chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Migraine; Mild pain at injection site; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 53-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 4178) Intramuscular on 08Jan2021 09:15 AM at left arm at single dose for COVID -19 immunization in Hospital. Medical history was none. No Known allergies. Concomitant medication in two weeks included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). No other vaccine in four weeks. Patient receive the first dose of bnt162b2 (lot number: EK5730), intramuscularly on the left arm on 18Dec2020 at 13:15 at single dose for COVID-19 immunization and experienced injection site soreness (Day 1 and Day 2) and mild headache (Day 2). Patient experienced mild pain at injection site (Day 1 and Day2, 08Jan2021 12:00 PM) and Migraine (Day 2, 08Jan2021 12:00). COVID was not tested post vaccination. No treatment received. Patient was recovered from the events in Jan2021.
pt received pfizer #2 on 2/20.  on ~3/7 family noticed that he was waking up at night more than his usual.  They noticed that the patient was more lethargic and was starting to have visual hallucinations.  Reportedly, the patient never endorsed any fevers or chills, neither did he complain of headaches.  He also reported that the patient had been having a nonproductive cough since 3/3, constipation around this time.  he was admitted 3/10 with altered mental status, respiratory failure s/p intubation.  difficult LP, no cell count, had elevated protein.  hospital course complicated by delirium, gout flare.   he was empirically treated with broad spectrum abx bacterial and viral meningitis, completed 5/6, without significant improvement in mental status.  repeat LP concerning for possible autoimmune encephalitis, started on steroids.
injection site pain; tiredness; headache; nausea; bad chills; fever; muscle pain; no motivation; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she and her mother took the Pfizer covid vaccine on Saturday. Patient's mother (94-year-old female) did not experienced any side effects but the patient experienced tiredness, headache, nausea, bad chills, fever, muscle pain, no motivation, injection site pain on an unspecified date in Jan2021. She took Tylenol, Aleve, feeling better tonight but still have few chills. The patient wanted to know if it is safe to take the second dose, if the second dose is worse and if is it the same medication. Chills had not resolved, while the remaining events were resolving.  Information on Lot/batch number has been requested.
Initial unsolicited report received from a pharmacist on 29 September 2015. This case involves a 50-year-old female patient who was vaccinated with a dose of FLUZONE QIV (batch number: U5310DA, expiry date, dose, dose in series were not reported) intramuscularly in left deltoid on 22 September 2015. The patient's medical history was not reported and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as pre-existing physician diagnosed allergies, birth defects, medical conditions reported as allergies: none known. Concomitant medications were not reported. On 26 September 2015, four days following the vaccination, the patient had experienced headache and a metallic taste. Laboratory data and corrective treatment were not reported. The patient was not recovered from the events. List of documents held by sender: none. Follow-up information received from a pharmacist on 06 November 2015. It was reported that patient received 0.5 ml of FLUZONE QIV. No additional information to provide.
1 person received Shingrix Adjuvant only; 1 person received Shingrix Adjuvant only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: Thre age at vaccination was not reported. The reporter stated that, there was 1 patient who received the Shingrix Adjuvant only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. All patients might receive 3 doses because they were unaware who received the diluent  only. The reporter consented to follow up. This case was linked with case US2021AMR238167, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR238167:Same reporter
stomach upset; felt nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach upset) and NAUSEA (felt nausea) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced NAUSEA (felt nausea). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach upset). At the time of the report, ABDOMINAL DISCOMFORT (stomach upset) and NAUSEA (felt nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Initially chills, achy, and sore arm, but then ok. Then that evening/next morning developed lip swelling and rash. Then now sore throat and no so dry. Said had to go to urgent care and they gave a cortisone shot and Medrol dosepak
flu like symptoms after receiving the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of  patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable to this report. An unknown number of patients were vaccinated with 1st dose of Shingrix. The  day or day after vaccination patients were experienced flu like symptoms. The symptoms were lasted for 3-7 days. No further details available. The reporter consent to follow up. This was 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020209434:same reporter US-GLAXOSMITHKLINE-US2020209432:same reporter US-GLAXOSMITHKLINE-US2020209416:same reporter
Pt recvd 1st dose of Engerix-B 26MAR92 & 27APR92 recvd 2nd dose & 30 mins later exp breathing difficulties & lost pulse; events reported as being immediately life threatening; pt hospitalized x 2 days; recvd tx w/prescription meds;
Narrative: one week after he got Moderna vaccine #1 on 1.29.2021/2.26.2021 he developed morning stiffness that was progressively getting worse. seen at ER and was DX with RA and currenlty on Presdnosine 10 daily
Patient stated that on the second day after the vaccine he started experiencing flu like symptoms. Patient stated that every since he received the vaccine he has developed a dry cough that will not go away.
Itching on Neck, Upper Legs at Hip area, Face seems to be irritated with little whelps,  Fingers and right arm around the wrist itching as well.   Lower stomach area.  Right now it just looks irritated but seems like it is getting worse.  I feel like my body is getting ready to go into Hives.   Called Pharmacy and they agreed with me to Start Benadryl.
Accidental overdose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Accidental overdose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced ACCIDENTAL OVERDOSE (Accidental overdose). At the time of the report, ACCIDENTAL OVERDOSE (Accidental overdose) outcome was unknown. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitent medications were provided  No treatment medications were provided
A perfectly healthy guy, who did not change anything else in his life, got the first vaccination, and 12 days later had a blood clot in his right lung.  Went to ER, was diagnosed, and spent 3 days in the hospital.   Serious.  Doctors so far has no explanation for why this happened.
tested positive for covid; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for covid) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was told she needed to wait 90 days for second vaccine. Concomitant medications were not provided. Treatment medication included infusion.
EXTREME TIREDNESS; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic, stomach problem, penicillin allergy, drug allergy (Aspirin), allergic to alcohol, no alcohol use, and no smoking, and other pre-existing medical conditions included: There was no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 68 years old. No concomitant medications were reported. On an unspecified date, the patient experienced extreme tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extreme tiredness was not reported. This report was non-serious. This case, involving the same patient is linked to 20220913752. This case, from the same reporter is linked to 20220911986.
numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE); felt acutely short of breath and anxious; felt acutely short of breath and anxious; numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE); This is a spontaneous report from a contactable physician. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 28Jan2021 16:00 (at the age of 47 years old) at a single dose for covid-19 immunization. Medical history included known allergies: shellfish, seasonal allergies and psoriasis. Concomitant medications included several medications in two weeks. The patient is not pregnant. The patient had no other vaccine in four weeks. On 29Jan2021 23:45, after being asleep for approximately one hour, felt acutely short of breath and anxious, which lasted less than a minute and was then followed by numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE). These events resulted in emergency room visit. The patient underwent lab tests and procedures which included PCR/nasal swab on 29Jan2021 (post vaccination) which showed negative. Therapeutic measures were taken as a result of all the events which included diphenhydramine (BENADRYL), IVF. Outcome of all the events was recovering.   Information on the lot/batch number has been requested.
extreme/debilitating fatigue. Patient already have chronic fatigue and after receiving the vaccination, it made the chronic fatigue worse/ extremely tired; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included  chronic fatigue. The patient's concomitant medications were not reported.  On an unspecified date, the patient experienced extreme/debilitating fatigue. Patient already have chronic fatigue and after receiving the vaccination, it made the chronic fatigue worse. Patient was extremely tired. Patient called to make sure that the side effect is common. The outcome of the event was not recovered.  Information about lot/batch number has been requested.
Approximately 1 week after I received the COVID 19 vaccine I developed a large red circular rash around where the injection site was. It was raised and extremely itchy and irritating. It lasted about 3-4 days.
Light headedness, dizziness, tingling/numbness in lower legs, faintness, blurry vision out of body experience, head ache sore/tender lymph nodes in armpit
Patient started having hives and itching 1-2 hours after vax. Mother had taken to park at this time she took child home and gave a bath thinking pt had got something on her. Condition worsened with increased hives and coughing. Mother took child to ER, was treated for allergic reaction. Given Benadryl sent home.
Headache, Myalgia, CoughWheeze, Diarrhea, NauseaVomiting, injection site reaction, chills, fatigue Narrative:  Employee reports "cough, sore/painful/body aches". Additionally reports injection site pain/discomfort, chills, headache, joint pain, body aches, fatigue, and stomach upset. Reports used naproxen to treat. Also reports elevated blood pressure, though does not give readings.
SORE ARM, FATIGUE, BODY ACHES, PAIN IN RIGHT ARM DOWN TO HAND
Information has been received from a physician concerning two MMR II (Lot# 0450AA is an invalid lot number for MMR II) might have been given. the vaccine were exposed to 50F for 24 hours and to 28F for 3 hours. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Patient received vaccines in office. Later that night broke out in hives around the vaccine site. Patient is favoring the leg. No treatment needed. Hives went away on its own.
Smallpox vaccine given 30Nov07. Patient states his Left arm began swelling a few days after injection date.  When he came in to have us view his localized reaction, the swelling and redness  in the area was encompassing his entire deltoid.  His swelling/redness was radiating to near his elbow area. Tricep area not affected.
PT STATES SHE HAD 'CARDIAC SYMPTOMS WITHIN 24HR OF DOSE #1 AND DOES NOT WANT DOSE #2.  HAD PALPITATIONS, SOB, FELT EXHAUSTED LASTING 10-30MIN OFF AND ON X 2 DAYS AND 02 SAT WAS 96% AT ONE TIME.'
I have had psoriasis for about 20 years. It has always been pretty static. It was on my head and elbows. After the second COVID  vaccination on March 31, the psoriasis was all over my body and it also changed in appearance. Some of the areas were harder than others and some of the areas were  just red and smooth. Hard to describe without images.  I have not yet seen a dermatologist. I have always managed it through diet. Now nothing seems to work. It's hard for me to imagine this was not related to the vaccine.
01/16/2021 1210 Per Vaccinator, "While injecting the vaccine, there was resistance when inserting the plunger.  Pushed plunger down until the end of the syringe.  When pulling out, additional fluid exited arm and syringe. Full dose not delivered.  Needle is not retracted.  Syringe and needle capped.  Plunger in down position."  01/19/2021 Follow-up phone call to individual who reported feeling well without any side effects (aside from the expected minor achy left arm) to report.  Individual advised to inform her primary health care provider for any changes in health status post-vaccination and to report the partial dose with the manufacturer's lot number.
Pt recvd vax & 12 hrs p/vax exp circumscribed rash on thigh which pt said tingled like genital herpes; reported indicated that this may have been a herpes rash; blisters are now less severe;
As with the first shot, I was very fatigued and achy.  A day or two after the shot I began having pain in the left side of my chest.  It was a tight feeling that made it difficult to breathe.  The pain only got worse and after a couple of days, I decided to go to the emergency room as I feared I was having some kind of heart attack.
At night sleep on April 17, I wake up by a sharp pain on top my left head and on and off since then until April 18 morning.  And the pain were not severe and keep on and off through out April 18. I felt right armpit and a rounding area bold vessels hurt since April 16.
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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Lot number: Fk9894) at the age of 68 years 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: "Renal disease" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Dec2020, stop date: 25Jul2022; VALSARTAN+HYDROCHLOROTHIAZIDE; VITAMIN B 12 [CYANOCOBALAMIN]; CRANBERRY; FISH OIL; TURMERIC [CURCUMA LONGA]; ASPIRIN [ACETYLSALICYLIC ACID]; ZINC; COQ10 [UBIDECARENONE], stop date: 25Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient received treatment Paxlovid from 25Jul2022 to 30Jul2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: Testing positive again due Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.
Headache, Myalgia & NauseaVomiting  Narrative: pt had headache, nausea, weakness, fatique,  pain & swelling redness and heat to the injection site.
Generalized pruritis, tachycardia (HR~100), tachypnea.
No additional adverse effects reported.; patient received improperly stored dose of VARIVAX which was administered via unspecified route.; This spontaneous report was received from a physician referring to a patient of unknown age and unknown gender. The patient's concomitant therapy included sterile diluent. Information about pertinent medical history, concurrent condition and drug reaction/allergy was not provided.    On 20-MAR-2020, the patient was vaccinated with improperly stored 1 dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S025609, expiration date 18-AUG-2021; strength, dose detail and route was not reported) for prophylaxis (improper storage of product in use). The vaccine was exposed to temperature excursion of  15 Fahrenheit degree to 46 Fahrenheit degree (also reported as -9 Celsius degree to 8 Celsius degree) (also reported as -5.48 Celsius degree) for 7 hours. No previous temperature excursion. No additional adverse effects was reported. The sterile diluent used to reconstitute the varicella virus vaccine live (oka/merck)(VARIVAX) was stored properly. Data logger was involved. The outcome of the event improper storage of product in use was unknown.
PAIN AND HOT WITH LARGE REDDENED AREA AT INJECTION SITE LASTING 1 WEEK / NO TREATMENT GIVEN.
It started our with numbness on the left hand that eventually went away.  Soreness on the arm and injection site.  Headache within 30 minutes of the shot.  Tylenol was given right away.  left side of the neck hurt. And she began to cry uncontrollably especially if she was laughing all throughout the day and night.  She took a 30 minute nap to see if the sore neck would go away.
my right arm over a week pain increased to a point that my upper arm became immobile.  It became swollen, no range of motion, could not lift it.. could only move from the elbow down.  Tylenol was not helping, nor ice, the pain was constant.. FINALLY today 7/16/19 I have full range of motion and can lift my arm away from my body.  the pain was horrible.
This patient broke out with mild case of chicken pox- unverified by the doctor 01/01. Received varicella 10/09/97.
Exhaustion, mild headache, achy all over, severe sore arm, sinus issues, sore throat , fever, chills
On 4/17/21 (ie within 48 hours of receiving COVID 19 Pfizer Shot #2 (4/15/21), my daughter began experiencing chest pain in the PM (PM of 4/17).  It was initially mild so we did a watch and wait overnight but when it did not go away by morning of 4/18/21 we went to Urgent Care  .  Upon presentation at urgent care, she had an irregular EKG, we were advised to immediately do to a Hospital ER , upon arrival she presented with same EKG findings from urgent care, BW was run and her troponin level was a 7, this hospital recommended (after consultation with their cardiologist) that based on her age and urgency of the heart condition, we should be transported to a pediatric hospital with cardiology expertise.  She was transported by ambulance to another Hospital, Cardiology Unit. .  After a scary 24 hour overnight stay at the hospital she was released on 4/19/21.
On 5/15/21 I started to get a rash that was the size of a grapefruit and I had to take Benadryl and steroids to get it to stop growing and it started out the size of a nickel. It lasted for 6 days till I had all of those medications in my system to get it to stop.