chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm within an hour of the vaccination then gradually because fatigued and achy throughout the day. Eleven hours after the vaccination I had a sudden onset of a fever with chills, nausea and muscle aches. Within a couple of hours after that I had a high fever with chills,  muscle/bone/skin aches, a headache and started  vomiting.  At 8:15 pm (five hours after fever onset) I took 400 mg of ibuprofen but it didn?t help any symptoms. Two hours later I took 325mg of Tylenol and the fever went down to 100.5 degrees. After sleeping a few hours I woke up at 3 am with violent chills/shaking and some vomiting. The fever subsided by then. The rest of the morning I had chills and aches. The next day I gradually felt better and was able to keep down food and water. Some body aches, headache and tiredness remain at 8 pm the next day.
LT LEG RED/SWOLLEN WARM TO TOUCH 6 CM X 8 CM INDURATION/ERYTHEMA
Fever to 102.9 the next day 05/16/07-records received from facility for DOS-5/1-5/2/07-DC DX: Fever, GERD. Otitis Media. Fever 101.9 and grunting. Not eating well. In office appeared to be in respiratory distress. PE: right tympanic membrane erythematous and bulging.
MOM NOTED REDNESS AT INJECTION SITE OF LEFT LEG ON 08-21-2003.  PATIENT PRESENTS TODAY WITH RED RASH ON LEFT THIGH.  MEASURES 4 1/2 BY 4 3/4.  PATIENT COMPLAINED OF HEADACHE YESTERDAY.  MOM ALSO REPORTS PATIENT HAD FEVER YESTERDAY.  TYLENOL AND MOTRIN WERE GIVEN YESTERDAY.
This spontaneous report has been received from a medical assistant referring to an unspecified patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medication. The medical assistant reported that on an unspecified date, an unspecified patient received a recalled lot of GARDASIL 9 which had a lot # N029069 with expiration date in 17-MAY-2020. No adverse effects were reported.
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 3:40 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 3:40 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 80.44 .  Concomitant medications details were not reported by the reporter.  Batch number 030B21A underwent temperature excursion on 03-April-2021 with temperature 34 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-April-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  Treatment details was not reported by the reporter   This case was linked to MOD-2022-566976 (Patient Link).
Presented to ED 6/11 with chest pain/pressure, elevated troponin (max 28.9, nml range 0.00-0.119ng/ml), diffuse ST elevation consistent with pericarditis, normal function on echo.  SARS CoV2 nucleocapsid negative, SARS CoV2 spike protein positive.  Admitted to hospital for pain management (Toradol, Tylenol and ibuprofen) and serial troponins. Discharged home 6/13 with cardiology f/u  in 1 month.
Arm pain at site of vaccination (left deltoid) 20 minutes after injection. Site was hot to touch. Tried ice to site, did not help. Had her see urgent care provider. Given oral Benadryl.
A serious spontaneous report of pneumonia and H1N1 has been received from a healthcare professional concerning 40 adults, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for these patients. The patient received FLUMIST immunization at various dates at the beginning of their recruitment. Approximately twelve weeks after receiving FLUMIST, the patients developed respiratory symptoms and contracted influenza. 17 of these patients were confirmed to have H1N1 via laboratory tests. Approximately twenty patients were eventually hospitalized with an initial diagnosis of pneumonia, with six patients needing ICU care and two to three patients needing ventilator support. The outcome for all these events are unknown. An investigation is underway for these patients, and additional information will be available once the investigation is completed.
pt exp local rxn following dose #1 of Engerix-B then exp swelling & redness of arm following 2nd dose;
Tinnitus in both ears. I hear a loud and constant high pitch sound that never stops. I feel that my body has MIS-A from the Moderna booster shot. I have received three COVID-19 vaccines. Two Pfizer shots and one Moderna shot. The constant loud noise is affecting me mentally at this point. I want peace and quiet like everyone else. I choose to not get vaccinated ever again due to the inflammation that is causing my tinnitus.
Cellulitis began 1 day after vaccines given, erythema doubled in size in 24' Temp 100.3 @ 24'. Treated with oral antibiotics
After 7/31/13 HPV, multiple flat warts appeared on hands and knees. 2nd dose 10/18/13, warts immediately intensified to > 100. 3rd Booster declined. Warts have persisted for almost a year. Patient has been seeing a Dermatologist for this condition since 10/18/13. 11/26/13 Spoke with pt mom states hands "oozy" concerned re: infxn and has developed new areas. Sched pt OV today. 11/26/13 hand draining (1) s/p ALDARA to VV. (R) hand - swollen with tender, warmth and open, draining areas. (2) Infected Rx KEFLEX 250 QID x 14d with food. D/C ALDARA for now. D/C TAC for 2 wks. 12/6/2013 CC - hand. S/P VV -> ALDARA - infection (R) dorsal hand (+). (+) retention hyperkatatosis palms. Wash hands, cont Vaseline. D/C ALDARA. 12/27/13 - new Rx request for cephalexin 500mg #56 1 PO QID x 14 days. (+) Pt crying d/t personal reasons. 10/28/2013 CC: hands "flat VV". (+) Itchy and miserable, esp since starting ALDARA/Saran wrap D/C a few days ago. (B) dorsal knuckles/PIP. Tan and erythematous VV papules flat approximately 100s of them (+) tender. VV with secondary inflamed rxn after ALDARA with occlusion. SW pt and mom at length. (R) TAC 0.1% oint BID x 5d. (S) TOPICORT .025 oint BID then resume ALDARA 3 x 1 wk no occlusion. F/U 2 wks. 11/18/2013 CC: hands - VV - s/p ALDARA x 3 wks and TAGAMET able to tolerate QD. No pain, pt feels better. (+) fissured plaque (R) dorsal hand and papules (R) dorsal hands. No obvious VV, hard to tell. ALDARA QD x 3 wks took 1 RF cont TAGAMET. Recheck 1 mo.
Approximately 3 days after DTaP, patient had a 2 hour, high-pitched crying episode. In middle of episode about 1 minute episode of shaking/twitching of whole body. Eyes rolled back, turned pale. Temperature 100. Went to ER but not evaluated. Normal exam 9 days later by myself.
chest pain X 4 days seen in ER. EKG, Echo, CXR and Troponin done.  given colchicine and now being followed up, Pt still being followed up at the time of this note.
sore left arm after first dose of Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm after first dose of Moderna Covid-19 vaccine) in a 101-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore left arm after first dose of Moderna Covid-19 vaccine). At the time of the report, PAIN IN EXTREMITY (sore left arm after first dose of Moderna Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided.  The patient received the vaccine in her left arm shoulder deltoid muscle.  No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Mar-2022: Follow-up received with no newinformation
01/28/2023 had Fever, headache and sore throat and very tired.  Called doctor and reported positive Covid test. Prescribed Paxlovid for 5 days.
flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event; flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event; Initial information received on 17-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9 years old female patient to whom influenza quadrivalent recombinant vaccine [Flublok] inadvertently ordered, staff administered to six patients, should have been influenza USP trival A-B subvirion no preservative vaccine [Fluzone] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.  On 04-Jan-2023, the patient received 0.5 ml dose of suspect influenza quadrivalent recombinant vaccine (lot UJ93AA; strength, formulation, frequency, expiry date: unknown) via intramuscular route in unknown administration site for prophylactic vaccination.  On 04-JAN-2023 the flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency: same day).  It is unknown if there were lab data/results available  Action taken : not applicable.  Outcome : Unknown.   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.
Information has been received from a husband of a 64 year old female who received a dose of ZOSTAVAX (lot number not provided) on 23-AUG-2012. Concomitant medications included VICODIN, an unspecified high blood pressure medicine and an unspecified small dose of estrogen. On 23-AUG-2012, after receiving her dose of Zoster vaccine live the patient experienced pain and redness at the injection site and remained in this state for 2 weeks but the redness continued. On 01-OCT-2012 the patient broke out in a rash and is currently seeking treatment (not specified). The patient had been unsure of her chickenpox history and underwent a test to determine if she had ever had chickenpox before. The test indicated that she had not had chickenpox. Under her treating physicians recommendation, she received the Zoster Vaccine Live vaccine on 23-AUG-2012. Follow up information has been received from the patient who on 23-AUG-2012 had received a dose of Zoster Vaccine Live. The patient reported that she has a prior history of cancer related to HPV. The patient reported that in addition to the previously reported symptoms, she experienced a bloody nose twice since receiving the vaccine and has lost her voice. The patient stated that she did have a prior history of chickenpox that was confirmed through unspecified testing. This contradicts her husband's statement about his wife having no prior history of chicken pox. As of the time of reporting, the patient has not recovered. Additional information has been requested.
This spontaneous report was received from a medical assistant regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, unspecified patients were administered with improperly stored ROTATEQ lot# M031807, expiry date: 02-APR-2018 for prophylaxis (dosing details not reported). Temperature was reported as 51.6 F and time frame was 2 hours 20 minutes. There was no previous temperature excursion. The call was due to data logger. No adverse effects were reported. No product quality complaint was involved.  This is one of the several reports due to the same reporter. Additional information has been requested.
Big red welt on arm at injection site that started the day I got the shot. Hot to the touch. I took Claritin during the day and Benadryl hat night. It grew overnight and was the size of a tennis ball the next day. It was hard and hot to the touch. Over the course of the weekend it grew to the size of a softball and was tender, hard, red and hot to the touch. It is currently still red and itches. It is not as hard and it is still big. I did take Benadryl every night to try and calm it down. I also iced my shoulder.
Numb lips; Severe migraine headache; Dizziness / Lightheaded; No apetite; Joint pain; Muscle ache; Nausea; Fatigue; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numb lips), MIGRAINE (Severe migraine headache), DIZZINESS (Dizziness / Lightheaded), DECREASED APPETITE (No apetite) and ARTHRALGIA (Joint pain) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bee sting (Bee allergy).   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced HYPOAESTHESIA ORAL (Numb lips), MIGRAINE (Severe migraine headache), DIZZINESS (Dizziness / Lightheaded), DECREASED APPETITE (No apetite), ARTHRALGIA (Joint pain), MYALGIA (Muscle ache), NAUSEA (Nausea), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 15-Apr-2021, HYPOAESTHESIA ORAL (Numb lips) had resolved. At the time of the report, MIGRAINE (Severe migraine headache), DIZZINESS (Dizziness / Lightheaded), DECREASED APPETITE (No apetite), ARTHRALGIA (Joint pain), MYALGIA (Muscle ache), NAUSEA (Nausea), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. Not Provided          No concomitant medications were reported.  Patient has an allergy to bees, therefore carries an EpiPen.   This case was linked to MOD21-077838, US-MODERNATX, INC.-MOD-2021-080159, US-MODERNATX, INC.-MOD-2021-080175 (E2B Linked Report).; Sender's Comments:  MOD21-077838:wife's case crosslinked US-MODERNATX, INC.-MOD-2021-080159:Husband's case crosslinked US-MODERNATX, INC.-MOD-2021-080175:Wife's case crosslinked
DEVELOPED A RASH ABOUT AN INCH AND A HALF AROUND THE INJECTION SITE AND DEVELOPED EXTREME NAUSEA AND VOMITING AT 3 AM
Eyes burning, on and off, even burning in the middle of the night. Still occurring after 4 days patient usually has side effects to flu shot (ex. headache) but usually goes away, this is the first time for the eye symptoms.
A consumer reported that her niece received an injection of Prevnar and subsequently developed a fever which persisted for 1 week and redness and swelling of both hands. The reporter declined to provide additional information and declined to grant permission for follow-up investigation.
No additional AEs; Vaccine that expired in 2023 was administered on 01-MAY-2023; Provider calling to report a temperature excursion. Product administered to 1 patient. No additional AEs. No PQCs.    ?    Names of vaccines involved (including lot/exp) VARIVAX W031816 10/05/2024        ?    Temperature: 45.03F        ? ; This spontaneous report was received from a provider referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 01-MAY-2023, the patient was vaccinated with an improperly stored (product storage error) dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose not reported) oral, lot number W031816, expiration date reported as 05-OCT-2024, but upon internal validation was confirmed as 16-NOV-2022 (expired product administered) for prophylaxis. No adverse event was reported.  The excursion of the vaccine was of 45.03 degrees Fahrenheit for 1 hour and 20 minutes. No other excursions were reported.
Have a high pitch ring in right ear only. Started 4/7/21 at 8pm. the ringing in ear is frequent and irregular. No treatment, I have never experienced Tinnitus before ever in my life and saw others that received vaccination are experiencing same issue, so I am reporting side effect. Issue is ongoing and currently affecting my wellbeing. I cannot concentrate, experiencing increased anxiety due to having this side effect as well. Will this go away?
On 10/16/13 evening started not feeling well with headache and clammy. Progressed through evening. 10/17/13 temp 102 and headache. Upon arrival in office temp 104 and pulse ox 89. Transported to hosp. via ambulance. Influenza A positive. Admitted to ICU. Discharged 10/27/13 - symptoms consistent with influenza A. Seeing pulmonologist.
small bulging rash on injection site that feels warm and is growing larger; small bulging rash on injection site that feels warm and is growing larger; small bulging rash on injection site that feels warm and is growing larger; BNT162B2 first dose was administered on 23Dec2020, second dose was administered on 04Jan2021; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 04Jan2021 09:00 at single dose for Covid-19 immunization. The first dose was administered on 23Dec2020 15:00 via an unspecified route of administration at single dose. The patient's medical history was not reported. No known allergies. Concomitant medication included fluoxetine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced a small bulging rash on injection site that feels warm and is growing larger on 04Jan2021 at 11:45 PM. It was unknown if a treatment has been received for the event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.  Information about batch/lot number has been requested.
Patient tolerated the vaccine administration well initially. However, a few moments following administration, she experienced a brief fainting spell with jerking and seizure like movements. Per Vaccine information sheet, this is normal. I held on to her (so she wouldn't fall out of the chair) and talked to her during the spell. She did come to and sat back up after about 30 seconds. She felt okay, "just weird." I offered her to lay down but she declined. I stayed with her a few minutes. She was okay with me leaving the room at that time to find staff to get ice water for her. Dr. briefly assessed her and there were no immediate concerns, he reccommended she sit in a chair for 15 minutes before being excused. After she started drinking the water, she complained of feeling nauseous. I gave her an emesis bag. She then stated she felt very hot and sweaty. She appeared diaphoretic. I offered her to lay down again and she did agree this time. I assisted her to lay down in order to prevent injury. I placed a cold rag on her forehead. There was a pool of sweat on the chair where she sat. After a minute or so of lying down she stated she felt much better. However, I did have her lay there for another 10 minutes or so. For the duration of this episode, she denied chest pain, difficulty breathing, swelling of the face/throat, fast heartbeat, dizziness, or weakness. She knows that these are signs of a serious allergic reaction and should she develop any of those signs within the next few hours, she should go to the ER. I sent her home with the meningococcal VIS and told her to be mindful of the signs of mild/serious/allergic reactions listed on the sheet. I offered to call her mom for her and she declined. She sat up and stated she felt much better, that all her symptoms were resolved, and capable of driving herself home. She did say she would tell me if she felt otherwise. I walked her out to the lobby, where she again stated she was okay, and proceeded to go home.
approx 3mos p/vax pt devel chickenpox w/less than 25 lesions. little red blisters w/white centers. addl info req
No additional AE/PQC.; HCP reported AE on behalf of a patient who was administered an expired dose of RECOMBIVAXHB with no prior TEs (SUPPORTED). No symptoms reported. Obtained consent to contact HCP. No additional AE/PQC.; This spontaneous report has been received from other Health Professional and referring to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB SYRINGE (DEVICE)) intramuscular injection, 0.5 milliliters (strength, dose description, lot #, expiry date, route of administration, and indication were not provided) with no prior TEs (SUPPORTED) (Expired product administered). There was no adverse effect reported (No adverted event).
Patient describes fever, chills, headache and sweating with burning in the chest that occurred 12 hours after administration of the Bivalent Moderna booster.