chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 10:47 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:47 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 56.57 No concomitant medications were reported. On 03-Apr-2021 at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and vial was initially moved to the fridge on 30-Mar-2021 and beyond use date was 29-Apr-2021. Product moved to clinic on 03-Apr-2021. Vial was stored on cooler 1, on 03-Apr-2021, Excursion duration At 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM : 41, 3 PM: 40, 4 PM: 40 and 5 PM : 41. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Initial and follow up information has been received from a physician and a registered nurse concerning a 75 year old female who on 10/12/05 was vaccinated IM in the left arm with a dose of Pneumococcal 23v polysaccharide vaccine. On 10/13/2005 the pt developed arm swelling around the injection site. The nurse indicated in follow up that the pts daughter reported her mother developed a red and swollen left upper arm from her shoulder to elbow and that it was painful. The pt was treated with Tylenol and cold compresses. Subsequently, the pt recovered on approx 10/20/05. It was also reported that the pt may have been one previous vaccination with Pneumococcal 23v polysaccharide vaccine. Additional information is not expected.
Hospitalized 05/09/2022-05/14/2022; COVID-19 positive 05/09/2022; fully vaccinated plus booster  Discharge Provider: Medical doctor. Primary Care Provider: Medical doctor.   Admitting Service: Internal Medicine Service Admission Date: 5/9/2022 Discharge Date: 05/14/2022  PRESENTING PROBLEM:  Hypertensive emergency   HOSPITAL COURSE:   The patient is an 83 yo man w/ CKD stage IV who was sent to the facility following 6 wks progressive SOB and exertional fatigue, acutely worse in recent days w/ URI sx.  Despite Covid vaccination, last boosted 8/2021, he was positive covid 19. Patient was admitted for acute flash pulmonary edema secondary to hypertensive emergency.  He presented with systolic blood pressure above 230.  He was placed on IV Lasix as well as resumption of his home antihypertensive medication in addition to nitroglycerin drip.  Nephrology was consulted who recommended stopping his hydralazine and norvacs due to high risks for worsening pleural effusion and edema. Unfortunately, he was found to be COVID-19 positive but remained minimally symptomatic and without hypoxia.  He was vaccinated and boosted. Patient was also found to have mild acute myocardial injury secondary to uncontrolled hypertension and pulmonary edema.  Echo with normal EF and no wall motion abnormalities.For his hypertension norvasc and hydralazine were discontinued and he was started on coreg, clonidine  with good results. He was successfully weaned off nitroglycerine gtt and blood pressures remained stable on the oral medication regimen described above. He evaluated by PT/OT who recommended home with home health. He was discharged in stable condition with plan for nephrology followup and repeat labs on 05/14/2022.
Injection site pain and tenderness within an hour of injection.  Headache, chills,  body aches, muscle pain, joint pain, fatigue within 7 hours.  Difficulty sleeping, fever of 100 degrees upon awakening with continuation of above side effects.  Used Tylenol, drinking fluids.
This case was reported by a healthcare professional and described the occurrence of arm numbness in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (unknown, right arm). At an unspecified time after vaccination with TWINRIX, the subject experienced arm numbness and neuropathy arms. At the time of reporting the outcome of the arm numbness and neuropathy arms were unspecified. The spouse of the subject reported "he and his wife had the TWINRIX series last year on the traditional schedule 0, 1 and 6 months. The spouse of the subject states both he and his wife have had problems with numbness and neuropathy in their arms. Both arms were alternated for the series and it was right, left, right; he reported that both arms are bothering them. She (the wife) went to the clinic and the doctor told her they are seeing this with the hepatitis vaccines (subject was not sure if the doctor meant all hepatitis vaccines or just the TWINRIX). He also said another friend of theirs is experiencing the same thing." This is second of three cases reported; for the first case (husband) see case A0977548A; for the third case (friend) see case A0977599A. Follow-up information was received on 15 June 2012 via healthcare professional who reported the 62-year old female subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (1ml) on 20 October 2010, 23 November 2010 and 02 May 2011 respectively. Concurrent medication included Synthroid. At the time of the report the events were unresolved.
On 5/21/00 post vax, the pt was dx with Bell's Palsy. She is currently being treated with steroids, but so far has not shown any improvement in her condition. The Bell's Palsy has not improved or resolved. The physician believes that the child will recover, as she stated most cases of Bell's Palsy do resolve.
Dose 1 and 2 Pfizer, Dose 3 Moderna; Felt warm briefly but drank water and that went away; Injection site hurt; Slight chills; Temp of 100.1 F/ The toilet seat felt extra cool which probably means I was running a temperature; Mild chills for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Dose 1 and 2 Pfizer, Dose 3 Moderna), FEELING HOT (Felt warm briefly but drank water and that went away), VACCINATION SITE PAIN (Injection site hurt), CHILLS (Slight chills) and PYREXIA (Temp of 100.1 F/ The toilet seat felt extra cool which probably means I was running a temperature) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU SYRINGE) for an unknown indication.    Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (First dose on 09-Feb-2021 and the second on 02-Mar-2021) on 09-Feb-2021.   On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU SYRINGE) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced CHILLS (Mild chills for 2 days). On 31-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Dose 1 and 2 Pfizer, Dose 3 Moderna), FEELING HOT (Felt warm briefly but drank water and that went away), VACCINATION SITE PAIN (Injection site hurt), CHILLS (Slight chills) and PYREXIA (Temp of 100.1 F/ The toilet seat felt extra cool which probably means I was running a temperature). On 31-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (Dose 1 and 2 Pfizer, Dose 3 Moderna) had resolved. At the time of the report, FEELING HOT (Felt warm briefly but drank water and that went away) and CHILLS (Mild chills for 2 days) had resolved and VACCINATION SITE PAIN (Injection site hurt), CHILLS (Slight chills) and PYREXIA (Temp of 100.1 F/ The toilet seat felt extra cool which probably means I was running a temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, Body temperature: 100.1 (High) 100.1 F.    No concomitant medications were provided. No treatment medications were provided.  The patient received the third dose of the Moderna Covid-19 Vaccine at the same time as the High Dose Flu Shot.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow-up received contains updated events- Feeling of warmth ,Temperature elevation, Vaccination site pain, Chills, Pyrexia and Chills
Suspected vaccination failure; Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 7th July 2020, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated she received 2 doses of Shingles vaccine 5 years ago. The patient believed the vaccine was Shingrix that she received, and stated "what else would I get that was two shots?" When further asked if she remembered when she received these doses, the patient stated she had no idea. On 7th July 2020, the patient diagnosed with Shingles. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided. The patient was unable to provide any additional details or information. The reporter consented to follow up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 at 13:00 as dose 1, single (Lot number: EWO151), in left arm and on 27Apr2021 at 12:00 as dose 2, single (Lot number: EWO171) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Nov2021 at 10:00 as dose 3 (booster), single (Lot number: 027H21B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "obesity" (unspecified if ongoing); "DVT (factor V Leiden mutation)" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; ATORVASTATIN; WARFARIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Treatment of COVID-19; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had anti viral treatment included COVID 19 Treatment, Brand was Paxlovid started on 23Jun2022 to 28Jun2022. Other medication in 2 weeks included Zoloft, Atorvastatin, Claritin and Warfarin. Covid rebound six days after end of paxlovid treatment (including testing negative by lateral flow antigen assay). No known allergies were reported.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Vaginal Blood Spotting; This is a spontaneous report from a non-contactable consumer. A 27-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration, in arm Left on 09Mar2021 at 15:30 (at the age of 27-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included etonogestrel (NEXPLANON), vitamin d nos, ascorbic acid vitamin c [ascorbic acid], fish oil and daily Multi (unspecified). On 11Mar2021 at 08:00, the patient experienced vaginal blood spotting. The patient received no other vaccine in four weeks. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Jan2021. Treatment was not given for the event. The patient tested covid post vaccination and covid test result was negative on 11Jan2021. Outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Pt developed redness and swelling at the site of DTPA/IPV (24 hours later) on right arm. Treated with Keflex for cellulitis of right upper extremity versus local reaction.
Right arm - swollen, hard knot, hot to touch, & tenderness w/ palpation of the lesion. There is a area of induration that is 6 cm by 6.5 cm. The redness extends out to 8cm x 9cm. Pt received allergy shot in same arm on same day & another clinic.
After 2 days: Hives  Dermatographia  Fatigue  Tried steroids and it came back after 2 days  Over the course of 8 months:  Hives Dermatographia Shortness of breath while doing activities  Migraines after activities  Elevated pulse with activities  Easily bruised  Extreme bloating and abdominal pain when eating  Extreme fatigue  Loss of appetite  Wheezing  Chest tightness  Nausea and vomiting  Uncontrolled shakes  Feeling to hot/to cold  Dizziness, lightheadedness, followed by blurry vision  Weakness   On famotidine 20 mg On pantoprazole 40 mg  Little to no improvement
There is a small painful lump on the bottom of my foot deep in the skin; a small painful lump on the bottom of my foot; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 06Apr2021 at 15:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension from an unspecified date. Concomitant medications included nebivolol hydrochloride (BYSTOLIC), and warfarin (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW6199) via an unspecified route of administration in the right arm on 10Mar2021 at 13:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient previously took vancomycin (MANAFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 16:15 the patient experienced a small painful lump on the bottom of his foot deep in the skin. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events mass, pain was not recovered.   No follow-up attempts are needed. No further information is expected.
This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever), chills and myalgia (body aches) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 023C21A) for COVID-19 immunization. No medical history reported. On Apr 28, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (fever), chills and myalgia (body aches). At the time of the report, pyrexia (fever), chills and myalgia (body aches) outcome: unknown/not provided. No concomitant medication or treatment information reported.
Immediately headaches, facial pain over nose and right eyes, tearing of eye. Headaches are excruciating.
-fatigue, fever, shortness of breath, vomiting, chills, headache  Began at 6:00pm (about 9 and a half hours after vaccination, and lasted for about 6-8 hours).  -soreness in arm, lump at injection site Continuous (3 days later and still sore).
w/in 2-3hr p/vax devel Bell's Palsy like sx drooping lt side of face & mouth;lt cheek appears swollen;lt arm has red area size of fifty cent piece;went to EER where MD ran test for lyme
Mixed series, administered Pfizer (lot # ew0153) 4/8/21 and Moderna (lot # 008B21A) on 5/7/21. No known adverse reaction. Patient came to Hospital Emergency Department for unrelated issue and it was found that his vaccination record demonstrated a mixed series.
Mom stated that about 3 hrs p/receiving vax let out a high shrill cry & soon p/became unresponsive & limp; To ER; p/about 45 min child came out of unresponsive state & has been fine;
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) injection (lot# L046509, expiry date 17-MAY-2017, albumin status rHA; dose and route of administration were not reported). There were no concomitant therapies reported. The reporter stated that the vaccines were exposed to a temperature of 7.5 degrees Fahrenheit for a total period of 14 hours (date unspecified). There was no previous temperature excursion or product quality complaint involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Rash on arms, back and stomach. Temp 102, stomach ache. Diagnosed with varicella. (Received Varivax 7/11/96).
Itching on hands and forearms that  started 2-3 days after shot and then blotches appeared btween 4-5 days after shot
This is a spontaneous report obtained from a contactable nurse through a sale representative. A patient of an unspecified age, gender and ethnicity received, on an unknown date, TRUMENBA, single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced rash on the arm which was larger n size (its got 4 inches big) than usual size. Clinical outcome was unknown at time of this report. Follow-up attempts completed. No further information expected.
Case previously recorded as MA2009-6276. Initial case received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN influenza A intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Agency reference no. NA09-008851.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JUN-2016, the patient was vaccinated with the improperly stored dose ROTATEQ (orally,  it was unspecified which lot # from the following: lot # K0022993 with expiration date 20-JUL-2016, lot # L035511 with expiration date 21-MAY-2017 or lot # L029618 with expiration date 20-MAY-2017; dose was not provided). No adverse event was reported. The vaccine was stored in the maximum temperature of 22.7 degrees of Celsius for 3 hours and 48 minutes and in the minimum temperature of 0.2 degree of Celsius for 31 hours and 1 minute. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no medical history or drug reactions/allergies reported. On 22-DEC-2015 the patient was vaccinated with an expired dose of ZOSTAVAX (lot# K012784 with expired date 02-DEC-2015, dose and route were unknown). No concomitant therapy was reported. The reporter stated that the ZOSTAVAX in question did not have any previous temperature excursions. No adverse symptoms were reported. Additional information has been requested.
I tested positive for COVID 19 on 11/6/2021 after receiving my COVID booster dose on 10/25/2021.  I was fully vaccinated against COVID 19 prior to my booster dose. I am asymptomatic (and have been the duration of my positive diagnosis), but was in close contact with my boyfriend who was positive for COVID 19 and was showing symptoms.
Extreme fatigue the day after shot, slept most of the day.. Felt like shingles was starting (had shingles before). Rash over both arms, both legs, right side of torso (different from shingles that had had previously) with a lot of itching. Started as individual red spots on skin, went to red bumps, then a larger rash. Still has it on 8/11/21, hasn't improved yet. Using Benadryl for itching.
Patient received first does of COVID-19 vaccine on 02/04/2021. Pt presented to clinic for second dose of vaccine.  Patient was asked several times by front desk staff and nurse about getting second dose of COVID-19 vaccine. Pt stated yes and was given vaccine.  While reviewing the patients chart, the provider noticed patient should have received one vaccine not other, but patient had already had vaccine administered to him.  The event was reported to Dr and patient was counseled by PA and monitored in clinic for 15min after vaccine.  Patient was advised he did not need to receive the second dose of the Covid vaccine. Patient was advised of possible side effects and instructed to contact the clinic with any adverse effects that were not normal.
Shoulder discomfort at location site. Pain, tenderness to the touch immediately following injection. In the afternoon the following day, I started with a headache, body aches, joint pain (shoulders, hips and neck), fatigue and fever (max. 101.0 F).