chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. On 1st October 2018, the patient received SHINGRIX. On 2nd October 2018, 1 days after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The day before reporting the patient received SHINGRIX late afternoon and felt great. The patient woke up with a fever in the morning on the day of reporting that keeps going up. At the time of reporting, the patient's body temperature was recorded as 101.5 degrees F.
except she felt a bit under the weather; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "except she felt a bit under the weather".  Follow-up attempts completed. No further information is expected. The lot/batch number is not available despite the follow-up attempts made.
HAD TO WALK SLOWER; FELT A WOW EFFECT WHEN TURNED HEAD; CHILLS; HEADACHE THAT PROGRESSIVELY GOT WORSE; LITTLE PAIN; This spontaneous report received from a patient concerned a 34 year old male. The patient's height, and weight were not reported. The patient's past medical history included: sinus infections, and concurrent conditions included: vitiligo, indoor allergies, environmental allergies, alcohol non-user, and non smoker, and other pre-existing medical conditions included: The patient did not have any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the patient experienced little pain. On 09-APR-2021, the patient experienced chills. On 09-APR-2021, the patient experienced headache that progressively got worse. On 10-APR-2021, the patient experienced had to walk slower. On 10-APR-2021, the patient experienced felt a wow effect when turned head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little pain, and chills on 09-APR-2021, and had to walk slower, felt a wow effect when turned head, and headache that progressively got worse on 11-APR-2021. This report was non-serious.
Complaint of sore/scratchy throat, runny nose/congestion, myalgia, and malaise
"I was getting: tired"; Muscle pain; Joint pain; Upset stomach; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Apr2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient had no past medical history. The patient did not receive any other medication within two weeks of vaccination. On 20Feb2021, the patient underwent COVID-19 (test type: nasal swab) and the result was negative. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had 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: UNKNOWN) via an unspecified route of administration in the right arm on 20Mar2021 at 09:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On 10Apr2021 at 09:45, the patient was getting tired and muscle pain and joint pain and upset stomach. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event "I was getting: tired", muscle pain, joint pain and upset stomach was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Cellulitis 48 hrs after injection about 8 cm diameter. Rx KEFLEX - resolved.
Twitch in elbow of some arm. Some swelling in shot area. Counseled to take anti-inflammatory measures and see doctor.
Sudden onset arrhythmia while walking at normal pace indoors. Past experience with  occasional SVT (more than 5 years ago since last) seemed consistent. Past successful mitigations did not stop episode which lasted approximately 3 1/2 hours. Some minor dizziness and slightly out of breath under non-stationary conditions (consistent also with prior events).
Right upper arm begin swelling, redness and warmth late in evening.  The next morning covered 80% of area between right shoulder and elbow with pain.  Gross edema, redness, and warmth.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 22-MAY-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M039067 with expiration date of 18-APR-2018; strength and dose were unknown; location was also reported as "2", dose number was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse stated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA014144.
SICK FOR 1 DAY AFTER EVERY COUPLE  OF WEEKS; SAD REACTION; SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a 45 year old male patient. The patient's weight was 170 pounds, and height was 68 inches. The patient's concurrent conditions included cancer and non smoker and other pre-existing medical conditions included no known allergies. The patient suffers from cancer and had gone through chemotherapy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: 1805018 expiry: unknown) dose was not reported, with frequency 1 total dose administered on APR-2021 (exact date asked but unknown) for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced sad reaction to the vaccine which lasted for 5 days (no hospitalization) and after every couple of weeks, patient felt sick for 1 day. On 20-JUN-2021, the patient started feeling fatigue and loss of appetite. On 23-JUN-2021, the patient tested for Covid-19, and the results came back positive on 24-JUN-2021. On 24-JUN-2021, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection. However, consumer could not provide details on the type of Covid-19 testing.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick, and sad reaction, and the outcome of suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000184005. The suspected product quality complaint has been confirmed to be not voided, the reported allegation could not be confirmed. a manufacturing related root cause could not be identified. based on the PQC evaluation/investigation performed.  Additional information received from product quality department on 28-JUN-2021. The following information was updated and incorporated into case narrative: PQC result updated.; Sender's Comments: V0: 20210654471-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, SPECIAL SITUATIONS.
Pt presents with generalized hives contacted Dr, advised Benedryl Q6H prn.
Pt had high pitched unconsolable cry greater than 3 hrs (all night); skin was "burning up" estimates greater than 102; but not taken; Was reported to MD; Used APAP pt improved by 12noon on 29MAY91;
Multifocal rash with inflammation at inoculation site and contralateral arm and chest without fever/chills.
Problem: Patient was given the incorrect dose of 0.5 mL for Moderna Booster at Vaccine Clinic. Nurse was given the incorrect dose dispensed by the pharmacist. This inadvertent incident happened due to a lack of communication in training given to the Nursing staff from the Pharmacy team.     Corrective Action: Nursing and Pharmacy has since been given a vaccine dose chart with correct dosing amounts listed for Moderna, Pfizer and Johnson & Johnson vaccines. Second, trays have been given to both teams to separate vaccine doses to prevent future error events.  Lastly, Pharmacy is only preparing the Pfizer vaccine since it is standardized to 0.3 mL presently. Going forward, Pharmacy and Nursing will continue to work together to maintain open communication.  Patient was notified of the incorrect dosing and given an opportunity to be seen in clinic by a provider if they remained concerned.
Information has been received from a physician concerning a 17 year old female student who on 30-MAY-2007 at 1:35 PM was vaccinated in the right upper extremity with the first dose of Gardasil (lot # 657737/0522U). Concomitant vaccination included MENACTRA (lot # U2234AA). There were no illnesses at time of vaccination. The patient experienced a syncopal episode within a few minutes of vaccination and fell of the exam table. Her body became stiff and her eyes rolled. She had a second episode approximately 20-30 minutes later. The patient was lethargic for approximately 24 hours. The patient subsequently recovered on 31-MAY-2007. Additional information has been requested.
Case number PHEH2014US024289 is an initial spontaneous report from a nurse received on 02DEC2014 and with a follow-up from a nurse received on 21JAN2015. This report refers to a 15 year old male patient.  His medical history and concomitant medications were not reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) into left deltoid intramuscularly at a dose of 0.5 ml on 05NOV2014. The nurse reported that FLUVIRIN 2014/2015 was stored at 49F for one hour and 15 minutes before administration to the patient. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up from a nurse received on 22JAN2015: Site of vaccination (right deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Initial unsolicited report received from a pharmacist on 02 August 2016. This case involves a 17-year-old female patient who was vaccinated with MENACTRA (batch number: U5155AB, expiry date: 15 November 2016) and VARIVAX (batch number: L02507, manufacturer: MSD) (expiry date, dose, dose in series, route of administration were not reported for both vaccines) on 21 July 2016. Patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced nausea and vomiting. Patient required ER/doctor visit. Lab test included pregnancy test was negative and other lab tests performed but types and results were unknown. Corrective treatment was not reported. The outcome of the events was unknown. Documents held by sender: none.
6 days after receiving vaccine, noticed a lump below my right collarbone. Diagnostic ultrasound is scheduled for 30Apr2021.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL0162) via an unspecified route of administration in the arm left on 15Apr2021 at 16:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The medical history included impaired fasting glucose, obesity, allergy to nuts and stone fruit. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included bupropion (MANUFACTURER UNKNOWN) and metformin (MANUFACTURER UNKNOWN), all from unknown dates and for unknown indications. On 21Apr2021 at 15:00, 6 days after receiving vaccine, the patient noticed a lump below her right collarbone. The patient reported that diagnostic ultrasound was scheduled on 30Apr2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lump below right collarbone was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 15Apr2021 as dose 2, single (Lot number: ER8735), in left arm, on 28Oct2021 as dose 3 (booster), single (Lot number: FH8028), in left arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "Known allergies: Environmental" (unspecified if ongoing), notes: Known allergies: Environmental; "Known allergies: dust" (unspecified if ongoing), notes: Known allergies: dust; "Known allergies: pollen" (unspecified if ongoing), notes: Known allergies: pollen. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Feb2023, outcome "unknown" and all described as "COVID 19 ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Feb2023) Positive; (17Feb2023) Negative; (18Feb2023) Negative; (19Feb2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19; patient took Paxlovid (09Feb2023 to 14Feb2023)  Clinical course: Tested positive for COVID 19 08Feb2023. Started Paxlovid course 09Feb2023 evening, finished 14Feb2023. Tested negative with home test 17Feb2023 and 18Feb2023, only slight congestion remained. On 19Feb2023 woke up with sore throat and worse nasal congestion, tested positive with home test.
headache, vomiting, nausea, muscle aches, body uncomfortability, fever, chills taking tylenol every 4-6 hours
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  On 06-Dec-2021,Lot 012H21B vials were placed in refrigerator.     This case was linked to MOD-2022-448109 (Patient Link).
APPROX 30 MINUTES AFTER VACCINES - 0932: PATIENT COMPLAINED OF TIGHTNESS IN THROAT, ITCHING, STOMACH PAIN 7/10, FEELING HOT, TALKING , ALERT 0933: EPINEPHRINE SC TO RIGHT THIGH  0940 IV 20 G,  NS, 50MG BENADRYL IVP AND 125MG SOLUMEDROL IVP 0942 ITCHING , TIGHTNESS TO THROAT, HOT FEELING RELIEVED, STOMACH PAIN 1/10 0944PEPCID 20MG IV, 0948 ALLSYMPTOMS RELIEVED, PAIN 0/10, TALKING REMAINS UNDER OBSERVATION , NO CHANGE , DENIED SYMPTOMS, AFTER 2 HOURS, REMAINS UNDER OBSERVATION
Bilateral pinky and ring finger tingling; Bilateral pinky and ring finger tingling/numbness; Tingling is uncomfortable and feels "cold"; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable nurse, the patient. A 46-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185), via an unspecified route of administration in the left arm on 14Oct2021 at 07:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and celiac disease. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. It was not reported if the patient received any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration on 10Feb2021 (at the age of 45-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration on 03Mar2021 (at the age of 45-years-old); both as single doses for COVID-19 immunisation. On 30Oct2021, the patient experienced bilateral pinky and ring finger tingling and numbness. The patient noticed it on a daily basis, it appeared to come and go. It had not affected her dexterity, but tingling was uncomfortable and the patient felt cold. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events bilateral pinky and ring finger tingling and numbness; the patient noticed it on a daily basis, it appeared to come and go; it had not affected her dexterity, but tingling was uncomfortable and felt cold was not resolved at the time of this report.
Sore arm at injection site, headaches, fatigue, chills, low grade fever, body aches, lower back pain (likely associated with the body aches)
It was recognized  after the vaccine was administered that the patient was 12yo.  This dose was consider the first dose in the series but due to the age in 21 days we will booster with and adult Pfizer Covid vaccine.  Parent was notified and was told of the error and how in 21 days we would be giving and adult Pfizer Covid vaccine they were fine with the explanation.  Going forward we changed our screening process to a 2 step process to put a second set of eyes on each form.
One day after vaccine, I had chills and fatigue. Fever resolved after one day; fatigue after 3. 12 days post vaccination, I developed itchy palms and feet, and, to a lesser extent, itchy abdomen at 13 days post vaccination. Taking Benadryl managed itch. Symptom started to improve 4 days after onset.
Day after vaccine started w/rash (L) axilla and has spread had tactile fever day after also.
Rash all over my body; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (Rash all over my body) in a  patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash all over my body). At the time of the report, RASH (Rash all over my body) 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.   Concomitant medications were not reported Treatment medications were not reported.
Muscle ache; Joint ache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle ache) and ARTHRALGIA (Joint ache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma.    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced MYALGIA (Muscle ache) and ARTHRALGIA (Joint ache). On 25-Mar-2021, MYALGIA (Muscle ache) and ARTHRALGIA (Joint ache) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Treatment information included, ibuprofen and paracetamol was provided.   This case was linked to MOD-2021-030252 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-030252:Same patient, 2nd shot
pt recv vax  & w/in 24h devel severe pain in elbows that spread to the soft tissue around all joints;swelling also devel;
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Seizure-Severe, Systemic: Tachycardia-Severe, Additional Details: Immediately after injection, pt became weak, unresponsive, possible seizure activity. ED called. Pale and tachycardic. Pt was removed to the floor with feet elevated. Pt regained alertness, speaking, color returning to face. BP was normal. Mom said he had seizure activity as a 6 year old and gets vagovagal. Eventually he was assisted to a chair and drank water. EMS arrived after approx 20 minutes and he was taken for observation.