chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effects; Product reported as GARDASIL but lot # valid for GARDASIL 9; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This spontaneous report as received from a registered nurse, referring to a patient (gender and age not reported).  No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 17-MAR-2020 at 09:50 hours, the patinet was vaccinated with an improperly stored dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) with lot # reported as R036912 (product lot number issue) at a dose of 0.5 mL intramuscularly (IM) on the Left Arm (LA) and with an improperly stored dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) dose of 0.5 mL intramuscularly (IM) on the left tight (LT) lot # U6575AA; for prophylaxis, however no adverse effects reported.   Administered dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes. Digital data logger was involved. There were no previous temperature excursions reported.  This is one of the several reports received from the same reporter.   Lot # R036912 is not a valid number for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine.   This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was splitted and determined to be valid for a specific patient.; Sender's Comments:  US-009507513-2008USA008876: US-009507513-2008USA008885: US-009507513-2008USA008883: US-009507513-2003USA002275: US-009507513-2008USA008889: US-009507513-2008USA008890: US-009507513-2008USA008875: US-009507513-2008USA008909: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008887: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008904: US-009507513-2008USA008920: US-009507513-2008USA008921: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008896: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008898: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008901: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008903: US-009507513-2008USA008932: US-009507513-2008USA008933: US-009507513-2008USA008907: US-009507513-2008USA008906: US-009507513-2008USA008890: US-009507513-2008USA008877:
Patient called to report starting yesterday she has had a fever 101.0, she admitted she took Tylenol this morning  and she took her temperature as we were talking on the phone she stated it was 97.5.  She also said she has been having chills and she is short of breath "after walking across the room".  I didn't notice any SOB while speaking on the phone.  We talked quite a bit and I kept asking her what else her symptoms she was having and she didn't have anything additional to say.  But when I asked if her throat and lips was tingling she stated yes it feels like her throat is closing.  The things I specifically asked about she stated "yes" that was happening to her.  She denied having any Benadryl at home.  I told her to go to urgent care immediately and to call me back once she is seen,
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    Concomitant medications details were not reported by the reporter.  Reportedly, Pharmacy intern reporting that correctional facility administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients. No patient information or product information available.  It was unknown if the patient received any other vaccines prior to 4 weeks of COVID-19 vaccine.  Treatment details were not reported by the reporter.  This case was considered for 15th adult patient out of 40 adult patients who were received expired bivalent dose of moderna.
Arm sore, fever, chills, body aches fatigue, weak, and a headache.
This appears to be a problem with delayed injection site injury from Novel Coronavirus Vaccine. I received treatment in November and December 2022 in the form of a cortisone injection and physical therapy. That treatment was in my opinion 95% effective. However a couple of months later it seems to have returned.
While uncapping a clean needle to administer vaccine, community health worker (CHW) reports that something hit her glove but she didn't think anything of it.  CHW then proceeded to vaccinate patient with same needle without her preceptor's ( Name, NP) knowledge of possible finger stick. Per (Name), NP she also observed CHW push on the plunger before contact with patient's skin and vaccine leaked onto patient's arm. NP feels that  patient received less that half a dose and feels that patient needs to have her dose repeated. After administering vaccine, CHW removed her gloves and realized that she had a small puncture to her left pointer finger. CHW then went to the bathroom, washed her finger, and made her preceptor aware that she had a needle stick. CHW and NP made clinical lead and pod manager aware of incident. Clinical lead observed CHW to have a small puncture wound to her left pointer finger with no blood or fluids visible. Attempted to find patient to make her aware of needle stick with dirty needle, but she had already left clinic. After checking the system and narrowing down patients by vaccinator it was determined that (Name) was correct patient. TC to patient x 2, left message to return call to clinical lead ASAP.  4/6/21- Clinical lead called patient back and she came in to repeat her second dose. Patient has a scheduled appointment with her PMD for blood work today at 1:30 PM.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient. A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 30Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 21Dec2021 as dose 3 (booster), single (Lot number: FL3198), in left arm for covid-19 immunisation. The patient's relevant medical history included: "historic pnemonia and plural effusion", start date: 2017 (unspecified if ongoing), notes: Other medical history: historic pnemonia and plural effusion (2017); "historic pnemonia and plural effusion", start date: 2017 (unspecified if ongoing), notes: Other medical history: historic pnemonia and plural effusion (2017). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: continuing to test positive for COVID with at home tests. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 02Jan2023 to 06Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.            Concomitant product use was not provided by the reporter. No treatment information was provided.    This case was linked to MOD-2021-028714 (Patient Link).
It is unknown if this condition and hospitalization is related to the SARS-CoV-2 vaccine.  I developed Left lung congestion, wheezing, crackles.  Treated with bronchodilator without relief.  Chest CT on 1/9/23 showed pulmonary edema in the right lung and trace effusion.  Symptoms persisted for weeks, echocardiogram performed on 1/24/23 showed left ventricular dysfunction with ejection fraction of 15-20%.  Hospitalized at Medical Center for 4 days.  Cardiac catherterization/angiogram result = no blockages.  Diagnosis = heart failure.
she had not seroconverted after receiving the first VARlVAX shot; Information has been received from a currently 25 years old female patient, referring to herself. The patient had no concomitant medications, no pertinent medical history and no drug reactions/allergies. The patient was not pregnant.  On 25-FEB-1998, the patient received her first varicella virus vaccine live (oka/merck) (VARIVAX) shot (one dosage form) (strength, route, lot # and expiration date were not reported) through upper arm for chickenpox.  On 14-JAN-2019, the patient performed a routine blood work with the result of her titer test indicated that she had not seroconverted (seroconversion test negative). The patient had sought medical attention by visiting the physician. On 10-FEB-2020, treatment was received by giving a booster shot of varicella virus vaccine live (oka/merck) (VARIVAX) (one dosage form; strength and route were not reported) (lot # S006017, expiration date was not reported, but upon internal validation established as 27-FEB-2021) and sterile diluent (STERILE DILUENT) in the upper arm for chickenpox. Therapy with the varicella virus vaccine live (oka/merck) (VARIVAX) was reported as continued. The outcome of the seroconversion test negative was unknown. The causality assessment was not provided.
left sided facial nerve paralysis (Bell's palsy) 9/7/07 Reviewed pcp medical records which reveal patient well & healthy on day of vax.  Only concern was for hair loss.  Returned to pcp on 8/15 s/p developed left eye watery & twitchy x 3 days.  Awakened 8/14 & could not smile or squint.  Exam revealed left ptosis w/sluggish light reflex & left side facial paralysis.  Tx w/steroid taper.  PCP discussed case w/neurologist & started on antiviral 8/16.  Noted to have tingling/burning s/s of herpetic outbreak 8/13 but no actual vesicles.  F/U visit on 8/29 revealed smile almost normal but still residual eye involvement.  Exam revealed improved smile but still mildly weak on left.  Eye exam WNL.  Immunization records do not include lot #s.  Does indicate patient received initial meningococcal 8/22/06.    FINAL DX: Bell's Palsy
Not feeling well; Severe body aches all over; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), MYALGIA (Severe body aches all over) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced MALAISE (Not feeling well), MYALGIA (Severe body aches all over) and HEADACHE (Headache). At the time of the report, MALAISE (Not feeling well), MYALGIA (Severe body aches all over) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, Blood pressure measurement: high (High) A little high. On 27-Aug-2021, Body temperature: 101.3 (High) 101.3F at 4:40am.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   Treatment information was not provided.
Accidentally gave bivalent Pfizer Bivalent Booster when the patient had previous completed the primary series with Moderna.
Breakthrough COVID case after vaccination, had subjective fever and chills onset 9/27/2021
Acute Gastrointestinal Bleeding per rectum with massive bloody diarrhea, transfer to Emergency room by EMS with IV placement and fluid resuscitation, vital signs unstable, emergency assessment and massive transfusion over next 4 hours of 4 units of PRBC and 2 units platelets, dual 16 gauge IV's, intrarterial line.  ER Summary available and can be scanned and sent.  Low HgB, Low platelets in 60 k range and multiple consultants and diagnositcs
This is a spontaneous report received from a non-contactable consumer (patient). A 25-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: ER8737) via an unspecified route of administration on 15Mar2021 (At the age of 25-year-old) as single dose and second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6208) via an unspecified route of administration on 05Apr2021 (At the age of 25-year-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. Since the vaccination, the patient had been tested for COVID-19. On 04Oct2021 the patient experienced breakthrough covid case, covid. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 07Oct2021. The patient did not receive any treatment for the adverse events. The clinical outcome of the event breakthrough covid case was unknown, and other event covid was recovering.  No follow-up attempts are possible. No further information is expected.
Flu-like symptoms 2 days after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms 2 days after the vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms 2 days after the vaccine). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms 2 days after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Patient received HepB#1 and Td#5 on 10/07/2004 and today (10/08/2004) per mother the child's right side of lips and face swollen.  School nurse called mother concerning event.  Mother took child to see MD and was given Benedryl.  Follow-up: per mother, swelling has decreased.
Abscess on Rt thigh hard red lump, warm to touch, no fevers using BACTROBAN oint and warm compresses.
Began sniffles on 12/19 and mild fatigue. My daughter tested positive on 12/21 due to the holidays coming. Went to the pharmacy on 12/22 for a PCR test. PCR test returned positive for COVID-19 on 12/27. 12/21 at home test was negative and mild symptoms. 12/23 symptoms worsened. 12/24 developed fever of 99.4 and chills. Fatigue was the worst symptom. Began having razor blade feeling in my throat. Began taking benzocaine cough suppressant and was counting down until the time for the next dose. Also developed mouth sores. 12/25 tested positive on at home test and this was the worst day of symptoms with a fever of 101.9 on ibuprofen. Symptoms began slowly improving. 12/28 one fever and taking less ibuprofen. 12/29 one fever and major headache. 12/30-01/02 Symptoms still improving and the mouth sores were the worst. 01/03 Symptoms mostly resolved except for fatigue. I am a physician and I found the CDC website quite confusing and contradicting. Guidelines could be much clearer for the average person.
Shingles/small patches of shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 83-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix two years before the date of reporting and then had shingles a few weeks later. The patient still had small patches of shingles (outbreak) if she get stressed. The doctor advised not to take second shot. The patient asked if she should receive the 2nd shot.
Event lasted 2 hrs & 45min t101, screaming high pitched unconsolable cry; rt thigh swollen, red & tender; mom gave APAP;
On May 29, 2021 at 01:00PM stated he was nauseated and sweating. Went to the emergency room at Hospital they sent him to a cardiac doctor and did a cardiac cap.
Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 1:29 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 1:29 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) 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 86.37 years.  Concomitant products were not provided.  On 08-Jan-2021, the vaccine with batch number 041L20A was moved to fridge. On 11-Jan-2021, 9 vials were moved to the clinic. On the same day at 09 AM and 02 PM, vials underwent temperature excursion with temperature of 34 and 35 degrees Fahrenheit respectively. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 07-Feb-2021. It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  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 Fisher brand traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.