chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Eyes were glassy; Weakness; Body ache; Fever; Pain at injection (left) arm; This spontaneous case was reported by a consumer and describes the occurrence of GLASSY EYES (Eyes were glassy), ASTHENIA (Weakness), PAIN (Body ache), PYREXIA (Fever) and VACCINATION SITE PAIN (Pain at injection (left) arm) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Hospitalized.) in January 2021.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced GLASSY EYES (Eyes were glassy), ASTHENIA (Weakness), PAIN (Body ache), PYREXIA (Fever) and VACCINATION SITE PAIN (Pain at injection (left) arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 dosage form and HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) at an unspecified dose and frequency. At the time of the report, GLASSY EYES (Eyes were glassy), ASTHENIA (Weakness), PAIN (Body ache), PYREXIA (Fever) and VACCINATION SITE PAIN (Pain at injection (left) arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Other treatment information included cold wash cloth.
The day after my first shot, I started spotting, which led to a period several days later. I bled for 10 days straight that first month. Every month since then, I have experienced breakthrough bleeding before my period, and have bled anywhere between 10-19 days each month.
Initial information received on 24-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 58 years old male patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UI994AB, expiry date: 09-APR-2019 via intramuscular route in the left arm on 22-Sep-2018 (Frequency: once). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to Inappropriate age at vaccine administration. It was reported that they had an offsite flu clinic and a FLUZONE HIGH-DOSE injection was given to a Male patient, age 58 years. It was unknown whether patient experienced any adverse reaction after the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
2 DVT?s in left leg ; presented with slight leg edema; Ultrasound was used for diagnosis;Treatment was Eliquis 10mg BID x 7 days, followed by 5mg BID currently; probably for 6-12 months; Dr will monitor and decide in 6 months; no family hx of clots.
Large area of cellulitis around KINRIX & MMR site. Small area of cellulitis around Varicella.
This spontaneous report as received from a consumer stated her room mate received the ZOSTAVAX (1 time vaccine, subcutaneous, lot # was unknown) about 1 month ago (in February 2013). She went on to state that he had what she described as a blistering red blotch on his back. She only stated that there was one. He only had 1, and the diameter was not stated. She stated that he was going to the physician today(on 04-MAR-2013). The outcome of event was unknown. The relationship between ZOSTAVAX and event was unknown. Additional information is not expected.
This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, less than a week after receiving BEXSERO, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to BEXSERO. Additional details were provided as follows: This case was reported by Certified Medical Assistant (CMA). The age at vaccination was not reported. The reporter said the patient called the day after she got the immunization to report a red spot about the size of a silver dollar on her arm where she was given the shot. The reporter agreed for follow up contact.
This spontaneous report as received from a nurse refers to a 67 year old patient. Medical history and concurrent conditions were not reported. On 12-FEB-2014, the patient was vaccinated with PNEMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a healthcare worker concerning nine unspecified patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the nine patients were vaccinated with improperly stored doses of VARIVAX with lot # L013066 and expiration date: 14-APR-2017 (dose and route of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. The temperature reported was 12.20 F. The time frame reported was 838 hours and 59 minutes. There was no previous temperature excursion and no digital data logger reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
needle pain sensation all over my body; joint pain; mild fatigue; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (Age:48; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as a DOSE 1, SINGLE for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient reported, she has been administered both doses of Pfizer covid vaccine. She is experiencing covid like symptoms. She had a negative PCR test and waiting on results from another PCR test. After her first dose, the day after, she had needle pain sensation all over my body and joint pain and mild fatigue. That lasted only a day, she had gone out and got the PCR test, and that test was negative. Outcome of the event was recovered on unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Bleeding, Myalgia, Fever, Diarrhea,  inj site pain and soreness, body aches, broken blood  vessel to L eye Narrative:
Woke up 1/20/21 with chills but no fever, increased heart rate of 99 when my normal is 68, dehydration, headache,  fatigue, body aches, injection site pain, nausea after eating oatmeal and coffee.
I experienced right flank pain and right sided abdominal pain after my vaccine. This really went off for 5 days. I went to ER on day 4 and clinical follow-up on day 5 and I have gradually better since day 5.  I still have right side flank pain, minimally bothersome at this point. I also felt fatigues and had a sore left arm. At the ER they did complete lab work, urine test and CT scan of the abdomen which tests were normal.  I can say I am about 90% better today, not back to normal, well on the way to getting better.
terrible joint aches; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (terrible joint aches) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045H21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (terrible joint aches). At the time of the report, ARTHRALGIA (terrible joint aches) outcome was unknown.            No concomitant were reported. No treatment were reported.   This case was linked to MOD-2022-554854, MOD-2022-554863, MOD-2022-554864 (Patient Link).
Patient started to experience a fever around 2 pm that afternoon and was followed by a heart rate of 95-105, no increased blood pressure, a fever of 102, and numb fingers. ADVIL was taken around 10pm at night and the fever broke around 3 am. By the next morning all symptoms had disappeared.
The patient received the shot at the pharmacy around 9am and called back around 10:30am concerned of symptoms. Her arm was tingling and she was a bit dizzy. Her heart rate had increased earlier but had gone down. The patient had an egg allergy that she stated caused her hives so the Flucevax vaccine was chosen that is not based on eggs. Patient was advised to seek medical attention if there was any problem breathing or symptoms worsen. She stated she would call back if any other symptoms occurred.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 04-MAY-2015 the patient was vaccinated with a dose of improperly stored MMR II, 0.5 ml, subcutaneously (lot number was not reported). No adverse effects reported. Additional information has been requested.
I came home from work due to not feeling well. I don't remember if I did take Nyquil and fell asleep. I then woke up and then went back to bed. And then I woke up suddenly in the middle of the floor which triggered a panic attack as well due to disorientation.  I was still pretty sick from the vaccine and I did have to sleep through the day. I have come down with COVID-19 twice since this vaccination, The first time was in January a few weeks after the vaccine. In January I was extremely sick. I did then come down with COVID-19 again on June 13th 2022 and by Wednesday I was feeling better however I do still have a cough and body aches along with fatigue. I did get in touch with a PCP to further investigate any autoimmune issues. I did call an eye emergency room due to extremely high pressure and discomfort.
received 2 doses of the Pfizer BioNTech Covid-19 vaccine and has tested positive for the Covid-19 virus.; received 2 doses of the Pfizer BioNTech Covid-19 vaccine and has tested positive for the Covid-19 virus; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team and product quality group. The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 03Mar2021 13:15 (Lot number: EN6205) at the age of 24 years as dose 2, single and intramuscular, administration date 03Jan2021 (Lot number: EH9899) as dose 1, single, administered in deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Measles, mumps, and rubella vaccines, for Immunization, reaction(s): "never got those diseases". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 30Dec2021, outcome "unknown", described as "received 2 doses of the Pfizer BioNTech Covid-19 vaccine and has tested positive for the Covid-19 virus."; COVID-19 (medically significant) with onset 30Dec2021, outcome "unknown", described as "received 2 doses of the Pfizer BioNTech Covid-19 vaccine and has tested positive for the Covid-19 virus". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive, notes: Tested with an at-home kit and was positive; (03Jan2022) positive, notes: Officially tested positive at a doctors office. Therapeutic measures were not taken as a result of covid-19.  Clinical course: Patient is a registered nurse who received 2 doses of the Pfizer BioNTech Covid-19 vaccine and was tested positive for the Covid-19 virus. Patient did not receive any additional vaccines on the same date as that of Pfizer suspect. Patient received no other vaccines within 4 weeks prior to the first administration of suspect COVID-19 vaccine. Patient experienced no adverse events with prior vaccines. Patient reported that the vaccine did not do what it was intended to do. Patient still got COVID and spread it to everyone in his house and his family is sick and that two other people in his house have received medical treatment and intervention. Patient reported that the two other people in his house were vaccinated and tested positive for COVID-19. They were his mom and step-dad. The patient reported that they are sick and not doing well. Patient reported that he infected his whole family. Patient reported it is serious as patient works with geriatric patients. Patient reported that the COVID-19 Vaccine is the only vaccine he had that didn't work. Patient did not visit the emergency room or physician office due to adverse event.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
I26.99 ACUTE PULMONARY EMBOLISM 4/18/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
received an extra dose DTap in error with no reported adverse event; prescribed IPV but instead were given the combo vaccine QUADRACEL with no reported adverse event; Initial information received on 26-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case US-SA-2023SA033514.  This case involves a 4 years old female patient who received an extra dose DTAP in error with no reported adverse event and was prescribed IPV but instead were given the combo vaccine diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar RA 27/3), varicella zoster vaccine live (oka/merck) (Proquad) for Immunisation.  On 24-Jan-2023, the patient received a dose of 0.5 ml suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (Suspension for injection) (lot: U7526AA; expiry date: 07-Sep-2024; strength: standard) via intramuscular route in the left thigh for immunization.  On 24-Jan-2023 the patient received an extra dose of DTAP in error with no reported adverse event (extra dose administered) and was prescribed IPV but instead were given the combo vaccine diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (Quadracel) with no reported adverse event (wrong product administered) (latency: same day).   Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fever 103.1 approximately 12 hours after administration  Body aches and pain (moderate)
Patient was administered the first dose of Gardasil 9 on 12/10/2018/The second dose was administered on 8/12/2019/The third dose administered on 5/18/2020; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reaction or allergies, concurrent conditions and concomitant medications was not provided.     On 10-DEC-2018, 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) by intramuscular route (strength, dose, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis.    On 12-AUG-2018, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1621934 with expiration date of 29-JAN-2022, by intramuscular route (strength, dose, frequency, and anatomical location, were not provided) for prophylaxis. Then, on 18-MAY-2020, the patient received the third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R027946 with expiration date of 27-APR-2021 by intramuscular route (strength, dose, frequency, and anatomical location, were not provided) for prophylaxis ( inappropriate schedule of product administration).    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: 1621934; expirationdate: 29-JAN-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
Second Dose Given was Engerix; Initial Report Received on 03-Mar-2021  A licensed practical nurse (LPN) reported that a 55 year-old male received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was given Engerix [Hepatitis B Vaccine (Recombinant)] as the second dose.  Medical history was reported as hypertension, diabetes, coronary artery disease (CAD). Allergy history was reported as hydrochlorothiazide (reaction of hypokalemia) and lisinopril (reaction of cough).  Medications at the time of vaccination were reported as potassium, glipizide, aspirin, atorvastatin, metformin, atenolol, losartan, and amlodipine.  20-Oct-2020, the patient received the first dose of HEPLISAV-B (Lot # 933622, expiration date 01-Aug-2021 and NDC # 43528-003-01), route and site unknown.   On 21-Dec-2020, 63 days after having been vaccinated with HEPLISAV-B, the second dose given to the patient was Engerix [Hepatitis B Vaccine (Recombinant)].   No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Patient developed "redness of the left eye" approximately 7 days after helping her boyfriend, a recent military smallpox vaccinee (he was 3-4 days post-vaccination at the time), change the bandage over his vaccination site.  She had been seen at the health clinic 2 days prior to onset of eye redness with c/o sore throat, nasal congestion, and transient fever (Tm 99).  Throat culture was sent and she was treated with penicillin and sudafed prn.  Three days later, on 3/21 she awoke in the morning with redness of the left eye.  She denied ocular pruritis, pain or changes in vision.  Her sore throat was still present (despite treatment with PCN) but she was otherwise asymptomatic.  She was seen at the health clinic who contacted the DOHMH because of the history of contact with a smallpox vaccinee.  She was referred to the Hospital for ophthalmologic consultation.  Thorough exam revealed only conjunctival injection on the left, but no periocular lesions, no evidence of keratitis, no changes in visual acuity.  After consultation with CDC, ocular specimens were sent for vaccinia PCR and for adenoviral culture.  No HSV testing done due to low clinical suspician.  She was treated with artificial tears and Naphcon A eye drops but NOT Viroptic.  Vaccinia PCR was subsequently negative (confirmatory testing at CDC pending).  Adenoviral testing is pending.  I spoke with an ophthalmologist on 3/24 who saw the patient that day and said she is "much improved."
Pt vaccinated on 4/2/2003.  On 4/10/03 noted to have erythema surrounding vaccine site, approx 3" Site warm to touch, tender.  No fever. Nodes palpable. Diagnosis: cellulitis. prescribed dicloxicillin 500 mg po qid x 10 days.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 20-OCT-2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of 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 direct and proximate result of these malfunctions, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
I felt very tired, (slept about 12 hours )and had no energy for about 14 hours.  My arm stopped hurting and my energy came back without any physician assistance
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 2/26/2021 and 3/26/2021. Presented to ED  on 9/1/2021 from Medical Lodge with complaints of shortness of breath requiring oxygen. Patient was placed on high flow oxygen and started on Dexamethasone, ceftriaxone, doxycycline, remdesivir, piperacillin + tazobactam, vancomycin, ascorbic acid, zinc, and Vitamin D. Per patient's wishes he was transitioned to comfort care at 08:40 and expired at 09:00 on 9/5/2021.