chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unspecified date in 2014 (reported as "vaccinations occurred between 13-OCT-2014 and 17-NOV-2014"), an unspecified number of patients received RECOMBIVAX HB (doses, routes of administration, lot # and expiration dates were not reported) stored at 33F for 3 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Within minutes of patient receiving vaccine, patient began to feel lightheaded and skin color began to turn white. Patient parked by EMS in observation parking and became unresponsive. EMS began vital signs and tried to get him to wake up. Patient stayed unresponsive and vital signs continued to decline. EMS transported patient to hospital. Upon arrival to hospital, staff conducted EKG, chest x-ray, and blood work. All tests came back normal. Patient began to become coherent, and staff began to try and feed him and get him up. After patient was able to get self up and eat food, he was sent home. Patient is now at home recovering. He states he only feels a sore arm and is fatigued.
reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.   On 16-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of -40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several cases, from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
sore throat; Intense body pain; back pain is sharp and burning, from the back of shoulder blades; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), MYALGIA (Intense body pain) and ARTHRALGIA (back pain is sharp and burning, from the back of shoulder blades) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013220A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), MYALGIA (Intense body pain) and ARTHRALGIA (back pain is sharp and burning, from the back of shoulder blades). At the time of the report, OROPHARYNGEAL PAIN (sore throat), MYALGIA (Intense body pain) and ARTHRALGIA (back pain is sharp and burning, from the back of shoulder blades) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: No specific follow-up information recorded.
The morning of May 6 started chills, aches , nausea, fever, continued into  next day. Fever & Nausea continue day 2  No appetite. Day 3 was able to get out of bed No appetite Nausea and feverish. Day 4 lack of energy no appetite diarrhea. Day5 still no appetite stomach aches muscle aches fatigue little appetite. Day6 still little appetite fatigue stomach aches Day 7 fatigue little appetite diarrhea Day 8 same
8JUL92 fever 101 x 24 hrs; 8JUL92 rash, joint pain, 2hrs screaming episode, staring, inconsolable screaming, joint pain;
left arm got sore; she got tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm got sore) and FATIGUE (she got tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (left arm got sore) and FATIGUE (she got tired). At the time of the report, VACCINATION SITE PAIN (left arm got sore) and FATIGUE (she got tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment Ibuprofen
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 28 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pre-diabetic" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "GERD" (unspecified if ongoing); "known allergies: dust mites" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Gardasil vaccine, reaction(s): "known allergies: Gardasil vaccine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  No follow-up attempts are possible. No further information is expected.
Pain; Really tired; Nausea; Fatigue; Joint pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), FATIGUE (Really tired), NAUSEA (Nausea), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concomitant products included PREDNISONE for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 30-Apr-2022, the patient experienced NAUSEA (Nausea), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN (Pain) and FATIGUE (Really tired). On 02-May-2022, NAUSEA (Nausea), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and HEADACHE (Headache) had resolved. At the time of the report, PAIN (Pain) and FATIGUE (Really tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: result not provided Result not Provided.         No concomitant medication information was provided. No treatment medication were provided.
PT SAID SHE IS FEELING SOMETHING IN MIDDLE OF CHEST. I ASKED IF CHEST PAIN SHE SAID NO, I ASKED IF ACID REFLUX BUT SAID NO. SHE IS NOT SURE HOW TO DESCRIBE. MAYBE ANXIOUS AFTER GETTING VACCINE. SUGGESTED TO CALL HER MD. PT SAID SHE HAD RASH AFTER VACCINE BUT GOING AWAY NOW.
right eye right peripheral vision became starburst; This is a spontaneous report from non-contactable healthcare professional (patient). A 56-year-old female patient received the first dose of bnt162b2 (BNT162B2; lot number EL3248), intramuscular on the right arm on 07Jan2021 at 15:45 at a single dose in the hospital for covid-19 immunisation. Medical history included myasthenia gravis. The patient did not have COVID prior vaccination. The patient was not pregnant at the time of report. The patient received unspecified concomitant medications (other medications received in two weeks). On 08Jan2021 at 08:15 (also reported as approximately 18 hours post injection), the patient's right eye right peripheral vision became starburst. It was odd enough that patient thought it should be reported even if it might be coincidence. The patient did not receive treatment for the event. Vision resolved in about 45 minutes, on 08Jan2021 at 09:00.   No follow-up attempts are possible. No further information is expected.
I95.9 HYPOTENSION 10/27/2021 ACUTE RENAL FAILURE, UNSPECIFIED I95.9 HYPOTENSION 10/27/2021 HEART FAILURE W REDUCED LVEF <=30%, UNSPECIFIED ACUITY I95.9 HYPOTENSION 10/27/2021 ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE
I received the vaccine on Friday afternoon at 4 and woke up on Friday night being extremely nauseous followed by chills and sweats. Saturday I felt achy and a little unsteady when I got up or walked around (these reactions I expected). Sunday morning I woke up covered head to toe in hives that lasted for three days. I have never had hives so bad before. I called the pharmacy and was instructed to take Benedryl which didn't work. I took Allegra on Tuesday which seemed to help clear them up by the end of the day.
I had extreme flu-like reactions - chills, fever, body aches, headache, fatigue, sour stomach. I had to take work off the next day as I was so tired/ill feeling.
BODY ACHE; CHILLS; FEVER; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced body ache, chills, fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, body ache and nausea was not reported. This report was non-serious.
Approximately 16 hours post vax pt woke up feeling sick with headache, body aches, dizziness, nausea and vomiting. Pt was treated with ibuprofen.
Extreme soreness through body. Arms, legs, back soreness - felt like it was in the muscles. Sleep was the only thing that made it feel better. Lasted about 24 hours. Small headache.
Redness, swelling, warmth R hand at  dorsal aspect around thumb and  between first knuckle
pt states she sometimes feels that her arm is not as strong as it was prior to imz, not all the time, just ocassionally.  when asked if it was problematic enough for her to avoid the second shingrix, she said no, she definitely wants the second shot.
This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 18-year-old female patient who received ENGERIX B. In August 2014, the patient received the 2nd dose of ENGERIX B .5 ml. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional information received: The pharmacist is not sure if the patient received her first or second dose of the ENGERIX B vaccine in August. The patient is trying to get the next dose of the ENGERIX B vaccine. If she received the first dose of the ENGERIX B vaccine in August then she is technically not receiving a late dose now. If she received the second dose of the ENGERIX B vaccine in August then she is late for her third dose.
This spontaneous report was received from a consumer referring to a 14 year old male patient. The patient's concurrent conditions and medical history were not provided. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route, lot # and expiration date were not provided). Concomitant therapies were not reported. On an unspecified date the patient died. It was unknown if an autopsy was performed and which was the exact cause of death. On an unknown date the reporter wrote on the "Merck Corporate Twitter Account". The relatedness between death and GARDASIL was unknown. Additional information is not expected as the reporter did not provide contact details.
Pain in right nipple. It hurts to touch. It can't be touched even by a towel without pain. It lasted about 3.5 weeks and now that I got next vaccine it started again. Only the right nipple and not left. I had a dramatic amount of more breastmilk in that breast so not sure if it is related.
pt devel reddened area, warm to touch on rt deltoid red pine pinpoint dots on deltoid moving under arm;immun given 16FEB98;pt was seen on 18FEB98 & referred to clinic w/DPH & ATB x 10 days;
PATIENT ADMITTED TO OUR HOSPITAL AFTER A FALL.  FOUND TO BE HYPOXIC IN OUR EMERGENCY ROOM.  COVID TESTING COMPLETED AND COVID PCR POSITIVE ON 2/1/22.  COVID BREAKTHROUGH CASE IN FULLY VACCINATED INDIVIDUAL
Went and had a COVID test and we have positive COVID-19; Went and had a COVID test and we have positive COVID-19; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.   An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), the first dose on Feb2021, then the second dose on Mar2021, both via an unspecified route of administration (at the age of 84-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer stated, "I just wanted to report that we had our Pfizer COVID Vaccination in Feb and Mar, my husband and I. And about a week and a half ago, 2 weeks we didn't feel well, went and had a COVID test and we have positive COVID-19. And my husband is (Name) and it 'affected' (voice feeble) both of us." When confirmed if it was the Pfizer vaccine, consumer stated, "Yes, we both have positive. It's been 2 weeks and one and a half week since he was tested and I was tested. 2 weeks ago he was tested positive and I was a week and a half positive. I want to report it and I want to know how many has there been other instances and what are some of the symptoms like I have nausea and my husband just 'doesn't, feel aches' (not clarified further), so all over he doesn't feel good he had a temperature a 102, a 101 for a couple of days. So, like we had the flu or something you know very discouraging." The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on an unspecified date. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : 2021466304 same reporter/drug, different patients, similar events; PFIZER INC-2021466304 Same reporter, drug, and events; different patient
On 11/18/00, the pt's deltoid became red and puffy. Went to ER, abscess exploded, physician then drained and packed site. Started on Keflex.
Shingles; This initial spontaneous report was received from a lawyer on 04-MAR-2020, regarding a case in litigation and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 17-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long term prevention of shingles and zoster-related conditions (additional dosage regimen information was not provided). Subsequently, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of vaccination with zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to mental and physical pain and suffering, medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and cost include care for hospitalization, physician care, monitoring, treatment, medications, and supplies, diminished capacity for the enjoyment of life, diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions, and other losses and damages, and would continue to suffer such losses and damages in the future.
Day 6 post injection, site turned red and felt hot.  Began to itch at injection site.  Within a few hours, inching spread to upper portion of entire body including scalp.  Feverish, cold chills, fatigue started approximately 6 hours after itching onset.
Pt received Flu immunization in am and then 4 hours later developed hives, coughing, wheezing, difficulty breathing. Child taken to ER and received Albuterol neb, Benadryl PO and Prelone PO. Child went home on Benadryl and Prelone PO x 4 days and recovered well.  Final dx: acute urticaria & bronchospasm./ss
Sick; This is a spontaneous report from a contactable consumer. This consumer (patient's grandmother) reported for a male patient (reporter's grandson). A male patient of an unknown age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and Expiration Date: not reported) via an unspecified route of administration, on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. The patients medical history and concomitant medication(s) are not reported. The patient previously took first vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and Expiration Date: not reported) via an unspecified route of administration, on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date the caller reported that her grandson got the second shot, they did get sick. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (16Sep2021):  Information about lot/batch number cannot be obtained. No further information expected
Two adult pts who were each vaccinated with the second dose of varicella virus vaccine live were revealed to have a lack of seroconversion. No other adverse experiences were noted.
Extreme exhaustion for four hours the morning after receiving the vaccine.  No treatment; stayed in bed for those four hours, then felt better and got up.
Severe pain in left knee after few days of second vaccine shot. Slight pain started in right knee  - pain while walking or standing for a long period of time
normal vaccine reactions (sore arm, swollen lymph nodes, tiredness, body aches) developed sudden hypertension 1/10/2021 (urgent hypertensive crisis), PCP put me on metroprolol succinate ER 50mg q24
experiencing left hand/fingers- redness; experiencing left hand/fingers- tingling; experiencing left hand/fingers- numb/burning/pain; experiencing left hand/fingers- numb/burning/pain; experiencing left hand/fingers- numb/burning/pain; This is a spontaneous report from a contactable consumer (patient's boyfriend).   A 25 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 05Mar2021 at 09:40 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 05Mar2021 at 09:40. About 2 hours after she was administered the vaccine she started to develop symptoms of 2 or 3 of her left fingers started to feel tingling, burning, numb and having redness. At the time of the reporting events outcome was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected
Little bit of fever on and off; Headache; being tired comes on and off; This is a spontaneous report received from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient got the vaccine last Tuesday and still having a little bit of fever on and off, headache and being tired on an unspecified date. Mainly that was headache while fever and being tired comes on and off on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
burning skin; tremors; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (tremors), SKIN BURNING SENSATION (burning skin) and NAUSEA (nausea) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 039B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 26-Mar-2021, the patient experienced NAUSEA (nausea). On 28-Mar-2021, the patient experienced TREMOR (tremors). On 04-Apr-2021, the patient experienced SKIN BURNING SENSATION (burning skin). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) for Symptomatic treatment, at an unspecified dose and frequency. On 11-Apr-2021, TREMOR (tremors) had resolved. At the time of the report, SKIN BURNING SENSATION (burning skin) outcome was unknown and NAUSEA (nausea) had resolved.            Treatment medications also included steroids.   This case was linked to MOD-2021-089502 (Patient Link).