chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient started feeling sick after watching another patient fainting after receiving his vaccine. Patient felt nauseated and vomited.
pt recv vax & got a dose of APAP 10AM & 2PM;pt took a nap 215PM & was unresponsive & shaking all over for 5min;temp went up @ that time & pt grunted for 15min afterwards;t101.9 R @ 3PM & had a nl exam w/grunting;
The spots than turned into an all over body rash covering her chest, legs, forearms, and back.; Muscle weakness; rash itches; scar; rash is open, bleeding; had 3 spots that developed on her body.; This non-serious case was reported by a consumer via call center representative and described the occurrence of spot-like rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes.   On 16-JAN-2023, the patient received the 1st dose of Shingrix. On 27-MAR-2023, 70 days after receiving Shingrix, the patient experienced spot-like rash (Verbatim: had 3 spots that developed on her body.). On an unknown date, the patient experienced generalized rash (Verbatim: The spots than turned into an all over body rash covering her chest, legs, forearms, and back.), muscle weakness (Verbatim: Muscle weakness), itchy rash (Verbatim: rash itches), scar (Verbatim: scar) and rash hemorrhagic (Verbatim: rash is open, bleeding). The outcome of the spot-like rash, generalized rash, muscle weakness, itchy rash, scar and rash hemorrhagic were unknown.   It was unknown if the reporter considered the spot-like rash, generalized rash, muscle weakness, itchy rash, scar and rash hemorrhagic to be related to Shingrix.     It was unknown if the company considered the spot-like rash, generalized rash, muscle weakness, itchy rash, scar and rash hemorrhagic to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-MAY-2023. The reporter was patient's daughter. The reporter stated that her mother had her first dose of Shingrix administered on 16 January 2023 and the second dose on 3 April 2023.  Her mother had 3 spots that developed on her body on 27 March 2023.   The spots than turned into an all over body rash covering her chest, legs, forearms, and back.  The patient also experinced Muscle weakness, rash was open, bleeding, and looks like a scar, rash itches after admistered shingrix. The patient did go to a dermatologist on 6 April 2023.  The patient also went to the hospital emergency room on 7 May 2023.   No further information was known. Emergency room Visit Required. Consent, address, and other questions were asked.   The daughter grew frustrated and disconnected the call prior to obtaining consent, address and more information.   The daughter stated how was me giving you this information going to help my mother. Something was wrong with the medication as her mother was not feeling liked this prior to vaccination with Shingrix.
severe side effects; funny taste on their mouth; vaccine was being administered directly in vessels; not being correctly administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION, TASTE DISORDER, INCORRECT ROUTE OF PRODUCT ADMINISTRATION, and PRODUCT ADMINISTRATION ERROR in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION, TASTE DISORDER, INCORRECT ROUTE OF PRODUCT ADMINISTRATION and PRODUCT ADMINISTRATION ERROR. At the time of the report, VACCINATION COMPLICATION and TASTE DISORDER outcome was unknown and INCORRECT ROUTE OF PRODUCT ADMINISTRATION and PRODUCT ADMINISTRATION ERROR had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were not reported. Treatment medication were not reported.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 1:59 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:59 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Batch number 044B21A underwent temperature excursion with temperature 34 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 6-Apr-2021 and beyond use date for the vial was reported as 9-May-2021. Product moved to clinic on 15-Apr-2021  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported
Patient had right knee joint pain from left arm tetanus shot that was given. He started noticing the pain the day after the shot was administered.
Information has been received from a registered nurse (R.N.) concerning a patient who may have been vaccinated with a dose of MENACTRA instead of the second dose of GARDASIL due to an office error. The nurse stated that the office documented that the patient was given GARDASIL but the lot number they recorded was indicating MENACTRA. The nurse did not have the lot number available to provide on the phone. She did not specify which dose this error was related to (first, second or third). No adverse reactions were reported. Additional information has been requested.
Fever Blisters; This case was reported by a pharmacist via call center representative and described the occurrence of fever blister in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th September 2019, the patient received Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced fever blister. The patient was treated with antivirals nos. On an unknown date, the outcome of the fever blister was unknown.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient underwent a dental procedure after she developed fever blisters. The patient had been prescribed antiviral medications. The reporter did not want to provide any additional details.
This spontaneous report as received from a other health professional refers to a unspecified number of patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates in approximately 2015 (reported as since 06-JUN-2015), the patients were vaccinated with a dose of MMR II (strength, dose and frequency were not reported) lot # K006396 expiration date 04-MAY-2016 and lot # K024036, expiration date 26-NOV-2016 that were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt developed allergic reaction within 1-2 m. after Hep A injection. (R) deltoid. Developed erythematous rash on both arms and anterior trunk. No resp. distress. 15ml Diphenhydramine.
0100 (am): nausea, vomiting 0200: hives, body rash  Within hours, hives had completely engulfed my body, to include perineal areas and chest.  0500-0600: Airway swelling, hives on neck. Required shot to decrease airway swelling.
Projectile vomiting began occurring the week of June 13th 2011.  He could not keep food down and would projectile vomit and would turn blue.  An ambulance was called because the child was struggling to breath.
VACCINE WAS FROZEN AND THAWED OUT PRIOR ADMINISTRATION; FROZEN AND THAWED OUT VACCINE ADMINISTERED; This spontaneous report received from a pharmacist 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 was not reported, administered on 02-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-JUL-2021, the subject experienced frozen and thawed out vaccine administered. On an unspecified date, the subject experienced vaccine was frozen and thawed out prior administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the frozen and thawed out vaccine administered and vaccine was frozen and thawed out prior administration was not reported. This report was non-serious.
Patient received his shot at 7 AM. He went home (works evening shift), and "felt slight headache around 1:00 PM." He went to work at 3:00 PM and around 8 PM "felt lightheaded and passed out and hit his forehead". A coworker called EMS and they tended to his forehead wound and transported him by ambulance to Hospital. He said that "they started an IV because they thought he was dehydrated?"  At the hospital, he said they did "full testing to make sure he didn't have a concussion". He was released and got home around 10 PM and took Ibuprofen. He said he "felt bad all day Sat. and laid around and rehydrated. He "felt OK by Sunday."
On 1/20/2022 about a month after getting my booster, I started having trouble seeing out of the upper quadrant of my right eye. It was extremely cloudy. The rest of my entire visual field seemed fuzzy, almost like looking at TV snow that comes on the screen. I wondered if it was just because I was tired and I let a week go by, before I called my doctor. They told me that it could just be floaters. Then the hospital clinic called me back and said that I could be having a retina tear or that it's detaching. They wanted me to come in immediately the next day. It was confirmed that I had tears in my right retina and I had laser treatment done in his office. It took a couple of weeks to heal.
Information has been received from a medical technologist concerning a 12 month old male with no known drug allergies who on 01/17/2002 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. It was reported that within a week of being vaccinated the child developed chickenpox with 90 + vesicular lesions over his entire body and a low grade fever. The pt sought unspecified medical attention. Additional info has been requested.
Given DTAP No 5. Next day developed pain, redness in the area of administration. Treatment: Ice pack, Advil, watch for fever.
Pt received vaccination on 9/19/12. Pt came into pharmacy on 9/22/12 complaining of pain and soreness at injection site. When observing pt noticed approximately 4" red streak surrounding injection site w/red puddle & lighter in surrounding area. Pt complained of difficulty lifting arm & has pain carrying purse. There were no complaints of itching. Recommended generic BENADRYL 25-50 mg every 4-6 hours for 24-48 hours. If not any better than contact dr.
After sitting down after receiving a covid immunization patient appeared to faint. Paramedics were immediately called. After a few seconds the patient was alert and verbal.  No signs of redness, local or systemic reaction. Patient's family waited with patient until EMS arrived. Paramedics determined patient was okay to return home and did not require further medical care.
Patient experienced syncope and fell down while shopping in the store following vaccination. Patient had sat in a chair for 15 minutes following her booster shot, had been jovial and in good spirits post-vaccine.  When asked how she was feeling, after waiting , she said she felt fine, but was ready to go home. She was provided with a small bottle of water, not at her request, but as a courtesy. Pharmacy staff did not witness her fall, but her husband said she fell quietly and he only heard her fountain drink hit the ground. EMS was called. Her sister, who was a nurse, was with her as well. BP was taken and was 144/83 and HR was 76. Her husband reported that those values were low for her normal BP. She did not go to hospital and ambulated out of the warehouse on her own.
9 HOURS AFTER SHOT EXTREME COLD FEELING.  THEN ALMOST PASSED OUT AND BODY FELT LIKE IT WAS GOING INTO SHOCK .  THROUGHOUT NIGHT BODY SHAKES, PERFUSE SWEATING ALL NIGHT LONG.  LASTED ABOUT 10 HOURS
Injection too high, given into the joint space. Increasing arm tenderness, pain with lifting and range of motion. Continues at 2 weeks out
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB, lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9, lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a timeframe of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 14-year-old patient of unknown gender. On 28-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot number N023828 (expiration date 25-JUN-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
shingles; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had developed shingles after taking the first dose of the Pfizer COVID-19 vaccine. Last Thursday (01Apr2021), the patient went to a walk-in clinic because the presentation of her illness was not typical of shingles but the doctor confirmed that it was shingles (on an unspecified date in 2021). She was prescribed with valaciclovir (VALTREX) and the antiviral therapy was started on an unspecified date (reported as this weekend). The outcome of the event was unknown.   It was stated that there had been conflicting recommendations by the doctors on whether the patient should go ahead with both the antiviral medication and the Pfizer COVID-19 vaccine. Reporter wanted to know if there would be more information about an active case of shingles while taking the Pfizer COVID-19 vaccine and also wanted to know if there would be interactions with antiviral therapy (ex. Valtrex) and antibiotics with the Pfizer COVID-19 vaccine.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Information has been received from a dentist concerning her 22 month old daughter, with no medical history, who on 01/07/2005 was vaccinated with a dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  There was no concomitant medication.  On 01/20/2005 the patient developed a measles like rash over all of her body.  It was also noted that she developed symptoms of the measles on 01/20/2005.  The patient's symptoms persisted.  Unspecified medical attention was sought.  No product quality complaint was involved.  Follow up information from a dentist indicated that on 01/20/2005 the patient had large spots on her arm, legs, and forehead.  There were raised dots, some as large as 50 cent pieces.  By the afternoon of the same day they resembled mosquito bites.  On 01/21/2005 all spots were gone.  The full rash had raised red dots that did not blanche on entire trunk, neck, ears, and alot on the face.  It was reported that the patient wore sunglasses for 2 days.  The rash disappeared completely by 01/27/2005.  It was noted that the patient had no fever.  Additional information is not expected.
Extreme lethargic, suicidal thoughts, sense of doom, irritability, headache, nausea, diarrhea
so painful when injected; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The reporter asked why was the Shingrix vaccine so painful when injected.
1:30AM on 2/12/21 awoke with headache and severe chills.  Could not get warm with multiple blankets. Temperature rose to 102 degrees by 6AM.  Could not sleep as body aches and shivering were intense.  Took tylenol at6AM.  Temperature started to decline and was only 100 degrees after 3 hours.  Temperature rose again to 101 degrees as tylenol wore off.  Took tylenol again at around noon.  Shivering had abated. still headache and body aches.  Was able to sleep but temperature remained elevated into the night. By 2/13/21 temp low grade, body aches, tired.  Arm very sore throughout.  Started to feel somewhat normal by 2/14/21 but still exhausted and having body aches and a very sore arm.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 as dose 4 (booster), single (Lot number: GL0446) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Vestibular migraine" (unspecified if ongoing). Concomitant medication(s) included: TOPIRAMATE; BUDESONIDE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3(BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 22Dec2022, outcome "unknown", described as "loud banging tinnitus". Therapeutic measures were not taken as a result of tinnitus. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination; Since the vaccination, patient not been tested for COVID-19. List medications the patient received within 2 weeks of vaccination was topiramate, budesonide nasal Spray not aware of any known allergies. No follow-up attempts are possible. No further information is expected.
Was sick; This is a spontaneous received report from a Pfizer-sponsored program, a contactable consumer (patient wife). A 71-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Pfizer NTEC), via an unspecified route of administration on an unspecified date as single dose and second dose via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included covid before vaccine. The patient concomitant medications were not reported. It was reported patient got his vaccine and was sick for 10 days after the first dose and 24 hours after the second dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Chest pain like indigestion. Threw-up every hour 1/7/2022. Pain in chest moved lower with cramps for 2 days. Diarrhea started 1/9/2022, lasted 2 days.
severe nausea, vomiting, diarrhea, headache, fevers, dizziness, arm pain and abdominal pain.
The patient initiated dose #1 of the oral typhoid vaccine on 5/18, took dose #2 on 5/20, then in the early morning of 5/21, woke from sleep with acute onset abdominal/chest/back pain. He went to the ED and was found to have transaminitis (elevated AST/ALT/GGT, mild bili elevation) and gallbladder thickening, but no stones and or other obvious etiology. He was admitted for acute liver injury and discharged after 1 day of admission with labs showing spontaneously improving transaminitis.
Flu-like symptoms: tired, muscle pain, a headache, shivering, fever, stomach pain, and nausea.