chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a five-year-old female who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient received the FLUMIST on 31-Dec-2008, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with the same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event
Pfizer-BioNTech COVID-19 Vaccine EUA  On January 28, 16 days after receiving the first vaccine dose, I experienced an extremely sore throat and subsequent sinus and respiratory infection.  This was diagnosed as a bacterial infection and I was prescribed a 10 day regimen of Amoxicillin 875 mg.  I started this regimen on January 28.  I'm scheduled for the second COVID-19 vaccine shot on February 2.  I had my flu shot in October 2020.  The aspect of this that alarmed me was the fact that I have not had such an infection in decades--I simply don't get sick.  Could the COCID-19 vaccine have negatively affected my immune system?
I had a rash from the shot and an immediate headache in my temple right above my eye. I started to get Migraines which became very painful four days after the vaccine. I had to go to the ER because the pain was so bad one day that I almost passed out. It is a much different pain than my normal Migraines my left arm and leg were numb. I have been getting Migraines daily for five weeks now. I have been trying to control my diet and switched medication in an effort to control the Migraines. The medication helps a little if I take it early. I also still get a little of the numbness in the left side of my body. All services provided by insurance company.
Tired; Arm soreness; Little headache; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Tired), PAIN IN EXTREMITY (Arm soreness) and HEADACHE (Little headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired), PAIN IN EXTREMITY (Arm soreness) and HEADACHE (Little headache). At the time of the report, FATIGUE (Tired), PAIN IN EXTREMITY (Arm soreness) and HEADACHE (Little headache) outcome was unknown.            The concomitant medication was not reported by reporter. On 11-Apr-2019, patient received Xeljanz XR tab 11 mg.  ~ The patient stated that she was tired, experienced arm soreness and had a little headache following each moderna covid-19 vaccine. ~ The treatment medication was not reported by reporter.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Approximate ten days after 16 NOV 2019 vaccination, facial pain developed, as if tooth ache extending to right year. On Sat 30 NOV 2019 a significant shingles rash with central blisters developed from the chin through the right cheek and eyelids to the middle of the scalp. Aciclovir 800 mg/5 times a dayfor eight days started on 2 DECEMBER 2019. Valacyclovir 1 g/3 times a day for seven days started on 9  DEC 2019.  Ending on 17 DEC 2019. Ocuflox 1 drop/4 times per day started on 4 DEC 2019 for 15 days until 17 DEC 2019. Within three days of antiviral medication, no new lesions developed.  Lesions left apparently permanent scars. On 24 DEC 2019 unbearable facial itching developed, non-responsive to Lidocaine 4%.  Subsided after three days. New shingles rash appeared on the nose on 26 DEC 2019.  On 27 DEC 2019 numerous nose lesions developed. Valacyclovir 1 g/3 times a day for seven days started on 27  DEC 2019.  Ending on 2 JAN 2020.  Rash responded to medication. Prednisolone Forte, 1 drop/2 per day started on 2 JAN 2020 for 26 days, and continuing  1 drop per day until 11 FEB 2020. New significant shingles rash over right eyebrow developed on 11 JAN 2020. Valacyclovir 1 g/3 times a day for seven days started on 11 JAN 2020.  Ending on 18 JAN 2020.
Patient presented to hospital 2 days after 2nd dose of  Pfizer COVID19 vaccine due to chest pain found to have elevated troponin undergoing evaluation for myocarditis. Currently admitted to the hospital for further management.
Heart palpitations, elevated blood pressure, lightheadedness started at 11:50am 2/6/21; Went to ER, diagnosed with palpitations.  Follow-up with my primary care physician on 2/9/21 and he ordered Holter monitor test. Description of tests and results below. After Holter Monitor test, he prescribed 25 mg of Metoprolol Tartrate twice per day. Still have recurring lightheadedness which has become more frequent every time to all day, every day.  Several premature heart beats and occasional heart flutters daily.
Information has been received from a physician concerning her 12 year old daughter who on 05-MAR-2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot # unknown) and concomitantly received (DTaP) (manufacturer not reported). On 16-MAY-2009, the patient received the second dose of GARDASIL (lot # unknown) with no concomitant vaccinations administered at that time. On 19-SEP-2009, the patient received the third dose of GARDASIL (lot # unknown) with no concomitant vaccinations administered at that time. Three weeks after the patient's second dose of GARDASIL on approximately 06-JUN-2009, she developed chronic arthritis and was seen by an orthopedist (name of orthopedist not reported) for arthritis-type symptoms. The patient was placed on MOTRIN. The patient developed psoriatic arthritis and initially needed a wheelchair. The patient was seen by a rheumatologist affiliated with a hospital. The patient had an MRI and a bone scan and was diagnosed with psoriatic arthritis. The patient was placed on sulfasalazine and therapy with prednisone for six weeks. The patient was not hospitalized. Within 2 days after starting the medications the patient's symptoms had resolved. The patient was back to her normal activities. The rheumatologist was definitely related to GARDASIL and the physician thought her daughter's arthritis was related to receiving GARDASIL. Psoriatic arthritis was considered to be disabling by the physician. The Health Care professional contacted during telephone follow-up could not supply the following information: lot number. No further information is available at this time. Additional information has been requested.
This spontaneous report was received from a consumer (mother) refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot # not reported) dose and route not reported. No concomitant medications were reported. The consumer reported that her daughter developed a lymph node in her neck after receiving GARDASIL. The outcome of the reported event was unknown. Additional information is not expected.
pt recv vax 1MAY97 & lab eval on 16OCT97 revealed negative varicella antibody titers (0.83);
Sterile water used as diluent; Sterile water used as diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA794A, expiry date 31-JAN-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Sterile water used as diluent) and inappropriate dose of vaccine administered (Verbatim: Sterile water used as diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 19-Apr-2023 The medical assistant called to inform that on an unknown date, a patient was administered a dose of Menveo, which was mixed using sterile water instead of the Menveo provided diluent.  The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. The healthcare professional did not have information of the patient or the date of administration, but agreed for the follow up by GSK safety team. The patient received the Menveo which was mixed with sterile water instead of provided diluent, which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered.
Pt received a flu shot at approx 9 am this morning. At 1330 PT called stepmother to bring him some nausea medication. At school he had O2 sats 86-90% and the school nurse asked that pt be brought into be seen. Upon rooming, pt appears to be working at breathing with deep, intentional breaths. He is able to speak in full sentences but states that he feels short of breath.  Per provider, patient had bronchospasm and O2 saturation of 90% at that time. Provider directed the RN to administer Benadryl and to titrated O2 to 94% and above. Patient could maintain his O2 above 94 for 5 minutes. At that time, provider recommended pt go to the ER for management of this reaction (possibly to an influenza vaccine) as we do not have resources for monitoring the reaction as severe as this. Patient also had hives to the armpits bilaterally.
This spontaneous report as received from a consumer refers to a 55 years old female pharmacy technician concerning herself. The patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (subcutaneous injection, lot and batch number not reported) in OCT-2012. No other co-suspects were reported. No concomitant medications were reported. In October 2012 within 48 hours of receiving the vaccine the patient experienced a local reaction. The reaction was an oval shaped "atrusion" from her arm. The site was 2 inches long by one inch and a half wide. This reaction lasted for about a month, and is still sensitive to touch. The patient asked a pharmacist, where she works and location where she received the vaccine, for advice. No treatment was given. The outcome of local reaction: an oval shaped "atrusion" from her arm was unknown. The outcome of sensitive to touch was reported as not recovered/not resolved. The relatedness for local reaction: an oval shaped "atrusion" from her arm and sensitive to touch is unknown for ZOSTAVAX. Additional information has been requested.
fever 103-104 started about 4 hrs p/vax, lasted for 48 hrs; pt would not eat, was very fussy, mom tried APAP 4 hrs x 3 doses ea time took pt vomited; concerned about dehydration took to see MD, used cold compresses & bathed;
Period started two weeks early and is heavier than I have ever experienced.  Hormonal a new breakout Extreme fatigue and irritability similar to PMS symptoms
Numbness and tingling in the L upper extremity. Pt reported numbness in the 2 smaller digits of the L hand, resolved after several minutes.
Within the first 5 hours I formed a rash on bottom side of right arm. Next morning it had jumped to left arm. Later that day it had traveled down my sides. 48 hrs later it was all over my body. Raised, swollen and hot to touch.
This spontaneous report as received from a physician refers to a 66 year old male patient. The patient's pertinent medical condition included psoriasis treated with ENBREL. The patient was considered to be immunocompromised. The patient was also taking other unspecified concomitant medications. Drug allergies were not provided. On 18-OCT-2017, the patient was vaccinated with ZOSTAVAX, 0.65 ml in the right arm, expiration date 27-OCT-2018 (route of administration was not provided) for prophylaxis. Lot number M021170 is an invalid lot number for ZOSTAVAX. Concomitant therapies included ENBREL, influenza virus vaccine (unspecified) (administered on the same day 18-OCT-2017, reported as "flu shot") and sterile diluent (MERCK). The patient experienced no adverse events.
The day after she received the shot she was at her softball game and told her coach she couldn?t run, her ankles hurt. This happened again during the following week at dance. I remembering her texting me from dance (I was at her open house) that she couldn?t do the jumps because of he ankles. Then Fri. morning she woke up and could not move her neck at all. I heard a scream come from upstairs, went up and she was standing there crying. We took her to the doc., who prescribed 800 mg of Ibuprofen every 4 hours. It did not make a dent in her pain. The next day she was still in pain and she asked me if I could take for acupuncture, which I did. The practitioner told us her glands were so swollen! The NP never mentioned this to us. She improved over the next few days after  acupuncture treatments, but now every month when she gets her period, she gets swollen lymph glands. We are seeing another doctor and working on detoxing her body.
Developed fevers, joint pains, chronic urticaria. Seen by multiple subspecialists over course of several months.
Onset one wk p/immun fever, rash, coryza, swollen nodes;
Next day immediate extreme pain in my right thumb joint, had to go to Doctor for help, I have had therapy, injections, medication since it began  and nothing is helping, I am still expericing a lot of pain and cannot use my my right hand.
Nausea, diarrhea (2) days, weakness, flu like body aching, 100.5 temp, tiredness,
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Lot number: EP7534), in right arm, in Apr2021 as dose 2, single (Lot number: ER8735), in right arm and on 20Nov2021 as dose 3 (booster), single (Lot number: Fj1670) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "MVP" (unspecified if ongoing), notes: MVP; "Recent tachycardia" (unspecified if ongoing), notes: Recent tachycardia; "medullary sponge kidney" (unspecified if ongoing); "gerds" (unspecified if ongoing), notes: gerds; "known allergies: latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "known allergies: Morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid treatment start date=30Jul2022, stop date=04Aug2022. No other medications/products within 2 weeks of starting COVID-19 treatment. Five days after stopping Paxlovid, symptoms rebounded on 09Aug2022 at 19:30 (fever, congestion, sore throat, increasing resting heart rate, runny nose). Device date was reported as 10Aug2022.
My arm was swollen for a couple days after (which I expected) receiving the vaccine. Then on saturday night after dinner and dessert (all things I've eaten recently so nothing new) I began swelling in my lips and under my right eye. I took 6 doses of off-brand benadryl and it would only decrease the swelling by very small increments. My breathing was alright, but to this day as of 03/22/2021 my lips are still slightly puffy.
ON JANUARY 19, 2021 THE RESIDENT WOKE FEELING "ACHES AND PAINS ALL OVER HER BODY" . SHE DID NOT TAKE HER TEMPERATURE SO SHE'S NOT SURE SHE HAS A FEVER. RESIDENT STATES THAT SHE CONTINUED TO WORSEN THROUGH OUT THE DAY AND FELT "REALLY BAD" LAST NIGHT. THIS MORNING, JANUARY 20,2021 SHE WOKE FEELING "A LITTLE BETTER".  HER  PULSE OX WAS 94 ON ROOM AIR, PULSE 71 BPM, TEMP 98.3. SHE WAS ALERT AND COULD ANSWER ALL MY QUESTIONS. SHE DID STATE THAT SINCE THIS MORNING SHE WAS "FEELING BETTER AS THE DAY GOES ON" SHE HAS OXYGEN IN HER APARTMENT FOR HER COPD SO SHE STARTED USING THAT  SINCE HER O2 LEVEL WAS LOW.. I WILL CONTINUE TO FOLLOW UP WITH HER THIS AFTERNOON. ON A SIDE NOTE SHE STATED THAT HER ARM WAS SORE FROM THE INJECTION.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 03-DEC-2015 at time- 11:52, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.4 and 3.1 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
pro dancer suffers heart attack; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case was received from a consumer/non-hcp (non health care professional) via social media.  This case involves a 33 year old and unknown gender pro dancer who suffered heart attack while receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (lot number, dose, frequency, expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination.  It was reported that the patient was a pro dancer and suffered heart attack (myocardial infarction) (latency: 5 days) following the administration of influenza vaccine. This event was assessed as medically significant. The reporter commented that the list went on and on, and on and it was happening everywhere, and was not normal. It was unknown if the patient experienced any additional symptoms/events.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (pro dancer suffers heart attack).  At time of reporting, the outcome was Unknown for the event pro dancer suffers heart attack.; Sender's Comments: Sanofi company comment dated 03-Feb-2022: This case concerns a 33 year old and unknown gender pro dancer who suffered heart attack, after vaccination with vaccine Influenza Vaccine. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, medical history, concomitant medication, would be needed to rule out the alternative etiology. Based on the reported information, the role of an individual vaccine cannot be assessed.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with 3 improperly stored doses of VARIVAX lot # L034372, expiration date 08-SEP-2017 (unknown route of administration) reconstituted with sterile diluent, for prophylaxis. There was no adverse effect reported. Administered doses of VARIVAX were exposed to an unspecified temperature excursion due to defrost cycle for an unknown time frame. There were no previous excursions reported. This is one of tow reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA006159:
CHIEF COMPLAINT Chest pressure    HISTORY OF PRESENT ILLNESS Patient is a 77 y.o. female with medical comorbidities including Cataract, Dry Eye Syndrome Bilateral, Gastroesophageal Reflux Disease NOS, Glaucoma Suspect Ocular Hypertension Bilateral, Hyperlipidemia, and Malignant Neoplasm Of Uterus Endometrial (HCC), Migraine Headache.   Chest pain at approximately 10:00 p.m. last night which she initially was secondary to her GERD.  Due to the chest pressure she was unable to fall asleep with frequent awakenings.  Chest pressure is non-pleuritic, non-positional. The pressure/pain radiated into her shoulders and across her back.  She described a sensation of heaviness in her left arm.  She has never had symptoms like this previously.  She has no history of cardiac pain or imaging or interventions.    She developed fatigue, headache, nausea and chills starting on October 8th and tested positive for COVID-19 on October 14th.  She received monoclonal antibody body infusion on the 15th.  She continues to feel fatigue.   No abdominal pain, no altered mental status, no anorexia, no anxiety, no cough, no diaphoresis, no dizziness, no fever, no headache, no heartburn, no nausea, no orthopnea, no palpitations, no PND, no shortness of breath, no vomiting and no weakness.
This non-serious spontaneous case, initially received on 21-Feb-2018, from other non-health professional, concerning a 66-year-old, elderly, female patient. The patient's history included urinary tract infection (unspecified date). The patient's current condition included: hypothyroidism. The patient's concomitant medication included SYNTHROID for an unknown indication. On 08-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular anatomical location: deltoid, batch number and expiry date: not reported). On the same day (08-Jan-2018), within a couple of hours of vaccination, the patient had hives, severe rash on lower legs and itch all over, these symptoms lasted for 3 weeks. The patient's body temperature (100.0 F) was increased. It was reported that, the patient also experienced dizziness and nausea along with severe abdominal pain, no vomiting was reported. On 09-Jan-2018, the patient consulted a general physician. The patient received treatment medications BACTRIM and TYLENOL for possible urinary tract infection (UTI) and left lower abdominal pain. Urine specimen analysis was not performed and no blood was found in urine. On an unspecified date, the patient had recovered from all the events (dizziness, abdominal pain, nausea, itching, hives, rash and fever). Follow-up received from other non-health professional on 19-Mar-2018: Added current condition as hypothyroidism in the patient tab. It was confirmed that the, patient received treatment medications BACTRIM and TYLENOL. The outcome of the event rash was changed from not recovered to recovered (in the event tab). The narrative amended accordingly. Follow-up received from the reporter on 09-Apr-2018: Added UTI in the history and indication for the treatment drugs TYLENOL and BACTRIM (UTI and left lower abdominal pain). Urine specimen analysis was not done and blood was not found in urine. Narrative was amended accordingly. Non-significant case-correction received with IRD 09-Apr-2018: The event term was updated from UTI to possible UTI in narrative and the case comment was amended. Narrative was amended accordingly.