chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning an 8 year old patient who was vaccinated with a dose of Zostavax instead of Varivax. It was reported that it was due to nursing error. No symptoms were noted. A product quality complaint was not involved. Additional information has been requested from the registered nurse who stated that the event occurred because both vaccines were stored in the freezer and an employee grabbed the wrong box. It was noted that the employee was new and was just confused. It was reported that they now have put a tape on Zostavax that says it is for adults only. Additional information has been requested. This is one of several reports received from the same source.
possible Guillain-Barre syndrome; possible allergic reaction to Shingrix; This case was reported by a physician and described the occurrence of guillain barre syndrome in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and allergic reaction. On an unknown date, the outcome of the guillain barre syndrome and allergic reaction were unknown.   It was unknown if the reporter considered the guillain barre syndrome and allergic reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The age at vaccination was not reported. The patient had a possible Guillain-Barre syndrome or possible allergic reaction to the flu vaccine years before reporting. The primary reporter would like GSK to contact him for further inquiry and to possibly speak to his colleague.  Minimal information provided.  The reporter consented to follow up. This case had been linked to the case US2021079377 reported by the same reporter and same patient for shingrix vaccine.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021079377:Same reporter
Patient developed rash on neck, upper chest, back and behind ears. Provider gave child diphenhrdramine PO- no changes in conditon. Provder administed epinephrine injection and called EMS to trasnport patient to Hospital.
Starting two days after vaccine, I got a raised red blob at injection site. The site is about 2inch by 2.5 inch blob. It is raised and sometimes itchy.
Vomiting; covid; covid; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4339756-00.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 07May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 43 years, all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (ongoing) (Lot number: 1160234), subcutaneous for psoriasis, psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "covid"; VOMITING (non-serious), outcome "recovering". The action taken for risankizumab was dosage not changed. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.The patient had covid. He had first two doses of vaccine but not booster and in 2021, he had a serious reaction to the second vaccine. He had covid several weeks ago and had myocarditis and a heart attack when he had the vaccine.  The reporter's assessment of the causal relationship of "covid" with the suspect product(s) BNT162b2 was not related and causal relationship of "vomiting" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (08Apr2022): This is a solicited Follow-up report based on information received by Pfizer (Manufacturer Control Number: 22K-163-4339756-00). A contactable consumer (patient) reported that:  Updated information included: Suspect dose 1 and dose 2 information, Co-suspect ''SKYRIZI' lot number and new event Vomiting' were added. Clinical information and causal assessment added in narrative.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of  events, Drug Ineffective, COVID-19 and vomiting  cannot be totally excluded
Received Phone call and client states that a month after receiving second dose of Moderna was unable to walk, and began breaking out with blisters.  She has seen her PCP, dermatology, and ortho.
NO adverse event, but medication error.  Dose  given by RN was  = 0.5mL instead of the 0.3ML intended.
FEVER; This spontaneous report received from a consumer 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: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced fever. On 12-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Evening of same day of immunization, c/o stiff legs and knees "hurt". Following day c/o joints hurting/headache. Started with "runny nose" on 3rd day. One week after injection temp of 104.5, headache, "red eyes", "sunken look". 8 days after immunization T of 104 -105 continued (able to lower temp with Motrin), with stiff neck and glands @ base of skull and back of neck was swollen. On 11th day temp was down, but had pronunced rash on forehead, neck, chest, abdomen and arms. Mom states primary physician dx is measles. Ruled out sinus or ear infection. Chest was clear. No cough.
Pain and tenderness in the injected arm lasted 2 days.  horrible headache that lasted 2 days, fatigue that lasted 3 days, chills lasted 3 days , dizziness  and muscle joint pain didn't really start till day 4.
The caller stated that they have already had the primary series and the first booster of the Pfizer Biontech COVID.19 vaccine before getting infected with COVID-19; The caller stated that they have already had the primary series and the first booster of the Pfizer Biontech COVID.19 vaccine before getting infected with COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "The caller stated that they have already had the primary series and the first booster of the Pfizer Biontech COVID.19 vaccine before getting infected with COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: infected with COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The caller states that she and her husband had COVID and took a whole treatment of Paxlovid. She asks when can she have their second booster dose after finishing the Paxlovid treatment. The caller stated that they have already had the primary series and the first booster of the Pfizer Biontech COVID.19 vaccine before getting infected with COVID-19. Failed to probe for age. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt received second Pfizer Covid-19 vaccination around 12:10. She went to the waiting room to wait 15 minutes. Around 12:15 she came to the front desk stating she felt warm all over. A PAR advised her to have a seat while she went to alert to the doctor. Patient went to return to her seat. At this time a RN was up front and asked the PAR to repeat what the patient had said as she did not hear it clearly. As the nurse was about to bring her into Room 1 for evaluation patient fell in the waiting room and hit her head against the wall. The nurse immediately ran out into the waiting room. Pt was unattended for about 10 seconds at most. Upon the nurse's arrival patient was alert and oriented. An APRN and a LPN assisted the patient and other nurse to lay down for around 5 minutes while her vital signs stabilized. Heart rate started at 37 then returned to the 60s. When she felt able to we transferred her to a wheelchair then to a bed. Pt was checked in for evaluation. At 12:51 patient walked out of the office unassisted after being seen.
developed no titers from the vaccine; This spontaneous report was received from a consumer (patient's mother) referring to a female patient of unknown age. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant therapies were not reported. On an unspecified date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (1 dosage form) (strength, route and lot number with expiration date were not reported) as prophylaxis. On an unknown date, the patient developed no titers from vaccine (varicella virus test negative). The reporter did not clarify what no titers meant. The outcome of varicella virus test negative was unknown. Reporter did not provide any causality of the event with respect to the suspect drug.
Got a stomach virus after her 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of GASTROENTERITIS VIRAL (Got a stomach virus after her 1st dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09K20A) for COVID-19 vaccination.     The patient's past medical history included Lymph node disorder, Knee replacement (left knee problems-   replaced 8 weeks ago.) and Lymph node excision (lymph nodes removed in right arm). Previously administered products included for Flu: flu vaccine (Guillain-Barre Syndrome from a flu shot 10 years ago.). Past adverse reactions to the above products included Guillain-Barre syndrome with flu vaccine.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GASTROENTERITIS VIRAL (Got a stomach virus after her 1st dose). At the time of the report, GASTROENTERITIS VIRAL (Got a stomach virus after her 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs were reported. The patient got a stomach virus after her 1st dose and that's why she put the 2nd dose off by a couple of weeks. No treatment drugs were reported.   This case was linked to MOD-2021-390427, MOD-2021-390455 (Patient Link).
My menstrual cycle has been irregular for the first time in my life. I have always been regular and I track my periods in an app. I had two 2-week cycles and one delayed cycle in the 5 months following my second dose of the Pfizer shot.
Due to the improper storage of the Pfizer vaccine, the patient's past injections are invalid. Mom will decide on a later date if she wishes to have pt revaccinated but it is not required.
Writer administered Moderna vaccine 08/16/22 and noticed 08/24/22 patient was inpatient at hospital. Per chart review, Patient sustained a fall 08/20/22 at home, emergency number and paramedics called and assisted patient up, Patient declined ER evaluation at that time, no head trauma or loss of consciousness. His mobility worsened after fall and wife notified office of fall 08/23/22 at 4:30 pm and was advised ER evaluation. Seen in ER 08/23/22 and found to have acute central burst/compression fracture L1 without Cauda Equina per doctor, also faint linear lucency in the right pubic bone. Admitted to trauma service, inpatient Neurosurgery consult and inpatient Orthopedic consult 08/24/22 no surgery advised, TSLO brace advised. Disposition pending, patient is inpatient.  Separately important information to note: Other COVID-19 vaccines received 1. 01/15/2021 Moderna Lot#037K02A-Dose 1 Primary series 100 mcg/0.5 ml IM Left arm 2. 02/11/2021 Moderna Lot#041L20A-Dose 2 Primary series 100 mcg/0.5 ml IM left arm 3. 11/02/2021 Moderna Lot#76C21A-Dose 3 Booster 50 mcg/0.25 ml  Of note 08/16/22 Moderna booster dose #4 COVID-19 vaccine dose Writer administered 50mcg/0.25 ml dose, is incorrectly listed as 100 mcg/0.5 ml dose administered, which was recently realized by Writer on 08/19/22 as a systems issue with transferring data from electronic health record with leadership working to correct this problem currently. Writer has no vaccine administration errors to report, patient on low dose prednisone and does not meet criteria of being moderately to severly immunocompromised.
Parents (mom & dad) came to the clinic 10/9/09. Reported & was concern that child has possibly a flu vaccine reaction with on & off slight nose spot bleed 3 days post vaccine (Flu) & up to now. Moved from another region 9/6/09. Advised to go to PMD. Stated no previous reaction on Flu from that region.
Severe, nausea, diarrhea  ( at least 6 episodes day one) onset two days after vaccine with severe HA, bodyaches, , rigors. No one else sick in family
pt recvd flu vax & devel large welt in the area of the inject which was warm;
pt recv vax 14MAY98 & pt devel h/a 1JUN98;dx by MD w/disseminated lesions (about 40) torso & extremities head & forehead;
fever 102.8F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 102.8F) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. On 01-Apr-2021, the patient experienced PYREXIA (fever 102.8F). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever 102.8F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 102.8 (High) Fever 102.8F.         No relevant concomitant medication was reported.
Patient female 58 years old is in the observation are and reports to the EMT of feeling dizzy. Approximately 30 min after the administration of the vaccine. Vitals signs are taken BP 120/70, pulse 60min, Sp0 99%, glucose 101. Consultation with Doctor R. is make, and she indicates to keep patient under observation for 15 more mins. Patient's condition is reassessed, vitals are taken 15 minutes later BP 120/70, pulse 60, Sp02 99%, dextrose 105. Patient reports not feeling dizzy. She proceeds to leave the vaccination center accompanied by her husband.
Info has been received from a physician concerning a pt with an egg allergy who was vaccinated, SC, with a 0.5 ml dose of varicella virus vaccine live. Subsequently, the pt experienced an allergic reaction following vaccination. Unspecified medical attention was sought. It was reported that the pt recovered. No further info was available. No product quality complaint was involved. Additional info has been requested.
About a week and a half ?  After vaccine started having heart palpitations, chest pain shortness of breath spells.  One episode caused heart rate to go  from 62 to 124.   Went to Dr had EKG.  Episodes still randomly continue seeing cardiologist Monday for further treatment/ evaluation
PROBLEMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of problems was not reported. This report was non-serious.
10/19/21 tested positive for COVID 19 despite being fully vaccinated 10/27/21 presents to the ED with SOB observed and treated with O2, dexamethasone, remdesivir, baricitinib, zinc discharged to home health 11/8/2021
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not reported, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estiamted total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 25-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested
Onset diffuse bruising prior to presentation to emergency department.  Platelets = 2,000.  Acute  ITP diagnosed.
Fever at 3am noon, fatigue at 6 am to current time (8:05 pm), upset stomach all day, very sore arm all day
The vaccine storage did not meet standards, vaccine stored in freezer beyond allowable time.  Recommend revaccination.
malaise; felt weak-ringing in ears.; Chills began then fever; fever; Headache shortly after exhaustion; next day headache+ Exhausted; This is a spontaneous report from a contactable consumer (Patient). A 53-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6205, Expiration date: unknown), via intramuscular route of administration, in left arm, on 08Mar2021 at 08:00 (at the age of 53-year-old), as a single dose for COVID-19 immunization. The patient medical history includes ongoing anxiety and depression and concomitant medications included ongoing sertraline hydrochloride (ZOLOFT) orally for Anxiety/Depression. On 08Mar2021, after the vaccination at 20:30 PM, 12 Hours post vaccine, the patient experienced Chills began then fever, Headache shortly after exhaustion, then 24 Hours in felt weak ringing in ears. Patient felt like was going to pass out-Sat down on bed and collapsed + Passed out- Woke up shortly after. Felt malaise ace day stayed at bed, 18 Hours next day headache+ Exhausted- Felt more like self is 72 Hours. + malaise all day. Treatment received includes Advil. Outcome of the events was reported as recovered on an unspecified date in 2021. The seriousness criteria was reported as non-serious.  No follow-up attempts possible. No further information expected.
Pt presents with one day history of erythema , swelling & warmth to touch at injection site, Erythema 6 X 3 & induration
DTaP, MMR, IPV given 06/17/05, pt started with rash - red swollen left cheek on 06/22/05. Increased on 06/23/2005. Pt seen in clinic. Had red and swelling L cheek angle of jaw. Little around eye. Blotchy, red, blanchy rash on right side of face. no other rash elswhere.
Extreme tachycardia (176), hypertensive episode, short of breath, syncope, initially within 3 minutes and then episodically about 15 more times for the next 4-5 weeks. Also tachycardia?resting heart rate went from 50 to 100 and increased with even light activity. Bilateral arm weakness, lower leg weakness, numbness in right face started within 48 hours and lasted about 4 days, extreme inflammation in my gi tract which was previously fine, new diagnosis of asthma. Several ER visits, hospitalizations, etc.
3 days after receiving the second dose of the vaccine, the area around the injection site became itchy, red, and warm.  The rash appeared in the morning but reduced by evening.  The next day (4 days after injection) the redness, itchiness, and warmness returned in the morning.
Itching, all over body. Not extreme where I can't function. but causes multiple pauses during each waking hour and did not sleep well last night. Feels like something is touching / crawling all over me. especially hips, shoulders, neck, and stomach. Started last night 05-APR-2021
A mother reports a rash on the body of a 3 year old, 1 day after Hep A # 2. The rash was gone in 24 hours.
I received my second dose of the vaccine and the following day I noticed my arm was red around the injection site. The redness grew a bit and was raised off my skin. It was slightly itchy, painful and I noticed it was warm. I did take the spots tempature out of curiosity and it was 100.7 but has since dropped to 99.7. I also noticed on day 3 that it spread a bit further on my arm.
Information has been received from a doctor of pharmacy concerning a patient on an unspecified date was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Subsequently, the patient "had extensive swelling and redness". It was unknown if the patient sought medical attention. At the time of reporting, the patient's outcome was unknown. This is one of several cases received from the same source. Additional information has been requested.
pronounced swelling from shoulder to above elbow, extreme pain, large egg sized lymph node that is very painful, rash, slight fever