, the subject experienced a breakout of rash on the arm of the injection site with a black dot in the middle of the injection site. The subject was seen at a physicians. Office and was treated with Benadryl. The health care professional considered the events were clinically significant (or requiring intervention) (OMIC). The outcome of the events was not reported.
02/17/04 at 12PM: Mom phoned stating possible reaction to immunizations.  Left arm red from left shoulder to left elbow swollen, tender to the touch.  Seen MD 02/17/04 at 4:10pm, 16cm erythema, slight induration, left shoulder-will not need another DPAT and unlikely the DT will be a problem when he gets that in 10 years (per MD notes).  Temperature 97.2 axillary.
Event occurred after 2nd dose. The patient presents with "feeling sick".  The onset was 11 days before presentation.  Associated symptoms: vomiting and shortness of breath.  Patient states he was diagnosed with Covid on December 5 states he did receive vaccine and states he also underwent monoclonal antibody injection but has worsening symptoms with body aches difficulty breathing cough  Ascorbic acid, folic acid,  Rocephin, Zinc, Tylenol  Still Inpatient
Cellulitis left leg at DTaP injection site, 7 x7 cm of erythema left thigh, Augmentin ES 600 mg/ 5cc 1/2 tsp po BID x 10 days
Approximately 9 days after second dose, small itchy rash appeared on injection arm, but not at injection site. Over the next three days three more rashes appeared on hip, neck and stomach. Arm rash also grew in size. Neck rash was particularly large and other two also became much larger, itchier and angry looking. Three days after onset of symptoms began to take Claritin once a day. Did not make itch go away. Affected daily life including sleeping. After seven days, itching ceased but the large red patches currently remain. Went to skin specialist who prescribed steroid cream for patches. She told me I was the 8th patient she had seen that week with similar rashes, all from Pfizer vaccine.  Note: not Covid arm as rashes spread throughout injection side of body. I have not previously suffered such a rash in my life and am a healthy individual.
Psoriasis; very itchy; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis) and VACCINATION SITE PRURITUS (very itchy) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, BENAZEPRIL, TIMOLOL, ACETYLSALICYLIC ACID (BABY ASPIRIN) and PREDNISONE for an unknown indication.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PSORIASIS (Psoriasis) and VACCINATION SITE PRURITUS (very itchy). On 20-Mar-2021, PSORIASIS (Psoriasis) and VACCINATION SITE PRURITUS (very itchy) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Non significant information provided (Reporter's address).
After first dose of Pfizer patient indicated bronchial spasm/tightness.  Patient left her Albuterol inhaler at home.  BP= 121/83, HR= 99, O2 sat= 98%.  Patient's dad indicated home was "5 min" away, EMS declined.  Dad indicated severity was 3-4 on a scale of 10.  No medication provided.  Patient walked out with both parents and one EMT unassisted.
Approximately 3 hours after shots-baby screaming, difficult to console lasted approximately 5 hours.
Burning and swelling on the right side of my face. Breaking out in cold sores on the said side of my face. Pain and clogging in my right ear.
received improperly stored vaccine; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) lot # S003865, expiration date: 08-AUG-2020 (strength, dose, schedule and route of administration were unknown) for prophylaxis (product storage error). The vaccine underwent temperature excursion at 32.5 Fahrenheit for a duration of 8 hours. There was no previous temperature excursion. There was an involvement of data logger. No product quality complaints (PQC) were involved.
Congestion. Headache. Body aches. Fever. Chills. Sore throat. Dizziness.
Rash on arms and legs; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration on an unknown date (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date the patient experienced rash on arms and legs. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash on arms and legs was recovering.
Dose administered beyond 30-day use; Dose administered beyond 30-day use; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered beyond 30-day use) and EXPIRED PRODUCT ADMINISTERED (Dose administered beyond 30-day use) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered beyond 30-day use) and EXPIRED PRODUCT ADMINISTERED (Dose administered beyond 30-day use). On 22-Oct-2021, PRODUCT STORAGE ERROR (Dose administered beyond 30-day use) and EXPIRED PRODUCT ADMINISTERED (Dose administered beyond 30-day use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter It was reported that date taken out of freezer was 9/8/2021.
This spontaneous report was received from a healthcare professional and refers to multiple unspecified patients with unknown demographics. Information about the patients' pertinent medical history, drug reactions allergies and concomitant medications was not reported. On an unspecified date in 2016 (reported as from 01-MAR-2016 through 08-MAY-2016), the patients were vaccinated with doses of improperly stored ROTATEQ, orally, lot # K019370 with expiration date 16-JUL-2016 and lot # L029618 with expiration date 20-MAY-2017. No adverse effects were reported. The vaccine experienced the following temperature excursion: 7.2F on an unspecified date. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. This is one of several reports received from the same reporter. Additional information has been requested.
This 6 month old female presents for Well child and shaking episode. Mother states that after the pt's last appointment on 3/24 when they took her home, the pt had an episode of shaking that concerned her for a seizure. Mother says later that night after the visit, the pt was crying a lot. Then, she ended up having an episode of shaking and was unresponsive. Mother did not noticed what she was doing with her eyes. Mother says the pt stopped crying during the episode. She was not cyanotic. Mother says the shaking lasted for longer than a minute, and they considered taking her to the ER, but it stopped. She did not respond to touch. Father says the pt's eyes rolled every once in a while and were not fixed during the episode. After the episode, the pt fell asleep and nursed throughout the night. She was not sweating during or after the episode. Mother says the pt seemed to be stiff during the episode, and her arms were fixed and shaking. Mother cannot recall if the patient was holding her breath beforehand and does not know if the pt had a fever or not. The pt has not had any episodes since then. Mother says she cannot recall many details of what happened as she was very distressed by the episode. Mother watched a video online that her friend sent her of a baby having a seizure and felt that the pt's episode was worse than the baby in the video.
Patient received an MMR vaccine as a requirement for her job at approximately noon today, approximately 30 minutes later developed generalized pruritus without rash, and chest tightness. She presented to the Emergency Department
Puffy, swelling - eyelids, sneezing no wheezing no local reaction at site of injections.
METASTATIC ADENOCARCENOUS OF THE CERVIX, METASTISIZED TO LIVER, LYMPH NODES, FATTY TISSUE IN STOMACH, AND OUTER SKIN OF VAGINA, THYROID ISSUES, GALLBLADDER PROBLEMS, BRITTLE TEETH
passed out; sweating; turned blue; This is a spontaneous report from a contactable other healthcare professional (hcp reporting for self). A 24-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW0173, expiry date not reported) via an unspecified route of administration, administered in left arm on 01May2021 18:00 (at the age of 24 years old) as first dose, single for covid-19 immunization. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. On 01May2021 18:00, patient immediately started sweating after getting the shot then passed out within a couple minutes. Pharmacist told the patient that she turned blue and they injected her with Epipen. Patient woke up after and felt fine. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were reported as serious medically significant. Since the vaccination, the patient was not tested for COVID-19. The patient recovered from the events reported on an unspecified date in May2021.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events loss of consciousness, hyperhidrosis and skin discolouration cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
After recieving shot within 10 minutes patient experienced rash, redness at cheeks with raised bumps and c/o itching all over. Patient was given Benadryl 25mg Im. Patient responded to tx with-in 20min redness gone and rash started to resolve.
People complaining of rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (People complaining of rash) 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. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (People complaining of rash). At the time of the report, RASH (People complaining of rash) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment medications were reported.
pt recv vax & 30min post vax pt became dizzy, pale, shaking, clammy & almost passed out;pt was fine when the dose was given, not afraid of inj;
3:11 pm mother requested help "son passed out" c/o light headed pallor and sweating  pt lowered to floor  pulse ox 97 bp 94/70 3:12 pm  pt responded color returned  3:19  HR 92 pulse ox 98% sitting up drinking h2o 3:19 hr 92  pulse ox 98% pt states hx of fainting post blood draw drinking h2o and apple juice  3:20 EMS arrives  5pm mother arrives back to let clinic know pt will go home instead of transport to urgent care/ER
Employee received Varicella vaccine on 062405 per Employee Health protocols;  On Friday, July 8th began itching on both arms.  Sat 070905 noticed one "welt" on left arm with a fever of 100 F.  By Sunday morning, employee reports macular lesions on abdomen with fever of 99 F.  On Monday morning, 071105, lseions were located on abdomen, a "few on chest and arms, one on back and one on leg and foot".  Employee reported feeling tired, nauseated.  Last lesion appeared on Thursday, 071405 and employees states she felt better.  Monday, 071705  No new lesions and all prior lesions crusted.
This spontaneous report as received from a registered nurse refers to a 9 week old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 06-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012722 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
severe hives, flushing (of face & ears);pt recv vax 17OCT96 2PM;pt had tx w/DPH, pred, zantac & po DPH;
Reaction to flu shot, bruise at site, weakness, dizziness, nausea, fatigue, Left. MEDROL Dose Pak started AM 9/30/16.
Pt. became infected with Influenza A despite having received the vaccine 2 months prior.
then told to get a 2nd shot but they gave her the pfizer vaccine; then told to get a 2nd shot but they gave her the pfizer vaccine; Myocardia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2 (initial pfizer dose), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna coviD-19 vaccine (Dose 1, single), administration date: 18Feb2021, for COVID-19 immunization, reaction(s): "brain bleed". The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" and all described as "then told to get a 2nd shot but they gave her the pfizer vaccine"; CARDIOMYOPATHY (medically significant), outcome "unknown", described as "Myocardia".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The pt developed numbness in the toes, fingers, tongue and vaginal area occurring 5 days post vax which progressively got worse. The pt was sent to the ER. The pt was admitted to the hospital with a diagnosis of Guillain Barre and was treated with IV IgG.
Pt had a seizure on 8/5/14 and was taken to ER via ambulance, treated and released. She became unresponsive, tonic/clonic movements while talking w/friends.
Care taker reported that patient vomited and started convulsing. She also reported that patient  history of seizures.   Care taker reported that was given rectal valium and was stable after administration.
has rotavirus type A; This spontaneous report has been received from a physician referring a 13-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (strength, specific dosage, vaccination scheme, route of administration, anatomical site of application, lot number and expiration date were not provided) and also, on an unknown date, experienced rotavirus type A (gastroenteritis rotavirus).  At time of reporting, the patient had not recovered from the event.   The causal relationship between gastroenteritis rotavirus and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported.
hallucinations; hearing voices; Psychosis\mental problems; paranoia; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucinations) and HALLUCINATION, AUDITORY (hearing voices) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (hallucinations) (seriousness criterion medically significant), HALLUCINATION, AUDITORY (hearing voices) (seriousness criterion medically significant), PSYCHOTIC DISORDER (Psychosis\mental problems) and PARANOIA (paranoia). At the time of the report, HALLUCINATION (hallucinations), HALLUCINATION, AUDITORY (hearing voices), PSYCHOTIC DISORDER (Psychosis\mental problems) and PARANOIA (paranoia) outcome was unknown.            No concomitant and treatment drugs were provided.  Company comment: This case concerns a 22 -year-old male patient with no medical history, who experienced the unexpected events of Hallucination, hallucination auditory, Psychotic disorder, Acoustic stimulation tests abnormal and Paranoia. The events occurred after the second dose of mRNA-1273, Moderna COVID-19 Vaccine. Event seriousness assessed as per Regulatory Authority reporting. The rechallenge was not applicable. The reporter did not provide a causality assessment. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-329076 (Patient Link).; Sender's Comments: This case concerns a 22 -year-old male patient with no medical history, who experienced the unexpected events of Hallucination, hallucination auditory, Psychotic disorder, Acoustic stimulation tests abnormal and Paranoia. The events occurred after the second dose of mRNA-1273, Moderna COVID-19 Vaccine. Event seriousness assessed as per Regulatory Authority reporting. The rechallenge was not applicable. The reporter did not provide a causality assessment. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.
was achy with the first dose; sore arm with first dose; This is a spontaneous report from a contactable consumer (patient). A 85-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EK4176), via an unspecified route of administration on 22Jan2021 as single dose (at the age of 85-years) in Arm Left for covid-19 immunization. Medical history included: knee arthroplasty from Apr2018 to an unknown date (knee cap was not replaced) and breast cancer from Aug2013 to an unknown date. The patient did not receive any other vaccination within 4 weeks. Concomitant medications included: levothyroxine sodium (SYNTHROID) 200mcg daily taken for hypothyroidism (since 35 years); omeprazole 20 mg daily taken for gastrooesophageal reflux disease; furosemide 40mg daily taken for left ventricular failure from 2017 to an unspecified stop date; spironolactone 25mg, takes half tab daily, taken for left ventricular failure from 2017 to an unspecified stop date; ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION), 1 daily taken for macular degeneration from 2011 to an unspecified stop date; colecalciferol (VITAMIN D) 5,000 units daily taken for vitamin d deficiency (since 6-7 years) (all are ongoing). On 23Jan2021, the patient experienced achy and sore arm with first dose. She is always achy. The degree of the achiness went away. On an unspecified date, the patient had ultrasound to check for deep vein thrombosis and results were unknown. The outcome of pain in extremity was recovered on 25Jan2021 and for another event it was unknown.