chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately after I felt sore tired as the days passed I felt like I?d been in a car wreck  I?m so sore feels like my muscles are being twisted I hurt all the time I?m keeping headaches I can?t even go to work for so my pain I?ve missed over 2 weeks straight now.
lips and tongue got numb; lost taste; diarrhea; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (lips and tongue got numb), AGEUSIA (lost taste), DIARRHOEA (diarrhea) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), CLONAZEPAM, CITALOPRAM, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), PREDNISONE and HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (ANTIBIOTIC EAR) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA ORAL (lips and tongue got numb), AGEUSIA (lost taste), DIARRHOEA (diarrhea) and HEADACHE (headache). At the time of the report, HYPOAESTHESIA ORAL (lips and tongue got numb), AGEUSIA (lost taste), DIARRHOEA (diarrhea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HYPOAESTHESIA ORAL (lips and tongue got numb), AGEUSIA (lost taste), DIARRHOEA (diarrhea) and HEADACHE (headache) to be possibly related.    No treatment information was provided.
ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a consumer concerned a 71 year old female. 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: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210944245.
Sore arm at the injection site after her first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer Sponsored Program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm at the injection site after her first dose. Verbatim and Event Description: Talked to (name) had both doses of the Pfizer Covid-19 vaccine in (withheld) (withheld), her 8 years old granddaughter attended a party and developed some symptoms like vomiting and she did a test on her that they found out that she's positive to Covid-19. Precautions how we should handle this to avoid the spread of the virus. (name) experienced Sore arm at the injection site after her first dose, can I visit my granddaughter if I am completely vaccinated. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up attempts are completed. No further information is expected.
Feelings of myocarditis. Shortly after 2nd dose, I received a diagnosis from my doctor that I had myocarditis. I filed a report at that time. I currently feel as if I have myocarditis again. I have insane tightness in my chest and it hurts to breathe deep. As far as I'm aware, symptoms do not show this late, but I wanted to make sure to report this in case others also were.
I had been eating some pork rinds, I inhaled them that caused me to have a bad cough, I made an appointment with my doctor. He ordered a chest x-ray to make sure I had not gotten any debris left in my lungs and gotten bacterial pneumonia. The chest x-ray showed, something in my right lung, so he ordered a CAT scan. The CAT scan confirmed there was something in my right lung. My doctor ordered a needle biopsy, the needle biopsy was inconclusive. I was the scheduled for a surgical biopsy, the results came back showing adrenal carcinoma. I have started chemotherapy, that has made me very ill.
neck pain; shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of   in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Arm fracture.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Nausea beginning roughly five hours after injection which lasted about 6 hours - no medication taken to cease. Headache beginning roughly two hours after injection - Advil taken (two OTC tablets). The headache persisted roughly 24 hours from onset. Painful arm at site of injection began roughly 10 hours after shot and lasted about 48 hours. Swollen and painful lymph nodes under both right and left armpits started two days after injection (6/10 in the evening) and lasted until 6/13 in the evening.
High fever, up to 104.0, shaking chills, pounding headache lethargy
The patient began her menses the day after her first injection, which was early for her.  She is generally regular as she is on BCP. That cycle lasted through June 4th.  July and August she did not experience any menstrual bleeding. September and October she had irregular spotting. As of November her cycles appear to have resumed normally.
Immediately following the shot I had pain up my neck and across my chest. That night I had horrible cold sweats and woke up with a kink in my back and neck which I assumed that?s all it was and now still 2+ weeks later it?s still causing me pain. I also started my period the day after the shot which was 10 days early. That has never happened my entire life.  I had warm sensation in my arms and legs and numbness.
patient who was inadvertently administered PROQUAD instead of the intended MMRll; He is unaware of any further adverse event/No additional adverse events; This spontaneous report was received from a registered nurse via company representative referring to a currently 15-year-old patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was inadvertently administered Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD)(rHA) 0,5 milliliter, for prophylaxis (vaccination scheme, route and anatomical location of administration were not provided) (lot number T030761 has been verified to be a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), expiration date not reported, but upon internal validation established as 08-MAR-2022) instead of the intended Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (Wrong product administered). The reporter was unaware of any further adverse event. No additional adverse events were reported.
Two days post vax, the pt developed a large area of redness, swelling, warmth and blisters at the site of Acel-Imune administration.  Pt was taken to the ER; no prescriptions were given.
Information has been received from a RN concerning a 66 yr old male who on 31Jan06 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot650453/0791P). On an unspecified date in 2006, the pt developed redness at injection site, the size of a baseball. the redness continued down his arm to his wrist. His entire arm was swollen, red, and tender to touch, and warm to touch. It resolved in 3 days. The pt sought unspecified medical attention. The RN reported that another pt received pneumococcal 23v polysaccharide vaccine with the same (lot650453/0791P) and had a reaction (WAES0603USA00281). A lot check of concern has been requested. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the quality control system revealed that there were no open quarantines registered against this lot/fill.  Additional information has been requested.
This spontaneous report was received from a physician refers to an approximately 16 year old male patient. No concurrent condition or medical history was reported. On 03-AUG-2015, the patient was vaccinated with GARDASIL (lot # K011562, dose 3, dose and route of administration not provided). Concomitant therapies included vaccination with meningococcal vaccine (unspecified). On 05-AUG-2015, the patient experienced fatigue and malaise. No treatment was given for the events. The patient called the physician's office on an unspecified date. The physician advised him to have unspecified blood work. The blood work was completed on 07-AUG-2015 but the results were unknown. The outcome of the events was reported as not recovered. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Grandma reported 3SEP92 that pt had fever of 101 or 102 (unsure) & had rash; MD said it was reaction to shots; grandma stated fever 2 to 3 days, starting on day shot given;
patients received a dose of acthib. however, one patient only received the diluent and not the lyophilized powder portion with no reported adverse event; Initial information received from country on 06-Nov-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2023SA343771, 2023SA345528 and 2023SA343809 .  This case involves a 1 years old male patient who received a dose of HIB (PRP/T) VACCINE [ACT-HIB] however, one patient only received the diluent and not the lyophilized powder portion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL); HEPATITIS A VACCINE (HEPATITIS A); and INFLUENZA VACCINE (INFLUENZA VACCINE) for Prophylactic vaccination (Immunization).  On 30-Oct-2023, the patient received a 0.5 mL dose 4 of suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection) (Frequency = once), (Strength = standard) (lot UK007AB and expiry date: 31-Dec-2024) via intramuscular route in the right thigh for Immunization.  On 30-Oct-2023, the patient received a dose of acthib. however, one patient only received the diluent and not the lyophilized powder portion with no reported adverse event (single component of a two-component product administered) (latency: same day) following the administration of HIB (PRP/T) VACCINE.  It was reported that "Pharmacist reported that four patients received a dose of ACTHIB. However, one patient only received the diluent and not the lyophilized powder portion. They noticed there was one extra powder vial left but they are unsure which patient only received the diluent. Should they revaccinate all or should they do serologic testing prior to re-administering?".  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 and Module 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.
Headache, Bleeding, Myalgia, gum bleeding and teeth pain Narrative:
This case was reported by a physician via sales representative and described the occurrence of bad rash in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included FLUARIX; GlaxoSmithKline; unknown; unknown given in 2012. On an unspecified date in 2012 the subject received unspecified dose of KINRIX (unknown). In 2012, immediately after vaccination with KINRIX, the subject experienced bad rash and pharmaceutical product complaint. At the time of reporting the outcome of the bad rash was unspecified. The sales representative called to report on behalf of physician who stated they vaccinated four child subjects with the same lot of KINRIX and all four of the subjects broke out into a bad rash immediately after KINRIX was administered. Three of the child subjects were also given FLUARIX on the same day, but the last subject was not given FLUARIX with KINRIX and that subject still broke out with a rash. The healthcare professional office stated "we are scared to use the remaining vaccine product"; there were six doses remaining to be returned to GSK for investigation. This is 1 of 4 subjects reported by the physician, for the other cases please see A1004135A - A1004137A. Quality Assurance (QA) results received on 20 December 2012. Based on the fact that no precise technical problem was reported, no technical investigation was performed. GlaxoSmithKline Biologicals considered this complaint as unsubstantiated. QA results received on 19 March 2013. The results from the final technical assessment for the case was provided. Based on the fact that no precise technical problem was reported, no technical investigation was performed. GlaxoSmithKline Biologicals considered this complaint as unsubstantiated. QA results and safety assessment received on 4 April 2013. A search was performed in the GSK safety database to retrieve reports with KINRIX in association with the batch number AC20B235AA(and similar batches:AC20B235). There is as of today, no report linked to that batch other than the ones linked to this complaint in the GSK safety database. Currently available safety data and expert assessment of the risk did not suggest any safety concern. GlaxoSmithKline Biologicals considers this complaint as unsubstantiated. Considering all safety available information, it is unlikely that the reported events are related to a manufacturing problem.
On 2/15/01, given vaccines at well child visit. On 2/19/01, noticed lump in right groin. Began Keflex for adenitis. On 2/23/01, right inguinal abscess-drained by surgeon. Admitted for IV antibiotics from 2/24/01 to 2/27/01 and re-incision and drainage on 2/24/01. Still healing and under treatment.
we did not know the patient had received the 1st dose of moderna as she had marked no on her vaccine questionaire                                                                                                                                                                                                                                                                                                                              and told the staff verbally she had not received any other version of the covid vaccine.
Heart skipping a beat; He got sick; He is losing his voice; Health condition is not good after the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXTRASYSTOLES (Heart skipping a beat), ILLNESS (He got sick), APHONIA (He is losing his voice) and MALAISE (Health condition is not good after the vaccine) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 016R21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRASYSTOLES (Heart skipping a beat), ILLNESS (He got sick), APHONIA (He is losing his voice) and MALAISE (Health condition is not good after the vaccine). At the time of the report, EXTRASYSTOLES (Heart skipping a beat), ILLNESS (He got sick), APHONIA (He is losing his voice) and MALAISE (Health condition is not good after the vaccine) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Additional information received. Reporter details updated and a new event Malaise was added.
Severe left sided chest pain; Heart palpitations; Severe left upper back pain; Excruciating left arm pain; Excruciating left jaw pain/ Too ache left lower jaw; Muscle spams to left upper body; Joint stiffness left side; Headache; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable nurse, the patient. A 49-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the left arm on 11Nov2021 at 09:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any medications within two weeks of vaccination. The patient received influenza vaccine (FLU VACCINE) on 20Oct2021 within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration in the left arm on 16Dec2020 at 12:00 (at the age of 48-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0142) via an unspecified route of administration in the left arm on 04Jan2021 at 01:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 11Nov2021 at 21:00, the patient experienced severe left sided chest pain, heart palpitations, severe left upper back pain, excruciating left arm and left jaw pain, muscle spasms to left upper body, joint stiffness left side, too ache left lower jaw and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of reported events which included treatment with pain medicine and muscle relaxers. The clinical outcome of the events severe left sided chest pain, heart palpitations, severe left upper back pain, excruciating left arm and left jaw pain, muscle spasms to left upper body, joint stiffness left side, too ache left lower jaw and headache was resolved with sequelae on an unknown date in Nov2021.
Tingling, vision blurry, flushing, slight feeling of wooziness, felt disconnected.
Myalgia; Headache; Nausea; The patient administered with third booster dose; The patient administered with third booster dose; This is a spontaneous report from a non-contactable physician. A 66-year-old non-pregnant female patient received dose 3 ( booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the right arm on 15Oct2021 at 14:30(at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient was allergic to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine within four weeks prior to the vaccination. Concomitant medications included influenza vaccine (MANUFACTURER UNKNOWN) from 08Oct2021 for immunisation and amlodipine (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing for an unknown indication. The patient previously received the first dose of (BNT162B2) PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the right arm on 23Jan2021 (at the age of 65-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN624) via an unspecified route of administration in the left arm on 13Feb2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. On 16Oct2021 at 02:30, 12 hours after vaccination, the patient experienced myalgia, headache and nausea. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events myalgia, headache and nausea were recovered on 16Oct2021 at 14.30, after12 hours of onset.  No follow-up attempts are possible. No further information is expected.
Had normal reaction to covid shot,fever,body aches and fatigue.  Jan 29 dizzy and unable to focus, no appointments available with pcp, went to urgent care and sent to er for possible stroke, stroke ruled out and sent to physical therapy for vertigo then not spinning and regaining balance. Feb 17  vertigo returned on right and left sides, treated. Feb 19 left sided vertigo treated,Feb 22  left sided vertigo treated, March 1 right sided vertigo treated, March 5 negative for vertigo but still dizzy and off balance, vestibular exercises required to regain balance.. Positive for covid in July.
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Lymph Node Swelling-Medium
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 86-year-old male patient who received SHINGRIX. Concurrent medical conditions included non-Hodgkin's lymphoma (had not changed in 6 years, asymptomatic). Concomitant products included amlodipine, Aspirin, fenofibrate, Losartan, omeprazole and Vitamins. On 23rd February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 23rd February 2018, less than a day after receiving SHINGRIX, the patient experienced bruising of arm. On 27th February 2018, the patient experienced fatigue, appetite lost, weakness and felt faint. On 4th March 2018, the outcome of the fatigue, appetite lost, weakness and felt faint were recovered/resolved. On an unknown date, the outcome of the bruising of arm was unknown. The reporter considered the fatigue, appetite lost and weakness to be probably related to SHINGRIX. It was unknown if the reporter considered the bruising of arm and felt faint to be related to SHINGRIX. Additional details were provided as follows: On 23rd February 2018, at 16:00 hours the patient received SHINGRIX on left arm. The patient had a large bruise on his arm. On 27th February 2018, 4 days after receiving SHINGRIX, the patient was feeling fatigued in the morning, and by evening he was very fatigued and had to go to bed early, he also felt weak, such that he would feel faint when standing, and had no appetite. The patient spent most of the next 2 days in bed.