chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Registered Nurse refers to a 19 month old patient of unknown gender. The nurse reported that the patient received a dose of VARIVAX (Merck) (lot# unspecified) (route, dose and location unspecified) on 09-APR-1999 and then vaccinated with a dose of M-M-R II (lot# unspecified) (route, dose and location unspecified) on 19-APR-1999. The patient had received VARIVAX (Merck) and M-M-R II at different times within a period less than 28 days. No adverse effect reported. This is one of several reports received from the same reporter. Follow up information had been received from the Registered Nurse refers to the currently 16 year old male patient. It was reported that their school records showed this child was given live vaccine too close together. Their office did not give any of these. They were trying to connect the problem. Varicella dose was given on 09-APR-1999 and did get chickenpox later date. M-M-R II dose was given on 19-APR-1999 by another agency. They gave another M-M-R II on 09-OCT-2013. There was no problem with the child. The patient did not require emergency room/doctor visit. The outcome was not provided. Additional information is not expected.
Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016564536) on 19 Dec 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (FLU VACCINE) (manufacturer: unknown, batch number, expiry date, dose, route and site of administration was not reported) on an unknown date. The patient's relevant medical history and concomitant medications were not reported. On an unspecified date, after the vaccination the patient had "flue" (it was reported that patient had terrible side effects to the medication). The patient lab tests and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
I became lightheaded/dizzy within the first few minutes.  Symptom subsided but came back in a mild way.  When I came home and after Seventeen (17) hours, I am still lightheaded, I have body aches and chills.  I have no fever.
Received second dose of Moderna 1/17/2021, had fever, HA, chills and dizziness. Began to feel a little better on Saturday and Sunday but Monday morning started having N/V, diarrhea and low grade fever.
Patient received Pfizer COVID vaccine on 1/18/21 and 2/18/21. On 5/16/22, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure, COVID19 infection, and generalized weakness. Patient discharged back to her AFH on 5/21/22.
customer began feeling dizzy lightheaded hot and nausea. she was given a bottle of water and orange juice and sat on a bench for 25 minutes and began to feel better.
Outside of my arm hurting pretty significantly; This case was reported by a consumer and described the occurrence of pain in arm in a 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and only reaction had pain in arm. For tolerances of 2nd dose, refer case US2020AMR078362, reported by same reporter for the same patient.
No adverse effects; patient received dose of PNEUMOVAX 23 that was improperly stored; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions/allergies were not reported.  On 10-OCT-2019, the patient was vaccinated with a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S012246, expiration date 10-FEB-2019 (strength, dose and route of administration were not provided) as prophylaxis (product storage error).   Administered dose of vaccine experienced the temperature excursion of 68 degrees Fahrenheit for 8 hours. Previous temperature excursion was reported as 57 degrees Fahrenheit for 2 hours. The data logger was involved. No adverse effects were reported.
Office visit after injection on 5-4-06. Left upper arm red from shoulder to elbow with mild swelling and tenderness. Redness had extended 8cm medially from shoulder to anterior chest, now improved. 3cm of redness beyond most medial marking on chest wall but within border, redness improved. Did give Benadryl 1tsp every 4 hours overnight on 5-3-06.
Extensive swelling left arm - red/tender and indurated. Rx: Pain meds and warm compress
Systemic: Dizziness / Lightheadness-Severe, Systemic: Seizure-Mild, Additional Details: patient suddenly fell down, had a slight seizure last around 5 sec and regains concious.  He feels fine but pharmacy still called 911 and was escort to receive emergery/urgent services.
The first dose received on 29-Aug-2021 and second dose received on 16-Sep-2021; The patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first dose received on 29-Aug-2021 and second dose received on 16-Sep-2021) and EXPIRED PRODUCT ADMINISTERED (The patient received expired vaccine) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first dose received on 29-Aug-2021 and second dose received on 16-Sep-2021) and EXPIRED PRODUCT ADMINISTERED (The patient received expired vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first dose received on 29-Aug-2021 and second dose received on 16-Sep-2021) and EXPIRED PRODUCT ADMINISTERED (The patient received expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported   This case was linked to MOD-2022-510159 (Patient Link).
This spontaneous report was received from a physician referring to a patient of unknown gender and age. There was no information provided about the patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies. On an unspecified date (reported as 05-NOV-2017), the patient received an injectable dose of VARIVAX for prophylaxis (expiration date reported as 05-NOV-2017) (strength, dose, frequency, route of administration, anatomical location and lot # were not reported). On an unspecified date, the patient experienced "hdhd" (adverse event). Additionally, it was reported that a product quality complain (PQC) was involved. At the time of reporting, the therapy with VARIVAX continued. The outcome for the adverse event and the relationship between the adverse event and VARIVAX were not reported. Additional information has been requested.
patient started having chest pain and heart palpitations 5 days after second vaccine dose. seen in the ER 3 weeks later still complaining of same symptoms
Patient recieved Zoster at 13:20. Patient denied sensitiveity to gelatin, yeast, or neomycin. Patient indicated sensitivity to tetnus toxoids (horse serum). At 13:30 patient presented with itching and redness at the injection site. The injection site appears red with a 4cm wheal and splotchy erythema covering the upper arm. There was no laryngeal swelling.
patient died; This is a spontaneous report from a contactable Other Healthcare Professional (HCP). This Other HCP reported similar event for 2 patients. This is 2nd of 2 reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  It was reported that patient died on an unspecified date. Cause of death unknown. Outcome of the event was fatal. It was unknown if an autopsy was performed.  Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the event death cannot be excluded as 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.,Linked Report(s) : US-PFIZER INC-2021102020 same reporter/drug/event, different patient; Reported Cause(s) of Death: patient died
moderna bivalent 10 mcg dose given instead of bivalent 25 mcg dose
This spontaneous report was received from a licensed practical nurse (L.P.N.) referring to unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with doses of GARDASIL (dose and route of administration were not reported) (Lot # K006960, expiration date: 24-FEB-2017; Lot# K007828, expiration date: 02-MAR-2017; Lot # K009482, expiration date: 06-MAR-2017), which were exposed to temperatures outside of the recommended range. No adverse experiences have been reported. There was no product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
Patient states arm hurt during the day then by evening about 5 pm she couldn't lift her arm. She couldn't lift up through the night and next day. She began to apply ice packs on and off for several days. By evening of the next day she could lift her left arm again but not fully. The arm continues to be sore and difficult to lift above her shoulder without assistance. She felt the injection was given too high. Healthcare provider administering did feel the dose was difficult to inject with resistance when pushing plunger. She did speak to a doctor but not her PCP who stated to her the injection was a "bad" one and the reason for the pain.
Flu vaccine given in right thigh on 11/7/16. Parents noticed redness on 11/8/16. Came into office 11/9/16. 8cm of erythematous firmness surrounding injection site with increased warmth. No fever.
SIRVA. Shot was administered way too high. Possibly in the bursa or rotator. Couldn't sleep due to pain. Arm locked up by morning. This feels worse than when a 2020 flu shot messed up my left shoulder for 6 months.
Fifteen minutes after recieving Fluzone vaccine patient began developing hives on face and trunk of body. No difficulty breathing or swelling of mouth or tongue. Doctor called and patient given 7.5mL of Benadryl and watched for another 30 minutes. Hives went down and patient evaluated again by doctor. Patient watched for another 15 minutes and then released to go home.
Itching all over body & rash x 2 weeks after vaccine administration (pt returned to clinic for eval & given steroid dose pack).
Subjective  57 y.o. male who was seen at COVID Vaccine Clinic today for his second  dose of the COVID 19 vaccination.    He was given the Moderna vaccination in the right deltoid muscle.   During his 15 minute waiting period after the injection, the patient began to experience Right sided chest discomfort, mild shortness of breath and intermittent dizziness.  He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and he was then assessed in the emergency  area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. patient denies any previous cardiac history but does have Asthma. Chest discomfort did not worsen with activity and actually improved some per his report.      ALLERGY REVIEW OF SYSTEMS:  Patient complains of chest tightness (Right side, no radiation) and dizziness (Intermittent)       Previous Reactions: None   Objective   Vitals Vitals:   02/05/21 1009 02/05/21 1019 BP: 136/83 130/83 Pulse: 70 62 Resp:   14 SpO2: 98% 98%   Physical Exam Vitals signs reviewed.  Constitutional:      General: He is not in acute distress.    Appearance: He is not diaphoretic.  Cardiovascular:     Rate and Rhythm: Normal rate.     Heart sounds: Normal heart sounds. No murmur.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing.  Neurological:     Mental Status: He is alert.       Assessment/Plan  Treatment included: albuterol, water and Acetaminophen Follow up response to treatment: Excellent Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash)   Symptoms developed just prior to patient leaving, started visit at 10:05 am, self administered albuterol at 10:10am. Self administered Acetaminophen 1,000 mg at 10:24 AM, Symptoms resolved and patient discharged around 10:30 AM.    History of anxiety. Showed great relief of symptoms with use of his personal Albuterol inhaler and 1,000 mg of Acetaminophen (also his own). Symptoms completely subsided prior to discharge.
Day 1 Initial symptom arm pain at site and surrounding area.  Day 2 Stomach pain similar to stomach feeling really empty this went away the next day Day 8 site soreness ,  circular area of skin at injection site red and hot 1-2" inches in diameter.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 20-NOV-2015, the patient was vaccinated with an improperly stored dose of COMVAX (lot number J013884; expiration date 19-AUG-2016) 0.5 ml "SDV;PK/10" (route of administration and anatomical location were not reported). On an unspecified dates, the COMVAX had nine temperature excursions: 72 hours, 152 hours, 976 hours, 488 hours and 64 hours, 328 hours, 64 hours, 40 hours and 88 hours. The lowest recorded temperature was 28 F (-2.222222222 Celsius) while the highest recorded temperature was 48 F (8.888888889 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not reported. On 14-AUG-2015 the patient was vaccinated with a dose of improperly stored GARDASIL (lot # K007828, expiration date 02-MAR-2017) (dose, route and dose number were unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Baseball sized swelling at site of VARIVAX reported by mom.  1-2 days after immunizations.  Later pt developed vomiting /diarrhea illness, 2 d after immunizations.  On exam 6 d after immunizations, mild bruising / erythema, mild tenderness.
Pt hospitalized on 7NOV90 & d/c 22NOV90; pt devel weakness w/inability to walk; had a weakness of the pharyngeal muscles in that voice has a nasal quality & has difficulty in swallowing food; had numbness; absent reflexes; polyneuritis;GBS
One day after receipt of Moderna Bivalent COVID vaccine in left arm, pt developed a rash in groin area extending to the right hip.  Rash erythematous, warm, tender, pruritic, and painful in some areas.  Slowly spreading over the past couple of days.  Took Benadryl to minimize discomfort, which seems to be helping.  Pt is not experiencing any other symptoms other than the rash.
This is a spontaneous report from a contactable consumer (medical assistant). This medical assistant reported on behalf of a female patient of unknown age and race who received the second dose of PREVNAR 13 at 0.5 ml single, intramuscular, on 15Jun2012 at 15:18. On the same day she received DTaP, HIB, ROTATEQ and Polio vaccine. Vaccines taken within the last four weeks were unknown. Previously the patient had received the first dose of PREVNAR 13, at 0.5 ml single, intramuscularly, on 13Apr2012 at 15:18. Relevant medical history was none. On 15Jun2012 the patient turned red. Illness at the time of the vaccination was none. Relevant lab data was none. The event did not require an emergency room or doctor visit. At the time of the report the clinical outcome of the event was unknown.
The inside of my mouth went numb, then my whole face went numb. I broke out with hives on my chest, My lips started to swell, and my throat started to close. My blood pressure shot to the roof.
Migraine headache; pangs of nausea intermittently; fatigue; lightheadedness; very low-grade fever
Shot didn't hurt when administered.  Arm grew sore shortly after and has hurt ever since.  Throbbing pain still 4 months later.
Thrombocytopenia  (platelets of 67 on 5/28/21 and 65 on 5/29/21)  had petechial rash and cbc done
Fever of 103F, mild rash on legs, back and little in front and neck. Give Tylenol and motrin for fever.
6/11/07 Dr office called to notify of pt into see them. At 8 days after receiving 5/30/07 vaccinations below became feverish. At day 10 started with a fine rash to stomach, rash, neck and arms, also lethargic and continuing with fever. Rash was not raised. Dr diagnosed as MMR reaction. Child recovering still has rash and low grade fever per mom. Fever was highest between 101-103.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were unknown. On an unknown date more than 18 months ago, the patient was administered with ZOSTAVAX (dosing details were not provided). Pharmacist reported that since vaccination, the patient experienced shingles multiple times on unspecified dates. She reported that she was interested in Varicella-Zoster virus analysis by Polymerase chain reaction (PCR) and wanted to send viral isolates. Outcome of the event was unknown. Reporting pharmacist had not assessed the causality of the event with respect to ZOSTAVAX. Additional information has been requested.
Patient noted that she experienced the expected soreness and flu-like symptoms following the injection. However, two days later, the left side of her neck (subclavicle) was swollen and "on fire." She went to her PCP who ordered an ultrasound. This revealed "aggravated lymph nodes." She called our office on 1/19/21 asking us to report this adverse event since we had given her the vaccine.
On 1/30 pt said he was having issues-with numb legs. On 2/3 pt said he woke up with no feeling at all in legs. He was taken to hospital. He said he was given a spinal tap The result of the spinal tap showed Guillain-Barre Syndrome. The patient was given a 5day IV of Ig and remained in hospital until 2/13. He was then transferred to rehab center for further therapy. When I last spoke to him 2/17/20 he was still in rehab center
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 03-AUG-2015, the patient was inoculated with the ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy, as recommended for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended. Instead, the patient contracted a persistent strain of shingles, or severe herpes zoster. On or about 12-DEC-2015, the patient was treated at a medical center for the onset of hearing loss associated with shingles. As a direct and proximate result of the defective ZOSTAVAX, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. As a further proximate result of the Zoster Vaccine Live (ZOSTAVAX), the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Upon internal review, hearing loss associated with shingles was considered to be medically significant. Additional information has been requested.
On 2/11/00, pt c/o severe abdominal pain & small bowel inflammation. From correspondence received on 2/25/00, pt had acute onset of abdominal pain and small bowell inflammation, resulting in surgery for a perforated jejunum.
Typically, after receiving my COVID-19 vaccine, I will feel tired, and I get a pressure sensation between my shoulder blades. I usually end up having to sit down. I wear a smart watch, which indicated that my heart was racing during those times. Typically, when I feel this type of reaction it is around 135 beats per minute. I also usually feel very hot, almost like a hot flash. I do know that now, since I've had a number of these vaccines; if I get very warm from it being too hot outside or if I'm washing dishes in hot water, that will also trigger the racing heart which I never had before. On 01/02/2023, I tested positive for COVID-19. I had cold like symptoms for around five days. It started with a sore throat and congestion. By day six, I was feeling basically normal again. However, that following Sunday, I wasn't feeling well, and I ended up going to the emergency room out of concern for a heart attack. They ran tests and said that I was not but should follow up with my doctor. I have seen a cardiologist and had a calcium score and a coronary angiogram done. I do have mild heart disease, and I have 25-49% blockage in my left artery. I have switched my blood pressure medication to metoprolol since having these racing heart episodes and that seems to have helped.
Swollen lymph on left under arm, golf ball size induration left arm,  area is red and hot, pain in scapula and pins and needles in left arm, headache
Pt vaccinated with Meruvax II developed swollen lymph glands in the area of the injection site & on the occiput and in the posterior cervical region.
Pt. states that after receiving the 1st dose of Shingrix 11/29/2021, started experiencing symptoms 12/03/2021 of headache and itchiness throughout the body. Primary communications with no recommendations. Still experiencing symptoms.