chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stated going downhill; He died; Got a little sick,he stated going downhill; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (He died) in a male 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.     The patient's past medical history included Surgery (Bladder surgery on 25 Feb.).    On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced ILLNESS (Got a little sick,he stated going downhill). On an unknown date, the patient experienced FEELING ABNORMAL (Stated going downhill). The patient died on 26-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ILLNESS (Got a little sick,he stated going downhill) and FEELING ABNORMAL (Stated going downhill) outcome was unknown.            Treatment and concomitant information was not provided by the reporter.  Patient had the modera shot on 16-Apr-2021 and he was recovering from a bladder surgery.  Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
I had a sore throat, headache, congestion, coughing, diffuculty breathing upon exerttion only.
Unconsolable crying - temperature 100.8 F rectal.  06/26/2008 MR received for DOS 5/19-21/2008 with D/C DX:  Irritability. Infant presented with fever, inconsolable crying and fussiness following vax. Admitted for sepsis w/u which was (-).
No adverse event; Patient had two Bivalent vaccines one in 12Sep2022 and the other today 03Apr2023; This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient had two Bivalent vaccines one in 12Sep2022 and the other today 03Apr2023) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Sinus congestion, Blood pressure high and Temperature intolerance (heat and cold temperature).   On 12-Sep-2022, 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 03-Apr-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (Patient had two Bivalent vaccines one in 12Sep2022 and the other today 03Apr2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient had two Bivalent vaccines one in 12Sep2022 and the other today 03Apr2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Patient had two Bivalent vaccines one in 12Sep2022 and the other today 03Apr2023).    No concomitant medication were reported. No treatment information was provided by the reporter.
Information has been received from a physician office concerning a male pt who in Aug 2006 was vaccinated with a dose of varicella zoster virus vaccine live. On 8/23/06 the physician reported that sometime this week, the pt was vaccinated and had an outbreak of chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
I knew 2 girls that didn't take their 2nd dose & died.; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (I knew 2 girls that didn't take their 2nd dose & died.) 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 an unknown date, the patient received first 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 medications were reported. No treatment medications were reported.  Company's comment: This is a spontaneous report concerning a female patient of unknown age and medical history. The reporter mentions that knew the patient and that she hadn't taken the second dose of the vaccine and died. The date of vaccination and manufacturer were not reported, nor was cause of death. No further information was disclosed. A query was raised requesting any information that can be provided to further elucidate this case.   This case was linked to MOD-2021-395669 (Patient Link).; Sender's Comments: This is a spontaneous report concerning a female patient of unknown age and medical history. The reporter mentions that knew the patient and that she hadn't taken the second dose of the vaccine and died. The date of vaccination and manufacturer were not reported, nor was cause of death. No further information was disclosed. A query was raised requesting any information that can be provided to further elucidate this case.; Reported Cause(s) of Death: Unknown cause of death
pt recv vax; 1 hr p/ vax, throbbing pain in arm,worsening w/ T 100-101;malaise; 2nd day erythema at inject site, 2cm induration, arm is tender;
Fever of 103 and chills. Chills was not listed on the vaccine information sheets for the shots my son received. Treated at home with tylenol. Chills were on and off between 0200 and 0700.
c/o pain & redness @ inj site x 3 days;observed redness, induration lt deltoid, advised to return in 2 days;seen again 13NOV97;area of redness, induration had inc in size, site;warm to touch, dx as rxn to either tetanus or diphtheria;
Information has been received from a physician concerning a 24 year old female patient with NKDA who on 01-DEC-2006 was vaccinated into the left deltoid with a first dose of Gardasil (yeast) (lot#653978/0955F). At the time of vaccination the patient had "mild URI symptoms and a cold" with no fevers. In the week following vaccination, the patient developed a temperature of 101.5 and her URI progressed to sinus congestion and cough. Additional information has been requested.
Fever 101, lasting 3 days Chills, lasting 3 days Fatigue, lasting 5 days Redness, soreness at injection side, lasting 13 days
Within four hours of receiving the Prevnar vaccine, my son has uncontrollable screaming, shaking/trembling-twitches, fever(which is normal), and a rash over the trunk area of his body/plus reddening of skin. He didn't sleep well for 24 hours after the shot. By 48 hours, all that remained was the skin rash which cleared within 96 hours.
Fever, Chills, Fatigue, Body aches, cold hands / feet even with the heater blasting. Duration of events: ~2 days.
SECOND DOSE OF SHINGRIX WAS GIVEN AFTER ONLY 28 DAYS - PATIENT EXPERIENCED SORE ARM AND GENERALIZED MALAISE
He had 2 seizures that following Monday, 08 Feb 2021 and another seizure on Friday, 12 Feb 2021.; discovered he had COVID; discovered he had COVID; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) at age of 61 years old as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient received his first dose of Pfizer's COVID vaccine on 06Feb2021. He had 2 seizures that following Monday, 08Feb2021 and another seizure on Friday, 12Feb2021. He also stated he discovered he had COVID. He was at the hospital for the seizures and diagnosed with Covid. He was due for the second dose which was supposed to be given the third week. He he spoke to the nurses there and they advised him not to do anything until after 90 days or something like that. He was told by the doctor that his second dose should be delayed until 30 to 90 days and heard from Department of Health that he had up to 42 days that he'll be ok. He stated that he just spoke to themDepartment of Health. He stated that they said after 40 or 42 some odd days, and there was an extra 7 days of leeway, he could get the second dose. He stated that his 42 days was up either today (24Mar2021) or yesterday (23Mar2021). He had an opportunity this Friday (26Mar2021) to get the second shot. He had to get the shot at the same location. He was tired of this. The patient stated when should he take the second shot? Should he wait the 90 days? He stated his primary said to see a neurologist, but he didn't see them until 05May2021 and the neurologist said they couldn't say anything because he was a new patient until they see him, so they say to go to his primary care. Dates for tested positive for covid after first dose of Covid Vaccine was unspecified. The outcome of events was unknown.  Information on the lot/batch number has been requested.
This case was reported by a consumer via call center representative and described the occurrence of swelling of feet in a 38-year-old female patient who received RABAVERT. Co-suspect products included HYPERRAB. Previously administered products included antibiotics (she had weird reaction to antibiotics). Concurrent medical conditions included rabies. On 1st December 2015, the patient received RABAVERT and HYPERRAB. On 1st December 2015, an unknown time after receiving RABAVERT, the patient experienced overdose. In December 2015, the patient experienced swelling of feet and dizziness. On an unknown date, the outcome of the swelling of feet, dizziness and overdose were unknown. It was unknown if the reporter considered the swelling of feet and dizziness to be related to RABAVERT. Additional details were received as follows: The reporter herself was the patient. The reporter had weird reaction to antibiotics. The reporter called to ask about rabies vaccine because she had rabies vaccines in emergency room due to being exposed to rabies. On 1st December 2015 (day before yesterday from reporting date), the patient received RABAVERT and HYPERRAB in the emergency room. The patient received 4 shots in total of rabies vaccine, which led to overdose. It was not clear how many doses of RABAVERT and how many doses of HYPERRAB were administered to patient. The reporter inquired about what could be the adverse events of both RABAVERT and HYPERRAB, and was informed that RABAVERT was divested to GlaxoSmithKline. She was told to contact the manufacturer of HYPERRAB for information about the same. In December 2015, less than a week after receiving RABAVERT and HYPERRAB the patient experienced feet swelled up twice the size, dizziness, could not feel her hand and did not know where she was. The patient did not know which medication caused her symptoms and is concerned about receiving more injections of these medications. Number was provided for GlaxoSmithKline, and attempted to connect the patient with a GlaxoSmithKline representative for assistance. The transfer could not take place as the message said that the GSK response center is temporarily closed and to call at a later time. The reporter was informed of this and told to call GlaxoSmithKline later. The reporter stated that she would like to find out if it was dangerous to continue with these rabies medications. The reporter was informed to contact her physician as her physician could advise her on her condition and treatments.
Severe headache with no remedy. Headache subsided  some over time but persists after months.
Redness measured 2.5 in x 2 in diameter around injection site. No pain. Hard to touch and warm. Site swollen. No fever. Symptoms started last night. Blistered and raised at site.
After receiving her 1st HPV, TDAP, Varicella and MCV4, patient asked if she could wait in waiting room for the 15 min time frame (post HPV shot protocol). I said yes. As she was walking out, someone yelled for me as pt became very clammy, pale, & started to faint.  (see attached for rest). Pt sat in chair nearby and put head btw her legs. Given juice.  Moved back to room with bed & had her wait 15 more minutes. Given more juice and crackers. Left at 1610 PM feeling & looking much better.
got the shots and still got shingles; got shingles on back and around the right side; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shots and still got shingles) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles on back and around the right side). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-Apr-2023 The patient reported this case via interactive digital media. The patient got the shots and still got shingles on his/her back and around the right side. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Ten minutes after vaccination, developed lightheadiness with cyclical symptoms.  Tingling in Left fingers.  Progressing to symptoms in Right hand.  Denies SOB/CP.  Observed by HCP.  0910: Member reports feeling okay but "sees stars".  No tunnel vision or narrowing vision.  Mild frontal headache and lightheadiness.  Still not having any SOB/CP.  Continue to monitor.  0907: Member feeling okay.  His symptoms continue to fluctuate.   Member released, informed to go to ER if symptoms worsen.
Developed supraclavicular lymph node 2 days after 2nd dose of vaccine.  Still present after 4 weeks.
shortness of breath; chills; pain like someone punched him at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), CHILLS (chills) and VACCINATION SITE PAIN (pain like someone punched him at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath), CHILLS (chills) and VACCINATION SITE PAIN (pain like someone punched him at the injection site). At the time of the report, DYSPNOEA (shortness of breath), CHILLS (chills) and VACCINATION SITE PAIN (pain like someone punched him at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
The same day of the vax, the pt "felt bad". The next day the pt vomited and had a fever of 101. The left deltoid area was red, swollen and very warm to the touch. In the office the are was 7 1/2 cm x 9 cm. Mom is to continue cool compresses, Tylenol and Benadryl.
Fatigue, body aches, lower back pain for 5 days before onset of shingles. Diagnosed by derm and rx of Valtrax prescribed.
inadvertently administered a third dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA638A, expiry date 30th November 2022) for prophylaxis.   Previously administered products included Menveo (received 1st dose on 15th August 2017). Concomitant products included MENVEO.   On 28th March 2022, the patient received the 3rd dose of Menveo. On 28th March 2022, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 29-Mar-2022 Reporter's Comments: Medical Assistant reported that a patient received first dose of Menveo (lot number and expiration date unavailable as it was administered at a different facility) and was given a booster dose. The patient was then inadvertently administered a third dose. Health care professional (HCP) gave permission for follow-up. The reporter consented to follow up. Additional Supportive Information : As the patient received a third dose of Menveo, which led to extra dose administered.
Patient complaining of excruciating pain to Right arm/shoulder 10/10. Denies numbness or tingling. Unable to perform full active or passive ROM or flexion or extension 2/2 pain. Patient needs to be evaluated by specialty physician for further testing.
Red, warm, indurated, 8x10cm, non tender, no fluctuance, no red streaks, no adenopathy.
psoriasis aggravated; This spontaneous case was reported by an other health care professional and describes the occurrence of PSORIASIS (psoriasis aggravated) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for an unknown indication.    No Medical History information was reported.   On 22-Mar-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced PSORIASIS (psoriasis aggravated). At the time of the report, PSORIASIS (psoriasis aggravated) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment drugs were reported.
Gave a Pfizer .3 ml into left arm IM.  Child was 9 years old.
Initial reaction-sore arm and headache-lasted 2 days Another initial reaction started at 8 pm  on day of 1st dose-tightness in chest  Got injection on Monday, 6/28/21. Tightness in chest got worse on Tuesday, Wednesday and Thursday..  It was very difficult to sleep-felt a lot of pressure when lying down. Went to a walk-in clinic on Friday-sent to ER due to an abnormal ECG
Swollen/tender lymph nodes under left armpit presenting about 6 hours after injection. Fever and headache presenting approximately 12-14 hours after injection
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 78-year-old female patient who received SHINGRIX (batch number 5Z5LX, expiry date unknown). On 23rd March 2018 10:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd March 2018, several hours after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema was recovering/resolving and the outcome of the injection site swelling and injection site pain were recovered/resolved. The reporter considered the injection site erythema, injection site swelling and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX vaccine in the left deltoid. The health care professional stated the patient developed raised, red, painful, swollen circle approximately 2 inches in diameter at the injection site within hours of receiving SHINGRIX vaccine. Symptoms lasted one week, all resolved except for slight redness remaining at the injection site which was still present on 3rd April 2018. The health care professional did not provide the expiration date for the SHINGRIX vaccine.
Information has been received from a registered nurse concerning a 51 year old female with history of renal transplant, depression, osteoporosis, hypertension, occipital neuralgia, past history of skin cancer, KEFLEX and Codeine allergies, who on 03-DEC-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 (lot # 664871/1142Y) IM. Concomitant therapy included CRESTOR, DARVOCET-N, CELLCEPT, RAPAMUNE, ZOMIG, ACTONEL, ECOTRIN, omega-3 marine triglycerides, NEXIUM, vitamin D (unspecified), ALLEGRA, TAMADOLOR, estrogens, conjugate PREMARIN and progesterone. On 03-DEC-2009 the patient experienced redness, swelling, warmth and pain on her arm at the injection site. It was also reported that the patient was having difficulty moving her arm on the side where the vaccine was given. There were no labs and diagnostic tests performed. The patient had made a phone call for medical attention. At the time of the report, the patient's status was unknown. Follow up information has been received from a registered nurse concerning a 51 year old female with history of renal transplant, osteoporosis, hypertension, skin cancer, KEFLEX and Codeine allergies, who on 03-DEC-2009 at 2:45 PM was vaccinated with a first dose of PNEUMOVAX 23 (lot # 664871/1142Y) IM in the left arm. On 03-DEC-2009 at 10:00 PM the patient experienced redness, swelling, tenderness in the upper left arm. The patient also had fever. There were no labs and diagnostic tests performed. The patient did not receive medical attention. On 06-DEC-2009 the patient recovered from redness, swelling, tenderness and fever. No further information is available.
Pt was given DTP on 24JUN92; Dad states that noc arm became sore, erythematous & edematous around site; applied ice; pt was holding arm out refusing to move it; area of erythema was approx 3x4 & indurated;
Patient reports that she felt extreme fatigue, heart palpitations, and light headed x 1 full week after receiving the first Pfizer COVID-19 vaccination. Case also reports that she had frequent urination and the veins around both of her knees turned black and purple. Patient had blood work completed on 11/12/21 that showed hypokalemia. She also had a UA completed that showed that she was dehydrated. Rapid COVID test was also completed that was negative. Case woke up this morning with a bloody nose and had a follow up appointment with her PCP today. Case reports that both the ER physician and her PCP recommends that she gets the second Pfizer vaccine in the series. Case states that she thought she was going to die after the first shot and is scared to get the second shot.
Patient noted low grade general headache for several hours the day after taking each of the evening four capsules of oral typhoid vaccine. Pt did not chose to take any medication. He did not alter his lifestyle.
A non-serious spontaneous report of fever of 100.8 F and runny nose has been received from a health professional concerning a six-year-old female, subsequent to FLUMIST. Neither relevant past medical history nor concomitant medications had been reported for this patient. The patient received FLUMIST on 20-Oct-2011. On 23-Oct-2011, the patient developed fever of 100.8F and runny nose. The outcome of the events fever of 100.8F and runny nose was unknown.