chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a the patient's mother referring to her daughter, a female patient of unknown age. Medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first and second doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown), (strength, frequency, dose, route, lot/batch number and expiration date were not reported) for prophylaxis. It was reported that, on an unknown date, the patient experienced amenorrhoea, reported as "I'm almost positive it triggered a menstrual because she hasn't has one since that vaccine", and discomfort, reported as "She hates it. She says it hurts really bad". The patient's mother stated "I feel bad but if it's not mandated that I won't have her do the last one". The outcome of amenorrhoea and discomfort was unknown. The relationship between the events and the suspect unspecified HPV vaccine was not provided. Additional information is not expected, there is no contact information.
At 6:00 p.m. on April 23rd I realized my lower back was hurting on the left side. The pain became worse gradually throughout the evening and extended to the front pelvic/ groin area on the left side. Buy the middle of the night, I was able to make it to the bathroom but could not get back to the bedroom alone because of the severity of the pain. I had to call my husband to help me back to bed. The pain was severe the next day and my husband called the doctor on call. She prescribed large doses of tylenol, ibuprofen, and she gave me a muscle relaxant. I took those as prescribed for a week and stopped gradually when I saw blood in my urine. For about 5 days after the onset of pain, I was unable to put my pants on unaided, tie my shoes, or climb into bed. There was also an area on the lower left pelvic area that was numb. The pain and numbness gradually subsided over a number of weeks. At this time, there is still a small amount of pain and numbness in the pelvic area at times, but my back is fine. It felt like the vaccine affected a nerve in my lower spine that went to the pelvic area. This was my second dose of the Pfizer vaccine. When I got that second dose on April 7th, I had poison ivy. I also got a different rash on my left arm on April 14th. The vaccine rash lasted about 2 weeks.
First shot just sore arm, tired     stuffy head   2nd shot     dizzy    nausea    weak   shaky   dehydrated  (got IV fluids )    ringing in my ears     still having these symptoms on today's date as I send this in
Administered Fluarix instead of Fluzone High-Dose Quadrivalent vaccine with no reported adverse event; Initial information received on 23-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 73 years old male patient who was administered fluarix instead of fluzone high-dose quadrivalent vaccine with no reported adverse event while receiving vaccines FLUARIX and INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 mL dose of suspect FLUARIX not produced by Sanofi Pasteur (lot EE3E2 and expiry date: 30-Jun-2023) (formulation, strength, route and administration site not reported) for prophylactic immunization instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On an unknown date, (latency: same day) the patient was administered fluarix instead of fluzone high-dose quadrivalent vaccine with no reported adverse event (wrong product administered).  Action taken was not applicable for both the suspects.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01292129: 01292108: 01291872:
Seen 9/28/13 for positive urticaria bilat legs and diaper area. Lg. patches of irregular erythema with central hive on RT thigh. Positive erythema LT thigh superior to positive hive at site. TX: OTC Benadryl every 4-6 hours and Ibuprofen every 6-8 hours -PRN.
-Fever 103 started at 3:00am and fell to 101 after Tylenol 500 mg every four hours  -nausea, vomiting: started at 3:00am and persists still. Contacted telehealth for nausea medication. Zonfran on order at pharmacy -diarrhea-started 8:00am and persists now. Attempted Pepto but nausea and vomiting limited ingestion
Normal day after vaccination. Awoke early am 7/30 feeling dizzy, faint. To kitchen and sat floor, clammy. Compresses and cool water helped. To bed 30 min, weak in am-better thru day 7/30.
Initial and follow-up information has been received from a pharmacist concerning a 64 year old female who on 10-OCT-2008 was vaccinated with her first dose of ZOSTAVAX (Oka/Merck) (lot #662971/1213X) SC into the left arm. On the morning of 11-OCT-2008 the patient developed redness (area at 4 inch x 8 inch) around the injection site and down the arm, red and itchy, with no blisters. The patient was treated with BENADRYL. Subsequently, the patient recovered. The patient had no adverse event following prior vaccination of FLUZONE on 29-NOV-2006 and 04-OCT-2007. No further information is available. This is one of several reports from the same source.
Immediately after receiving his vaccination, the patient reported developing body vision, reading in his bilateral ears, as well as lightheadedness. He was taken by EMS to a private section of the arena monitored. HR was 60, BP 85/42. Three minutes later, his heart rate was 89 beats per  minute and his  and BP was 105/64.  Blurry vision and bilateral tinnitus resolve within 2 to 3 minutes, and his lightheadedness had resolved by 20 minutes after onset. He subsequently developed a headache after 20 minutes of monitoring.
Information has been received from a physician via field representative referring to a 73 year old female patient. No relevant medical history or concurrent conditions were reported. In 2010 the patient was vaccinated with ZOSTAVAX (one injection/once; route, lot# and expiration date not reported). In 2012 the patient experienced her first case of shingles and recovered on an unknown date. In 2015 the patient experienced her second case of shingles and had not recovered. Causality assessment was not reported. Additional information has been requested.
This case was reported by a pharmacist and described the occurrence of allergic reaction in a 2-year-old female subject who was vaccinated with DTAP vaccine (manufacturer unspecified) for prophylaxis. Approximately in 1982 or 1983 the subject received unspecified dose of DTAP vaccine (unknown). In 1982 or 1983, at an unspecified time after vaccination with DTAP vaccine, the subject experienced allergic reaction, pertussis vaccination reaction, fever, erythema and swelling. The pharmacist, who is also the subject reported when she was about 2 to 3 years old, after receiving DTAP vaccine from an unknown manufacturer she experienced an allergic reaction with symptoms of spiking a fever of 105 degrees Fahrenheit, redness and swelling. The fever could not be reduced with TYLENOL so the subject was sent to the emergency room and packed in ice. The subject could not recall what additional treatment took place. The subject was not hospitalized overnight. The subject was diagnosed with an allergy to the pertussis component of the vaccine [pertussis vaccination reaction]. The events have since resolved. The subject, who is also a pharmacist, received a booster shot in 2004 containing Diphtheria and Tetanus and no adverse reaction was experienced. At the time of reporting the events were resolved. Immunization series with DTAP vaccine was discontinued. The pharmacist considered the events were probably related to vaccination with DTAP vaccine.
Case number PHEH2015US017646, is an initial spontaneous report received from a nurse o 09 Sep 2015. This report refers to a 39 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) in the past and was well tolerated. He was vaccinated with 0.5 ml of FLUVIRIN (batch number: 157103) pre-filled syringe (PFS) intramuscularly into the left deltoid on 08 Sep 2015. It was reported that the patient received vaccine which was out of temperature range at 33.2 degree Fahrenheit on 08 Sep 2015. The event was reported as non-serious. No adverse events were reported following the inadvertent administration. Follow up report received from the nurse on 27 Oct 2015: updated patient demographics, vaccination history, vaccination details and other clinically relevant information.
Headache, Sedation, Myalgia, Arthralgia, RespDepression, CoughWheeze & Diarrhea Narrative:  Other Relevant History:
Moderate soreness in left arm; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 40-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included TOZINAMERAN (PFIZER BIONTECH VACCINE FOR COVID-19 (BNT162B2)) (batch number 330308D, expiry date unknown) for prophylaxis.   Previously administered products included Zinacef with an associated reaction of hypersensitivity, Pfizer BionTech (1st dose received on 9th March 2021 Lot No: EL3247 intramuscular in left arm) and Pfizer BionTech (2n dose received on 1st April 2021 Lot No: EPF955 intramuscular in left arm).   On 21st November 2021, the patient received the 1st dose of Influenza vaccine Quadrivalent 2021-2022 season and the 3rd dose of PFIZER BIONTECH VACCINE FOR COVID-19 (BNT162B2) (intramuscular). On an unknown date, less than 2 weeks after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were reported as follows: This case was reported by the patent for himself. The patient received on same day same location flu shot and COVID-19 vaccine and experienced moderate soreness in left arm (injection arm for both the COVID booster and the GSK flu shot). It was unknown if the reporter considered the pain in arm to be related to PFIZER BIONTECH VACCINE FOR COVID-19 (BNT162B2).
Information has been received from a female patient with no known drug reactions/allergies and no pertinent medical history, who on 18 18-DEC-2008 was vaccinated with ZOSTAVAX (Merck), 0.65ml. No lot number was provided. There was no concomitant medication. The patient reported that on approximately 01-JAN-2009, two weeks after vaccination, she developed a case of shingles. At the reporting time, she was experiencing a little pain however the most of the pain had went away. The patient stated that she had a feeling she may had had the shingles before receiving the vaccine however she was not diagnosed with them. Patient did not want to provide physician's name. At the time of the report, the patient was recovering. The patient sought unspecified medical attention. Additional information is not expected.
PATIENT SAID INJECTION SITE STARTED TO GET RED, RAISED AND HOT THE EVENING AFTER INJECTION. IT CONTINUED TO GROW IN SIZE FOR 7 DAYS. AFTER 7 DAYS, IT WAS ABOUT 4 INCHES BY 6 INCHES IN SIZE AND WENT TO THE UNDERSIDE OF HER ARM. AFTER A WEEK, THE AREA WENT AWAY BUT HER ARM WAS "BLUE-LOOKING" AFTER THE SWELLING AND REDNESS WENT DOWN.
Information has been received from a consumer concerning a 6 year old male with an allergy to  the protein in chicken and fish and no other medical history who at 13 months of age was vaccinated with a SC dose of measles virus live (Ender-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn)(+) rubella virus vaccine live (Wistar RA 27/3). There was no concomitant medication. Subsequently the patient developed non stop vomiting.  Unspecified medical attention was sought. "Back pricking with the panel" was performed. The patient recovered after 2 days. There was no product quality complaint. Additional information has been requested.
chills, swelling + pain L arm seen in ER 4/7/21 - Dx:  local    reaction to vaccine    mom counseled on supportive care ( Tylenol,   Rice ).  mom reports doing fine  4/8/21
Patient's dad called and said he was suffering a 101ºF fever, muscle aches and pains, fatigue and headache.
Fever; body aches; feeling of sickness; This case was reported by a other health professional via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, general body pain and feeling unwell. On an unknown date, the outcome of the fever, general body pain and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the fever, general body pain and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided. The age group was not reported but was selected as adult as per vaccine indication.  The patient received dose of Shingrix and experienced fever of 101 degrees Fahrenheit, fever, body aches, and overall feeling of sickness for several days. The follow up consent was not granted.      Lab Comments: lab test performed on unknown date.
8 days (01/23) after receiving vaccine at injection site: -itchy arm  -red, swollen  -rapidly spreading circular reaction  -uncomfortable but not painful  - fatigue, chills  01/28: -swelling has reduced -itchiness reduced - redness reduced  - symptoms still present, but less intense
Initial unsolicited report received from consumer (Patients mother) on 06 Feb 2018. This case involves nine years old male patient who was vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT (frequency: once, batch number: unknown and expiry date not reported) intramuscularly in left deltoid on 31 Jan 2018. She state it was a multi dose vial. The patient's medical history and concomitant medication were not reported. On 31 Jan 2018, immediately after the vaccination patient had an exacerbation of Tourettes syndrome. On an unspecified date, post vaccination patient had hyper mind, increased cramps and ticks. Laboratory investigation and corrective treatment were not reported. Outcome of event was unknown. Upon internal review the case was considered as serious because of important medical event: exacerbation of Tourettes syndrome. List of documents held by sender: none; Sender's Comments: Patient experienced an exacerbation in Tourette's syndrome after vaccination. Time to onset is compatible with the role of vaccine. More details regarding patient's medical history, previous vaccination history, condition at the time of vaccination, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine seems unlikely.
severe brain fog; body high; dilated pupils; flushed skin; acting "silly"; This is a spontaneous report from a contactable consumer (Patient's daughter). An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history was not reported. The patient previously received Valium and was extremely hyper. The patients concomitant medications were not reported. On an unknown date after vaccination, the patient had severe brain fog, body high, dilated pupils, flushed skin and acting silly. The outcome of the events was unknown at the time of report.  No follow-up attempts are needed. No further information expected.
Swelling below the armpit in chest area; pain as in muscle or vein pull; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27May2021 at 12:15 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol. The patient previously received paracetamol (PARACITAMOL) on an unspecified date for an unspecified indication and experienced drug allergy. Concomitant medications included colecalciferol (VIT D) of dose 5000 international unit per day. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Apr2021 at 11:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to COVID-19 vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since vaccination the patient had not been tested for COVID-19. On 28May2021 the patient experienced swelling below the armpit in chest area and  pain as in muscle or vein pull. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swelling below the armpit in chest area and pain as in muscle or vein pull was recovering at the time of report.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 31Jan2022 as dose 2, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRAMADOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid as Treatment of COVID-19. No Known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Paralyzed head to feet, speech affected, prickly feelings in body like needled, double vision, extreme pain in feet and leg, unable to walk, affected vision, unable to sleep at night due to the pains, choking and symptoms are getting worse
28 weeks pregnant at my first dose; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (28 weeks pregnant at my first dose) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 025J20A) for COVID-19 vaccination.     The patient's past medical history included Live birth on 11-Oct-2018.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 21-Jun-2020 and the estimated date of delivery was 24-Mar-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (28 weeks pregnant at my first dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy.  On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (28 weeks pregnant at my first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MATERNAL EXPOSURE DURING PREGNANCY (28 weeks pregnant at my first dose) to be not related.    No treatment related information has been reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Initial report was received on 15 August 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. This is one case in a series of 232 pertussis cases received during the surveillance period from 01 January 2010 to 15 August 2014. A case of pertussis disease in a four-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS). The subject had received four doses of PENTACEL on 17 December 2009, 17 February 2010, 20 April 2010 and 19 April 2011 (lot numbers, route and site of administration were not reported). Approximately three years after the last dose, on 20 July 2014, the subject developed a cough without a whoop. Seven days later on 27 July 2014, the subject developed a paroxysmal cough. The subject also experienced post-tussive vomiting and sleep disturbance (onset dates not reported). Cold-like symptoms were unknown (U). Laboratory testing included positive PCR on 27 July 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 27 July 2014 for "99" days. The subject was not hospitalized. At the time of final contact on 12 August 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.