chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 10:07 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 10:07 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Age of patient was reported as 71.12 for dose administered on 28-FEB-2021 and 71.20 for dose administered on 28-MAR-2021.  Batch number 014M20A underwent temperature excursion on 28-FEB-2021 with temperature 27 degrees Fahrenheit at 09:00 AM and 26 degrees Fahrenheit at 1.00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-FEB-2022. Batch number 019B21A underwent temperature excursion on 28-MAR-2021 with temperature 35 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 23-MAR-2022 and beyond use date for the vial was reported as 22-APR -2021. Product moved to clinic on 27-MAR-2021  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Intense headache plus recurrent ones (back of head) nerve endings tingling (several weeks) like contact with H.D. bug killer, dizziness, slower to act, spacey , slight fever went away. headache recurrent and slowness to act. ?? No meds taken that day due to strange feeling, etc.
Severe shoulder pain started in L shoulder about 2 hours after receiving seasonal flu vaccine. The pain was different than previous vaccine related pain. Took Bandaid off and realized injection site was too high on shoulder. Pain has persisted for 12 days with limited range of motion and unable to lift, reach for items. No swelling, redness, or bruising. Motrin and heat for treatment. Pain still persists and is different than previous vaccine related pain.
Breakthrough case  admission after 2 vaccines Pfizer 4/27/21 Lot# EW0176;  PFizer 5/18/21 Lot# Ew0183
PATIENT HAD INJECTION IN THE MORNING OF 10/20/2014.  THE NEXT MORNING (10/21/2014), THE PATIENT WENT AND WORKED OUT AND CAME HOME FEELING VERY TIRED.  HE STATES HE WAS FEELING WEAK, DISORIENTATED, LAPSES OF MEMORY AND KEPT ASKING HIS WIFE WHAT SHOTS HE HAD.
only had sniffles the first night; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (only had sniffles the first night) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (only had sniffles the first night). At the time of the report, RHINORRHOEA (only had sniffles the first night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Breakthrough case admission after three vaccines Moderna 3/16/21 Lot# 040A21A;  Moderna 4/13/21 Lot# 016B21A;  Moderna 10/27/21 Lot# 039D21A
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot#J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow up information has been received from the registered nurse who provided patients details. This report refers to a 2 months old infant patient of unknown gender. On 03-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot#J016188, expiration date 02-OCT-2014) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Pt reports she woke up 9/25/2010 with itchy rashes, redness and swelling left side of face and swelling Lt face and neck. Went to Urgent Care was told she had a dermatitis, not a reaction, but pt believes it was due to vaccine.
Pt recvd 1st dose of Hep B vax on 31MAR87 following needle stick & on 7APR87 devel t102 x 24 hrs; 9APR87 rash, flu-like sx, body aches, fatigue, could barely move, abn liver function & pos antinuclear antibody; elevated serum creatinine;
Received DTaP im and IPV SQ in left arm on 8/13/02 at clinic. Next day left upper arm was red, hot and swollen with a noticeable red line running between the two vaccination sites (per mom) Taken to ER. Dx was cellulitis-received Benadryl and antibiotic. Resolved in 10 days (per mother). This was listed under item 7 received vaccines 08/13/2002. On 08/14/2002 (time not known) mother took child to ER
4May92 pt recvd vax 10 min later p/ dose pt exp LOC for 2.5 hrs;unable to change positions;hypertension. Events reported as poss life threatening. Tx observation. Events  abated p/ 7 hrs.
SWELLING OF CHIN AND LIPS HIVES & WELTS DEVELOP ALL OVER THE BODY, INCLUDING HIS NASAL MEMBRANE
The night after the injection, severe dryness, thirstiness. Got up for water 5-6 times.  In the morning I was nauseated,  wanted to vomit but nothing, not even water, came up. Severe headache began. Low-grade fever (99.3)
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. Previously in 1999, my husband was given 3 anthrax shots in a series of 6. The shot records indicate they were all from lot FAV037. All his medical records before this indicated him to be in excellent health with no medical problems until he took these anthrax vaccinations. His body began systematically breaking down in early 2000. The blunt of the illness began when my husband, whom served his country with prode and honor, returned home in July of 2002 from his fourth tour of duty. The man I married left for his final tour of duty in 2002 and came back as someone I did not recognize. So far his diagnosis have been: GERD, acid reflux, IBS, benign Prostatic hyperplasia, Rheumatoid arthritis, depression, chronic fatigue and autoimmune disease. He suffers from memory loss and muscle weakness daily. He has endured medical testing and treatment, which is ongoing, daily sporadic symptoms keeping him from functioning in a normal healthy life style, ridicule, being let down by he commanders and unit, and everyday life in a previously healthy body that is breaking down daily. He is a proud man who stood strong in his beliefs in the military and the government. Little did he know that they would all turn a blind eye to him and many others that have fell sick or died because of the atrocious vaccine that is slowly disabling or killing our military personnel. (OMIC) Information from 60 day follow-up report states: Patient continues with symptoms described in adverse event report. Further information if desired is available through National Vaccine Healthcare Center.
URTICARIA Narrative: Pt reported historical urticaria from his last 2018 influenza vaccine.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 11:00 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "Allergy to Fluoroquinolone antibiotics" (unspecified if ongoing); "Known allergies- contrast dye" (unspecified if ongoing). Concomitant medication(s) included: Nortriptyline; Ambien; Advil [Ibuprofen]. Vaccination history included: Bnt162b2 ({product=COVID 19, brand=Pfizer,, lot unknown=True, lot unknown reason=Unable to locate or read the details, administration date=26Jul2021, administration time=09:30 AM, dose number=1, vaccine location=Left arm}), administration date: 26Jul2021, for COVID-19 immunisation. The following information was reported: INSOMNIA (non-serious) with onset 20Aug2021 22:30, outcome "recovering", described as "Insomnia"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 20Aug2021 22:30, outcome "recovering" and all described as "Widespread muscle and joint pain"; HEADACHE (non-serious) with onset 20Aug2021 22:30, outcome "recovering", described as "Headache"; FACIAL PAIN (non-serious) with onset 20Aug2021 22:30, outcome "recovering", described as "Facial pain"; VACCINATION SITE PAIN (non-serious) with onset 20Aug2021 22:30, outcome "recovering", described as "Pain at injection site". The events "insomnia", "widespread muscle and joint pain", "widespread muscle and joint pain", "headache", "facial pain" and "pain at injection site" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of insomnia, myalgia, arthralgia, headache, facial pain, and vaccination site pain. The patient did not had any treatment for AE. The patient did not had COVID prior vaccination. The patient did not tested COVID post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
strange side effect after her second dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (strange side effect after her second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION (strange side effect after her second dose). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (strange side effect after her second dose) outcome was unknown.            No concomitants or treatment medications were reported.
Blood pressure has been better than its ever been; Headaches started the day after; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches started the day after) and THERAPEUTIC RESPONSE UNEXPECTED (Blood pressure has been better than its ever been) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included Thrombus. Concurrent medical conditions included Hypertension. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and LISINOPRIL for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced HEADACHE (Headaches started the day after). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Blood pressure has been better than its ever been). At the time of the report, HEADACHE (Headaches started the day after) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 117/78 (Inconclusive) blood pressure 117/78.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment medicine includes asprin For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
Pt states that she got her second SHINGRIX last week. The night of the injection she developed a low grade fever, was tender at injection site and axillary region. Progressed to bruising down arm and across breast.
This spontaneous report was received from a registered nurse concerning a 67 year old female with no pertinent medical history and drug reactions/allergies who on 12-DEC-2012 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 intramuscular in left arm (lot number H014196, expiration date 19-MAR-2014). No other co-suspects were reported. No concomitant medications were reported. On 13-DEC-2012, the patient experienced from the injection site of the upper left arm to the elbow: redness, swelling and discomfort. The patient was seen by the physician on 13-DEC-2012 and sent home to ice the area, and take TYLENOL and to call the office if the reaction was worse. The patient's daughter called the office the next day on 14-DEC-2012 and stated that the left arm of the patient was worse. The patient's daughter was instructed to take the patient to the emergency room. (It was not reported if the patient was taken.) At the time of the report, the patient's outcome was not provided. Additional information has been requested.
Menstruation began the next day after the vaccine was administered. It was 2 weeks early.; Period was extremely heavy/It lasted for 14 days; Headache; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: BP7533) via an unspecified route of administration in the left arm on 03Apr2021 at 10:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid cancer on 2006 and unknown if ongoing. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included birth control pills (MANUFACTURER UNKNOWN) taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 10:00, the next day after the vaccination, the patient experienced menstruation which was 2 weeks early. Her cycle was regulated by birth control pills so it was always regular where vaccine started her period the way the placebo pill does on her birth control pills. Her period was extremely heavy and never had heavy bleeding prior to the vaccine. It lasted for 14 days whereas her regular period was light and lasts 3-4 days. She had a headache for 7 days and 7th day her headache was so extreme that she was about to go to the Emergency Room but she was worried about the costs of the ER so she didn't go. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event menstruation began the next day after the vaccine was administered and 2 weeks early and extremely heavy period was recovered on 18Apr2021. The clinical outcome of the event headache was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
I couldn't breathe, I got breathing issue; Chills real bad; Real bad headache like almost a migraine headache; Real bad headache like almost a migraine headache; My body really achy, and it was shaky for a good half hour; My body really achy, and it was shaky for a good half hour; Booster; I am still weak; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 11:00 (Lot number: FJ8762) at the age of 65 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "I am taking heart medication" (unspecified if ongoing); "breathing" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 11:00, outcome "unknown", described as "Booster"; DYSPNOEA (non-serious) with onset 10Dec2021 08:15, outcome "unknown", described as "I couldn't breathe, I got breathing issue"; CHILLS (non-serious) with onset 09Dec2021 17:30, outcome "not recovered", described as "Chills real bad"; HEADACHE (non-serious), MIGRAINE (non-serious) all with onset 09Dec2021 17:30, outcome "unknown" and all described as "Real bad headache like almost a migraine headache"; PAIN (non-serious), TREMOR (non-serious) all with onset 09Dec2021 17:30, outcome "unknown" and all described as "My body really achy, and it was shaky for a good half hour"; ASTHENIA (non-serious) with onset Dec2021, outcome "not recovered", described as "I am still weak". Therapeutic measures were taken as a result of dyspnoea, pain.  Additional information: The patient took rescue inhaler for breathing issue eventually it got better and the patient could breath. The patient takes heart medication, medication for arthritis and also medication for their breathing. Patient was staying home and resting .   No follow-up attempts are possible. No further information is expected.
Fever became 105.7 within 41 hours of shot fever (lowered) lasted a total of 3 days. Febrile seizures began with fever 33 hours after shot and repeated several times over next 2 days.
patient started feeling adverse effects on 3/7/2021, day after vaccination. She reports being nauseous, appetite loss, fatigue, no fever and having diarrhea. She had the corona virus 19 in November and was hospitalized. We recommended to take loperamide for the diarrhea or Pepto-bismol  and emetrol or nauzene for nausea. She wanted to  go to urgent care which we said is a good idea.
GENERALIZED URTICARIA (EVERYWHERE EXCEPT FEET) DAY FOLLOWING VACCINATION WITH MODERNA VACCINE, FIRST DOSE. LASTED 4 DAYS . TOOK BENADRYL FOR  ITCHING.
Patient received Moderna first and was fine. I administered Adacel second and right after she tells me that she has a history of passing out from shots. She was sitting in a chair at the time of vaccination. She said she felt like she was going to pass out and slumped back in the chair and was out for about 30 seconds. She came to, and felt lightheaded for about 15 minutes, then she was ok. I stayed with her and gave her a bottle of water. Her husband was with us too.
Pain in right leg lasting 8 days and skin postules (also on right leg) that are not yet healed.
This case was received from a health care professional, via another manufacturer (reference number WAES 0906USA00846), on 25 August 2009. The following is verbatim from that report: "Initial and follow-up information has been received from a nurse practitioner concerning her daughter, a 18 year old female student who on 06-MAR-2009 was vaccinated with her first dose of GARDASIL, 0.5 ml, intramuscularly into her right deltoid (LOT# 661703/0651X) at 10:40 am." "On 03-MAR-2009, the patient was vaccinated with her third dose of VARIVAX (Lot: 659845/0270X) intramuscularly into her right deltoid at 15:00 pm and with her first dose of MENACTRA (lot # U2669AA) intramuscularly into her left deltoid at 15:00 pm. Concomitant therapy included an unspecified birth control pill." "Subsequently the patient had an "allergic reaction, where you could write on her skin with a pen and still see it 3 hours later". However it was not specified if she meant that she could still saw ink on her skin 3 hours later or if she could still saw the indentation on her skin 3 hours later. The reporter's daughter also experienced joint pain. The nurse practitioner said that her daughter's allergist thought that it was an allergic reaction to MENACTRA (manufacturer unspecified). At the time of reporting the patient's present status was unknown." "Additional information has been received from the medical assistant and provided the following additional details:" "The patient has a past medical history of acne, no known drug allergies." "The exact AE onset date is unknown, but the chart notes show an ER visit on approximately 22-MAR-2009. The patient went into the office on 23-MAR-2009 for blood work (values mostly within normal limits; WBC slightly elevated). The patient was treated with a MEDROL dose pack and BENADRYL. The medical assistant couldn't say if the events were disabling or life threatening. The patient's status was unknown." "The health care professional contacted during telephone follow up could not supply the following information: date of event and recovery status." "Additional information has been received from the nurse practitioner who reported that the adverse events onset date was on 15-MAR-2009, the conditions were diagnosed on approximately 01-MAY-2009 by the physician as "serum sickness and dermographism probably due to MENACTRA". The nurse practitioner reported that the conditions were not life threatening but joint pain was disabling (The patient missed a week of work): currently the patient is being treated with H2 blockers and antihistamines, she was recovering (the nurse reporter that the physician stated that the full recovery would take about six months)." "Follow-up information has been received which reported that the patient with focal seizures experienced joint pain, dermographism and serum sickness on 22-MAR-2009. The outcome of the patient was not reported but she was still taking meds." "No further information is available." Documents held by sender: None.