chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX (lot # L024998, expiry date: 06-OCT-2016) (incorrect product storage). No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions or medical histories provided. On unknown dates (reported as on or after February 2016), the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # N016090 with expiration date on 23-AUG-2018 (dose and route of administration were not reported). The sterile diluent (MRK) used for reconstitution did not undergo a temperature excursion. There was no adverse effect reported. Administered doses of vaccines experienced unknown temperature excursion for unknown time. Data logger was involved. There was previous excursion reported. This is one of several reports received from the same reporter.
Information has been received from a physician concerning a 12 month old male who on 4/14/2006 was vaccinated with a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process). On 4/17/2006, the patient presented with a rash which was all over the child's body. The physician noted that the child had not been feeling well on the date of vaccination, but did not have a fever. The physician did not thing that the rash was related to therapy with measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process). Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
04/13/2015:  Reports to clinic with right arm swelling and tingling. Had Tdap Rt deltoid on 04/06/15. Had some minor soreness for a few days, then on 04/10/15 developed swelling and soreness right deltoid, no redness. Since then has experienced intermittent swelling, tingling and loss of sensation right lower arm and hand. Right hand and lower arm is now mottled with visible swelling; has difficulty with ROM right arm. Radial pulses present bilaterally. Has treated with ice QID, BioFreeze topical and Ibuprofen every 4 hours since 04/10/15. States history of surgery C-6, C-7 with right arm nerve symptoms 2 years ago.
Patient is our employee and she works as Medical Assistant.  She received Fluzone Quad at 0850 on 10/11/2023.   She continue to work her whole 8 hour shift.   After work, she states, she went to the gym.   After gym, around 10:30, while driving  she started to have chest pain and shortness of breath.  Per patient, went to ER  and arrived around 11:00 PM.   She went to ER.  She states,  EKG, blood works, chest x-ray were normal except for low potassium, and elevated WBC.  Per patient, they said symptoms were adverse reaction of the flu vaccine. She was discharged from the hospital at around 3:30 AM 10/12/2023.  No medication was prescribed.  She also complaint of cough post vaccine.  Patient denies redness, bleeding, warmth on the injection site; fever, chills, nausea, vomiting.
STORAGE IN REFRIGERATOR (2C-8C) UP TO 320 DAYS. (VACCINE USED AFTER 10/16/2021)
A MD reported the occurrence of arthritis in a 23-y.o. male who received Hep B vaccine recombinant (Engerix-B). Medical history, concurrent conditions, and concurrent medications were not provided. On 5/1/02, the subject received Hep B vaccine recombinant, Hep A vaccine inactivated, and yellow fever vaccine. ON 6/6/02, 5 days post immunization, the subject experienced arthritis. On 5/10/02, the following tests were performed: antinuclear antibody (ANA) was 1:40 (reference range unspecified) c-reactive protein (CRP) elevated, rheumatoid factor (RA) within normal limit (WNL), and antistreptolysin o titer (ASO) within normal limit (please see relevant diagnostic tests for details). It was not indicated if treatment was given for the event. The outcome of the event was reported to have improved. The reporting physician considered the even to be possibly related to the injection of Hep B vaccine recombinant (Engerix-B).
Information has been received from a physician concerning an 18 year old female full time student who on 14-JAN-2009 was vaccinated intramuscularly with a dose of GARDASIL (lot# 1423X, site of administration not reported). On 14-JAN-2009 the patient developed flu symptoms for 24 hours. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Developed a rash around mid-section that started to spread over the body.  Tongue swelled up causing breathing problems.  EMS was called and patient was seen in the ER for an allergic reaction.
Child developed red, raised area on left thigh approximately 2" in diameter at injection site. No fever, but on Advil/Tylenol. Does not mind it--active.
since the 2nd dose of Moderna, pt has had ringing in her ears. This has not resolved.
Patient's mom, patient and sibling (under 12 years old) presented for vaccination. Nurse administered the vaccine, but did not realize the patient and sibling are different ages. Patient who received the vaccine is doing okay. We also spoke to the mom as a follow-up. We have different tables for different age groups, so their mom also went to the wrong table.
3 episodes of vertigo, temporary reaction to Anthrax. Onset of symptoms, 30 minutes to 4-6 hours, post vax. Duration of symptoms, 2 hours to 2 days (last shot). Vaccine administration: 1/11/00, 1/27/00, 2/11/00 and 7/10/00.
left arm around injection site was noted to be warm, red, and swollen ~23 hours after the injection for the second dose.  There was mild pain and discomfort but the site did not itch.  Applied ice when able without interfering with other activities and took cetirizine tablets.
Chronic left arm pain 2-3 months following injection, refractory to ibuprofen and acetaminophen
Patient Fainted when he got to his cart. Pharmacist rushed to his side. He was already blue, and pharmacist could not feel a pulse. Patient was moved quickly to start CPR. CPR was started and patient was aspirating. Mouth and nose were cleared out. CPR was continued. Patient was aspirating and breaths could not me administered. CPR was continued until EMT arrived. EMT continued CPR. Patient was not responsive. EMT called time of death.
Patient reports blood clots in nose, nasal congestion, swollen joins in knees and fingers, and pain in right ankle tendon from previous sprain. Patient visited Dr to follow up
Upper back pain started 2 weeks after vaccination. Achy uncomfortable feeling in neck and right armpit. Still experiencing symptoms
Hives, swelling and redness around area with itching and warmth to site. Treated with BENADRYL.
Underarm rash, both arms. Itchy and some burning sensation.  As of 4/20/23 at 11pm I still have it but no other symptoms.
Feeling faint/dizzy/groggy ~13 min post injection. Onset of feeling was sudden and accompanied by reduced feeling at the injection site. Symptoms were mild so they went unreported at the vaccination site as patient was able to stand and walk 16 min post injection. Feelings persisted for 2-3 hours post injection, were joined by mild headache and fatigue ~1 hour in. Faintness/grogginess and headache dissipated almost completely by the evening (4-6 hours post injection) and patient was left with lingering feelings of fatigue that continued until the next morning and the following day. Patient also reported significant arm soreness that began the night of vaccination and worsened the next morning.
Patient was vaccinated with Moderna#1 on 3/15/2021 in error. She presented for vaccine #2 and was given Moderna per the site director doctor in off-label/compassionate use. Counseled by the safety RN. Troubleshooting: This was missed in screening two times; the scribe and vaccinator did not ask birth date at the time of the first vaccine.
Early the morning after my arm swole with increased swelling and pain and I treated with OTC Tylenol
chills; Body Rash; No energy; Aches; This is a spontaneous report from a contactable consumer other non HCP/ patient. A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via unspecified route of administration on 02Mar2021 at 13:00 (at the age of 59-year-old non-pregnant) as UNKNOWN, SINGLE DOSE for COVID-19 Immunisation. Medical history was reported as none and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient experienced Body rash, chills, aches, no energy on 04Mar2021 at 00:00 and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse event included urgent care from dermatologist which included treatment with cream for rash and punch biopsy for back. Lab data included biopsy with unknown result on an unknown date. Clinical outcome of the events body rash, chills, aches, no energy was recovered.   Information about lot/batch number cannot be obtained. No further information is expected.  Amendment was made by DSU: This follow-up information is being submitted to amend previously reported information on Patient's first Name added, Age/Units captured as 59 years per event's onset "4Mar2021", Country added, Age at Vaccination updated from 60 to 59, For the reported event rash Treatment Received was captured as "yes' as per source dermatologist who did a punch biopsy and gave patient a cream for rash. Relevant Med History changed to None added since provided other medical history as none, removed Unknown from Lot# field, punch biopsy on back captured as lab data. Also, it was mentioned as Information about lot/batch number cannot be obtained. No further information is expected. updated as "No follow-up attempts are needed; information about lot/batch number cannot be obtained." Per SER055
Repeated vomiting - abd pain and hives on abd and legs and face. Epinephrine.
This spontaneous report as received from a registered nurse refers to a 16 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 21-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N008823, expiry date: 26-MAY-2018) and GARDASIL 9 (dosing details were not reported) (lot # N019923, expiry date: 28-APR-2019) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
perfuse sweating; mild tenderness of arm; Muscle pain; Chills; Weakness; This is a spontaneous report from a contactable physician (patient).   A 78-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2) intramuscular at single dose at left deltoid on 11Jan2021 around 13:00 for covid-19 immunisation, administered at hospital.  Medical history was none, he was basically healthy. There were no concomitant medications. No prior vaccinations (within 4 weeks), but the patient received the 1st dose of bnt162b2 (BNT162B2) at single dose exactly 3 weeks before 1st dose on 21Dec2020 for covid-19 immunisation. No additional vaccines administered on same date of bnt162b2. The patient began to have muscle pain, chills, and weakness about 8 hours or so after the 2nd vaccine on 11Jan2021. He states these symptoms have maybe gotten a little better, but have been continuing on for 2-3 days now. He is also experiencing perfuse sweating during 13Jan2021night. Right now, he was not experiencing this. Maybe a little bit, but not much. The caller experienced mild tenderness of arm on 12Jan2021: he explained when you press his arm, it hurts a little bit. No events required a visit to Emergency Room or Physician Office. The outcome of muscle pain was and perfuse sweating was unknown, of chills, weakness was recovering, of mild tenderness of arm was not recovered. The patient was his own primary doctor. The reporter considered all events as medically significant and he believed these symptoms are related to receiving the vaccine because he stated he was okay before that.   No further information expected. Information about lot/batch number has been requested.; Sender's Comments: There is a reasonable possibility that the event muscle pain was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other events with BNT162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
No previous pregnancy prior to this. 1st vaccine 12-31-2020, home pregnancy test positive 01-05-21, in office intravaginal ultrasound and pregnancy test positive 01-11-21, miscarriage (bleeding, cramps, nausea) started 01-18-21 ended 01-23-21, had 2nd vaccine 01-21-21.
Information has been received on 13-APR-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 24-OCT-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-JUL-2015, the patient was treated by a health care professional in a health clinic for the onset of a severe vesicular rash which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Fever of 103; This case was reported by a other health professional via other manufacturer and described the occurrence of fever in a adult patient who received Hepatitis B vaccine for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included tofacitinib citrate (Xeljanz).   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, less than 9 months after receiving Hepatitis B vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. In 2019, the patient experienced fever. The patient after receiving the last injection in February 2019 experienced fever of 103. The reporter stated that the patient was missing 2 months due to insurance mishap and another 1 month down the line due to switching pharmacies and noticing that he needed xeljanz again. The patient reported that xeljanz was working very well.      Lab Comments: On an unknown date body temperature was recorded
Warmth, redness, pruritis to (R) upper arm, on 9/718 - 9/10/18 OV (office visit). Tx: 1% hydrocortisone cream, ice pack.
2 days p/vax pt had sz lasting 5-10 min- started w/crying then jerking legs more than arms; pt was unaware of parents' presence through this episode; low grade fever (<101);
Tension Headaches daily now almost 3 weeks in duration, no neurological symptoms or signs
ringing in ears; Hyperactivity; extreme energy; inability to concentrate; dose received 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Dec2021 14:30 (Lot number: FJ8757) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), administered in arm left, administration date 20Dec2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. Relevant medical history included: "Goat/sheep milk" (unspecified if ongoing), notes: known allergies: Goat/sheep milk; "Hypertension" (unspecified if ongoing); "Herpes" (unspecified if ongoing); "PVC's" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR]; TOPIRAMATE; PHENTERMINE; AMLODIPINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0168, Location of injection: Arm Left), administration date: 07May2021, when the patient was 46 years old, for COVID-19 Immunization, reaction(s): "ringing in ears", "Hyperactivity", "extreme energy", "inability to concentrate"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0153, Location of injection: Arm Left), administration date: 09Apr2021, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 14:30, outcome "unknown", described as "dose received 3"; TINNITUS (non-serious) with onset 20Dec2021 16:00, outcome "recovering", described as "ringing in ears"; PSYCHOMOTOR HYPERACTIVITY (non-serious) with onset 20Dec2021 16:00, outcome "recovering", described as "Hyperactivity"; ENERGY INCREASED (non-serious) with onset 20Dec2021 16:00, outcome "recovering", described as "extreme energy"; DISTURBANCE IN ATTENTION (non-serious) with onset 20Dec2021 16:00, outcome "recovering", described as "inability to concentrate". Therapeutic measures were not taken as a result of tinnitus, psychomotor hyperactivity, energy increased, disturbance in attention.  Additional Information: No other vaccine was administered in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow up attempts completed. No further information is expected.
UTI; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URINARY TRACT INFECTION (non-serious) with onset Feb2021, outcome "unknown", described as "UTI". The event "uti" was evaluated at the emergency room visit.  Additional information: PQC was not present. This report was not related to a study or programme. NDC number of covid vaccine was not provided. Other Products was not provided. Investigation assessment was not provided.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101070859 same reporter/drug/AE with different patient;US-PFIZER INC-202101069940 same reporter/drug/AE with different patient
received the vaccine on 6/10/21.  Noticed trouble breathing when exercising.  On 06/22/21  extreme difficult breathing and was admitted to hospital.   Congestive Heart Failure,  Acute Myocarditis with EF of 20% ,  Severe global Hypokinesis, Heart catherization,  Neurological symptoms.       Admitted again to the hospital on 7/7/21  CVA(stroke) MRI Ultrasound of CArtoids, echocardiogram , Barium swallow, MRA  and now wearing a  defibrillator 24 hours
Severe episode of Meniere's Disease. Dizziness and vomiting all day long. Had to call 911 and was hospitalized until nausea was under control. TX with Ondansetron and ANTIVERT and VALIUM to control N and V. Dizziness persisted even after discharge. ENT referral sent me to balance therapy.
mRNA-1273 treatment under Emergency Use Authorization(EUA): After getting the Covid vaccine 1/4, I developed a tingling, skin of numb area on my left upper lip 1/5 and it continues today, 1/6. Also had some diarrhea and left sided abd pain for 2 days but seems to be resolving today.
05Feb98 pt recv 1 dose vax. 18Feb98 pt exp 3 little bumps that were red,itchy & warm at inject site. Area size 1x 1 1/2 inches.
Diffuse papular rash on lower extremities, clustered around buttocks/diaper area, with some papules on bilateral elbow creases, and palms/soles.
Pt received PNEUMOVAX vaccine 1/25 @ ~ 6:45 pm & that night had fever of 104.
I broke out in a rash all over with made me itch and create whelps all over me
In PM of day vax given both thighs swelled up & became red & hot & pt would not walk; sl fever (<100); pt improved by PM of the next day p/remaining very noticible in the morning; by that evening pt was walking;
Patient began having joint stiffness and pain 3 weeks following vaccination. By ~6 weeks following vaccination, stiffness and pain escalated to the point that she struggles to perform daily tasks. (Hold a pencil, get in and out of a chair, go up and down stairs, put on daughter's clothing, etc.) Primary joints affected were hands (predominantly right), ankles, and knees. Occasional pain through wrist. Pain continued for 14 months, flaring more significantly during hormonal changes seemingly relate to breastfeeding. During these periods, patient experienced significant fatigue and was unable to perform daily activities. Chiropractic care, nutritional supplements, and dietary changes with the intent to decrease inflammation had positive impact on severity. Patient continues to need lifestyle measures to manage symptoms. There is no other medical explanation for patient's symptoms, so this is a probable reaction to MMR
The left side of my face, neck and ear feel like they?re on fire, like I have a hot towel on just that side of my face. Same side as the shot was administered
Slight tenderness at injection site one after receiving the injection with tiredness.  Symptoms cleared within 24 hours. Large inflamed area at site of injection appeared 8 days after injection, soreness, redness itching at the site and chills.