chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lost baby; This is a spontaneous report from a Pfizer-Sponsored Program via Regulatory Authority with Support from a non-contactable consumer. The reporter reported three same cases. This is one the three cases. A pregnant female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, lot/batch number unknown) via an unspecified route of administration as a single dose, on an unspecified date, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had lost her baby after receiving the covid-19 vaccine. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101200160 Same reporter/drug/event, different patients.;US-PFIZER INC-202101200080 Same reporter/drug/event, different patients.
sick; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via social media.  This case involves a patient of unknown age who got sick (illness), while received INFLUENZA VACCINE.  The patient's past vaccination included influenza vaccine as prophylactic vaccination.  The patient's medical history, past medical treatments, concomitant therapy, and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness) (unknown latency; non-serious) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on lot number for this case.
Aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches) and FATIGUE (Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012AZ1A) 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced PAIN (Aches) and FATIGUE (Fatigue). At the time of the report, PAIN (Aches) and FATIGUE (Fatigue) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Concomitant medications was not provided by the reporter. Treatment information was not provided.
Given 3 shots: Cried vigorously after first 2 shots, furious , then held by mother after third shot: cried then "stopped breathing" . Child grunting, diaphoretic, pale, eyes glossy , deviated to left around 60 seconds, them somnolence , felt to be vasovagal reaction after third shot.
Information has been received from a physician concerning a female who was vaccinated with GARDASIL. The patient experienced headache after vaccination. On an unspecified date the patient recovered from headache. The patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report was received from a nurse and refers to a multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies, and concomitant therapy were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of VARIVAX lot # M047661, expiration date 02-DEC-2018 (dose and route of administration were not reported) for prophylaxis. The administered doses of vaccines were exposed to a temperature in the range 15 Fahrenheit degrees to 46 Fahrenheit degrees for an undetermined amount of time and then stored at "room temperature" for 1 week. It was unknown if there were previous temperature excursions. Data logger was involved. No adverse effects were reported. Additional information has been requested.
Medical assistant is reporting that a 16 year old patient received PROQUAD.; This spontaneous report was received from a medical assistant, referring to a 16-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 21-AUG-2020, at the age of 16-year-old, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number S035107, had been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, and expiration date 03-MAY-2021) as prophylaxis (product administered to patient of inappropriate age).
Vaccine administered at 11am. By 11:30am, I was severely nauseous. Abdominal cramping. Nausea until 2:30pm. By 3:30pm, head ache, body aches, chills, joint paint, fatigue, fever of 100.8 By 6:00pm, my hands and feet became red, swollen, and hot. Rash on my legs. Racing heart rate of 115bpm. Continued body aches and joint pain. No more fever. By 9:30pm, 25mg Benadryl taken. By 10:30pm, redness and swelling reduced, heart rate decreases to 85bpm. 06/05/2021: diarrhea and continued fatigue and body aches, residual swelling of extremities. Currently, it?s 6/10/2021, and fatigue and body aches/joint pain are continuing.
PN 12/15/2004 late PM patient complained of pain, swelling, and redness at injection site (right deltoid).  Mother reported area hot to touch.  Gave tylenol.  Mother stated she is a nurse and felt like it is a localized reaction.  On 12/16/2004 Mother received a phone call from school nurse regarding right deltoid.  Nurse told her it was as big as a baseball.  Mother took her to see the doctor.  Dr. stated to mother it was a sterile abscess vs localized reaction - Keflex for 5 days.
Moderna COVID-19 Vaccine EUA Mild itch at injection site at night.  The following morning noted very red circular area on skin around the injection site ( about 3 inches).  This progressed to larger area until most of outer upper arm was involved over next 2 days.  This was unexpected since it has been 11 days since receiving vaccine.  As of today the redness is less pronounced and will hopefully go away.
Patient received covid vaccine and instructed to sit in waiting area near the pharmacy for 15 minutes. Patient ambulated to waiting area and sat down. Approximately 2 minutes later a customer walked in and stated " That man is having a reaction". As this nurse walked over, this patient could be seen grimacing and moaning in pain. Patients Right hand noted to be over his chest area. Per patient statement " I am having severe muscle spasms. They hurt so bad" BP 184/98 HR 73.  Muscle Spasms and grimacing continued. 911 Called and Squad arrived to pharmacy area. Patient taken to Truck. No further info regarding ED visit.
This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Developed a pulmonary embolism) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PULMONARY EMBOLISM (Developed a pulmonary embolism) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Developed a pulmonary embolism) outcome was unknown. Not Provided   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications and treatment details were not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I started to have a very strong headache and sore throat. These symptoms made me feel that I should test myself for COVID-19. I performed an at home test and it came back positive. I contacted my physician, and they suggested that I stay home and isolate. I was not given any medication to assist with the virus. I just used TYLENOL and ibuprofen to help with the symptoms.
1-24-07 arm pain 3-15-07 c/o pain an swelling, hot, red, swelling
eye problems; slight sensation in the ears; sore arm; fever; This spontaneous case was reported by a patient and describes the occurrence of EYE DISORDER (eye problems), EAR DISCOMFORT (slight sensation in the ears), PAIN IN EXTREMITY (sore arm) and PYREXIA (fever) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CRATAEGUS LAEVIGATA, MAGNESIUM CITRATE, PLECTRANTHUS HADIENSIS, THEANINE, THEOBROMA CACAO (HIGH BLOOD PRESSURURE) and DICLOFENAC SODIUM (ANTI-INFLAMMATORY) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced EYE DISORDER (eye problems), EAR DISCOMFORT (slight sensation in the ears), PAIN IN EXTREMITY (sore arm) and PYREXIA (fever). At the time of the report, EYE DISORDER (eye problems), EAR DISCOMFORT (slight sensation in the ears), PAIN IN EXTREMITY (sore arm) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.
Pt rec'd Recombivax vax that night experienced transient lip swelling & hives;
An intermittent pain in her inner left lower leg/receiving the second Pfizer Covid 19 Vaccine the pain started back intermittently; Muscle pain; I have had my second shot I am still having the peculiar pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 19Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), administration date: 28Mar2021, for Covid-19 immunization, reaction(s): "Intermittent pain in her inner left lower leg". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "An intermittent pain in her inner left lower leg/receiving the second Pfizer Covid 19 Vaccine the pain started back intermittently"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; PAIN (non-serious), outcome "unknown", described as "I have had my second shot I am still having the peculiar pain".  No follow-up attempts are possible. No further information is expected.
swelling of the left arm, lymph nodes in arm and neck on the left side started within 60 mins. Woke up in the middle of the first night with extreme arthritis type pain in all of my upper joints. such as shoulders, elbows, wrists, neck, back and hips. The arthritis like pain continued in all of my upper joints in different locations for the next 6 days. On Monday Jan 4th when I woke up I had extreme vision issues in my right eye for about 6 hours.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 30th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st July 2018, 1 days after receiving SHINGRIX, the patient experienced injection site swelling. On 2nd July 2018, the patient experienced injection site warmth and injection site erythema. On 7th July 2018, the outcome of the injection site swelling, injection site warmth and injection site erythema were recovered/resolved. The reporter considered the injection site swelling, injection site warmth and injection site erythema to be probably related to SHINGRIX. Additional details were reported as follows: At 13:00, the patient received Shingrix in the left deltoid. Two days after vaccination, the patient's injection site was hot and red. The injection site red, swollen and hot lasted for about a week and recovered 100 per cent.
Pt recvd vax & exp nausea that resolved during that day ; pt indicate had eaten full day old broccoli, which questioned may have been the cause; pos may be pregnant;
While injecting the vaccine dose into left deltoid with a needle and luer lock syringe, vaccine sprayed out of connection point instead of going through the needle into the intermuscular space. Spoke with clinic supervisor to advise on further action. As it could not be verified that patient received over half of the dose, it was recommended that patient receive full dose in opposite arm. Patient then received full 0.5ml dose  of Moderna vaccine in right deltoid.
7/17--7/20 52y.o. female who presented with RLQ abdominal pain and was found to have acute appendicitis with cecal involvement. Given higher risk of need for bowel resection she was nonoperatively managed. She was incidentally COVID positive and did have symptoms of congestion. She was admitted on IV abx and abdominal pain, nausea, and emesis improved over the next several days. Diet was advanced. Pain was controlled on PO medications. Patient was passing flatus and ambulating. The patient was deemed stable for discharge on hospital day 3 plan to complete a course of PO abx with interval colonoscopy prior to elective appendectomy.
Parent called on 04/23/2002 to report onset of mild, generalized rash that is light red and fine. The pt is afebrile, eating well and does not appear bothered at all by the rash. Non-itching. No treatment other than Tylenol that has been previously given after vaccinations.
After about 3 hours (around noon) I began to feel like I was coming down with a cold and fever. By 4PM I had chills and body aches. By 8 pm I took my temperature and it was a low grade 99.8. Through the remainder of the night the chills worsened to the point where I was shaking uncontrollably and I could not get warm. I was also very dizzy. The next day (2/26/21) was more of the same along with a very painful headache and muscle aches especially in my shoulders and neck. That night all of those symptoms continued along with very sharp stabbing pains in my left leg above the knee cap. The dizziness also continued and I nearly passed out trying to get out of bed early in the morning. My fever had increased to 100.5 at the highest. I was also very weak by the end of the day on 2/26/21. On 2/27/21 I was beginning to feel a bit better but still had that low grade fever (now about 99.8) a headache and I remained very weak. The weakness was especially evident in my legs - it was very hard to stand up. It is now 2/28/21 and I am feeling nearly 100% myself again.   From all I had read and understood I was expecting to have a reaction to the 2nd vaccine. I did not consider any of this life threatening nor necessary to call my PCP. Still, I wanted to report these reactions as it is my understanding the adverse reactions to the 2nd vaccination are common in people much younger than me.
Information has been received from a physician concerning her 7 year old white son with no past medical history and no known drug allergies who on 09/13/96 was vaccinated with a first dose of varicella virus vaccine live (Lot # 616497/0416E). There was no illness at the time of vaccination. Concomitant therapy that day included a first dose of MMRII (Lot # 618391/0890D). Subsequently, the pt developed "breakthrough disease" with 150 lesions and "no fever". It was noted that the child had to stay home from school. Follow up information received from a physician indicated that the child was immunized for chickenpox and developed chickenpox (approximately 100 lesions) on 11/16/03 at 8:00AM.  The outcome was reported as recovered on 11/21/03.  No relevant diagnostic tests or lab data were obtained. There were no adverse events following prior vaccinations of the pt.  The physician also mentioned the pt's sibling (WAES # 0312USA01108) and one other child (WAES # 0312USA00828) experienced similar reactions. No further information is expected.
Beginning in October my asthma became worse. I spoke to my allergist in November that I was having to use my emergency inhaler more often. I saw my allergist on November 15th, and they gave me a nebulizer due to an asthma attack. I was seen in the urgent care center for asthma attack I was given prednisone and a different inhaler. I was diagnosed with pneumonia. I saw my doctor via virtual visit, and they prescribed more prednisone due to uncontrollable asthma attacks. As of now I have used my rescue inhaler and nebulizer nonstop for almost a few months. I am now just starting to feel like I do not need to use it all the time. I did not test positive for COVID19 on time in that span of time.
Vomiting, vision impairment (read very slow to me), and seizure(s). Rushed to ER in ambulance. Was put on a ventilator (sedation). Received a CT scan showing a CVST and hemorrhaging in her right temporal lobe.  Life-Lined to Hospital. Wore an EEG on her head to monitor seizure activity for 4-5 days. Was put on 4 types of seizure medication and blood thinner for the clot. Did another CT scan which showed her Mid-Line shift was pushing into the left side of the brain by 15mm. Discharged from Hospital on 3/27/21 to Rehabilitation Hospital. She was discharged to home with a caregiver on 4/16/21. She will continue outpatient therapy at the rehabilitation hospital. She will see Speech, Vision, PT, and OT every week until further notice.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 69-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.
pt admitted to hospital; found to be positive for COVID 7 days prior; presents to hosp with increasing SOB, fever, joint pains, diarrhea; O2 supplementation via NC and face mask, O2 sats between 70 - 80 % depending on exertion); worsening renal function; worsening O2 requirements; required intubation with mechanical vent; placed on antibiotics and steroids; pt's condition worsened and she died in the ICU
This spontaneous report was received on 12-DEC-2014 from market research (research hub project # 14-1133). On an unknown date a patient (age, gender not reported) was vaccinated with ZOSTAVAX. The reporter reported, "I had a patient that got shingles from the shingles vaccine." The outcome of shingles is unknown. Additional information has been requested.
I HAD TYPICAL SIDE EFFECTS FROM THE VACCINE THE DAY FOLLOWING THE VACCINE:  ARM SORENESS, SLIGHT FEVER, FATIGUE.  HOWEVER, AT 11:49AM MY HEART RATE SHOT UP TO 161 BEATS PER MINUTE.  I WAS JUST STANDING IN MY KITCHEN NOT DOING ANYTHING, NO EXERTION.  IT IMMEDIATELY WENT BACK DOWN.  IT WAS VERY STRANGE.  IT HAS SEEMED FINE SINCE THEN AND I DID NOT GO IN TO THE DOCTOR.
Mom stated "10 minutes p/vax was given, pt looked glassy-eyed & could not hold head up; This lasted about 30 minutes; There were no other side effects & pt was fine;
Lt. thigh with 5 X 5 cm erythema distal to injection site, 0 tx at this time.
sore arm for a couple days/ more so than with a flu shot; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient had sore arm with a flu shot. This case had been linked with US2021AMR025675, US2021025175 and US2021025187 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021025175:same reporter US-GLAXOSMITHKLINE-US2021AMR025675:same reporter US-GLAXOSMITHKLINE-US2021025187:same reporter
Feeling tired,swelling under armpit the size of a chicken egg after first dose Feeling weak, dizzy, throwing up for 1.5 weeks after second dose. Had to seek medical.  Dose should've been according to weight, not adult After Moderna booster I passed out the next morning. Had to cancel work for 2 days
Arm was red and warm to touch. Later it turned itchy. With my advice pt finally went to the doctor after over 2 week was doctor said it was cellulitis. Doctor prescribed KEFLEX 500 mg twice a day for 7 days.