chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pneumonia; flu; Based on information received on 21-DEC-2020, the report previously considered as non-valid became valid (suspect product corrected from Sanofi product NOS (not otherwise specified) to INFLUENZA VACCINE).   Initial information was received on 19-Nov-2020 regarding an unsolicited valid serious social media case from a consumer/non-health care profession (patient).  This case involves a patient (unknown demographic) who had pneumonia and flu (influenza), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dosage, route, batch number and expiry date were unknown) for prophylactic vaccination.  On an unknown date, the patient developed serious pneumonia and flu (influenza) (unknown latency) after vaccination. These events were assessed as medically significant. Reporter stated that pharmacy gave him both for the last three years and doing great.  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting the outcome for both the events were not reported.    Follow up information was received on 21-Dec-2020 from a consumer (patient) via social media.  Gender of the patient updated. Suspect product corrected from Sanofi product NOS  to INFLUENZA VACCINE and case considered valid.; Sender's Comments: Follow up information received on 21-Dec-2020 changes the previous medical assessment of this case. This poorly documented facebook case concerns a patient, who had pneumonia and influenza after vaccination with  INFLUENZA VACCINE . The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect product cannot be assessed.
MINOR SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a 51 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported.  On APR-2021, the subject experienced minor side effects. The action taken with covid-19 vaccine  was not applicable. The patient recovered from minor side effects on APR-2021. This report was non-serious.
Vaccine adm pm of 6-26-06, Sx developed 4am 6-27-06 - Temp near 105 and general malaise - Mom stated MD said BP low and pulse high, white "sorta" high.
tired all day; itchy; About 4 min high, and a couple of inches across; pulse was high; I was very sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (I was very sleepy), PRURITUS (itchy), RASH (About 4 min high, and a couple of inches across), HEART RATE INCREASED (pulse was high) and FATIGUE (tired all day) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concomitant products included CALCIUM for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced SOMNOLENCE (I was very sleepy). On 03-Mar-2021, the patient experienced PRURITUS (itchy), RASH (About 4 min high, and a couple of inches across) and HEART RATE INCREASED (pulse was high). On 05-Mar-2021, the patient experienced FATIGUE (tired all day). On 02-Mar-2021, SOMNOLENCE (I was very sleepy) had resolved. On 07-Mar-2021, FATIGUE (tired all day) had resolved. At the time of the report, PRURITUS (itchy) outcome was unknown, RASH (About 4 min high, and a couple of inches across) was resolving and HEART RATE INCREASED (pulse was high) had resolved.            Concomitant medications also included vitamins. Treatment details included Antihistamine pill the first night of the rash.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant follow-up received-New events are added.
5 days p/vax broke out in rash, severe itching, fever 101, diarrhea & child uncontrollable screaming;pt broke out all over in a rash 12FEB98;pt went to ER calamine lotion suggested;15FEB98 returned to ER called it allerg rxn, itching;
This spontaneous report as received from a nurse refers to a 68 year old female patient with no drug reactions/allergies. No information on patient's medical history or concomitant therapy was provided. On 13-JAN-2015 the patient was vaccinated with PNEUMOVAX 23 (route, dose and frequency not reported, lot # not reported as K018528). On 14-JAN-2015 (also reported as today) the patient called the office to report extreme tenderness, redness and swelling about the size of a half dollar at the injection site. There was no lab diagnostic studies performed. The nurse reported that advised the patient to administer cold compresses to the site and ibuprofen as needed to treat the symptoms. Patient's present status was reported as not recovered. The patient sought medical attention and called to physician office. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Migraine 8 days later on October 6, 2022.  Migraine has been persistent since that day. Now working with neurologist to find medication. Also, trying to control with diet.  Was not immediately diagnosed as a migraine until after about a month of evaluation (CT scans of brain and sinuses, course of antibiotics and prednisone while waiting for doctor appointments).  Neurologist dismissed as vaccine-related, but I thought it was really coincidental and thought it should be reported. I only had possibly one migraine-like episode March 2, 2022, but it resolved within approximately 3 days.
Large, red area to left upper arm, treated with Benadryl PRN, Augmentin 400/5 1 tsp BID x 10 days.
Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications are provided.No treatment medications are provided. Did the vial undergo any temperature excursions? No.
Infant presented with moderate fussiness at approximately 2 pm (about 3 1/2 hours after vaccination). No fever. After a dose of Acetaminophen she fell asleep with less fussiness.
Tongue went numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Tongue went numb) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: POLIO in December 2020. Concurrent medical conditions included Breast cancer.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (Tongue went numb). At the time of the report, HYPOAESTHESIA ORAL (Tongue went numb) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included a pill for breast cancer.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
The patient developed knots in his legs 2 days after receiving the flu shot. The knots were gone by the next day. The patient started with a fever, headache, chills, and congestion that evening.  The patient has alot of muscle and joint soreness at the present time.
Approximately 10 minutes after receiving the COVID vaccine (second dose) pt. Experienced a fainting episode, with the possibility of loosing his pulse for approximately 30 seconds according to RN.  Pt. Was in his vehicle in the monitoring area.  When RN arrived after approximately 1 minute, the patient had a strong carotid pulse of around 80.  Airway was maintained until patient woke up.  Pt stated that he had not eaten before coming.  BP's follow: 1230:99/64, P-48-Sat 94% 1243:109/74,P-67,Sat-97% 1248: 102/63,P-73,Sat-95% 1253-106/72,P-68, Sat-93& 1258-105/64,P-66, Sat-94% 1305-106/73,P-63,Sat 95%. 1311-112/74,P-59,Sat 94% 1316-99/68,P-59, Sat 92% 1322-112/73,P59, Sat 94% Pt remained weak and nauseous for approximately 45 minutes.  It was decided at that time he would need to go to the ER and EMS was called.  At approximately 1330 Pt. Was assisted to the stretcher and transported to ER for further evaluation. ED physician determined that patient had a vasovagal reaction to the vaccine and was discharged home.
Bad pain in back around kidney. Started around 6pm and went to ER at 1am. 05/09/2021 CT scan was done and found a kidney stone.
Reported developing ache in shoulder, base of neck and across upper back that persisted over 3 days.  States has happened with 3 or 4 previous flu vaccines in recent years past.  This time also developed an itchy bumpy rash early the next morning across her abdomen and lower  back which faded the next day and then reappeared the following day on her abdomen, R arm, back and also then stated  that her head was itchy.
pregnant patient received Flublok/ no adverse event; Initial information received on 13-Mar-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 36 years old pregnant female patient who was exposed to a dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The patient was exposed to vaccine at unknown gestation period. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient previous pregnancy details not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1905, expiry date: 21-May-2020, via unknown route in unknown administration site for prophylactic vaccination.  This was a case of Vaccine exposure during pregnancy. (Pharmacist stated that she was giving the vaccine today and only that vaccine, it was not confirmed if vaccine was given or not).  Prenatal test not reported.  At the time of report no adverse event reported.   Pregnancy outcome was unknown at the time of report.
After her first dose of SHINGRIX she did not have a reacion. She received her second dose of SHINGRIX on 11-23 and that evening she developed a red rash that was a little raised and had heat and was itchy at the injection site that did spread down her arm to roughly her elbow. Today (11-27) was the first she had time to get in to explain what had happened. The rash had mostly cleared, only a small bit remains by her elbow.
Around day 7 , the vaccination site was itchy then within a day became red, hard and warm to touch. Area was about 2.5 x 4 inches.  The symptoms subsided a bit then at around day 14 I noticed very slight burning and itching sensation. Wen I looked the area was now larger reaching down my arm about 7 inches in length, no longer hard but now slightly raised and the outer perimeter was red and still a little warm to touch.
A serious report of trauma has been received from a study investigator concerning a 41-month-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 23-Oct-2008, the subject received FLUMIST. The subject was admitted to the hospital for trauma on 07-Nov-2008. The length of stay was one day. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the event was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.
Miscarriage at 9wk gestational age (missed abortion measuring 6wk) Required office uterine evacuation procedure  Unsure if considered adverse event but as an OB/Gyn MD, would like to contribute to pregnancy and fertility data if it is being collected.  Thank you!
Vaccine was expired on 02-Apr-2022 and removed from fridge on 08-Apr-2022.; Vaccine was expired on 02-Apr-2022 and patient administered on 08-Apr-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 02-Apr-2022 and patient administered on 08-Apr-2022.) and PRODUCT STORAGE ERROR (Vaccine was expired on 02-Apr-2022 and removed from fridge on 08-Apr-2022.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 02-Apr-2022 and patient administered on 08-Apr-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 02-Apr-2022 and removed from fridge on 08-Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 02-Apr-2022 and patient administered on 08-Apr-2022.) and PRODUCT STORAGE ERROR (Vaccine was expired on 02-Apr-2022 and removed from fridge on 08-Apr-2022.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that patient took vaccine on 08-Apr-2022, after the expiration date i.e on 02-Apr-2022.The BUD date was reported as 02-Apr-2022.  The vaccine was moved from the fridge on 08-Apr-2022.  It was reported that the vaccines were stored in the freezer and only removed as needed to thaw and then administered. The reporter doesn't have the information about the date the vial was 1st moved from the freezer to refrigerator. The vial was taken out at a time and thaw as they don't thaw enter box.  No treatment medication were reported.
patient was given pediarix instead of proquad, per the direction of Dr. patient was administered the proquad and he advised that  it would not lead to any adverse reaction to patient.  Patient's mom was made aware of wrong vaccine given.  After proquad was given, patient was monitored and left office with no reactions.
This spontaneous report as received from a pharmacy technician refers to unspecified number of patients of unknown age and gender. It was reported that between 01-NOV-2015 and 03-DEC-2015, the patients received unspecified doses of PROQUAD (Merck) (lot # L031600, expiration date 18-FEB-2017) (dose and route not reported) that were improperly stored. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
The patient was given a "3rd dose" of Pfizer but never had Pfizer previous. The patient had completed a Moderna Series previously.
I got COVID-19 because I got lazy. I made a mistake, and I did not follow up to schedule the next dose in time; I got COVID-19 because I got lazy. I made a mistake, and I did not follow up to schedule the next dose in time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I got COVID-19 because I got lazy. I made a mistake, and I did not follow up to schedule the next dose in time".  Clinical information: The patient would like to know how long to wait between a current COVID-19 infection and the next dose of the COVID-19 vaccine. The patient got COVID-19 because she got lazy. she made a mistake, and she did not follow up to schedule the next dose in time. It's her fault, that's all she have to say.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Varivax #2 given 9-4-07 (L) arm SC. 9-6-07 Mother called stated son has huge red area - hot to touch on (L) arm. 9-6-07 - Presented to office with above red area at injection site about 4" in diameter. Advised Benadryl and ice.
SkinRash & UrticariaPruritus Narrative:  rash at injection site, reported to
6 hrs after shot - fever, erythematous arm, headache. 12 hrs after shot - headache, body aches, pain in hands. 24 hrs after shot- headache, extreme fatigue, diarrhea. 2 days after - palpitations, hospitalization, atrial fibrillation.
Grandmother reports that patient had a fever of 101.4 9/28/10 P.M. and redness at upper left arm, the size of a baseball. States it appears to be "bumpy" and itching. Took BENADRYL X 1 dose last pm. Did not take temp this am. but gave MOTRIN. Has has previous flu shots without problems.
Client received Td - left deltoid im on Fri. am 7/30/04. On Sun. 8/1/04, client began experiencing pain in left arm from elbow to shoulder. Later that day pain radiated to neck and down spine to mid-shoulder blade. H/A - back of head; hold/cold flashes. Did not consult physician - took ibuprofen for discomfort.
cough; fever; fatigue; 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 COUGH (cough), PYREXIA (fever) and FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced COUGH (cough), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, COUGH (cough) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication included.  No treatment medication included.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-Significant follow up received. No new information
sensory neuropathy / started in lips and inside mouth and progressed to involve; This case was reported by a physician via call center representative and described the occurrence of sensory neuropathy in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced sensory neuropathy (serious criteria GSK medically significant). On an unknown date, the outcome of the sensory neuropathy was unknown.   It was unknown if the reporter considered the sensory neuropathy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The patient receved 1st dose of Shingrix and after one month experienced sensory neuropathy, lips and inside mouth and progressed to involve extremities. The follow up consent was not granted.
10/22/08 - 8pm- Body aches, fever/chills, post nasal drip, sore throat.  Evening of 10/23/08, had increased sinus congestion, body aches, fever/chills and unable to sleep.  10/24 AM, saw Dr.  for viral infection and sinus infection.  Given Zithromax.   Relieved of fever & chills.
muscle aches; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2023, the patient received the 1st dose of Shingrix (intramuscular). On 14th January 2023, 1 days after receiving Shingrix, the patient experienced muscle pain. On 15th January 2023, the outcome of the muscle pain was recovered/resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-JAN-2023 Reporter's Comment: The reporter was the patient. The reporter reported that patient received Shingrix vaccine, in an unknown arm.  The day after the Shingrix vaccine she had some muscle aches that was resolved.  The reporter did not consent to follow up. The reporter did not give permission for GlaxoSmithKline to contact HCP.
Starting Fri 9/11/15 arm was achy and painful at injection site. On Sat 9/12/15 she reported redness abt the size of a softball around injection site and swelling.
pt exp sz rx w/phenobarb & sent home;sz was prolonged & focal w/no documented fever greater than 102
Bumps all over legs and arms; blisters; Itches; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration, administered in right arm on 23Apr2021 at 13:45 (at the age of 55-year-old) as dose 2, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included chronic mononucleosis, chronic fatigue and chronic migraines. The patient previously took ibuprofen and experienced drug hypersensitivity. Concomitant medication(s) included bupropion, raloxifene, estradiol, estriol (BIESTROGEN) and aloe spp, rhamnus purshiana bark (CASCARA SAGRADA plus ALOE). Patient had no COVID prior to vaccination and was not covid tested post vaccination. On 23Apr2021 same date vaccine, patient received other unspecified vaccine. Patient did not receive other vaccine in four weeks. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8732), dose 1 via an unspecified route of administration, administered in left arm on 02Apr2021 at 13:45 (at the age of 55-year-old) for COVID-19 immunization and bumps started showing five days after first shot. On an unspecified date, the patient experienced bumps all over legs and arms. Looks like fire ant bites. Tiny little, oozy blisters on some if the bumps and Itches like crazy. Three days after the third shot-POOF, started spreading and itching. Patient received Prednisone and Zyrtec as treatment for an events. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is excepted.