chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT RECEIVED DOSE AND WITHIN 5 MINS NOTICED SYMPTOMS OF ONSET OF ANAPHYLASIS - PATIENT EXPERIENCED THESE SYMPTOMS BEFORE WITH A PNEUMONIA IMMUNIZATION.  PATIENT HAD PRE-MEDICATED WITH 25 MG OF DIPHENHYDRAMINE AND HAD BROUGHT THE LIQUID FORM WITH HER.  WE ADVISED A SECOND DOSE AND TO SIT DOWN IN FRONT OF THE PHARMACY,  staff member STAYED WITH THE PATIENT AND WHEN SHE FELT SHE NEEDED TO ADMINISTER A DOSE OF EPINEPHRINE staff member CALLED 911.  PARAMEDICS ARRIVE WITHIN 5 MINS APPROX 1:35PM AND ESTABLISHED AN IV PORT.  PATIENT TOOK ONE MORE DOSE OF DIPHENHYDRAMINE WITH THE PARAMEDICS AN WAS TAKEN TO HOSPITAL.   IN A FOLLOW UP CALL TO THE PATIENT SHE STATED SHE WAS WELL.  SHE BELIEVED SHE RECEIVED ONE MORE DOSE OF EPINEPHRINE AND A DOSE OF STEROID BEFORE DISCHARGE HOME.
febrile seizure, dad gave respiratory support (4 breaths), took to ER with fever of 40.2 C
chills; vomiting; nausea; severe dizziness; Weakness; Fatigue /severe fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 21:30 (Lot number: EW0169) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Schizoaffective disorder" (unspecified if ongoing); "POTS" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: RISPERIDONE; PRAZOSIN; FLUDROCORTISONE; RITALIN. Past drug history included: Amoxycillin, reaction(s): "Known allergies: Amoxycillin". The following information was reported: VOMITING (non-serious) with onset 24Apr2021 12:00, outcome "not recovered", described as "vomiting"; NAUSEA (non-serious) with onset 24Apr2021 12:00, outcome "not recovered", described as "nausea"; DIZZINESS (non-serious) with onset 24Apr2021 12:00, outcome "not recovered", described as "severe dizziness"; ASTHENIA (non-serious) with onset 24Apr2021 12:00, outcome "not recovered", described as "Weakness"; FATIGUE (non-serious) with onset 24Apr2021 12:00, outcome "not recovered", described as "Fatigue /severe fatigue"; CHILLS (non-serious) with onset 25Apr2021 13:00, outcome "not recovered", described as "chills". The events "vomiting", "nausea", "fatigue /severe fatigue" and "chills" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vomiting, nausea. Therapeutic measures were not taken as a result of dizziness, asthenia.  Additional Information: The patient did not have any other vaccines 4 weeks prior to vaccination .The patient did not have Covid prior to vaccination. The patient was not tested for Covid post vaccination. vomiting and nausea for 5 out of the following 6 days, severe dizziness, weakness and fatigue. Days 2-13 post-vaccination have been throwing up nearly every day. On Day 7 went to urgent care and received Famotidine 40 mg 2x/day and Promethazine 25 mg 4x/day to treat nausea/vomiting and it works to keep food down sometimes. Also, patient frequently had chills and severe fatigue. No fever.   No follow-up attempts are possible. No further information is expected.
Swelling and pain at injection site hours after the injection.  The next day my entire body was sore and in pain. I could feel it all the way down to my bones. It was like this for over a week. My lower back has remained in constant  pain since 5/25/2021. It is difficult to get up in the morning and often times hard to walk.
Patient is 2 months old and received a Flu vaccine by mistake. Tha vaccine is recommended for 6 months and older.
This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with GARDASIL (dose numbers, route, lot numbers and expiration date were not provided). Concomitant therapy information was not provided. On unknown dates, the patients experienced incorrect product storage as GARDASIL was improperly stored and unspecified doses were administered. No adverse effects were reported. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. Additional information has been requested. This is one of several reports received from the same source.
pt complained of chest pain on left side starting the night after flu shot. still having pains on 10/28/19
This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with GARDASIL. Dose, route, lot number and expiration date were not reported. The nurse reported that unspecified number of patients may have received GARDASIL outside the schedule listed in the prescribing information. No known adverse effects. This is one of two reports from the same source (other case # 1409USA008890). Additional information has been requested.
At around 6:30 in the afternoon, I felt sick to my stomach. I didn't know if I had to throw up or have diarrhea. At around 8 pm I couldn't do anything but lay in bed. I had high flashs and cold flashes every 30 mins. I was laying in bed with a hoodie and sweat pants on and could not stop shaking from being cold. Then 30 mins later I was so hot I had to take everything off. It kept going on like that till the next morning. I just now started to feel better around 10 am the next day.
Syncope, seizure tonic clonic type lasting about 1 minute, came to administered 02.
Client states "feeling warm, shaky, tongue tingling and dry", observed face flushed.  O2 Saturation = 98%
Face became extremely red.  High blood pressure for her.  The fingers of the hand turn black and the patient complained that has trouble breathing and then fainted.  Once the patient regained consciousness she started with cold sweats and 911 was called and at that point the patient started to vomit.  The patient end up in the hospital.  In the hospital she kept getting worse all the small vessel of the face and neck broke.  The sclera of the right eye filled with blood.  The patient remained 12 hours at the hospital.  She was also a COVID-19 patient back on the February 17 2021 and was given monoclonal therapy.
She was not perfect on her feet prior to that but could go anywhere she wanted to go; She can't drive but she could get out of bed and go to the bathroom,She could use her walker, and after the shot she can't do it by herself; She will fall; Tired; Laying in bed for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Laying in bed for 3 days), MOBILITY DECREASED (Patient has hard time using her legs, She was not perfect on her feet prior to that but could go anywhere she wanted to go), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She can't drive but she could get out of bed and go to the bathroom,She could use her walker, and after the shot she can't do it by herself), BALANCE DISORDER (She will fall) and FATIGUE (Tired) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036ZIA) for COVID-19 vaccination.     No medical history reported.  Concomitant products included FEXOFENADINE, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), AMLODIPINE BESILATE (NORVASC), CLOPIDOGREL BISULFATE (PLAVIX), UBIDECARENONE (COQ10 [UBIDECARENONE]), GLIPIZIDE, LEVOTHYROXINE, SITAGLIPTIN PHOSPHATE (JANUVIA), PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]), COLECALCIFEROL (VITAMIN D3), PIOGLITAZONE HYDROCHLORIDE (ACTOS), ARIPIPRAZOLE (ABILIFY) and CALCITONIN for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced BEDRIDDEN (Laying in bed for 3 days) and FATIGUE (Tired). On an unknown date, the patient experienced MOBILITY DECREASED (Patient has hard time using her legs, She was not perfect on her feet prior to that but could go anywhere she wanted to go), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She can't drive but she could get out of bed and go to the bathroom,She could use her walker, and after the shot she can't do it by herself) and BALANCE DISORDER (She will fall). At the time of the report, BEDRIDDEN (Laying in bed for 3 days), MOBILITY DECREASED (Patient has hard time using her legs, She was not perfect on her feet prior to that but could go anywhere she wanted to go), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She can't drive but she could get out of bed and go to the bathroom,She could use her walker, and after the shot she can't do it by herself), BALANCE DISORDER (She will fall) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient stated that it all happened after the shot and she went down the hill too fast. Doctor was called, the patient had no temperature and doctor asked to watch her breathing and if any changes bring her to emergency room.  The patient did not take any medications to try alleviate these symptoms.
fainted; unconscious for a few minutes; This is a spontaneous report received from a contactable consumer (reporting on himself). A 28-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number and Expiration Date was not reported), via an un-specified route of administration in in Arm Left on 09Apr2021 10:45 as single dose for COVID-19 immunization. The patient medical history was not reported and known allergies included Codeine, Abilify. The patient's concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination. Not tested COVID post vaccination. It was reported that 09Apr2021 11:00 patient fainted about a hour after getting home. Then the next day at approximately 2:45 she fainted again both times hitting the floor and laying unconscious for a few minutes. Patient had to go Emergency room and hospitalization for a few hours. The outcome of the events was recovered on an unspecified date.   Information on the lot/ batch number has been requested.
This spontaneous report as received from a physician refers to three patients of an unknown gender and age. The patients' medical history, concurrent condition and concomitant medications were not reported. On unknown dates, the patients received the first and the second dose of VARIVAX 0.5 ml (lot#, expiration date and route of administration were not reported). The physician reported that on an unknown date, during evaluation for "pre-college", varicella-zoster serology was performed and the patients had "an antibody response that was not applicable (below level)". The patients did not receive treatment for the event. Product quality complaint (PQC) was not involved. The outcome of the patients had "an antibody response that was not appropriate (below level)" was not reported. The relatedness between the patients had "an antibody response that was not applicable (below level) and VARIVAX was not provided. Additional information has been requested.
I have a patient who has waited 8 months; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date, received first dose.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: I have a patient who has waited 8 months). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 09-JUN-2023 The reporter reported that the he or she needed verification and documentation that the first Shingrix dose did not have to be repeated if given more than 6 months after the first dose. The reporter reported that he or she had a patient who had waited for 8th months. At the time of reporting the patient initial and birth of date was not provided. The follow-up could not be possible as the as no contact details were available. The reporter reported that till the time of reporting the patient had not received the 2nd dose of Shingrix vaccine, which lead to incomplete course of vaccination.
I didn't notice anything until after my ultrasound. I was diagnosed with a small Ovarian cyst or uterine small fibroid on 9/21/2021 on my reproductive organ. Before I got the vaccine my ultrasounds were normal. Also, my AC 6 level went up about 0.3 after I got the shot.
she was sweating; had a fever; diarrhea; This is a spontaneous report from a contactable consumer (Patient). A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6206, patient was 66-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 19Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included type 2 diabetes mellitus. Concomitant medication(s) included metformin (METFORMIN, Formulation: Tablet, Frequency: Twice a day; Route of Administration: Oral) taken for type 2 diabetes mellitus, start and stop date were not reported. On an unspecified date in Mar2021, the patient experienced she was sweating at morning when she woke up, had a fever, diarrhea. The patient underwent lab tests and procedures which included body temperature: temperature but the fever went away, sars-cov-2 test negative both on an unspecified date. The outcomes of events (she was sweating, had a fever) were recovered on an unspecified date in 2021 and the outcome of event (diarrhea) was recovering.  No follow-up attempts are possible. No further information is expected.
On March 29 2021, I received the first dosage of the Moderna vaccine. The second dosage was given on April 26th.  I was just getting off my period when I got the shot on the 29th but it kept going afterwards. It has not stopped since then, including after the second dosage. Some days it is heavier, and other days it is very light.  I have had a period for 4 months now.
After vaccination, the patient developed a small bruise at injection site and a red, raised, warm, rash below the injection site. Patient returned to the pharmacy a few days later and showed RPh on duty. We advised her to be seen by primary care doctor. She was seen and PCP said it looked like allergic type skin reaction and recommended Tylenol and Anti-histamine.
Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Pt had a period of nausea within 30 seconds after receiving vaccine. Pt vomited a small amount once into the clinic sink and immediately felt better. Pt and Pt's father said that Pt had been very anxious. Monitored Pt for 15 minutes. All of Pt's vital signs were within normal limits. Pt said she was feeling back to normal and was able to independently walk out of the clinic.
This spontaneous report was received from a pharmacist and refers to a 66 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in Spring of 2015, the patient was vaccinated with ZOSTAVAX (frequency reported as once, dose, injection site, lot# and expiration date were not provided), subcutaneously. The patient had a hard small round lump, located at the injection site (reported as where she had the "shingles shot"). The patient sought medical attention via visiting the pharmacy on 17-OCT-2016, but the pharmacist couldn't evaluate, if the patient had this small round lump since the Spring of 2015 (when she had the ZOSTAVAX), or if she experienced it after the vaccination. No treatment was given for the adverse event. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Patient developed hives on her feet after immunizations were given. She was then given the appropriate dose of BENADRYL and monitored.
24hr p/vax lt thigh devel red, warm to touch, edematous area;10AUG96 830PM c/o leg pain;noted red edema from knee to groin, surrounded by dark red rim;also clusters of eraser-size blisters;called MD-to ER;allerg rxn;pt hosp
dizziness and lightheadedness onset after receiving the COVID-19 vaccine.  Pt transported via EMS to the ED for f/u.  Ibuprofen 600mg po
pt recv vax 7NOV97 & on 8NOV97 pt devel hives on abd, legs & arms;
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" ¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬Individual came in Clinic for 2 ND dose of Covid-19 Vaccine.  When individual was asked if this is visit for the second dose of Pfizer vaccine she said yes. He did not have his vaccination card for the first dose on hand.  His vaccine card was misplaced.  I give the Pfizer vaccine then proceeded to complete the client vaccine card. I went to computer to get the 1 st information that is when I noticed she had received Moderna as the 1st dose. Patient did not report any reaction to the vaccine during he 30-minute wait period.
Aprox. 15 hours post vaccine: chills-lasted 4 hours, fever ranging 99-100.2 - lasted  15 hours, body aches and headache- lasted 18 hours, very tired and weak -lasted 24 hours, nasal congestion -lasted 24 hours, rapid heart rate-lasted 24+ hours, lymph nodes under arms tender -lasted 18 hours.  Took combination of Tylenol and Advil to control symptoms.
I had my first AND ONLY SHINGRIX  injection August 13th 2020 from Pharmacist  several hours after injection arm began to swell and become painful. Called Pharmacy- was told to ice site. Swelling continued through August, September, October and November - small painful 'bump' can still be felt at Inection site.  I have NO RANGE MOTION IN UPPER LEFT ARM. I Cannot LIFT MY LEFT ARM OVER MY HEAD i CANNOT LIFT MY LEFT ARM LEVEL  MY LEFT ARM HURTS CONSTANTLY ANTI-INFLAMITORIES (TRAMADOL) DO NO HELP
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant were not reported. Approximately in 2015, an unspecified number of patients was vaccinated with GARDASIL lot number K010215, expiration date 05-MAY-2017 (dose and route of administration were not reported). The is one of several reports received from the same reporter. Additional information has been requested.
Patient was administered DTaP instead of Tdap - NO adverse effects as of 5/16/2007.
Crying 6 hours inconsolably; intermittently for 48 hours.  No pallar/fever/local reaction.   Treated with Tylenol, prior to immunization.
It was a horrible ickiness feeling accompanied by nausea, impenetrable headache, diarrhea and loose stools.
C/O "headache" approx. 10 days after receiving H1N1 nasal vaccine. No other complaints voiced.
Within two weeks of all 3 Moderna vaccinations I developed a UTI requiring medical treatment.  I have no history of UTI's.  Dose 1 4/7/21   UTI 4/20 Dose 2 5/5/21  UTI 5/14 Booster 12/17/21  UTI 12/29
no adverse event; incorrect product storage; This spontaneous report has been received from an office manager referring to an unknown age and gender patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported.  On 18-AUG-2021, the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, strength, route of administration and anatomical location were not provided; lot # U009260, expiration date reported as 19-SEP-2022, albumin status recombinant Human albumin (rHA)) for prophylaxis. The vaccine underwent temperature excursion of -10.7 degree Celsius for total 192 hours. It was reported that there were no previous temperature excursions. At the time of report, there was no adverse event (AE) reported.
With the first vaccine, patient experienced dizziness within hours of receiving the vaccine. After the second vaccine, patient experienced fainting and hit her head. She was evaluated by a physician.
Pt came to ER with difficulty breathing, came by EMS.  Pt admitted to ICU.
A few minutes after vaccine  my arm and two middle fingers began to tingle and go numb. Then I continue to have this happen several times a day. Sometimes my arm at vaccine site hurts really bad. It makes it hard to hold anything or type until the numbing and pain goes away
Pt had the vaccine at 7:15 a.m. today, sat at the facility where he received the vaccine for 15 minutes, pt was with his mother who was driving.   Pt then went to his mom's car, they were driving when pt had a syncope episode, per his mother his hands were shaking, pt's mother then drove him to our ER facility.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 12 hrs after receiving SHINGRIX, the patient experienced pain in arm, influenza-like symptoms, nausea and erythema. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, nausea and erythema were recovered/resolved. The reporter considered the pain in arm, influenza-like symptoms, nausea and erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but could be 69 years or 70 years. Twenty four hours after vaccination, the patient experienced flu-like symptoms and nausea which lasted about 24 hours. Arm pain and redness were lasted 7 days. The pharmacist did not have vaccine lot or expiry information readily available at the time of the call. The pharmacist did not feel like any medications or medical history contributed to this.
Mild fever Extreme weakness and body ache Pounding head ache Mouth ulcer Breathlessness Increased heart rate (85bpm instead of normal 65bpm resting)  Symptoms started about 12 hours after vaccination (this was the second dose) an persisted till 48 hours after vaccination gradually getting better  Taking crocin alleviated symptoms
Fever to 100.5 2-3 hours after vaccine. Fever and fussiness continued for 48 hours. Had septic work up which was negative. A follow up report received 9/20/2002 adds: No site reaction reported.