chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US022017 is an initial spontaneous report received from a health care professional on 31 OCT 2014. This report refers to a 36 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412501) at a dose of 0.5 ml intramuscularly in the arm on 10 OCT 2014. It was reported that on an unknown date, she experienced sore and tender arms at the vaccination site. She complained that her arm hurt so much that she could not lift it. The event outcome was unknown. The seriousness and causality were not reported.
Had morning SAM-e and one coffee.  Symptoms began ~ hour later.  Chills came on quick and strong. Then nausea with a feeling of hunger. Then bad headache that felt similar to sinus headache (pressure in the head) that seemed to move around in my head depending how I laid or held my head. Felt like my head wanted to explode.  Had a fever but did not take temp. Chills slacked off by evening (12 hours after starting). No vomiting. Finally could eat piece of dry bread and take one Advil and one Tylenol ~ midnight
About 18hours after shot I felt my chest just ?froze-didn?t move?  for a few seconds.  After that there  have been no episodes to the present time .
5 mins after administration pt complained increased heart rate and scratchy throat. Pt breathing normal BP 105/83 pulse 72, Pt ask sit a little longer. Rechecked 10 mins pt complained headache, throat sore. Rechecked 5 mins. Pt stated feeling dizzy, throat tighter. EPI-PEN administered and 911 called.
The patient came to the pharmacy for a Shingrix Vaccination , filled out the paperwork, and was given the vaccine, However after the vaccination was given we found out the patient had already received both doses in the series in 2018/2019.
second dose past 36 day mark; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose past 36 day mark) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose past 36 day mark). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose past 36 day mark) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medications are not provided.  No treatment information was provided.   Reporter did not allow further contact
Several days after receiving the vaccination the pt began to get various pox all over his body. There are 30-50 present and they itch.
pt said he did not like needles, no adverse reactions in past, no issues in past. After vaccinated, gave him a minute to breathe, said he was feeling ok, then asked him to proceed to our observation area for the 15 minute post  monitoring. After he sat in chair, witnesses said he rolled to his right side out of chair. He was completely conscious when attended to him immediately after him passing out. He stated he does not remember passing out. Had him lie on floor for 5 minutes, got him some water, he sat up for about 15 minutes. she took him home when he felt he was ready which was about 25 minutes after the dose was administered. Gave call 5 hours later, and said he felt much better and was doing an online class
This is a spontaneous report received from a contactable reporter(s) (Physician). A 39-year-old male patient received BNT162b2 (BNT162B2), on 16May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "HIV (undetectable)" (unspecified if ongoing). Concomitant medication(s) included: GENVOYA oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (12Jun2022) positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
the vial was initially stored in the refrigerator 21MAR2023 and administration of vaccine 21MAR2023; No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 21MAR2023 and administration of vaccine 21MAR2023) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1420B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2023, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 21MAR2023 and administration of vaccine 21MAR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 21MAR2023 and administration of vaccine 21MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 21MAR2023 and administration of vaccine 21MAR2023).    No concomitant medication were reported.  It was reported that one stored correctly said 21-FEB-2023, remained frozen until removed from freezer on 21-MAR-2023 and administered to patient. Sticker from their pharmacy said 21-APR-2023 on the box, charted then found it wasn't in inventory. Checked expiry on website and it showed that vaccine expired 21-FEB-2023. The patient (3-years & 5 Months-old) received expired First Primary dose, Monovalent Moderna COVID-19 vaccine Blue Cap, Magenta label. Dose administered after manufacturer date of expiry Monovalent vaccine in intact cartons with vial size of 10 dose vial. The vial was initially stored in the refrigerator on 21-MAR-2023. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 74-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Lot number: FL3209) at the age of 74 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Prostate Cancer" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Patient received treatment of Covid-19 (Brand: Pfizer) from 12Jul2022 to 16Jul2022. No follow-up attempts are possible. No further information is expected.
CHILLS, FEVER, DIZZINESS, BODY ACHES AND FATIGUE LASTING FROM 6:00 PM ON 4/5/2021 TO 3:30 AM ON 4/6/2021.  BODY ACHES, FATIGUE AND HEADACHE LASTING FROM 3:30 AM 4/6/2021 TO 2:00 PM ON 4/6/2021.  COLD SORE ON LIP APPEARED ON 4/6/2021 AS WELL.
Patient requested influenza vaccination and was inadvertently administered the Pfizer COVID-19 vaccine instead. No immediate adverse effects occurred.
Client received vaccine on 10/26/12.  Started having shoulder & arm pain that night.  Saw MD on 11/11/12, given steroid injection.  Has not been able to work-out or use arm in normal capacity.  There was no redness or rash associated at site.  Pain improved with steroid but now returning as steroid is wearing off.  Still having arm pain - not able to move arm to full extent.
she is taking ibuprofen all the time for pain.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "she is taking ibuprofen all the time for pain.". Therapeutic measures were taken as a result of pain.  Additional information included: The patient took Ibuprofen for the treatment of pain.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Pt. received the vaccine at approx. 8:50 AM. At 9:10 AM the pt. began vomiting. Pt. stated that she didn't feel good prior to the administration of the vaccine but did not tell anyone. Vital signs stable pulse 80, Temp 96.9, Resp 22, BP 80/68. We had the pt. to lay down on cot with legs elevated. Continued to monitor. Grandfather came to the school to pick child up. Discussed the situation and instructed to cont. to monitor.
pt devel a rash day p/shots;pt has been sleepy all weekend & had dec appetite;
Fever up to 102.9, nasal congestion, productive cough, occipital headache
Bad reaction in their arm on the site if the injection; Bad reaction that went over their shoulder/bad reaction  that went to the side of the neck/bad reaction that went  into their jaw like a charley horse; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Bad reaction in their arm on the site if the injection) and VACCINATION COMPLICATION (Bad reaction that went over their shoulder/bad reaction  that went to the side of the neck/bad reaction that went  into their jaw like a charley horse) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052G21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced VACCINATION SITE REACTION (Bad reaction in their arm on the site if the injection) and VACCINATION COMPLICATION (Bad reaction that went over their shoulder/bad reaction  that went to the side of the neck/bad reaction that went  into their jaw like a charley horse). On 19-Aug-2021, VACCINATION SITE REACTION (Bad reaction in their arm on the site if the injection) and VACCINATION COMPLICATION (Bad reaction that went over their shoulder/bad reaction  that went to the side of the neck/bad reaction that went  into their jaw like a charley horse) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medicine were not provided by the reporter.  Treatment medicine were not provided by the reporter.
Patient received first dose more than a year ago and now coming for their 2nd dose of the primary series; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient received first dose more than a year ago and now coming for their 2nd dose of the primary series) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient received first dose more than a year ago and now coming for their 2nd dose of the primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient received first dose more than a year ago and now coming for their 2nd dose of the primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient received first dose more than a year ago and now coming for their 2nd dose of the primary series).    No concomitant medications were provided. No treatment medication was provided.   Reporter did not allow further contact
Seriousness criteria other medically significant. Other manufacturer's reference number: A0636913A. Initial report received from another manufacturer on 26 February 2007. The information was provided to the other company by a health care professional. A patient of unspecified age or gender received the following injections on an unspecified date: DTaP (manufacturer unspecified), Ipol, and MMR II for prophylaxis. The patient's medical history and concurrent medications were not provided. An unspecified time after vaccination, the patient experienced anaphylaxis that required an emergency room visit. The reporting pharmacist considered the event to be clinically significant (or requiring intervention). At the time of this report, the outcome of the event was unspecified. The reporter of this case is the same as for case 2007-00548, which involved a case of anaphylaxis following the administration of DTaP, Ipol and MMR.
Injection site pain; This is a spontaneous report from a non-contactable consumer. This 50-year-old female consumer (patient) reported. A 50-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Right on 24Feb2021 (at the age of 50-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. 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 24Feb2021, the patient experienced injection site pain. The patient did not receive any treatment. Outcome of the event was not recovered, at the time of this report. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Soreness at injection site roughly 10 minutes after injection, soreness went away a few minutes afterwards. Injection was given in the morning, around 10am, around late afternoon, 4-5pm, area around injection site was very sore, as if there was a bad bruise there, but there was no visible marks. Shoulder was very sore to the point of hardly being able to lift arm to the side away from the body. Day after injection arm was still sore but the pain was less. 2 days after injection, arm was only slightly sore in the morning with no pain by mid afternoon.
2-3 hours crying episodes.  Very fussy 2-3 days, temperature greater than 101.8.  Parent gave Tylenol and treated without calling or seeking medical care.
ACUTE RESPIRATORY FAILURE 6/29/2022 PAIN  ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/29/2022 PAIN  ACUTE RESPIRATORY FAILURE 6/29/2022 ATRIAL FIBRILLATION, PAROXYSMAL  ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/29/2022 ATRIAL FIBRILLATION, PAROXYSMAL  ACUTE RESPIRATORY FAILURE 6/29/2022 ACUTE RESPIRATORY FAILURE  ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/29/2022 ACUTE RESPIRATORY FAILURE  ACUTE RESPIRATORY FAILURE 6/29/2022 ATRIAL FIBRILLATION, PAROXYSMAL  ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/29/2022 ATRIAL FIBRILLATION, PAROXYSMAL
Narrative: 81 y/o M w/ refractory dyshidrosis started Dupixent. 10/15/21 with marked improvement now with rash on back and flank spreading to extremities reported 11/23/21. Also noted with increased secretions as well as 3rd Moderna vaccine given 10/26/21. Patient's initial evaluation 11/5/21 thought reaction consistent with candidal eruption given satellite papules but could not r/o drug or viral rash. At follow up visit 11/8/21, rash appeared stabilized/improving with application of ketoconazole cream BID and discontinuing topical steroid/tacrolimus. However, patient consulted 11/15 for worsening rash on trunk, biopsy performed of pustule from the abdomen. Wound/mycology swab collected on 11/15 which had no growth. Biopsy returned consistent with a pustular drug eruption. On 11/23 follow-up, pustular drug eruption significantly improved from prior and likely culprit is dupixent due to onset of rash soon following administration of new medication. However, booster of the COVID vaccine is also a possible culprit (at least one case report of AGEP arising after Moderna vaccine) although less likely given lack of cutaneous reaction to 2 prior vaccines from series. Patient continued with clobetasol oint BID, tacrolimus oint BID to hands and ammonium lactate 12% lotion to hands at 11/29/21 visit but then clobetasol was stopped and prednisone oral taper was added. Reaction is now resolving as of 12/3/21 Patient follow up visit.
very sleepy that evening and passed out on her bed; eyes were spinning around in my head; very sleepy that evening and passed out on her bed; sinus is acting up; headache; During the call she was coughing; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (very sleepy that evening and passed out on her bed), VERTIGO (eyes were spinning around in my head), SOMNOLENCE (very sleepy that evening and passed out on her bed), COUGH (During the call she was coughing) and SINUSITIS (sinus is acting up) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced COUGH (During the call she was coughing). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (very sleepy that evening and passed out on her bed), VERTIGO (eyes were spinning around in my head), SOMNOLENCE (very sleepy that evening and passed out on her bed), SINUSITIS (sinus is acting up) and HEADACHE (headache). At the time of the report, LOSS OF CONSCIOUSNESS (very sleepy that evening and passed out on her bed), VERTIGO (eyes were spinning around in my head), SOMNOLENCE (very sleepy that evening and passed out on her bed), COUGH (During the call she was coughing), SINUSITIS (sinus is acting up) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported   It was reported that After the 2nd dose she had a headache, her eyes were spinning around in her head, and she was very sleepy that evening and passed out on her bed. During the call she was coughing and stated that her sinuses are acting up.  No treatment information was provided   This case was linked to MOD-2021-405166 (Patient Link).
Fever, chills, nausea, vomiting, diarrhea, joint pain
This is one case out of a cumulative total of 224 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 24 January 2014. These 224 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 24 January 2014 from the Investigator participating in a study under reference number M5A16. A case of pertussis disease in a three-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL (lot numbers not reported) on 12 August 2010, 12 October 2010, 10 December 2010, and 19 September 2011 (routes and site of administration not reported). The subject developed a cough on 26 December 2013, approximately two years and three months after the last dose, and on 07 January 2014 developed a paroxysmal cough without a whoop. He also experienced apnea and sleep disturbance. Laboratory testing included a positive PCR on 04 January 2014; a chest x-ray was negative. Corrective treatment included azithromycin for 5 days. The subject was not hospitalized. At the time of final contact on 15 January 2014 the subject's cough had resolved. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per the protocol. Documents held by sender: None.
One incident of diarrhea, vomited once overnight. Her shoulder had been quite red and sore.  May be unrelated of course, but felt that reporting should be done.
Patient received 2 Bivalent vaccine given 9/10/22 and then again 3/29/23. Patient reports today that her symptoms are the same as before cold/hot , dizziness and she took Tylenol same as previous vaccines. Patient states she has not had a symptom different with the other vaccines.
Moderate to severe sharp, pleuritic chest pain, associated with dyspnea, lasting approximately 16 hours.  No associated vital sign abnormalities.
Soreness on shoulder, limited mobility, when I'm very active as standing for 8 hours it begins to feel like it's hanging off my body.
On 1/02/08 Patient was given TriHib, Prevnar, and MMR.  That evening patient had a fever of 104.5F and seizure.
Information has been received from a registered nurse concerning a multiple female patients who on unspecified dates (since October 2006) were vaccinated with the first dose of Gardasil. Concomitant medication was not reported. Subsequently on unspecified dates, the patient felt faint after receiving Gardasil, 0.5 ml, IM. The patient's were treated with smelling salts, cool compress, food and cranberry juice. The nurse reported that the patient's usually had not eaten prior to the vaccination. The outcome and causality of the event was not reported. Additional information has been requested.