chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 24 year old female pt who in approximately 1996 was vaccinated with varicella vaccine. The pt received two doses about one month apart. Subsequently, the pt's serology results indicated that she failed to seroconvert. The specifics of the serology test used were not known. Unspecified medical attention was sought. Additional info has been requested.
Patient experienced breathing problems beginning 4 days after vaccine administration and continuing for another day.  Patient went to an urgent care clinic and was given a prednisone shot.
hx given by dad vax given on 12AUG92; On 22AUG92 had low grade fever & vomiting;
This spontaneous report, received from a patient, concerned a male, of unspecified age, race and ethnic origin. The patient's height, weight, medical history, concomitant medications and concurrent conditions not reported. The patient received the COVID-19 vaccine ad26. cov2.s (dose number in series 1, suspension for injection, route of admin, batch/lot# not reported; expiry: unknown), dose not reported, 1 total, on Mar 9, 2021 for immunization. It was unknown whether patient had any adverse events following vaccination with first dose of COVID-19 vaccine ad26. cov2.s (dose number in series 1). The patient received additional booster dose of the COVID-19 vaccine ad26.cov2.s (dose number in series 2, suspension for injection, route of admin not reported, batch/lot# 1822811 and expiry date: Mar 20, 2022), dose not reported, 1 total, on Oct 22, 2021 for prophylactic vaccination. On an unspecified date, patient got Omicron (dose number in series 2).The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of got Omicron: not reported.
Between 1 and 3 days after 12 month vaccines, she broke out in a rash. The rash went away and came back in 2 wks. It disappeared again and came back in 1 month. Provider believes it could be MMR related.
Pt admitted for GI bleed, suspected lower GI bleed, which he has had previous.  Routine COVID testing returned positive.  Pt with no COVID symptoms, vaccinated with Moderna.
Information has been received from a physician concerning an adult female who was vaccinated with a first dose of varicella virus vaccine live. The reporter indicated that the pt developed a mild chickenpox rash after the initial dose. Unspecified medical attention was sought. Additional information has been requested.
Arm sore for several days.   about a week later 4" redness and very itchy started has not stopped yet.
Received three spots of Moderna previously with zero reaction. Received the Pfizer booster at 5pm on Monday. Got the flu shot at the same time. Felt fine beside a sore arm until around 1:30pm the next day. Went out for a run (I am an avid long distance runner), about one mile in I noticed that I couldn't breathe well, which is very unusual. Decided to stop running and walk home. As I was walking home, my breathing was getting worse, and I started to feel itchy. By the time I got home, my eyes were swollen, lips were swollen, had hives all over every part of my body. I had been in my apartment with the windows open all day so felt it was unlikely that it was environmental, plus all pollen levels were low, air quality was good, hadn't recently eaten anything. I have had allergies my whole life but never have had a reaction similar to this.  Took benedryl which helped with the hives, however the eyes and lips are still swollen a day later. Since reaction, I have not been outside, have had all windows closed, showered and cleaned clothes all in case it was environmental. Despite this, face is still swollen
Red, itchy rash/hives appeared buttocks and thigh areas.  Applied Caldyphen and reaction was relieved and disapeared only to recur to a lesser degree.  Same situation thru this writing.
About 30 minutes after receiving the shot my pinky and ring finger on my left him again to go slightly numb. That was followed by my pinky finger lightly  twitching for about 40 minutes.  About three hours later there is just a mild numbness but the twitching has stopped.
This spontaneous report was received from a Certified Medical Assistant and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unknown dates, an unspecified number of patients received doses of GARDASIL 9 (lot # L014198, expiration date 05-SEP-2017; lot# L004741, expiration date 04-MAR-2017; dose frequency, indication and route of administration were not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd flu vax on 25OCT91 & the following day exp large red area that was warm around the site of inject; rxn improved each day, by fourth day p/vax, red area had faded & almost completely disappeared; MFR felt poss hypersensitive to vax;
On 03/12/2023 I had a painful rash on my left side of my face.  I went to the urgent care then I called my doctor and schedule an appointment on the same day. At the urgent care they diagnosed me as having Shingles. They  prescribe me Valacyclovir for 7 days 3 times a day. I was also prescribe Gabapentin, and Prednisone. The anti viral helped to stopped the rash from spreading.
Flu like symptoms; nausea, migraines, muscle aches, chills, fever. Treated with NyQuil and Ibuprofen
1700 C/O rt arm numbness.  No pain. Left observation area at 1714.
In March 2000, the pts developed local, large red patches and pain. The pts sought unspecified medical treatment.
Pt complained of numbness and went to the doctor on 11/14/2011. Later the doctor found a lesion on the spine after many MRI's.
over 42 days 1st dose 04/14/21, 2nd dose 08/23/21
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history or drug reactions/allergies were reported. The nurse reported that on 28-NOV-2012, the patient received PREVNAR (Lot#, dose and route not provided) and then, on 27-DEC-2012, the patient received PNEUMOVAX23 (lot#, dose and route not provided); less than the 8 minimal interval. No adverse effect were reported. Additional information has been requested.
Pt. states that after receiving the 1st dose of Phizer 09/02/2021, burning during injection, pain in the left arm *continuous, Emergency Room visit 10/05/2021, X-Ray preformed (Normal), * diagnosed with Muscle Spasms treated with Muscle Relaxers. Cramping throughout the *both legs, still continuing to experience symptoms.
per the death certificate, pt died at home with COVID 19 being a cause of death; pt had been hospitalized with COVID on 12/25/21 and dc'd to home on hospice 1/5/21 after family deciding on comfort measures and supportive care such as feedings, home medications and supplemental O2 if needed;
I received both of my Pfizer Covid shots. I believe I had Covid few weeks back; I believe I had Covid few weeks back; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender (age 77, unit not specified) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single for COVID-19 immunization. The patient's medical history includes COPD. The patient concomitant medications were not reported. On an unknown date, the patient had Covid few weeks back. It was reported that the patient received both Pfizer COVID shot and going to take part in Covid booster trial starting next week. The patient queried if any research going on about patient condition with regards to his level of immunization.  No follow-up attempts were possible; information about lot/batch number could not be obtained. No further information was expected
Flu shot adm in left deltoid. PNEUMOVAX 23 adm in right deltoid } on 1/12/17 on 1/18/17 pt alerted via phone that right arm had red spot, 2 horizontal lines, and was painful.
ACUTE NON ST ELEVATION MI ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPERCAPNIC RESPIRATORY FAILURE 2/6/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Information has been received from a physician concerning a 13 year old female who was vaccinated with her first dos of Gardasil early in the day and around 9 p.m. she developed a rash all over her body. When she was seen by the doctor he sent her to a hospital. The patient's outcome was not reported. Additional information has been requested.
Pt rec'd first dose of Pfizer vaccine at approximately 0950 and immediately after reported feeling nauseous and dizzy. MA retrieved a water bottle for pt and called for the RN. The RN, also responded, pt was pale, moist, coherent.  At 0954, pt had seizure activity while sitting in chair, dad held pt, hands, arms, and legs stiffened and pt's head rolled back.  Pt was secured by dad and activity lasted approximately 7-10 seconds.  Immediately after this activity, pt was oriented to self, place, date, and situation, then reported increased nausea.  At approximately 0958 pt started vomiting.  911 was called by the RN, at 0955 and provider, was retrieved immediately from COVID testing tent.  During this time, pt started to report seeing purple lights at approximately 0957.  Vitals were attempted at 0954 but pt started seizing.  At 1001 pt reported total vision loss.  At this time, EMT's arrived on site and began to obtain vitals.  Pt's BP was 50/30, EMT's started an IV and prepared pt for transport to gurney.  At 1008 pt reported sight returning.  8L of 02 were applied to pt via non-rebreather at approximately 1000 at which pt's 02 sats registered at 72%.    EMT's placed pt on gurney at 1008 and started en route to Hospital.  Prior to seizure activity, pt's medical hx, medication list, and allergies were confirmed with pt's father.  Father reported pt has no medical hx, does not take any medications, and does not have any known allergies.  Father denies pt having any seizure before, any hx of brain tumors, hx of epilepsy, hx of diabetes.    Father remained with pt during duration of incident and accompanied pt and EMT's in ambulance to the hospital.
Red blotchy rash around inject site & a red streak trailing down to the groin area & swollen node in the groin area;
Information has been received from a physician concerning a female (age unknown) was vaccinated with a dose of Gardasil. Subsequently, after receiving the vaccination the patient fainted. The patient sought unspecified medical attention. At the time of the report, the patient had recovered on an unspecified therapy. No product quality complaint was involved. Additional information has been requested.
Developed fever and chills approximately 12 hours following vaccine. The next morning discover rash on right side of lower abdomen approximately the size of a quarter. Thought the rash was hives, however of the course of the next 2-3 days the rash became blistered. Had rash cultured at local urgent care which came back positive for shingles.
One week after I began with itchiness on my rear scalp, then my, neck, and upper torso. Through  the weeks I would get random flares on all the body legs, arms stomach. Everywhere. Itchiness. In some I would have red rashes from scratching. Also faces flares on ears.
Suspected vaccination failure; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 18th April 2019, the patient received the 2nd dose of Shingrix. On 19th August 2019, less than 2 years after receiving Shingrix and 123 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was considered as suspected vaccination failure since the details regarding completion of laboratory confirmation of herpes zoster were unknown at the time of reporting. The reporter was consented to follow up. The reporter did not have lot or expiration date at time of call.
Immediately after vaccine was given, pt had a small swollen lump at site of administration on his left arm. An ice pack was put on it for 10 minutes and patient was monitored. He felt okay, and after 10 minutes the swelling had gone down to almost nothing. Called patient at 5:05pm to check up on the patient. He reported he felt okay besides some muscle soreness and still a little swollen at site of injection. He was instructed to report to the pharmacy if anything changed or got worse.
slight fever; body aches; similar to a mild flu; planning to have the remaining dose/Because the virus hit, I have yet to have this done; This case was reported by a consumer via call center representative and described the occurrence of fever in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 13th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, general body pain, influenza-like symptoms and social problem. On an unknown date, the outcome of the fever, general body pain and influenza-like symptoms were recovered/resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the fever, general body pain and influenza-like symptoms to be related to Shingrix.  The age at vaccination was not reported. On 13th July 2020, the patient received the 1st dose Shingrix. The patient had a slight fever, body aches last time, similar to a mild flu and wonder if the patient would get these again, or even worse. The patient was planning to have the remaining dose within 6 months. Because the virus hit, the patient has yet to have this done. The patient physician said the patient should go ahead despite the time lapse. The patient asked to advise would be getting the 2nd dose at my local if or when he decide. The reporter did not consent to follow up.
Just a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Just a sore arm) 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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Just a sore arm). At the time of the report, PAIN IN EXTREMITY (Just a sore arm) outcome was unknown. Not Provided
Covid 19 documented by positive PCR.  Symptoms: sore throat, headache, cough, fatigue (physical and mental) Paxlovid Recovered @ 19 days with some lingering fatigue and nighttime cough
No adverse event; Received booster dose of Moderna COVID-19 vaccine from a pediatric vial (6Y-11Y) instead of Bivalent booster vial; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received booster dose of Moderna COVID-19 vaccine from a pediatric vial (6Y-11Y) instead of Bivalent booster vial) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received booster dose of Moderna COVID-19 vaccine from a pediatric vial (6Y-11Y) instead of Bivalent booster vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received booster dose of Moderna COVID-19 vaccine from a pediatric vial (6Y-11Y) instead of Bivalent booster vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received booster dose of Moderna COVID-19 vaccine from a pediatric vial (6Y-11Y) instead of Bivalent booster vial).    This case contains information on 1st of 6th adult patients as described by the reporter.   No concomitant medications were reported.  It was reported that 6 Adult patients were received Booster dose of Moderna COVID-19 vaccine from a Pediatric vial (6Y-11Y) instead of Bivalent booster vial.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-660860, US-MODERNATX, INC.-MOD-2022-661292, US-MODERNATX, INC.-MOD-2022-661298, US-MODERNATX, INC.-MOD-2022-661299, US-MODERNATX, INC.-MOD-2022-661300 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Additional follow-up received : Narrative updated and IRD of initial version was captured to 17-Oct-2022. On 17-Oct-2022: Additional follow-up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660860:Adult patient 2 US-MODERNATX, INC.-MOD-2022-661292:Adult patient 3 US-MODERNATX, INC.-MOD-2022-661298:Adult patient 4 US-MODERNATX, INC.-MOD-2022-661299:Adult patient 5 US-MODERNATX, INC.-MOD-2022-661300:Adult patient 6
Fatigue, sore throat, congestion, pain, nausea, dizziness, hot and cold,  chills, and sneezing for 36 hours.
bexsero expired 1/31/22, administered; 42 year old received bexsero; bexsero administered as part of post splenectomy series; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 42-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA81EZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th April 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 6th April 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used, inappropriate age at vaccine administration and drug use for unapproved indication. On an unknown date, the outcome of the expired vaccine used, inappropriate age at vaccine administration and drug use for unapproved indication 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: 06-APR-2022 Reporter's Comment: The reporter stated that expired Bexsero vaccine that was accidentally administered to a patient as part of a post splenectomy vaccine series and wanted to know what recommendation was for repeating the vaccine. The reporter did not confirm with the healthcare professional that the series was a repeat but coded it as possible extra dose/repeat series since HCP stated that it was part of a post splenectomy vaccine series.  The reporter consented to follow up via postal. Additional Supportive Information: A 42 years patient accidentally received Bexsero vaccine that was already expired on 31st January 2022 as part of a post splenectomy vaccine series, which led to expired vaccine used, inappropriate age at vaccine administration and drug use for unapproved indication.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR061753:Possibly same patient
having some swelling in one side of his face; This is a spontaneous report from a contactable consumer via medical information team. This consumer reported for a 71-year-old male patient.  A 71-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history included diabetic from an unknown date and unknown if ongoing, hypertense from an unknown date and unknown if ongoing. The patient concomitant medications included epinephrine (EPIPEN) taken for diabetes mellitus, hypertension, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation and experienced a little soreness in the arm that went away after taking medication. The patient experienced having some swelling in one side of his face on 18Mar2021. The reporter stated in regard her father that had the second dose of the Pfizer Covid vaccine and apparently was fine yesterday (the day he got it) but today (18Mar2021) he sent her a picture to her phone with him having some swelling in one side of his face. She would like to know how long after the vaccination a side effect can occur. She mentions that her father is 71 years old, diabetic and hypertense and he has been using an antiallergic called EpiPen. She is not sure this is related with the swelling. She mentioned that the swelling in the face of her father has happened before the vaccination. The outcome of the event was unknown.  No follow up attempts are possible; information about Lot/batch number cannot be obtained.
Severe chills; Fever; Vomiting; Diarrhea; Fatigue; Headache; Increased tinnitus; Night sweats; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 12Apr2021 at 11:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetic and allergy to sulpha drugs. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included rosuvastatin calcium (MANUFACTURER UNKNOWN) and hydrochlorothiazide, olmesartan medoxomil (BENICAR HCT), both taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 22Mar2021 at 16:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021 at 23:00, the patient experienced severe chills, fever, vomiting, diarrhea, fatigue, headache, increased tinnitus and night sweats. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe chills, fever, vomiting, diarrhea, fatigue, headache, increased tinnitus and night sweats were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.