chrisvoncsefalvay/vaers-outcomes huggingface dataset:
broke out in a rash 2 to 3 weeks after; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. An 87-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number was not reported, Expiry date: unknown, at the age of 87-year-old), via an unspecified route of administration on 15Jun2021 as dose 1, single for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient experienced broke out in a rash 2 to 3 weeks after vaccination on an unspecified date in 2021 and called her physician and was started on Zyrtec. She was doing better today. Caller asking that can she receive the second dose of the Pfizer COVID-19 Vaccine that she was scheduled for tomorrow. The outcome of the event was resolving.   Information on the lot/batch number has been requested.
Vertigo; This case was reported by a consumer via call center representative and described the occurrence of vertigo in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In September 2021, 24 hrs after receiving Shingrix, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was not recovered/not resolved.   The reporter considered the vertigo to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. On 2nd September 2021, about 24 hours after vaccination, the patient began to experience vertigo.  The patient was asking if this was a side effect of Shingrix and how long it would last.  No Lot number or expiration date was provided. The reporter consented to follow up.
I woke up with shivers, and a headache.  Earlier I had cramps in my legs and feet.  I took 1 500mg. Acetaminophen and put a blanket on.  I fell asleep what seemed like a few minutes, but I am not sure.  I woke up this morning feeling better.
had a fever afterwards; This is a spontaneous report from a contactable consumer via Pfizer Sponsored Program. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot# unknown) and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot# unknown), both via an unspecified route of administration, on unspecified dates, as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. On an unspecified date (after second dose), patient had a fever. No patient identifiers were provided but the reporter had firsthand knowledge of the patient and was reporting on a specific patient. The reporter reported that the wife got second shot from covid vaccine and inquired if fever was normal. The outcome of the event fever was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt given vax approx 2wk ago & since had a dead leg which is numb;from f/u reportof 10JUL98 pt was reported to have been sent for x-rays & baby had a broken leg;
The boy developed severe stuttering to the point of not being able to speak. It has not one away as of today 1.30.10
three inch area of redness and induration surrounding injection site (left deltoid)with itching. no fever, full range of motion.
Symptoms/Signs: Swelling around the injection site (size of golf ball), fever, chills, sore throat, hives. The hives and swelling/reaction lasted about 3-4 days, and the fever, and chills lasted about 24 hours. The sore throat lasted about 48 hours.
1st dose of Shingrix on 22Nov2019 and is late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 22nd November 2019.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of SHingrix, which led to incomplete course of vaccination. No symptoms were reported. At the time of reporting, the reporter did not had lot an expiration date. The reporter consented to follow up.
Painless swollen of Left eye lid, lower and upper eye without (angioedema), with erythrema developed about 24 hours after immunizations were given.
Very sharp pain from shoulder to arm. Intense  pain in left arm - felt like a knife cutting my arm.  Recovered after 4 weeks.
Pt tested positive for COVID on 2/6/2021. Deceased on 2/15/21. Not marked COVID death on death certificate.
My sense of taste and smell has increased and the smells and tastes are now unpleasant.
Induration - 2x2, Erythema - 5x3 left arm warm compressor.
Vaccine site was itchy, swollen and red 1 week after vaccine was given.  I felt warm on the side of the body vaccine was given.  I took a Benedryl.    On day of vaccine I was tender to the touch with swollen and redness.  But that only lasted up to 2 days.  I felt no issues between this day and the the day 1 week after.
ran fever of 106 R evening of immun dates; mom gave APAP; taken to ER was given med;
Hives, welts, intolerable itching. Skin turns bright red if any itching is done and stays that way for hours. Taking 4x the recommended amount of zyrtec just to stop the itching. Hives / redness still there even after taking zyrtec.
Patient received second dose too early. First dose was 3/29/21, 2nd dose was given 23 days after 1st dose.
Red giant nod; Felt somewhat tired; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Red giant nod) and FATIGUE (Felt somewhat tired) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MASS (Red giant nod) and FATIGUE (Felt somewhat tired). At the time of the report, MASS (Red giant nod) and FATIGUE (Felt somewhat tired) outcome was unknown.            Treatment medications were unknown.
Had flu like symptoms the next morning 102 fever, chills  ,body aches. Took Tylenol to help. Soreness in left arm. The next it felt i was getting better and then I spiked a fever and and my left arm was burning hot at the injection site And swollen
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 in 02/2023. I contacted my provider and got a prescription for Paxlovid. I tolerated the medication without any complications.  As of today, I am feeling better without any side effects.
9:45 am received vaccine 12:00pm Began feeling very sleepy  after eating lunch - laid head down on desk at work - told co-worker I was feeling sleepy - told co-worker after a few minutes I was not feeling well - co-worker went to get the school nurse - EMS was called and I was transported via ambulance to Medical Center with low blood pressure,  abnormal heart beat, generalized weakness.   After lab test were run the white blood count was 20.9 and frequent PVC's. I was released from the ER at about 5:00pm.
Headache, Myalgia, Fever, Chills, congestion, fatigue, injection site pain, rigors  Narrative:
Left arm soreness, fatigue, headache all began same day. Migraine, joint stiffness (elbows, hips, ankles), nose bleed, left armpit pain, fever, chills, night sweats began next day (5.4.21) and continued to 5.5.21. Adverse effects ongoing.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 01-APR-2014 the patient was vaccinated with VARIVAX (Merck) that was improperly stored, 0.5 ml, subcutaneous (lot# not provided). No adverse effects reported. Product quality complaint was not involved. Additional information has been requested.
Weight loss; Having less appeptite; This spontaneous case was reported by a patient and describes the occurrence of WEIGHT DECREASED (Weight loss) and DECREASED APPETITE (Having less appeptite) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Cervical spondylosis, Chronic lymphocytic leukemia, Allergic reaction to bee sting and Wet macular degeneration. Concomitant products included RANIBIZUMAB (LUCENTIS) and IRON for an unknown indication.    In March 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced WEIGHT DECREASED (Weight loss) and DECREASED APPETITE (Having less appeptite). At the time of the report, WEIGHT DECREASED (Weight loss) and DECREASED APPETITE (Having less appeptite) outcome was unknown.            Treatment medications were not reported.   This case was linked to MOD-2021-029029 (Patient Link).
Itching all over; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from an Agency (manufacturer control number: US-AMGEN-USASL2021097487). This case was split from master case 2021808247 for taking COVID-19 experienced itching all over.  A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as single dose (unknown dose number) for COVID-19 immunization. Medical history and family history was not reported. Concomitant medications included: Etanercept (ENBREL) on an unknown date in 2006 (15 years ago prior to this report). On an unknown date, the patient had itching all over. The patient did not receive any treatment for event. Outcome of event was unknown.  No follow up attempts are possible. No further information is expected.
got first dose on 30Dec2020 and another "first" dose on 24Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got first dose on 30Dec2020 and another "first" dose on 24Apr2021) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got first dose on 30Dec2020 and another "first" dose on 24Apr2021). On 24-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got first dose on 30Dec2020 and another "first" dose on 24Apr2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient got another "first" dose of the Moderna vaccine (at second dose provider contact) on 24Apr2021, also on the left arm. No concomitant medication was reported.  No treatment medication use was reported.
child came in for wcv and was given havrix, after administration Dr. came to double check the registry and noticed that it was a bit to early for the dose, she went straight in and explained to the parent what had happened. parent scheduled an appointment to have proper dose admin.
Patient was admitted  after being diagnosed with acute pyelonephritis with sepsis. Per routine screening protocol for transfers he was tested for Covid and was incidentally positive. He was asymptomatic.
Patient received influenza and Pneumovax vaccines both in right arm.  Developed body aches and low grade fever which resolved and then developed redness and swelling of upper arm.  Diagnosed as right upper arm cellulitis.
p/inj 16JUN95 on 15th day began to break out in mosquito like bites (total 27 spots) from head to toes; all broke out in the 15th & 16th day p/1st inj; spots itched but did go away in 5 to 6 days;
Dizziness; lightheaded; Fatigue; Sore Left Arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore Left Arm), DIZZINESS (Dizziness), DIZZINESS (lightheaded) and FATIGUE (Fatigue) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Diabetic and Heart rate irregular.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced MYALGIA (Sore Left Arm). On 07-Apr-2021, the patient experienced DIZZINESS (Dizziness), DIZZINESS (lightheaded) and FATIGUE (Fatigue). On 08-Apr-2021, MYALGIA (Sore Left Arm) had resolved. On 11-Apr-2021, DIZZINESS (Dizziness) had resolved. At the time of the report, DIZZINESS (lightheaded) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.   Treatment information not provided.
Developed cellulitis left upper arm 12 days after receiving IPV and Pneumonia Vaccine.  Was Rx'd with antibiotics and a steroid injection.  Felt better after about 4-5 days.
Patient received pfizer vaccine first dose one June 14, 2021. Patient said she experienced itchiness thirty minutes after vaccine. She did not have any rashes. She notified her provider and her provider said that it was okay to still received the 2nd dose of pfizer covid shot.
A report has been received from a Health Professional concerning an Adult, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced HEADACHE and MALAISE. The outcome of the event of HEADACHE and MALAISE is unknown. The report is considered to be non-serious.
Experiencing severe body/muscle pain. Cannot raise left arm (site of injection) above chest level.
The child received immunizations on 8/28/01 PM and did fine. Mother noticed that child was irritable on 8/29/01 and later in the day, about 19:00, pt went outside to play X 15-20 minutes and mother noticed area was red. Mother brought child to clinic on 8/30/01 for comfort measures. Reviewed with instructions to see LMD if problems persisted or worsened.  Diagnosed with cellulitis.
Redness and hard lumps from injection site down arm to wrist. Cephalexin given by MD. Pt presented to pharmacy on Day 4 and arm showed only small amount of redness.
foot blister which developed within the week of getting booster. Coming into ER after clinic visit, needing admission and antibiotics
Pt recvd vax 9PAR94 mom noted p/2 hrs given pt lips swelled & had a temp of 101.6 R; several hrs later blisters appeared;
T/C from the pt's mother.  States daughter developed a severe headache involving the top of her head. she gave her Motrin, but it took awhile before the severity of headache was decreased. Mom states hx of migraines in the family but the child never exhibited any symptoms so far Advised the mother, can have mild fever HA irritability as the result of the Hepatitis vaccine. Advised that if her daughter headaches continued to have evaluated by family physician. 4/26/02 T/C to mom states HA subsided post Motrin (no recurrence.  doctor think the pt has tendency for migraines since family history.)
Approx 1 hr p/inject, thigh became red & swollen; Also developed a fever. Mom states did not take temp but had fever all night. 1MAR91 vomiting started, & called ER.
tingling L side, tingling of mouth and L side of face Narrative: 25 minutes into monitoring patient described tingling in her fingertips. within 5 minutes reported worsening to include L side of face, L arm, L leg. EMS called at 0837 -10 minutes later the addition of right fingertips involved. No further progression.
Information has been received from a registered nurse concerning her 30 month old granddaughter who was vaccinated with a dose of varicella virus vaccine live (lot number not provided) when she was younger. The reporter indicated that in approximately March 2004, the child had a breakthrough of chicken pox. She had twenty to thirty lesions, which were located below the child's waist, primarily on her buttocks and legs. No other information was provided. Unspecified medical attention was sought. There was no product quality complaint.
Arm is hot; Rash; Arm was sore; Couldn't lift her arm for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), LIMB DISCOMFORT (Couldn't lift her arm for 2 days), VACCINATION SITE WARMTH (Arm is hot) and RASH (Rash) in a 58-year-old female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore) and LIMB DISCOMFORT (Couldn't lift her arm for 2 days). On 09-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Arm is hot) and RASH (Rash). On 02-Apr-2021, PAIN IN EXTREMITY (Arm was sore) and LIMB DISCOMFORT (Couldn't lift her arm for 2 days) had resolved. At the time of the report, VACCINATION SITE WARMTH (Arm is hot) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided.  Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Telephone Contact Report (TCR) received on 20-Jun-2021, contains no new information and patient declined further follow up.
Vaccine was administered outside of proper storage conditions. Vial was at room temp for >2 hours but <6 hours at the time of dose being drawn up. Manufacturer did not have stability information for these storage conditions so it was recommended that this dose be considered invalid and to re-administer. Patient will be coming in to get dose in near future. Patient had to adverse reactions after immunization.
Intense Lymphadenopathy, left neck below the ear, hard, warm, fever, headache, swollen, painful. Am onset impaired neck movement but no challenge to swallowing or breathing.
A lot of pain and swelling at injection site that lasted several days, then continued to mildly hurt afterwards for at least one month.   Diarrhea and stomach pain Headache  Mental fog
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and unknown gender. Drug reactions or allergies and pertinent medical history were unspecified. On 23-JUN-2014 an unspecified number of patients were vaccinated with improperly stored ROTATEQ oral, (strength, dose, dose number and lot number were unspecified). No adverse symptoms reported. Concomitant therapies were unspecified. The outcome of received improperly stored vaccine was unknown. This is one of several reports received from the same reporter where other patients were vaccinated with improperly stored MMR II (MARRS # 1406USA011509) and GARDASIL (MARRS # 1407USA001947). Additional information has been requested.
Fever, Rash - Information has been received from a physician concerning a 14 month old caucasian male patient who on 16 May 2000 was vaccinated Im in the left arm with a first dose of varicella virus vaccine live (lot 632056/1449J) There were no concomitant medications, past medial history or known allergies.  On 29 may 2000 the patient woke up with a fever.  It was noted that his fever was 102 fahrenhit during the day and went up to 104 fahrenbelt at night.  On 01 Jun 2000 the patient developed a few dots on his body and as of 02 Jan 2000 the patient had approxiamtely 40-50 dots all over his body and remained febrile.  Follow up information received from a physician reported that the fever lasted for three days.  The patient was seen in the physician's office and the rash that the patient developed was noted to be a probable roseola virus infection.  The patient recovered on an unspeicified date.  no further information is available.
Developed pruritus a few hrs after vaccination with MENVEO and HPV9. Proceeded to hives and chest pain within 24 hrs. Seen in office by me on 10/12/2017. 2 days after vaccinated. TX - BENADRYL.
SLEEP RESTLESS; This spontaneous report received from a patient concerned a 58 year old male. 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: 043A71A, 04321A, and 043Z1A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the subject experienced sleep restless. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleep restless on 04-APR-2021. This report was non-serious.
I went to see my kidney doctor and he discovered that I had a rapid heart beat. He recommended that I saw Dr. which ordered a Holter monitor. I wore the Holter monitor for two weeks and I am currently waiting on those results. I have an echocardiogram scheduled for 7/15/21. My heart rate has doubled since receiving the vaccine.
The entire upper left arm bright red, swollen, and somewhat painful.  Iced the area.
This spontaneous report as received from a nurse practitioner via a company representative refers to a 11 year old male patient with no pertinent medical history. The patient's concurrent conditions were not reported. On 22-AUG-2016, the patient was vaccinated with a dose of GARDASIL 9 (lot # M005714, expiration date: 03-OCT-2017) intramuscularly. Concomitant therapies included MENACTRA and ADACEL. On 22-AUG-2016, the patient experienced syncope and fainted, had fallen and hit his head. Patient sought medical attention. He was hospitalized on the same date. The therapy with GARDASIL 9 was discontinued, also on 22-AUG-2016. The outcome of reported events was unknown at the date of this report. The causality assessment was not provided. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-DEC-2014 the patient was vaccinated with M-M-R II (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. On 17-DEC-2014, the patient was vaccinated with a dose of VARIVAX and sterile diluent (STERILE DILUENT) (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. It was reported sterile diluent(manufacturer unknown ) was used to reconstitute the VARIVAX. No adverse effects were reported.