chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme headache, aches & pains the day following the vaccine. Headache has persisted off and on for one week.; ache and pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 14:15 as dose 4 (booster), single (Lot number: GH9693) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 23Sep2022 at 05:00, outcome "recovering", described as "Extreme headache, aches & pains the day following the vaccine. Headache has persisted off and on for one week."; PAIN (non-serious) with onset 23Sep2022 at 05:00, outcome "recovering", described as "ache and pains". Therapeutic measures were taken as a result of headache, pain.  Additional information: the patient had no other vaccines in four weeks and no other medications in two weeks. The events were treated with Advil.  Follow-up attempts are completed. No further information is expected.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EW0181), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jul2021 10:30 (age at the time of vaccination (42-year-old) as dose 1, single, dose 2 via an unspecified route of administration on 04Aug2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. On 30Aug2021 patient experienced tested positive for covid. Received second dose on 04Aug. Tested positive for Covid on 30Aug. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with medicines. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 30Aug2021. The outcome of the events was not recovered.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Mpderna COVID-19 Vaccine EUA   At 0630 pm fatigue  At 0930 severe chills / nausea /joint pain arm pain whole time resolved by 5pm next day
skin was irritated, purple, swelling on site of shot, joint pain, headaches, dizziness, loss of short term memory, sinus problems.
ReCEiVED 4yr old Boosters ON 8-10-2020. DeVEloped a fever the same night with T.max 101.5 No fever today IN office 8-12-20. INjection site swollen, red & painful. ABEL to move arm well
Within 30 minutes of vaccine administration, lower back myalgia developed.  Myalgia worsened over the next 24 hours with gradual improvement by 72 hours after injection.  Fatigue developed 7 hours after injection and improved by 24 hours after injection given.  Chills developed 9 hours after injection and resolved by 24 hours after injection given.  Moderately severe injection site tenderness developed 4 hours after injection given and improved after 48 hours.  Still with some low back pain, but slowly improving .
Due to a change of school, our son had gone to his doctor's for a physical. Doctor physician assistant took our son's vitals and then the doctor proceeded with the examination. At the end of the examination, Doctor stated that he was due for a tetanus shot, and we asked the P.A. if the shot had a mercury derivative as a preservative. We were informed, after the P.A. went to check, that it did not contain any mercury derivative. It was further explained that only the MMR had a mercury derivative, but that it had been discontinued. After conferring between ourselves, my husband gave permission for the shot. Our son took the injection well, without the normal fighting and need for restraint, got dressed, and we left the examination room. While I waited at the receptionist's window to receive requested medical records, approximately thirty-five feet from the examination room, the receptionist and I heard a noise and turned to see my son collapsing into my husband. At first, my husband thought he was just giving him a hug, but our son continued to lean into my husband and fell to the floor. Our son lay on the floor for about five minutes; his body twitching as if in a seizure for about one minute. We have seen seizures prior to this having family members with epilepsy, and immediately informed the office personnel, only to be told that he was not having a seizure and that the doctor was coming. Once the trembling had ceased, we called his name and patted his face, but he remained unresponsive. It was another minute until he said he was alright in reply to our questions and thirty seconds longer for him to be able to move. Our son tried to roll onto his side in order to sit up, but he was not able to do it, so he laid there an additional minute. He again tried to sit up, and being able to, tried immediately to stand up, but was too weak and unstable, which caused him to fall back down. Five minutes after he lost consciousness, his father carried him back to the examining room. Doctor said, after checking him over, that the reaction was no big deal, that it happens all the time, and that our son would be fine. The doctor elevated his feet, had him resting, and under observation for another ten minutes before he felt secure enough to release him.
Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: husband said pt noticed symptoms about half an hour after shot was administered. Did not notice symptoms while they were waiting for 15 mins in the store. said she is also having a panic attack. Advised to goto urgent care/er if anaphylactic s/sx occur or take benadryl. husband purchased benadryl. followed up at 7 pm,pt is fine per husband. no follow up needed.
This spontaneous report was received from a licensed practical nurse, referring to a 13 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 14-JUL-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Balance has been off  Ability to heal is now hard  Allergic reaction to Advil  Headaches  All of these were NEVER an issue before the pressured vaccine was given
Reactive Lymphnodes on right side as indicated on Mammogram (01/09/2021) . Follow up Ultrasound (01/14/2021) confirmed benign.
Painful Lump at injection site. Painful lump in armpit, body ache, chills, headache, nausea, chills, trouble sleeping, stomach ache, diarrhea followed by 3 days of constipation. Burning eyes
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Feb-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was 33.80 years.  Concomitant products were not provided.  On 27-Feb-2021, Excursion time was 09 AM, temperature was 33, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 14 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 27-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 AM: 35, 1PM: 35, 2 PM: 35, 3 PM: 34, 4 PM: 34 and 5 PM: 35.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
After injection I too seat to wait 15-20 minutes. Immediately I started to lose peripheral vision and then my hearing....I called for help. They took me in a room to lay down and said my blood pressure had dropped vary low.  After an out of doing better I just needed t get home. So another hour passes and I get home, go directly to bed and what seems like a bad flu begins.   That night my temperature continues to climb, the aches and headache are horrible.  I continue fevers for 3 nights.  Feel a little better and then with 2 days it relapse and all starts again.  I am in bed for 1 and 1/2 weeks, then stay home due to continued headache, dizziness.  After 3 weeks the dizziness continues and I then start getting an aching pain in the back of my left leg.  Seeing my doctor on May 11th and hope to discuss.
Case number PHEH2014US000914 is an initial spontaneous report from the pharmacist received on 08 JAN 2014 with a follow-up received on 02 FEB 2014. This report refers to a 12-year old male patient who was accidentally vaccinated with 0.5 ml of FLUCELVAX (batch number: 010011A, expiry date: JUN 2014) intramuscularly in to the left deltoid on 07 JAN 2014. No adverse event reported following this medication error (inappropriate age at vaccine administration).  Follow-up received from the pharmacist on 02 FEB 2014: Updated site of FLUCELVAX.  Non-significant follow-up received from Vaccine Adverse Event Reporting System (VAERS ID: 518888) website on 06 MAR 2014. Updated VAERS ID only.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 02 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "adult product administered to child".
Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/12/2021 and 4/9/2021. Patient presented to emergency department on 8/26/21 with shortness of breath, cough, fatigue, and diarrhea, all starting 11 days prior to admission.  She was diagnosed with covid on 8/25.  She was admitted with acute respiratory failure with hypoxia due to covid 19 pneumonia.She was initially placed on airvo.  Inflammatory markers were elevated.  Her procalcitonin was elevated and she received and completed a course of Rocephin. She completed a 10-day course of Decadron and was changed to solumedrol.  She completed a course of remdesivir and baricitinib. She was subsequently started on cefepime with dense consolidation on her Xray. She was on Lovenox that was decreased to DVT prophylaxis dose.  Her echo showed normal LVEF of 55-60% with Grade II diastolic dysfunction. Her oxygen requirements increased, and she was intubated on 9/16. She was switched from solumedrol to a prednisone taper. Her Lovenox dose was changed to bariatric dose. She was continued on insulin.  Her Lovenox was switched to heparin.  She had worsening pulmonary fibrosis and developed hypoxia refractory to ventilatory support (saturations in the 60% range).  She was not deemed a candidate for CRRT.  ICU team met with family and her code status was changed to DNR/AND.  Patient's ventilation was deescalated. Patient expired at 1444 on 9/22/21.
Reddened, moderately swollen, slightly warm at injection site, 4" in diameter.  No tenderness or itching.
Flu vaccine given at 1045 at 1400 symptoms of hoarseness, lip swollen, throat tight.  Also had injection to back of neck on same day.  Also c/o chest pain and feet cramps, c/o cough and was anxious.  EPINEPHRINE, SOLUMEDROL, TORADOL, ATIVAN and PREDNISON given in ER.
not being able to lift his arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "not being able to lift his arm".  Additional information: The patient had developed the issue of not being able to lift his arm after either the first or second COVID vaccine, patient already reported it on his own to Pfizer so she doesn't want to do a report for him.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
each arm-swelling, soreness, hep A x 3-4 days;flu- x 1 day;
Member had shortness of breath, tachycardia, sesnation her throat was closing up. went to ER given epi, decadron, benadryl, and pepcid
Swelling and redness on arm down to elbow. Within six days rash and spots over groin and trunk area. Also redness on hands and wrists plus swelling. Lower lip swelled outward -also spots on face, arms and legs. Itching.
Pt devel fever following vax; ax temp went from 100.6 to 103.2F, chilled w/fever; Seen by MD who reported that the pt remained conscious & alert but chilled; Seen in ER;
pt recvd vax; devel large pruritic hive at inject site w/in 2 hrs of vax; lasted 2 days; did not spread;
Myalgia, Fever, NauseaVomiting, fatigue, lightheaded, chills, sore arm, tender shoulder Narrative:
28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were given. No treatment information were provided.
BODYACHE; CHILL; FEVER; HEADACHE; This spontaneous report received from a consumer via a company representative concerned a male 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: unknown) dose, start therapy date were not reported for prophylactic vaccination. 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 an unspecified date, the subject experienced bodyache, chill, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chill, headache and bodyache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210358272.
Headache, fatigue, extreme exhaustion, chills, vomiting, body aches, nausea, excessive sleeping, loss of appetite, nose bleeding 24 Hours
Pfizer-BioNTech COVID-19 Vaccine EUA - Chest Pains radiating to back; headache; shortness of breath; coughing - symptoms began 5 April 2021; went to Urgent Care 10 April 2021; subsided o/a 15 April 2021
Patient received the vaccine on 4/13/2021 and woke up the morning of 4/14/2021 with her face and eye swollen. She contacted to her Doctor and was instructed to take Benadryl.
Unresponsive to mom; drooling from mouth; Mom phoned 911-was taken to ER w/rapid heartbeat; Episode lasted approx 5-10 min; T104(R) @ER; Meds given and T dec; Blood & CXR done; Told had ear infect & throat was red; Sent home w/meds;
Information has been received from a Nurse Practitioner (N.P.) concerning a female patient who was vaccinated with a first dose of Gardasil. The patient fainted after 1 1/2 hours receiving the injection. Unspecified medical attention was sought. The patient's outcome was recovered. Additional information is not expected.
The caller did not definitively confirm the brand name for the previous HPV vaccines that were administered in 2017 and 2018; No additional AE reported; Patient inadvertently received a third dose of GARDASIL 9 on May 3, 2022 after completing a two dose regimen.; Patient inadvertently received a third dose of GARDASIL 9 on May 3, 2022 after completing a two dose regimen. Patient received their first dose of a HPV vaccine on April 28, 2017 and their second dose on March 27, 2018.; This spontaneous report was received from a medical assistant concerning a 12-year-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history and concomitant medications were not provided.   On 28-APR-2017, the patient was vaccinated with the first dose of Human Papillomavirus (HPV) vaccine (manufacturer unknown) for prophylaxis (Dose, route of administration, anatomical location, lot # and expiration date were not reported).   On 27-MAR-2018, the patient received the second dose of HPV vaccine (manufacturer unknown) for prophylaxis (Dose, route of administration, anatomical location, lot # and expiration date were not reported) (Inappropriate schedule of product administration).   On 03-MAY-2022, after completing a two dose regimen, the patient inadvertently received a third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 mL once, lot # U029623, expiration date 26-OCT-2023, for prophylaxis (Route of administration and anatomical location were not provided) (Extra dose administered). The reporter mentioned that no adverse effects were noted after the administration of extra dose of  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and no additional adverse events were reported (No adverse event).
3:40pm pt. c/o lightheadedness, ringing in ears and getting sweaty.  Patient requested water.  Water was provided.  BP 117/66, HR 66, O2Sat 99% on RA.
This spontaneous report as received from a nurse refers to an 11 months 18 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Initial report was received on 28 April 2010 from a consumer, who is also the patient's daughter. A 72-year-old female patient (also reported as 71 year-old) who had a history of hypertension, had received an injection of FLUZONE SV 2009-2010, lot number U3378AB on 13 January 2010 and three days later, she developed tingling and a sensation of pin pricks in her lower right leg. These symptoms spread across her waist and to her right leg. According to the reporter, the patient became paralyzed from the waist down and she became incontinent of urine and feces. The patient was taken to the emergency room and was hospitalized for seven days (dates not reported). Diagnostic testing included an MRI, brain scan and lumbar puncture (results not reported). Corrective treatments were not reported; however the patient was being seen by both "ortho and neuro". The patient had been taking DIOVAN 80 mg concomitantly and she had no concurrent illness at the time of vaccination. She had not received any other vaccines within four weeks of receiving FLUZONE SV 2009-2010. At the time of the report, the patient had not recovered. Documents held by sender: None.
Starting about 18 hours after vaccination, achy body, fatigue, headache.  Tylenol helped but did not entirely alleviate.  At about 24 hours after vaccine, aches substantially increased, chills set in, and fever of 101.5 reached.  Advil did not reduce fever.  By 32 hours after vaccine, all symptoms gone except light headache.  Lots of water and gatorade taken as well.
Moderna dose #1-  within 15-25 min after receiving vaccine to right arm, began experiencing muscle spams/ involuntary contractions on entire right side. Pharmacy staff advised symptoms were not normal and needed to contact my doctor. I contacted my doctor through messaging portal to advise.  Over course of next few days I began feeling pinching feeling inside of my legs/ inner knee calf area, this turned to dark bruises (photographs collected), hands began to have involuntary shaking intermittently,  muscle spasms/ contractions began to worsen and spread to other large muscles intermittently in legs, bottom of foot, arms, chest area (documented some areas via video over course of several weeks).  The spasms continue for long durations of time and cause extreme fatigue to those muscles affected. As bruises on legs dissipated I now have extreme pain in same place of bruising/ pinching in mainly in right leg and some in left leg (this pain is isolated to the area of the bruise/ pinching but radiates at time straight down. Symptoms still continue to date of reporting this.