chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got the shot and 4 days later he dies; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Got the shot and 4 days later he dies) in an adolescent male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication information was provided. It was reported that patient age was 12 or 13 years. No treatment medications were provided  Company Comment: This is a Spontaneous case concerning an adolescent male patient, with no medical history reported, who experienced the unexpected event of Death. The event occurred 4 days after an unspecified dose of mRNA-1273 vaccine. It is unknown if an autopsy was performed. The cause of death was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning an adolescent male patient, with no medical history reported, who experienced the unexpected event of Death. The event occurred 4 days after an unspecified dose of mRNA-1273 vaccine. It is unknown if an autopsy was performed. The cause of death was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Got the shot and 4 days later he dies
Initial and follow-up information has been received from the Merck Pregnancy Registry via a registered nurse concerning an 18 year old white female with a urinary tract infection and a previous full term delivery who on 23-MAR-2007 was vaccinated with a first dose of GARDASIL (Lot #657006/0188U). On 22-MAY-2007 the patient was vaccinated intramuscularly with a 0.5 ml second dose of GARDASIL (Lot #657006/0188U) On 10-JUL-2007, the patient began therapy with prenatal vitamins (unspecified). On 17-AUG-2007, the patient was vaccinated with a third dose of GARDASIL (Lot #658556/1060U). Subsequently, the patient was 10 weeks pregnant when she received the last dose of GARDASIL. The patient's last menstrual period was in May of 2007 and the estimated date of delivery will be on 07-MAR-2008. On 12-JUL-2007, the patient was seen in the office and an early obstetrical ultrasound revealed the gestational age to be 5 weeks and 6 days. The patient was going to have an amniocentesis. On 05-MAR-2008, the child was delivered via cesarean section (indication not reported). Upon internal review, child was delivered via cesarean section was considered to be an other important medical event. Additional information has been requested.
Seemingly high susceptibility to respiratory infection.  Historically, I have not had back to back respiratory conditions.  Twice since the injections I have experienced a prolonged respiratory infection with symptoms lasting well over one month.  Uncommon fatigue and heavy chest.  Significant head congestion without runny nose or perceivable "drainage".    I am currently sick with a respiratory infection that has gone on for appx. 6 weeks with heavy symptoms recently (i.e. bed ridden, extreme difficulty breathing, heavy congestion, etc.)
Vasovagal syncope.  Had vaccine on the 17th on the 25th in the early morning hours I got out of my bed, passed out or had a seizure in my kitchen.  Went to doctor 4 days later because I was in pain mainly in feet, was told I broke my foot.  I asked if vaccine could have caused it and was blown off by 3 different healthcare providers, I thought by law they were supposed t report adverse effects like this.
About 6 pm my arm (at the injection site from 8 days ago) started itching.  The site is red, hard, slightly swollen, quite itchy...about 1 inch around at this time.  'Covid arm'.....as it were - somewhat mild but noteworthy.  Odd, after a week.  Hoping it doesn't get worse....
Developed diptonia in neck and back several hours after getting Menactra vaccine. He has given IV Benadryl in ER and reaction stopped. He is also taking Seroquel and Trileptal.
I had the vaccine and got Shingles/Suspected vaccination failure; I had the vaccine and got Shingles; COVID; worst pain; pain in my back is still there; headache; nausea; electrical shock type feelings; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, covid-19, pain, back pain, headache, nausea and electric shock sensation. On an unknown date, the outcome of the vaccination failure, shingles, covid-19, pain, headache and nausea were unknown and the outcome of the back pain and electric shock sensation were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, covid-19, pain, back pain, headache, nausea and electric shock sensation to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-JUL-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient had the Shingles vaccine before Covid and he/she still got Shingles.  The patient said it was the worst pain, headache and nausea ever felt. The shingles were dried up but the pain in his/her back was still there and still had electrical shock type feelings throughout his/her body daily. Additional Supportive Information: This case was considered as suspected vaccination failure as the details regarding completion of primary vaccination, time to onset and laboratory confirmation for shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Information has been received from a nurse concerning a 28 year old female with an allergy to aspirin who in approximately May 2007 (about a month ago), was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). In approximately May 2007 (about a month ago), the patient experienced itching, redness, swelling and hardness around the area of injection on her right arm after her first dose of varicella virus vaccine live (Oka/Merck). The symptoms returned yesterday after the patient received the second dose of varicella virus vaccine live (Oka/Merck). At the time of the report the patient had not recovered from the itching, redness, swelling and hardness around the area of injection on her right arm. The patient sought unspecified medical attention. Additional information has been requested.
Extreme headache, nausua, vomitting, muscle spasms, muscle pain twitching, pain in spine, every day muscle spasms and muscle stiffness is worsening.  Short of breath and dizzy - chest pressure.  Called doctor today and he presribed phenegrim and instructed me to take tylenol and call back if I don't improve.  I continue to feel awful and not well. I'm very concerend for my health
PATIENT CAME BY CLINIC TODAY. STATES VACCINE WAS GIVEN 1/12/2021 LEFT DELTOID. STATES NOTICED REDNESS 1/23/2021. SAW PCP 1/26/2021 AND HE DID BLOOD WORK AND STARTED ANTIBIOTICS 1/26/2021. TO RETURN TO MD 1/29/2021. STATES ARM STILL RED. MD DREW CIRCLE AROUND SITE TO EVALUATE.
severe pain  from left wrist to left mandible and down to left hip most heavily concentrated in the left shoulder and chest region, with accompanying stiff neck and reduced mobility of the neck rapid onset after post vaccination fever broke.  pain and neck rigidity lasted ~72 hours. Reduced neck  mobility still present 1 and a half months later.
Patient received vaccine on a Thursday. By Monday she said she was going upstairs and felt very foggy or something obstructing her visual field.  She felt very run down and ended up taking of the rest of the week from work as she didn't feel good. She spoke to her doctor who referred her to neurologists for scans. Patient was afraid of a stroke.  She is still doing follow ups due to this. She believes it is from the vaccine as she looked online and found ocular issues a problem  so decided to come in today (11/15/22) to ask what she should be doing to get it reported.
Extremely sore at injection site (swollen & hot to touch) still lasting after 4 days. Chilled & shivering about 7 hours after injection. Headache 7 hours after injection, lasting for about 12 hours-improved with Ibuprofen. Tired & a little achy the day after injection, lasting for about 24 hours. Injection site became a little itchy on 3rd & 4th day.  Do not know if the following is attributed to the vaccine - cold sore developed on lip on day 3, very painful. Inside of mouth became sore in several spots. (I rarely have cold sores)
Pt recv vax on 11/19/98; on same day pt exp red/ inflamed vax area-LA; tx=Ibuprofen &ice
Keeps awake at night; Progressing down arm; Injection site hot; Injection site is itchy; Injection site swollen; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Keeps awake at night), CONDITION AGGRAVATED (Progressing down arm), VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site is itchy) and VACCINATION SITE SWELLING (Injection site swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0031321V) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site is itchy) and VACCINATION SITE SWELLING (Injection site swollen). On an unknown date, the patient experienced INSOMNIA (Keeps awake at night) and CONDITION AGGRAVATED (Progressing down arm). At the time of the report, INSOMNIA (Keeps awake at night), CONDITION AGGRAVATED (Progressing down arm), VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site is itchy) and VACCINATION SITE SWELLING (Injection site swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Administered to patient after temperature excursion; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number 5295P, expiry date 27th December 2022) for prophylaxis.   On 1st August 2022, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 4-Aug -2022 Reporter's comment: Medical assistant called in to report a temperature excursion for Engerix B that was administered to the patient.  The reporter stated that the product had a temperature excursion with a lowest temperature of 35.9 degree Fahrenheit  for 40 minutes on 18th July 2022.  The reporter consented to follow up. Additional supportive information: Engerix B had a temperature excursion with a lowest temperature of 35.9 degree Fahrenheit  for 40 minutes, which led to Incorrect storage of drug.; Sender's Comments:  US-GSK-US2022AMR115355:Same reporter
Information has been received from a registered nurse concerning a 22 year old female with a history of migraine and anaemia and no known drug allergies/reactions reported who on 12-MAY-2008 was vaccinated with the first dose GARDSIL (lot # 657006/0188U), 0.5 mL, IM. On 23-JUL-2008, the patient was vaccinated with a second dose of GARDASIL (lot # 657737/0522U), 0.5 mL, IM. A urine pregnancy test on 13-AUG-2008 was negative and on 11-SEP-2008 a urine pregnancy test was positive (LMP: 04-AUG-2008, estimated delivery date: 12-MAY-2009). The patient sought medical attention in the office. Follow-up information has been received from a nurse who reported that the patient experienced "severe" headaches during the pregnancy but she did not know the status of those headaches at the time of reporting. It was unknown if the patient sought medical attention. On an unspecified date, the patient delivered her baby. The baby was healthy and normal. No further information is available.
On Dec 23rd I woke up with a full body red itchy rash and severe HA.  I was at times during the day dizzy, fatigued and had tinnitus.  I had just begun the spironolactone and bactrim 8 days prior.  I took 50 mg of benadryl in the AM and some ibuprofen which did not really help.  On the 23rd I d/ced the spironolactone thinking that was the cause of the reaction.  The next day on the 24th I took the bactrim in the AM and the rash got worse afterwards.  I then had diarrhea, extreme muscle aches and fatigue in addition to a severe HA.  I did a virtual appt and also d/ced the bactrim.  I was prescibed montekulast and prednisone but did not fill either presciption or take due to fear it would interfere with the vaccine.  The following day on the 26th my symptoms resolved after stopping both meds.  The doctor I saw advised that I report these symptoms.
worsening bilateral infraorbital perioral edema; worsening bilateral infraorbital perioral edema; generalized myalgias; fever of 101.6F; A spontaneous report was received from a literature article  regarding, a 36-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Circumoral edema, Orbital Edema, myalgia, and fever/pyrexia.  The patient's medical history was not included, other than that she was considered a healthy female. Concomitant medications known to have been used by the patient were not included.  In November 2019, prior to the vaccination, the patient received hyaluronic acid injections in the tear troughs and in both the upper and lower lip.  On 05 Jan 2021, prior to the onset of the events, the patient received the first of two doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.    On 05 Jan 2021, about 12 hours after the vaccine was administered, the patient presented with a fever of 101.6 Fahrenheit and had generalized myalgia. Treatment included acetaminophen.   On 06 Jan 2021, the fever and myalgia were resolved. As the day continued, the patient noticed pain and swelling in the right tear trough and increasing swelling around her mouth.   On 07 Jan 2021, approximately 36 hours after vaccination, the patient was administered 10 mg of cetirizine. At 48 hours the patient reported that the swelling was at it's peak and she was unable to open her right eye. The patient then took 20 milligrams of cetirizine. Throughout the morning, the left tear trough began to increase, and the rest of her face remained persistently swollen. The patient was administered 5mg lisinopril. Within about 5 hours of dose of lisinopril, the patient reported that swelling had stopped and was decreasing. Over the next 24 hours, edema was improved, and patient returned to baseline.  Action taken with mRNA-1273 was not provided.  The outcome of the events, circumoral edema, periorbital edema, myalgia and fever, was considered resolved.; Reporter'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.
Migraine; Allergies; Rashes; Lower back pain; Dizziness; Vomited; Severe headache; Numbed left arm; Muscle spasm on the neck; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbed left arm), MUSCLE SPASMS (Muscle spasm on the neck), BACK PAIN (Lower back pain), DIZZINESS (Dizziness) and MIGRAINE (Migraine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced HYPOAESTHESIA (Numbed left arm), MUSCLE SPASMS (Muscle spasm on the neck), MYALGIA (Soreness) and HEADACHE (Severe headache). On 03-Apr-2021, the patient experienced BACK PAIN (Lower back pain), DIZZINESS (Dizziness) and VOMITING (Vomited). On an unknown date, the patient experienced MIGRAINE (Migraine), ALLERGY TO VACCINE (Allergies) and RASH (Rashes). At the time of the report, HYPOAESTHESIA (Numbed left arm), MUSCLE SPASMS (Muscle spasm on the neck), BACK PAIN (Lower back pain), ALLERGY TO VACCINE (Allergies), RASH (Rashes), MYALGIA (Soreness), VOMITING (Vomited) and HEADACHE (Severe headache) outcome was unknown and DIZZINESS (Dizziness) and MIGRAINE (Migraine) had not resolved.            Concomitant product use was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received included reporter details and new adverse events.
Expired vaccine. No temperature excursion occurred. Moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration." No reported adverse reactions.
allergic reaction; arm got red; Rash was about the palm of my hand, not sore but very itchy; Initial information was received on 16-Nov-2021 regarding an unsolicited valid non-serious case received from a non-healthcare professional (patient) via social media (under reference number: US-SA-SAC20211122001377).  This case involves a patient of (unknown demographics) who experienced allergic reaction (hypersensitivity), arm got red (erythema), rash was about the palm of hand, not sore but very itchy (rash pruritic) when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication 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 an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious allergic reaction (hypersensitivity), arm got red (erythema), rash was about the palm of hand, not sore but very itchy (rash pruritic) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Over the hill, shots were much stronger."  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the outcome was unknown for all the events.  There will be no information available on the batch number for this case.
This spontaneous report as received from a physician via Company Representative refers to a 6 month old female patient. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with ROTATEQ third dose, lot #K023535, expiration date 22-MAY-2016 (dos was not reported). On an unknown date, the patient developed blood in the stool and experienced diarrhoea for 2 weeks straight. The patient was taken to the emergency room (unknown if the patient was admitted). Medical attention was sought in a doctor's office. No adverse effect were reported with the first 2 doses of the vaccine. The outcome of haematochezia and diarrhoea was reported as recovering. The relatedness between the events and ROTATEQ was not reported. Additional information has been requested.
My first menstrual period following the vaccine was 10/4 and it was normal. My second period was almost nonexistent- some spotting for approximately two days.
Shortness of breath developing over 7-10 days after the Pfizer injection, then extreme congestion, sneezing, and trouble breathing on Oct. 12.
Severe pain at injection site day of Delayed pain at injection site 12 days later, with migraine
Patient received vaccine and was asked to wait for twenty minutes (in the waiting room) and be checked before leaving.  She went out to the waiting room and went up to the front desk to schedule her next dose. She felt "not right", then she said "everything went black". She fell to the floor and hit the back of her head on the lobby door.  She immediately regained consciousness and was assisted into a wheelchair, taken to the bed in the observation room.  Blood pressure was 136/74, pulse 76.  She was given Gatorade to sip. Dr. examined the back of her head. Patient rested and sipped three boxes of Gatorade until about 11:30AM.  Then she was assisted to sitting up in bed. Given ibuprofen 600 mg for the bump on her head and an ice pack to apply.  Discharged feeling "fine" at 12:15PM.
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 63-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in March 2018). On 25th March 2019, the patient received the 2nd dose of SHINGRIX. On 26th March 2019, 1 days after receiving SHINGRIX, the patient experienced tiredness. On an unknown date, the patient experienced product supply issue. On 27th March 2019, the outcome of the tiredness was recovered/resolved. On an unknown date, the outcome of the product supply issue was unknown. It was unknown if the reporter considered the tiredness to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient's wife. After receiving 1st dose of SHINGRIX, the patient was unable to find the 2nd dose available 2 to 6 months later. The patient found 2nd dose of SHINGRIX 1 year later from 1st dose. The patient was confirming that if it was fine to receive 2nd dose too long after 1st dose. After receiving 2nd dose of SHINGRIX, the patient experienced tiredness the next day and the event resolved after 1 day. The reporter consented to follow up. This case has been linked with case US2019GSK057807 and US2019058160, reported by for patient's wife.
First 3 days (72 hrs) I had severe flu symptoms, the following week to 10 days after the dose, fatigue and malaise.  At day 9 following dose (May 9) and since, there has been redness and swelling of mouth and tongue, bleeding during toothbrushing, painful tongue (like a burn from hot liquid) and excessive dryness of the lips causing splitting and peeling, diminished feeling in the inside of the mouth (no diminished feeling on tongue), and loss of taste.
This spontaneous report as received from a consumer refers her a 79 years old mother with colon cancer, chronic obstructive pulmonary disease (COPD), diabetic and allergy to penicillin. The patient was vaccinated with a dose of PNUEMOVAX 23 (lot # reported as 0225AE, Expiration date 2013)(dose and route not reported) on 01-JUN-2012. Other suspect therapies included PLAVIX, budesonide, SYMBICORT and "CLONOPAN". The consumer stated on 01-JUN-2012, her mother developed cellulitis down her arm that was injected with PNEUMOVAX 23. Her arm became swollen and red, she also had to be hospitalized, because her chronic obstructive pulmonary disease (COPD) became worse. Unspecified antibiotics were given as a treatment for adverse events. On unknown date lab diagnostics studies were performed -"blood work, computed tomography (CT scan)". On 17-JUL-2012 the patient recovered. Additional information has been requested.