chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Morning after vaccination (on 4/6/21), pt got diffuse intermittent headache which focalized later into the right temporal area daily for 3 weeks, which she calls 8/10 in severity. These headaches have been so severe to the point that it induces nausea and creates abdominal cramping. She has not as photophobic as before during her headaches, and nothing seems to alleviate it but water and tylenol (but that has little lasting effect). Prior to these headaches her migraines came once every 2 weeks and lasted 2-3 hours at a time, with a 5/10 severity that was bitemporal with more pronounced photophobia.
Swelling under lower lip discovered 4 hours after shot. Treatment: ice on swelling and watchful waiting. Still not resolved after 4 days.
This spontaneous report was received from a registered nurse concerning two patients of unknown age and gender. The patients who were intended to received ZOSTAVAX were inadvertently vaccinated with 0.5 milliliter (ml) of VARIVAX (Merck) (lot number and expiry date unspecified), subcutaneously due to human error on an unknown date in August 2012. No concomitant medications were reported. No adverse effects were reported. This is one of the two reports from the same source. Additional information has been requested.
This spontaneous report was received from a Medical assistant concerning to an unspecified number of patients. On an unknown date the patients were vaccinated with a dose of VARIVAX (Merck) (dose, route, lot # and expiration date not provided). No other co-suspect therapy was reported. Concomitant medications were not provided. It was reported that an improperly stored VARIVAX (Merck) was administered to an unspecified amount of patients. The VARIVAX (Merck) had had multiple excursions since June 2013 reaching a highest temperature of -100C for a total time of 864 hours. The reported did not think that the overall average temperature for the VARIVAX (Merck) had remained between -50C and -15C. She reported that the VARIVAX (Merck) was also exposed to 08C for 24 hours on an unspecified date. No adverse effect reported. At the time of the report patients outcome was unknown. Additional information has been requested.
Infant ate 1/2 jar baby food finishing around 7:00 PM. He vomited, his eyes rolled back, his body went limp and his lips turned bluish in color. Parents rushed him to ER. After waiting 20 minutes his color improved and he was smiling. Parents left with him to Immediate Care clinic rather than wait any longer to be seen at ER. Dr at Immediate Care found him to be OK. Suggested he not get so many shots at once next time. Currently without problems. Looking for doctor. New to area.
15 mins p/vax pt began to devel a 13mm x 40 mm white, hard welt around site; 1 tsp DPh elixer was given, welt began to difuse w/erythema @ 40mm x 60 mm; 02 sat 98%, HR 110, no SOB;
she felt very cold and unwell; she felt very cold and unwell; dizziness; headache; extreme fatigue; fogginess/Foggy brain was described as she was not able to focus very well; Strong chills was not going away almost like a feeling of ice in her veins; Arm ache at the site; She was not able to get work done due to extreme fatigue and foggy brain/It was very disturbing and interfering with ability to do work; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration in the left arm on 16Jan2021 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had her first COVID19 vaccine dose. Immediately, on 16Jan2021, she felt very cold and unwell. She also experienced dizziness, headache that started right after the shot, extreme fatigue that started later in the day and fogginess that started right after the shot. Strong chills was not going away almost like a feeling of ice in her veins. She is taking paracetamol (TYLENOL) and ibuprofen for these. The events were not improving. She was just surprised, she was ok with a day's worth, but it was hanging on dizziness (not enough to fall down), but she has to hold onto a rail to go upstairs which was not normal. She doesn't feel like she is real anchored. Headache was described as very bad and is not changing. Foggy brain was described as she was not able to focus very well. She was not able to get work done on Jan2021 due to extreme fatigue and foggy brain. She also experienced arm ache at the site on 06Jan2021 for which the patient expected. It is reducing some, the ache is not as bad as it was while the other things seem to be growing and it is still there. She had to be set aside when she took the shot, because she had these reactions after she got the shot. She had to be watched because of her almost immediate reactions. The patient wants an advice on what to do now, if there is any help for the side effects, and if this will go away. It was very disturbing and interfering with ability to do work. Outcome of the vaccination site pain was recovering while of the remaining events was not recovered.
Shingrix adjuvant only without the lyophilized antigen; Shingrix adjuvant only without the lyophilized antigen; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received a dose of the Shingrix adjuvant only without the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No symptoms reported. The reporter was not in the office at the time of report and did not have any of the patient's information at that time. The reporter consented to follow up. This case was 1 of 12 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179297:Same reporter US-GLAXOSMITHKLINE-US2021AMR179299:Same reporter US-GLAXOSMITHKLINE-US2021AMR179298:Same reporter US-GLAXOSMITHKLINE-US2021AMR179307:Same reporter US-GLAXOSMITHKLINE-US2021AMR179300:Same reporter US-GLAXOSMITHKLINE-US2021AMR179301:Same reporter US-GLAXOSMITHKLINE-US2021AMR179302:Same reporter US-GLAXOSMITHKLINE-US2021AMR179304:Same reporter US-GLAXOSMITHKLINE-US2021AMR179305:Same reporter US-GLAXOSMITHKLINE-US2021AMR179306:Same reporter US-GLAXOSMITHKLINE-US2021178442:Same reporter
Initial unsolicited misuse report received from a Physician on 08 December 2016. This case involves female patient (onset age unknown) who was vaccinated with 0.5 ml dose of Fluzone Quadrivalent (lot number, expiration date, dose in series and route of administration not reported) and Menactra (lot number, expiration date, dose in series and route of administration not reported) in arm on an unknown date. The medical history and concomitant medications were not reported. On an unknown date, unspecified time following the vaccination patient had sore arms, inability to move and lift her arms, and reported pain. This was a case of wrong technique in product usage process. Lab data and corrective treatment was not reported. The outcome of the event sore arms, inability to move and lift her arms and pain was not reported. List of the documents held by sender: none.
killed my mother and my father; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed my mother and my father". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical Course: Caller received an email from Pfizer. It was asking her to take a Covid vaccine. She wants to know how we got her email address. She states I am just really upset. You dont have any business having my email address. I am going to tell you right now; your vaccination killed my mother and my father. I became an orphan in 14 days. useless vaccination. (Name withheld) needs to burn in hell. He knew.  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-202300030989 same reporter/product/AE, different patient;; Reported Cause(s) of Death: killed my mother and my father
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL1283), in right arm, on 19Feb2021 as dose 2, single (Lot number: EN6200), in right arm and on 28Sep2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 42 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "POTS" (unspecified if ongoing), notes: POTS; "asthma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Penicillin, reaction(s): "known allergies Penicillin", notes: known allergies Penicillin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medications in two weeks: No. Anti-viral details. Product= COVID 19 treatment. Brand=Paxlovid. Treatment start date= 01Jun2022. Treatment stop date= 05Jun2022. Indication= Treatment of COVID-19. Adverse event: Rebound 4 days after ending treatment, 2 days after negative test. Adverse event start date: 09Jun2022. If patient recovered: Not recovered. If treatment ae: No (as reported).
Patient developed a headache and vomiting after his basketball camp the day after his Gardasil was received. He developed severe pain in his right eye
Patient on Field Trip with school.  Patient complaints of feeling dizzy, light headed, stomach hurting, stomach sick and blurry vision.  Laid down on school bus, returned back to school.  School nurse notified Mother while bus enroute back to school.  Mother took child to Pediatricians office.  Full Examination done including neurological exam.  Patient complaints of dizziness when standing.  Orthostatic BP's obtained.  Lying down 108 sys. and standing 98 sys.  Patient returned home, fluids, rest and monitor. Plan on follow-up exam at Pediatricians office again following day.  Awoke next morning still a little dizzy, although "much better".
Patient was given a Janssen Covid vaccine today. After administration, it was discovered that the vial had expired the previous day (09/21/21). No harm was realized as a direct outcome to the patient. He was monitored for the standard 15 minutes. We reached out to the vaccine manufacturer, but no further guidance was given on what to do in the event a patient was given an expired vaccine other than to complete a VAERS report. We also notified the patient's primary care provider and he made a note to discuss it further with the patient at his next office visit.
Admited to the hospital for CHF exacerbation; COVID-19 pna+; tx w/abx, Vit C, zinc, steroids, singulair, O2. developed hepatic failure, renal failure, and worsening mental status; dc'd to hospice.
My period was affected. I Had heavy spotting on January 2 where I thought my period had started. My period was not due for another 3 weeks. When I did have my period I had intense cramps more than I normally have. My period also lasted longer than normally.
This spontaneous report as received from a office manager refers to a currently 52-year-old female patient. The patient medical history included administration of TWINRIX vaccine, in 2013, after that she did not "seroconvert". The patient concurrent condition, concomitant medication and drug reactions or allergies were not reported. On an unknown date in February 2014, the patient was vaccinated with two combined doses of pediatric RECOMBIVAX HB, intramuscular for prevention of hepatitis b. She was administered 2 combined doses of pediatric RECOMBIVAX HB in order to receive an adult dose of RECOMBIVAX HB as a booster. The patient did not seek medical attention. On 06-JUN-2018, an unspecified test was performed with a result of "hepatitis B borderline titres". No treatment was given for the adverse events. The outcome of the event of hepatitis B borderline titres was reported as not recovered. The relatedness between the event and vaccination with RECOMBIVAX HB was not reported.
TOOK BACTRIM WHILE ON VIVOTIF; URINARY TRACT INFECTION; This spontaneous case report (PVX2019-2101) was received from a consumer on 14-Aug-2019. It described a 54-year-old adult female consumer who had "urinary tract infection" (UTI) (PT: Urinary tract infection), after the administration of Vivotif capsule for an unknown indication. She "took Bactrim while on Vivotif" (PT: Labelled drug-drug interaction medication error) for UTI.  Case report: The consumer took two doses of Vivotif two months ago. On fourth day of Vivotif therapy, she got UTI. The consumer took Bactrim (sulfamethoxazole) as a treatment for 7 days. It was reported that, within the third dose of Bactrim, the UTI symptoms went away. She stated that she did not have UTI in 25 years and thought maybe it was a coincidence.  The consumer's medical history included cold sores, hormones imbalance, and also she had a pacemaker.  Concomitant medication included hydrochlorothiazide and spironolactone as diuretics, estradiol for hormones and Valtrex (valacyclovir) for cold sores.  Action taken with Vivotif with respect to the event "urinary tract infection" was unknown, while with respect to the event "took Bactrim while on Vivotif" was not applicable. Action taken with Bactrim with reported events was not applicable.  The clinical outcome of the event "urinary tract infection" was resolved, while that of the event "took Bactrim while on Vivotif" was unknown.  Company's Comment: In this case, the consumer developed urinary tract infection (UTI) after receiving Vivotif vaccine. Due to the fact that UTI is an infectious condition the causality of the event was assessed as unlikely with Vivotif. The causality of the event "took Bactrim while on Vivotif" was considered as not applicable.  Follow-up information was received on 04-Nov-2019 with number (PVX2019-2733).  Additional reported nurse was added.  The start date of UTI was confirmed as May-2019. ; Sender's Comments: Company's Comment: In this case, the consumer developed urinary tract infection (UTI) after receiving Vivotif vaccine. Due to the fact that UTI is an infectious condition the causality of the event was assessed as unlikely with Vivotif. The causality of the event "took Bactrim while on Vivotif" was considered as not applicable.
1st: 9/7: Sharp axillary pain started. 9/9: left arms started to go numb starting at my shoulder and moved its way to my wrist. 9/10: left leg was numb and weak, especially with driving. Treatment was ibuprofen to reduce swelling.  2nd: 10/13: woke up with right arm pain. 10/14: upper anterior right arm line bruise and stomach ache. 10/15: bruise moves past elbow and pain. 10/16 bruising moves to forearm, arm swelling, arm pain, bad stomach ache. Arm pain continues. 10/19: ER visit. SOB, chest heaviness, epigastric pain. 10/20: severely nauseous for an entire week. 10/21: nauseous more severe with any activity, chest heaviness. Walking upstairs and putting laundry away caused these. 10/25: temporal headache on and off, dizzy, nauseous. Varying degree of nausea ongoing . Chest heaviness and shortness of breath with activity.
Sunday January 9th I felt achy and tired and sore. My youngest son tested positive for Covid-19 the day before so I took a home Covid-19 test and it was positive. The next day a really bad headache which did respond to Tylenol, fever of 99, congested and runny nose and still felt achy and tired. I sent my doctor's office a message on my portal Sunday night. They called me back on Monday, and not could get me in until Thursday. Tuesday I started having a cough. Wednesday I started having difficulty breathing I doubled my inhaler and had to use a rescue inhaler, also started coughing up yellow and green solids. I was very exhausted. Thursday I had a telehealth with my doctor's office and put on a round of antibiotics- V-Pak 5 day due to my lung condition. Also prescribed steroids - methylprednisolone dose pack 5days They were afraid I would get pneumonia. We also discussed emergency Covid treatments, after the provider researched them she came to the conclusion I had too many contraindications. Friday and Saturday I felt great better then I ever have- due to steroids. I continued to have a cough with clear solids.- Most of the symptoms went away by Sunday. I continued to have a cough through the rest of the week with clear solids. By the next weekend I was feeling much better. Total length about 2 weeks. Omicron.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 15F for cold temperature and in 51F for warm temperature) doses of PNEUMOVAX 23 (lot # L019836; dose, route of administration and expiration date were not reported). The call was made because of the data logger. No previous excursion and no adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
pt did not have a reaction to vaccine. Pt was given vaccine beyond refrigeration time. Lot number was not expired.
Hives on chest transient noticed at 4:30 pm, diffuse red raised patches and erythema, gone by 8 pm, no pruitis.  Site injection deltoid soreness, beginning about 1hour after injection, soreness increasing through today.
pt dx w/infantile spasms-a sx disorder;MD could find no underlying cause: underwent ACTH inj for 30 days;pt is still home awaiting full recovery of immune system a/returning to daycare;has been sz free 1mo;sz returned 23May
Complained of sore arm and headache after injection.  Had taken Tylenol and Ibuprofen, headache resolved but arm muscle pain persisted especially with movement. No reported swelling, redness, or excessive warmness noted to injection site.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: el3248), in right arm, on 03Feb2021 as dose 2, single (Lot number: en5218), in right arm and on 23Aug2021 as dose 3 (booster), single (Lot number: fl3187) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Metformin, reaction(s): "Known allergies: Metformin"; Codeine, reaction(s): "Known allergies: Codeine"; Ropinirole, reaction(s): "Known allergies: Ropinirole". No Other medication in 2weeks. The patient was treated for COVID-19 from 21May2022 to 25May2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
MAGNETIC RESONANCE IMAGING ABNORMAL; RIGHT ARM WEAKNESS; STIFF NECK; HEAVY HEAD FEELING; TINGLING; This spontaneous report received from a physician concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included white matter changes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced stiff neck. On 25-JUN-2021, the subject experienced heavy head feeling. On 25-JUN-2021, the subject experienced tingling. On 25-JUN-2021, the subject experienced right arm weakness. On 05-JUL-2021, Laboratory data included: CAT scan (NR: not provided) unknown. On an unspecified date, the subject experienced magnetic resonance imaging abnormal. Laboratory data (dates unspecified) included: MRI (NR: not provided) White matter and vasculo ischemic changes, micro angiopathic ischemia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stiff neck, heavy head feeling, and right arm weakness, and the outcome of tingling and magnetic resonance imaging abnormal was not reported. This report was non-serious.
Vaccine received Friday afternoon around 4:00 pm. I was fine all evening. I slept well, THEN... Saturday: headache, body aches, fever, deep chills (despite the house being 70 degrees and me in a jacket and a blanket), shortness of breath (blood oxygen 90), and extreme tiredness (slept 5 hours during the day, then 14 hours at night). Sunday: headache gone, body aches partly gone, fever gone, chills better but not gone, shortness of breath better (blood oxygen 94), and still very tired (slept 2 hours during the day, and 8 at night). Monday (today): still tired. Blood oxygen 96. everything else normal.
Patients was sweaty and pale after vaccination. Patients blood pressure dropped to 93/52mmhg. Patient was given 2 cups of warm water and 2 glucose tablets because patient did not eat breakfast or lunch prior to the vaccination. Crushed ammonia capsules were also provided to the patients to smell and CPR was not needed. After 15 minutes of treatment, patients pulse and blood pressure normalized and he was observed in the pharmacy for another 20 minutes before he said he was fine and went home.
Maybe 5:00 a.m. woke up and needed to use the restroom, got up slowly and walked to the Bathroom slowly; I passed out and fell on the floor; not sure if my head hit the floor or just the trash barrel. I fell on my right side and the bathtub was at my back. When I realized where I was, I knew I still needed to use the restroom; I meneuvered myself slowly and carefully; I did use the restroom and then I carefully went back to bed.
A nurse reported that a pt received vaccine on 11/13/00, the next day she developed an injection site reaction characterized by a 4" area of redness, warmth and swelling.
Violent nausea (dry heaves. could not eat) shook and trembled all night.