chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; Pain in my right knee; I had pain in my right leg moving around between thigh groin and knee; I had pain in my right leg moving around between thigh groin and knee; As I received my vaccine I immediately got pain in my right knee. Found it strange. Each day following for 4 days I had pain in my right leg moving around between thigh groin and knee. Day 5 rash brok; As I received my vaccine I immediately got pain in my right knee. Found it strange. Each day following for 4 days I had pain in my right leg moving around between thigh groin and knee. Day 5 rash brok; This is a spontaneous report from a contactable consumer (Patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection via an unspecified route of administration, administered in Arm Left on 16Apr2021 17:45 (at the age of 60-year-old) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included tetanus vaccine (TETANUS VACCINE) on 01Apr2021, metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET) and atorvastatin calcium (ATORVASTATIN CALCIUM). Patient had no known allergies. Patient was not diagnosed with COVID-19 prior vaccination. On 21Apr2021, the patient experienced shingles, pain in my right knee, had pain in my right leg moving around between thigh groin and knee, as he received vaccine immediately got pain in right knee. found it strange. each day following for 4 days had pain in right leg moving around between thigh groin and knee. day 5 rash brok. It was reported that, as he received his vaccine he immediately got pain in his right knee. Found it strange. Each day following for 4 days he had pain in his right leg moving around between thigh groin and knee. Day 5 rash broke out and was determined to be Shingles. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Apr2021. Therapeutic measures were taken as a result of adverse events, antiviral drug and pain meds. Event resulted into emergency Room and physician office visit. The outcome of events was recovering.   The lot number for [BNT162B2], was not provided and will be requested during follow up.
Swollen, red, soreness, feel exhausted, muscles ached, pinprick pain, unable to lift arm without pain, sleep disturbances, and feel tightness in the chest (may be from rain and asthma though). Not yet recovered, but it's been <2 days since vaccinated.
received Pfizer vaccines on 12/29/2020 and 1/19/2021 ER visit and hospitalized on 3/23/2021
4 inch x 4 inch in diameter, swelling on (L) thigh with warmth and redness. Treated with AUGMENTIN, 600 mg/5ml-25ml, PO, BID.
Given First Moderna covid vacc 1/19/2021.  Doing well on multiple contacts from health care providers, then 2/5/2021 was driving, pulled over to the side of the road into a yard, got out of the car and told an observer that he could not breathe, collapsed face down in the snow, EMS called, unable to revive him.
pt recv vax 1OCT97 & 2OCT97 pt c/o redness & soreness @ inj site that traversed down the arm to elbow;pt seen by MD & treated w/med;
12/22/22 presents to ED for "cough". PMHx of "renal transplant"
pt recvd vax 12AUG93; on morning of 14AUG93 pt was taken to hosp DOA; autopsy stated no gross abnormality; baby was reported healthy without problems following vaxs;
Flu-like symptoms-fever and chills. Per patient, temp 101 for much of time from 3/29-4/01/07 fever down with IBU (took 1 ibuprofen 600 mg every 6 hr). On 4/02/07, felt only slight headache; On 4/03/07 no symptoms at all, no headache, no fever, no chills
Started with pain in neck. Could not turn head. Polymyalgia. X-rays taken. Stated was muscle spasm. Put on prednisolone 5 wks. Muscle pain progressed to shoulders & hips. Could not raise legs or arms to comb hair. Placed on prednisone 20 mg/day. Will see rheumatologist.
2nd-dose 3/6/2021 -extreme fatigue, first 48hrs. -chills/shakes daily in evening starting day 3 through present
This initial spontaneous case, received from other non-health professional on 18-Oct-2017, concerning a 33-year-old female pregnant patient. The patient's concomitant medications included Prenatal vitamins. The patient's last menstrual period date (reported as 18-Aug-2017) and estimated date of delivery (reported as 25-May-2018). On 18-Oct-2017, the pregnant patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195213 and expiry date: 31-Mar-2018). The outcome of the event was not reported. The reporter assessed this case as non-serious.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received its 30-days Exp date; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2022 at 3:16 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Jan-2022 at 3:16 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Vaccine administration time was reported as 15:16:15. No treatment medications were reported.
Breakthrough case admission after 2 vaccines  Moderna 2/26/21 Lot# 010A21A;  Moderna 3/26/21 Lot# 018B21A
This spontaneous report was received from a physician refers to a patient of unknown age and gender. No further information was reported. In November 2009 the patient was vaccinated with ZOSTAVAX (dose, lot #, expiration date and route were not reported). On 01-AUG-2014 the patient experienced vaccination failure and got shingle. The outcome of the patient got shingle and vaccination failure was unknown. Additional information has been requested.
Had small red area initially after vaccine was given. 12 days later it increased to baseball size and is itchy. States she had similiar rxn with pneumonia vaccine in past.
Discharge Provider: DO Primary Care Physician at Discharge: MD  Admission Date: 5/11/2022  PRESENTING PROBLEM: Acute hypoxemic respiratory failure due to COVID-19 (HCC) [U07.1, J96.01]   HOSPITAL COURSE: Patient is a 74 year old male with a pmhx of severe COPD with O2 dependent, recent throat cancer on tube feeds, CAD, HTN, HLD, pulmonary HTN, and smoker. Patient had been short of breath and fatigued for the past three days. He was taken to PCP today and found to have 70% O2 saturations on his home 2L. EMS was called placed him on non-rebreather, gave solumedrol, and duoneb. Patient was in respiratory distress upon arrival with RR into the high 30's. He was found to have COVID-19 and CXR was concerning for a superimposed RLL pneumonia.  His initial VBG was ok and he was placed on bipap due to his respiratory distress. Patient then became lethargic, CO2 retention worsened and he became unresponsive.  Daughter stated she feels he has just given up with all he has been through. She has been updating family and she notes that he has made it well known he is to be a DNR/DNI. This is evident from prior hospitalizations. ER provider discussed withdrawing care but more family would like to be present so the patient was admitted to the hospital. Family said goodbyes and bipap O2 therapy was withdrawn. The patient passed away later that evening with family at the bedside. HE was given medications for comfort measures and respiratory dyspnea. Patient passed at 2132.
c/o dizziness, lightheaded, syncopal, BP 120/40, HR 80/min stable @ all times; recovered immediately; Epi given;
This case was reported by a physician via sales rep and described the occurrence of injection site reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site reaction and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX.
This spontaneous report was received from a Healthcare Worker refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of M-M-R II (lot#, expiry not reported). On an unknown date, the patient developed mumps after receiving the MMR II vaccine. The patient sought medical attention. The patient was hospitalized, for an unspecified duration, for the Mumps. The outcome of mumps was unknown. Additional information has been requested.
Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history was reported.     On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm pain). At the time of the report, VACCINATION SITE PAIN (Arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.
Red, swollen, hot at injection site. Felt a little bit better by 10/27/17 when she called the office.
on the evening of the injection, the patient began to experience redness to injection arm (entire arm) along with papular rash and severe itching
Rash Narrative: Developed golfball sized rash over site of vaccination, which started about a day after and persisted for about a day after and persisted for about a week. Described as erythematous and indurated. Not warm to touch or pruritic. No associated pain or sloughing, hives or other areas of swelling. No therapies applied or tried and no other adverse reactions reported.
Shingles pain beginning on upper back, lower neck.  Started a day or so after the vaccine.  Just as an itch and irritation and now has moved from left shoulder to a larger area and become painful.  Looks very red like I have scratched it when I do not touch it.
Throat felt swollen and was feeling tingling sensation in the mouth. Also complained of ear pain.
Dose 1/Dose 2/ Dose 3: Pfizer / BioNTech; Dose 4: Moderna; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex sensitivity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1/Dose 2/ Dose 3: Pfizer / BioNTech; Dose 4: Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Positive, notes: initial positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was so grateful she was able to get paxlovid while abroad in France. She tested negative on day 5 of treatment and remained negative (have been testing for rebound) until today, one week after completing the course, and 13 days after her initial positive test. So far she just had cold symptoms. When she first tested positive she had a very unpleasant sore throat, fatigue, lack of appetite, mild fever, and beginnings of a painful cough. Paxlovid stopped all of those things.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
shingles in her eye; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes zoster was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's neighbor. The age at vaccination was not reported. The patient received shingles shot and right after got shingles in right eye.
TESTED POSITIVE FOR COVIS VIA RAPID SWAB .  ASYMPTOMIC
1-20-15 Left arm site red warm swollen; felt tired and cold, irritable. Today 1-21-15 left is red swelling has gone down, symptoms are now milder than 1/20/15. Afebrile 97.5.
LETHARGIC; JOINT PAIN; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced lethargic, and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lethargic and joint pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20211130190.
Stomach cramps; nausea; headaches; chest heavy; sore throat; some swolling; body aches; coughing; tingling sensation on hands, feet and ankles; Moody tired feeling; Like I'm comin down with the flu; Puking; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient of received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the right arm on 09Jul2021 (at the age of 52-year-old)as a single dose for COVID-19 immunisation. Medical history included celiac disease, IBS bipolar, major depression, gastritis and hiatal hernia . The patient previously took paracetamol (TYLENOL), acetylsalicylic acid (ASPIRIN), celecoxib(CELEBREX), amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient has known allergy to penicillin, wheat, barley, rye, jalapeno and mesquite. The patient received other vaccine within four weeks prior to the vaccination. The patient received shingles shot (MANUFACTURER UNKNOWN) on 21Jun2021. On 16Jul2021 at 12:00 the patient experienced stomach cramps, puking, nausea, headaches, chest heavy, sore throat, some swelling, body aches, coughing, tingling sensation on hands, feet and ankles, moody tired feeling like she was coming down with the flu. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events stomach cramps, puking, nausea, headaches, chest heavy, sore throat, some swelling, body aches, coughing, tingling sensation on hands, feet and ankles, moody tired feeling like she was coming down with the flu was not recovered at the time of report.
Narrative: Hospitalization, Fully vaccinated, COVID positive (h/o asthma with ongoing cough)
Per office visit with Dr. 7/27/15 following the allergic reaction: Patient had Prevnar vaccine administration over L upper arm and has had swelling/itching/erythema/warmth over this arm, no mouth/throat/eyes/breathing issues or swelling.
My lips started tingling/burning a few days after the receiving the RSV vaccine.  The condition wasn?t terrible but it was bothersome.  It helped using lip balm. The condition has very slowly improved but has still not gone away. BTW I didn?t know which RSV vaccine I received so I just picked one of the ones listed above.
Left arm Tdap given on 2/10/06 pain started on 2/11/06. The arm was tender, warmth, slight edema, and red. Treatment was ice and alternate with heat, and Zyrtec and use the arm.
pt recv vax 13SEP96 to lt deltoid area;returned 16SEP for check of wound & arm noted to have approx 2inch knotted area in fatty SQ tissue in back of arm;sx appeared late afternoon p/inj;mild itching yet no pain;redness, area knotted/firm;
A few weeks after vaccination I was still having a sore left arm, it never went away, and then started having soreness on my shoulder and it never went away completely.
Patient received the second dose of the Moderna COVID-19 vaccine on 2/1/21. Early morning (0400) on 2/2/21, patient reported nausea, body aches, and severe headache. Patient treated initial side effects with acetaminophen 500mg every 6 hours for 4 doses. Upon awakening on 2/3/21 around 0700, patient noticed red, raised rash across face, neck, back, front of chest, abdomen, and bilateral arms. Patient reports rash was itchy and warm. Patient did not seek treatment initially upon noticing rash. Patient reported to work, at which time a supervisor instructed patient to seek medical evaluation in the emergency department. In the emergency department, patient received cetirizine 10mg and prednisone 40mg.
No additional AE details were available; shipment of GARDASIL 9 late/ the vaccine was in transit for too long; shipment of GARDASIL 9 late/ the vaccine was in transit for too long; This spontaneous report as received from a medical assistant referring to 12-year-old male patient. The patient's pertinent medical history, concurrent condition, and concomitant medication were not reported.    It was reported that there was a shipment of hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) late. It was tried to deliver the vaccines on 26-FEB-2021, but it was unable to and actually delivered in shipping container on 01-MAR-2021 at 09:38 am. On that day, the patient was vaccinated with hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml (lot# T008151 has been verified to be a valid lot number, expiration date 21-JUN-2022) intramuscularly for prophylaxis at the private doctor's office/hospital  by trained healthcare professional (product distribution issue and circumstance or information capable of leading to medication error). The reporter reported the events to doctor and manufacturer previously. As a result of a reading from a digital data logger, there was no temperature excursion. The vaccine was available for return/evaluation. No additional adverse event was reported (no adverse event) and no drug treatment was prescribed for the experience. It was also reported that when reporter received an email regarding the vaccines were in transit for too long, they immediately stopped administering vaccines.  This is one of two reports received 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: T008151; expirationdate: 21-JUN-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; productavailableforevaluation: Yes; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513- 2103USA001248:
Body covered in hives, shortness of breathe, none of which is reactive to steroid injections or Benadryl. Legit thought I was going to die. Vomiting every time I tried to eat. Symptoms have lasted for days and there is no sign of relief. Cannot sleep.
Minutes after Japanese Encephalitis vaccine was given, pt stated he was seing white spots, nauseated, sweating and a near syncopal episode. BP dropped to 90/70 and P 60. Vomited x 1 time. Did not lose consciousness.
passed out; busted head; bruised/broke elbow/dont know if it chipped elbow or just bruised; about 1 hr after shot my stomach started feeling upset; had diarrheas' and gas; had diarrheas' and gas; This is a spontaneous report from a contactable consumer (Patient). A 55-year-old male patient received bnt162b2 (Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 23Mar2021, 12:30 (Lot Number: EP7534) as single dose for Covid-19 immunisation (age at vaccination was 55 years).  Medical history included high blood pressure (controlled with RX). There were no known allergies. No other vaccine was received in four weeks. Patient received other medications in two weeks. Historical vaccine included bnt162b2 (Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 02Mar2021, (Lot Number: el9266) as single dose for Covid-19 immunisation (age at vaccination was 55 years). On 23Mar2021, the patient about 1 hour after shot her stomach started feeling upset and she stopped at a rest area, had diarrhea and gas. This continued some through the evening. On 24Mar2021 (The next day), while outside with her friend, she passed out, ended up with a busted head and bruised/broke elbow/don't know if it chipped elbow or just bruised. She could feel it was coming on but then it started to pass, and the next thing was that she woke up in her driveway. No treatment received for events. No covid prior vaccination and no covid tested post vaccination was reported. The outcome for all the event(s) was recovering.  No follow-up attempts are possible. No further information is expected.
Within 24 hours of getting his flu shot, Patient developed fever up to 102, body aches, and generalized flu like symptoms that have persisted into a second day. He came to my office on the second day of having these symptoms.
On 8/3/00 at 09:30, child woke up with swollen upper lip, lasting a couple of hours. Swelling is gone now. Denied fever. No treatment needed.