chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The client tested positive for COVID-19 after being fully vaccinated. (This is also a suspected reinfection. The client first tested positive for COVID in November 2020. She tested positive, again, outside of her 90 day immunity period on 2/26/21.
pt recv vax 12NOV97 & 19NOV97 pt devel 12015 lesions, 50% were vesicular, w/a fever of 100.7;
Patient reported suicidal thoughts after receiving vaccine. Since vaccination, she reports fecal and urinary incontinence. She has stated that she called her cardiologist and went to PCP. Patient has referral to psych.
TC recvd from mom 12JUL91 stated child devel generalized rash over face, abdomen, back & extremities small red bumps 2 days p/vaccines given 9JUL91; Denies fever;
Fever to 104, persisted for 24 hours, vomiting x 3, fine spotty rash on both legs
SAME EVENING AS SHOT (GIVEN IN MORNING HOURS)-REDNESS AND SWELLING OF ARM. PT ALSO REPORTS FEVER AND CHILLS, REPORTED TO PHARMACY ON 3/11 AT APPROX. 5:30 PM . AT THIS TIME PATIENT REPORTS SWELLING AND REDNESS HAS EXTENDED DOWN ARM JUST PAST ELBOW. PT ADVISED TO SEE PHYSICIAN. PT CONTACTED MD VIA PHONE AND WILL BE SEEN IN THE MORNING
I had been feeling sick from first Vaccine in July, however, after booster in Aug I started feeling worse and around Sept 20 I got sores in my mouth and a small pus pimple next to mouth.
Initial information received on 08-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA312306. This case involves a nine years old male patient who received only 4 of the necessary 5 doses of DAPTACEL. The patient's medical history and concomitant medications were not reported. The patient received historical vaccine with DAPTACEL. It was an actual medication error due to incomplete course of vaccination. It was also reported that the patient received last dose DAPTACEL vaccine when he was < 4years old. It was unknown whether the patient had any adverse event. 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 Directive and Module VI of the 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. List of documents held by sender: none.
This spontaneous report as received from a nurse refers to a 23-year-old female patient with asthma. Historical conditions included rash caused by penicillin. On 11-DEC-2017, the patient was vaccinated with M-M-R II lot # M047302, expiry date: 30-NOV-2018 for prophylaxis (dose, route and site of administration were not reported). Other suspect therapies included TUBERSOL. Concomitant therapies included VENTOLIN and unspecified birth control pills. On 11-DEC-2017 (reported as "that evening"), the patient experienced hives all over her body. On the telephone call was advised by her doctor to medicate with BENADRYL and EPSOM salt bath. On 12-DEC-2017, the patient called back and stated, that the hives were still on her face. She was advised to take CLARITIN or ZYRTEC. The patient was seen in the office on 13-DEC-2017 and the hives were gone, subsequently the event was considered as recovered. The patient stated that she did not take CLARITIN or cetirizine hydrochloride, but was continuing taking BENADRYL. No labs diagnostic were performed. The causality assessment was not provided.
Erythema, edema, tenderness, to anterior aspect of right upper arm. Decreased ROM to right upper arm. BENADRYL and ATARAX ineffective, Prednisone prescribed at this time.
Patient came in the store on 02-19-20 and reported that her arm was swollen, and her shoulder was hurting after the flu shot. Her shoulder is still hurting now. I told her to contact her pcp to check it out. I also called PCP to report the adverse event. Patient said she will call her PCP to schedule appointment to treat her shoulder.
Initially 0.125ml  and later recieived correct dose 0.25ml; This spontaneous case was reported by a pharmacist and describes the occurrence of OVERDOSE (Initially 0.125ml  and later recieived correct dose 0.25ml) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to morphine derivaties), Penicillin allergy, Drug allergy (Allergic to Tetracycline and related), Hypertension and Respiratory system disorder. Concomitant products included BENZONATATE for Cough, ONDANSETRON and PROCHLORPERAZINE for Nausea, HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN) and TRAMADOL for Pain, SALBUTAMOL (ALBUTEROL HFA) for Wheezing, AMLODIPINE BESYLATE, AZITHROMYCIN, CEFUROXIME, DEXAMETHASONE, DOXYCYCLINE HYCLATE, GABAPENTIN, GUAIFENESIN, HYDROCHLOROTHIAZIDE, LIDOCAINE, PRILOCAINE (LIDOCAINE/PRILOCAINE), LORAZEPAM, NITROFURANTOIN (NITROFURANTOIN MONO/MAC), OLANZAPINE, POTASSIUM CHLORIDE and SULFAMETHOXAZOLE, TRIMETHOPRIM (SULFAMETH/TRIMETH) for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .375 milliliter. On an unknown date, the patient experienced OVERDOSE (Initially 0.125ml  and later recieived correct dose 0.25ml). At the time of the report, OVERDOSE (Initially 0.125ml  and later recieived correct dose 0.25ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.  Patient was initially administered with 0.125ml as booster and she came back and received the correct 0.25ml.
got the Shingrex shot and still got the shingles/suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: got the Shingrex shot and still got the shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK receipt date: 17-Mar-2023 The case was received from the patient via interactive digital media. The patient stated nasty, got the Shingrix shot and still got the shingles. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient with erythematous/edematous reaction to vaccines administered on 9/26/17. She denies decreased use of arm.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). Years ago, on an unspecified date the subject received 1st and 2nd dose of ENGERIX B. Recently, on an unspecified date the subject completed another ENGERIX B (unknown) series and received 3rd, 4th and 5th dose. After an unspecified time after the 1st and 2nd dose of ENGERIX B, and approximately 1 month after the 3rd, 4th and 5th dose of ENGERIX B, the subject experienced not responding to therapy. The male subject received "at least two dose of ENGERIX B years ago". Recently the subject completed another full series with this clinic. Titers performed one month later were negative (absence of expected effect). The subject was recently exposed to bodily fluids and given hepatitis b immunoglobulin (HBIG). The reporting healthcare professional did not have subject details or refused to provide further information upon request.
Fatigue, fever (103.5 def F), headache, muscle aches x12hours. Ibuprofen 800mg helped some.
Patient is under the age of 18 and received the COVID19 Moderna vaccine. Called the patients mom on 3/1 to check the status of the patient. Patient's mom states patient is fine with no side effects from the vaccine.
body aches that continued to get worse over days on the left side of my body   i havn't as yet seen a doctor as yet but the body aches are still on going
Patient is a 42-year-old male who presents for evaluation of abdominal injection site reaction. Patient states he had injection on 10/3/18 in his proximal left upper extremity. Denies any drainage of the lesion on his left upper extremity. States that the area has not opened. Denies erythema. States that he has been sick since October, stating he has had drainage, cough, and he "can't get better". I and D performed, cultures obtained, WTD drsg BID.
I have a terrible ringing in my ear and a bad pain in my ear; I have a terrible ringing in my ear and a bad pain in my ear; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old male patient received bnt162b2 (BNT162B2), administration date 27Dec2021 (Lot number: FD7218) at the age of 23 years as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Dec2021, outcome "unknown", described as "booster"; EAR PAIN (non-serious), TINNITUS (non-serious) all with onset 28Dec2021, outcome "unknown" and all described as "I have a terrible ringing in my ear and a bad pain in my ear". Therapeutic measures were taken as a result of ear pain, tinnitus.  Additional information: Consumer stated, "he like to report an adverse side effect from, have the question about it, he got booster shot yesterday and now he had a terrible ringing in his ear and a bad pain in his ear and he didn't know that was the common, he couldn't find anything online about that being a side effect so he wanted to see if that side effect was reported before or it was anything known about that." Consumer stated that he wanted to know if that's a common side effect, if not he would like to report it.The patient took Ibuprofen, like over a counter pain medication. Consumer didn't see the expiration date on vaccine card. Consumer stated he had no underline conditions and I take no medications." Further probing was not done. Hence, limited information was available over the call. Patient had no family history.   Follow-up attempts are completed. No further information is expected.
43 year old established male presents for evaluation. HPI and reason for visit - Here today for a focused visit on cough. Reports this started 12/8/09. He was seen in the unit he and had a chest x-ray and AMOXICILLIN for 10 days. He had the H1N1 flu shot last Friday and the cough and sob started on Saturday afternoon. He feels very tired now and has intermittent fevers/chills. Reports mid throat tenderness. Sinus drainage. Tolerating liquids with no problem, not eating much. Pt does smoke and has smoked for about 10 years. Symptoms 1. cough wheeze. 2 dyspnea Treatment drugs used 1.ALBUTEROL/ipratropium dose 2 units PUFFS freq QID route inhale 2-PREDNISONE dose 20 units mg freq:other Route PO
Patient reported feeling dizziness and loss of hearing in the left ear. First blood pressure taken was low at 73/36. Retaken 3 minutes later and was within normal range at 121/83. Symptoms resolved 10 minutes later.
killed all those 5 people; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "killed all those 5 people". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course:Reporter had friends who had strokes, heart attacks, lost their babies. They put that man's daughter in a coma. It killed all those 5 people. They weren't told the truth. They weren't given a choice. Companies said they had to get the shot. AE transmitted. Caller hung up before being able to ask for demographics.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: killed all those 5 people
This spontaneous report was received from a medical assistant referring to a patient of unknown age and unknown gender. Information about pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medication was not reported. On 11-FEB-2019, the patient was vaccinated with a dose of M-M-R II (therapy type rHA, lot# R002510 with expiration date 25-JAN-2020, intradermally, dose detail and frequency was not reported) for prophylaxis (incorrect route of product administration). No adverse effects reported.
Pt recv vax on 9/4/98; on 9/15/98 pt exp fever (101), red rash; dx=ear infection & virus
shortness of breath; body rash; allergy confirmed to covid pfizer; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Jan2021 (Lot number: EL0142) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergy-carrot" (unspecified if ongoing); "Known allergy-penicillin" (unspecified if ongoing). Concomitant medication(s) included: BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]. Past drug history included: Morphine, reaction(s): "known allergies : morphine". Vaccination history included: Bnt162b2 (DOSE 1, brand=Pfizer, lot number: EL1284, administration date: 26Dec2020, vaccine location: Right arm.), administration date: 26Dec2020, when the patient was 48 years old, for COVID-19 Immunization, reaction(s): "full body red rash", "full body red rash", "slight shortness of breath". The following information was reported: DYSPNOEA (non-serious) with onset 16Jan2021, outcome "unknown", described as "shortness of breath"; RASH (non-serious) with onset 16Jan2021, outcome "unknown", described as "body rash"; ALLERGY TO VACCINE (non-serious) with onset 16Jan2021, outcome "unknown", described as "allergy confirmed to covid pfizer". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dyspnoea, rash, allergy to vaccine.  Additional information: Facility where the most recent COVID-19 vaccine was administered: to the patient was Hospital. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had medications within 2 weeks of vaccination tyl 1000mg, 50 mg ben prior to dose 2. The patient had full body red rash with slight shortness of breath on first dose. When he got the 2nd dose a month later he took 1000mg tyl and 50 mg benadryl 1 hour prior to vaccine and still ended up with body rash and shortness of breath. both time this was with in less then 5 minutes of getting the Pfizer vaccine. The patient had treatment for adverse event. The patient was confirmed allergy to covid Pfizer. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 since the vaccination. The patient had covid test type post vaccination was nasal swab. The patient had no serious criteria of adverse event.  No follow-up attempts are possible. No further information is expected.
Fever and respiratory difficulty. The annual follow up received on 5/23/03 states "she died from vaccine reaction. Pneumovax in pneumonia pt's may not be safe."
a dose of Flublok was given to a 15 years old patient/ No AE; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 years old female patient who received 0.5 mL dose of an INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA, expiry date: 30-Jun-2021) via an unknown route in left arm on 12-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age).   The patient's medical history, medical treatments, vaccinations and family history were not provided.  She didn't receive any other vaccinations or medications on that visit.  It was an actual medication error due to inappropriate age at vaccine administration (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 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.
This spontaneous report as received from a nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with the second dose of GARDASIL (dose, route and lot# not reported) late (start date, route and lot # of first dose were unknown). Additional information is not expected. There is no contact information for the nurse.
This spontaneous report as received from a physician, as part of a marketing research program, refers to 11 to 18 year old female patients. There were no concurrent condition and medical history. On an unknown dates, the patients were vaccinated with GARDASIL (lot number, dose and route were not reported). There was no concomitant therapy. The physician reported regarding patients who between 2006 to 2012, fainted when they received vaccination with GARDASIL. The physician reported that the incidence of fainting occurred 1 in 30 girls. The pediatrician would then have the patients leg elevated, recover and watch the patient for 15-20 minutes before letting them go. This event did not prevent the administration of second and third doses. The outcome of event was reported to be recovering/resolving. The physician stated that now her practice reminds patients to eat before vaccine and had them sit in office for 15. The physician did not see this adverse event with GARDASIL 9. The physician considered fainting to be non-serious and related to GARDASIL. This case is one of the two reports from same reporter. Additional information is not expected since the physician does not wish to be further contacted.
Pt. states @ 300pm area became Itchy with Red whelps. Whelps lasted lasted for 24 hours. After 24 hours area became red. From Wednesday to Friday normal color returned. Today only painful to touch. No medication taken. Nothing applied to area.
I can't say it is from the vaccine, but since getting the shot my resting heart rate has been high.  It was 120 resting when I first started checking on 10/8 when I was checking my pulse ox levels when I got sick with a cold since I didn't know if it was COVID.  The illness resolved within 3 days and got antibodies testing for COVID after the fact since after the fact I found out I had exposure to COVID prior to getting sick.  The COVID antibodies test showed no antibodies.     Anyway, about 10/10 my resting heart rate was 120 and walking around my house or up the stairs would raise my heart rate to 150.   I am now a month out and my resting heart rate is now down to 90-100.  My resting heart rate remained elevated until about 9/25 then it started to return to normal slowly.  It still goes up faster than normal.  As I said, I am not sure if it was the vaccine or the illness since I had not taken my pulse from 10/1 to 10/8 when I first starting getting sick with what felt like a mild cold.  But I do normally take my pulse, especially pre exercising and exercising and all the heart rates I have got during that time have never been in that range except for one time in 12/2020 that prompted an ER trip with a rapid pulse and constant vomiting (ultimately diagnosed as a virus- non covid).
Bells Palsy on left side of face on side of injection. I still have sensations on that side of my face, but there is no obvious signs.
patient passed out after receiving her 2nd pfizer vaccine. Vaccine administration went well and she left booth as she walked to waiting area, she fell to the floor hitting right side of head. Store management filled out with parents an incident report.
Pruritus with in 15 minutes of injection starting on lips/tongue. progressed to chest, neck and  to peri-orbital. Rash to chest/neck. Treated with Benadryl 50 mg. symptoms resolved in 72 hours.
Some side effects after first Moderna vaccine.; Stomach pain; Indigestion; Burning in head/Head was on fire; Dizziness; Vertigo episode; Injection site pain; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Some side effects after first Moderna vaccine.), ABDOMINAL PAIN UPPER (Stomach pain), DYSPEPSIA (Indigestion), BURNING SENSATION (Burning in head/Head was on fire) and DIZZINESS (Dizziness) in a 59-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.     Concomitant products included RANITIDINE HYDROCHLORIDE (ZANTAC) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), DYSPEPSIA (Indigestion), BURNING SENSATION (Burning in head/Head was on fire), DIZZINESS (Dizziness), VERTIGO (Vertigo episode), VACCINATION SITE PAIN (Injection site pain), CHILLS (Chills) and FATIGUE (Fatigue). On an unknown date, the patient experienced VACCINATION COMPLICATION (Some side effects after first Moderna vaccine.). At the time of the report, VACCINATION COMPLICATION (Some side effects after first Moderna vaccine.), ABDOMINAL PAIN UPPER (Stomach pain), DYSPEPSIA (Indigestion), BURNING SENSATION (Burning in head/Head was on fire), DIZZINESS (Dizziness), VERTIGO (Vertigo episode), VACCINATION SITE PAIN (Injection site pain), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient received concomitant medications like allergy medications and vertigo medications.   This case was linked to MOD-2021-168509 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow-up
Extreme abdominal pain, went to ER at 10pm after hours of pain with no relief. CT scan revealed appendicitis, emergency appendectomy performed 4:00pm 06/21/2021
Information has been received on 03/01/02 from a registered nurse concerning a male patient with a negative titer who was vaccinated with the first dose of Varivax (site unknown). A titer after vaccination was negative. The patient sought unspecified medical attention. Additional information has been requested.