chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to one female patient vaccinated with improperly stored RECOMBIVAX HB (lot# N011851 with expiration date 19-DEC-2019) on 02-OCT-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter(link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004592,  1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
Extraneous dose. Patient has had per state records: Janssen 0.5ml, Moderna 0.5ml, Moderna 0.5ml, Pfizer 0.3ml, and last Moderna 0.25 ml (one being reported from my clinic). Per local records, she couldn't access patient ASIIS report online and validated patient record per picture of COVID-19 record card on patient phone. Tried to contact patient using phone number listed on file. Phone number does not dial out. Unable to contact patient to verify her status.
Bad taste in mouth; Muscle cramps and spasms; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Bad taste in mouth) and MUSCLE SPASMS (Muscle cramps and spasms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) 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) (unknown route) 1 dosage form. On 14-May-2022, the patient experienced TASTE DISORDER (Bad taste in mouth) and MUSCLE SPASMS (Muscle cramps and spasms). The patient was treated with TIZANIDINE in May 2022 for Muscle cramps, at an unspecified dose and frequency and MELOXICAM in May 2022 for Muscle cramps, at an unspecified dose and frequency. At the time of the report, TASTE DISORDER (Bad taste in mouth) and MUSCLE SPASMS (Muscle cramps and spasms) had not resolved.            No concomitant medications were reported. Co-suspect information included the patient had a COVID-19 Treatment. The patient was taking  other medications or products within two weeks of starting COVID-19 treatment.  No treatment medications were specified for bad taste in mouth.
Pt developed a fever to 100 degrees 2 to 3 hours post vax. Seen in ER on 7/15 and in the physician's office on 7/17. Fever persisted. Dx with otitis media and treated with antibiotics.
Administered HPV vaccine then administered varicella vaccine noticed patient head dropping forward. Called out for help. HM3 brought over ammonia. Patient responded quickly to ammonia. Patient transferred into gurney with feet elevated & head down. 1600 - BP 101/60, HR 77, RR 16, 100% O2 sat. Patient still feeling dizzy, gave water to drink. 1615 - BP 107/63, HR 75, RR 16, 100% O2 sat. Assessed by Dr. 1615 - Patient states feeling OK.  Per MD to discharge.
Per telephone call with the pt's mother on 02/08/2002. On date of vaccine, am 10/08/2001, mother reports infant ran a fever of "about 102" and was lethargic in the afternoon after vaccines were given. Infant given Motrin and put down to bed. Infant awoke on 10/09/2001 at about 4-5 am, nursed and given Motrin as "warm to touch." Back to sleep until approx. 8am. He aroused a bit but did not want to nurse. He returned to sleep. Mother took the infant along in a stroller to the mall. Prior to lunch, mother awoke infant and tried to feed him some juice, he took one sip. He was given Motrin and returned to sleep in his stroller. At about 1pm, mother became concerned as child had not nursed since 5am. She attempted to awaken him by walking with him and patting him on the back. Grandmother also tried to awaken him, but he would not awaken completely. He was breathing normally and would open his eyes momentarily and try to life his head, but then fall back to sleep. Mother states, "he was like a rag doll." Mall security guards noted mom's increasing anxiety and they attempted to wake infant without success. They called first responders. They took infant's temp which now was 103.6 degrees F, Motrin was given again and EMS then arrived. Infant began to wake up, cried and temp. then was 101.2 deg F. Mother refused ambulance. By the time she returned home, her private physician's office was closed. Infant was more alert, nursed later that evening and Motrin was again given. Next morning Wednesday 10/10/2001, infant was alert, nursed "much better," not "limp" per mom. Last dose of Motrin was given and by noon temp was 100-101. Per mother, infant has been well since. Mother to inform private physician about the infant's reaction and recommendation re:future vaccines.
Left upper arm swollen and red. Pain in touching, moving or pressure  down past bicep. Put ice, took naproxen. Didn't help. Lasted 3 days.
Pounding headache, nausea, upset stomach, chills, facial swelling, fatigue
injection site swollen; injection site pain; chills; A spontaneous report was received from a consumer concerning 83 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site swollen, injection site painful and chills.  The patient's medical history was not reported.  Concomitant medications were not reported.  On 04 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via intramuscular for prophylaxis of COVID-19 infection.  On 04 Feb 2021, same day of first dose of vaccination the patient experienced injection site swollen, injection site pain and chills.  Laboratory test was not done.  Treatment information was provided as the patient took tylenol but for what event is not reported.  All the events occurred after first dose of vaccination.  The outcomes of the event remain unknown.  Action taken with mRNA-1273 in response to the events are unknown
dx w/infantile spasms @ age of 6mo;4mo when spasms began;
Not feeling good; This is a spontaneous report from contactable consumer (for daughter 16-year-old) via Pfizer sponsored program.   A 14-year-old female patient received first dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 27May2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller wants to check if her daughter can take the Pfizer vaccine. Her daughter is only 14yo and she had taken the 1st dose yesterday on 27May2021. on an unspecified date in May2021, Her daughter is not feeling good and she's not sure of the symptoms yet since her daughter is sleeping. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
I LEANED DOWN TO TIE MY SHOE AND I LOST VISION IN MY EYE. I WENT TO THE OPHTHALMOLOGIST HE PERFORMED SEVERAL TESTS. BLOOD PRESSURE WAS 137/100 WHICH ISNT NORMAL FOR ME. 41 WAS MY EYE PRESSURE AT THE EYE DOCTOR. AT THE ER IT WAS 17. A 4MM ANEURYSM BUT ITS BEETN THERE SINCE BIRTH. I SEEN A FEW DOCTORS AND NURSES. MY VISION HAS RETURNED BUT MY VISION IS STILL HAZY
Patient came into the pharmacy and stated she had been having flu like symptoms and her arm was red and sore to the touch since Thursday 2/27/20. The patient claims they are feeling better today on 2/28/20.
Redness and swelling of upper arm. Got Td shot on 01/30/07, 3 days later 10 cm red and hot area on arm. 4 days later 14 cm, 5 days 18 cm, 6 days 22 cm. Not as red but still spreading,not hot to touch. Went to 1st assist after 2 1/2 days and was given antibiotics. Today (2-5-07) we gave her Benadryl. No SOB, heart palpitations, or other side effects.
COVID 19 Treatment; COVID 19 Treatment; Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Pfizer/ Dose #4: Pfizer/ Dose #5: Pfizer.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Dec2021 as dose 3 (booster), single (Lot number: FJ8762), in left arm and on 25May2022 as dose 4 (booster), single (Lot number: FM0173), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Apr2021 as dose 1, single (Lot number: 007C21A), in left arm and on 20May2021 as dose 2, single (Lot number: 024C21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 21Dec2021, outcome "unknown", described as "Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Pfizer/ Dose #4: Pfizer/ Dose #5: Pfizer."; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 20Aug2023 to 25Aug2023.  Clinical course: Rebound 4 days after 5-day paxlovid course Symptoms: heavy chesty cough, runny nose, nasal congestion.
Facial hives. 11/19/09 saw his own pediatrician in follw-up. No residual. No add'l treatment.
Background: A routine 2-dose varicella vaccination program was adopted in 2007 to help further decrease varicella disease and prevent varicella outbreaks. We describe trends and characteristics of varicella outbreaks reported to the Centers for Disease Control and Prevention (CDC) during 2005-2012 from 9 states. Methods: Data on varicella outbreaks collected by 9 state health departments were submitted to CDC using the CDC outbreak reporting worksheet. Information was collected on dates of the outbreak, outbreak setting and number of cases by outbreak; aggregate data were provided on the numbers of outbreak cases related by age group, vaccination status and laboratory confirmation. Results: Nine hundred and twenty-nine outbreaks were reported from the 6 states, which provided data for each year during 2005-2012. Based on data from these 6 states, the number of outbreaks declined by 78%, decreasing from 147 in 2005 to 33 outbreaks in 2012 (P = 0.0001). There were a total of 1015 varicella outbreaks involving 13,595 cases reported by the 9 states from 2005 to 2012. The size and duration of outbreaks declined significantly over time (P <0.001). The median size of outbreaks was 12, 9 and 7 cases and median duration of outbreaks was 38, 35 and 26 days during 2005-2006, 2007-2009 and 2010-2012, respectively. Majority of outbreaks (95%) were reported from schools, declining from 97% in 2005-2006 to 89% on 2010-2012. Sixty-five percent of outbreak-related cases occurred among 5-year to 9-year olds, with the proportion declining from 76% in 2005-2006 to 45% during 2010-2012. This literature marketed report as received from an author of the article regarding unspecified patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with VARIVAX. No concomitant medication was reported. On an unknown date the patient experienced varicella outbreaks. The outcome of varicella outbreaks was unknown. The reporter considered varicella outbreaks to be related to VARIVAX. Additional information has been requested.
24-48 hours after vaccination  Numbness and tingling 24-48 hours after vaccination  Followed by internal tremors, paresthesias, loss of smell and taste, electrical shock sensations,  dizziness, orthostatic intolerance, fatigue, myalgias, lower extremity paralysis and upper and lower limb weakness, cognitive fatigue, inability to concentrate, headaches, exercise intolerance, temperature dysregulation and heat intolerance, sudomotr dysfunction consistent with autonomic dysfunction/dysautonomia and small fiber neuropathy
Blood pressure immediately went up to almost 200  . was keep at the site until is came down . whole left side was numb had to have someone drive her home .  Numbness lasted 2 weeks . headaches have not stopped and pressure is still elevated
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient's medical history was not reported. On 18-JUN-2015, the patient was vaccinated with one dose of improperly stored GARDASIL lot # K008931, expiration date reported as 04-MAR-2007 (dose, route and site of administration were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Entire body turned red and burning, felt hot to the touch.  Symptoms started at 11:30am two days after the vaccine.  I immediately took 40ml of Benadryl.  Within an hour the symptoms subsided.
A report has been received from a Pharmacist concerning a 2 year old, subject of unknown gender, who had been receiving FLUMIST, (intranasal). FLUMIST started on an unknown date. The pharmacist reported that on 11-Dec-2013 patient received expired FLUMIST. The outcome of the event of received expired FLUMIST is unknown. The report was considered to be non-serious.
pt recv vax & devel an inj site rxn characterized by redness & soreness;this is 1 of 3 pt from this facility to devel an inj site rxn p/vax lot# 4978198;
Information has been received from a woman in a physician's office concerning a 9 year old female with no medical history who on 27 MAY 1997 was vaccinated SC with first dose of Varicella.  Concomitant vaccinations on that same day included an IM fourth dose of TRIPEDIA.  There was no illness at teh time of vaccination. It was reported that on 10 JAN 2005 the patient's mother called the physician's office indicating that her daughter developed slightly itchy leasions on her chest, legs and back and subsequenlty developed more.  As of Feb 2005 the patient was noted to be recovering as her lesions were in the process of scabbing.  Subsequently the patient's slightly itchy lesions resolved.  Additional information is not expected.
Lump on left side of neck, 2-3 inches above the collarbone, about the size of a kumquat. Stiff neck and shoulder. (Unrelated but the question prompts me for it: I am 12 weeks pregnant with EDD of 11/8)
Patient reports generalized body rash developed 2 hours after receiving Flu vaccine on 11/1/07. No medical attention seeked. No known reactions to previous vaccines. No known egg allergy has received Flu vaccine in the past
12/30/20 - fever of 101.6 degrees F 12/31/20 - fever of 100 degrees F, headache, congestion - tested for COVID-19 01/01/21 - fever of 100 degrees F, congestion 01/02/21 - congestion, partial loss of smell 01/03/21 - congestion, partial loss of smell 01/04/21 - congestion, partial loss of smell
Fever, 39, rigors, myalgias 24 hours,  fatigue 48 hrs
Experienced polymyalgia condition: Described stiff muscle of neck and shoulder the night of vaccination date. Fully symptom free 10/10/15.
"Received FLU shots on 9/18/2009 at 0700. Later that day - sore arm, scratchy throat, achy feeling, "Several days later - now had repeated numbness that came- went to L arm and face and lower legs and scalp area. Progress to dizziness when standing and weakness to lower extremities. Continued weakness, numbness, dizziness as of 10/09/2009. 10/22/2009 records from PCP. Patient with sx of arm soreness, arthralgias, numbness/tingling of bilateral LE's, fatigue, weakness and dizziness. PE was normal, Tx: Medrol dose pak. Patient referred to neurologist when sx became progressive. 12/09/09 Neurology records received for DOS 10/16/09. Pt presented with intermittent numbness and tingling sensation of arms and legs and constant muscle weakness of arms and legs x 1 month. Assessment: large myelinated fiber neuropathy in a glove stocking distribution
Left thigh wheal, 8x4cm, erythema, induration, nontender
RN received call from school nurse, stating that client was in her office with a rash on the outer aspect of her B/L arms. Rash raised sl, not fluid filled, and itchy. RN called clients mother. Rash was noted 4/27/07 in arm, itchy and raised only located on B/L arms. Child did not see MD. Rash is now subsiding. Mother instructed to take child to MD if rash worsens.
Left thigh subcutaneous calcified hematoma with connective tissue remolding causing skin dimpling.
Had no adverse events from the vaccine but my spouse and I went on a cruise and he tested positive after we returned home. I started having cold symptoms and a headache a little over a week ago and tested positive on 4-22-22, last Friday. I am reporting a breakthrough COVID-19 case.
Area of erythema and edema 8cm x 7.5cm (L) deltoid (site of Proquad). Also 3 small papules at center of swollen area.
LOWER INTESTINAL DISCOMFORT; FOGGY THINKING; FORGETTING THINGS; DIARRHEA; HOT EAR; COULD NOT SLEEP; NAUSEA; HEADACHES; INJECTION SITE PAIN; INCORRECT PRODUCT ADMINISTERED; ARM PAIN; FELT LIKE POSTICTAL PHASE OF EPILEPSY; DISORIENTATION; DAZE/FEELING WONKY; ITCHING; OVER-SENSITIVE SKIN; FACE FEELING "SUNBURNED"; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported.  The patient's past medical history included polycythemia year diagnosed, and concurrent conditions included frontal lob partial focal epilepsy, recovering alcoholic, nicotine free, vegetarian, anaphylactic shock to contrast dye, no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination.  Concomitant medications included oxcarbazepine for frontal lob partial focal epilepsy. On 06-APR-2021, the subject experienced felt like postictal phase of epilepsy. On 06-APR-2021, the subject experienced disorientation. On 06-APR-2021, the subject experienced daze/feeling wonky. On 06-APR-2021, the subject experienced itching. On 06-APR-2021, the subject experienced over-sensitive skin. On 06-APR-2021, the subject experienced face feeling "sunburned". On 06-APR-2021, the subject experienced incorrect product administered. On 06-APR-2021, the subject experienced arm pain. On 06-APR-2021, the subject experienced headaches. On 06-APR-2021, the subject experienced injection site pain. On 07-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced hot ear. On 13-APR-2021, the subject experienced could not sleep. On 16-APR-2021, the subject experienced diarrhea. On 18-APR-2021, the subject experienced foggy thinking. On 18-APR-2021, the subject experienced forgetting things. On 19-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 111/70 mmHg, and Body temperature (NR: not provided) 96.7 F. On 20-APR-2021, the subject experienced lower intestinal discomfort. Treatment medications (dates unspecified) included: ibuprofen, cortisone, hydrocortisone, and hydroxyzine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching on 19-APR-2021, arm pain on 06-APR-2021, and headaches on APR-2021, was recovering from face feeling sunburned", had not recovered from nausea, and the outcome of injection site pain, disorientation, daze/feeling wonky, felt like postictal phase of epilepsy, over-sensitive skin, diarrhea, foggy thinking, forgetting things, hot ear, lower intestinal discomfort, could not sleep and incorrect product administered was not reported. This report was non-serious.; Sender's Comments: MAC comment: V0; Medical Assessment comment not required  per standard procedure as the case is assessed as non-serious.
Vial was initially stored in the refrigerator on 10-Jun-2022 and adminsitered on 12-Jul-2022; Dose administered after 30 day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Jun-2022 and adminsitered on 12-Jul-2022) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Jun-2022 and adminsitered on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Jun-2022 and adminsitered on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patients weight was given as 175.   Concomitant medication list was not provided.  The vial was initially stored in the refrigerator on 10-Jun-2022. The vial had not undergone any temperature excursions. The patient had not experienced any adverse reactions. Treatment information was not provided.