chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. Beginning on 23-MAY-2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX 19400 Plaque-Forming Units (PFU) lot # M037654, expiration date 29-NOV-2017 and lot # M035149, expiration date 31-OCT-2017 (dose and route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). There was no symptoms reported. Administered doses of vaccines experienced the temperature excursion of -10 degrees Celsius for 2 hours and 50 minutes. Digital data logger was not involved. There were no previous excursions reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA015528:
shingles; This initial spontaneous report was received from a patient (gender and age were not reported) regarding a case in litigation and refers to himself/herself. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 13-AUG-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a Nurse Practitioner for shingles and was treated by a Nurse Practitioner. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
On 12/05/2021 I received a booster. 30-60 seconds later I became really light headed, and dizzy. It is now a week later, and light headedness hasn't gone away, but shaky at times.
COVID; COVID; This is a spontaneous report from a contactable consumer (patient's daughter) via a Regulatory Authority. A 93-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, in Mar2021 (lot number not reported), as dose 1, single; then via an unspecified route of administration, in Mar2021 (lot number not reported), as dose 2, single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 01Aug2021, the patient developed COVID-19 after being fully vaccinated. It was reported that the patient had a breakthrough (as reported) and the reporter asked if there is a waiting period after recovery before getting the booster shot. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
got the flu and it went into pneumonia; got the flu and it went into pneumonia; Initial information regarding an unsolicited valid social media serious case received from a consumer/non-health care professional on 23-Dec-2022.  This case involves female patient of unknown age who got the flu and it went into pneumonia after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA521397(related husband case).   On an unknown date, the patient received suspect Influenza Vaccine produced by unknown manufacturer at unknown (formulation, strength, dose, expiry date, lot number, route, administration site) for prophylactic vaccination.  On an unknown date, the patient developed a serious got the flu and it went into pneumonia (pneumonia, influenza) at unknown latency following the administration of Influenza Vaccine.  Action taken: Not Applicable.  It was not reported if the patient received a corrective treatment for both the events.   At time of reporting, the outcome was Unknown for both the events.  Seriousness criteria : Medically significant for pneumonia; Sender's Comments: Sanofi Company Comment Dated 23-Dec-2022: This case involves female patient of unknown age who got the flu, and it went into pneumonia after receiving vaccine Influenza Vaccine. The time to onset is not reported with the role of the vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed
She was experiencing severe muscle aches; Injection site soreness; After her second dose she is not feeling well; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program. This is one of two reports. A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EW0182; Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 10May2021 (at the age of 67-years-old) as dose 2, single for covid-19 immunization. Medical history included bad hip and knee. There were no concomitant medications. The patient previously took first dose of historical vaccine bnt162b2 (Lot number: EW0161) via unspecified route in right arm on 19Apr2021 (at the age of 67-years-old) for covid-19 immunization and experienced injection site soreness. NDC number and expiry date was unknown and COVID vaccine stated as dosage previously discontinued or treatment completed. The patient experienced she was experiencing severe muscle aches, injection site soreness on 11May2021, after her second dose she was not feeling well on unspecified date in May2021. She had her first dose of the COVID vaccine 19Apr2021, and second dose on 10May2021. After her second dose she was not feeling well. She was experiencing severe muscle aches. This was happening earlier. The muscle aches started on the 11th and 12th. She was still sore. Patient did not have a prescribing doctor. She has a bad hip and knee that was probably not helping. The bad hip and knee started before the vaccine. She had no problems except injection site soreness with the first one. But she had that with every vaccine. She got both doses in her right arm. Investigation assessment included none. Clinical outcome of severe muscle aches was resolving and outcome of other events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up(22Jul2021): Follow-up attempts have been completed and no further information is expected.
I started experiencing muscle aches in left arm and swelling started on clavicle area lower neck it was dime size in morning and went to doctor after July 4 continuous to grow a little bit. Lymph node on neck is swollen.
Within five minutes of vax, the pt experienced projectile vomiting which resolved. One day post vax, the pt experienced diarrhea, vomiting and abdominal pain. The most recent information received reported the condition of the pt as unknown.
Presented to the ED 7/27 with complaint of headache. He reportedly began with a pressure-like headache behind the eyes that started on Friday. He reports he also had some numbness and tingling in the cheeks. This got progressively worse to the point where he decided to come to ED on Saturday and he was treated with pain medication and discharged home. He reports that he did get the first dose of HPV and a dose of tetanus vaccines 2 weeks ago. He also had both doses of moderna vaccine earlier this year. On Tuesday he came back to the ED with persistent symptoms and he developed tingling in the mouth and hands. Neurological derangement concerning for guillain barre variant. EMG done today revealed reduced recruitment in arm and leg, no denervation seen, consistent with early neurogenic process. IVIG treatment started on 7/29/21 to continue for 5 days.
I was called to patient's room at approximately 09:35 after she received her COVID vaccine at 09:14. The nurse reports she was pale and diaphoretic while in observation at 09:20. She had no chest pain, SOB, nausea/vomiting, headache. She stated that she was feeling weak and had lost all her energy. When taken, her BP was elevated, but her other vitals signs and blood sugar were normal. Her heart rate/rhythm was normal and regular. She reported some epigastric pain.  Overtime, her symptoms improved without intervention. She was given water, and rested under observation. Her daughter came to drive her home. She was released after a minimum of 45 minutes post-injection.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (patient had shingles in his 40's). Concomitant products included Tamsulosin. On 19th July 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, dizziness, fall and dysequilibrium. On an unknown date, the outcome of the pain in arm and fall were unknown and the outcome of the dizziness and dysequilibrium were recovering/resolving. It was unknown if the reporter considered the pain in arm, dizziness, fall and dysequilibrium to be related to SHINGRIX. Additional details were provided as follows: The patient has reported this event to via VAERS.
Suddenly had muscle "screaming" at top of both legs when standing from a sitting position, and when bending over to retrieve something from the floor.  Lasted 2 months, then just as suddenly disappeared.  Doctor sees no other explanation.
pt recv vax 28AUG95 & 31MAR97 pt devel chickenpox-like rash w/a moderate to severe case of lesions that were too many to count;fever 102 for 3 days, h/a, malaise & itching;dx chickenpox;
No previous fever or signs of illness prior to vaccinations. On that evening hours after vaccinations given that day, developed febrile seizures, status epilepticus, required intubation, emergent transport, ICU stay.
found cold/blue/not breathing in crib, no response to resuscitation, presumed SIDS autopsy pending
pt recv vax; rash & hives devel;rx w/ dph;lethargic; T of 101 & emesis; focal sz >20 min duration;to ER; to hosp;abn EEG; lt temporal frontal slowing;
Initial case received from a Health Care professional on 15 April 2014. A 46-year-old male patient, with a reported medical history of seasonal allergies and no reported concomitant therapies, had received an intradermal dose of FLUZONE on 30 October 2013 (batch number UT4722BA, site of administration not reported). The reporter denied any illness at time of vaccination in the patient. On 01 April 2014, the patient was tested positive for influenza B with a Rapid Test. He received a corrective treatment with TAMIFLU. The outcome was reported as unknown. The reporter also reported another adverse event which is captured in case number 2014SA049810 (same product and same reporter). Documents held by sender: none.
Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that total 19 patients received expired vaccine out of which 3 were males and 16 were females. It was reported that 10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F.   HCP mentioned that they always had the freezer between this range. Two vials were used to administered HCP's office employees. All doses were injected intramuscularly in deltoid muscle.  Vaccine administration dates were reported as 23-Nov-2021 and 27-Nov-2021.  No concomitant medication reported No treatment medication reported
t104, mottled cyanotic skin; dec responsiveness; fever lasted 24 hrs-36 hrs;
No adverse reaction.  Patient was given 2 doses of Hep B in error.  Hep B vaccine was given and also Pediarix vaccine that includes Hep B.  Contacted CDC and at a higher risk for a local reaction, not likely to have a serious reaction.
Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Additional Details: After vaccination, mother said she is being evaluated for epilepsy and this was the 3rd or 4th time patient has had a seizure after receiving a vaccine.  She first received the Pfizer covid booster, and then moments later received the flu shot.  She showed no symptoms of seizure/fainting after receiving the covid booster, but  after receiving the flu shot, she briefly lost consciousness and began shaking for approximately 10-15 seconds before regaining consciousness. Dr. office notified.
6 year old with Left deltoid redness, swelling at injection site and given ibuprofen and Benadryl.
pt devel cellulitis covering a 4 by 6 " area between the elbow & the shoulder; sx included pain, swelling, erythema & warmth @ the inject site;
Pt had hives on face after H1N1 shot. No SOB noted. Lung sound clear Bi Lat. 122/80 Pules 88 RR 20. No swelling of tongue. 50ML 9.55 Hydramine liquid adm. by
PROQUAD administered instead of MMR that was ordered. Separate Varicella vaccine also administered. Received double the Varicella. Low grade fever and irritable but symptoms resolved 12/4/18.
Severe headaches 2-3 times a week since having the booster. There are very different from a migraine and prevent me from working.
Patient states that she still has pain in her arm over one month later. She said that she can't lift her arm above her head. She was instructed to be evaluated by her physician to determine the cause of the pain and if any further medical testing is needed.
Fever, fussy, bad cough that came out of nowhere, rash first formed around hairline. Fever and intense rash all over body for 5 days. Child could not sleep. Seemed very uncomfortable and agitated.
Pt was seen by a local physician who recommended EMG. 07/26/01 Follow up. This information was faxed to VAERS 05/18/2001. Per health dept, the date of the adverse event was 12/21/2000 and thet time 07:30am.
After vaccine administration, about 30 minutes after,described itching in various area not localized to injection site and not systemic  Benadryl was given and symptoms resolved shortly after.  Advised to follow up with PCP.  Follow up phone call was made  to client and denied any other symptoms and stated that no further itching .
Sore Arm; Headache; Numbness on Left Side of face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 10:00 (Lot number: EL3247) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Drug allergy", notes: Known allergy: Codeine; Oral clindamycin, reaction(s): "Drug allergy", notes: Known allergy: Oral Clindamycin. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Mar2021 10:45, outcome "recovered" (2021), described as "Sore Arm"; HEADACHE (non-serious) with onset 09Mar2021 10:45, outcome "recovered" (2021), described as "Headache"; HYPOAESTHESIA (non-serious) with onset 09Mar2021 10:45, outcome "recovered" (2021), described as "Numbness on Left Side of face". Therapeutic measures were not taken as a result of pain in extremity, headache, hypoaesthesia.  No follow-up attempts are possible. No further information is expected.
8/17/07 started w/sinus cold, 2 days later vomiting. After feeding, then diarrhea x 7 days. 9/28/07 started w/sinus cold, then diarrhea x 4 days
Almost immediately following vaccine administration, patient reported feeling like she was going to faint. She was in a seated position and within 30 seconds her head and upper torso started falling forward. Her eyes closed briefly. Her airways stayed open the entire time, There was no observable foaming at the mouth or convulsions. Within a minute or two she regained full consciousness. 911 was called almost immediately. Prior to EMT arrival, we obtained a blood pressure about 5 minutes following this and it was about 100/66. At that time the patient reported only feeling a little dizzy. Upon further questioning after the event, the patient stated that a similar outcome to this occurred following a blood draw in the past. When Paramedics arrived, the patient was checked out and she declined to go to the hospital and was driven home by a family member.
Very itchy rash; Big redness; This spontaneous case was reported by a physician and describes the occurrence of RASH PRURITIC (Very itchy rash) and ERYTHEMA (Big redness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TAMOXIFEN from 05-Jan-2015 to an unknown date for Breast cancer.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced RASH PRURITIC (Very itchy rash) and ERYTHEMA (Big redness). At the time of the report, RASH PRURITIC (Very itchy rash) and ERYTHEMA (Big redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Patient demographics, start date of concomitant drug, outcome of events were updated.
Muscle aches, n,v; h/a slight fever; fully recovered p/approx 36 hrs;
Lightheaded, itchy, heart palpitations, breathing distress. Sent to UC transferred to ED.
Approximately two and a half hours after vaccinations patient reported feeling light headed and dizzy before having a grand mal seizure. This prolonged for an unknown amount of time before she regained consciousness and was evaluated by paramedics. While advised to visit a doctor no follow up was taken.
Inappropriate vaccine given (Pediarix) pt was 7 years old when received vaccine. Pt had mild fever.
Pain/swelling of injection site, muscle pain throughout body, redness throughout body, itching, high tempature, headache
had a Pins and Needles sensation in his legs; Fatigue; Headache; His arm was Sore / his legs were Achy; This case was reported by a consumer and described the occurrence of pain in arm in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th December 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 5th December 2020, the patient experienced fatigue and headache. On 14th December 2020, the patient experienced pins and needles. On an unknown date, the outcome of the pain in arm, fatigue, headache and pins and needles were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fatigue, headache and pins and needles to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient's spouse. The patient received the Shingrix vaccine and expereinced arm was sore. One day after vaccination, the patient had headache and fatigue. On 11th December 2020, 7 days after the vaccination, the patient's legs were achy. 10 days after the vaccination, the patient had pins and needles sensation in his legs. The all symptoms had resolved, till the time of report. The patient did not consent to follow up. This case had been linked with the case ID US2020251650, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020251650:same reporter
Moderate joint pain in knees, preventing sleeping and normal movement, onset 24 hours hours post-vaccination, resolved 60 hours post-vaccination Headache onset 24 hours post-vaccination, resolved 48 hours post-vaccination Fatigue and chills onset 24 hours post-vaccination, resolved 48 hours post-vaccination
pt w/ asthma recvd a small chicken pox at inject site;28oct95 pt had an exacerbation of asthma; tx w/ inc bronchodilator & pred;
I had gone online and scheduled the second dose appointment in the system for the Pfizer dose on 2/11/2021.  I received an email from the system that the appointment was cancelled at the facility.  I called the facility to see if they were still administering the vaccines. They are still administering the vaccines but somehow my appointment was cancelled.  There are no appointments now available.
Pt was given injection high on (L) arm, above deltoid muscle C/O pain into the next day, had to take Tylenol 1000mg q 12'
PATIENT'S MOTHER CALLED THE DAY AFTER VACCINE ADMINISTERED ON 3/2/2010 STATING CHILD'S ARM INDURATED THE DIZE OF MOTHER'S PALM.  WARM TO TOUCH, SORE AND ITCHING CHILD ON LEFT ARM BETWEEN THE SIDE AND BACK OF ARM.
Had fever beginning 8 days after DTaP/IPV/MMR vaccination.  A day later, she fainted and was unconscious less than 1 minute.  I saw her in the office a few hours later, at which time she was asymptomatic.  Her exam was normal.