chrisvoncsefalvay/vaers-outcomes huggingface dataset:
really sick; feeling crummy; flu symptoms; she did not get her 2nd dose of Shingrix; she had a sore arm; was in bed for 2 days; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 23-MAY-2018, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 23-MAY-2018, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm (Verbatim: she had a sore arm). On an unknown date, the patient experienced bedridden (Verbatim: was in bed for 2 days), sickness (Verbatim: really sick), feeling bad (Verbatim: feeling crummy), flu symptoms (Verbatim: flu symptoms) and incomplete course of vaccination (Verbatim: she did not get her 2nd dose of Shingrix). The outcome of the pain in arm, sickness, feeling bad and flu symptoms were resolved and the outcome of the bedridden was resolved (duration 2 days) and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm, bedridden, sickness, feeling bad and flu symptoms to be related to Shingrix.     It was unknown if the company considered the pain in arm, bedridden, sickness, feeling bad and flu symptoms to be related to Shingrix.   Additional Information: GSK receipt date: 31-OCT-2023 The patient self-reported this case. The patient reported that she received the 1st dose of Shingrix, she thought in her left arm but was not sure, according to the pharmacy records and thought she had a sore arm that same afternoon and was in bed for 2 days really sick and felt crummy, with flu symptoms that started the morning after receiving the vaccine. The patient also reported that she received Zostavax, on 20-OCT-2021, according to the pharmacy records, but that her physician told her these dates were backwards.  The patient also felt the dates were backwards, as she remembered felt sick from Shingrix on her birthday, which would make the Shingrix vaccine the one received on 20-OCT-2021. The patient had used the dates in the pharmacy records in this report.  The patient could not obtain records from the pharmacy to verify this, as it against law to obtain them.  The patient also reported she did not get her 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. Patient also reported that she received a Covid Booster a week ago in Oct-2023 (from the date of reporting) and a Flu vaccine last week in Oct-2023 (from the date of reporting) both unknown product information. The patient had no lot/expiry information or route of administration information to provide. The consent to follow up granted.
Hypo-, diaphoretic, nauseated, blotchy redness at injection site. All resolved within one hour after Benadryl 25mg IM. Received follow up care by MD at CWU Student Health Center.
Patient contracted COVID after being fully vaccinated. Booster given 12/27/2021. Disability coverage for the patient was 9/13/2021.
Medical Assistant thought she was giving the patient a meningococcal conjugate but gave the patient a HIB
This spontaneous report was received from a pharmacist concerning a female patient of unknown age who on 15-JAN-2013 was vaccinated with a dose of PNEUMOVAX23 (route, lot number and expiration date were not provided) and on unknown date, prior to the administration of PNEUMOVAX23, she was vaccinated with a dose of Influenza Virus Vaccine (manufacturer unknown) (route, lot number and expiration date were not provided). No concomitant medications were reported. The pharmacist reported that on 15-JAN-2013, the patient developed tenderness, pain and erythema at the injection site. She was given arm compresses as treatment for the event. At the time of the report, the patient was recovering from the events. Additional information has been requested.
developed shingles on an unspecified date in 2019.; late 2nd dose on 16Jun2020; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 21st December 2018, the patient received the 1st dose of Shingrix. On 16th June 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and drug dose administration interval too long. On an unknown date, the outcome of the shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose. The patient received 1st dose of Shingrix and developed shingles on an unspecified date in 2019. The patient was late for 2nd dose, which led to lengthening of vaccination schedule. The reporter consented to follow up. The HCP did not have the date or information on the shingles outbreak only that it occurred last year.
Shot administered approx. 2:00 p.m. 12/6/07.  That evening I was extremely tired and did not complete my obligations after shopping for our business.  Next day I was extremely tired and weak, left work early which is very unlike me and went home and slept for 3 hours 3:00 p.m. to 7:00 p.m..  Woke not feeling quite right but continued as normal until approx. 3:00 p.m. at which point I could not continue.  Weak and feverish I layed down on the couch and went to sleep.  I had diareah that evening which continued until 12/18/07.  Fever ended Tuesday 12/11/07 but weakness, sleepy/tired feeling and stomach problems have continued.  I have not taken any medication except for ibuprophen for fever and occassional head ache.
Pt. c/o feeling light-headed while underobservation approx. 5 minutes after receiving vaccine.  Pt. notes she did not eat breakfast.  Pt given H2O2 + fig energy bars and started feeling better.  VS:  BP140/66, 98%-76  repeat BP124/64, 98%, 77.  Pt noted she started feeling better and she denies lightheadedness, pt states she is ok to drive.  Pt offered note to stay home from work, and she declined.  Pt. left approx. 12:05pm.  Pt advised to call 911 if she notes shortness of breath, swollen throat, swollen eyes, swollen tongue.  Rest & tylenol prn
on April 13th I contacted my doctor I had a rash on my left arm on the injection site it looked like hives and it was red and itchy and it spread through out my whole arm it was a red patch and the itch had gone away. Doctor gave me Aleve and it cleared up in a couple  of days. I also had fatigue headache following up my appointment from the doctor.
This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 68-year-old female patient who received SHINGRIX (batch number C7B9P, expiry date 27th February 2021) for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a month after receiving SHINGRIX, the patient experienced headache and weakness. On an unknown date, the outcome of the headache and weakness were recovered/resolved. It was unknown if the reporter considered the headache and weakness to be related to SHINGRIX. Additional information was provided as follows: This case was reported by the patient's daughter. The patient received SHINGRIX in the right arm. After receiving SHINGRIX, the patient experienced headache and weakness, that was resolved but timeframe was unknown. The patient experienced adverse events with both doses of SHINGRIX. This case has been linked with case US2018195860, reported by same reporter for same patient.
Severe Nausea Headache Weakness  Tiredness Dreams Fever Muscle pain  Chest pressure
Vaccines went into 2-8 C thawstate on or about 24-Dec-2021; Received vaccine past its 30-days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days expiry date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thawstate on or about 24-Dec-2021) in a 35-year-old male 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 12:02 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Jan-2022 at 12:02 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thawstate on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days expiry date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thawstate on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at time of vaccination or at the time of the adverse event were reported as unknown. Other vaccines given on the same day as Moderna COVID-19 vaccine and other vaccines received within one month prior to any dose of Moderna COVID-19 vaccine were reported as unknown.  No concomitant medications were provided by reporter.  No treatment medications were provided by reporter.  On 31-Jan-2022 at 12:02:07, patient received an expired booster dose.   This case was linked to MOD-2022-542869 (Patient Link).
Neck pain; Upper back pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), BACK PAIN (Upper back pain) and HEADACHE (Headache) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Thalassemia minor (thalassemia minor(beta)) and Anemia (anemia(iron deficiency)). Concomitant products included IRON, FOLIC ACID and CALCIUM for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced NECK PAIN (Neck pain), BACK PAIN (Upper back pain) and HEADACHE (Headache). At the time of the report, NECK PAIN (Neck pain), BACK PAIN (Upper back pain) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants included multivitamin.  No treatment information was provided.    Reporter did not allow further contact
Complaint of nausea, vomited once, fever (up to 101.) and generalized achiness.
Information has been received from a Licensed Practical Nurse concerning an unspecified numbers of patients. On an unspecified date, the patients received a batch of improperly stored M-M-R II (dose, strength and route were not reported, lot number K002528, expiration date 18-FEB-2016). No adverse effects reported. This case was one of the three reports received from the same reporter. The other two lot # for M-M-R II was captured in case 1502USA005910 and 1504USA002730. Additional information has been requested.
inadvertently given an expired dose of Imovax Rabies with no reported adverse event; Initial information received on 14-Jul-2021 regarding an unsolicited valid non-serious case from a nurse.  This case involves an unknown age female patient who was inadvertently given an expired dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (expired product administered).  The patient's past medical history included cat bite. The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received an expired dose of suspect RABIES (HDC) VACCINE (lot number not reported via unknown route in unknown administration site for post exposure immunization (expired product administered).  It was reported that, "A patient was bitten by a cat and presented at the clinic on June 30th. She was inadvertently given an expired dose of Imovax Rabies. My colleague called, the patient was re-vaccinated with unexpired vaccine, on the same day. She also received immunoglobulin on that day. Today, she is back, 14 days later. How should I proceed with the series? Should I start over or give the day 3 dose?"  It was a case of actual medication error due to expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the lot number for this case.
ACHES; DIZZINESS; MALAISE; LOW GRADE FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-DEC-2020, Laboratory data included: Coronavirus test (NR: not provided) positive. On MAR-2021, the subject experienced aches. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced malaise. On MAR-2021, the subject experienced low grade fever. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the aches, malaise, low grade fever, nausea, dizziness and headache was not reported. This report was non-serious.
PATIENT WAS GIVEN SHINGRIX VACCINE WHICH IS INDICATED FOR PATIENTS OVER THE AGE OF 50. THE PATIENT WAS ONLY 46 AT TIME OF VACCINATION. SHE DOES NOT REPORT ANY ADVERSE REACTION TO THE VACCINE BUT IS CONCERNED THAT IT MAY BE HARMFUL DUE TO LACK OF INDICATION.
Disorentation Narrative: Patient was taken to ED by 911 services, called to residence by his son. Patient was hospitalized for syncope, disorientation, fever and pain/swelling and the injection site
severe joint pain; it feels like a broken bone & no range of motion in the arm; it feels like a broken bone & no range of motion in the arm; pain at the injection site; This is a spontaneous report from a contactable nurse. This contactable 32-year-old female nurse (Patient) reported that:  A 32-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number; Unknown), via an unspecified route of administration as dose 2, single on 20May2021 (at the age of 32-year-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number; Unknown), via an unspecified route of administration as dose 1, single on unspecified date for COVID-19 immunisation. Caller received her second dose of the Pfizer COVID 19 Vaccine on 20May2021. Caller reported about 1-2 hours after receiving the vaccine she experienced pain at the injection site on 20May2021. Caller continued to have severe joint pain on unspecified date. She reported it felt like a broken bone and no range of motion in the arm on unspecified date. She thought it may be a reaction and took hydroxazine and muscle relaxer. Caller asked if symptom had been reported. Therapeutic measures were taken as a result of events with hydroxazine and muscle relaxer. At the time of this report, the outcome of events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
They gave my mother her Shingrix SQ rather than IM in her left arm.  Her arm is bright red, swollen, and very warm to touch.  It is also very painful.  She was told to use cold/warm presses and take Tylenol.
My daughter's pediatrician does not believe that the flu vaccine caused my daughter's seizures, which occurred 14 days after the vaccine was given, approx. on 11/15/02 at 10:30am. My daughter was perfectly healthy with no colds or illness prior to the flu shot being given. 14 days later we have been in and out of the hospital(s) with her seizures and have had tests including: Catscan, spinal tap, EEG, and an MRI run at the hospital, where they could find no cause for the seizures. There is no family history of epilepsy or seizures on either parent's side. My daughter has stopped breathing for 5 mins. with her first seizure in which I called 9-1-1 and she was taken by ambulance to the Medical Center and released that afternoon. She returned home, had more seizures and was taken to The Hospital where she stayed 5 days.  She has since had to ride in an ambulance due to the seizure two more times.  She is on a very high dose of Phenabarbitol for her seizures and is still having trouble controlling them. I would like this to be investigated because I feel that the flu shot may have caused the seizures, because she did not have them before. Medical record states shaking, limp, mental retardation, irritable. msv
Shortness of breath, nauseousness, chills, cough, runny nose, achy skin, achy bones and joints, chest pain while coughing, congestion
Moderate fatigue and fairly significant body aches 24 hours after vaccine. Lasted about 24 hours. Red rash about 6" in diameter appeared 48-72 hours after infection.
pt recvd vax & exp a syncopal or vasovagal episode; pt recovered w/o any residual effects; No further details were provided; MD reported 20 pts;
Dose administered too soon  Narrative:  Second dose in COVID-19 Vaccination series administered too soon. Patient did not have reaction as a result. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
Excessive vomiting, face turned pale green, listless, all after waking up from nap.
18 hours after the 2nd Covid19 Pfizer vaccine, I began to feel lightheaded with a headache. 15 minutes later I became extremely fatigued and felt like I was going to pass out. I stumbled down the hallway to a family member for help and collapsed. I could not stand or walk and could barely talk. The family member helped me to a vehicle and drove me to urgent care. I had to be taken inside by wheelchair as I could not walk, could barely move. At the urgent care facility they took my vitals and all were normal. Oxygen at 100%, BP  was a bit high. They said this was a "normal" reaction to the Covid 19 vaccine. I had read about extreme fatigue....but not to the point of not being able to even stand up. I was sent home and slept almost non-stop for the next 48 hours. The fatigue lasted another 4 days after that.
CDC reports : 6 yo child developed local rxn at inject site following DTP/OPV immunization. Lasted 3 days.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding patient's concurrent conditions, medical history and concomitant therapies was reported. On 07-APR-2017, the patient received improperly stored dose of ROTATEQ administered orally (dose was not provided) lot # M039061, expiration date: 28-APR-2018. The vaccine was stored in temperature of 33.8 degrees Fahrenheit (F) for 42 minutes. There was no previous temperature excursion. Temperature excursion was detected by Digital Data Logger. No symptoms were reported. Additional information has been requested.
A BIT OF AN UPSET STOMACH; SORE ARM; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported, batch number: Unk) 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/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced a bit of an upset stomach, sore arm, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, a bit of an upset stomach and headache was not reported. This report was non-serious.
1/14/21 complaining of chest heaviness and sharp pain to left side of chest. Lasts for hours at a time off and on.  Nothing helps or makes the pain/heaviness worse. I referred patient to urgent care/ER. I followed-up 1/19/21 and she called the hospital and they told her it is a new vaccine and no meds needed. She was to go into ER if it got worse. She reported the pain/chest heaviness went away by next day 1/15/21.
I had a Pfizer booster shot around 3:30 PM on Friday, October 8, 2021. Other than the sore arm on October 9 and some fatigue, I was fine. Then on Sunday, October 10th I had a very bad headache on the left side of my head. Since I had had General Cell Arteritis a few years before at first this got me a little anxious as my headache at that time was also just on the left side of my head. As I am a person who normally does not get headaches and this one seemed to be more spastic since it would come and go, I kept tract of the timing of when the pain would hit. It started about nine in the morning when I got up and ended at 1:45 PM. Since it never came back I would attribute it to the Pfizer booster  that I had on Friday, October 8th.
Information has been received from a physician concerning a female who was vaccinated with her first dose of GARDASIL. Within 12 to 16 hours post vaccination the patient developed a diffuse rash that was not located at the injection site. The patient's outcome was not reported. Additional information has been requested.
Patient presents to clinic with headache, body aches, rash, and enlarged, swollen and tender left supraclavicular lymphadenitis.