chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Subsequently post vax, the pt developed an injection site reaction characterized by swelling and stiffness.
Bruising in knuckles of both hands. Started on 5/18/21 No additional symptoms other than soreness at side of injection.
Pharmacist is sure they added 1.8mL to Pfizer vaccine vial in order to dilute. When he went to draw a dose he could only obtain one complete dose. Before he reported the even the dose drawn was administered to an unknown patient. He suspects he accidentally withdrew some of diluent when he meant to withdraw air from the vial. The single dose given would have been more concentrated than usual. No severe allergic reactions were reported that day.
pt recvd 1st dose of Hep B vax on 29JAN92; pt devel diaphoresis; pt also devel erythema & swelling which extended from the inject site down arm; also lightheaded; tx w/aspirin, DPH & heat app;ications; seen by MD;
tics started on 08/22/2021 moving her head up and down side to side, dizziness, next day tics with her hands and mouth, 2 days later impulsiveness and no control of her steps or body for like 3 hours.  Patient with no history of tics or disability disorder.
Pt complaining of pain in right upper arm down to right index finger. 5/10 pain scale. Pt states that she can not sleep because of the pain.
Arm pain at site of injection, swelling of axila in injection arm, axillary lymphadenopathy
Pt had seizure lasting  5 minutes one hour after vaccine was administered. Pt does have seizure disorder but had not had a seizure for about 5 months prior to this event.
devel hives to body especially chest & back w/itching;saw MD & suggested getting flu shot @ MD office next yr;
Left arm at injection site, up to shoulder and into lower arm painful and weak after activity 4 mo later.
Approximately 8 minutes after vaccination, while seated in monitoring area, experienced sudden onset of dizziness, profuse sweating, shakiness, difficulty speaking, stammering, difficulty sitting or standing without assistance, increased blood pressure, headache in right temple through back of head on right side.  Nursing support response included taking me by wheel chair to isolated area, removing face covering, providing drinking water, monitoring pulse and blood oxygen rates and blood pressure.  Began to feel better after several minutes, then symptoms returned but not as severe.  Cycles of improvement and return of symptoms but diminished in severity occurred over the next 30 minutes.   Tired feeling for approximately 4 hours following vaccine and low grade headache.  Took 2 Tylenol regular strength approximately 1 hour following vaccine and again 4 hours later.  20 hours following vaccine, still feeling episodes of dizziness, headache, fatigue, difficulty with speech (stammering), shakiness, difficulty focusing/concentrating.
Patient received Novavax as a booster but was too young. She was only 14 and needs to be 18.
9pm same day of shot - ringing ears, sweating, dizziness  8am next morning/day after - lymph nodes in neck around face, behind ears, and in arm pits are very large, swollen and painful . Hives on left arm. Red blotchy spots and welts on bottom half of both legs, very itchy.
Pt fainted approx. 4-5 minutes, post vax. He had twitching of arms, legs and mouth; lethargic; nausea; excessive sleepiness; diaphoretic and vomited. Observed X 30-45 minutes.
Pt experienced a fever of 101F, induration, warmth, pruritus 6 " diameter.
patient felt a very bad burning on her whole left side,patient felt a very bad burning from her back to the ankle; weakness on the left leg; Patient felt weak on her left side; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Patient felt weak on her left side), BURNING SENSATION (patient felt a very bad burning on her whole left side,patient felt a very bad burning from her back to the ankle) and MUSCULAR WEAKNESS (weakness on the left leg) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A, 030M20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to chemicals, Diabetes (No recent change in status such as improvement or worsening.) since 1993 and Kidney disorder (No recent change in status such as improvement or worsening.). Concomitant products included DULAGLUTIDE (TRULICITY), INSULIN DETEMIR (LEVEMIR), GLIPIZIDE, METOPROLOL, LOSARTAN, FAMOTIDINE, ASPIRIN [ACETYLSALICYLIC ACID] and ROSUVASTATIN for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (Patient felt weak on her left side). On 30-Sep-2021, the patient experienced BURNING SENSATION (patient felt a very bad burning on her whole left side,patient felt a very bad burning from her back to the ankle) and MUSCULAR WEAKNESS (weakness on the left leg). The patient was treated with GABAPENTIN for Adverse event, at a dose of 100mg 3 a day. On 30-Sep-2021, ASTHENIA (Patient felt weak on her left side) had resolved. At the time of the report, BURNING SENSATION (patient felt a very bad burning on her whole left side,patient felt a very bad burning from her back to the ankle) and MUSCULAR WEAKNESS (weakness on the left leg) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient height was reported as 5'2. Patient did not ever had COVID positive test or diagnosis. The patient did not have any other vaccines within 1 month prior to Moderna COVID-19 vaccine. It was also reported that patient did not experience a similar event in the past. The patient seeks the medical care and visits the physician office. Further it was reported that the symptoms were worsened.   This case was linked to MOD-2022-552512, MOD-2022-552517 (Patient Link).
Rash of raised red bumps starting as a small crescent on lower front right ribs.  Stretched around the ribs along relatively straight path just above waistline to end just about an inch onto the back. Diagnosed by doctor as shingles. Patient never had chickenpox or had been exposed to anyone with chickenpox but had varicella vaccine on 1/25/10.
Dizziness, Headache, Myalgia, Arthralgia, Anaphylaxis, Tachypnea, CoughWheeze, Palpitations, Syncope Narrative:  Rapid onset of anaphylaxis (prior history) treated in ED with steroids, Benadryl and pepcid
Shaking chills (this is not a shiver which is significantly underplayed in package insert), this was over 4 hours of rigors associated weakness and nausea for 12 hours after that (which are reported adverse effects). This in a person who has absolutely never had any reaction to a vaccine other than a little soreness at the site administered. This is an entirely different vaccine reaction and I wonder how safe it is now for my patients.
received vaccine during work and was itchy by that evening. The following morning upper arm was swolen, bright red, itching, with hives. These side effects lasted 3 days
Caller and her wife experienced little bit soreness on their right arm where the vaccine was administered.; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for an unspecified age of female patient she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL0739), via an unspecified route of administration on 13Feb2021 at single dose in right arm for covid-19 immunization. The patient historical vaccine included BNT162B2 for covid-19 immunization (dose-1). Concomitant medications were not reported. On an unknown date, the patient experienced little bit soreness on their right arm where the vaccine was administered. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
pt recvd 5MAY94 24-48 hrs later exp allerg type of skin rash, swelling of eyelids & face, & difficulty breathing; pt exp V shaped rash appeared all over the face; could not open eyes in AM;
vaccination site got a little warm; vaccination site got a little red; A spontaneous report was received from a consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events vaccination site got a little red, vaccination site got a little warm.  The patient's medical history was not provided.  relevant concomitant products usage were not reported by the reporter.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) vaccination site got a little red, vaccination site got a little warm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), vaccination site got a little red, vaccination site got a little warm was unknown.
I received the Pfizer booster for COVID-19 on 12/7/2021. On 1/6/2022, I woke up with headache, body aches, fatigue, and sore throat. I self-isolated in case I had COVID-19. I took a home test that day and got a negative result. I then arranged to get a PCR test later that day; when I got the PCR results back a few days later, they indicated a negative result. On 1/8/2022, I took another home antigen test and got a positive result. The headache, body aches, fatigue, and sore throat persisted for about 7 days, and I ended up being off from work for a week and half. I also developed chills and nausea at one point, and those lasted for about 3 days. I never vomited, though. I treated my symptoms with TYLENOL, which helped a little, but not much. The COVID-19 exacerbated some of the symptoms of my pre-existing conditions. For example, the dizziness and fatigue associated with POTS were exacerbated for about a week or two after I became infected.
This spontaneous report as received from a consumer refers to a 12 month old male patient with immunization. On 26-AUG-2014, the patient was vaccinated with (oka/merck) VARIVAX. The patient was vaccinated with (oka-merck) PROQUAD on the same day. On 26-AUG-2014, the patient's mother reported that injection sites on her son's thighs were still red and hardened underneath 10 day after vaccination. The patient sought medical attention and called the office. No treatment was given for the events. Product quality complaint was not involved. The outcome of the events was unknown. Additional information has been requested.
After receiving DTaP, IPV, & Hep B on 07/11/01, the patient spiked a fever of 103 and was fussy most of the day and throughout the night. When the patient awoke on 07/12/01, the mother felt she had hives that covered her whole body. The patient was taken to the ER. She was given Benadryl. The ER doctor felt hives were unrelated to the vaccines. Benadryl eleviated hives totally within 8 hours. The client had no further fever or symptoms. The patient's pediatrician felt public health should be notified of the reaction. The mother did not report reaction to our office until 09/28/01.
Rash developed on neck.; This is a spontaneous report from a contactable consumer (patient). An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not pregnant. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient experienced rash developed on neck on Mar2021 with outcome of unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
muscle pain/muscle pains in her left arm; Muscle weakness: it is only in the arms right now, but she did have it in the legs; muscle pains in her left arm and that was the arm she got the shot in; bad pain in right arm; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 15Mar2021 (Batch/Lot number: unknown) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing), notes: started at least four years ago; "Anaemia" (ongoing), notes: been about a year that she has had it; "Allergies" (unspecified if ongoing), notes: the allergies are pretty much year-round. Concomitant medications included: AMLODIPINE taken for blood pressure abnormal (ongoing); ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity (ongoing); IRON taken for anaemia (ongoing). The following information was reported: MYALGIA (non-serious), outcome "not recovered", described as "muscle pain/muscle pains in her left arm"; MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "Muscle weakness: it is only in the arms right now, but she did have it in the legs"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "muscle pains in her left arm and that was the arm she got the shot in"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "bad pain in right arm". Additional Information: She was wondering how long does the side effects muscle pain and muscle weakness last. She has been having it since the first shot and it is time for her to get the second. She was still having muscle pains in her left arm and that was the arm she got the shot in. She also had bad pain in right arm. She was still feeling muscle pains in her left arm. It was a week after getting the vaccine when muscle pains and muscle weakness started. Both the muscle pain and muscle weakness were ongoing. The muscle pain in the right arm it was pretty bad, but it improved. In the arm she got the shot it has worsened. Her left arm was fine after the shot, but now she was having muscle pain in it. The muscle weakness was only in the arms right now, but she did have it in the legs. The muscle weakness was staying the same. The patient has no history of all previous immunization and has no additional vaccines administered on same date with COVID Vaccine. The adverse events did not require emergency room nor physician office visit. The patient has no prior vaccinations within 4 weeks and has no adverse events following prior vaccinations.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Employee was given hepatitis B vaccine 2nd dose of series at 15:45 IM in right deltoid. 16:00 he came back and stated he's having pain and numbness on his right hand, arm, shoulder, and collar bone area.
Pt had fever of 104F, approx. 3-4 hours, post vax, lasting 2 days, brought down by Tylenol and 2nd day had syncope vs seizure activity as described by parents.
It was discovered on 12/26/22 that this vaccine was given 23 hours after BUD of 12/22/22 at 12:15pm. Patient did not report any issues. Moderna stated "In reference to Case ID Thank you for your patience. Analysis of the vials associated with your storage excursion is complete. The vaccine administered on December 23, 2022 from lot number 023H22A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration."
Fever +100, sore arm, low/ high heart rate, exhaustion, lack of appetite
PER ID MD NOTE IMPRESSION & PLAN 1.  Recent left facial palsy. Secondary to #2? 2.  Recent L auricular rash, possible shingles, concern for Ramsay Hunt syndrome.  Was on prednisone and Valtrex before admission. 3.  Meningitis with CSF lymphocytic pleocytosis 4.  Intractable nausea and vomiting. 5.  Recent COVID-19 (Pfizer) and shingles/Zostavax vaccine 10/30/2023 and Seqirus QV Flu caccine 10/26/23.  Patient is a 71 y.o. female admitted to the hospital 11/20/2023 by MD  . ID service consult for evaluation of CSF pleocytosis, and suspicion for possible meningitis. The patient was admitted to the hospital on November 20, yesterday, presenting with left facial weakness, headache, dizziness nausea photophobia.  Was evaluated by neurology, was found to have Bell's palsy and left facial weakness.  Had an MRI of the brain that shows enhancement of the left facial nerve and the temporal bone.  It would be consistent with a possible inflammatory or infectious related abnormality of the left facial nerve. At the time of admission the patient had no fever but had a mild leukocytosis of 14,000.  She had blood cultures collected on admission which are in progress.  There was a concern for possible associated meningitis, so she had an LP this morning that shows 43 white cells with 96% lymphocytes and 4% monocytes, the protein is 64 mildly elevated glucose is normal at 65.  She has also 8 RBCs.  The Gram stain and in the ankle and the CSF is negative, and therefore meningitis panel is negative for all the pathogens as well.  She was a started empirically on treatment for possible viral or bacterial meningitis with acyclovir ceftriaxone, vancomycin. She has some associated headache, and some concern for possible Rines and Hunt syndrome. I was asked regarding input for possible CNS infection. At this point her main complaint is intractable nausea, with occasional vomiting and headache.  She also has some photophobia. She does not have eye pain.  The possible Ramsay-Hunt syndrome lesions on the ear are at this point dried out.  There is no vesicles. Other pertinent labs include a negative syphilis EIA, normal renal function, normal TSH, negative ENA panel.  Mild leukocytosis of 11,000, normal hemoglobin and platelets.  ESR is normal with a value of 1.   Review of the chart shows that the patient does not take any immunosuppressive therapy at home other than prednisone 20 mg daily.  This was prescribed November 15 by PA.  I reviewed the outpatient ENT note, they apparently suspected Ramsay Hunt of radicular syndrome.  Review of other additional records shows that she was prescribed Valtrex on November 10 for 7 days by her PCP for treatment of shingles involving the left ear. The notes from ENT indicates she had a left facial palsy and also some lesions in the left ear that were sparing the ear canal. She denies history of previous episodes of meningitis. She has a healthy dog, no exotic animals.  No travel to tropical regions.  No other unusual exposures.
This spontaneous report as received from a physician's nurse via a company representative refers to a female patient of unknown age. In approximately 1998 (reported as 15 or 16 years ago, also reported as a couple of years ago) the patient was vaccinated with GARDASIL injection (lot#, strength, dose, frequency not provided). The patient came back to the office 10 minutes after receiving the GARDASIL and passed out at the front desk. The outcome of passed out is unknown. The causality of the event passed out and GARDASIL was not provided. Additional information has been requested.
This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency, expiry date and route of administration were not reported) (lot # M042599) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 degrees C to 1 degrees C for 8.25 hours. It was reported the exact temperature and time below 0 degrees C was: -1.9 degrees C for 15 minutes, -1.2 degrees C for 15 minutes, -1.0 degrees C for 15 minutes, -0.8 degrees C for 15 minutes, -0.4 degrees C for 15 minutes and -0.2 degrees C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Pt exp unusual high pitched constant cry, poor feeding, myoclonic jerks, no true sz, pale & clammy;
Generalized aching/Heavy body aches due to covid vaccination; Chills/Cold shakes due to covid vaccination; COVID-19/Contracted covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19/Contracted covid-19), PAIN (Generalized aching/Heavy body aches due to covid vaccination) and CHILLS (Chills/Cold shakes due to covid vaccination) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In November 2020, the patient experienced COVID-19 (COVID-19/Contracted covid-19). On an unknown date, the patient experienced PAIN (Generalized aching/Heavy body aches due to covid vaccination) and CHILLS (Chills/Cold shakes due to covid vaccination). At the time of the report, COVID-19 (COVID-19/Contracted covid-19) and PAIN (Generalized aching/Heavy body aches due to covid vaccination) had resolved and CHILLS (Chills/Cold shakes due to covid vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   On unknown dates, the patient experienced cold shakes due to covid vaccination and heavy body aches due to covid vaccination. In November 2020, the patient experienced contracted covid-19. On unknown dates, heavy body aches due to covid vaccination and contracted covid-19 resolved. Moderna vaccine was also considered suspect.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Has been having aches and joint pains since the 11th. Received Gardasil # 1 in our office on the 10th. Has not had any URI symptoms last week or this week. No fever noted. The pain is not in the legs any more, but the arms have gotten worse. She played Tues and Wed in the volleyball tournament. She is used to playing in volleyball. When she finished playing volleyball yesterday she had numbness from her armpits down to her forearms. Her fingers had sensation. The numbness lasted until she fell asleep. When she woke up this morning she could feel her arms, but they hurt very badly. The discomfort is on both arms. First noticed a mild headache on Sunday and had had a mild headache at least every other day since then. Did not eat any new foods or nut containing foods last week. She stayed home from practice on Monday because of the discomfort. It hurt a little bit to walk when her legs were hurting but on Tuesday the leg pain was gone and has not come back since then. The bruise on her right knee has gotten bigger. Had a spontaneous bruise on her right knee first noticed on Sunday, but does not remember hitting knee, as there was no volleyball last weekend. Mother has been giving Tylenol and not ibuprofen since Monday. Prior to Tues & Wed this week, last volleyball play was on the 10th for a routine practice which was uneventful, and prior to getting Gardasil vaccine. Gardasil was given in left deltoid.