chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 84-year-old female patient who received Influenza vaccine unspecified. Co-suspect products included fluticasone furoate, BREO ELLIPTA inhalation powder (batch number R712207, expiry date October 2016) for difficulty breathing. The patient's past medical history included lung neoplasm (surgically removed 2 years before reporting date). Concomitant products included Z-PAK and medication unknown (Nebulizer (Name Unknown)). On 14th November 2016, the patient received Influenza vaccine unspecified and BREO ELLIPTA (inhaled) 100/25 ug 1 puff(s) once daily (1 puff(s) daily). On 14th November 2016, less than a day after receiving Influenza vaccine unspecified and BREO ELLIPTA and less than a day after starting Influenza vaccine unspecified and BREO ELLIPTA, the patient experienced tiredness, incorrect storage of drug and expired drug used. In November 2016, the patient experienced redness of legs and palmar erythema. On 15th November 2016, the patient experienced feeling bad and blood pressure high. BREO ELLIPTA was discontinued on 15th November 2016 (Dechallenge was unknown). On an unknown date, the outcome of the tiredness, redness of legs, palmar erythema, feeling bad, incorrect storage of drug and expired drug used were unknown and the outcome of the blood pressure high was not recovered/not resolved. It was unknown if the reporter considered the tiredness to be related to Influenza vaccine unspecified and BREO ELLIPTA. The reporter considered the redness of legs, palmar erythema, feeling bad and blood pressure high to be related to Influenza vaccine unspecified and BREO ELLIPTA. Additional details were provided as follows: The patient reported that she tried BREO ELLIPTA about 8 to 9 months before the reporting date, but discontinued because she could not afford to purchase the medication. The day before reporting date, her doctor told her to start taking BREO ELLIPTA again, so she used a dose from the inhaler she opened several months ago. The inhaler had been opened for more than 6 weeks and was already expired in October 2016. In addition to starting BREO ELLIPTA, she also received a flu shot. She did not know what brand of flu shot she received. Around 8 pm (evening), the patient took the dose of BREO ELLIPTA and afterwards she felt tired, so she went to the bed. Around 4 am she woke up and the palms of her hands and her knees were red. She went back to sleep and when she woke up later in the morning she felt lousy. The patient took another dose of BREO ELLIPTA around 10 am on the date of reporting. She took her blood pressure and it was at 202 by 93. She had taken blood pressure medication to bring it down again and had decided not to continue BREO ELLIPTA.
Bright pink rash from wrist of right are extending onto the chest. (vaccine was given in the left arm- there was no reaction at the injection site).
2 days after Imms - decreased muscle tone, difficult to wake. Resolved next day.
My entire left arm started to throb at 1:00am. I then started to get nauseous and vomited. After I vomited I was walking to the couch and started to feel very light headed and my knees were starting to buckle and my ears were ringing. I felt like I was going to pass out. I laid down and went to sleep. When I woke up at 7:00 am my entire left  arm was sore all the way to my wrist and the soreness was going to my shoulder down my left side all the way down to my thighs. My entire left side is sore. I am also having stomach cramps.
Feels tired and dizzy right after mist given at 9:02am. 9:30 dizziness resolved. Still feels tired. BP 90/68, P 80.
This spontaneous case was reported by a consumer and describes the occurrence of SPEECH DISORDER (Could barely talk after booster shot), MALAISE (Not feeling good after booster shot), SOMNOLENCE (Wants to sleep after booster shot), HEADACHE (Headache after booster shot) and VACCINATION SITE PAIN (Left arm injection site hurts after booster shot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced SPEECH DISORDER (Could barely talk after booster shot), MALAISE (Not feeling good after booster shot), SOMNOLENCE (Wants to sleep after booster shot), HEADACHE (Headache after booster shot) and VACCINATION SITE PAIN (Left arm injection site hurts after booster shot). At the time of the report, SPEECH DISORDER (Could barely talk after booster shot), MALAISE (Not feeling good after booster shot), SOMNOLENCE (Wants to sleep after booster shot), HEADACHE (Headache after booster shot) and VACCINATION SITE PAIN (Left arm injection site hurts after booster shot) outcome was unknown. Concomitant medication information was not provided by the reporter.Treatment information was not provided by the reporter. The patient stated that she received 2 doses of Moderna COVID-19 vaccine more than 6 months ago.
pt recvd vax;had a 3 min sz & stopped breathing;FTR put pt in cold water & pt retrieved a breath;apap given & mom called 911;to er; T 102 at hosp;apap suppository given;blood test done;discharge 3 hrs later;pt not to recv any more pertussis
No additional adverse effect reported; the patient received one improperly stored dose of V ARIV AX; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. No information regarding patient's medical history, concomitant medications and concurrent conditions was provided. On 03-MAR-2020, the patient was vaccinated with one dose of an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S028920, expiration date 19-SEP-2021 for prophylaxis (route of administration, dose and frequency were not reported). The vaccine was reconstituted with a properly stored sterile diluent. Digital Data logger was involved. The vaccine was stored at the temperature reported as from 6 to 14 degrees of Fahrenheit (F) (5.69 degrees of F), the time frame as 1 second. There was a previous temperature excursion: reported as from 6 to 14 degrees of F (5.81 degrees of F) for 28 minutes.  No adverse effect reported. This is one of two reports received from the same reporter and concerning the same suspect therapy and the same event.
This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE DISCOMFORT (discomfort in their injection arms), HEADACHE (headache), EXPIRED PRODUCT ADMINISTERED (booster doses of Moderna vaccine stored in the fridge past 30 day BUD administered to 3 patients) and PRODUCT STORAGE ERROR (booster doses of Moderna vaccine stored in the fridge past 30 day BUD administered to 3 patients) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster doses of Moderna vaccine stored in the fridge past 30 day BUD administered to 3 patients) and PRODUCT STORAGE ERROR (booster doses of Moderna vaccine stored in the fridge past 30 day BUD administered to 3 patients). In January 2022, the patient experienced VACCINATION SITE DISCOMFORT (discomfort in their injection arms) and HEADACHE (headache). On 14-Jan-2022, EXPIRED PRODUCT ADMINISTERED (booster doses of Moderna vaccine stored in the fridge past 30 day BUD administered to 3 patients) and PRODUCT STORAGE ERROR (booster doses of Moderna vaccine stored in the fridge past 30 day BUD administered to 3 patients) had resolved. At the time of the report, VACCINATION SITE DISCOMFORT (discomfort in their injection arms) and HEADACHE (headache) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Vaccine was stored in the fridge (4.7 C) since 03-Dec-2022. All three patients stated discomfort in their injection arms and had no fever or no chills. The patient had headache the next day. No concomitant medication information was provided. No treatment medication information was provided. Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2022: Follow-up received: Reporter details, patient age and events updated.
Information has been received from an office administrator concerning a 19 year old female who on 12-JAN-2009 and 18-MAR-2009 was vaccinated with the first and second doses of GARDASIL 0.5ml (lot # not reported). The patient reported her period being 2 weeks late on 30-MAR-2009. The patient sought unspecified medical attention from the physician. Additional information has been requested.
PT presents with generalized weakness, HA and chills x this morning. reports she received JJ vaccine 1845. took 650mg tylenol PTA.
Pt recv vax on 8/25/98; on 8/26/98 pt exp vax site swelling from shoulder to elbow; tx=Cephalexin
Two days after receiving vaccine, patient developed shingles.  Patient has painful, disseminated rash on back and stomach in traditional shingles pattern.  Rash has continued to spread for 5 days without treatment.  Pt treated with acyclovir 800mg po daily x 10 days.
This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 13:15 (Lot number: EN 6202) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (lot number=EM 9810, administration time=11:45 AM, vaccine location Left arm), administration date: 10Feb2021, when the patient was 46 years old, for COVID-19 immunization.The following information was reported: HEADACHE (non-serious) with onset 04Mar2021, outcome "not recovered", described as "I've been having serve headache / severe headache that makes me cry"; VACCINATION SITE REACTION (non-serious), VACCINATION SITE VESICLES (non-serious), SKIN EXFOLIATION (non-serious), WOUND (non-serious) all with onset 04Mar2021, outcome "not recovered" and all described as "reaction on my left arm at the spot of injection the following day in form of a blister and it later pealed off and turned to a wound"; HYPERTENSION (non-serious) with onset 04Mar2021, outcome "not recovered", described as "high blood pressure". The events "i've been having serve headache / severe headache that makes me cry", "reaction on my left arm at the spot of injection the following day in form of a blister and it later pealed off and turned to a wound", "reaction on my left arm at the spot of injection the following day in form of a blister and it later pealed off and turned to a wound", "reaction on my left arm at the spot of injection the following day in form of a blister and it later pealed off and turned to a wound", "reaction on my left arm at the spot of injection the following day in form of a blister and it later pealed off and turned to a wound" and "high blood pressure" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, vaccination site reaction, vaccination site vesicles, skin exfoliation, wound, hypertension.Additional information: Patient applied elimination series by cutting off coffee and soda to try and figure what was going on as he had never in his 47 years of existence experienced such severe headache that makes him cry. Treatment was received for events and were CT scan, medication.
Patient reported itching all over a few minutes after receiving vaccine. Patient said he felt fine other than that. I advised patient to take Benadryl.
Td administered on 10/23/14. Frday inj site redness grew from shoulder to elbow with red hot, fever until Monday.
pt recv vax 22SEP95 & 13FEB96 pt devel full blown chicken pox of more that fifty lesions;no further details were provided;
Information has been received on 13-APR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 23-AUG-2010, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 19-MAR-2012, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed acyclovir, XYLOCAINE and tramadol for management of her painful symptoms. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
VACCINE ERROR ADMINISTERED 10 MINUTES PAST 6 HOURS OF 1ST PUNCTURE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced vaccine error administered 10 minutes past 6 hours of 1st puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine error administered 10 minutes past 6 hours of 1st puncture was not reported. This report was non-serious.
Systemic: Rash (other than injection site)-Medium, Systemic: Chills-Mild, Systemic: Exhaustion-Medium, Systemic: Headache-Mild, Systemic: upper body test rash, itchiness around eyes and mouth, she discribed a tingling sension in the back of her throat, verbilized her tongue was swelling; symptoms lasted 1 day
Mother did a pregnancy test on the day of the vaccine that was negative, so she answered that she was not pregnant at the time of the vaccine.  The next day she called the office late in the day to say that her latest pregnancy test was positive.
My wife got the Covid and then I started to get sick five days later. I had a cough at first and then a few days later I got a headache. I started to run a fever. I went to the medical center and I tested positive for Covid-19. I was given an antibody infusion three days after I started to have symptoms. For the next few days I had aches and pains and my fever went as high as 104 degrees. My fever was going up and down. On the third day after the fever started I felt much better. I did not lose my sense of taste or smell. I still feel tired after six weeks. I can?t do as much activity as I normally do.
Aching, fever through weekend.  On Monday November 2nd, employee broke out in a fine rash on trunk, arms, legs.
booster; high temperature; unresponsive to stimuli; flushing; This is a spontaneous report from contactable pharmacists. This pharmacist reported similar events for two patients. This is the second of 2 reports. A patient of unspecified age received third dose of bnt162b2 (COMIRNATY) via unspecified route of administration on unspecified date (lot number: FD0810, Expiration Date: 30Nov2021) as DOSE 3 (BOOSTER DOSE), SINGLE for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient previously received the first and second doses of COMIRNATY on unspecified dates for COVID-19 immunisation. On unspecified date, within 24 hours of receiving the booster, the patient experienced flushing, high temperature, and unresponsive to stimuli. The patient had been transported to the hospital and are still hospitalized. The pharmacist stated, it raised a red flag for them since they have given ten to thousand doses. Outcome of the events was unknown.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect product BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-202101489288 same reporter/drug/AE, different patient
Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was unknown. The reporter stated that her patient experienced flu like symptoms for approximately 2 days after shingrix vaccine. The reporter did not consent to follow up. The reporter provided limited information. This case is 1 out of 4 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022026665:same reporter US-GLAXOSMITHKLINE-US2022026668:same reporter US-GLAXOSMITHKLINE-US2022AMR027150:same reporter US-GLAXOSMITHKLINE-US2022026674:same reporter
I was sitting at my computer with my partner. It was time to go to bed. on the third floor. As I turned in my chair I was dizzy and fell over into my partners lap. I sat up and thought it was the end. As I stood up to go to the third floor to go to bed, I felt like my brain and forehead moved back and forth in my head. That's all I remember. I went to wash my hands I was falling into to sink. My partner got me to bed and noticed I was unconscious. My partner called 911. I somehow ended up on the floor. And my spouse said he had to yell for me to breathe. The EMT came, the took my vitals and said that everything was normal. They did not want to take me to the hospital because the hospital was not accepting patients. They stood me up and noticed that I was drenched in sweat. I had peed all over myself while I was still upright. I have no memory of this. It has never happened before. The EMT left, I did not sleep at night. The next day I was afraid to drive. I was afraid it would happen again. ALL that day and into the next day., It was hard for me to find words. It was very strange. It has so far been okay, but I now still get dizzy spells. The EMT mentioned during the call and assessment that I seemed as if I had a seizure.
Sick; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious social media case received from non-health care professional via social media.  This case involves a patient of unknown demographics who got sick (Illness), while he/she received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, family history and concurrent condition were not provided.  Concomitant medication was not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route on unknown site of administration for prophylactic vaccination.  On an unknown date, the patient reported that it might not be the flu but it made sick (illness, non-serious) (Unknown latency) following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as unknown for sickness, at the time of reporting.  There will be no information available on the batch number for this case.
Patient had flu-like symptoms including fever, sore throat, cough, headache, itchy eyes and itchy ears, aches. This resulted in an office visit to physician who confirmed a negative flu test.
Pt states heart fluttering, rush, feeling terrible run down. Still continuing, feels as though heart skips a beat ever so often, refuses medical care.
1 day after vaccine was administered, pt developed redness, pain and swelling at injection site. Day 2 the area of erythema, induration measured 2x3 inches. Pt complained of pain.
See ER notes- treated with 1. Clindamycin 300mg 4xdaily/900mg IV 2. BENADRYL Cap 2 25 mg at Bedtime 3. Prednisone 40mg po.
local 6cm erythematous rash with mild tenderness starting 6 days after vaccine at vaccination site (covid rash)
Hives on skin, on arms, legs, chest, various areas on the body, itchiness on skin and hives.
Dizziness, slushed, increased blood pressure.  Patient left emergency department AMA.
Lightheaded, fever 101 degree, vomit, nausea, mild headache, redness at injection site of FLUZONE.
pt recvd vax 7AUG90 & 24SEP92 dx w/mumps; lab eval showed inc serum amylase & a pos titer for mumps; No further details were provided;
This spontaneous report as received from a physician refers to an 13 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 18-JUL-2017, the patient was vaccinated with an improperly stored GARDASIL 9 lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766.
Initial report received from a healthcare professional on 22 Dec 2009: This patient was vaccinated with S-OIV FLUVIRIN (batch no. 102045P1) on 16 Dec 2009. The patient experienced general weakness, sweating, burning and pain in the stomach and rib pain on the same day after vaccination. The events were not resolved. Outcome of the events was reported as condition unchanged.
J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/7/2022 METABOLIC ENCEPHALOPATHY