chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Eyes roll back and she looked like she passed out and then she looked like she started having a seizure. Then she stiffened and would not respond. This lasted for about 2 minutes. Then for 10 minutes after she felt very drained and disoriented.
no adverse event; patient was administered VARIVAX after a temperature excursion; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 07-JAN-2022, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # U019904 exp date 24-JUN-2023) (route not reported) after a temperature excursion. The temperature of excursion was 12.4°F for a time frame of 20 minutes. The previous temperature excursion was 6°F to 14°F (11.6F) for 25 minutes.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2203USA010794: US-009507513-2203USA010843: US-009507513-2203USA010696: US-009507513-2203USA010654: US-009507513-2203USA010652: US-009507513-2203USA010658: US-009507513-2203USA010686:
had tunnel vision ups on walking to bathroom and almost blacked out; had tunnel vision ups on walking to bathroom and almost blacked out; Achy and restless legs; Achy and restless legs; nauseous however did not allow self to vomit; headache; fatigue; rapid heart beat; low grade fever; chills; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EM9809) via an unspecified route of administration on 16Feb2021 12:45 at single dose (left arm) for COVID-19 immunization. Medical history included hypothyroidism, and allergies: Sulfa. The patient was not pregnant. Concomitant medication included topiramate (TOPIMAX), metformin, levothyroxine, and phentermine. The patient received 1st dose of bnt162b2 for COVID-19 immunization on 26Jan2021, 12:45pm (lot EL9263). On 17Feb2021 03:30, the patient experienced achy and restless legs, nauseous however did not allow self to vomit, had tunnel vision ups on walking to bathroom and almost blacked out, headache, fatigue, rapid heart beat, low grade fever, and chills. The patient had no treatment for the events. The patient had no other vaccine in four weeks and had no covid prior vaccination. Patient was not covid tested post vaccination. Outcome of events was recovering.; Sender's Comments: A possible contribution role of the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of Tunnel vision cannot be completely excluded due to temporal relationship.  The case will be reassessed should additional information become available.  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.
Thursday: I felt very tired especially in the afternoon. Headache started in the evening. Bad sleeping due to headache and nauseas. No fever. Tylenol extra strength and Paracetamol 1000mg to decrease the pain and nausea from Thursday night.  Friday: Strong headache and nauseas all day long. Low fever in the morning 37.5  Saturday: Headache decrease during the day as well as nauseas. Good sleeping. No fever.
Started with headache and mental confusion within a hour of first injection.  Right eye was becoming blurry by day 3 and loss of vision apx 6 days after first injection.
Initial unsolicited report received from a consumer (patient's parent) on 7 January 2016. This case involves an 11-year-old male patient who had received intramuscular fifth dose of DTAP (batch number and site of administration not reported) on an unspecified date. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as multiple food allergies, environmental and chemical allergies. No medical issues and illness at time of vaccination was none. Concomitant medications were not reported and vaccination within four week of vaccination was unknown. On an unspecified date after the vaccination the patient experienced whooping cough. The patient required ER visit. Laboratory investigations were reported as the patient had nasal swabs and whooping cough was confirmed. The patient was treated with antibiotics and steroids and the patient's family was also treated prophylactically with antibiotics without confirming diagnosis. The event outcome was recovered on an unspecified date. Upon internal review the case was assessed as serious due to important medical event whooping cough. Documents held by sender: none.
This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 33-year-old male subject who was vaccinated with Engerix B for prophylaxis.  On 5 January 2006, 13 February 2006, and 24 July 2006 the subject received the first, second, and third doses of Engerix B (unknown).  On 10 April 2007, approximately 9 months after the third vaccination with Engerix B, the subject experienced "possible nonresponse"/decreased therapeutic response in that the hepatitis B surface antigen titer was less than 3 mIU/mL.  The nurse indicated that it was unknown whether the subject was a "nonresponder" at the time of completion of the vaccination series, or if his antibody levels had "since waned".  At the time of reporting the event was unresolved.
Vertigo; Suspected vaccination failure; Very severe case of internal shingles; Haven't been the same, Really down for three months, never been so sick; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 27th September 2021, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced vertigo and feeling abnormal. On an unknown date, the outcome of the vaccination failure, shingles and vertigo were unknown and the outcome of the feeling abnormal was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, vertigo and feeling abnormal to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-Mar-2022 Reporter's Comments: This case was reported by a consumer via  interactive digital media. The reporter had the Shingrix vaccination in 2018 and ended up with a very severe case of internal shingles.  With it, the patient suffered with vertigo and was really down for three months.  The patient lost three months out of his/her life. The patient had never been so sick and had not been the same. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Hive started at injection site. Swelling, itching, warmth, red skin. Lasting until current >12 hrs even with Benadryl taken.
patient had a syncopal episode in the observation area post vaccination. she has POTS syndrome and states that she losses consciousness about twice per week. She had no extremity weakness, no bowel or bladder incontinence.
12 hours after second dose patient experienced following symptoms: headache, fever, chills, body aches, pain at injection site. All symptoms subsided in 28 hours after injection except headache which persisted for about 4 days.  12 days after second dose patient experienced intense pain and redness at site of injection leading to loss of mobility in left arm, and outbreak of hives across torso, upper arms and legs, which have persisted for 5 days (to date of Adverse Event report). Arm pain subsides with 400 mg ibuprofen taken daily. Pharmacist recommended Benadryl for hives, taking 25 mg Diphenhydramine HCI once daily with little improvement in symptoms. Patient recalls no previous history experiencing acute or chronic urticaria. Hives are moderately itchy, mostly painless, and have gradually increased to 2-3 inches in diameter.
Headache, Myalgia, NauseaVomiting, c/o fatigue,chills,sweating,right eye twitching,injection site sore. Told to see primary care physician if problems persist. Narrative:
Sharp chest pains like needles in upper chest area lasting 15-60 sec's each two days in a row,  1 week after vaccine.  Since then periodic tingling sensations in chest in upper chest and side.
No adverse events to report. Patient was given a booster dose of the Pfizer vaccine however, she is currently not eligible because she is under the age of 18.
The biggest symptoms monoclonal gameography of unspecified origin, MGUF, blood disorder; numbness;  The other issues were noted in each Vsafe check-in. I have an allergy to an ingredient in the vaccine but now I have been diagnosed with something that I don't understand.
Pulmonary Embolism  Diagnosed 1/14/23 via CT Scan with contrast Started having chest pain and pain with breathing on 1/12/23 Went to ER on 1/14/23 Now I am taking Eliquis 5mg Symptoms of chest pain and breathing occurred exactly one week after receiving the Bivalent vaccine
03/09/2006 Mother noted this a.m. that child had some moderate swelling on left deltoid at site of DTAP administration, redness and warmth to touch.  Child complained of no distress, behavior normal according to Mother.  03/08/2006 recommended cool compresses, Tylenol if desires and contact private doctor if worsens.
"pain radiating from where it was administered" on the left arm "all the way down with to her fingers"; "pain radiating from where it was administered" on the left arm "all the way down with to her fingers"; "pain radiating from where it was administered" on the left arm "all the way down with to her fingers"; This is a spontaneous report from a contactable 38-year-old female consumer reported for herself via Medical Information Team. A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 15Jun2021 (at the age of 38 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She reported that within minutes, she experienced "pain radiating from where it was administered" on the left arm "all the way down with to her fingers" on 15Jun2021. She said that she has already spoken to her doctors, but asked if there was any other information or has it been previously reported? No information found on "pain from the injection site radiating to the fingers" and referred to Health Care Professional for further guidance. Reporter considered events as non-serious. The events resulted in Physician Office Visit. The outcome of events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Headache, Sedation, Myalgia, Arthralgia, Fever, Chills, Pain @ injection site
Fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021 at 10:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 13-Jan-2021, the patient experienced PYREXIA (Fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Severe headache, mental confusion, nausea and stomach pain, temperature changes, tired/sore, ear/neck pressure. Pt went to ER @ hospital 10/21/19 and was given Fioricet tablet as outpatient prescription.  Was given Zofran in hospital for nausea and an unknown med for headache.  Was discharged after about 8 hours.
Sore arm with slight redness on 10/25.  On 10/26 more redness.  On 10/27 blotchy redness and rash down to elbow on right upper arm.
6pm fever/wheezing motion, 9pm breathing tx with albuterol, 0230 to ER, SA02 93%, 101, chest x-ray, breathing tx, wheezing, saw doctor 02/24/07 was given Rodia-pred SAO2 in office 94%.
Eyes swollen/hives on 10/22/15 am shot given 10/21/15 pm. Prednisolone 1 1/2 tsp BID x 5days.
father took pt into tub to rinse off diarrhea when pt rolled eyes back & had shaking 445PM; pt had sl fever prior to having diarrhea; It was not measured; pt adm to hosp 23SEP94;
Information has been received from a registered nurse concerning a male patient who was vaccinated with a dose of VARIVAX. Other suspect vaccination administered at the same time included a dose of MMR II. Concomitant vaccines administered along with the previously mentioned vaccines included a dose of poliovirus vaccine inactivated and an dose of pneumococcal conj vaccine. The registered nurse reported the patient broke out in hives, however it was not reported where the hives occurred on the body. The registered nurse reported that initially the patient was treated with acyclovir because the physician though the hives were chicken pox. It was noted the patient was then treated with diphenhydramine. It was noted that therapy with the vaccines was discontinued. The adverse event abated, and the patient recovered. There was no product quality complaint reported. Additional information has been requested. This is in follow-up to report(s) previusly submitted on 5/14/2004. Information has een received from a registered nurse concerning a male patient who was vaccinated with a dose of VARIVAX (Merck) (Lot# 547269/1101N). Other suspect vaccination administered at the same time included a dose of MMR II (Lot #  646740/0822N). Concomitant vaccines administered along with the previously mentioned vaccines included a dose of IPOL (unspecified) and a dose of PREVNAR. The registered nurse reported the patient broke out in hives, however it was not reported where the hives occurred on the body. The registered nurse reported that initially the patient was treated with ACYCLOVIR because the physician thought the hives were chicken pox. It was noted the patient was treated with BENADRYL. It was noted that therapy with the vaccines was discontinued. The adverse event abated, and the patient recovered. There was no product quality complaint reported. Follow-up information was received from a registered nruse who is also the patient's mother which reports more detailed information of the event experienced by her son. a 12-month-old male with no pre-existing allergies or medical conditions, who on 19-FEB-2004 was vaccinated in the left thigh with a 0.5 mL dose of VARIVAX (Merck) (Lot# 647269/1101N). Other suspect vaccine therapy administered on the same day, 18-FEB-2004, included a 0.5 dose of MMR II (Lot# 646740/0822N) in the left thigh. Concomitant vaccines administered along with the previously mentioned vaccines included a 0.5 mL dose in the right thigh of PREVNAR (Lot # 495-888) and a 0.5 mL dose IPOL (Lot W1233) in the right thigh. The patient was not ill at th time of vaccination. On 19-FEB-2004, reported as last Thursday, the patient developed a rash on his face that comes and goes. It was mentioned that he has received immunizations prior to this. The reporter thought that the rash could be an allergic reaction to something, possibly immunization. There were no laboratory studies performed. It was menttioned that the patient recovered on "10-FEB-2004". No additional information has been requested.
Large Red welt on the site where the vaccine was given. Symptoms started about 10 hours after receiving his vaccine and lasting much longer than what he experienced with the first or second vaccine. Started with a low grade fever, headache, muscle aches, chills, and sweats. He did get some mild relief with OTC medications. For the first few days he could not be upright for more than 5 minutes before he felt extremely flushed and sick and then had to lay back down. After three days, most symptoms resolved but was still struggling to be on his feet more than a few minutes without developing a ?horrific headache? and neck pain.
Screaming and crying that day and refused to eat that day. After that she started with gastro symtpoms that she didn't have prior (vomiting, extreme gas, crying, acid reflux, excessive bowel movements).
Bivalent COVID vaccines was given after being declared no longer authorized. We didn't receive the email notification that it was no longer authorized until the evening of 9/12/23, after the vaccine was given. No issues for the baby after vaccine was given.
7/01/2007;  2 days following vaccination patient called health department and complained of "lump under left arm followed by numbness/tingling down left arm into 4th and 5th fingers".  Symptoms have continued without relief since 7/1/07.  Patient called private care provider and was instructed ti report to health department.  Denies any recent changes in activities, insect bites, injuries, fever, or any recent illnesses.
This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age and gender. On an unknown date 2 doses of M-M-R II (dose, route of administration, lot # and expiration date were not provided) all of which reached the temperature outside the product information, have been administered to unspecified patients. The temperature was supported. No adverse effects were reported. This is one of several reports from the same source (MARRS# 1406USA008283, 1406USA008285, 1406USA007026). Additional information has been requested.
General malaise, body aches, fever, HA, light headiness, weak. sweaty, nauseated, and dizzy. Seen at military facility 9/7/05 at 18:12. Tx: Motrin, fluids, and rest.
Patient reports pain in the left arm that extends to the shoulder. The pain began roughly at October 1st (18 days after the vaccine administration). Patient went to ER and his primary doctor. He was prescribed Tizanidine 4 mg and Ketorolac 10 mg  but reports no improvement in pain. Cardiologist performed an ECHO and discarded the possibility of the issue involving the heart and suspects it may be due to the vaccine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of covid-19. Patient started Paxlovid on 27May2022 and stopped on 31May2022 for the treatment of COVID-19. Other medication in 2weeks were not taken by patient. Vaccine lot no was not available/provided to reporter at the time of report completion.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Drug ineffective, Covid 19 cannot be completely excluded.
Fever, body aches, severe headache, inability to lift arm, lethargy I did phone my Doctor on Thursday morning 09/20 I'd never had a flu shot and a pneumonia shot together. My doctors over the years have given them separately. The Pharmacist also did both injections in same arm. Don't know if that would have any bearing on the adverse reaction.
Sudden onset of irregular heart beats while at rest. HR 20's with associated dizziness and chest pain with deep inspiration 2/1/03 at 1330.ER visit identified frequent unifocal  PVC's
Day after the vaccine my body started aching, I was having chills and fever of 103 so I went back to the ER. They did another X-ray and found that I had Pneumonia in my right lung. I was given anti-biotics, breathing treatment and an inhaler and sent me home. I rested until I got better.
Within the hour I felt a shiver, started feeling shaky, my teeth chattered intermittently. I had an extreme headache all over my head and behind my left ear. I had body aches and pain - even in my feet. It hurt to turn over in bed.  My stomach was gurgling. No appetite - could not have tea or coffee - only water. The next day I was able to drink some ginger ale. All I wanted to do was lay down, sleep and sip water. The aches diminished as the days passed. Today, Sunday is the first day I felt well enough to go to pharmacy which is less than a half mile from my house.
Patient is a 74-year-old female past medical history COPD on 2 L nasal cannula chronically at home presenting for shortness of breath, vomiting, no appetite, cough, rhinorrhea, diarrhea.  Patient states that she has not eaten anything in 4 days and she has become very weak.  She states that her shortness of breath is at baseline as well as exertional.  Patient states she has been using more than just her normal 2 L lately just to try to be able to manage at home.  Patient states her PCP is Dr.
Elevated heart rate/ difficulty breathing 17 hours after vaccination  220 beats per minute  diagnosis was SVT
altered dosing schedule: "in 2011" the patient received the first dose in the HPV vaccination series with CERVARIX, on 09-JUL-2013 the patient received the second dose in the HPV vaccination series with GARDASIL and on 30-JUL-2019, the patient receiv; altered dosing schedule: "in 2011" the patient received the first dose in the HPV vaccination series with CERVARIX, on 09-JUL-2013 the patient received the second dose in the HPV vaccination series with GARDASIL and on 30-JUL-2019, the patient receiv; No adverse effects reported; This spontaneous report was received from a physician regarding a currently 23-year-old patient of unknown gender. There was no information reported about the patient's concomitant medications, pertinent medical history and drug reactions or allergies.   On an unspecified date in 2011, the patient received the first dose of the HPV vaccination series, with the dose and frequency reported as: 0.5mL "0,2,6 months", with HPV rL1 16 18 VLP vaccine (baculovirus) (CERVARIX) (dose, route, lot number and expiration date were not provided); then, on 09-JUL-2013, the patient received the second dose with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route, lot number and expiration date were not provided); and then, on 30-JUL-2019, the third dose with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number and expiration date have been verified as valid: R003557, 20-NOV-2020) for prophylaxis (Interchange of vaccine products, Inappropriate schedule of product administration). No adverse effects reported.  This case one of two cases from the same reporter (MARRS# 1907USA016808).; Sender's Comments:  US-009507513-1907USA016808: