chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered Kinrix as the 4th dose for DTAP series, following 3 doses of Pediarix; administered Kinrix at 3 years; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5AY2J, expiry date 10-JUN-2024) for prophylaxis.   Previously administered products included Pediarix (received 3 doses of Pediarix on an unknown date).   On 11-AUG-2023, the patient received Kinrix. On 11-AUG-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: administered Kinrix as the 4th dose for DTAP series, following 3 doses of Pediarix) and inappropriate age at vaccine administration (Verbatim: administered Kinrix at 3 years). The outcome of the inappropriate schedule of vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-Oct-2023 Medical assistant reported that Kinrix as the 4th dose for DTAP series, following 3 doses of Pediarix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received a dose of Kinrix as 4th dose for DTAP series at an inappropriate age, which led to inappropriate schedule of vaccine administered and inappropriate age at vaccine administration.
Patient complained of left arm rash after receiving the flu vaccine. Stated it felt hot at first. Patient seen by clinician and given Benadryl 25mg IM to left deltoid. Patient experienced no shortness of breath.
Whole body aches; swollen left arm pit; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735), via an unspecified route of administration in the arm left on 03Apr2021 at 13:00(at the age of 35-year-old), as a single dose for COVID-19 immunisation. Medical history included depression, anxiety, headache and drug allergy. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and acetaminophen (MANUFACTURER UNKNOWN) started from an unknown date and for an unspecified indication. 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in the arm left on 13Mar2021 at 12:45 (at the age of 35-year-old), as a single dose for COVID-19 immunisation. The patient was allergic to levaquin (anaphylactic), sulfa based meds (rash) and amoxicillin (rash). On an unknown date in 2021, the patient experienced whole body aches and swollen left arm pit. The patient did not receive any treatment for the events. The adverse 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 event whole body aches and swollen left arm pit was recovering.   No follow-up attempts are needed. No further information is expected.
Headache, Myalgia,  Fatigue, arm pain, chills/shakes Narrative:
Pt seen 10/17/2005 for well check. Received Hep B vaccine #2. Developed fever to 101 10/18/2005 admitted to hospital R/O Sepsis.
Daughter stated she had diarrhea for 3 weeks while we were at the hospital on 6/2 for IV fluids and severe dehydration.  Her poop was mushy, and not diarrhea, however for her it was much softer than normal.  She collapsed at home and was unresponsive, 911 was called, ER doctor determined she was severely dehydrated and administered 2 bags of IV fluids to stabilize her blood pressure.
Pains in eyes, sinus congestion, chest problems. Pt felt better next morning. Only eyes side effects left.
Complaining of severe pain in big toe/Gout; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date Mar2021 (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: GOUT (non-serious) with onset 23Mar2021, outcome "recovering", described as "Complaining of severe pain in big toe/Gout". The pain in his toe that he thought might be related to him receiving the vaccine has subsequently been diagnosed as gout.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
C/O fatigue, malaise, stomach ache x 2 days no fever. Presented scattered, raised non fluid filled areas to bilateral palms, more pronounced between fingers. Observed upon returning to clinic for PPD reading. Advised to MD for rash.
pt recvd vax; hives, itching, swelling of hands, blurred vision; tx w/ dph;
This spontaneous report as received from a nurse practitioner via company representative refers to a 15 years old female patient. Approximately on an unknown date in December 2012 (reported as 4-5 months ago), the patient was vaccinated with a first dose of GARDASIL (Lot number, expiry date were not reported) 0.5 milliliter (ml) (reported as standard dose), intramuscular. Concomitantly the patient also received HAVRIX in the same visit on the opposite arm. Approximately on an unknown date in December 2012, the patient developed short seizure after receiving her first dose of GARDASIL. The event occurred in the office. No treatment was provided for the event. On an unknown date, the event short seizure was recovered/resolved. Upon internal review the event short seizure was considered as medically significant. Additional information has been requested.
Observed shortness of breath climbing a flight of stairs; fitness tracker logged 15 minutes where heart-rate was over 111 while sitting at a desk (normal day at work, minimal physical activity). Heart rate was more generally elevated throughout the day. Additional complications - flare-up of reflux and intestinal bloating (existing condition); diarrhea around 8:30pm; generalized muscle ache, and pain at injection site.
sore left arm; "weird feeling" in his stomach; "core down to his chest from stomach felt weak"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm), ABDOMINAL DISCOMFORT ("weird feeling" in his stomach) and ASTHENIA ("core down to his chest from stomach felt weak") in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PREDNISONE, IBRUTINIB, AMOXICILLIN, ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore left arm), ABDOMINAL DISCOMFORT ("weird feeling" in his stomach) and ASTHENIA ("core down to his chest from stomach felt weak"). On 25-Feb-2021, ABDOMINAL DISCOMFORT ("weird feeling" in his stomach) and ASTHENIA ("core down to his chest from stomach felt weak") had resolved. At the time of the report, PAIN IN EXTREMITY (sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I started to have ringing in my ear on left side. It started about 30 after i got the shot; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event.   A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), via an unspecified route of administration, administered in left arm on 16Mar2021, at 09:00 as single dose for covid-19 immunization.  Medical history included blood pressure high from an unknown date, type 2 diabetes mellitus from an unknown date. Patient was not pregnant at the time of vaccination. Prior to 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. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; losartan (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; metformin, metformin hydrochloride, sitagliptin (JANUMET) taken for an unspecified indication, start and stop date were not reported. The patient previously took lisinopril and experienced drug allergy.  The  patient reported  "I started to have ringing in my ear on left side. It started about 30 after I got the shot " on 16Mar2021, at 09:00 with outcome of not recovered.  No treatment was given for the event.  No follow-up attempts are possible; information about lot number cannot be obtained.
Pt states no pain at time of injection for the PNEUMOVAX but that later at night he developed severe pain in bicep/shoulder/neck and head 9-10 on pain scale. He used ice and ibuprofen and in the morning the pain went down to 6-7.
Breakthrough case admission after three vaccines Moderna 2/18/21 Lot#015M20A;  Moderna 3/18/21 Lot# 010A21A;  Moderna 10/20/21 Lot# 014F21A
2nd dose on September 8th 2020 and had not yet received the third dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (2nd dose received on 8th September 2020).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. The patient had received 2nd dose of Twinrix and till the time of reporting patient did not received 3rd dose of twinrix, which led to incomplete course of vaccination. No further events were reported. HCP (Healthcare professional ) did not consent to follow up.
Patient had vaccine 9/1. Saw his cardiologist, complained of sob 9/13. His follow up with cardiology in June continued to have worsening sob with then angina. Patient had a stress test, then cath which showed unexplained worsening of EF despite patent vessels and appropriate medical management. Patient followed up with specialist, started on lisinopril, changed his beta blocker to metoprolol. In the middle of the changes of his medications repeat echo showed improving EF despite no other interventions or changes.
Night of: 103 degree fever, severe chills, night sweats, myalgia, nausea Next day: 99-100 degree fever, headache, brain fog, excessive fatigue
Information has been received from a registered nurse concerning an approximately 89 year old female who 5 or 6 years ago in approximately 2005 was vaccinated with a dose of PNEUMOVAX 23, (Lot number not provided). Suspect secondary therapy included Flu vaccine (manufacturer unknown) administered at the same time. On an unknown date, the patient developed flu and hives over her whole body, the nurse did not have any other information about the flu or hives. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was recovered. No further information is available.
atypical and severe diarrhea; I want to declare side effect; GI infection; fever; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (atypical and severe diarrhea), VACCINATION COMPLICATION (I want to declare side effect), GASTROINTESTINAL INFECTION (GI infection) and PYREXIA (fever) in a 46-year-old male patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (atypical and severe diarrhea), VACCINATION COMPLICATION (I want to declare side effect), GASTROINTESTINAL INFECTION (GI infection) and PYREXIA (fever). At the time of the report, DIARRHOEA (atypical and severe diarrhea) had not resolved and VACCINATION COMPLICATION (I want to declare side effect), GASTROINTESTINAL INFECTION (GI infection) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  Patient had atypical and severe diarrhea for several days (still ongoing).   After 3rd dose little fever no relevant other symptoms(notably not respiratory symptoms) no contact or other reasons to believe that it was a gastrointestinal infection of other origin, symptoms unusual for GI infection.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2022: Follow-up information includes patient and event details.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 19-APR-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # H012351, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. This is one of the many reports received from the same source. Additional information has been requested.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 24-JUN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX), lot # R018140  and expiry date 25-JUN-2020, (strength, dose and route were not reported) for prophylaxis and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown.  This is one of several reports received from the same reporter.
This 57 year old woman was given an MMRV instead of MMR and was taking ASA at the time.  The error was not found until she called asking questions about the number of vaccines she received versus what her husband received. It was discovered at that time, that she received the wrong vaccine.  She was advised to call her primary doctor to see if she should stop her ASA for the next 5 days.  She was rightfully upset about not being notified.
MMR #2 documented at 3 years 7 months delayed immunization, MMR#3 given at 4 years age.  Noted MMR#2 actually given at  January 2006 so child was 4 years.  No adverse effects, symptoms noted.  No treatment given.  Per grand mother (guardian) child well.  contact agency for contraindications. CRNP aware.  No adverse reaction.
This spontaneous report as received from a physician refers to unspecified patients. It was reported that unspecified patients were vaccinated with improperly stored M-M-R II (lot#, dose, strength and frequency were unknown) subcutaneous. No adverse effects were reported. Follow up information has been received from registered nurse. 61 unspecified patients received the improperly stored M-M-R II, lot # J003785 and expiration date: 28-MAR-2015. She stated that the dates of administration of the M-M-R II for the 61 unspecified patients were as followed: 09-JAN-2014, 13-JAN-2014, 14-JAN-2014, 15-JAN-2014, 17-JAN-2014, 20-JAN-2014, 21-JAN-2014, 22-JAN-2014, 24-JAN-2014, 27-JAN-2014, 28-JAN-2014, 29-JAN-2014, 31-JAN-2014, 03-FEB-2014, 05-FEB-2014, 06-FEB-2014, 10-FEB-2014, 11-FEB-2014, 12-FEB-2014, 13-FEB-2014, 20-FEB-2014, 21-FEB-2014, 24-FEB-2014, 25-FEB-2014, 26-FEB-2014, and 27-FEB-2014. This is one of several reports received from the same source. Additional information has been requested.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 17-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Moderna vaccine pulled from freezer on 16-Dec-2021 BUD date of 15-Jan-2022 printed in red and taped to the top of the boxes.  On 26-Jan-2022 staff brought it to attention that it was still in the fridge and expired 5 doses had been given at that point.  On 27-Jan-2022 Remaining sites checked. All other clinics found to have same error of not noticing the BUD date. Moderna contacted and report filed. BUD date added to the daily Covid usage and wastage report.  On 31-Jan-2022 Moderna responded revaccination Not required.  Patient notified of error and that a repeat vaccine is not required. Patient denies any adverse effects.  No concomitant medication was provided. No treatment information was provided.
lung congestion, generalized pain, lack of energy,   typical flu symptoms. cough, alternating chills and low grade fever. sleeplessness.  Was sick all weekend 48 hours.  still not feeling 100%  4 days after weekend.
HAD CHILLS, FELL ASLEEP GOT UP TO BRUSH TEETH HAD EXTREME NAUSEA, PASSED OUT CAME TO ON FLOOR IN COLD SWEAT.  FEEL FINE TODAY
I had micro doses in multiple shots over 4 hours in both arms due to having an immune disorder. I had micro doses in multiple shots over 4 hours in both arms due to having an immune disorder. 2nd shot, I was wiped of energy and my blood sugar elevated int the 400 range, which lasted about a week and a half. I felt horrible for about 3 weeks due to the sugars.
3-17-21 6:30PM 'A LITTLE NUMBNESS TO RT FOREARM'. PTP INDICATES ANTERIOR ASPECT. MOTOR AND SENSORY INTACT; NO DEFICIT NOTED. CAP REFILL GOOD.  BOTH ARMS PINK, W/D. EQUAL STRENGTH AND GRIP NOTED. NO ACUTE OR OBVIOUS DISTRESS NOTED.
mom states that pt had t103(a) w/moaning & lethargy that began last noc 2FEB95; unable to dec T x/ w/cool bath T rises p/removing from bath; referred to MD for f/u eval; TC from MD states bulging red ear drums; no adverse react to the vax;
Myalgia, Fever, UrticariaPruritus, brief throat and tongue discomfort in 2 mins post  vaccination. injection site soreness and raised erythema Narrative:  Other Relevant History:
Subsequent to receiving vax, the pt developed a large local reaction. No specifics were provided. Additional correspondence received reports that the pts injection site reaction consisted of a large hot area that was the size of a small orange.
5x6" fevered hot local rxn to R arm 3 days post vax. Pt not hospitalized, no work days missed.
The patient developed cellulitis which is traveling down his right arm.  Antibiotics were picked up less than 24 hours after the vaccination was administered.  It kept traveling so an additional antibiotic was prescribed.
Red, warm, 3 cm area of warmth/edema. Use warm compress and TYLENOL.
chills; fatigue; small rash on left arm (size of half dollar); 1 pinpoint spot "hive": under chin, on right arm, under left foot; This is a spontaneous report from a contactable nurse (patient). A 60-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1284), via intramuscular route of administration in the right arm on 28Dec2020 at 05:30 AM (at the age of 60 years-old) as a single dose for COVID-19 vaccination. Medical history included diabetic and asthma. The patient's allergies included sulfa, iodine, shellfish and latex/rubber. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported; however, there were other medications the patient received within 2 weeks of the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 28Dec2020 at 06:30 AM, the patient experienced chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot. The report was reported as non-serious. The patient was not treated for chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot. The clinical outcome of chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
STOMACH FEELS FULL; NO BOWEL MOVEMENT FOR 2 DAYS; This spontaneous report received from a patient concerned a 74 year old male. The patient's height, and weight were not reported. The patient's past medical history included left rotator cuff tear, and hip replacement, and concurrent conditions included type 2 diabetes, no alcohol use, non smoker, and penicillin allergy, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a21a, expiry: 21-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced no bowel movement for 2 days. On an unspecified date, the subject experienced stomach feels full. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from no bowel movement for 2 days, and the outcome of stomach feels full was not reported. This report was non-serious.
After patient got home from pharmacy right after receiving vaccine, he was very disoriented, dizzy, couldn't stand up, for about 30-60 minutes. Ok after that.