chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pneumococcal vaccine given L deltoid 10/19 approx 6am by LPN. Influenza vaccine given R deltoid 10/19 approx 10am by another LPN. At approx 6pm on 10/19 pt. c/o sore throat. During the night it progresses to chills, diaphoresis, body aches, headache, and malaise. Temp 99.6 at 6am 10/20. 12:30pm vitals 154/90-78-101.7. Motrin and clonidine ordered. Suggested pt. push fluids. 10/21 pt developed reddened area L deltoid which was hot to touch. Question of some streaking. Vitals 144/83-98.2-83-18. Dx of cellulitis of L deltoid. Bactrim DS ordered. Stil c/o sore throat, chills, sweats. 10/22/11 Low grade fever, sweats, chills. Vitals 135/82-101.0-86-18. Positive local cellulitis / erythema L deltoid. 10/23/11 Decreased fever, decreased induration L deltiod, less erythema. Vitals 112/62-96.0-85. 11/24 Minimal sweats, chills. Temp 97.9. Increased energy. Less erythema. Mild induration. Vitals 142/95-97.9-80-16. 10/25/11 L arm still painful but good range of motion. Slight erythema. Feeling better. Vitals 124/80-96.3-77-16.
About one hour after shots, pt started to have difficulty breathing went limp, eyes rolled, rash in upper eyelids. Mom does not know for how long.
Friend tested positive for Covid virus; Friend tested positive for Covid virus; runny nose; sneezing; feeling terrible; got very sick; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's friend) reported that a 5-decade-old (in her early 40's) female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Formulation: Solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration in Mar2021 (age at the time of vaccination was not provided) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The medical history included unspecified allergies from an unknown date and unknown if ongoing (does have allergies). The patient's concomitant medications were not reported.  The reporter was at a friend's house on Saturday night, and her friend (patient), was in her early 40's, and was vaccinated in Mar2021. The reporter later clarified that she was not sure which Covid vaccine her friend received. The reporter stated that her friend was very healthy, and they ate outside. The reporter stated her friend was sneezing and had a runny nose at the time, but her friend does have allergies. The reporter's friend (the patient) started feeling ill and went to the doctor and tested positive for Covid. The reporter stated on Sunday, her friend woke up feeling terrible and on Monday in 2021, her friend (the patient), tested positive for Covid (medically significant). The reporter declined to complete a safety report. Full details not obtained. The patient was tested positive for Covid virus after being vaccinated with unspecified Covid vaccine: had runny nose, sneezing, feeling terrible on an unspecified date in 2021. The patient got very sick in 2021, and the reporter thought that the booster should be recommended to not only older people but younger people as well. The reporter stated there was no reason for someone as healthy as her friend, to have a breakthrough case. Reporter seriousness for tested positive for Covid virus after being vaccinated with unspecified Covid vaccine: had runny nose, sneezing, feeling terrible was unspecified. The sample of the product was not available to be returned, if requested. Reason for no lot number: of Covid vaccine, unspecified manufacturer: Caller unwilling to complete the report. The patient underwent lab tests and procedures which included SARS-COV-2 TEST: positive in 2021. The outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I started having chest pains and rib soreness. I woke up feeling like I got hit by a truck. I started taking ibuprophen thinking I may have pulled something but the soreness never subsided. It hurts to move, when I cough, sneeze, etc. I went to the Urgent Care/ ER last night because I wanted to see if something major was wrong, They did blood work and ran a couple of tests but everything came back fine. I didn't mention to them that I received the first dose of vaccine because I didn't think I could get a side effect a week later until I looked on the  website today. I'm still in pain and I have no idea what could have caused this other then the vaccine.
Information has been received from a physician via a company representative referring to a male patient of unknown age. The patient's concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 (strength, lot#, expiration date, dose and route were unknown). On an unknown date the patient's arm swelled up and the patient went to an unknown emergency room and received unspecified treatment. It was not known which hospital, if the patient was admitted or discharged to home, or the dates. The outcome of the event was unknown. Additional information has been requested.
Hx of dizziness with blood donation. NeaR syncopy + NAuses @ 0822  Observed 30 minutes + Resolved
This spontaneous report as received from an Emergency Medical Technician (EMT) refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients received improperly stored doses of ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). It was stated that the vaccine underwent a temperature excursion of 17.6 degrees Fahrenheit for 84 hours. No previous excursion was reported. No data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax & devel chicken pox on 28MAY95; pt seen in ER 28MAY95 where dx of chicken pox was confirmed; pt devel over 400 vesicles predominantly located on the trunk;
Patient was vaccinated at 2:00 pm on Friday (04/09/14). This night she experienced pain at her left arm. On Saturday she presented pain, edema, fever and erythema on her left arm. She decided to go to emergency department and Dr. diagnosed her with cellulitis on Monday. Medication list: Levaquin 750 mg (1 tab x 7 days) and Sulmdec 200mg (1 tab every 12 hours).
Patient received 1st and 2nd dose of pfizer vaccine in Jan 2022. On office visit June 2022 she complained of right side pain for a couple months. She is a current smoker. She was sent for CT scan chest in July which revealed "Lymphadenopathy, bilateral lung masses and nodules with partial destruction of the posterior right fifth rib suggestive of malignancy." She was ultimately diagnosed with stage IV lung adenocarcinoma. While her smoking history is certainly more then enough to explain her cancer, the timing of her symptom start after her vaccine doses was suspicious, and thus report made.
A non-serious spontaneous report of received expired FLUMIST was received from a health professional concerning a 29-month-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2011. The patient received the expired FLUMIST on 23-Nov-2011. The patient received a repeat dose. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. The reporter stated that the patient did not experience any late occurring adverse events. This case will be submitted in accordance with MedImmune FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Information has been received from a Registered Nurse concerning a 67 year old male patient with osteoarthritis and hypertension and "no known" drug allergies, who on 27-JUL-2006, was vaccinated intramuscularly with the first 0.5 ml dose of PNEUMOVAX 23 (Lot #651332/1049P; expiration date unknown) and on 16-MAY-2011, was vaccinated intramuscularly with the second 0.5 ml dose of PNEUMOVAX 23 (Lot #667695/1028Z; expiration 28-JAN-2012). Concomitant therapy included simvastatin (manufacturer unknown), finasteride (MSD), lisinopril (manufacturer unknown) and aspirin. The nurse reported that the patient experienced fever, general achiness and a sore shoulder after administration of his second dose of PNEUMOVAX 23 on 16-MAY-2011. On 17-MAY-2011, the patient experienced dizziness and nauseousness. The patient fell and broke his right leg that day (17-MAY-2011). The patient was examined in the emergency room and was admitted at the hospital. The patient underwent a surgery on his leg. Laboratory diagnostic tests included a basic metabolic profile, blood count and prothrombin time (date and results not provided). At the time of the report the patient's outcome was unknown. The reporting nurse considered the events to be disabling. Additional information has been requested.
pt recvd vax 16JAN96 & 26JAN96 devel 3 1/2 x 4cm area of redness, warmth, tenderness & pruritus
On 3/27/09 the employee went to the ER around 10 pm due to swelling in neck, change in voice and difficutly speaking.  States he did not have difficulty breathing.  Was given Predisone.   Patient stated later that he had noticed some swelling in neck after 1st injection on 2/24/09.
This spontaneous report was received from a registered nurse referring to a 12 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 26-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored (incorrect product storage). This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA008666:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 46-year-old female patient who received FLUARIX QUADRIVALENT (batch number 9D325, expiry date June 2017). On 15th September 2016, the patient received FLUARIX QUADRIVALENT .5 ml. In September 2016, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising was recovering/resolving. The reporter considered the injection site bruising to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were received as follows: The patient experienced bruising at injection site lasting over 12 days after vaccination. The start date of bruising was unknown.
Moderna monvalent peds 6-11 vaccine administered in error.  Should have received Moderna Bivalent booster dose.  No adverse event reported.
Headache; Fever; strong pain in the chest; This is a spontaneous report from a contactable consumer (patient's mother). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number unknown) via an unspecified route of administration on 24May2021 as 2nd dose, single (at the age of 18-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no effects, but patient went to bed early at 20:00 last night and did not mention anything. On 24May2021, patient experienced headache, fever, strong pain in the chest. Patient still felt pain in chest. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
ocular migraine; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 12:30 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Osteoarthritis" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: OPHTHALMIC MIGRAINE (non-serious) with onset 12Apr2021, outcome "recovered", described as "ocular migraine". The event "ocular migraine" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of ophthalmic migraine.  Additional information: facility type vaccine: pharmacy or drug store. Patient did not receive any other vaccines in four weeks. Patient took other medications in two weeks. The patient had no known allergies. The patient was not tested for COVID post vaccination. Patient had not COVID prior vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021488844 same reporter/patient, different dose/AE
5-9-18 at 3:30. Phone call from Grandmother who brought infant in for immunizations. States "crabby" evening of shots and yesterday. Today just wanting to sleep, feels like running a fever, had water diarrhea x3 this morning. No redness or swelling of injection sites. Advised Grandmother to seek medical attention either with infant's provider or Emergency Room.
Information unavailable.  Patient died at home.  Covid 19 listed as cause of death on death certificate.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 05-APR-2016 the patient was vaccinated with an improperly stored (at 14.9 Celsius degree for 280 hours) dose of (Oka/Merck) VARIVAX (lot# reported as I04688, expiration date 23-NOV-2017, dose and route unknown). There was no out of range before. No adverse events were reported. Lot number I04688 is an invalid lot number for (Oka/Merck) VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Patient presented to the ED with complains of generalized weakness after receiving her 2nd COVID vaccination the day prior. She noted weakness and fatigue and inability to ambulate well. EMS noted patient's home had feces and bottles of urine on the counter. She was admitted under observation. Pt was discharged with instructions to follow up with PCP and is now pursuing medical leave/disability
Varicella vaccine given 11/16/99. Developed fever (102) 11/17/99 & subsequent pox, on 11/17/99. No known exposure to chicken pox.
Limited range of motion: can't raise my arm. Severe pain, tingling, numbness, pain to touch at the injection site, burning sensation.
I was told that the client stated was willing to have a Tdap today I checked chart and viewed order, I prepped the vaccine Went to room discussed the vaccine with client in detailed confirmed name date of birth had no further questions I gave vaccine. I charted vaccine as as I was closing the vaccine I saw the order change to delete. Dr. came out and asked if I gave the Tdap yet or not and I stated yes. She stated she deleted the order as he didn't need it. and would note the chart as vaccine given without order.
Day1 - head cold, body aches, pruritis, bilateral hand swelling,  Narrative:
10:58 Reported increased HR HR 77-80, BP 138/90, Reported High HR and High BP.  Water provided. 11:15 HR 77, BP 132/80, Reports feels better and this is a normal feeling for her.  Encouraged to  notify PCP
Received MCV4, HPV4, then FLUARIX, mom noticed was shaking whole body, then fainted (loc for about 2 mintues), went to car, was shaking/pale, then 7:30pm started shaking again; shaking throughout day and night. Went to MD office on 11/15/12, was seen to have intermittent episodes of brief (few seconds) fine tremors in various locations not all at once (head, shoulders, left foot, arms). Normal neuro exam otherwise.
I woke up around 1:30 am on January 5th with a temperature of 99.9 degrees F.  By 3:00 am, my temperature spiked to 100.5 degrees F.  By 7 am, my temperature had returned to normal, around 98.6 degrees F and I have felt fine the rest of the day, besides some soreness at the injection site. I did not take any medications to help with the fever.
Patient reports that she started having watery, itchy and burning eyes about 5 hours after the administration of the flu vaccine. She also reports experiencing pain with swallowing, headache and some nasal congestion. Her eyes were also pink. She says that the pain with swallowing and nasal congestion subsided about 20 hours after getting the vaccine and the pink eye is also clearing up. She reports to clinic about 24 hours after injury. Now, conjunctiva is still erythematous. No other positive finding on physical examination. Treatment: Supportive.
first dose 13-JUL-2022, second on 18-JUL-2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) (batch number LG3B4, expiry date 8th April 2023) for prophylaxis.   Concurrent medical conditions included hiv infection. Concomitant products included Herpes zoster (Shingrix).   On 18th July 2022, the patient received the 2nd dose of Shingrix. On 18th July 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's comment: Pharmacist reported that a patient inadvertently received his first dose of Shingrix on 13th July 2022 and the second dose on 18th July 2022. The pharmacist opted out of providing additional information. The reporter did not consider the patient to be immunocompromised due to the patient's blood levels. The reporter did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix earlier than the recommended interval, which led to shortening of vaccination schedule.
Patient was inadvertently administered the Fluzone High-Dose Quadrivalent vaccine, rather than the Fluzone Quadrivalent vaccine with no reported adverse event; FLUZONE HIGH DOSE QUADRIVALENT was given to a consumer under 65, with no adverse event; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case from a pharmacist via agency (under reference- 00791171 ).  This case is linked to case 2021SA326103 (CLUSTER).  This case involves a 19 years old female patient who was inadvertently administered the QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT), rather than the QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) [wrong product administered and product administered to patient of inappropriate age].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ733AA, expiry date-30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error due to wrong product administered and product administered to patient of inappropriate age. (latency: same day).  It was reported "HCP (Healthcare Professional) stated FLUZONE HIGH DOSE QUADRIVALENT was given to a consumer under 65 and wanted to know if there was any data? Pharmacist stated that two patients under age 65 had inadvertently been administered the Fluzone High-Dose Quadrivalent vaccine".  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt recvd 2 doses of Engerix-B & 2nd dose given 7JUL92; 14JUL92 devel severe h/a & pains in the neck, arm & shoulder; describes the pain in neck & shoulder as feeling like a hot knife;
Patient received 2nd dosage of vaccine 4/29. Patient experienced pain at time of injection. Injection site reaction of localized pain and red swollen area after shot. This localized pain has resolved. Symptom onset 5/3 of very sore arm/shoulder. Sharp/severe pain in shoulder/trap area. Was seen at prescriber office 5/4...inflammation of muscle. Patient is not improved with use of ice, tylenol, or ibuprofen. Patient has continued pain at time of reporting.
toothache all over my mouth. it felt like every tooth is hurting.....migraine type headaches  for brief periods at a time consecutive days following vaccination.  .....sharp, intense electrical type pains in right arm and corresponding right side of face consecutive days following vaccination
"FROZEN SHOULDER" DIAGNOSED 5 DAYS POST VACCINATION.  PAIN, INABILITY TO REST.  PT STILL RECEIVING PHYSICAL THERAPY.
received the expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received the expired vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received the expired vaccine). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (received the expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medications are provided. treatment to the events not reported. patients received the expired vaccine. 21 patients received expired vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Significant Follow up received- ADR form received, patient DOB updating, batch number updating.
At first, my  left arm was just sore at the place of injection.  After a few days--perhaps 3 or 4, I noticed a swelling  at the sight, with a reddish coloring to the swelling.  (My arms are tanned so the redddish coloring is not that prominent. ) The swelling feels slightly tight, or hard to the touch and also slightly warmer than the skin  surrounding it. There is no soreness or pain at the swelling.
fatigue; headache; This is a spontaneous report from a contactable consumer via Pfizer Sales Representative. A elderly patient (reported as over 80 years) of an unspecified gender received BNT162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced fatigue, headache on an unspecified date with outcome of unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
HIGH FEVER NOW GOING ON FOUR DAYS, (102-104.6 DEGREES)IBUPROFEN AND TYLENOL BRING FEVER DOWN FOR A SHORT TIME. HAS NO APPETITE. IS WEAK, IF SHE MOVES AROUND HER TEMPERATURE GOES HIGHER.  HER FACE IS OF PALE COLOR, DARK BELOW HER EYES.