chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Graves' disease" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "allergies" (unspecified if ongoing); "asthma" (unspecified if ongoing); "overweight" (unspecified if ongoing). Concomitant medication(s) included: METHIMAZOLE, start date: 01Feb2022, stop date: 29Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive, notes: COVID 19 Treatment, Brand: Paxlovid; (29Oct2022) Positive, notes: Rebound covid. Positive antigen test in 29Oct. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (Treatment start date: 19Oct2022; Treatment stop date: 23Oct2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Arm was hard like a charley horse; he felt run down and tired; Arm was really sore; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (Arm was hard like a charley horse), FATIGUE (he felt run down and tired) and VACCINATION SITE PAIN (Arm was really sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INDURATION (Arm was hard like a charley horse), FATIGUE (he felt run down and tired) and VACCINATION SITE PAIN (Arm was really sore). At the time of the report, INDURATION (Arm was hard like a charley horse), FATIGUE (he felt run down and tired) and VACCINATION SITE PAIN (Arm was really sore) outcome was unknown.            Concomitant product use was not provided.  Treatment product information was not provided.   This case was linked to MOD-2021-269938, MOD-2021-270022 (Patient Link).
This is a spontaneous report from a contactable medical assistant via a Pfizer sales representative and from a contactable Consumer. A 17 year-old female patient of an unspecified ethnicity received TRUMENBA (Lot # M68769 Exp. 30Apr2017) via an unspecified route of administration at 0.5 ml single, and GARDASIL, both on 29Jul2016 for immunisation. The patient medical history and concomitant medications were note reported. On 29Jul2016 the patient experienced severe headache, dizziness, fever, chills, myalgias, and malaise. The patient was admitted to ER 45 min after immunization for severe headache, chills, myalgias, and malaise. While in ER the body temperature was 103 degrees. The events were treated with TORADOL, Prednisone, BENADRYL, TYLENOL. The outcome of the events was recovered. Follow-up (20Sep2016): This is a follow up spontaneous report from a contactable Consumer included: Lot Number and Expiration Date; vaccination date; events outcome; co-suspect medication; lab test; additional events Chills, Myalgias, Malaise; course of events; ER required; treatment.
Employee received injectable influenza vaccination on 17Sep14. Stated started feeling sore throat, congestion, nonproductive cough, tight chest, headaches, body aches, loss of appetite during the evening of 17Sep14. Unable to sleep during the night, reported feeling sweaty with chills. Currently still feeling the same symptoms as above also nausea with vomiting x 1 today (nausea started 18Sep14). Site of injection noted to have outline of band-aid, employee reported same reaction during April 2013 post-op with steri-strip and tegaderm. Possible sensitivity to adhesive.  Employee reports site has improved since band-aid removed. Employee states took robitussin DM, pseudoephedrine, Motrin, Celebrex on 17Sep14 without relief.
Sharp stabbing cramp pain on right side (lower abdomen), similar to cramping during ovulation (mittelschmerz). But much more painful. Also dull, numbing sensation prior to sharp stabbing cramp. It has subsided about 30 mins later. I took an ibuprofen.
Injection site soreness, cold cloth, hurt to move arm or touch, about 36 hours.  Whole body aches, warm bath/ heating pad, aches that felt like flu and made it hard to sleep, from 9 hours after injection to 30 hours after.    Tingling skin, warm bath, body tingles when touched or moved, from 11 hours after injection to 36 hours after.    Nausea and/or decreased appetite, eat small light foods like crackers and applesauce, had Waves of nausea and then decreased appetite after nausea wore off,  from 6 hours after injection to 32 hours after.
BIBA for possible reaction to covid vaccination. Pt received first covid vaccination today, reprts 5 min later developed sensation of throat closing up, heart racing, dizziness, and "heat inside chest and abdomen".  Denies facial swelling, rash, emesis, diarrhea, abdominal pain.  Sensation of throat closing resolved approximately after 10 minutes.  Currently only complains of feeling slightly dizzy and " heat inside chest and abdomen) No other new medications, environmental exposures, lotions/soaps, foods. NO meds given pta   No prior similar reaction to vaccinations No history of anaphylaxis  Allergies: Tuna (hives)  BP 129/61  | Pulse 84  | Temp 37.5 °C (99.5 °F) (Tympanic)  | Resp 18  | SpO2 96%  Physical Exam  Constitutional: She appears well-developed and well-nourished. No distress.  HENT:  Head: Normocephalic and atraumatic.  Right Ear: External ear normal.  Left Ear: External ear normal.  Nose: Nose normal.  Mouth/Throat: Uvula is midline, oropharynx is clear and moist and mucous membranes are normal. No uvula swelling. No posterior oropharyngeal edema.  No facial swelling, no oral lesions, oropharynx patent Nl phonation  Eyes: Conjunctivae and EOM are normal.  Neck: Trachea normal, normal range of motion, full passive range of motion without pain and phonation normal. Neck supple. No neck rigidity.  Cardiovascular: Normal rate and normal heart sounds.  Pulmonary/Chest: Effort normal and breath sounds normal. No respiratory distress. She has no wheezes.  Abdominal: Soft. There is no abdominal tenderness.  Musculoskeletal: Normal range of motion.  Lymphadenopathy:    She has no cervical adenopathy.  Neurological: She is alert. GCS eye subscore is 4. GCS verbal subscore is 5. GCS motor subscore is 6.  Skin: Skin is warm, dry and intact. Rash noted. She is not diaphoretic.  Psychiatric: She has a normal mood and affect. Her behavior is normal. Judgment and thought content normal.  Nursing note and vitals reviewed.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 21-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (Lot # L027067, expiration date 06-APR-2017) (Dose and route were not provided). Concomitant medication was not reported. No adverse effects were reported. It was stated that excursion of temperature was 33.9F; Time frame; 6 hours; No previous temperature re excursion. It was mentioned that it was call because of a "data logger". No product complaint (PQC) was involved. Additional information has been requested.
Dizzy; mild headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Lot number: ENS199) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included heart disease (ongoing); triple bypass operation, start date: Oct2017 (unspecified if ongoing); Stents placed, start date: Sep2019 (unspecified if ongoing); dizziness associated with treatment for heart disease as well (unspecified if ongoing); chronic possible dizziness if he stands up too fast (unspecified if ongoing). There were no concomitant medications. The following information was reported DIZZINESS (non-serious) with onset 05Mar2021, outcome recovered (06Mar2021); HEADACHE (non-serious) with onset 05Mar2021, outcome recovered (06Mar2021).  It was reported that he got the vaccine on 05Mar2021 and afterwards he had to sit for 45 minutes because he was dizzy. His dizziness lasted until the next morning. The evening after the shot, he had a mild headache that lasted the whole evening. He never had headaches his whole life.   No follow-up attempts are possible. No further information is expected.
Patient called to inform PCP that after shingrix injection last week, arm became swollen, red and painful. Reports it is back to normal at this time but reports does NOT want second injection.Advised patient to come to PC or UR in the future for any reaction to any medication. Will inform PCP.Patient agrees to come in immediately if any reaction appears
The pain started in the injection site and lingered for about 3 days. The Friday after my vaccination, the pain moved from my left shoulder muscle down to my elbow. It was almost a dull throbbing pain on 4/30/21. This lasted through the weekend the next week until finally, the pain moved down to my left wrist. It hurts every time make a fist, bump it slightly, or jam it just doing normal things. It has been hurting for nearly 5 months now and I never had any wrist problems prior to the vaccine. I used to be able to do high intensity training and weight lifting. No issues. The pain is excruciating when I wake up. I have to wear a brace while I go to bed. The ibuprofen is making my stomach hurt. I have resorted to Diclofenac Sodium for temporary but insufficient relief.
Fever of 102 degrees (while pregnant) for 4 hours (reduced with Tylenol). Severe chills for 6 hours. Significant pain at site of injection for 2 days. Severe body aches for 2 days.
After receiving the vaccination I started experiencing a dry cough  and problems breathing 3 months after. I visited the ER for the severe symptoms and was tested for COVID 19 to ensure I did not have another variant. I tested negative.
Right hand was tingling and numb; Right hand was tingling and numb; This case was reported by a consumer via call center representative and described the occurrence of numbness in a 27-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   In July 2020, the patient received the 1st dose of RabAvert. On an unknown date, less than 2 weeks after receiving RabAvert, the patient experienced numbness and tingling. On an unknown date, the outcome of the numbness and tingling were recovered/resolved.   It was unknown if the reporter considered the numbness and tingling to be related to RabAvert.  Additional details were reported as follows: The reporter was the mother of the patient. The patient received Rabavert for post-exposure prophylaxis. The patient received 1st dose of RabAvert on 19th or 20th July 2020 in right arm after that his right hand was tingling and numb. The patient received 2nd dose refer case US2020152664 and for 3rd dose refer case US2020AMR153823.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR153823:same patient US-GLAXOSMITHKLINE-US2020152664:same patient
This is a pleasant 87 y.o. female with history of who presented to the Hospital ED  on 10/14/2022 ED for evaluation of positive COVID test. Patient presently with a chief complaint of progressive shortness of breath since the past few days. Patient was recently diagnosed with COVID at her facility. Patient was placed on oxygen at her care center but she was not sure why. Patient reported fatigue. She denied any recent falls or injuries. Since being at care center she has been wheelchair dependent. No fevers or chills. No nausea or vomiting. No chest pain, abdominal pain. No diarrhea or constipation. Chest Xray revealed a large left-sided pleural effusion with compressive atelectasis, substantially larger than on the comparison study and patchy right basilar opacity. Per note, this patient was admitted to hospital for Management of acute hypoxic respiratory failure likely in the setting of CHF exacerbation and recent COVID-19 flexion. Health Department has no further information on this person?s outcome. For further information on this patient?s outcome, contact Hospital.
This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program (159558). A 6-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FL0007, expiration date: Feb 28, 2022), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient developed  urticaria (hives all over back), and upper abdominal pain (stomachache), with outcome of unknown. Additional information: Reporter's grandson developed hives all over his back and had a stomachache after receiving the first dose of the Pfizer COVID-19 vaccine. They took him to the doctor. The doctor said it was most likely a reaction to the vaccine, and said he should not get the second dose since the reaction could be worse. The expiration date on the vaccination card was Sep 2021. She encountered three different stories. She got in contact with someone else who provided them with an updated expiry date from Sep 2021 to Dec 2021, which was when he got the vaccine. Now Pfizer was telling her it was Feb 2022. This report was related to study or program. No follow-up attempts possible. No further information expected.
9 am HPV #3 GARDASIL vaccine given LA deltoid without diff. A few minutes after injection pt start scratching injection site. About 5 minutes later entire arm is itching per pt. BENADRYL 25mg PO given per protocol. Pt waits 20 min and itching has stopped and pt states she feels fine.
Complaints of soreness in armpit and arm almost a week post vaccine. Hurts to even touch under armpit. Bruise on left arm. Rash with round light red spots in both inner thighs.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age with hyperlipidemia. The patient's medical history included Arteriosclerotic cardiovascular disease (ASCVD). On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot#, expiry not reported). Concomitant therapies included lisinopril and ALDACTONE. On an unknown date the patient experienced allergy to with PNEUMOVAX 23. On an unknown date patient started therapy with LIPITOR 20mg/day orally for hyperlipidemia. Patient desired generic and not trade name LIPITOR. Patient desired to switch from trade name atorvastatin to generic. The outcome of allergy to with PNEUMOVAX 23 was unknown. Causality was not reported. Additional information has been requested.
9JUL91 mom noted "swollen glands behind ears & on neck", fever 103, controlled w/APAP; To MD placed on Ceclor; Pt has poor appetite-takes fluids well; No n/v; no rash;
did not receive the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 21st October 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not receive the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 05-JUN-2023 The patient did not receive the second dose of Shingrix The reporter stated that she was going to follow up and would get the second dose at the time of reporting. The reporter had limited details to provide during the call. The reporter consented to follow up. Details reported for 1st dose. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Though I got the shot in my right arm, a few hours later I had swelling in my left arm. It felt like I had a blood clot, swollen, tender, and a few days later, I started getting chest pain which worsened with excursion. I went to ER for a CT; they could not find any clots or pulmonary embolisms. Immediately after getting my 2nd vaccine, same thing happened again.
temperature excursion for Fluzone QIV NP that was left on the cooler after shipment for 3 days with no reported adverse event; Patient was vaccinated with Fluzone QIV NP that was left on the cooler after shipment for 3 days (with no reported adverse event); Initial information received on 11-Sep-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves an unknown age and unknown gender patient and reporter reported temperature excursion for influenza quadrival A-B vaccine [Fluzone QIV] that was left on the cooler after shipment for 3 days with no reported adverse event and patient was vaccinated with fluzone QIV NP that was left on the cooler after shipment for 3 days (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza quadrival A-B vaccine Suspension for injection (lot UT8306MA, expiry date- 30-JUN-2024) via unknown route in unknown administration site for Immunization.  Caller reported temperature excursion for influenza quadrival A-B vaccine that was left on the cooler after shipment for 3 days with no reported adverse event (product storage error) (unknown latency) and patient was vaccinated with fluzone QIV NP that was left on the cooler after shipment for 3 days (with no reported adverse event) (poor quality product administered) (latency- same day).  Reportedly, Doctor calling from doctor's office wanted to know if the patient who was vaccinated FLUZONE QIV NP that were left on the cooler after shipment for 3 days should be revaccinated if the vaccines used were left inside the cooler with melted icepacks after shipment.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  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.
patient got sick; Initial information received on 08-Nov-2021 regarding an unsolicited valid social media non-serious case from a consumer/non-non health care professional.   This case involves a patient (unknown demographics) who got sick (illness) after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s), Concomitant medication(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient got sick (illness, non-serious) (unknown latency) following the administration of vaccine.  It was unknown if the patient experienced any additional symptoms/events.  No laboratory data reported.  It was reported "Yeah, they do their best to package what flu viruses they anticipate being prevalent that year, but there are so many flu viruses sometimes you can get sick from one they did not expect. Happened to me, too. Still got my shot."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There would be no information on the batch number for this case.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX 0.5 ml, subcutaneously, lot # L025205, expiration date: 07-JUL-2017: lot # L030160, expiration date: 11-AUG-2017; Lot # L043619, expiration date 02-NOV-2017. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 23.3 degrees Fahrenheit for 2 hours 10 minutes; 10.4 degrees Fahrenheit for 1 hour 30 minutes: 10.9 degrees Fahrenheit for 1 hour 20 minutes. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Shingles outbreak, severe and debilitating, extended. ER visits multiple OV, still with active shingles lesions over 2 months.
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Right shoulder down 27 cm is a blanching rash with mild erythema that is same temp as other arm. Mainly outer arm and rash is pruritic but not painful. Treatment: Continue BENADRYL or CLARITIN and follow up if worse.
On 11/02/2006 I received a Flu shot and a Pneumonia shot. Flu symptoms of aches and listlessness lasted for over two months - Elevated Blood Pressure, pulse rate increase and irregular heart beat started immediatly after receiving the shots and lasted for over six months.  My doctor immediately prescribed blood pressure medication.  When the high blood pressure and arythmia persisted, I had a complete cardiac screening and blood workup.  The symtoms were declared "innocent." In the last six months my body has slowly come back to normal.  My pulse is regular, although still higher than previously.  My blood pressure is slightly lower than before, however, I am now on medication...Lisinopril and triamterene.