chrisvoncsefalvay/vaers-outcomes huggingface dataset:
21 year old male who had received his first dose of GARDASIL 9 over a year ago; No additional information; This spontaneous report has been received from a pharmacy technician referring to an adult male patient who was 21 years old at the time of the report.    The patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not reported.   On an unspecified date (reported as "over a year ago"), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) (inappropriate schedule of product administration).   The reporter asked if the patient needed to restart the vaccine schedule, and the time frame between the second and the third dose. No additional information was provided (no adverse event).
Within a week, numbness and tingling in finger tips along with flare ups in joints( both knees, both elbows, both writs and hands and hips.  Pain in wrists and hands are excruciating at times.  One flare up may only encompass the right hand/wrist, another time it may encompass two effected joints.  The numbness and tingling in finger tips is constant but painful flare ups will come out of no where and no rhyme or reason to the effected joint or joints.   This pain at first could be managed with OTC meds such as Tylenol and ibuprofen but the pain is so intense now that Prescription meds are being tried to see what will help the best.  I've had all kinds of different blood tests done with nothing positively found.
pt recv vax & devel rash started out on head now on body;giving DPH;
Pain, redness, swelling at injection site. Patient received his HPV on Thursday 8/8/16, the following day woke up to pain redness, swelling. Warmth and swelling extended distally to injection site on 9/12/16. ER visit.
Can not extend arm fully; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can not extend arm fully) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Injury NOS (arm had screws).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can not extend arm fully). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can not extend arm fully) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.  The vaccination was taken on the arm that had screws in due to a previous injury.
Vaccine was stored after expiration date in the refrigerator; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was 29-Oct-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
Extreme anxiety. I felt like I was coming out of my skin. Extremely anxious. I had to walk outside several times. Felt very fatigued. Not nervous but as if I couldn?t stay in one place.
One of five pt's, immunized from same vial of DTP, devel high fever (103-104) & irritability w/in 12 hrs p/immun; also given HIB-TITER/OPV; tx APAP & tepid bath;
Patient received Pediatric Pfizer dose instead of Pfizer adult dose. Called parent to check on patient and she had no reactions to occur. Patient has not experienced any severe reaction from receiving the vaccine.
Patient  inadvertently received 1cc of Moderna COVID vaccine instead of 0.5cc. Patient was notified. State of Vaccination notified.
Beginning approximately 8 hours after the injection was given, the patient complained of hives and welts covering her body from head to toe.  She immediately contacted her primary care provider, was referred to a dermatologist, an allergist and a hematologist. After some testing of the welts, results came back as a super-sensitive reaction to an unknown drug. Her provider suggested she report this Adverse Reaction to the Pharmacist/Pharmacy where the vaccine was given.  It is now 4 weeks later and she is still experiencing symptoms of this severe reaction.
Information has been received from a Certified Medical Assistant (C. M. A.) concerning a 9 year old female patient with no medical history and with allergy to fresh pineapple who on 22-JUL-2010 was vaccinated with 0.5 mL first dose of GARDASIL (Lot # 663559/1178Y) IM into the right upper arm. No concomitant medications were reported. It was reported that 2-3 minutes after the patient received GARDASIL and VARIVAX (Merck) by subcutaneous injection in the left upper arm, she reached for the wall while walking out of the office. The patient then fell to the floor, and bit her lips at some point. It was also reported that the patient felt hot and sweaty, seemed "spacey and out of it". The patient was moved to a treatment room, where she laid down for 10-15 minutes with a cool compress before walking out of the office accompanied by her mother. No laboratory tests were performed to the patient. Follow up information was received from the Certified Medical Assistant concerning the female patient who on 22-JUL-2010 at 14:10 was vaccinated IM with a first dose of GARDASIL  (Lot # 663559/1178Y). The medical assistant reported that within 4 minutes of vaccination at 14:14, the patient was walking out of the examination room, leaned towards the right and fell flat on face, hurt mouth where braces lacerated her top lip. The medical assistant reported a near syncope but she was not sure if the patient totally passed out. Additional information has been requested.
Female patient, 70 y/o , presented to the pharmacy for Flu and Tdap vaccine (12:28pm). Vaccines were administered by 12:45pm. By 1:13pm the patient start to present hot flashes, develop nausea/vomiting and disorientation. Medical emergencies services was requested (911). Patient indicated that she has an empty stomach; apple juice was given. Blood pressure was taken: 131/87 mm/Hg; Pulse: 69. Blood sugar was taken: 116 mg/dL.  Patient was taken to the Emergency Room.
pt recvd vax;rapid deterioration of mental state;nuchal rigidity;lumbar puncture showed turbid cerebrospinal fluid;leukocytes/L;mild papilledema;cerebral edema;disseminated intravascular coagulation;synd inappropriate ADH;streptoccocus pneu
Patient received a moderna vaccination on 1/8/22. As his second dose in the series he was given a Pfizer vaccine on 2/7/22
Information has been received from a pharmacist referring to a patient of unknown age and gender. On 12-JAN-2016 the patient was inadvertently administered improperly stored ZOSTAVAX (lot # L027321 with expiration date: 21-OCT-2016 or lot# L035283 with expiration date: 15-DEC-2016, route and dose were unknown)(incorrect product storage). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
This subject is a 67 year old female who was admitted to the hospital due to labored breathing while enrolled in a study. The subject received 2 doses of RSV vaccine or Placebo and Influenza vaccine with the last dose administered on 10/22/03. The subject presented with labored breathing on 2/21/04, 122 days post immunization and was admitted to the hospital on the same day. The causality has not been assessed by the investigator. Additional info has been requested. Additional info received on 3/1/04. The laboured breathing was assessed by the investigator as unrelated to the study vaccine. Outcome is unknown at this time. Additional info received 3/9/04. Subject was admitted to hospital on 2/21/04 with acute cholecystitis, septic shock, CHF, respiratory failure, labored breathing. Subject was on a respirator. Subject died on 3/5/04, 13 days after admission and 135 days post immunization. Additional info received 3/10/04. Subject received first dose of RSV or Placebo and Influenza vaccine on 10/31/02. Additional info received on 3/11/04. The acute cholecystitis, septic shock, CHF, respiratory failure were reported by the investigator as unrelated to the study vaccine. The death certificate received on 3/22/04 states COPD. The medical record received on 3/22/04 states neuropathy, GERD, ulcers and hypothyroidism. The hospital discharge summary received on 3/23/04 states hypotension, SOB, decreased po intake and elevated liver enzymes. Follow up on 03/24/04: "Copy of death certificate: Cause of death: Sepsis syndrome-cholecystitic. Other significant conditions contributing in death but not resulting in the underlying cause of death is advanced COPD."
chills; fever; sore throat; This is a spontaneous report from a contactable consumer. An 87-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 87 years old on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history was not reported. Concomitant medication included palbociclib (IBRANCE). On an unspecified date, the patient experienced chills, fever and sore throat (believes sore throat is due to dry environment at facility). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
so cold all the time; not feeling well; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (so cold all the time), MALAISE (not feeling well) and NAUSEA (nauseous) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced FEELING COLD (so cold all the time), MALAISE (not feeling well) and NAUSEA (nauseous). At the time of the report, FEELING COLD (so cold all the time), MALAISE (not feeling well) and NAUSEA (nauseous) outcome was unknown.            No concomitant medication was provided  Treatment medication was not provided by the reporter
had my first episode of dizziness,20 minutes later I had a second episode of dizziness; loss of balance/complete loss of balance; Bp was 105/55; tired; soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (had my first episode of dizziness,20 minutes later I had a second episode of dizziness), BALANCE DISORDER (loss of balance/complete loss of balance), HYPOTENSION (Bp was 105/55), FATIGUE (tired) and MYALGIA (soreness in arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20) for COVID-19 vaccination.     The patient's past medical history included Hives and Hay fever. Concurrent medical conditions included Pollen allergy (Runny nose, eyes sneezy) since 20-Jan-1957, Allergy to molds, Dust allergy, Type 2 diabetes mellitus since February 2001 and Macular telangiectasia since March 2017. Concomitant products included LISINOPRIL for Diabetes, FUROSEMIDE, ALLOPURINOL and INSULIN DEGLUDEC, LIRAGLUTIDE (XULTOPHY) for an unknown indication.   On 03-Mar-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (had my first episode of dizziness,20 minutes later I had a second episode of dizziness), BALANCE DISORDER (loss of balance/complete loss of balance), HYPOTENSION (Bp was 105/55), FATIGUE (tired) and MYALGIA (soreness in arm). At the time of the report, DIZZINESS (had my last episode of dizziness,20 minutes later I had a last episode of dizziness), BALANCE DISORDER (loss of balance/complete loss of balance), HYPOTENSION (Bp was 105/55), FATIGUE (tired) and MYALGIA (soreness in arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 188 (High) elevated sugar level 188. normal level is 139 to 110 and 181 (High) two hours later 181. On an unknown date, Heart rate: 62 (normal) pulse 62. On an unknown date, Oxygen saturation: 95 (normal) oxygen 95.         No treatment information was reported.   This case was linked to MOD-2021-261608 (Patient Link).
2 months after last dose, a routine bloodwork revealed high kidney numbers. Voice became hoarse and difficulty in swallowing ease was noted. Repeat blood work confirmed kidney numbers still high after hydration, IV fluids given at home. Fatigue increased and I took my mother to the ER.  She was admitted and she spent 3 weeks in the hospital, 1 week in ICU. She was eventually diagnosed with the autoimmune disease ANCA Vasculitis. Biopsy confirmed. No previous kidney disease or abnormal blood work. She was treated with high dose steroids and  chemotherapy.  There was no positive response to treatment. Condition worsened and she was moved to Hospice care. My mother died on 05/16/2021
Severe arm pain with limited mobility; Severe arm pain with limited mobility; This is a spontaneous report from a non-contactable consumer(patient) or other non hcp. A 62-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration on 17Feb2021 (at the age of 62-year-old) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive COVID prior vaccination and was not tested for COVID-19. The patient experienced severe arm pain with limited mobility on 17Feb2021. Therapeutic measures were taken as a result of severe arm pain with limited mobility with Acetaminophen 650mg. Outcome of the events was unknown.   No follow up attempts are possible. No further information is expected.
COVID-19; COVID-19; vaccine brand: Pfizer / BioNTech; vaccine dose number: 5/vaccine brand other: Moderna;vaccine dose number: 4; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Dec2020 as dose 1, single (Lot number: 025J20-2A), on 21Jan2022 as dose 2, single (Lot number: 057G20A), on 19Nov2022 as dose 3 (booster), single (Lot number: 081F21A) and on 27Jun2022 as dose 4 (booster), single (Lot number: 054A22A) for covid-19 immunisation. The patient's relevant medical history included: "Sjogren's" (unspecified if ongoing); "NASH w/F3 liver fibrosis" (unspecified if ongoing); "Autoimmune gastritis" (unspecified if ongoing); "CKD Stage2" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "known allergie", notes: known allergies. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Oct2022, outcome "unknown", described as "vaccine brand: Pfizer / BioNTech; vaccine dose number: 5/vaccine brand other: Moderna;vaccine dose number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jan2023) positive; (03Feb2023) negative; (05Feb2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID Treatment).
no fetal heartbeat; pregnant and received vaccine; A spontaneous report was received from a 37-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) while pregnant, and there was not fetal heartbeat.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included prenatal vitamins.  The consumer received the second of the two planned doses of mRNA-1273 on 26-JAN-2021 (Batch# 041L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 02-MAR-2021, the patient stated her fetus had no heartbeat. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events was considered recovered.; Reporter's Comments: This is a case of product exposure during pregnancy for this 37 year old woman with associated event of absent fetal heartbeat. The patient will continue to be contacted for follow-up.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 16-OCT-2008, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 07-NOV-2014, the patient was treated at a medical center for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, 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 significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
PATIENT HAVE ERYTHEMA AND GENERALIZED PAIN IN LEFT ARM. REDNESS IS NOT LOCALIZED IN THE AREA OF INJECTION. PAIN PRESENT IN AREA OF INJECTION. SYMPTOMS AND SIGNS OCCURRED NEXT DAY EARLY IN THE MORNING WHILE SHE WAS SLEEPING. NO PHARMACOLOGICAL TREATMENT AT THE MOMENT.
tachycardia,sob, cp,  fevers, SIRS, elevated troponin anca vasculitis
swelling on his left armpit, half a dollar in size, non tender, lymphadenopathy (in CT scan); flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and LYMPHADENOPATHY (swelling on his left armpit, half a dollar in size, non tender, lymphadenopathy (in CT scan)) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On 10-Mar-2021, the patient experienced LYMPHADENOPATHY (swelling on his left armpit, half a dollar in size, non tender, lymphadenopathy (in CT scan)). The patient was treated with PARACETAMOL (TYLENOL) on 09-Mar-2021 for Flu like symptoms, at an unspecified dose and frequency. On 09-Mar-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. At the time of the report, LYMPHADENOPATHY (swelling on his left armpit, half a dollar in size, non tender, lymphadenopathy (in CT scan)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood test: normal (normal) Normal blood works came out all normal. In April 2021, Computerised tomogram: normal (normal) Normal CT scan was done which came out all normal (other than lymphadenopathy).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Reporter contact information and route of administration updated.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 73-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included BOOSTRIX. On 5th July 2018, the patient received SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced fever. In July 2018, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: On 2nd July 2018, the patient received a dose of BOOSTRIX. The fever lasted a couple of days. The healthcare professional could not access SHINGRIX or BOOSTRIX lot numbers or expiry dates at the time of call.
Covid-19 weakness diarrhea pneumonia hypoxia Acute Kidney Injury Sepsis
Sore, warm and red arm at injection site. Shoulder pain bilaterally. Neck pain. Leg and muscle aches.  Headaches. Dizziness.
31 year old male with of c/o  generalized itching  20 minutes post 2nd dose of Moderna Covid vaccine. He was given 50 mg of benadryl injection  and his symptoms progress to  scratchy throat . Patient premedicated with zyrtec prior to his vaccine. He was given prednisone 60 mg and monitored in clinic for an hour. Patient symptoms resolved and was discharge home. Patient was initially hypertensive and mildly tachycardia and  his VS was stable. Patient has a hx of anaphylaxis.
She reports swollen arm after vaccine as well as itching and burning for about a week. She did not have the experience after the first two doses.   Her arm is back to normal now and she did not have to seek medical treatment.
Numbness on right side of face/mouth/tongue (prior site of trigeminal neuritis flare)  ~1 hour after injection.