chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got my first Pfizer COVID shot on March 2.  On March 9 I had an episode of double vision for a couple of minutes but it went away. On March 10 it returned and worsened such that when I looked to the left my vision had a magnifying effect. After consulting with my Ophthalmologist and my primary physician it was decided that I should not at this time get my second shot scheduled for March 23 due to potential exacerbating problems from my March 2 first shot.  Further it was seen that my blood glucose was showing me diabetic for which I have begun medical treatment for type 2 diabetes.
Initial information received on 31-Aug-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case was linked with 2018SA251660, 2018SA251703 and 2018SA251618 (Same reporter). This case involves a six-year-old patient (gender not reported) who received 0.5 ml of FLUZONE QUADRIVALENT batch number: UI997AA on 31-Aug-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. This is actual medication error case due to product storage error (received FLUZONE QUAD 0.5 mL and 0.25 mL syringes after the 48 hours shipping, MA said it was still cool). No other vaccine was given to patient. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
I started feeling bad on 12/31/2021. My symptoms was moderate. The onset was like flu like symptoms, I had fever for abut 10 days, the cough started immediately. I had a sore throat, chills, fatigue,  body aches headache, sweats and running nose. I didn't lose my taste or smell. I went to bed early and I woke up the next day. I know then that I had COVID. My co-worker had it and I knew then that I will get it. I was so tried. I slept pretty much for the next 10 days. I then called my PCP and she had me to come in and she sent me to another location to get a chest x-ray.
Depression, Dizziness, Headache, Myalgia, Diarrhea & NauseaVomiting Narrative:  On 12/28/20 continue with headache, abdominal malaise, Dizziness. But referred is improving.
(Mom) child's mother called 09/01/16 C/O child developed rash on both arms, swollen eyes, and swollen lips that started Wednesday.
13 days after imm. given, pt. had 3 tonic clonic seizures. Then 2 wks. later (27 days after imm.) she had to be hospitalized to stop seizures.  She seized routinely for 7 days.  Terms added from Discharge summary rec'd 01/08/2006: Status epilepticus. Preexisting conditions: asthma. Illness at time of vax: rhinitis.  Lab test: EEG abnormal
After the patient got the vaccines she started to have the pre-verso symptoms related to cardioinhibitory syncope
This is a spontaneous report from a noncontactable consumer (patient). A 34-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0169), via an unspecified route of administration, left arm, on Apr 15, 2021, at 13:15, single dose, for COVID-19 immunisation. The patient did not report any other health issue. The patient has no allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. Concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER8733), via an unspecified route of administration, left arm, on Mar 25, 2021, at 16:45, single dose, for COVID-19 immunisation. On Apr 16, 2021, patient experienced fever, chills, body aches and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of fever, chills, body aches and headache resolved on an unspecified date in Apr 2021. No follow-up attempts possible. No further information expected.
Post-scab detachment lesion.  Scab fell off on 04/07/03 (post vaccination day 19).  A vesicle appeared on PVD 110 (07/07/03).  Itchy.  Two additional lesions have appeared 3 days later, within a 1 cm diameter area.  The lesions are 3 mm diameter each.
Oct 15th, attack of Vestibular Neuronitis, admitted to emergency room, in hospital one day, released with Lorazapan & Prednisone, ok now.   May not be related to flu vaccine.  11/11/08 Reviewed hospital medical records of 10/16-10/17/2008. FINAL DX: vestibular neuronitis Records reveal patient experienced acute vertigo w/persistent vomiting.  Seen in ER but symptoms persisted & admitted overnight for continued observation & treatment.  Improved overnight w/IVF & meds.  D/C to home on steroid taper.
Covid19 breakthrough.  1st vaccine received on 01/14/2021.  80 y/o PMH stent placement, HTN, GERD, HLD, CVA, Hypothyroid, Carotid stenosis s/p CEA prestnts to ED from Facility well for possible NSTEMI.  Pt c/o dizziness, feeling off balanced.  Positive troponins.  MRI brain with acute infarct.  Room air sat 97%. CXR- early consolidation or atelectasis left lung base.  Pt found Covid + preprocedural heart cath swab.
Initially, patient experienced nausea. The blood pressure was around 130/100. Then patient reported to have severe dry mouth and the throat started to get itchy. 'There is barely any saliva in my mouth' as what the patient complained. Vitals were checked again. The blood pressure was elevated again 160/110 which is way higher than baseline (110/80). Patient was transported to ED using wheelchair afterwards.
Developed shingles rash on face day 12/13 post 2nd injection. Treated with 5 day course of prednisone and 7 days of valacyclovir.
Nurse reported to Nurse Manager on 7/1/21 she diluted the vaccine with 0.8 ml. diluent instead of 1.8 ml with Pfizer vaccine and administered 0.3ml to patient in left deltoid on 6/30/21.   Once she recognized her error she notified provider and pharmacist.  She was advised by medical director to contact patient for the next couple of days to ensure that no adverse reactions had occurred.  She continues to follow patient daily telephonically and patient is doing well and has not reported any adverse reactions or side effects.
SPASMS ON LEGS, ARMS AND HEAD; SLIGHT HEADACHE; EXTREME TIREDNESS; SLIGHT FEVER; NAUSEA; BODY ACHES; PROFUSE SWEATING; POSSIBLE SEIZURE; This spontaneous report received from a consumer concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included food allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: unknown) dose was not reported, 1 total administered on 11-APR-2021 around 11:30 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, after vaccination patient had done lower body workout. On 11-APR-2021, the patient experienced nausea, extreme tiredness, slight fever, slight headache, body aches, and profuse sweating by evening. She took some children's liquid paracetamol (Tylenol). On 12-APR-2021 about 02:00, she also had spasms of her arms, legs, and head that lasted about 20 minutes. She took paracetamol (Tylenol) at about 03:00 and was pretty out of it. The patient's mother was concerned that it could had been a seizure (possible seizure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spasms on legs, arms and head on 12-APR-2021, and the outcome of nausea, extreme tiredness, slight fever, slight headache, body aches, profuse sweating and possible seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210423951-Covid-19 vaccine ad26.cov2.s-seizure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
This spontaneous report as received from a pharmacist refers to a 36 year old female patient. On 23-MAY-2013 the patient was vaccinated with a dose of VARIVAX (lot # 1321AA, exp. date: 18-AUG-2013) 0.5 ml, intramuscular injection. The patient did state that the injection hurt. The outcome of event was unknown. It was unknown whether the patient sought medical attention. Additional information has been requested.
This is in follow-up to report (s) previously submitted on 06/14/2007. Information has been received from a mid 70's year old female consumer with hypertension and hypercholesterolaemia and food allergies who on 14-MAY-2007 (also reported as 15-MAY-2007) was vaccinated IM with a dose of Zostavax. It was reported that on 14-MAY-2007 (also reported as 15-MAY-2007), 1 to 2 hours after vaccination, the patient experienced headache lasting from 4:30 PM 14-MAY-2007 until 19-MAY-2007. The consumer said she had called the physician on 15-MAY-2007 and saw him on 18-MAY-2008. Patient underwent a MRI on 18-MAY-2007 because of continuing headache pain. Blood test were undertaken. The results of both tests were normal. The consumer does not have past history of headache. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been received from the physician who reported that the patient developed a headache within 1-2 hours after vaccination. The headache persisted for 1 week. The patient was treated with a "mild liquid acetaminophen (TYLENOL) type" pain reliever. Additional information has been requested. Additional information has been received from the physician who stated that patient developed fronal headache within 2 hours on inoculation. Headach lasted for 6 days with no sequelae. Ophthalmological exam was undertaken by patient and the result was negative. The patient recovered in 1 week. No further information is expected.
Vaccines given at 11:20AM which consisted of HPV, MENACTRA and Tdap. MENACTRA given first then GARDASIL and finally Tdap. Child complained of pain even after first vaccine was given. After administering Tdap mother child called out to mother and went limp. Eyes were open the whole time but unresponsive. Arms tightened and clutched together. Patient came to after about 20 seconds. Information has been received from a medical assistant concerning a 12 year old female with no medical history on 02-JUN-2008 at 11:20 was vaccinated IM in the left arm with a first dose of GARDASIL (lot # 659962/1740U). Cocomitant vaccinations included a first dose of MENACTRA (lot # U2552AA), administered IM in the left arm, and a first dose of ADACEL (lot # C2825AA) administered IM in the right arm. There were no illnesses at the time of the vaccinaiton. It was reported that  MENACTRA had been administered first, then GARDASIL and then ADACEL. The child complained about pain after administration of GARDASIL. The medical assistant proceeded to adminster the ADACEL and at 11:20 the child fainted upon the needle being withdrawn. The child' eyes were open and glossy, but was unresponsive. The child's arms were tightened and clutched together. The child also voided during this time. The child "came to" aafter about 20 seconds. No laboratory diagnostics were performed. The patient recovered on 02-JUN-2008. Additional information was received from the FDA which reported that the vaccines was given at 11:20 AM, which consisted of GARDASIL, MENACTRA and ADACEL. MENACTRA was given first, then GARDASIL and finally ADACEL. The child complained of pain even after first vaccine was given. After administering ADACEL the child called out to her mother and went limp. Her eyes were open the whole time but unresponsive. Arms tightened and clutched together. The patient came to after 20 seconds. No further information is available.
No additional adverse effects were reported.; Medical assistant reported patient received improperly stored ROTATEQ; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 01-JUL-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.2 milliliters (ml) once, orally administered as prophylaxis (lot number S012679 which has been verified to be valid, expiration date reported as 17-JAN-2021, but upon internal validation established as 07-JAN-2021) (vaccination scheme was not reported). The administered dose of the vaccine experienced a temperature excursion of highest temperature above 47 degrees Fahrenheit (F) (47.2 F), during a time frame of 30 minutes, as recorded by a digital data logger. There was no previous temperature excursion. No additional adverse effects were reported in the patient.
Following administration and engagement of retractable safety syringe a drop of clear liquid leaked out of the patient's arm; possible insufficient dose.
The patient requested and received this vaccine without disclosing receipt of the Janssen COVID-19 vaccine in march of this year. It was not discovered that the patient had received the Janssen vaccine until submitting information into our computer system following her departure from the pharmacy.
Smallpox site crusted over; surrounding dark, red, confluent, papular rash. Fever and headache.
No adverse effects; patient was administered a dose of MMR II which expired on 3/24/2019; This spontaneous report was received from a medical assistant, referring to a 5 year old patient of unknown gender. Concomitant therapy included sterile diluent (STERILE DILUENT). No information was provided regarding the patient's medical history and concurrent conditions.   On 30-APR-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(RHA)(lot # N009799 (expiration date: 24-MAR-2019) for prophylaxis (strength, frequency and route of administration were not reported). No adverse effects were reported.
Starting around the end of August, I had a rash that started on my left arm, as well as my chest and abdomen (upper right to lower left).  The rash on my arm was quite bad, and despite using over-the-counter Cortizone, started oozing and scaling.  I contacted my doctor who prescribed a 7-day steroid pack, which resolved the problem.    It was presumed to be either plant origin or due to recent use of highly-concentrated milk products.
Initial report received from a healthcare professional on 27 September 2012. A 23-year-old pregnant female patient; had received an intramuscular (IM), first dose of ADACEL vaccine (lot number U4421AA, and site of vaccination was not reported) on 27 September 2012. Date of last menstrual period was 01February 2012 and the estimated date of delivery was reported as 02 December 2012. At the time of the report, the patient had not experienced any adverse events. The patient's health during pregnancy, previous pregnancy history, other medical history and concomitant medications were not reported. Follow-up information was received on 02 August 2013 from a health care professional. The patient's LMP was 16 July 2012 (previously reported as 01 February 2012). According to the reporter, any relevant illness during pregnancy/ongoing included thrombocytopenia and SUA (single umbilical artery) (dates of onset were not reported). The patient also received AFLURIA for one day (manufacturer, lot number, route site and date of vaccination not reported). According to the report, they did not experience any adverse events following vaccination. The patient had 4 pregnancies. No further information was available at the time of the report. Outcome was normal. Documents held by sender: None.
Fever 100.4 deg F, nausea, vomiting, fatigue, drowsiness
mild anaphylactic reaction; Both of her eyes looked like someone punched her because they were black, purple, blue under her eyes; The top lip swelled, was red, and very painful; The top lip swelled, was red, and very painful; lip swelled, was red; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included anaphylactic reaction, swollen tongue, typical can't breathe and disabled. The patient's concomitant medications were not reported. Caller stated she was calling about the Pfizer COVID 19 vaccine. Caller stated she went all over the internet to try to figure out what to do if one has a reaction and it is not helpful. Caller stated she called her physician office and her physician has not called back. Then she called VAERS and the representative at VAERS suggested to call a pharmacist. The caller then called the pharmacy and told the pharmacist everything that was going on and the pharmacist told the caller she had a mild anaphylactic reaction to the first shot and the pharmacist suggested to call Pfizer to find out Pfizer's input. Caller stated what happened is both of her eyes looked like someone punched her because they were black, purple, blue under her eyes and also the top lip swelled, was red, and very painful. Caller stated at first it was only the top of her half lip and she said she refers to it as kind of like duck lips and she still has it and she got the shot last Thursday but it has gone down some. Caller stated she has had an anaphylactic reaction before but never got these symptoms she would have a swollen tongue and typical can't breathe. Caller stated it has never been lips or her eyes. Caller stated her question is if she should get the second dose of the vaccine. Caller stated she was very high risk for COVID and she has only got one vaccine and no one was able to help her and this was utterly ridiculous. Caller stated she is disabled and has 50 health problems and can not go through another report. The event outcome for all events was unknown.  Information about lot/batch number has been requested.
I went in for my routine mammogram on March 29, 2023. The mammogram showed something on my right breast. M doctor scheduled me to have an ultrasound and biopsy on April 10, 2023. The ultrasound was able to confirm the location of the mass in my right breast, the biopsy came back positive for in situ ductal carcinoma. I have surgery scheduled on May 26, 2023.
Stomach and Back has a red rash; It is itching; It is sore; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Stomach and Back has a red rash), PRURITUS (It is itching) and PAIN (It is sore) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Stomach and Back has a red rash), PRURITUS (It is itching) and PAIN (It is sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Stomach and Back has a red rash), PRURITUS (It is itching) and PAIN (It is sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Fever, chills nausea since two hours after receiving the Gardasil shot x3 days ago.
infanrix that expired was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-month-old female patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 07-NOV-2023, the patient received Infanrix. On 07-NOV-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: infanrix that expired was administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-NOV-2023 Healthcare professional reported that an Infanrix that expired on 10th June 2023 was administered on 7th November 2023. No reactions reported. The reporter consented to follow up. The patient received Infanrix beyond the expiration date, which led to expired vaccine used.
Rash; This case was reported by a physician via sales rep and described the occurrence of rash in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was in her 80's. It was reported that the patient experienced rash after the dose of Shingrix.
Pt received the incorrect Havrix immunization. Pt received Havrix 1440 instead of 720 on 8/16/2021. No adverse event. Pt was in store to received second shot today.  Discovered today about incorrect immunization.
MY HEART BEAT IS OUT OF RHYTHM  SINCE RECEVING THE JANSSEN COVID 19 IMMUNIZATION.
Woke up with one eye that was puffy; Both eyes swollen; Left arm really sore; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PERIORBITAL SWELLING (Woke up with one eye that was puffy), EYE SWELLING (Both eyes swollen), PAIN IN EXTREMITY (Left arm really sore) and FATIGUE (Felt tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Patient is allergic to kidney medication).  On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PERIORBITAL SWELLING (Woke up with one eye that was puffy), EYE SWELLING (Both eyes swollen), PAIN IN EXTREMITY (Left arm really sore) and FATIGUE (Felt tired). At the time of the report, PERIORBITAL SWELLING (Woke up with one eye that was puffy), EYE SWELLING (Both eyes swollen), PAIN IN EXTREMITY (Left arm really sore) and FATIGUE (Felt tired) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   It is reported that on 18-FEB-2021, patient took medication for symptoms as Warm Compresses and patient is continue to take medication regularly for Blood pressure. Concomitant product use was not provided by the reporter.