chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for COVID after treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID after treatment) in a 57-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Drug allergy.   On 14-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-May-2022,  after starting mRNA-1273 (Spikevax), the patient experienced COVID-19 (Tested positive for COVID after treatment). At the time of the report, COVID-19 (Tested positive for COVID after treatment) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       The patient's race was given. Concomitant medication list was not provided. No treatment was received. Company comment: This spontaneous case concerns a 57-year-old, male patient with no relevant medical history, who experienced the unexpected, non-serious of COVID-19. The exact date of administration of an unknown dose of mRNA-1273 was not specified in respect to the onset of the event, hence latency could not be assessed. On May 14, 2022, patient was started on treatment regimen of Paxlovid however on, May 25, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 57-year-old, male patient with no relevant medical history, who experienced the unexpected, non-serious  of COVID-19. The exact date of administration of an unknown dose of mRNA-1273 was not specified in respect to the onset of the event, hence latency could not be assessed. On May 14, 2022, patient was started on treatment regimen of Paxlovid however on, May 25, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Covid positive; Covid positive; First and second dose on 05Mar2021; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 05Mar2021 (at the age of 27-year-old) as dose 1, single (Lot Number: EN6204) and via an unspecified route of administration, administered in Arm Right on 05Mar2021 (as reported) as dose 2, single (Lot Number: ER8730) for COVID-19 immunization. Medical history included PCOS and Known allergies: Gluten, tree nuts. The patient received medication within 2 weeks of vaccination which included birth control & anxiety meds. The patient experienced COVID positive on 18Sep2021. Case was reported as non-serious. The events resulted to a doctor or other healthcare professional office/clinic visit. No treatment was received. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included covid-19 Test: positive (Nasal Swab) on 18Sep2021. Outcome of the event was recovering.
some of the vaccine "leaked out" when the provider pulled the needle out; some of the vaccine "leaked out" when the provider pulled the needle out; vaccine gave it to her almost exactly between her shoulder and her elbow; She reports that her arm was a little sore after this dose as well and it is also red in the area that she received the injection.; She reports that her arm was a little sore after this dose as well and it is also red in the area that she received the injection.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's previously received first dose of BNT162B2 for covid-19 immunization and had soreness in her arm after her first dose. The patient is concerned because she stated the person who administered her vaccine gave it to her almost exactly between her shoulder and her elbow instead of "3 fingers down from her shoulder" like her first dose was given. She also stated that some of the vaccine "leaked out" when the provider pulled the needle out. The patient was concerned that if the second dose was not given in the appropriate place that she will not be protected against Covid or that the vaccine will not be as effective. She reported that her arm was a little sore after this dose as well and it was also red in the area that she received the injection on an unknown date in Apr2021. She denied any other type of side effects at this time. The outcome of the events was unknown. Patient wanted to known if the vaccine was as effective if it is administered somewhere other than 3 fingers down from the shoulder, what she should do if the second dose of the Pfizer COVID-19 vaccine was in fact administered incorrectly and if she should get tested for antibodies to evaluate for efficacy of the Pfizer COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Weakness, nausea vomiting, panocytopenia, mental confusion, hyponatremia.
Patient called by phone 3 hours after receiving the vaccine. He started to feel burning in his right arm, left arm, neck and face.
a patient received a dose of Infanrix (DTap) instead of a Tdap dose; inappropriate age at vaccine administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received DTPa (Infanrix) for prophylaxis.   On 02-AUG-2023, the patient received Infanrix. On 02-AUG-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: a patient received a dose of Infanrix (DTap) instead of a Tdap dose) and inappropriate age at vaccine administration (Verbatim: inappropriate age at vaccine administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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: 2-Aug-2023 The reporter did not consent to follow-up. The patient received a dose of Infanrix instead of Tdap dose at an inappropriate age, earlier on the day of reporting, which led to wrong vaccine administered and inappropriate age at vaccine administration.
swollen, itchy spot-2" 24 hrs p/inj;next to it another spot swollen, sl itch, red 2 1/2x3";whole body ached 24hrs p/vax;no fever;arm red, swollen x 1 wk
1/15 Vaccination  1/20 In the morning, I woke up and my eyes were swollen. The whites were swollen, bulging out, very red. Eyelids so swollen. Looked like severe allergic reaction. No drainage site. I went to the ER. Dr. thought I had peri orbital cellulitis and referred to ophthalmologist. Given medication. 3rd person I saw that day and she said it was allergic reaction. Said to take allergy medicine and drops. It cleared up within 4 days before I could go out in the public, completely gone within a week.
Fatigue, malaise > 60 days, dizziness (lightheadedness - feels like going to faint or knees going to give out), nausea without vomiting (only with movement and headaches) - primary symptom of motion sickness, memory loss, short term and cognitive changes. Follow up 5/24/05: Received neuro psycho report and narrative summary for military medical board. The following was an update on patient's status obtained by phone this morning.: Patient had a military medical board evaluation and received a disability rating of 40%. He was placed on the Temporary Disability Retirement List for 5 years, which will include re-evaluations every 1-2 years. He denied any significant changes in his symptoms.
Caller said his son suffered an autoimmune response; This is a spontaneous report from a contactable consumer (Mother) reported for patient (son). A 13-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 14May2021 (at the age of 13-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient was reported as none. The concomitant medications of the patient were not reported. The reporter said that after receiving one dose and got tested for antibody, the result was negative. She wanted to know if that was normal and if it happened and wanted to know if her son was protected while testing negative for the antibody. She called on behalf of her son who received the 1st dose of the Pfizer Biontech COVID19 vaccine on 14May2021 and was supposed to receive the 2nd dose on 08Jun2021, but missed it due to hospitalization. She said her son suffered an autoimmune response 2 days after. Her son also tested negative for the antibody after first dose. She wanted recommendation on getting the 2nd dose of the vaccine beyond the 21-day window. The event led to hospitalization. The patient underwent lab tests and procedures which included antibody test: negative on an unspecified date. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
Patient fell in her driveway and needed assistance in getting up, approximately 3-4 hours after the vaccine.  Her left side felt weaker.  Two days later she fell again.  She still feels unsteady on her feet and utilizes a walker and crutches. Patient states that she "does not know where she feet are".  For two weeks after the vaccine, patient states that she felt  like  pins were poking her legs and thighs 8-10 times/day.  "Intention Tremors" that she had experienced 10 years ago were noted following the vaccine.  She contacted her PCP, when she noted all these symptoms ocurring. Patient has not been to the Hospital MS Clinic for two years but has made an appointment that will be in August.  She has been advised to keep the appointment and not receive the second dose until seen by her MD.
Received shot in the shoulder joint instead of arm muscle. After pain continued in shoulder I was diagnosed with Frozen Shoulder.
Red, tender, edematous area at injection site.  Warm compresses (right arm).
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 63-year-old female patient who received HAV (Havrix) (batch number 2B8BA99, expiry date 16th December 2022) for prophylaxis.   On 4th January 2023, the patient received Havrix. On 4th January 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK receipt date: 05-JAN-2023 Reporters comment: The Nurse reported that Havrix expired dose administered on 4th January 2023 which expired 16th December 2022. The reporter consented to follow up. Batch number HCP provided did not come up upon searching given number.  The HCP declined to provide patient initials.  The HCP consents to safety team follow up. Additional supportive information: The Nurse reported that the patient received expired dose of Havrix, which led to expired vaccine used.
3 days after second hepatitis b vaccine, knee gave out and repeatedly gives out with severe pain and inability to walk.  Cortisone shot into knee followed next day with flushing on face and chest, elevated blood pressure, fever, hot flashes, insomnia, tacchycardia, swollen throat, thirst.
It started with pain in the left eye and then the right eye turned red  then both were red and itching.
Fatigue, high fever, neck pain on right side, numbness and tingling in feet and hands, persistent headache, nausea, joint pain Started early morning on April 3rd. Started to subside on April 4th however neck pain and headache continues.  I do not feel sick enough for hospital.
Dizziness, dim vision, sweating, flushing, metallic taste in mouth, chest pressure
It was reported that the patient came in for her second Shingrix vaccination. The technician who ran the vaccine ran it for Fluarix instead of Shingrix. The pharmacist filled out the lot and expiration on the vaccine form for the Fluarix. It was reported by our technician who administers vaccinations that she had a patient form and called back the patient who was actually another patient, but patient responded and followed her back, the technician reported that at that time she asked the patient if she was there for a flu vaccine and the patient responded yes, then the Fluarix vaccination was administered. Upon the patient leaving the staff found that there had been a mistake on the paperwork and patient was supposed to receive a Shinrix vaccination. The pharmacist then called the patient to let her know about the wrong vaccine administration. The patient received the vaccination at 1:04pm and was called at 1:19pm.
Pt given a Pfizer booster at the age of 14, against CDC recommendations of 16 and older. No adverse reactions observed or reported during observation period.
Shingles, Herpes Zoster on forehead severe pain. ? Varicella disease mild yrs ago.
FEET/ANKLES FEEL LIKE STUCK THEM IN A HOT BUCKET OF WATER; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient have no change in colour or swelling. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-AUG-2021, the patient experienced feet/ankles feel like stuck them in a hot bucket of water. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feet/ankles feel like stuck them in a hot bucket of water. This report was non-serious.
ASYMPTOMATIC COVID INFECTION Patient is resident of facility and completed vaccine series on 1/5/2021. No symptoms following vaccine, but tested positive during screening on 1/28/2021, at which time he was moved to the inpatient acute care observation. Was discharged after 10 days of observation back to facility. No other hospitalizations between vaccine and covid positive test. No recent hospitalizations prior to vaccination.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of VARIVAX lot # L017142, expiry date 13-MAY-2017 (routes and sites of administration, dose were not reported). No adverse effects were reported. Follow-up information was received on 07-DEC-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received on 08-DEC-2015 from the reporting nurse. She reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from the nurse on 14-DEC-2015. This case concerns a 15 year old patient. On 11-SEP-2015, the patient was vaccinated with VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Site where vaccine was given was super hard, big and bumpy and red and warm; Site where vaccine was given was super hard, big and bumpy and red and warm; Site where vaccine was given was super hard, big and bumpy and red and warm; Site where vaccine was given was super hard, big and bumpy and red and warm; itching; huge bumps all over her arms and legs; left knee was huge and swollen/ ankles were swollen; rash/ rash was all over her arm/ rash was on her feet and legs and ankles; allergic reaction; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 19-year-old female patient (reporter's daughter) that who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0-87) at the age of 19-years, via an unspecified route of administration in left arm on 12Jun2021 at single dose for COVID-19 immunization, in physician office. Medical history was not reported. No other products. The patient historically received flu vaccine and had reactions to it- super sick, a lot of fever, couldn't sleep, talked in her sleep, crying, she would miss school,  and right after vaccine she got a bad severe cold and cough, it got super severe and turned into a mild bronchitis and had to take salbutamol (ALBUTEROL), when patient was about 6 or 7 years old. This consumer reported that the patient developed severe reactions which required her to go to the doctor, such as huge bumps all over her arms and legs 12 hours after getting the dose, left knee was huge and swollen, like overexaggerated swelling, the reaction was probably in the joints and really severe; ankles were swollen. Her doctor advised not to receive the 2nd dose as this may be an allergic reaction from the vaccine. Doctor told her not to get the second dose and that the first dose could have been deadly for her. Consumer also reported that on the same day, 12 hours after, around midnight, patient had a rash but her doctor called it something else, and little bumps. The next morning, patient woke up with bigger bumps all over her arms and other parts body. It was on the weekend so the patient did not see a doctor until Monday. The reaction was a little less at that time. The reaction lasted about 7-10 days, patient continued to get little rashes that faded away and then more would come. It was also mentioned that site where vaccine was given was super hard, big and bumpy and red and warm, did not get a rash next to it, but the rash was all over her arm, just not in that area, the mother said the rash was on her feet and legs and ankles. Patient was given allergy mediation to help with reaction but it did not help, she was given cetirizine hydrochloride (ZYRTEC) 1mg/mL oral solution, it did help with the itching but did not help with the rash. Rash result in physician office. The mother wanted to know if these were reported side effects of the vaccine and if her daughter can still get the 2nd dose which is scheduled on 03Jul2021. Lab data included: weight was 138 pounds when she got the vaccine. Outcome of the events was unknown.   Follow-up attempts completed. No further information expected.
Sense of smell and taste decreased on 10/25, within next 1-2 days, I could not smell or taste anything. Marginal improvement as of 11/04.    11/25/09:  Ortholaryngology and radiology consultation received for date of service10/28/09 to 11/6/09.  Dx:  Trigeminal neuralgia, anosmia, pulsatile tinnitus.  Presents with decreased sense of taste and smell for two weeks.  Also left facial pain and tinnitus which resolves with Valsalva maneuver or extreme neck tortion.
Initially reported HA in afternoon after booster. Then awoke from sleep with altered mental status. Intubated on arrival for airway protection in ER.  CTa/CT showed large edema with hemorrhage and mass effect pf right frontal lobe.  LP showing polys, elevated protein, normal glucose. Running diagnosed was HSV meningoencephalitis. Culture, however, returned negative.  Stated on Decadron for concerns of autoimmune in setting of booster. Transferred to for MRI compatible with AICD leads.
This spontaneous report was received from a pharmacist via company representative refers to a 38 year old male patient who was pharmacist family member. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) (dose, route, lot# were not reported). On an unknown date, the patient experienced rash all over his body and rash looked like mosquito bites. Patient was prescribed antibiotic, amoxicillin and AUGMENTIN by his physician. Patient sought medical attention by visiting physician. No Product Quality Complaint (PQC) was involved. The outcome of rash all over his body and rash looked like mosquito bites was unknown. Causality was not provided by the reporter. Additional information has been requested.
Case number PHEH2015US022834 is an initial spontaneous report received from a health care professional on 05 Nov 2015 and from the health care professional on the same date (combined report). This report refers to a 62 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with an expired 0.5 ml dose of FLUVIRIN (batch number: 145004) intramuscularly on 04 Nov 2015. The case was reported as non-serious. No adverse events were reported following the maladministration.
Around 6AM this morning when I woke up, there was a slight rash on my lower cheek on the left side of my face. No swelling, slight itching that comes and goes over the entire face, but rash is only evident on a small patch of the lower cheek. Very slight burning sensation where the rash is evident.
t105 ax x 10hr;high pitched screaming x 10hr;large red area lt leg;
Myalgia, Fever, Rash, NauseaVomiting, severe fatigue Narrative: RASH AROUND TORSO THAT BLACHES
Loss of appetite; Fever (low grade); Headache; Chills; Sore injection Site; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), PYREXIA (Fever (low grade)), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE PAIN (Sore injection Site) in a 34-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 August 2020.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced DECREASED APPETITE (Loss of appetite), PYREXIA (Fever (low grade)), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE PAIN (Sore injection Site). On 13-Mar-2021, DECREASED APPETITE (Loss of appetite), PYREXIA (Fever (low grade)), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE PAIN (Sore injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment information were not reported.  Patient's father reported that the daughter had adverse events after Moderna vaccine.
Generalized tonic-clonic seizure 4/25/06 X 2. Work-up in ER negative. Medical record state irritable, droopy, diarrhea, vomiting, cough. msv
5" diameter by 1" height lump on my arm after injection, still present today, but smaller 1.5" x 1"