chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a health professional concerning a 12 year old, male subject, who had been receiving FLUMIST Quadrivalent.  FLUMIST Quadrivalent started on 10-OCT-2014. The patient wads given 1/2 dose FLUMIST administered for dose which started on 10-OCT-2014. The outcome of the event 1/2 dose of FLUMIST administered for dose is unknown. The report was considered to be non-serious.
Stiffness, tingling, weakness in my hands, feet and arms. Dizziness, Brain Fog, Headaches.  Have been having symptoms for over a month and have not received any answers.
low pulse, low oxygen level  BP 165/55 extreme fatigue   has copd symptoms
pt recv vax;had flu like sx;to er;lab eval revealed elev liver enzymes;HBsAg pos,anti-HBs neg & anti-HBc pos;
Chills, felt like she had a fever but did not take temperature. Was also dizzy, pale and had a headache. This lasted for 5 hours. Felt better after taking Tylenol.
This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 26Jan2021 (Lot number: EL8982, Expiration Date: May2021) at the age of 71 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Blood pressure measurement" (unspecified if ongoing), notes: Verbatim: Blood pressure; "Prediabetic" (unspecified if ongoing), notes: Verbatim: Prediabetic. Concomitant medication included: TRAJENTA; AMLOD-OLMESA taken for blood pressure measurement. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "little pain on bottom of my feet of heel for couple of days". No follow-up attempts are possible. No further information is expected.
Breastfeeding my 2 month old at the time; My milk supply significantly lowered so much that my child wasn't growing enough; This is a spontaneous report from a contactable consumer or other non hcp(patient's mother). A 2-months-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number: ER8731), via unspecified route of administration, administered in Arm Left on 15Apr2021 13:15 as single dose for covid-19 immunization. The patients medical history was not reported. Concomitant medication(s) included sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported. The reporter reported that after receiving her first dose, inexperienced intense cramping and her period started the next day. She was breastfeeding her 2-month-old at the time and her milk supply significantly lowered so much that her/his child wasn't growing enough and had to switched to formula. When she breastfed her first child, she didn't get a period for 8 months, so she definitely think that it was related to the vaccine. This time she was only 2 months post pregnancy and although she was happy to get her vaccine this has been very hard for them and her postpartum depression. The outcome of the events was unknown.  Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021691747 mother/baby case
she has experienced a soreness whenever she lays down on her left arm/shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (she has experienced a soreness whenever she lays down on her left arm/shoulder) in an 87-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 056M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-May-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-May-2022,  after starting mRNA-1273 (Spikevax), the patient experienced ARTHRALGIA (she has experienced a soreness whenever she lays down on her left arm/shoulder). At the time of the report, ARTHRALGIA (she has experienced a soreness whenever she lays down on her left arm/shoulder) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  She had received 5 doses of the Moderna COVID-19 vaccines on: 3-MAR-2021 with lot number 038K20A, On 31-MAR-2021, lot number 023M20A, On 26-NOV-2021, lot number 058H21A, On 2-MAY-2022, lot number 056M21A.  On 20-SEP-2022, lot number AS7148B After receiving the injection of the Moderna vaccine on 2MAY2022 she had experienced a soreness whenever she lays down on her left arm/shoulder. Other times if she' sleeping it hurts so bad that it wakes her up.  No vaccines 4 weeks prior to COVID-19 vaccines. No medications or treatments provided.
pt had a positive COVID test on 8/13/22; pt resides in hospice facility on comfort measures; pt passed away the following day
CEDV chronic (EpsteinBarr virus) underlying condition it made; muscle weakness specially in face/feet that lasted for 10 weeks; very severe fatigue lasted for 10 weeks/very severe fatigue; haven't received the 2nd shot more than 36 days; She slept for 3 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EPSTEIN-BARR VIRUS INFECTION REACTIVATION (CEDV chronic (EpsteinBarr virus) underlying condition it made) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Epstein-Barr virus infection (CEDV chronic (EpsteinBarr virus)), Allergy to chemicals NOS (Chemical allergy. For which is she is taking phenobarbital and TB tine.) and Guillain Barre syndrome. Concomitant products included PHENOBARBITAL and TUBERCULIN PPD (TUBERSOL) for Allergy to chemicals.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced HYPERSOMNIA (She slept for 3 days) and PRODUCT DOSE OMISSION ISSUE (haven't received the 2nd shot more than 36 days). On 15-Feb-2021, the patient experienced MUSCULAR WEAKNESS (muscle weakness specially in face/feet that lasted for 10 weeks) and FATIGUE (very severe fatigue lasted for 10 weeks/very severe fatigue). On an unknown date, the patient experienced EPSTEIN-BARR VIRUS INFECTION REACTIVATION (CEDV chronic (EpsteinBarr virus) underlying condition it made) (seriousness criterion medically significant). On 11-Feb-2021, PRODUCT DOSE OMISSION ISSUE (haven't received the 2nd shot more than 36 days) had resolved. At the time of the report, EPSTEIN-BARR VIRUS INFECTION REACTIVATION (CEDV chronic (EpsteinBarr virus) underlying condition it made) and HYPERSOMNIA (She slept for 3 days) outcome was unknown and MUSCULAR WEAKNESS (muscle weakness specially in face/feet that lasted for 10 weeks) and FATIGUE (very severe fatigue lasted for 10 weeks/very severe fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, this patient's underlying medical condition remains a confounder.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, this patient's underlying medical condition remains a confounder.
diarrhea; fever; aches / severe pain; no appetite; weakness; headaches; sharp shoulder pain; balance was off; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (diarrhea), PYREXIA (fever), PAIN (aches / severe pain), DECREASED APPETITE (no appetite) and ASTHENIA (weakness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced DIARRHEA (diarrhea), PYREXIA (fever), PAIN (aches / severe pain), DECREASED APPETITE (no appetite), ASTHENIA (weakness), HEADACHE (headaches), ARTHRALGIA (sharp shoulder pain) and BALANCE DISORDER (balance was off). At the time of the report, DIARRHEA (diarrhea), PYREXIA (fever), DECREASED APPETITE (no appetite), ASTHENIA (weakness), HEADACHE (headaches), ARTHRALGIA (sharp shoulder pain) and BALANCE DISORDER (balance was off) outcome was unknown and PAIN (aches / severe pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter  Treatment medication included Tylenol
Vomiting; Diarrhea; Mouth sores; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), DIARRHOEA (Diarrhea) and STOMATITIS (Mouth sores) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced VOMITING (Vomiting), DIARRHOEA (Diarrhea) and STOMATITIS (Mouth sores). At the time of the report, VOMITING (Vomiting), DIARRHOEA (Diarrhea) and STOMATITIS (Mouth sores) outcome was unknown.            No concomitant were provided. No treatment medication were provided.
Very severe headache, with light and sound sensitivity lasting over 36 hours,  inability to produce urine or bowel movements (even with proper hydration and nourishment) for 24 hours,  Mild fever of 99.8  with severe body aches and chills, lasting over 24 hours
Information has been received from a woman in a medical office concerning a 9 yea old male patient who on 30Apr96 was vaccinated in the left thigh with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 16Oct2003, the pt developed varicella and presented to the medical office with less than 50 lesions. Laboratory tests were not performed. Additional information has been requested.
Fever / chills / arm redness & swelling & pain around injection site of Left arm - site of PNEUMOVAX.
Tenderness-blotchy rash around site L arm-dry throat, nausea. Discontinues red plaques, tender, not itchy. Shoulder aches.
Headache Narrative:  Side Effects: Dose 1: day 1 and 2: sore arm, HA, muscle aches Dose 2: Days 1 - 4: sore arm; Days 1 and 2: HA, muscle aches, fever(day 3 only)
Flat red rash at site of injection. Patient noticed it 6 days after injection. No itching, pain or open sores.
This patient was given a subcutaneous injection of Merck brand varicella zoster vaccine -ZOSTAVAX- in the right deltoid area in the early afternoon of 10/16/2012. The reaction began as a vague soreness at the area of injection in the evening. The patient reported that the reaction reached its peak the next day with a tennis ball sized lump at the site of injection accompanied by redness, warmth and was sore to the touch. She also reported body aches and headache. The patient had read the literature provided and correctly applied ice and took acetaminophen for her symptoms. On the second day, the above symptoms were still present but had diminished. Today she reports that symptoms of soreness at the site of injection are still present but slight. The lump has disappeared along with the systemic symptoms described above.
Systemic: Weakness-Medium, Additional Details: patient reports feeling a jolt in her arm (possible due to nerves) during administration. After vaccination finished her arm felt weak.  She still has movement in her arms but says it just feels weak and harder to move her arm.
Arm was only slightly sore and a bit swollen; Arm was only slightly sore and a bit swollen; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 1st May 2019, refer case US2019080706).   On 17th July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm and swelling arm. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm and swelling arm were recovered/resolved.   It was unknown if the reporter considered the pain in arm and swelling arm to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient called to reporter few days after vaccination and reported there were no adverse events like after 1st dose.  The patient had premedicated with Ibuprofen before receiving the vaccination. The patient reported icing her arm and continuing with Ibuprofen. The patient's arm was slightly sore and a bit swollen for a day or two.
Severe drowsiness after 2 hours; Light headedness immediately as well as tingling pain in the opposite arm from the injection; Light headedness immediately as well as tingling pain in the opposite arm from the injection; Light headedness immediately as well as tingling pain in the opposite arm from the injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27May2021 12:30 (Lot number: EW0183) at the age of 25 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), PARAESTHESIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 27May2021 12:30, outcome "recovering" and all described as "Light headedness immediately as well as tingling pain in the opposite arm from the injection"; SOMNOLENCE (non-serious) with onset 27May2021 14:30, outcome "recovering", described as "Severe drowsiness after 2 hours". Therapeutic measures were not taken as a result of dizziness, paraesthesia, pain in extremity, somnolence.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 Since the vaccination. Device Date: 27May2021.  No follow-up attempts are possible. No further information is expected.
RASH OVER ANKLES WRISTS AND BACK OF KNEES; FLU LIKE SYMPTOMS/BODY ACHES; MIGRAINE; This spontaneous report received from a patient concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, and eosinophilic esophagitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. he batch number was not reported and has been requested. No concomitant medications were reported. On 09-SEP-2021, the patient experienced flu like symptoms/body aches. On 09-SEP-2021, the patient experienced migraine. On 14-SEP-2021, the patient experienced rash over ankles wrists and back of knees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms/body aches, and migraine on SEP-2021, and the outcome of rash over ankles wrists and back of knees was not reported. This report was non-serious.
Rash occurred on upper right arm day after then moved to lower arm and then to upper and lower right arm.  Then welts appeared on my thighs and more itchy welts on stomach.
Left inner ear ache, fever 100.9, body aches, chills, diarrhea
The pt experienced red arm inflammation which was red and sore. The arm was difficult to mobilize and was painful. The area was from the deltoid to the elbow. It was hot to the touch. The pt was treated with Tylenol and Benadryl.
Ovarian cyst formed and ruptured within 1 week of vaccination; This is a spontaneous report from a non-contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 29-year-old, via an unspecified route of administration on 14Apr2021 (Lot number and expiration date was not reported) unknown, single for COVID-19 immunization. Medical history included rheumatoid arthritis, fibromyalgia, postural orthostatic tachycardia syndrome (POTS), endometriosis, asthma, chronic anemia, and known allergies to gluten, dairy, corn, soy, eggs, and leuprorelin (LUPRON). The patient was not pregnant at the time of vaccination. Concomitant medications included diphtheria vaccine toxoid, tetanus vaccine toxoid (TETANUS DIPHTHERIA) administered at the left arm and pneumococcal vaccine administered at the right arm; both on 23Mar2021. The patient experienced ovarian cyst formed and ruptured within 1 week of vaccination on Apr2021. This was a known personal inflammatory response, as she has rheumatoid arthritis and endometriosis. No treatment was received for the event. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
24 y/o  male PT Approx. 140 kg (308 lb) Pt stated he felt nauseous and dizzy.  Pt denies difficulty breathing or fatigue. NKA allergies at this 'time. No current medications. Pt threw up @ 1635p,  Pt seemed anxious  and the following V/S were taken at 16:30p  BP 90/70 HR 59 SAT 96%  Tacos @1400p   PT was placed in a laying down position with his feet elevated  current Vitals reassessed at 16:40 BP 110/70 HR 77 SAT 99%  PT refused to call EMS.  Pt Patient remained AAO x4,    refused activation of EMS
Patient had no reaction.   Patient was given Flu vaccine on 01/31/2023 at another facility.  Patient stated she had not had flu shot.  Therefore was given in our clinic 02/07/2023
acute onset maculopapular lesions along the left dorsal cervical area, consistent with shingles or herpes zoster 17 days following a booster dose of Pfizer COVID vaccine
threw up for hours; This case was reported by a consumer and described the occurrence of vomiting in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose on an unknown date and it was fine).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown.   It was unknown if the reporter considered the vomiting to be related to Shingles vaccine.  Additional details were provided as follow: This case was reported by the consumer. The age at vaccination was not reported. The patient received the 2nd shot and after that it was fine for the first day and the second day it threw up for hours. No further information was provided. This case has been linked with US2021AMR101858, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR101858:same reporter (reporter´s case)
NUMBNESS IN THE LEFT ARM; NUMBNESS IN THE LEFT LEG UNTIL THE TOES; TINGLING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination to left arm. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 07-APR-2021, the subject experienced numbness in the left arm. On 07-APR-2021, the subject experienced numbness in the left leg until the toes. On 07-APR-2021, the subject experienced tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in the left arm, numbness in the left leg until the toes, and tingling. This report was non-serious.
Information has been received from a consumer concerning a male with a "weakened immune system" who was vaccinated with a dose of ZOSTAVAX. On an unspecified date the patient developed shingles. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested.
Had febrile seizure, fever of 104 and rash 8 days after. went to ER
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), in Dec2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 11Sep2023 to 16Sep2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Rt dt warm to touch no temp, no pain with 50mm slight induration/mom states child's maternal maternal gd mt allergic to Td.
Allergic reaction to her face cream; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction to her face cream) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction to her face cream). At the time of the report, HYPERSENSITIVITY (Allergic reaction to her face cream) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Approximately eight minutes post vaccination Client became  pale and very diaphoretic, saying he did not feel well,  looked hypotensive. 4:05PM B/P was 55/32  Pulse -48 R-14 C/O dizziness.  Called 911.  Gave him 6.7oz apple juice, retook VS at  4:10PM  99/53 P-64  R-16 placed in supine position.  4:15PM EMTs arrived. O2 sat 99%  Vital signs continued to improved to  B/P 110/80 . Orthostatic B/P done, no change. Client declined to go to hospital. Wife is MD she escorted him home