chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doses administered after excursion on 22-Aug-2022 to 04-Sep-2022; No adverse event; Administered dose that experienced the excursion; Patient received 0.25 ml as a first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered dose that experienced the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion on 22-Aug-2022 to 04-Sep-2022), UNDERDOSE (Patient received 0.25 ml as a first dose) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Aug-2022 at 11:45 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On 24-Aug-2022 at 11:45 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered dose that experienced the excursion) and UNDERDOSE (Patient received 0.25 ml as a first dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion on 22-Aug-2022 to 04-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered dose that experienced the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion on 22-Aug-2022 to 04-Sep-2022), UNDERDOSE (Patient received 0.25 ml as a first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Administered dose that experienced the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion on 22-Aug-2022 to 04-Sep-2022) and UNDERDOSE (Patient received 0.25 ml as a first dose).    No concomitant medications were reported.  Vaccine was stored in fridge at the time of excursion. The maximum temperature reached was 52.8 Fahrenheit and the excursion duration was 8 days, 16 hours, and 30 minutes. on 22-Aug-2022 the vial was moved from freezer to refrigerator and vaccine was stored in fridge as of now. Total 3 doses were impacted from the vial. A total of 3 doses were administered with no previous excursions. On 05-Sep-2022 fridge died, ever since the fridge went out of range that past weekend and no doses was administered. The temperature went up to 70 degree and the vaccine in that fridge were moved to another fridge.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2022: Follow up received no new information.
Pt noted injection site to be red and warm to touch with a fist size lump the morning after injection of PNEUMOVAX 23.
On 3/14/07 mother states son started having chills around 6pm, severe back pain around 7pm which ended around 8pm, at which time he started having mid-chest pain. Son taken to Hospital ER around 8:20pm. CXR normal, WBC 23.2, Temp 99.3. Discharged from ER around 11:30pm on Amoxicillin with diagnosis as Local reaction to immunization.
FEVER; MUSCLE CRAMPING WORSEN AS THE DAY PROGRESSED; HEAVY LEGS WORSEN AS THE DAY PROGRESSED; This spontaneous report received from a patient concerned an adult male. 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) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On AUG-2021, the patient experienced muscle cramping worsen as the day progressed. On AUG-2021, the patient experienced heavy legs worsen as the day progressed. On 16-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from heavy legs worsen as the day progressed, and muscle cramping worsen as the day progressed. This report was non-serious.
On Sunday morning, upon waking up at 8 am, 01/23/2022, patient reported "haziness and blurry vision" started. She was afraid for her sudden loss of vision. She went to ER. She said they ran all kinds of test and did not find anything. She also visited her optometrist to check her eyesight. He said everything was ok. She still has problems with her vision as of today 01/29/2022. She wanted to report this possible adverse reaction after booster vaccine dose.
has a cold after the booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 08Oct2021 13:00 (Lot number: PF8841) at the age of 77 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII, administration date 02Oct2021; FLU, administration date 27Sep2021. Vaccination history included: Bnt162b2 (Vaccine Name: Pfizer Covid Vaccine , Lot Number: EL3247, Expiry Date: Unknown, Anatomical Location:  Right arm, caller guesses. , No. of Previous Doses: First dose, Date: 27JAN2021, Age at Immunization if date not available: 76 years, Time the Vaccination Was Given: First dose: Around 1030), administration date: 27Jan2021, when the patient was 76 years old, for Covid-19 Immunization; Bnt162b2 (Vaccine Name: Pfizer Covid Vaccine, Lot Number: EM9810, Expiry Date: Unknown, Anatomical Location:  left arm, No. of Previous Doses: Second dose, Date: 17FEB2021, Age at Immunization if date not available: 76 years, Time the Vaccination Was Given: Second dose: 1030.), administration date: 17Feb2021, when the patient was 76 years old, for Covid-19 Immunization. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 08Oct2021, outcome "recovered", described as "has a cold after the booster dose". Therapeutic measures were not taken as a result of nasopharyngitis.  Follow-up attempts are completed. No further information is expected.
The day after vaccination, she presented high blood pressure, headache. (Very strong headache). Today blood pressure seems to be under control.
Had vaccines at 130pm 8-16-18 first symptoms started at 5pm Headache, fever, stiff neck, dizzy, blurred vision, decreased appetite fever 103.0. Diagnosed w/otitis externa (R) ear at office visit.
A report has been received from a Health Professional concerning a 51 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. Reporter stated that we inadvertently gave FLUMIST to a 51 year old patient which started on 15-NOV-2014. The outcome of the event of inadvertently gave FLUMIST to a 51 year old patient is unknown. The report was considered to be non-serious.
Fever of 101.5 the next morning.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the left arm on 16Mar2021 at 12:30 (at the age of 50-years-old), as a second single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had no known allergies and no medical history. Concomitant medications included vitamins (MANUFACTURER UNKNOWN), move-free (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and pollen (MANUFACTURER UNKNOWN), for an unknown indication from an unspecified date and unknown if ongoing. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the left arm on 23Feb2021 at 13:30 (at the age of 50-years-old), as a first single dose for COVID-19 immunisation. On 17Mar2021 at 09:30 hours, the patient experienced fever of 101.5. The patient did not receive any treatment for the adverse events. The clinical outcome of fever of 101.5 was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
I had chest and heart pain also known as myocarditis. I had these pains even when seated on chair and while resting on bed. This is not constant pain. There are times when I am not in pain.
Upon recent news of concerns of intussusception following ROTARIX, I remembered this young patient's case. On 12/3/10, he developed painful bowel movements which progressed to bloody stools. He became very fussy and started vomiting later that day. He presented to hospital where abdominal CT revealed an intussusception. He was transferred to another Hospital where he had an exploratory laparotomy. In surgery, they manually reduced his intussusception and performed a prophylactic appendectomy. He recovered well and was discharged on 12/7. Since that time he has remained in good health. I have provided copies of his hospital records.
Tested positive for COVID on December 5, 2022.  Mild Symptoms--congestion, mild cough, and fatigue.
Patient was admitted to hospital on 3/18/2021, within 6 weeks of receiving COVID vaccination.
Within 1 hour developed soreness, pain, itching at injection site.  Within 24 hours developed systemic itch/rash.  Saw doctor on 11/03/2005, colestone 2cc given intramuscularly, and Zyrtec 1mg by mouth, Eladel cream.
Presented to emergency department on 4/24/21 with shortness of breath following testing positive for COVID on 4/19/21. Patient was admitted for further management, discharging to home on 4/26/21.
Muscle aches, severe headache, chills, nausea - overall flu like symptoms. These same symptoms occurred with the first injection in November, as well.
At post 10 hour mark mild general discomfort. At post 17 hour mark onset of coughing, with slight tightness in chest, headache, body chills, mild general discomfort. At post 22 hour mark tight chest/wheezing/coughing/asthma and pain in chest, 101 degree fever, headache, body chills, moderate general discomfort. At post 24 hour asthma symptoms progressing, called on call nurse line to determine if should be seen, was advised to go to the Emergency room due to chest pain and difficulty breathing.
Delayed injection site reaction. Redness, hot skin, pain starting a week after the vaccine.
I saw patient on 5/06/09 - Thin with history of fainting spells, near "black outs" that started summer '08. Start near time of 2nd HPV. Symptoms worsen from 3/09-5/6/09. Multiple labs, EKG, cardiology eval was done. EEG 8/4/09 was abnormal. Placed on Keppra 750 mg BID. Followed by neurology.  Follow up - Please note - the exact "onset date" can not be determined. You may wish to contact the mother of patient for more details; she stated that she was available for questions. Pt received her first HPV on April 15, 2008, along with Tdap, MCV4, and Hep A. On June 17, 2008, pt mentioned that she had almost fainted the previous week, and that she had been having episodes of "near-fainting" approximately once per week since her second HPV. She stated at that time that she never falls to the floor but feels that if she does not hold herself, she would probably fall. No exact date as to when first episode occurred except to say that it started around the time of the second HPV. I told mom to keep calendar of these near-fainting episodes (I felt at that time that the patient's diet was a possible cause). Pt received her third HPV that day. On October 29, 2008, I saw pt for a sport physical. Mom felt that the near-fainting episodes were better and may have resolved. She did mention that after the third HPV, that her daughter was a "little fainty". On May 06, 2009, pt came in because for the last 2 months the near-fainting spells were now daily. Mom stated that in the fall of 2008, near-fainting episodes were few and far between but now were almost daily. labaoratory workup and EKG were done. She was referred to a cardiologist, and to a neurologist. Pt saw a neurologist on July 10, 2010, and attributed her near-syncopal episodes to dehydration. On August 04, 2009, pt had an abnormal EEG. As a result of the abnormal EEG, pt was started on KEPPRA, an anticonvulsant. On follow-up visit witht the neurologist on October 22, 2009, her near-syncopal episodes resolved with KEPPRA. Patient's last name corrected.
Patient came in on 10/19 asking if the rash on her right arm was normal adverse reaction (it was near the elbow area (it extended from half way between her elbow and her shoulder blade down to her elbow and wrapped almost half way around her arm), which is away from the site of injection). She said she didn't know if it was from the pneumonia shot since she had also received the flu shot in her left arm and started a new medication (Multaq, which made her very sick to her stomach) all at the same time, but she wanted me to report it since there is a very rare occassion of a rash as an adverse reaction to the PNEUMOVAX. She said it was red and warm, but she did not report any itching. She did report she had the soreness at the injection site but no redness at the injection site.
Information has been received from a 53 year old female patient with no drug reactions/allergies referring to herself. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneous in the left arm (dose and lot# were unknown). Concomitant therapies included MIRAPEX. On 26-OCT-2015 the patient experienced a burning pain all the way down her arm into her fingertips, and a tingling feeling that went all the way down her leg. She also stated she has a dull ache in her shoulders that made it difficult to lift anything. The patient did not see her physician about this issue for financial concerns. No treatment was given for the events and no lab diagnostics studies were performed. At the time of the report, the patient said that her arms were still in pain and it hurt for her after being told her arm up to a certain level. The outcome of other events was reported as not recovered/not resolved. The causality was not reported. Additional information is not expected as the reporter didn't like to be contacted.
Covid arm .  Onset approximately one week after first dose, 12 or so days in and raging.  Hives with itching and blistering and crusting over.  Encompasses entire armpit, shoulder, and now creeping into back area and working its way down my side to my waist.  Was forced to postpone second dosage today.
One hour after administration client transferred to hospital for severe vomiting. Hospitalized for overnight observation by the facility she is living.
I have non-stop ringing in both my ears. The ear on the left is often worse than ear on the right, but ringing is present in both ears, 24/7. I never had ringing, but after the 2nd shot of Pfizer, a few days later, it started and it has not gone away. It's been a month since receiving the vaccination.
Caller reported an Improperly stored administered PROQUAD; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history, concomitant medication or drug reactions/allergies was not provided.  On 21-SEP-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD); lot # T013540, expiration date 17-OCT-2021 (strength, dose and route were not reported) for prophylaxis (product storage error).   The storage temperature of the vaccine was 6 Fahrenheit degrees to 14 Fahrenheit degrees (11.7 Fahrenheit degrees) for a time frame of 25 minutes recorded by a data logger. There was no previous temperature excursion.
Vomiting starting about 30 hours after vaccination; large local reaction at vaccination site -- erythema, induration, warmth
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient said was feeling dizzy, shaky and had a warmth spreading throughout her body. She is a type 1 dm and said her glucose level was high at 162 and that she had only had water prior to the vaccine. No issues with first 2 doses which were pfizer. per patient has a history of lightheadedness & shaking when glucose is high so wasn't sure if due to vaccine. Was monitored for additional 15 min. After that patient said she was feeling better, no longer dizzy or shaking. had taken insulin to fix.
6 year old daughter's deltoid started to swell and was red and hot to the touch.  Gave Benadryl but next morning shoulder is still swollen.  Have given her Benadryl during the day but still swollen on 2nd day.
SADDLE PULMONARY EMBOLISM HYPOTENSION ACUTE PULMONARY EMBOLISM 1/20/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Suspected vaccination failure; Second time was far worse than the first time...; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received the dose of Shingles vaccine and patient experienced Shingles. The reporter stated that he/she did not think that patient could get it a second time but one certainly could. The patient stated that the second time it was far worse than the first time and patient did get the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
some minor TIAs; had excessive bleeding from administration site; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number unknown) via an unspecified route of administration on 14Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had excessive bleeding from administration site and using four baby wipes until saturated and bled for approximately one hour.  She received her vaccine last Thursday and is due for the next dose 05Feb2021. She is currently on clopidogrel and metoprolol for some minor TIAs. Is this a common issue with the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
N17.9 - Acute kidney injury (CMS/HCC) SEIZURES FALL
I tested positive for COVID via home test kit on 05/18/22 and verified by PCR test from work on the same day.  I had rhinitis, coughing, sore throat, elevated temp at 99.5 F, body aches, headache.  I called my doctor?s office and was seen via telehealth by Dr for treatment and was prescribed Paxlovid.  I was off work from 05/18 and still have occasional cough, rhinitis and now some mild loose stools with the possibility of going back to work either tomorrow or Wednesday.
Information has been received from a nurse who reported that an unknown number of doses of MMR II were exposed to 47 degree F. for 24 hours, which may have been administered. No adverse effects reported. Additional information has been requested.
Patient is exchange student. Her host mother texted me a photo of patient's arm about 48 hours after vaccination. The photo showed 2 quarter sized circular patches of skin on her anterior forearm just above her antecubital area. Patient told her host mother that these patches were "itchy" and that her arm was achy. The vaccine was given in her left deltoid muscle several inches away from reddened area. Patient told her host mother that this started about 8 hours after the vaccine was given and skin was itchy. The reddened patches had not changed in size in last 24 hours per client. She also described her arm as "achy." Reviewed routine side effects with her host mom which includes sore muscle and instructed that ibuprofen or acetaminophen could help with achiness. Also recommended cool compress to arm. Suggested marking edges of reddened area with waterproof marker to determine if reddened area was increasing in size. Instructed to seek medical attention if skin worsening or any additional reddened area appears.
Irregular menstrual cycle after years of being 100% regular. Extreme cramping, clotting, shorter cycle and heavier bleeding.
Had the Tdap and Hep A shot at 16 mo. Shot was taken at 830am afterwards he was fine. He look drowsy around 5 so I laid him down for a nap. Nap till 8pm that night. When he woke up he was over heated and looked disoriented. I warped him in a blanket and try to cool him down with a wet towel, also gave him water to hydrate. I put him back to sleep at 930pm. At 1130pm he woke up with a 103 fever and he started to shake. Called the EMT. They told us to give him Tylenol. We gave it to him and his fever and shakes went slowly away.
This is an instance of breakthrough COVID-19 after which death occurred. The individual received the Moderna product on 11/05/2021 and the Pfizer product on 02/06/2021 and 02/27/2021. They tested positive for COVID-19 via antigen test on 08/20/2022. They presented to emergency department on 08/21/2022  with general weakness and unwitnessed fall.  They were admitted to hospital on 08/21/2022. They were diagnosed with COVID-19 pneumonia and found to have an acute subarachnoid hemorrhage. Due to poor prognosis, they were transitioned to comfort care and remained hospitalized until their death on 08/26/2022.
Within 12 hours of injection: Body aches, fever, severe chills ( convulsions ), headache, nausea, threw up three times, passed out.
Two week later, approximately, I started having real bad headaches. I was having them at least 5 times a week. I called my doctor. The headache would last 15 or 20 minutes and then it would go away. Sometimes the pain would wake me up. The headache pain had gone away before I saw the neurologist (the last week of March - maybe the 29th); the doctor had referred me to see a neurologist and they gave me a medication to take: Topiramate. It was a 60 day supply and I'm still currently using it. I have a follow up appt to follow up with neurologist on May 3rd. I've not had the headache symptoms. I had the second dose of the vaccine on January 7th, 2021.
Parent registered child using on-line registration system that included parental consent.  7am morning of clinic, child on registration list. Child bused by school to clinic site.  Child administered vaccine.  Discovered that parent had cancelled the appointment after the 7am roster was printed.
mom called chicken pox-type rash all over last noc, only on face & legs today-itchy;
8-1-11 - PENTACEL, Hep B, PREVNAR 13, ROTARIX given. 8-8-11 - Seen in clinic for fever 104 (R). Lab, X-ray done. Normal finding except for pos Lactoferrin. Flu, RSV also neg.