chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash on her chest; Localized reaction; This case was reported by a nurse via call center representative and described the occurrence of rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash and local reaction. On an unknown date, the outcome of the rash and local reaction were unknown.   It was unknown if the reporter considered the rash and local reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had some localized reactions developed on her arm and after she experienced a rash on her chest.  The HCP did not had further details to provide. The reporter consented to follow up. No further clarifications performed by HCP.
Severe pain from base of skull down spine to mid back. Can't turn head or move without pain.; Severe pain from base of skull down spine to mid back. Can't turn head or move without pain.; This is a spontaneous report from a contactable Other Health Professional (patient). A 36-year-old female patient not pregnant received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=BL), intramuscularly in left arm on 21Jan2021 19:15 at single dose for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included Known allergies: Latex, morphine, Possible MS.  Concomitant medication in two weeks included Phentermine, vitamin D NOS (VITAMIN D), Vitamin B12 NOS (VITAMIN B12), probiotics, multivitamin. If other vaccine in four weeks: No. The patient experienced severe pain from base of skull down spine to mid back. can't turn head or move without pain on 22Jan2021 17:00 with outcome of not recovered. If treatment AE: No. If covid prior vaccination: No. If covid tested post vaccination: No.
2 days after the second dose vaccine I began to feel slight burning  on 2 parts of my face. Over the nExt few days they formed into pretty major scabs, one on the nose and one below the lip. They were not necessarily painful but gross. Unsure if it was the vaccine but I can?t think of anything else that would cause it, they did not form like pictures of the actual monkey pox lesions I have scene, they just scabbed. Looks like a minor burn on my face.
She explained her husband has not been vaccinated, tested positive to COVID-19,  and thus they both have to quarantine; This is a spontaneous report from a consumer via a Pfizer-sponsored program.   A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on 19Feb2021, as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. Patient stated that her husband has not been vaccinated, tested positive to COVID-19, and thus they both have to quarantine until 08Mar2021. She asked if she should receive her second dose as planned. Patient stated that her second dose scheduled on 13Mar2021. At the time of this report event outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
We had a customer who had an appointment today to get a 1st dose Pfizer vaccine. On consent form, she answered "No" to the question, "Have you ever received a dose of COVID-19 vaccine before?" I verified with her before giving vaccine. She did not have any vaccination card with. I administered Pfizer vaccine and gave her the vaccination card. When I processed the vaccine, it returned with this reject: " Patient received a single dose vaccine. Records indicate patient received single dose 20210405." I confirmed she received J&J vaccine on 4/5/2021. I attempted to call the patient multiple times before able to reach her. She confirmed that she did get the J&J vaccine. This is her statement: "I have Non-Hodgkin's Lymphoma, and oncologist is not happy with J&J level of coverage/effectiveness (especially against the Delta variant) and wanted me to get one of the mRNA vaccines to get additional coverage/effectiveness."  I told her that she should have mentioned this on the consent form and in person prior to us administering the vaccine, and she said she misread the question as if it was asking if she had received a 1st dose of Pfizer or Moderna, so she answered "No."
Received second vaccine on 01/04/21 at 1230 and began having axillary lymph node swelling and tenderness the following morning (01/05/21) along with headache and severe fatigue. Fatigue and headache have subsided, but axillary swelling remains. Axillary tenderness beginning to subside.
Chills for several hours, migraine headache, dizziness, aches in neck & upper back,
The shot was given into the left deltoid within the safe zone (triangle). Patient reported that the pain in the arm did not subside after the shot and continued to bother her with a 7/10 pain. There was tingling down in the fingers, general arm weakness, and limited mobility of the left arm. Patient was consulted and told to follow up with her primary care provider.
The patient was minimally responsive when I arrived at her car consistent with a severe vasovagal episode with syncope. The patient rapidly regained consciousness with a supine position with legs elevated. The patient was given oral hydration but had large volume emesis. The patient was given SL 8mg Zofran. Emesis continued. The patient was transferred to EMS. The patient was given IV fluids and IV Zofran via EMS.  A severe vasovagal episode with true syncope and significant emesis. Improved with IV fluids and antiemetics via EMS. Patient discharged home with father as the driver.
Patient suffered cardiac arrest 30Mar2021 died 04Apr2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 46-year-old male patient received bnt162b2 (BNT162B2), on 11Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: CARDIAC ARREST (death, hospitalization) with onset 30Mar2021, outcome "fatal", described as "Patient suffered cardiac arrest 30Mar2021 died 04Apr2021". The patient was hospitalized for cardiac arrest (hospitalization duration: 5 day(s)). The patient date of death was 04Apr2021. Reported cause of death: "Patient suffered cardiac arrest 30Mar2021 died 04Apr2021". It was not reported if an autopsy was performed.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Patient suffered cardiac arrest 30Mar2021 died 04Apr2021
"A mother reported that her 4 month old son received Rota Shield, IPV (PMC France),and DTP (manufacturer unknown) vaccines on 6/22/99. On 7/2/99, the infant experienced irritability, inconsolable crying, a 'slight' fever (body temperature not provided) and constipation." From follow up #1 correspondence receivedm on 01/17/00, additional patient and responsible physician information was provided. It was also reported that the patient recovered from this experience. No further information was provided from follow up #2 correspondence received on 06/31/01. No further information was provided from correspondence returned to Adventis Pasteur Inc.on 12/03/01. This case is closed.
1/7-1/10 felt tired, 1/11 dizzy, confused, headache, Lt side facial numbess; 1/12 - less dizzy, 10% facial numbness - reduced, little confused - reduced.
Started crying right after vaccine and is still crying about 5 hours later. Stops briefly, only when wears herself out. No fever or vomiting. Resolved without incident.
Narrative: Fully vaccinated, COVID positive on admission for hyperglycemia secondary to new onset of DM. Patient was asymptomatic.
she was not able to speak afterward and then the left side of her face was numb; she was not able to speak afterward and then the left side of her face was numb; This is a spontaneous report from a contactable pharmacist. A 32-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 15Sep2021 (Batch/Lot Number: FF2588; Expiration Date: Dec2021) as DOSE 1, 0.3 ML SINGLE (at the age of 32 years) for covid-19 vaccination. The patient has no medical and family history. There were no concomitant medications. Later on 15Sep2021 (in the evening), the patient was not able to speak afterward and then the left side of her face was numb. The patient went to bed and when she got up everything had turned to normal. The outcome of the events was recovered on 16Sep2021.   Follow-up attempts are completed. No further information is expected. Information about batch/lot number already obtained.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events  Hypoesthesia, Aphasia  and the administration of the vaccine cannot be excluded. 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.
Right deltoid has cyst like area at injection site. It is raised, fluid filled, warm to the touch, and about 2.5inch in diameter. No pain.
Flu-like symptoms: fever, chills, aches, headache, redness at injection site, skin hot to touch at injection site, soreness at injection site
01APR - Vaccine 02APR - Chills, 2 hours 12APR - Onset hot/cold flashes, paresthesia 23APR - Onset bilateral Bell's Palsy, loss of taste, pain in kidney area; continuation of hot/cold flashes and paresthesia in arms, legs, mouth area, esophagus and lungs 23APR - Antivirals, prednisone, 1 week + XS Tylenol for pain 23APR-02MAY - severe pain, over time moving up the spine and into the shoulders and neck. Stopped after 02MAY. 01MAY - Suspect Lyme, begin 3 weeks antibiotics; hot/cold flashes cease. 01MAY-09JUL - gradual improvement of paresthesia, return of taste, and facial paralysis 09JUL - partial loss of vision in left eye 21-24JUL - hospitalization
Injection site bump; Injection site erythema; injection site pruritis; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA190A, expiry date 30th September 2020) for prophylaxis.   Concomitant products included DTPa (Reduced antigen) (Boostrix) and Gardasil.   On 18th December 2019, the patient received Menveo. In December 2019, 2 days after receiving Menveo and not applicable after receiving Boostrix, the patient experienced injection site swelling, injection site erythema and injection site itching. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site itching to be related to Menveo.  Additional details were provided as follows: The patient received Menveo and he also received Boostrix and Gardasil at another injection site. Two days after he developed a good sized 30 mm red bump with severe itching at the Menveo injection site. The reporter consented to follow up.
Patient received Moderna Bivalent Vaccine on 9/15/22 and 11/11/22.   No adverse effects noted from incorrect administration.
large joints were quite painful-shoulders; fever; knees hurt like crazy / joints were quite painful / hip pain; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2019, the patient received the 1st dose of Shingrix. On 24th July 2019, 1 days after receiving Shingrix, the patient experienced fever (serious criteria other: serious per reporter) and knee pain (serious criteria other: serious per reporter). In August 2019, the patient experienced shoulder pain (serious criteria other: serious per reporter). The patient was treated with naproxen (Aleve) and meloxicam. On 26th July 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the knee pain and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the fever, knee pain and shoulder pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had a serious reaction to the first injection and asked to advise him or her. The patient enquired about getting the second injection or the timing of that second injection. A day later both knees hurt like crazy when going upstairs. The patient also had a fever of 101. These symptoms were faded over a couple of days, but several weeks later (mid-August) all large joints were quite painful including knees, hips and shoulders. Treating with Aleve was only partially effective in relieving the pain, so patient visited to Internist. The Internist prescribed Meloxicam 25 mg for 2 weeks and patient then refilled that for an additional 10 days. That round of medication was just completed and patient's joints were much improved, but not back to normal. The Internist had suggested pushing out the second injection as late as possible, and had also referred patient to a rheumatologist. Rheumatologists were apparently in hot demand as the first available appointment would not until February. The patient would like to see the rheumatologist prior to getting the second injection, but wondered how long between doses was acceptable, and whether had any additional advice. The patient never had any reaction to a vaccine other than at the site. Unless the rheumatologist felt it was not recommended based on the reaction to the first one. This had been quite scary as patient felt like it added about 15 years of age. The patient was sure hope it continued to improve and that did not regret getting the Shingrix for the rest of life. The reporter requesting consent to follow up.
R/arm pain, chills, hot flashes, mild nausea, 4 x 6 cm area of erythema & induration, temperature to touch & tender. Treated with warm compresses, Keflex & Motrin or Tylenol.
I was having a runny nose and sore throat. The next day I took a home COVID-19 test and that was positive for COVID. I had gotten some congestion since the first symptoms. I tested the next day and it was positive as well and my daughter in law let me know that she was also positive and then my spouse also tested positive. I called my Doctor and I was given Paxlovid. While on the Paxlovid I had really bad migraines for about 6 nights in a row. I was then put on an antibiotic because we thought I developed an ear infection as well. I ended up going to an urgent care because I was still testing positive for about 14 days afterward as well
weeping; This is a spontaneous report from a contactable Other Health Professional. A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for covid-19 immunisation. Medical history, concomitant medications or past drug history were not provided. He was weeping. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
SIDS; Autopsy report received on 3/5/2003 indicates that the cause of death was undetermined.
Fever, NauseaVomiting, low grade fever chills nausea sore arm Narrative:
Patient was vaccinated on 04/01/2021. Patient is 15 years old and was not supposed to be vaccinated on that day, she should have been refused. It is unknown as to what occurred on that day that patient was vaccinated even though she is 15 years old. It was not brought to the attention of the site lead or charge nurse on 04/01/21. Patient returned to the site on 04/22/2021 for second dose. Vaccinating nurse and scribe asked the patient and looked at her date of birth which states she is 15 years old. It was brought to the attention of the charge nurse and site lead that the patient had been incorrectly vaccinated 3 weeks ago. Patient was not given second dose and educated that she may not receive it until she is 16 years old. Patient and mother understood and left site without incident.
PSORIASIS TO FLARE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included psoriasis. 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 prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced psoriasis to flare. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of psoriasis to flare was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
The pain at the injection site spread to my entire bicep. The pain prevents me from raising my arm due to the pain but i was able to raise my arm to shoulder height. Originally if I did not move my arm I had minimal to no pain but with movement, it was 7-8/10. I took 1000mg Tylenol at the start of the pain. while sleeping I could not lay on the arm and could not have it in certain positions without having pain. The next day (4/15/21) I began having pain even while resting but it was only 2-3/10 and with movement became 8-9/10.  I could only move my arm up around 30 degrees before it would stop moving and the pain became severe. I took 1500mg of Tylenol with minimal relief. Additionally, I took a hot shower which helped in the shower but the pain returned. That night I could not find any position that did not hurt my arm and my sleep was impacted due to the pain. Today even with no movement, I am experiencing the pain of 6/10 and with movement 9-10/10. I have less range of motion than I did previosuly. I took an Epsom salt bath which helped the pain but then returned when I got out. i can now barely move my arm without it stopping. I have taken 1000mg of Tylenol with no relief.
Red, raised, circular spots on back, abdomen, arms, legs, head, face, fever, Dx: Viremia due to poss MMR or varicella. OTC Benadryl, RTO if not resolved.
Pt received TD and states that she experienced a temperature of 100.5 early the following morning with moderate to severe muscle/joint pain lasting approximately 4 days. Pt felt improvement 4 days post vax on 10/24/00.
Pain at administration followed by stiffness and pain in left arm. Persistent but gradually diminished for month following injection. I am trying to improve range of motion as per my own doctor's advice. Pain still persists in motion and sometimes when sleeping. Cannot lay on that arm.
Approx 1300 pt was SOB then collapsed at golf club facility. No pulse, Bystander started CPR, EMS arrived 2 rounds of epinephrine and intubated. Arrived at ER @ 1334 Tachycardia rhythm, pulses lost, CPR restarted. Pt given Epinephrine, Sodium bicarbonate and calcium gluconate. Return of spontaneous circulation. @ 1336 1mg Epinephrine IV Push @ 1336 50 mEq Sodium Bicarbonate 8.4% IV push @ 1344 1g Calcium gluconate IV push @ 1347 1 liter over 1 hr 0.9% Sodium Chloride @ 1446 8mg/500ml levophed in 05w started at mcg/min @ 1503 1mg Epinephrine IV push, @ 1504 50 mEq Sodium Bicarbonate 8.4% @ 1506 1mg Ephinephrine IV push @ 1509 50 mEq Sodium Bicarbonate 8.4% @ 1512 1mg Epinephrine IV push @ 1517 1mg Ephinephrine/250 ml 0.9% Sodium Chloride via gravity feed 200cc total given until end of code @ 1523 compressions @ 1524 1mg Epinephrine IV push @1527 no pulse @1528 1mg Epinephrine IV push @1529 no pulse @1531 no pulse @1532 1mg Epinephrine IV push @1533 no
Child seen 5/25 for routine WCC visit. Had hx of fever 101. At time of visit fever was 99; 6 hours after vaccines, child had fever 103, arching back, irritable and difficult to console. Was sent to ED. Was batter on arrival to ER per ER notes.
Healthcare provider calling because a patient received her 2nd dose to early; the 2nd dose was given within 17 day and not at 28 days.; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Healthcare provider calling because a patient received her 2nd dose to early; the 2nd dose was given within 17 day and not at 28 days.) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047M21A and 047M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Healthcare provider calling because a patient received her 2nd dose to early; the 2nd dose was given within 17 day and not at 28 days.). On 08-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Healthcare provider calling because a patient received her 2nd dose to early; the 2nd dose was given within 17 day and not at 28 days.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no information provided about the patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies. On an unspecified date in 2014, the patient received the first dose of GARDASIL for human papillomavirus (HPV) vaccine series (formulation, strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported). On 16-MAY-2017, the patient received a dose of injectable GARDASIL 9, reported as the second dose in the HPV vaccine series (lot # N002720 with expiration date on 12-MAY-2019) (strength, dose, frequency, route of administration, anatomical location and indication were not reported). There were no adverse effects reported. Additional information has been requested.
Right chest, right shoulder, right shoulder blade pain, extreme to the point where i wasn't able sleep and a burning sensation in those areas as well
Reports after receiving flu shot at approx 1520 began to have hives on her arms, chest and ear. Reported itching on her back. Symptoms began at approx 1600pm. She states she took a CLARITIN at approx 1645 and by the time she reported to ER symptoms were nearly resolved according to providers notes.