chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 40 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Jan2021 as dose 1, single (Lot number: 029L20A), in left arm and on 06Feb2022 as dose 2, single (Lot number: 029L20A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ARMOUR THYROID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: Positive rapid Ag test after 2 negative tests 48hrs apart; Negative, notes: Positive rapid Ag test after 2 negative tests 48hrs apart; Negative, notes: Positive rapid Ag test after 2 negative tests 48hrs apart. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.
AFTER RECEIVING HIS 2ND DOSE MODERNA VACCINE, THE PATIENT SAT IN THE OBSERVATION AREA.  5 MINUTES IN THE OBSERVATION AREA, THE PATIENT CAME TO OUR COUNTER TO ALERT ME THAT HE FELT DIZZY.  I IMMEDIATELY ASKED HIM TO SIT BACK DOWN,  AND CAME OUT TO HIS SIDE.  HE THEN TOLD ME THAT HIS DIZZINESS SYMPTOM INTENSIFIED.  HIS BODY SUDDENLY SHOOK A BIT, I HELD ON TO HIM TO KEEP HIM STEADY.  THEN I HAD HIM SAT DOWN ON THE FLOOR, THEN HE TOLD ME HE NEED TO LIE DOWN.  SO I HELP HIM LAY DOWN.  HIS SKIN STARTED TO FEEL VERY DAMP.  HE SAID HE FELT EXTREMELY NAUSEOUS.  I HAD MY TECHNICIAN CALL 911 FOR HIM,  I REMAINED WITH HIM BY HIS SIDE THE WHOLE TIME UNTIL PARAMEDIC GOT TO US IN 8 MINUTES.  THEY TOOK HIS VITAL SIGNS.  EVERYTHING CHECKED OUT.  HE DIDNOT GO TO THE HOSPITAL.  PARAMEDICS LEFT.  HIS MOM CAME TO PICK HIM UP.  HE FELT NAUSEOUS FOR THE NEXT 5 HOURS, THEN HE SLOWLY FEELING BETTER.
stage four Cirrhosis of the liver; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknow, single for covid-19 immunisation. Relevant medical history included: "breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEPATIC CIRRHOSIS (medically significant), outcome "unknown", described as "stage four Cirrhosis of the liver". The patient underwent the following laboratory tests and procedures: scan: cirrhosis of the liver. Two months prior to taking the Covid-19 vaccine the patient was a breast cancer survivor. She had a full body scan after taking the vaccine she was told that she had stage four Cirrhosis of the liver which she did not have prior to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reports that within an hour of getting the injection she started having swelling and tenderness of the arm.  She reports having problems lifting the arm.  She reports that within a couple minutes she started having a tightness in the throat.  She is able to swallow but it feels more difficult.  No wheezing or shortness of breath.  No dizziness or lightheadedness.  Never had a reaction like this before.  No history of problems with vaccines as a child.  No reaction like this since being in the military.
Client was given ACTHIB on 10/12/10 & the vaccine was mixed with the wrong diluent. Instead of the diluent that comes with the vaccine the shot was mixed with the diluent we use for MMR & Varicella.
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction and sickness. On an unknown date, the outcome of the adverse reaction was unknown and the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the adverse reaction and sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient who received SHINGRIX about 3 months ago before the date of reporting. The patient experienced a terrible reaction and was sick for 3 days. The patient hung up before any demographics or further details could be obtained.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 78-yaer-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 10-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805446 was crossed linked to original case 201804863 due to same reporter.
Fever,101.9 was highest; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever,101.9 was highest) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, the patient experienced PYREXIA (Fever,101.9 was highest). At the time of the report, PYREXIA (Fever,101.9 was highest) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.9 (High) 101.9 was highest.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided
An 18 year old female received 5 vaccines on 8-10-19 at our Shots clinic at the Fire Station.  Upon completion of the last vaccine ( MMR) she then slouched over and proceeded to lose consciousness for a total of 5-10 seconds.  She was then lowered to the floor and was given a cold compress and alcohol swab to sniff. She was given a juice box before the shots were administered and was instructed to keep sipping on the juice. Paramedics then stepped in and monitored her status.  They were able to get her off the ground and onto the stretcher where they moved her head up gradually.  Pt stated no SOB and or nausea. She recovered within 15 minutes and was escorted out to her mothers car to be transported home.  VAERS COMPLETED 8/13/2019 Pt stated she did not eat breakfast that morning, therefore a juice was given to her before shots were administered. She drank about half before passing out with the last vaccine.  It was also very warm where the shots were being administered.   Mom stated after the incident that her other child passes out as well..... and that they do not like needles. Education was provided to the parent and patient to always eat breakfast before getting shots. They were also instructed for future visits to always let the nurse know that the patient has a history of passing out and that we can give the shots laying down if needed .
anaphylactic shock (wheezing, coughing, swelling of face and arm, fast heartbeat, trouble breathing & hives)
Patient came in for 11 yr old vaccines and was given Kinrix by mistake. Patient has not followed up since the event.
Pt was to receive 0.25 ml booster dose Sars-2-COVID, instead received 0.50ml dose. "Dizzy if I stood up fast for a few days." per patient.
DRY COUGH; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (DRY COUGH) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Arthritis and Blood pressure.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced COUGH (DRY COUGH). On 31-Jan-2021, COUGH (DRY COUGH) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concurrent medications included medication for treating arthritis and blood pressure. Treatment medication was not reported.
Very soon after vaccine dose, patient began having unrelenting headaches. Causes awakening in early AM.  Work-Up in progress;  Note: Patient has strong family history of clotting disorder
Wokeup at 4:30 AM with extreme body aches. The body aches were so intense I felt like I had the flu. I was so cold and felt like I had a fever but my body temperature was normal. I also had a throbbing headache and was so fatigued I slept until 3:00 PM. Felt completely back to myself 48 hours after the vaccine was given.
VACCINE WAS FROZEN BEFORE GIVEN TO PATIENT; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported and batch number: 1820095 expiry: 04-JUL-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced vaccine was frozen before given to subject. The action taken with covid-19 vaccine  was not applicable. The outcome of vaccine was frozen before given to patient was not reported. This report was non-serious.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 17Feb2021 as dose 2, single (Lot number: EN9581), in right arm and on 25Oct2021 as dose 3 (booster), single (Lot number: 32030BD) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diverticulitis" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: ZOVIRAX [ACICLOVIR]; LEVOTHYROXINE; VITAMIN D3; ALLERCLEAR; ROBITUSSIN DM; FLUTICASONE PROPIONATE; ACETAMINOPHEN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti viral details COVID 19 Treatment, brand Paxlovid. treatment start date was 24Aug2022 treatment stop date was 25Aug2022 .  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Itchy rash on various parts of the body, arms, legs, stomach.  It seemed better and then received 2nd vaccine the end of  February.  It seems like it gets better but not completely gone and then flares up again.    I am using soap, no change in detergents, loratadine daily.    ( I see on the internet that others have noted a rash on different parts of body besides the injection site so felt I should note mine as well)
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of an unknown age and unknown gender. On multiple unspecified dates, the multiple unspecified patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # L020003, expiration date: 02-JUN-2015) (dose, strength, dose number, vaccination site, route of administration was not provided). There were no adverse effects reported. It was also reported that reporter inquired about the stability of VARIVAX (Merck) with lot # L026410 and expiration date; 15-FEB-2015, but none of this lot number and expiration date of VARIVAX (Merck) has been administered to patients. Additional information has been requested.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Massive outbreak of urticaria/Hives) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced RASH (Rash). On 22-Jan-2021, the patient experienced URTICARIA (Massive outbreak of urticaria/Hives) (seriousness criterion medically significant). On 26-Jan-2021, the patient experienced SKIN REACTION (Delayed reaction). At the time of the report, URTICARIA (Massive outbreak of urticaria/Hives), SKIN REACTION (Delayed reaction) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case concerns a 80-year-old female with a serious unexpected event  of urticaria, and nonserious unexpected skin reaction and expected rash. Latency 8 days after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 80-year-old female with a serious unexpected event  of urticaria, and nonserious unexpected skin reaction and expected rash. Latency 8 days after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 07-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 72 hours, the lowest recorded temperature was 28F (-2.222 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Patient stated her arm was very sore, warm to the touch, itching and a large rash around the vaccination site.  Informed the patient to go in to get it checked out and to take some Tylenol for the pain and could take benadryl for the itching. Informed if it wasn't getting any better to go into urgent care to get it looked at.
This spontaneous report was received from a registered nurse refers to a 20 years old patient of unknown gender. Medical history was not reported. On 11-JUN-2014 the patient was vaccinated with ZOSTAVAX, lot number, expiration date, strength, dosage and route was not reported. Concomitant therapy was not reported. The reported informed the on 11-JUN-2014 the patient was mistakenly administered ZOSTAVAX instead of VARIVAX. No adverse effects were reported. Additional information is not expected.
I started feeling bad the first night. I woke up with energy @ 1am and then later that day I started feeling extremely drain and exhausted and very tired and weak. I woke up @ 11:30pm and I passed out and hit hit the floor, face first and my wife don't know how long I was passed out up to 30- to 60 mins. I had to put frozen meat on my face. I felt like I was about to pass out again. Felt like my legs was giving out. I do have a spinal disease and it felt worse then that. Then it took my headache away. I felt like a different person.
postherpetic neuralgia; cardiovascular event; vision problems; balance problems; multiple outbreaks of herpes zoster; Information has been received from a lawyer, regarding a case in litigation, concerning a currently approximately 70 years old patient (pt) of unknown and gender. There was no information provided regarding the pt's concurrent conditions, medical history or concomitant medications. On or about 07-APR-2015, the pt was administered the zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, anatomical location, and route of administration were not reported) by a pharmacist at the pharmacy for the long-term prevention of shingles and zoster-related conditions. On an unknown date, reported as subsequently to the zoster vaccine live (ZOSTAVAX) administration, the pt was treated by providers for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: multiple outbreaks of herpes zoster, postherpetic neuralgia, cardiovascular event, vision problems and balance problems. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
chills; low grade fever; achiness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (low grade fever) and MYALGIA (achiness) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced CHILLS (chills), PYREXIA (low grade fever) and MYALGIA (achiness). At the time of the report, CHILLS (chills), PYREXIA (low grade fever) and MYALGIA (achiness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.  The events lasted for 24 hours.
Fever, fatigue, nausea, severe body aches, malaise, swollen lymph nodes under arm on left side, the injection side after 3 days post shot. Symptoms started the morning after and lasted for 3 days, except the lymph node swelling which started 3 days postshot and lasted sore and painful for 2 days. No prior vaccine issues ever, including yearly flu shot First dose of moderna was bad enough, second dose was almost as bad as previous covid infection 13 months prior, but did not last as long The likelihood of me returning for a booster is doubtful, even though I believe in vaccinations. The cure should not be as severe as the disease.
Small rash at injection site days 2-4 and it went away. A larger rash (Covid Arm) showed up on day 8 - redness, slightly raised, and warm to the touch.
SkinRash, Rahs, employee had itchy red rash all over body Narrative:  Pt developed COVID 2 days post vaccination. Has been under doctor's care since.
Reported to me by onsite staff:  Patient seemed to tolerate the vaccine fine at time of administration.  Following day (appx 24 hours) following administration, patient was having fever and unresponsive.  Patient also had local, large, hard hematoma at injection site.  It is worth noting that the patient had recently completed CDC recommended isolation protocol, and was symptom free at time of administration - determining they were qualified to get vaccine.  The facility is also aware that the patient's present condition could be related to an active COVID 19 infection / relapse.
1005 Pt received vaccine. 1010  pt had  sudden onset shortness of breath, dizziness, nausea, vomiting, confusion. Vitals obtained and blood pressure and heart rate elevated. Injection site swollen, warm, reddened. Pt was administered Benadryl 50 mg x1 IM, Phenergan 25 mg x1 IM, Solu-Medrol 125 mg x 1 IM, and used her ProAir inhaler 2 puffs. Pt was oriented but slow to respond. Per provider request, EMS notified to transfer pt to Hospital ER.
Initial information was received on 04 September 2009 from a consumer. A female patient with no reported past medical history received an influenza vaccine on an unspecified date (manufacturer, lot number, route, site of administration and number of previous doses were not reported). Following vaccination, the patient stated that she developed diabetes. She also reported that her diabetes medication (medication not specified) caused her "heart problems". No additional information was provided. List of Documents held by sender: none.
rash on back and side; Large red itchy bumps; bumps are sore with a little pain; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old non- pregnant female patient received bnt162b2 (BNT162B2) formulation solution for injection, dose 2 (Lot Number: EN5318 expiry date was unknown) via an unspecified route of administration at arm Left on 26Feb2021 13:45 (at the age of 63-years-old) as a single dose for covid-19 immunisation. Medical history included hiv infection from an unknown date and unknown if ongoing HIV undetected viral load, hypertension from an unknown date and unknown if ongoing High blood pressure. The patient previously took codeine and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation. Patient had known allergies with Codeine. Historical vaccine dose 1 (Lot Number: EN518 expiry date was unknown) via unspecified route of administration at arm right on 29-JAN-2021 as a single for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.Other medications in two weeks: Same maintenance medications as before first shot. On 06Mar2021 rash on back and side. Large red itchy bumps that have fluid inside. The risings vary in size. The largest bump was the size of a dime that has burst and has a black scab. The other bumps are in a line along her waist and are approximately 1/4 of a dime. There was also a bump on her ear. The bumps are sore with a little pain. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 04Mar2021. No treatment was given for adverse events. Outcome of the events was on rash was unknown and other events was unknown.    No follow-up attempts are possible. No further information is expected.
- This is client's 1st dose, client is a receptionist at the Health Department - Day of vaccination (12/28/2020): swelling at injection site, bruising & headaches - Day 1 (12/29/2020) through Day 7 (01/04/2021): swelling, bruising & headaches - Day 8 (01/05/2021) : abscess-looking bump to left deltoid area (the size of a small tangerine), itching to site, redness (mild-rash-looking), warm to touch, tender, pain to site, and states "feels as if something stung" - Client was sent home from work today (01/05/2021) mid morning and went to see Dr. from Primary Care - Clinic - Client states MD told her that reaction was from vaccine, to monitor reaction, to take over-the-counter Benadryl orally, to apply cold compresses, and was given release letter to return back to work on Wednesday 01/06/2021