chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a certified medical assistant (CMA) concerning a 6-month-old patient who was vaccinated PO with the second dose of Rotateq vaccine (human-bovine) 16 weeks after the first dose. It was unknown if medical attention was sought and no problems were reported. Additional information has been requested.
Pt came to ER with syncope, diagnosed with covid 19 2 days ago.
Information has been received from a registered nurse referring to a 12 year old patient of unknown gender. On 03-AUG-2015 the patient was vaccinated with GARDASIL 9 (lot # L006547, intramuscular, expiration date and dose were unknown) which excursed the storage temperature (incorrect product storage). No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt stated itchy and swelling face at the time of her first vaccine, She did not report this at the time of the 1st dose and took benadryl when she returned home. Upon receipt of her 2nd dose, she notified the vaccinator, the medical OIC was notified. Benedryl  was administered prior to onset of symptoms. Pt was instructed to be observed for 30 mins and observation was notified.
A circular red spot occurred the second day the size of a quarter.  By the next day it had doubled in size.  Then it continued down the arm.  By 4/3/2014 it had diminished to a faint outline.  There was itching through all of this.
Patient brought to medical tent after collapsing after he got vaccinated. Nursing reports he has been unconscious for 2 minutes after standing up and was caught by nurse.   Pt was sweaty which got better when supine.  Pt felt weak, headache,  dizziness and pale. no difficulty swallowing. attempted to sit up and dizziness worsened. Pt's symptoms did not improve so EMS initiated.
Upon waking on 7/9/2020 child felt warm to touch and had body aches. He seemed confused and did not know his mom's name. Parent took child to Hospital ER for evaluation.  PHN attempted a follow up call on 7/13/2020 to ask parent about the child's status.  Left a detailed voicemail message for mother.
Temp of 105F, sz for 55 min; Hospitalized; D/C & doing fine; 3rd DTP; No prior problems; No family hs of convuls; No Known Allergies;
Problems with her hands; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Problems with her hands) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Problems with her hands). At the time of the report, LIMB DISCOMFORT (Problems with her hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No Treatment Information was provided by the reporter.
pt had severe swelling in lt arm from shoulder to elbow; saw PMD & was given antihistamines;dx'd as allerg rxn to tetanus;had body aches & t103
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756545A, A0756547A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The reporter indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.     On 27-Feb-2021 at 4:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Feb-2021 at 4:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 31.72.  Concomitant medication of the patient was not reported.  Batch number 014M20A underwent temperature excursion on 27-Feb-2021 with temperature of 33 degrees Fahrenheit at 09:00 AM, 35 degrees Fahrenheit at 11:00 AM, 12:00 PM, 01:00 PM and 02:00 PM, 34 degrees Fahrenheit at 03:00 PM and 04:00 PM and 35 degrees Fahrenheit at 05:00 PM. These vials were moved to fridge on 24-Feb-2021 and beyond use date for the vials was reported as 26-Mar-2021. The vaccines moved to clinic on 27-Feb-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
test for Covid was positive and I already had my three shots (Pfizer COVID-19 Vaccine); test for Covid was positive and I already had my three shots (Pfizer COVID-19 Vaccine); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and on 26Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.Consumer stated, "No, I am not taking any medication." The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "test for Covid was positive and I already had my three shots (Pfizer COVID-19 Vaccine)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: test for Covid was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from unspecified date to an unspecified date. Clinical course includes consumer stated, "My test for Covid was positive and I already had my three shots (Pfizer COVID-19 Vaccine), my vaccination since my test was positive two days ago". She was prescribed with Paxlovid and she was getting 3 medication in the morning and 3 in the afternoon   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Both shots activated HSV-1 that had been dormant for years.; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15May2021 at 15:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included herpes simplex (HSV-1). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced both Pfizer shots activated HSV-1 (Herpes simplex virus-1) that had been dormant for years. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with unspecified medicine. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event activated HSV-1 was unknown at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Previously well 20yo woman who takes birth control pills only received H1N1 vaccination at Hospital on the afternoon of 12/17/09. 1-2 hours following vaccine administration in the left deltoid, she developed diffuse myalgias and malaise. The following day developed exquisite left thigh tenderness that worsened over the next 24 hours. Had an emergency room evaluation that was unrevealing except for mildly elevated CPK (163) and mild lymphocytosis. An ultrasound of the left leg to evaluate for deep venous thrombosis was negative. By 12/22/09, pain in the thigh has resolved somewhat. CPK has normalized, CRP and ESR remain normal. Clinical appearance is that of a focal myositis or mononeuritis of the lateral femoral cutaneous nerve.
This spontaneous report as received from an unknown reporter refers to a 3 years old male patient. On an unknown date 2 years ago in June 2011 the patient was vaccinated unspecified varicella zoster virus (VZV) against. On 11-JUN-2013, VZVIP sample was obtained from axilla vesicle/lesion. The outcome of axilla vesicle/lesion was unknown. Additional information is not expected.
Within 40-50 min, pt was noted to have swollen left eye, cough, was advised to given EPIPEN JR and call 911 but 911 operator advised no EPIPEN JR. EMS gave 20 mg BENADRYL IM en route to ER, with resolution of symptoms while in the ER. No respiratory compromised, pt was discharged after 2 hr observation.
Was fine after the shot for the rest of the day.  Woke the morning of the 7th and felt good until around noon.  Started having severe body aches and chilling.  Never ran a fever.  Became weak where i could barely walk.  Body aches were worsening until i had to lie down.  Went to bed around 6:30pm but tossed and turned  because of body aches.  Finally fell asleep around 10:30pm and woke up  around 9:00 am feeling like a new man.  All symptons were gone.
101 fever; Body aches; Very swollen/painful axillary lymph node on side of injection; Swollen lymph nodes in neck on both sides; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration, administered in Right Arm on 08Mar2021 (at the age of 41-years old) as dose 2, single for covid-19 immunisation. The patient medical history included asthma. The patient concomitant medications within 2 weeks included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID], vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS], vitamin a [retinol] (VITAMIN A [RETINOL], zinc (ZINC). No known allergies. The patient previously received bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration, administered in Left Arm on 08Feb2021 12:15 (at the age of 41-years-old) as dose 1, single for COVID-19 immunisation. The patient was not diagnosed with covid prior vaccination and has not been tested for Covid-19, post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Mar2021, the patient experienced 101 fever, body aches, very swollen/painful axillary lymph node on side of injection for more than 1 week, and swollen lymph nodes in neck on both sides. Patient did not receive treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
I noticed small bumps on her wrist, the next day on stomach, face, arm and back and every day since then moving to different areas. They could have started earlier, on back or somewhere I didn't notice since they go away quickly. They appear at different times during the day, not after meals or eating, sometimes when she wakes up in morning. The hives have not resolved yet. I spoke to pediatrician office and daughter seen by doctor. She said the bumps are hives and probably from a virus/infection. She was not ill recently.
Walking difficulty; Speech disorder; Impaired work ability; COVID-19; Feeling abnormal; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Walking difficulty), SPEECH DISORDER (Speech disorder), IMPAIRED WORK ABILITY (Impaired work ability), COVID-19 (COVID-19) and FEELING ABNORMAL (Feeling abnormal) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (Walking difficulty), SPEECH DISORDER (Speech disorder), IMPAIRED WORK ABILITY (Impaired work ability), COVID-19 (COVID-19), FEELING ABNORMAL (Feeling abnormal), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, GAIT DISTURBANCE (Walking difficulty), SPEECH DISORDER (Speech disorder), IMPAIRED WORK ABILITY (Impaired work ability), COVID-19 (COVID-19), FEELING ABNORMAL (Feeling abnormal), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 112, 104 patient stated fever of 112, then states Fever of 104.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information provided. The AEs agent was able to capture are Fever of 112, then states Fever of 104, can't walk, can't talk, can't use the bathroom, sick to her stomach, can't take care of her baby.   Reporter did not allow further contact; Sender's Comments: This case concerns a 23-year-old, female patient with no relevant medical history, who experienced the non-serious unexpected events of gait disturbance, speech disorder, impaired work ability, COVID-19, Feeling abnormal; non-serious expected events of Nausea and Pyrexia. The events occurred on an unknown date after the first dose of Spikevax. The rechallenge was unknown since the Patient experienced AEs after the first dose and at the time of report there is no information about second dose. The events Nausea and Pyrexia are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax in not affected by this report.
Started as a raised red area at injection site. Woke up next morning with itching and hives inside red area.  Still have itching and rash.
Red rash on underside of left forearm in the shape of a "P". It itches a little bit.
This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The SHINGRIX made the patient sick.
Approximately 3 hours after 2d innoculation PT experienced onset of dizziness which continued to intensify over next 72 hours. Symptoms became highly disorienting, resulting in PT seeking  treatment. Otolaryngolist diagnosed left ear positional vertigo, and while the physician recommended some treatments the symptoms continue to be experienced regularly as PT moves head or shifts body position.
Massive Brain hemorrhage. Collapsed on 4 Feb 2021. Air medevac to Hospital.   Life support removed on 07 Feb 2021
Pfizer-BioNTech COVID-19 Vaccine  I received my injection on 2/6/21. On 2/9/21 or 2/10/21, I began to feel swollen nodes under my left arm (injection arm) and developed a mild rash on my left arm. The rash worsened and spread to my torso, right arm, and both legs. I saw a teledoc on 2/16/21 who told me to take benedryl every 6 hours and pre-treat prior to getting the second shot. I took benedryl for two days, but then switched to Allegra, to reduce fatigue. Rash did not improve. I saw an urgent care provider on 2/23/21 who prescribed antihistimine, anti-itch med, and steroid pac.
Edematous upper and lower eyelids b/l, erythema of b/l upper and lower eyelids. On Left thigh there is a 5cm x 6cm erythematous and indurated area. Injection site of BEXSERO.
?Patient came to pharmacy to get her 2nd dose of Moderna vaccine. During screening process patient disclosed she had injection site reaction on left arm including rash, redness, itching and swelling on her arm that had resolved. She also disclosed a similar area occurred occured on right side of abdomen that has somewhat resolved; however she still has sporadic occurences of redness and itching. Due to the patients reported adverse event; patient was advised to hold therapy of 2nd dose of Moderna vaccine; and if she needed to continue therapy the 2nd dose should be given under medical supervision.
I'm experiencing itching, tingling sensation with pain in left arm. Started the following week after shot and I'm still having it. It feels like it's in a nerve or something (the pain).
Developed disseminated shingles on 7/9/21, 7-day course of Acyclovir.  Then, found down at home on 8/18, intubated in the field, concern for seizure activity.  Now remains intubated with ongoing encephalopathy, no discernible etiology of seizures.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/05/21 2nd dose01/26/21 Diagnosed covid positive:09/09/21 Symptom onset:09/06/21 Exposure: Symptoms:SORETHROAT
Patient became pregnant within 4 weeks after receiving smallpox vaccination.  Date of vaccination: 3/20/03.  Date of start of last period: 3/17/03.  Pregnancy discovered during week of 4/21/03.
Information has been received from a medical assistant concerning a 70 year old male with hypertension and thyroid disorder who on 03-SEP-2008 was subcutaneously vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (lot# 659615/0162X). The patient took unspecified medicines to treat hypertension and thyroid diseases. On approximately 10-DEC-2010 (3 to 5 days before 15-DEC-2010), the patient developed shingles. On 15-DEC-2010 the patient was given a second dose of ZOSTAVAX (Merck) (lot# not reported). The patient also saw an ophthalmologist for his symptoms. At the time of reporting, the outcome was unknown. Additional information has been requested.
No additional AE reported; patient received her first dose of GARDASIL 9 three years ago (exact date unspecified). Patient received the second dose today (June 21, 2021).; This spontaneous report was received from a nurse practitioner who was reporting on female patient of unknown age. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On an unknown date in 2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 milliliter (strength, route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis. Second dose of the vaccine also 0.5 milliliter was administered on 21-JUN-2021 (inappropriate schedule of product administration). No additional adverse events were reported.
Arm had a knot; Hot to the touch at injection site; Arm  swollen at injection site; Arm was bright red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Arm had a knot), VACCINATION SITE WARMTH (Hot to the touch at injection site), VACCINATION SITE SWELLING (Arm  swollen at injection site) and VACCINATION SITE ERYTHEMA (Arm was bright red) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE MASS (Arm had a knot), VACCINATION SITE WARMTH (Hot to the touch at injection site), VACCINATION SITE SWELLING (Arm  swollen at injection site) and VACCINATION SITE ERYTHEMA (Arm was bright red). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Arm had a knot), VACCINATION SITE WARMTH (Hot to the touch at injection site), VACCINATION SITE SWELLING (Arm  swollen at injection site) and VACCINATION SITE ERYTHEMA (Arm was bright red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.