chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was scheduled for shingrix but was given prevnar by mistake.  No detectable harm to patient
REceived SHingrix vaccination at Pharmacy. 4 hours later had sudden onset increase in cervicogenic headache and cervicalgia pain.  Reduced in intensity after the initial 24 hours, still with increased neck pain flare after 5 days.
Information has been received from a physician concerning a 21 year old female with a history of fainting during medical procedures who on approximately 07-JUL-2008, reported as "3 weeks ago", was vaccinated 0.5mL, IM with a 1st dose of GARDASIL vaccine (yeast) (lot# not reported). It was reported that the patient fainted as soon as the needle was withdrawn from her arm and was unconscious for approximately 2 minutes. It was reported that the nurse moved the patient's feet up and eventually the patient was conscious. The patient sought medical attention from the physician in the office. Additional information has been requested.
Arm is sore at injection site; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 11Mar2021 at 12:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 at 14:00, the patient experienced arm was sore at injection site. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm was sore at injection site was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Was feeling pretty good, but as the day goes on I'm feeling worse; No appetite; Weak; Diz; Sore arm; Nausea; Headache; Tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Was feeling pretty good, but as the day goes on I'm feeling worse), DECREASED APPETITE (No appetite), ASTHENIA (Weak), DIZZINESS (Diz) and MYALGIA (Sore arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Was feeling pretty good, but as the day goes on I'm feeling worse), DECREASED APPETITE (No appetite), ASTHENIA (Weak), DIZZINESS (Diz), MYALGIA (Sore arm), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Tired). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Was feeling pretty good, but as the day goes on I'm feeling worse), DECREASED APPETITE (No appetite), ASTHENIA (Weak), DIZZINESS (Diz) and FATIGUE (Tired) outcome was unknown and MYALGIA (Sore arm), NAUSEA (Nausea) and HEADACHE (Headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.    Reporter did not allow further contact
Initial report received on 21 October 2011 from a physician. This is a case of misuse where the patient was under dosed with one 0.15 mL of FLUZONE (manufacturer's recommended dose for this age group is 0.5 mL administered in 2 doses at least 1 month apart). An 8-year-old female patient with medical history of environmental allergies and allergy to nuts had received a 0.15 mL intramuscular right deltoid injection of FLUZONE No Preservative 2011-2012 (lot number U4124AA) on 21 October 2011 at 11:10 am and within minutes she developed a hive at the injection site and complained of her throat feeling funny with no visible swelling. She then developed an extraneous hive approximately 1.5 inches above the site of the injection, and periorbital edema. She was medicated with 90 mg of fexofenadine and ALLEGRA, EPINEPHRINE (dose not reported), and 30 mg of ORAPRED. Routes for treatment medications were not reported. It was noted that 3 years prior, the patient had experienced hives followed vaccination with a flu vaccine (trade name and manufacturer name not reported) and at that time was administered oral BENADRYL. The recovery status was reported as unknown for the current events. Document held by sender: None.
Tachycardia.  Normal my resting heart rate is 50, heart rate at rest between 100-135 sustained for hours.
1/19/8-Fevers, high of 103.2 degrees, chills, sore body, weak, headache.  1/20/8-Fevers, high of 103.4 degrees, chills, sore body, weak, headache.  1/21/8-Fevers, lower 101.8 degrees, sore body, chills, sweats.  1/22/8-Fevers, 101.7 degrees.  1/23/8-Lower fever in morning 100.9 degrees, went to hospital, ER in AM (fever for 5 days).  1/24/8-No fever in morning today.  Prescribed antibiotic at hospital.  Hospital Dr. believes he had bad reaction to shot first 2 days plus/or then a virus.
injection arm was considerably swollen; red spot at injection site was intensely red; the same symptoms came back more worse that before after 8 to 9 days; injection arm was more itchy.; injection arm soreness; injection arm was itchy; injection arm was swollen; developed red spot at the injection site; fatigue; malaise; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection arm soreness), PRURITUS (injection arm was itchy), VACCINATION SITE SWELLING (injection arm was swollen), VACCINATION SITE ERYTHEMA (developed red spot at the injection site) and FATIGUE (fatigue) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection arm soreness), PRURITUS (injection arm was itchy), VACCINATION SITE SWELLING (injection arm was swollen), VACCINATION SITE ERYTHEMA (developed red spot at the injection site), FATIGUE (fatigue) and MALAISE (malaise). On an unknown date, the patient experienced VACCINATION SITE SWELLING (injection arm was considerably swollen), VACCINATION SITE ERYTHEMA (red spot at injection site was intensely red), VACCINATION SITE REACTION (the same symptoms came back more worse that before after 8 to 9 days) and PRURITUS (injection arm was more itchy.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (injection arm soreness), PRURITUS (injection arm was itchy), VACCINATION SITE SWELLING (injection arm was swollen), VACCINATION SITE ERYTHEMA (developed red spot at the injection site), FATIGUE (fatigue), MALAISE (malaise), VACCINATION SITE SWELLING (injection arm was considerably swollen), VACCINATION SITE ERYTHEMA (red spot at injection site was intensely red), VACCINATION SITE REACTION (the same symptoms came back more worse that before after 8 to 9 days) and PRURITUS (injection arm was more itchy.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.
Pt received his 2nd dose of Monkey pox vaccine on his Rt forearm, Pt started complaining of dizziness 5mins after, Pt was laid flat supine on the floor, he drank some water and verbalized that he felt better, he was clammy, pale, denies being diabetic but he stated that he has hx of hypertension, initially 02 sat was 92% on RA, pulse 58, BP 165/80, Temp 97.9-Pt stated that he has not taken his BP meds today. After about 10mins of observation with Pt still lying down, 02 sat 98% on RA, pulse 78, no change in BP. Skilled nurse instructed patient to take his BP meds as soon as possible-he verbalized understanding. He was monitored for 30mins after the incident and he stated that he was fine and able to go home. He came with a friend so he was not alone.
SPOTS ARE SWOLLEN/ SPOTS FEEL HOT TO THE TOUCH SLIGHTLY LOWER DOWN THE ARM; SPOTS VERY ITCHY SLIGHTLY LOWER DOWN THE ARM; HARD/RED/SWOLLEN/ HOT TO THE TOUCH/VERY ITCHY SPOT ON THE EXACT SPOT VACCINE WAS RECEIVED; HARD RED SPOTS SLIGHTLY LOWER DOWN THE ARM; This spontaneous report received from a patient concerned a 46 year old female. 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, intramuscular, batch number: 706190 and expiry: 03-AUG-2021) dose was not reported, administered on 24-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUL-2021, the subject experienced spots are swollen/ spots feel hot to the touch slightly lower down the arm. On 26-JUL-2021, the subject experienced spots very itchy slightly lower down the arm. On 26-JUL-2021, the subject experienced hard/red/swollen/ hot to the touch/very itchy spot on the exact spot vaccine was received. On 26-JUL-2021, the subject experienced hard red spots slightly lower down the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from spots are swollen/ spots feel hot to the touch slightly lower down the arm, spots very itchy slightly lower down the arm, hard red spots slightly lower down the arm, and hard/red/swollen/ hot to the touch/very itchy spot on the exact spot vaccine was received. This report was non-serious.
Patient's mother report child began complaints of rash and difficulty breathing at 2:00AM. She gave Benadryl and monitored status.
Tx with NSAIDS/muscle relaxer - Brachial neuritis - hurt to move head - lg local reaction - no strength in left arm and work up arm and into left shoulder.
Mother of child called and brought child in for possible IZ rx. Right thigh has large, red, swollen area approx 22mm at site of HIB immunization area. Warm to touch. Mother of child  does not know if any fever. Instructed mother to have child seen by physician-called mother for F/U and treatment info. No return call from mother.
Migraine with aura and pain 1 hour after injection. Laid down, took OTC migraine medicine and applied ice pack to head pain area. Migraine disappeared after 3 hours.
Swollen lymph nodes; Chills; Aches; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 02Apr2021 at 09:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. The patient had no known allergies to medications, food or other products. Concomitant medications included curcuma longa (TURMERIC), fish oil (MANUFACTURER UNKNOWN) and loratadine (CLARITIN), all from unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 12Mar2021 at 10:00 (at the age 45-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021, the patient experienced swollen lymph nodes, aches and chills. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of swollen lymph nodes, ache, and chills was not resolved at the time of the report.  No follow-up attempts are needed; information about lot/ batch number cannot be obtained.
8 hours after receiving: fever 101.2,  metallic taste in mouth, scratchy throat, dizzy, drippy nose, severe chills with shaking, mild headache and exhaustion to the point that after waking the next morning I could only remain awake for 2-3 hours before needing a 2-hour nap. I took Tylenol and snuggled in blankets even though that day it was 80 degrees. The next day my fever was 99.6 degrees. I was chilled but not shaking. I had enough energy to do computer work for 4 hours before needing a nap. Little muscle strength, metallic taste in mouth, drippy nose and scratchy throat with no appetite.
malaise; This case was reported by a nurse via sales rep and described the occurrence of malaise in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were reported as follows: The nurse reported that one of her friend received Shingrix and experienced malaise and was in bed all weekend after receiving the vaccine. The reporter did not provide any additional details.  The adverse event was reported during a conference, so there was no opportunity to obtain additional details, however contact detials were provided.
Information has been received from a certified medical assistant and a office manager referring to the 32 years old female certified medical assistant. The patient was not pregnant. Pertinent medical history and drug reactions/allergies were not reported. On 22-JUN-2015, the medical assistant was cut by a prefilled RECOMBIVAX HB syringe (dose was not reported, lot# L009155, expiration date 29-OCT-2016) when the syringe broke as she was preparing a dose for administration. Concomitant drug was not reported. The patient did not seek medical attention. On an unknown date, the patient treated her cut by bandaging it. Product quality complaint was involved in the case. On 29-JUN-2015, the patient was recovered from the injury associated with device. Additional information has been requested.
The pt was seen in the doctor's office on 1/11/02 for complaints of joint pain, general malaise, fever and sweats since 1/7/02. Pt also had a headache. Dx'd with serum sickness due to Hep-B injection.
Patient received Pfizer 12yrs+ primary series dose instead of a bivalent booster. Will return in 2 months for correct vaccine.
Diarrhea; Nauseas; fever over 100°F; Dizziness; No appetite; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DECREASED APPETITE (No appetite), DIARRHOEA (Diarrhea), HEADACHE (Headache) and PYREXIA (fever over 100°F) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and METOPROLOL for an unknown indication.    On 25-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Sep-2021, the patient experienced HEADACHE (Headache). On 26-Sep-2021, the patient experienced DIZZINESS (Dizziness), DECREASED APPETITE (No appetite) and PYREXIA (fever over 100°F). On 27-Sep-2021, the patient experienced DIARRHOEA (Diarrhea) and NAUSEA (Nauseas). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO-BISMOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 27-Sep-2021, PYREXIA (fever over 100°F) had resolved. At the time of the report, DIZZINESS (Dizziness), DECREASED APPETITE (No appetite) and HEADACHE (Headache) had not resolved and DIARRHOEA (Diarrhea) and NAUSEA (Nauseas) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2021, Body temperature: 100 (High) 100 degree Fahrenheit..         This case was linked to MOD-2021-335510, MOD-2021-335520 (Patient Link).
HCP called to state that the patient was given PROQUAD after a TE event.; no additional AE/PQC.; his spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose, route of administration, lot number and expiration date not reported) for prophylaxis (product storage error). No adverse event was reported.; Sender's Comments:  US-009507513-2303USA006990:MSD US-009507513-2303USA007002:MSD US-009507513-2303USA006967:MSD
The child developed a 40 mm reddened area and a 15 mm - swollen area at the injection site of MMR vaccine w/i 5 min of administration.
Pt recvd vax on 5NOV92 & w/in a few hrs, pt exp nausea & devel vomiting, which lasted 1 to 2 days; pt also exp body aches & a headache for several days; No further details were provided;
No PQC or additional AEs reported; Patient had gardasil 4 x3 in 2011, given extra dose of gardasil 9 on 24-MAY-2021; This spontaneous report has been received from a nurse prescriber, concerning a 21-year-old female patient. The patient's historical vaccine included hpv vaccine vlp rl1 4v (yeast) (GARDASIL 4) three doses in 2011. The patient's medical history and concurrent conditions were not provided. Concomitant therapies included hepatitis a vaccine inact(HAVRIX).  On 24-MAY-2021, the patient was vaccinated with an extra dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R036912 with expiration date 23-SEP-2021, subcutaneously in the right deltoid (dose and frequency were not provided) for prophylaxis. No adverse effects noted. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R036912; expirationdate: 23-SEP-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
3/19 cold sore, then next day blister in oral mucosa, within 5 days itchy rash on one side of abdomen.  During this time frame when walking would lose my balance and stagger when trying to walk, this problem with walking lasted about 10 weeks then got better.
PATIENT DESCRIBES RED/WELTY SKIN ON THE LEGS AND COMPLAINS OF ITCH
Patient did not need 3rd dose of HPV, given by mistake due to incorrect forecasting by system.
Vaccinated at public Health clinic " drive through" .Within the 1st 5 minutes of getting the dose she noticed her face became very red she said almost beet  red although she says she did not feel flushed, nauseous or hot but she saw the red in the mirror. She really felt perfectly fine she had no tachycardia, anxiety, nausea, itching, tingling of the mouth throat or tongue. In fact because she was asymptomatic except for the visual appearance she chose to not call over the attendants to check on her. After the 15 minutes she just drove home and by the time she got home her face was normal she has had no other symptoms since.
Approximately 20 minutes after receiving vaccines, patient expressed not feeling well, eyes rolling -> seizure activity, collapsed, decreased HR 40s. Given O2; remained breathing at all times. 911 called. Patient aroused after 1 minute; alert, oriented. EMS arrived; episode repeated at clinic and patient again alert. Transported to ER via EMS.
3 weeks after his 2nd shot, he was seen in the ER due to drooling, facial spasms, and facial paralysis. After many tests and MRI, they found a mass tumor on his brain, They transferred him to Med Center and they did more testing. On March 13th they preformed surgery to remove the mass tumor. After pathology reports were ran, it came back as a cancerous tumor know as a Glioblastoma or GBM. They were able to remove 80%. The remainder of the tumor was in a part of the brain that they would run the risk of permanent damage or paralysis. He will undergo Chemo and Radiation to treat the 20% left.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 10-DEC-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5 mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 8.5 (0 Celsius) for 24 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
1st Shingrix in May 2018 / 2nd dose on February 3, 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in May 2018).   On 3rd February 2021, the patient received the 2nd dose of Shingrix. On 3rd February 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix later than recommended schedule, which led to lengthening of the vaccination schedule. The reporter consented to follow up.