chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Admitted to Hospital on Date of Adverse Event [recorded in Agency] for treatment of Covid-19 Positive following completion of Covid Vaccine Series
Two vial of Moderna vaccine were identified with brow particles inside.  Product sequestered   Narrative:  On February 19, 2021 pharmacist preparing Moderna COVID-19 vaccine syringes, identify a product problem. Moderna vaccine vial with lot  number 006M20A was being used. Upon visual inspection of vial prior vial puncture, a brown particulate was noted on the bottom of the vial. The vial was gently swirl and particulate floated in the suspension confirming particulate matter was inside of the vial. Based on "Dose Preparation" section of Emergency Use Authorization fact sheet for healthcare providers administering the vaccine (vaccination providers): the vial was separated from the rest and labeled as "DO NOT USE" until further disposition is made. The remaining vials with same lot number were inspected and one additional vial was found with particulate matter but in a lesser amount when compared with the first vial. Manufacturing  company (Moderna) was notified of the situation. Both vials are currently separated from the rest and are labeled as "DO NOT USE". Current storage condition of vials with brown particulate matter is refrigerated (BUD: 3/18/2021@15:20).
Injection site muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 24Feb2021 11:15 (Lot number: EN6203) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, intramuscular, Batch number: EN5318), administration date: 03Feb2021, when the patient was 66 years old, for covid-19 immunisation, reaction(s): "Injection site muscle pain". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered" (26Feb2021), described as "Injection site muscle pain". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: It was reported as none on the prior patient vaccination within four weeks.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130049 same patient and drug and event, different dose
Onset of shingles started 24 hrs after administration of flu shot. patient had prev. had shingles and shingles vaccine. Patient was healthy/on a wellness routine (exercise, eating healthy) and active/high energy until 1 day after flu shot.
This spontaneous report was received from a pharmacist referring to a multiple unspecified patients. No concurrent or historical conditions were reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, (Lot # L029631, expiration date 14-AUG-2017) doses, routes, anatomical locations were not reported. No concomitant medications were reported. No adverse effects were reported. No further information was provided. No product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Tdap booster. T=101 Tachycardia last booster >10 yrs
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013, a healthcare provider (not further specified if it was a pharmacist) at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2013, the patient was treated by a healthcare provider at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
3 days after getting first Moderna vaccine, he experienced dizziness and falling. He fell at least 3 or 4 times and is now using a walker to prevent falls. He had not used a walker before. He had not seen his doctor,but was encouraged to make an appointment to see if he has fluid in his ears, etc. He reports no nausea or broken bones. I will foolw-up with him at the end of this week to check progress. He states some improvement.
Pt received vaccine at age 5 1/2, at age 11 developed Varicella rash with minimal systemic symptoms, temp 100 one night approx 200 lesions on 3rd day of rash.
This spontaneous report was received from a physician via company representative and refers to a 19 year old female patient. There were no concurrent conditions, medical history or concomitant medications. On 05-JAN-2017, the patient was vaccinated with GARDASIL for prevention of Human Papillomavirus (HPV), M-M-R II for prevention of measles, mumps and rubella and hepatitis a vaccine, inactivated (Manufacturer unknown) (dosing details were not reported) for prevention of Hepatitis A. On the same day, after the vaccines were administered, the patient stiffened up, fell over and was unresponsive. The patient was taken to the emergency room at an unspecified hospital. There were unspecified tests and blood work performed (results not reported). It was unknown if any treatment was provided for the adverse events. On the same day, the patient recovered. Reporting physician had not assessed the causality of the events with respect to the suspect vaccines. Upon internal review, the event, unresponsive to stimuli was considered to be medically significant. Additional information has been requested.
I had a sore throat, headache, slight fever, tight chest, dry cough, and achy. I tested positive for COVID-19 the next day. I called my doctor, and she prescribed me Paxlovid. I was feeling better while taking it, but about two weeks later I started to have the same symptoms again. I took another COVID-19 test and it was positive again. I spoke to the doctor again and she told me it was a rebound case and to stay hydrated. I was sick for about 5 days.
Report received from a pharmacist on 17-SEP-2010 (received via Merck WAES: 1009USA03785). A female patient in her 70s (initials unknown, date of birth unknown) received AFLURIA (lot number M50907, expiry 30-JUN-2011) on 16-SEP-2010 for vaccination. The patient had no pertinent medical history and had no concomitant medications. On 16-SEP-2010, the day of vaccination with the suspect drug, the patient complained of 'stings' when she received the cold AFLURIA vaccine that was just taken out of the refrigerator. The patient sought medical attention. (This case was initially reported as two sisters who both complained of stings. The sibling case is WAVES number 2010026495). The event outcome was not recovered. The reporter did not give a causality assessment. This case was reported as not serious. The company considered events possible in relation to the suspect drug, AFLURIA. Information derived from this AE report does not change the current safety profile of the product.
Pt recvd 3 doses of Hep B vax & immediately following vax pt tested pos for antibody titer; 1 yr later pts titer was neg;
Written order from provider for Polio, DTaP and HepA. Clinician administered KINRIX (DTaP, IPV) and separate HepA. After administration, clinician discovered that the age range for KINRIX is 4-6 years of age. Clinician did not realize that PEDIARIX could have been administered (DTaP, IPV, HepB) or that we had DTaP and separate IPV available.
Pain, redness, swelling at injection site (L) deltoid. Had fever and headache 24 hrs post injection.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 02-JAN-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R019391 with expiration date 05-JUL-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Information has been received from a 32 year old female patient with no pertinent medical history or drug reactions/allergies who on 18-JAN-2007, was vaccinated with the first dose of GARDASIL vaccine (yeast), on 19-MAR-2007 was vaccinated with the second dose of GARDASIL vaccine (yeast) and on 19-JUL-2007 was vaccinated with the third dose of GARDASIL vaccine (yeast) into her buttocks. There was no concomitant medication. In May or June-2007, the patient reported that her hair fell out in clumps, she experienced pain in the lower legs and sore joints (though not constant), after she was getting her second dose of HPV vaccine. Also she stated that her periods have gone from a steady every 28 days to between 28 and 50 days. She has not been on birth control for years. She has had no family history of female hair loss. The patient had also consulted a nutritionist and dermatologists. The blood work performed showed no vitamin or mineral deficiency. The patient's hair fell out in clumps, sore joints, pain in the lower legs and irregular menstrual cycle persisted. Additional information has been requested.
Pruritic maculopapular rash on chin and lower face, on right trunk at bra line, on right waist line, and on left low back.
small itchy hives 3 days after the second shot; small itchy hives 3 days after the second shot; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (small itchy hives 3 days after the second shot) and URTICARIA (small itchy hives 3 days after the second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (small itchy hives 3 days after the second shot) and URTICARIA (small itchy hives 3 days after the second shot). At the time of the report, PRURITUS (small itchy hives 3 days after the second shot) and URTICARIA (small itchy hives 3 days after the second shot) outcome was unknown.            No concomitant medications reported by investigator No treatment medications provided by the reporter
Cancer; This spontaneous case was reported by a non-health professional and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The suspect product dosage text was reported as unknown. No concomitant medication was reported. It was reported that the Moderna Covid-19 caused cancer in 25 patients who were the friends of reporter. The patient will not provide any additional information on these patients. It was also reported that those patients who died were killed by the Moderna Covid-19 vaccine because Moderna vaccine was poison Cancer rates for jabbed Moderna Cancer patients was up 300% The Doctors were part of it along with Moderna. No treatment medication was reported.  This case contains information about patient 19th out of 25 patients.  Company comment: This is a fatal spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected serious (death/medically significant) event of neoplasm malignant. The event occurred after a dose of mRNA-1273.222 vaccine. No information disclosed about diagnostic tests performed or treatments received. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case; Reported Cause(s) of Death: Cancer
Soreness, weakness, fatigue, and short term fever; treatment none; fever ended in hours; fatigue and soreness decreased over 1-2 days
Patient woke up from nap with blotchy red spots, swollen ears. No fever.
Dizziness, severe headache, heart palpitations /racing heart, lightheaded, feeling faint.
RECEIVED FLU VACCINE AT 1515 ON 10/27/02, AT APPR 2320 ON 10/27/02 WOKE UP WITH CHILLS FEVER AND BODY ACHES AND PAINS, LASTED THRU 10/29/02
pin pricking; drooling; It was just a cranial nerve interrelated to the centers on the right side of my face; tingling; numbness; This is a spontaneous report from a contactable consumer (Patient) reporting herself.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on an unknown date for COVID-19 immunisation. Medical history and concomitant medication were not reported. On an unknown date, she had tingling and numbness 10 days after her first dose of Pfizer's COVID vaccine. She stated "she went to her PCP yesterday and she didn't have Bell's palsy. The PCP told her it looks like a rare reaction and it was only her 2nd patient. her side effects were 10 days after the first dose with pin pricking, tingling, and numbness on the right side over by the eye, by the temple, by the cheek, and by the mouth, even drooling." Tingling and the numbness on the Thursday on the right side of her face; It was just a cranial nerve interrelated to the centers on the right side of her face. She had some questions and what she had was the tingling and the numbness on the Thursday on the right side of her face. she just went to her primary care doctor today and she confirmed that it was not the stroke. she had not the palsy. It was just a cranial nerve interrelated to the centers on the right side of her face. her question was it had improved. It was almost gone. The outcome of event cranial nerve disorder was recovering and outcome for the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
4/8/2021 About 10:30 am tingling in throat, took a cetirizine 11:00 am extreme fatigue, took a nap Thru out the day shoulder blade painful, joint point on side of injection.    4/9/2021 Fatigue Nausea Injection site felt like it was burning around 2pm, looked at injection site was raised up, red and had a rash. Took a cetirizine.   Chest hurts like it does when I accidentally eat something that contains tree nuts.   Sight fever
"Janssen COVID-19 Vaccine EUA"  Migraine, Eyes sensitive to light, body aches, body felt very hot but was shivering and cold, dizziness, fatigue.
Hives first occurred the end of March 2020 after the second dose. Moderately severe outbreak of hives occurred again on May 14, 2021 and is ongoing as of today - 17Mar2021.
This case was reported by a nurse via sales rep and described the occurrence of syncope in a 16-year-old female patient who received BEXSERO. In January 2017, the patient received the 1st dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced syncope and urinary incontinence. On an unknown date, the outcome of the syncope and urinary incontinence were unknown. It was unknown if the reporter considered the syncope and urinary incontinence to be related to BEXSERO. Additional details were provided as follows: This case was reported by licensed practical nurse. The age at vaccination was not reported. The nurse told GlaxoSmithKline employee that one of their patients received BEXSERO and experienced an episode of syncope and urinary incontinence during the syncope episode. The patient did not fall nor had any head injuries. The patient lied down with her feet up and recovered and went home.
Felt like she had the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Felt like she had the flu) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016CZ1A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced INFLUENZA (Felt like she had the flu). At the time of the report, INFLUENZA (Felt like she had the flu) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.    This case was linked to MOD-2021-364501 (Patient Link).   Reporter did not allow further contact
Got the shot on 1/26/21, the next day 1/27/21 her arm was a little red and sore and was nauseous.  Then about 8 days later, just over a week she woke up and her arm was red again and more swollen and looked like a black and blue area where the needle went in.  There was a red rash around that point.  The rash was larger than the palm of her hand.  She was tired that day and it did go away after 2-3 days.  She took Tylenol one night due to the pain to help sleep.  She did not call her doctor.  It has now totally resolved as of today, 2/10/21.
Injection area inflammed, red area got very big and hard. Lasted about 3 days. She took some Allegra tablets.
Patient reported nose bleed that required ER visit to stop. Patient taking Xarelto. Reported BP>140, no fever.