chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a patient's mother and refers to a 10-month-old female patient. The patient received unspecified hepatitis B virus vaccine at birth and did not get any ''shots'' again until she was 7-month-old. The patient was on a new schedule with her physician to ''catch her up on her vaccine'' at the time of this report. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. On 05-DEC-2018 (reported as yesterday), the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not provided) and PENTACEL for prophylaxis. No adverse effects were reported.
Large nodules came up under my skin. Itching was horrible. Injection shot swell to the size of a softball. Did not secure for three or four days. Blood pressure was very elevated
Information has been received from a health professional concerning a pt who was vaccinated with a dose of Pneumovax 23 (lot # 649988/0692P). Subsequently, the pt experienced an inflammatory allergic reaction to the vaccine. The pt's outcome was unknown. No product quality complaint was involved. Additional information is not expected. It was also reported that two additional patients were vaccinated with a dose of Pneumovax 23 (WAES0412USA02933, WAES0501USA00539) and experienced adverse events.
Pain in chest, jaw, throat; Pain in chest, jaw, throat; Pain in chest, jaw, throat; Headache; This is a spontaneous case, reported by other non-healthcare professional to Company [reference number: SEQ19-06089] and initially received on 04-Nov-2019, concerning a 47-year-old, female patient.  The patient's medical history was not reported. The patient's concomitant medications were not provided.  On 30-Sep-2019, the patient was administered Afluria Quadrivalent [influenza vaccine; dose: 0.5 ml, anatomical location: deltoid, route of administration, batch number and expiry date: not reported] for prevention of seasonal influenza.  On the same day, after vaccination, the patient experienced pain in the chest, jaw and throat, and developed headache. No corrective treatment was given for the events.  On 01-Oct-2019, the patient recovered from the events. It was reported that the events subsided after one day.  This case was assessed as non-serious.   The reporter did not provide the causality assessment.  This case is linked to cases: 201905875, 201905877 and 201905878 (same reporter).  Company comment: The patient developed chest pain, pain in jaw, oropharyngeal pain and headache associated with the suspect product, Afluria Quadrivalent. Reportedly, the patient developed mentioned events on the same day, after vaccination. Chronology is plausible. More information regarding medical history and concomitant drugs is needed. Causal role of the suspect vaccine is assessed as possibly related for all events.; Sender's Comments: The patient developed chest pain, pain in jaw, oropharyngeal pain and headache associated with the suspect product, Afluria Quadrivalent. Reportedly, the patient developed mentioned events on the same day, after vaccination. Chronology is plausible. More information regarding medical history and concomitant drugs is needed. Causal role of the suspect vaccine is assessed as possibly related for all events.
pt recv vax 17APR95 & 21APR95 pt exp no menstrual period and had spotting only;a pregnancy test on 21APR95 was neg;no further info was provided;
Most concerning was the Shortness of Breath, lasting 5 days. Also cough, runny nose, congestion, post nasal drip, but no fever.
Fever, chills, shaking with onset 8 hours. Severe headache for two weeks.
I started getting symptoms of sore throat and cough. I was taking cough drops. The next day I tested positive for COVID-19 and was very sick. I had chills, body aches, fatigued, and was not able to get out of bed. I had facial pain with my sinuses. I felt somewhat congested but then it progressed to worse congestion days after. The next day the chills and body aches subsided. Then my ears hurt and had pressure. I had somewhat of a cough as well. I contacted an emergency doctor and did a telehealth visit. We discussed PAXLOVID but since it was not tested on pregnant women, I did not take it. My symptoms lasted a total of 6-7 days. Her EDD is 12/29/2022.
Lightheaded, dizzy, hot flashes. Patient stayed in the store about 30 minutes. Her mother was driving her home and patient was not doing anything later in the day. Gave patient 50 mg of liquid Benadryl. Follow-up the next day, patient is doing fine, per mother.
COVID+ 12/28/22.  Vaccination Status- J&J x1, Pfizer x1 + Moderna BIVALENT x1 Discharge Summary MD (Physician) ? ? General Medicine  BRIEF OVERVIEW: Discharge Provider:  MD Primary Care Provider:  MD Admission Date: 12/28/2022 Discharge Date: Dec 29, 2022    Active Hospital Problems   Diagnosis Date Noted POA ? Anemia 08/25/2022 Yes ? Chronic diastolic congestive heart failure  11/21/2016 Yes ? Depression 11/20/2013 Yes ? RA (rheumatoid arthritis)    Yes ? Fibromyalgia   Yes ? Hypertension   Yes ? OSA (obstructive sleep apnea) 03/14/2013 Yes ?  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia [R09.02] Acute on chronic congestive heart failure, unspecified heart failure type  [I50.9] Acute hypoxemic respiratory failure due to COVID-19  [U07.1, J96.01] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 63 y.o. female with a history of OSA, rheumatoid arthritis, chronic diastolic heart failure, and hypertension who presents with shortness of breath and general malaise, found to be COVID-19+. There was radiographic evidence of mild pulmonary vascular congestion, the patient had not taken her lasix as she was very nauseated. She was admitted as she was very short of breath. In the ER she was given lasix IV and admitted to the hospital. She diuresed well and felt much better. She got one dose of remdesivir as well due to some hypoxia in the ER. Patient felt much better the day after admission. Patient was able to walk without shortness of breath or desaturation below 88%. Patient declined staying for 3 doses of remdesivir. She was fully vaccinated for COVID-19 and was feeling better. She was tolerating a general diet. She was instructed on signs and symptoms of when to return to the ER. She was instructed to continue taking her lasix, she was then discharged home in stable condition.
PATIENT IS INFORMED THE PFIZER GIVEN WAS EXPIRED BY 3 DAYS. NO ADVERSE EVENT AT THE TIME OF THIS REPORT
Developed mono Dec. 01. Relapsed January & February - symptoms worsened to Chronic Fatigue. Unable to attend school. He was totally exhausted all the time, poor concentration, memory prob. After seeing several MD's, PT and mother tried many things. Through all this, PT's tonsils were enlarged and sore. PT & mother had scheduled a tonsillectomy when PT's mom heard about another treatment. PT had Quantum Xeroid testing, and after a total detox program/diet change, he is now back in school half days. No tonsillectomy!
This case was reported by a consumer via call center representative and described the occurrence of taste metallic in a 70-year-old female patient who received ENGERIX B adult. The patient's past medical history included lung nodule, lung disorder (near aorta, which had not changed in over 3 years), difficulty breathing (hospitalized), hospitalization (because the patient could not breathe) and adverse drug reaction (Weird reactions). Concurrent medical conditions included sickness (sick for 3 weeks prior to reporting). On an unknown date, the patient received ENGERIX B adult at an unknown dose. On an unknown date, less than a day after receiving ENGERIX B adult, the patient experienced taste metallic. On an unknown date, the outcome of the taste metallic was unknown. It was unknown if the reporter considered the taste metallic to be related to ENGERIX B adult. Additional details were provided as follows: The patient had weird reactions to medications. The reporter stated that, 7 or more years ago the patient was administered with ENGERIX B adult and the patient was left with a metallic taste in her mouth for a couple hours. The reporter did not remember the details. This case has been linked with a case US2016065417, reported by the same reporter.
Patient  reports feeling wiped out. Received flu vaccine Tuesday afternoon and then went home but could not get out of bed the next AM. He was unable to eat until lunch time next day. He also did not feel well the day after that.
Pain on the left side of the body; Diagnosed with shingles; Rash on the left side of his body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain on the left side of the body), HERPES ZOSTER (Diagnosed with shingles) and RASH (Rash on the left side of his body) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history reported by the patient.  Concurrent medical conditions included High cholesterol. Concomitant products included ATORVASTATIN for High cholesterol.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain on the left side of the body), HERPES ZOSTER (Diagnosed with shingles) and RASH (Rash on the left side of his body). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Shingles, at a dose of UNK, q8h and IBUPROFEN for Pain, at a dose of 600 mg. At the time of the report, PAIN (Pain on the left side of the body) outcome was unknown and HERPES ZOSTER (Diagnosed with shingles) and RASH (Rash on the left side of his body) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: no findings (Inconclusive) no findings.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Contact information e-mail was added.
Eight days post vax, the pt had viral syndrome symptoms and fever. One month post vax, the pt developed tinnitus and hearing loss in left ear.
This case was reported by a other health professional via call center representative and described the occurrence of shivering in a 60-year-old female patient who received SHINGRIX (batch number H7JY4, expiry date 1st July 2021) for prophylaxis. Co-suspect products included MENACTRA for prophylaxis.  On 13th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) and MENACTRA. In March 2019, less than a month after receiving SHINGRIX, the patient experienced shivering and cold. On an unknown date, the outcome of the shivering and cold were recovered/resolved. It was unknown if the reporter considered the shivering and cold to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that patient was administered MENACTRA on the same day but in a differed arm, SHINGRIX first dose administered in the right arm deltoid. Patient experienced chills down to the bone for about a week. Shivering and cold for several days.
arm hurt; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt) and FATIGUE (feeling tired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt) and FATIGUE (feeling tired). On 31-Mar-2021, PAIN IN EXTREMITY (arm hurt) and FATIGUE (feeling tired) had resolved.            No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-366442, MOD-2021-366464 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: The follow up received it contain no new information.
I spiked a fever of 105 degrees F and had a heart rate of over 180 bpm. After consultation with the Health Nurse Line, my boyfriend was told to take me immediately to the emergency room for treatment. Upon arrival, I was taken back as a "trauma cardiac event" and treated by the trauma team. They determined that the only thing that was different that could have caused this severe of an event was the fact I had had the Moderna COVID-19 booster shot about 24 hours prior.
numbness in the neck on the same side as the shot within 10 minutes of administration.  Kept patient for 30 minutes and pt stated
Case number PHEH2013US010020 is an initial spontaneous report received from a pharmacist on 02 May 2013. This report refers to a 14-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with an intramuscular dose of expired MENVEO (batch number: A10047, expiry date: not reported) on 01 May 2013. No adverse reaction was reported. No further information was provided.
c/o lt arm discomfort PM p/flu vax that AM;discomfort inc & occurs only w/movement;MD eval 11NOV97 & dx parasympathetic reflex disorder;MD does not feel this was directly from flu vax;may have been the stress that set off the problem;
This case was reported by a consumer via other manufacturer and described the occurrence of decreased appetite in a 6-month-old male patient who received PEDIARIX (batch number N2LK2, expiry date unknown). Co-suspect products included PREVENAR 13. Concomitant products included PREVENAR 13. On 18th November 2015, the patient received PEDIARIX (intramuscular) .5 ml and the 2nd dose of PREVENAR 13. In 2015, less than a month after receiving PEDIARIX, the patient experienced fluid intake reduced and restlessness. In November 2015, the patient experienced weight loss. On 18th November 2015, the patient experienced decreased appetite and sleep decreased. On an unknown date, the outcome of the decreased appetite, fluid intake reduced, sleep decreased, restlessness and weight loss were recovering/resolving. It was unknown if the reporter considered the decreased appetite, fluid intake reduced, sleep decreased, restlessness and weight loss to be related to PEDIARIX. Additional details were received as follows: On 5th November 2015, the patient received a dose of PREVENAR 13. On 5th November 2015, the patient could not eat and sleep for about a week and a half and both the events were completely resolved. The reporter clarified that her son could eat but his appetite was decreased to a fraction of what he normally ate. The patient was sleeping might be for 30 minutes and was very restless. On 18th November 2015, the patient received a dose of PEDIARIX and accidentally again received a dose of PREVENAR 13 (13 days after 1st dose of PREVENAR 13). On 18th November 2015, less than a day after receiving a dose of PEDIARIX and PREVENAR 13, the patient experienced decrease in appetite and decrease in sleep. Both decreased appetite and decreased sleep were getting worse and worse. Patient was only sleeping for 30 minutes and was restless. In November 2015, less than a month after receiving PEDIARIX and PREVENAR 13, the patient lost some weight, about half a pound in a week and a half. In 2015, the patient experienced fluid intake reduced and restlessness and was not drinking bottles very well. The reporter stated that, on the day of reporting it was 1st morning that the patient ate a decent breakfast and he had dinner last night. So, might be that was the start of slight improvement. At the time reporting, the patient was still not drinking very well and the reporter had coaxed him to drink a 4 ounce bottle. The patient did not have other medical conditions and no other investigations. The reporter wanted to know if there was an antidote she could give the patient because 6 weeks of events was too much.
A report has been received from a Health Professional concerning a 6 year old, Female subject, Height: 48.0 Inches; Weight: 53.0 Pounds, who had been receiving Nasal FLUMIST. The patient's concurrent disease(s) included THROMBOCYTOPENIA and ADHD. Concomitant medications included AMOXICILLIN, CLAVULANIC ACID for PARONCHIA TOE. FLUMIST started on 27-Sep-2013. The patient experienced WORSENING OF BACTERIAL PNEUMONIA which started on 16-Oct-2013, VITAL SYNDROME which started on 14-Oct-2013, VOMITING which started on 04-Oct-2013, STOMACH ACHE, CHILLS, POSITIVE FOR FLU TYPE B and FEVER which started on 27-Sep-2013 and HEADACHE. At the time of reporting, the event of STOMACH ACHE, CHILLS, POSITIVE FOR FLU TYPE B and FEVER was improving. At the time of reporting, the event of WORSENING OF BACTERIAL PNEUMONIA, VIRAL SYNDROME and VOMITING was ongoing and the outcome of the event of HEADACHE is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 29-Oct-2013 from Health Professional: E-mail id for primary reporter added. Ethnic origin and siblings information were added, indication for FLUMIST was added. New non serious events of vomiting, viral syndrome, WORSENING OF BACTERIAL PNEUMONIA and headache were added. Concomitant medication Augmentin was added. Medical history was also updated. Vaccinate at and Vaccine purchased with information was added.
This spontaneous report as received from a healthcare worker refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with VARIVAX (Merck) lot # K011082, expiration date: 08-AUG-2016 and reported lot # K021487, expiration date: 30-JAN-2016 (dose and route were not reported), after they were exposed to temperature excursion of 25 Fahrenheit (F) for 41 hours. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Swelling left arm and a lump under her axilla c/o of pain. 1 inch needle used. Half of upper arm was swollen. Came to clinic on 6/12 and back on 6/18 with pain and decreased swelling, lump still present.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Mild, Systemic: Weakness-Medium
Dizziness Narrative: mild dizziness, little shortness of breath (employee with Hx of COPD and former tob. smoker - quit 10 years ago)
Pt recvd vax 14SEP92 & 2 days later devel a flat, dry pruritic rash on upper arm & chest; No further details were provided;
Runny nose and cough beginning 7/9/22. Elevated temperature ~99.6 but never higher for a couple days. Negative PCR test for COVID on 7/10/22. On 7/12/22 she began having difficulty breathing in the morning and very rapid heartbeat along with loose stool. Taken to Pediatrics urgent care in at noon on 7/12/22 where she then vomited. Pediatrics detected pulse ox ~94 and administered zofran for the vomiting and albuterol nebulizer along with an oral steroid. Urgent care recommended transfer to the ER, and she was taken to the hospital in the late afternoon on 7/12/22. They gave additional albuterol nebulizers and continuous monitoring. At the hospital she test negative for COVID, RSV, and Flu A/B. She was admitted overnight with respiratory distress and put on low flow oxygen overnight. She responded well to the O2 oxygen and was discharged from the hospital late morning 7/13/22 with home treatment steroid and albuterol inhaler.   At follow up with pediatrician on 7/14/22 vitals were good but detected wheezing, possible asthma. Prescribed 4 day course of prednisone and follow up visit. The patient is slowly getting better but with wheezy cough. The cough is now productive and discharging mucous.
Local reaction in left arm. large raised welt beneath the injection site. painful, red and warm to touch
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (lot #N021583 and expiration date: 18-NOV-2019). In October 2017 (reported as on 17-OCT-2017, 19-OCT-2017, 26-OCT-2017 or 27-OCT-2017, the patient was vaccinated with unspecified doses of improperly stored VARIVAX (dose, units, frequency and route not reported) (lot # N019133 and expiration date: 22-JUN-2019). Reporter informed that, there was multiple temperature excursions for the VARIVAX as follows, on 02-OCT-2017, temperature excursion was at 14 F for the duration of 2 hours, on 03-OCT-2017, temperature excursion was at 16.7 F for the duration of 2 hours, on 04-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 05-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 10-OCT-2017, temperature excursion was at 17.1 F for the duration of 0.5 hours, on 11-OCT-2017, temperature excursion was at 18.1 F for the duration of 4 hours, on 16-OCT-2017, temperature excursion was at 19.2 F for the duration of 1 hour, on 17-OCT-2017, temperature excursion was at 19.40 F for the duration of 2 hours, on 18-OCT-2017, temperature excursion was at 17.40 F for the duration of 1 hour, on 19-OCT-2017, temperature excursion was at 21.90 F for the duration of 1 hour, on 20-OCT-2017, temperature excursion was at 17.10 F for the duration of 2 hours, on 24-OCT-2017, temperature excursion was at 5.80 F for the duration of 0.5 hours, On 25-OCT-2017, temperature excursion was at 8.20 F for the duration of 0.5 hours, on 26-OCT-2017, temperature excursion was at 17.80 F for the duration of 0.5 hours, on 27-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour, On 30-OCT-2017, temperature excursion was at 16.90 F for the duration of 2 hours and on 31-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour. It was reported that there was multiple previous excursions for the VARIVAX. Reporter did not state that sterile diluent was improperly stored. No adverse effects reported. No product quality complaint was involved. No further information was provided. This is one of the 8 reports (Same reporter link). Sender's Comments: US-009507513-1802USA003097: US-009507513-1802USA005084: US-009507513-1802USA005086: US-009507513-1802USA005090: US-009507513-1802USA005087: US-009507513-1802USA005088: US-009507513-1802USA005089: US-009507513-1802USA005088: US-009507513-1802USA007559.
NO ADVERSE EVENT REPORTED - IT WAS DISCOVERED WHEN REPORTING VACCINATION ADMINISTRATION THAT THE PATIENT HAD ALREADY RECEIVED 2 DOSES OF SHINGRIX (7/27/20 AND 10/14/20). NURSING STAFF REPORT THAT PATIENT HAD INSISTED WITH DR THAT THEY RECEIVE THE SHINGLES SHOT TODAY
swollen face & body;rt leg more swollen, fever 102 next morning;evening a/seemed to be higher but not taken;nasal congestion;more crying hr p/inj than usual
SORE ARM AFTER INJECTION, PAIN WORSENED BY EVENING AND WAS UNABLE TO LIFT ARM WITHOUT SEVERE PAIN. BY NEXT DAY SORE THROAT, RUNNY NOSE AND FEVER. BY THE END OF THE WEEK ALL THE ABOVE PLUS STIFF NECK/BACK AND CHEST CONGESTION. THIS CONTINUED FOR ABOUT TWO MONTHS. WITH IN A FEW WEEKS OF GETTING THE FLU SHOT, CAME SEVERE BACK PAIN THAT RADIATED TO MY FEET, THEN ULCERATIVE COLITIS FLARE UP. NEXT CAME IRITIS TO THE POINT I'D WAKE UP IN THE MORNING UNABLE TO SEE. MONTHS LATER I WAS DIAGNOSED WITH ANKYLOSING SPONDYLITIS AND AM TAKING MEDICATION.
24OCT96 pt w/pain rt upper arm, then swelling, redness progressed to purple discoloration & skin eruptions;no oozing, but hot;swelling was 1/2" diameter, pains in the joints on the same side of body, muscle aches, anorexia, sweat, tiredness