chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse (LPN) concerning a 5 and 3/4-year-old male who on 17-SEP-2007 was vaccinated with a subcutaneous dose of 0.65 milliliters of Zostavax (Oka/Merck) instead of Varivax.  Subsequently, the patient did not experience any known symptoms.  It was unspecified if medical attention was sought.  It was reported that this was not product confusion but a medical error.  No product quality complaint was involved.  Follow-up information from the LPN indicates that the patient's mother reported that the patient was doing fine and had not experienced any problems with the vaccine.  The lot number for the Zostavax (Oka/Merck) administered was 656412/1476F.  The LPN reported that the clinic does not routinely have Zostavax (Oka/Merck) in stock but will order it when a patient requests it.  Both vaccines were maintained in the same freezer on the same shelf.  The Zostavax (Oka/Merck) vaccine was for a patient in a satellite office and the nurse thought it had already been sent to the other office.  The nurse grabbed the Zostavax (Oka/Merck) vaccine by mistake since it was in a single-dose baggie on top of the note card that said Varivax.  There was also a note in the freezer in the same area to save 2 Varivax doses for 2 specific patients.  The LPN indicated that it was a medical mistake.  The clinic is now going to separate the Varivax from the Zostavax (Oka/Merck) vaccine in the freezer by putting them in 2 different containers on two different shelves.  They are also going to clearly label them.  Additional information is not expected.
Fatigue- started at 3pm on 3/16/2021 ended morning of 3/18 Nausea- started at 3pm on 3/16/2021 ended noon on 3/17 Fever- started at 8pm on 3/16/2021 ended noon on 3/17 Chills- started at 8pm on 3/16/2021 ended noon on 3/17 Headache- started at noon on 3/17/2021 ended at 5pm on 3/18  Body aches- started at 3pm on 3/16/2021 ended at 5pm on 3/18
I received the vaccination around 1:00 pm on saturday. About 1 hour after that started to get a headache. For the rest of the day I felt ill, then around 8:00pm that night I took my temp and it was 99.9. Around 10pm I took my temp again and it was 104. I then preceeded to take 400 mg of motrin, then again at 11:00pm due to my temp being around 102. This morning (Sunday) my temp is at 100-101.
Patient stated he wasn't feeling well RPh yelled to call 911, got EMT on staff to assist Patient was feeling like passing out, was sweating was taken by ambulance
Patient said arm has hurt for 12 days after shot - cannot raise above her head. Patient states she feels she has nerve damage. She was advised to see a physician.
Experienced likely myocarditis, (chest pain, discomfort, tightness, un-ignorable sensation of rapid and erratic heartbeat)
redness to warmth @ inj site tx for early cellulitis w/augmentin;
Insomnia more than 4 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 15:45 (Batch/Lot number: unknown) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: INSOMNIA (non-serious) with onset 20Apr2021 21:00, outcome "not recovered", described as "Insomnia more than 4 days". Therapeutic measures were not taken as a result of insomnia.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left Arm Tenderness on side red Band around arm tha was Lumpy 3-4 inches, Ice, Tylenol
I do believe that the vaccination was on the left arm. On 04/20/2022 I began to notice during my exercise routine that my pushups were starting to aggravate a pain in my left shoulder. The pain was not severe enough to cause me to worry too much so I did not reach out to a doctor at this point. I did avoid causing strain to my arms and avoided pushups. I did notice that I was starting to have trouble with raising my left arm and bending it to wash myself and I was unable to duplicate normal ranges of motion  as I was with my right arm. I decided to reach out to my doctor when I noticed that I was experiencing issues now with sleeping positions and the motion of the arm in the shoulder joint were causing more pain. I became increasingly concerned due to these events. After speaking with my doctor in June of 2022, she recommended that I see a physical therapist and began in July. Since then my range of motion has increased however it has not completely regained its full range. Pain has reduced since utilizing physical therapy as well.
01/17/2021 Pain in Right opposite of the arm got vaccination in 01/18/2021 felt a lump and had spotting bleeding . Unusual hormonal changes after the shot. Dr. seemed unconcerned. Sen to the Breast Specialist and she is schedule for a diagnostic mamma gram.
Flu Vaccine was not administered correctly.  the dose was not injected into the muscle of the arm as recommended.
1 hour after injection developed rash, hives and itching. Stopped 12 hours later. 12 hours later at objection site has bump and red blotchy spot.
Information has been received from a physician and a nurse in the physician's office concerning an 8 year old male with nephrotic syndrome who on 3/19/99 was vaccinated with his first dose of varicella virus vaccine live. Subsequently, on 3/14/05, the patient developed chicken pox like rash, less than 50 lesions and an exacerbation of pre-existing nephrotic syndrome. Unspecified medical attention was sought and the patient was given prednisolone sodium phosphate 27mg every other day to treat the nephrotic syndrome exacerbation. He was noted to have responded promptly to the steroids. The patient was seen by a nephrologist on 5/11/05 for follow up and as of 5/13/05 the steroid dose was being tapered. The patient recovered from chicken pox like rash and exacerbation of pre-existing nephrotic syndrome. It was noted that the patient had one other flare up of nephrotic syndrome in 2003. No product quality complaint was involved. The physician considered the patient's exacerbation of nephrotic syndrome to be an other important medical event (OMIC). Additional information has been requested.
Information has been received from a medical assistant on 15JUN2015 concerning a patient (age and gender not specified). The medical assistant reported that on 09JUN2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Total arm pain the next day from finger tips to top of shoulder. It felt like the bone and evert joint in my hand was aching.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the arm left on 08May2021 at 09:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm left on 17Apr2021 at 08:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 09May2021, the patient experienced total arm pain the next day from finger tips to top of shoulder. It felt like the bone and evert joint in my hand was aching and pain was gone by next day. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included treatment with ibuprofen (ADVIL) and naproxen sodium (ALEVE) for pain relief. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event total arm pain the next day from finger tips to top of shoulder, It felt like the bone and evert joint in my hand was aching and pain was gone by next day was resolved on 10May2021, after the duration of 1 day.  No follow-up attempts are needed. No further information is expected.
COVID Rebound; COVID Rebound; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 03Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Aug2022 at 12:00, outcome "not recovered" and all described as "COVID Rebound". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was not received other medication in two weeks. Antiviral details reported as Paxlovid for COVID-19 treatment start date: 27Jul2022 and stop date 01Aug2022. All vaccine lot number reason was reported as not available/provided to reporter at the time of report completion. Adverse event was not resulted in physician office or emergency room visit. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt states had pain swelling to site for 3-4 days after receiving inj, then seemed to resolve, today 8/25/21 states pain/swelling returned last night, swelling to site noted with redness to area
Itchy rash around site of vaccine administration beginning 4 days after administration and continuing to spread outward at time of this form being filled out.  Also, "hot" sensation generally throughout bones in the evenings.
Event happened within week after 2nd dose of COVID vaccine   -January 22 2021: loss of taste - started after eating something spicy but remained for days; foods were tasting very bland -- > COVID test negative; also had already been vaccinated -- > acupuncture and then sx seemed to slowly resolve, and it is back to normal   -January 27 2021: double and blurred vision - having trouble seeing computer and driving; improved with closing one eye -- > evaluated by Dr. in neuro-ophthalmology Feb 1 2021 and found to have RIGHT optic atrophy, in addition to LEFT exotropia in right gaze (LEFT INO causing adduction deficit)  -- > MRI brain (Feb 1 2021) and C/T spine (Feb 12 2021) with multiple non-enhancing lesions c/w demyelination; RIGHT optic nerve thickening -- > blood tests with +ANA, elevated anti-dsDNA (rheum did not think patient had SLE) -- > CSF studies not done -- > sx now resolved without steroids (only lasted 3 days); There was measurable improvement on her follow-up exam with Dr. on February 12, 2021
Information has been received through a Merck pregnancy registry concerning a female patient with no medical history or allergies who on 14-FEB-2007 was vaccinated SC with a 0.5mL dose of Proquad (lot number 655847/1386F). Concomitant vaccines given that day included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of hepatitis A virus vaccine (unspecified (+) hepatitis B virus vaccine (unspecified) (lot number AHABB050AA). It was reported that the patient is now 6 weeks pregnant. The nurse stated that the vaccination record lists "MMRV" and she believes that the name of the vaccine was Proquad. Subsequently, about six weeks ago the patient experienced nausea, queasiness and dizziness related to her pregnancy. Unspecified medical attention was sought. The patient's status is not recovered. No diagnostic laboratory tests were performed. No product quality complaint was involved. Additional information has been requested.
2inch red circle, pain, itchy, warm, hard protruding lump at site of injection
When administering HAVRIX the fluid leaked out of syringe and patient did not receive full dose. Called manufacturer and CDC and recommended give shot again. This was administered next day on 6/21/11.
thrombocytopenia (platelet count = 98 / microliter on 11/10/09)
fever 105-105.4 for about 16 hrs crying uncontrollably, started about 2 hrs /p receiving DTP. Pt examined 29-jun-90 has rash that looks like enterovirus.  Her fever has resolved & she is clinically fine.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient had COVID-19 in November 2020 with myalgias and joint pain. Patient reports to clinic to establish care. One week after immunization developed severe right should pain and weakness that improved with physical therapy. Patient now has almost full range of motion. Diagnosed with Parsonage-Turner Syndrome.
Severe fatigue/malaise.; Severe fatigue/malaise.; This is a spontaneous report from a contactable Other Health Professional (patient). A 32 years old male patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EH9899), intramuscular at 21Dec2020 11:00 AM at single dose in left arm for COVID-19 immunisation. Medical history included Asthma, ADHD and Known allergies: Sulfa. Concomitant medications included salbutamol sulfate (PROAIR), fluticasone propionate, salmeterol xinafoate(ADVAIR), montelukast sodium (SINGULAIR) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient experienced Severe fatigue/malaise on 22Dec2020 06:00 AM. Remained afebrile during symptoms. The patient did not receive any treatment. Outcome of events was recovering.
temperature excursion/ the GARDASIL 9 was given to 3 different patients./ ABOVE 47 degrees Fahrenheit (54.2F) for 0 hours 30 minutes; no adverse effect; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On an unspecified date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter, lot# 1637648, expiration date 19-JUN-2022 (route was not provided) for prophylaxis.      Digital Data Logger registered a temperature excursion above 47 Fahrenheit degrees (54.2 Fahrenheit degrees) for 0 hours 30 minutes and 0 seconds.      This is one of three reports received from the same source. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637648; expirationdate: 19-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2011USA009546: US-009507513-2011USA009526:
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: injection site reaction limited to left arm-Medium, Additional Details: Injection site had inflammation and formed crust. Appears potentially infected.
The patient received dose from vial beyond 30-day use by date; The patient received dose from vial beyond 30-day use by date; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Oct-2021 and was forwarded to Moderna on 25-Oct-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration was on 7 -may-2021. Concomitant medication use was unknown Treatment information was unknown
This spontaneous report as received from a reporter refers to a 16-year-old male patient as a part of a market research agency. On an unknown date in July 2012 the patient was vaccinated with quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) (reported as HPV vaccine) (lot # not reported) dosing details unspecified. No concomitant medications were reported. On an unknown date in July 2012 the patient experienced shot hurt, pain in the arm. The reported events were resolving at the time of this report. This is a corrected report. The suspect therapy has been changed to human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) (reported as HPV vaccine) V501 GARDASIL. Additional information is not expected.
Information has been received from an 80 year old female with a history of shingles, and a "very bad reaction to pneumonia vaccine and to a tetanus shot" who on 09-AUG-2007 was vaccinated SC with a 0.65 ml dose of Zostavax (Oka/Merck).  Concomitant therapy included unspecified "cholesterol medication" and "blood pressure medicine".  On approximately 10-AUG-2007 ("the next day or so") the patient broke out in shingles on the right side of her head.  The patient went to the ER because of the headache from the shingles, but she was not admitted.  No lab studies were performed.  At the time of the report the patient was recovering.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
PATIENT HAD C/O NAUSEA AND VOMITING WITH DIZZINESS
Pt recv vax on 11/9/98; on 11/17/98 pt exp achy feeling, hot/ cold feeling, restless, leg pain/ weakness; tx=Vicodin
Has minor case of varicella despite receiving Varivax on 08/01/96 at 12 months of age.
Sedation & Myalgia Narrative:  On 1/20/21 (day of 2nd dose) had arm stiffness at injection site. On 1/21/21 had diffuse muscle stiffness and decreased energy. No fever. Missed work 1/21/21. Worked for a few hours on 1/22/21 but left due to fatigue. Still fatigued through the weekend and Monday 1/25/21. Returned to work 1/26/21. No known prior covid infection.  Other Relevant History:
She became very red; Dizziness; Vomiting; Diarrhea; Hypotension; This is a spontaneous report from a contactable healthcare professional. A 17-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0158), intramuscular, administered in left arm on 09Apr2021 16:30 as single dose for COVID-19 immunization. Medical history included 3 weeks of urticaria prior to vaccination. The patient has had no COVID history prior vaccination. The patient has not been tested for COVID post vaccination. Concomitant medications included fish oil; diphenhydramine hydrochloride (BENADRYL); cetirizine hydrochloride (ZYRTEC); ibuprofen (MOTRIN), and an unspecified multivitamin. The patient previously took Amoxicillin and experienced drug allergies. After vaccine, the patient became very red, had dizziness, vomiting and diarrhea and hypotension on 09Apr2021. The events resulted in an emergency room/department or urgent care visit and hospitalization for 1 day. Treatment included epi, Benadryl, steroids, Pepcid, and fluid boluses. The outcome of the events was not resolved.
A healthcare worker was setting up and approached me and asked if I wanted a free J&J vaccine. I was very hesitant . I told him that I had a flight later that night and didn?t want to have any side effects on the plane.  He assured me hardly anyone ever has bad reactions to it and was very salesy, not seeming concerned much for my health or my questions, more like he needed to meet a quota. Against my better judgment, I got the shot and was absolutely miserable on the flight and that whole night. I developed a fever, body aches, headache, chills, and fatigue around 8 hrs after receiving my shot. It was one of the worst nights of my life with a fever reaching 103.5, and that was with Tylenol in my system to try to keep the fever down.  I didn?t feel normal for 3 days.