chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 10:31 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 10:31 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (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 patient was provided as 82.45   Concomitant products were not provided.  On 07-Jan-2021, Excursion time was 09 AM and 10 AM, temperature was 34, total doses given for the day was 96, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 07-Jan-2021. 6 vials were sent to clinic. Vaccine BUD date was 27-Jan-2021.  Vial was stored on cooler 1, on 07-Jan-2021, Excursion duration At 9 AM: 34, 10 AM: 34, 11 AM: 36, 12 AM: 37, 1PM: 38, 2 PM : 38, 3 PM: 40, 4 PM: 40   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 on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
missing antigen, adjuvant-only used; missing antigen, adjuvant-only used; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's Comment: The health care professional (HCP) reported administering Shingrix adjuvant only (missing antigen) to patient, for whom she had no identifying information. The reporter consented to follow up. Additional Supportive Information: The reporter reported administering Shingrix adjuvant only (missing antigen) to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022193689:Same reporter US-GSK-US2022193688:Same reporter US-GSK-US2022193690:Same reporter US-GSK-US2022AMR194824:Same reporter US-GSK-US2022193680:Same reporter US-GSK-US2022193682:Same reporter US-GSK-US2022193685:Same reporter US-GSK-US2022193687:Same reporter
Received the 2nd dose on day 46 ¨; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose on day 46 ¨) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose on day 46 ¨). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose on day 46 ¨) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
well that night i lost all taste and smell that was Friday today is Monday and still no better - Saturday was the hardest i just tried to sleep the pain away- by Sunday i had full on covid19 symptoms and was very sick - now 4 days in i still have a headache , cant brethe these symptoms arent just mild and i worry about someone older then me taking this
With the second does I experienced headaches . blurred vision I would not say that these are adverse events but I experienced nausea and chills. as well.
Vaccine administered after temperature excursion; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   relevant concomitant products usage were not reported by the reporter.treatment details not included.
Rash (and hives) on left side of face; (Rash and) hives on left side of face; This is a spontaneous case from initially received from agency (case ID: SEQ19-03449) by other healthcare professional on 27-Sep-2019, concerning a 44-year-old, female patient.    On 27-Sep-2019, the patient was administered Afluria Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscularly, anatomical location: deltoid, batch number: P100118564, expiration date: 30-Jun-2020) for influenza prophylaxis.   On the same day as vaccination, the patient experienced a rash and hives on left side of face. The patient used a cold compress as a treatment.   The outcome for the both events was not recovered.   The reporter did not provide seriousness and causality assessment.  All events were assessed as related per company; Sender's Comments: All events were assessed as related per company.
feeling pain in the Left Pelvic area; The pain limits my daily routine such as put the socks on, move my body side to side, etc; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  An 81-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "prostate cancer" (unspecified if ongoing); "liver cancer" (unspecified if ongoing), notes: liver cancer. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Nov2022, outcome "unknown", described as "The pain limits my daily routine such as put the socks on, move my body side to side, etc"; PELVIC PAIN (medically significant) with onset Nov2022, outcome "unknown", described as "feeling pain in the Left Pelvic area". The events "feeling pain in the left pelvic area" and "the pain limits my daily routine such as put the socks on, move my body side to side, etc." required physician office visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: Negative, notes: all negative.  Clinical course:A week ago, patient was feeling pain in the left pelvic area.The pain keeps on at night and off sometime in the day. The pain limits my daily routine such as put the socks on, move my body side to side, etc. Patient was 81, prostate cancer, liver cancer.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Woke up next day with extreme pain in arm unable to lift it.  ROM returned about 2 weeks later.  received medical attention and physical therapy.  Provider recommended to receive 2nd dose.  Provider was unable to diagnosis it to be allergic reaction or nerve damage.
Lymph node under left arm became swollen; shingles; Fever; Chills; Headache; This is a spontaneous report from a contactable Consumer (patient herself). A 54-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 at 04:45 (at the age of 54-years-old) as a DOSE 1, SINGLE for covid-19 immunisation at the age of School or Student Health Clinic. The patient medical history included hypertension (High blood pressure) and anxiety both from an unknown date and unknown if ongoing. Concomitant medications included lisinopril (LISINOPRIL) and escitalopram oxalate (LEXAPRO) both were taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. The patient did not receive other vaccine in four weeks. It was unknown if patient had covid prior vaccination. The patient was not tested for covid post vaccination. On 25Mar2021 at 04:45, the patient experienced lymph node under left arm became swollen, shingles, fever, chills and headache. The patient reported that, one week after 1st does broke out with shingles. Event resulted in the Doctor or other healthcare professional office/clinic visit. Treatment was received with Anti-viral medication. Outcome of all the events were recovering.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
limited medical records received on this pt; pt admitted to the hospital with coffee-ground emesis and vomiting bright red blood; positive for COVID; PMH: cirrhosis and esophageal varices; per death certificate pt died of GI bleed, COVID, blood loss anemia and cirrhosis
This spontaneous report was received from a nurse, and refers to a 23 year old patient of unknown gender. The patient has been taking aspirin 81mg (Manufacturer unknown) daily, since 08-JUL-2014 for an unknown indication. No information was provided regarding the patient's concurrent conditions and medical history. On 19-APR-2018, the patient was vaccinated with VARIVAX lot # N014371, subcutaneous for prophylaxis (dose not reported). No adverse effect reported. I was not reported if the patient continued the therapy with aspirin.
no adverse event/No adverse reaction; Expired vaccine used; Age: 16 months old; This spontaneous report was received from a nurse, concerning a 16 month old patient of unknown gender. The patient's concurrent conditions included IgG deficiency. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.  On 11-MAR-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), at a dose of 0.5 milliliter (ml) once in the right thigh (lot number S003872, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 22-DEC-2020) as prophylaxis (route of administration and vaccination scheme were not reported) (expired product administered and product administered to patient of inappropriate age). The vaccine did not have any prior temperature excursions. No adverse events were reported.
My left arm was very sore for about 3 days after 1st dose, but went away. 8 days after injection I developed a large lump at injection site along with a very itchy rash.
9/17/12 received call from client to report reactions following receipt of Tdap vaccine. States experienced headache "severe", diarrhea, muscle aches and weakness. States has recovered.
Intense heart pain/heart inflammation beginning the day after my first vaccine. This lasted for around two weeks or a little less. It has been a while since my first dose and sometimes I still feel a heavy feeling in my heart but nothing like that first week after. I am a healthy 22 year old male with no previous heart problems (although I was prescribed amphetamines for a while in high school).
Within 48 hours post vax, this pt developed a severe injection site reaction characterized by swelling which extended to her elbow, pain and warmth. The pt recovered. The reporter indicated that 4 individuals experience this event.
Patient called and reported on 10/30/23 she was seen by ER on 10/26/23.  Fever 100.4    Right arm from shoulder to Elbow very swollen and painful.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: 02-OCT-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211239223 and 20211239215.
No adverse events. Patient was given ZOSTAVAX rather than pneumococcal 13. Patients mother was informed and told to watch for rash, fevers, etc. and to go to ED if symptoms appeared.
A booster shot administered as requested. Upon entering vaccination record, it was discovered the resident already received a booster on 10/7/2021. No adverse effects reported.
Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. Concurrent and historical condition was not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L013202 with expiration date 27-JAN-2017; dose and route unknown). Concomitant therapy was not provided. The physician reported there were no adverse effects. There was no previous excursion. The vaccine was exposed to 33.3F for 3 hours and 59.1F for 5 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax & the next evening pt devel chills, fever of 102.5, redness @ the Pnu-Imune 23 inj site w/red streaks radiating to the inner arm & axilla & lt axillary;lymphadenopathy;2 days p/vax MD dx secondary infect;
LEFT EYE ITCHING; HAND ITCHING; SWELLING; FINGERTIPS HARD AND RED IN COLOR; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on left deltoid on 12-MAR-2021 approximately at 14:00 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced hand itching. On 16-MAR-2021, the subject experienced swelling. On 16-MAR-2021, the subject experienced fingertips hard and red in color. On an unspecified date, the subject experienced left eye itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hand itching, and swelling, and the outcome of fingertips hard and red in color and left eye itching was not reported. This report was non-serious.
Foot swelled up a balloon; gout flare up; Injected arm  felt tight; Injected arm  felt sore; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Foot swelled up a balloon), GOUT (gout flare up), VACCINATION SITE INDURATION (Injected arm  felt tight) and VACCINATION SITE PAIN (Injected arm  felt sore) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Gout. Concomitant products included FENOFIBRATE, ALLOPURINOL and COLCHICINE for an unknown indication.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 15-May-2021, the patient experienced VACCINATION SITE INDURATION (Injected arm  felt tight) and VACCINATION SITE PAIN (Injected arm  felt sore). On 17-May-2021, the patient experienced PERIPHERAL SWELLING (Foot swelled up a balloon) and GOUT (gout flare up). The patient was treated with PARACETAMOL (TYLENOL) on 15-May-2021 for Vaccination site pain, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Foot swelled up a balloon) was resolving and GOUT (gout flare up), VACCINATION SITE INDURATION (Injected arm  felt tight) and VACCINATION SITE PAIN (Injected arm  felt sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that swelling of foot going down on 18-May-2021  Treatment: Soaking in Epsom's salt bath and steroid patch.
Information has been received from a registered nurse concerning a 25 year old female patient with no pertinent medical history and no drug reactions or allergies who on the morning of 05-APR-2011, was vaccinated with the second dose GARDASIL, 0.5 milliliters, single dose vaccine, intramuscularly (Lot number not provided). There was no concomitant medication. On 05-APR-2011, the patient called the practice after close of business and left a message complaining of sudden onset of nausea and upper gastric pain. Nurse reported that when she spoke with the patient on the morning of 06-APR-2011, the patient reported she was still feeling nauseous and fatigued. Nurse also reported that multiple unspecified household members of the patient experienced an unspecified gastrointestinal virus over the preceding weekend. No treatment was given for the adverse event. Laboratory diagnostics studies were not performed. At the time of the report the patient had not recovered. Follow up information has been received from the registered nurse who reported that the 24 year old (previously reported as 25 year old) female clerical patient with no pre-existing allergies, birth defects or medical conditions. There was no illness at the time of vaccination. On 05-APR-2011 at 10 AM, was vaccinated with the second dose of GARDASIL intramuscularly on the left deltoid (Lot number 0057AA). On the evening at 17:00 of 05-APR-2011, the physician stated that the patient reported nausea and upper gastrointestinal pain that lasted a couple of hours. On 06-APR-2011, the patient complained of nausea and fatigue. The patient also noted that two members of her family had nausea and vomiting "two days prior". The patient did not seek medical attention. At the time of the report the outcome of the patient was unknown. Additional information has been requested.
Rash in lower leg both legs ankle area/Rash in back of hand/wrist area/Rash on face; This is a spontaneous report from a contactable consumer.  A 51-years-old female patient reported that she received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in Arm Right on 17Apr2021 13:45 (Batch/Lot Number: EW0162) (at the age of 51-years-old ) as single dose for covid-19 immunisation.  The patient had received the first dose of bnt162b2 (Lot ER8727) on 27Mar2021 at 01:45 PM in Right arm . Medical history included High Blood Pression -taking meds, 2 pelvic surgeries, 1 hysterectomy. The patient was not pregnant. The patient had not COVID prior vaccination and did not receive other vaccine in four weeks. Concomitant medications included lisinopril 5mg for blood pressure. Past drug included Estrace vaginal hormonal cream. 5 days after vaccine on 21Apr2021, the patient experienced rash in lower leg both legs ankle area, rash in back of hand/wrist area  9-10 and rash on face after 10-11 days of second dose of vaccine. The events resulted in Doctor or other healthcare The patient was treated with Steroid Shot. The patient was not COVID tested post vaccination. The outcome was not recovered.
On 7/23/21 I had a myocardial infarction.  I?m am still recovering.
PATIENT REPORTED NON-LIFE THREATENING RASH OVER MOST OF BODY 18 HOURS AFTER INJECTION. PATIENT RECEIVED PREDNISONE.