chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse event; patient received improperly stored vaccine which was administered via unspecified route; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 05-FEB-2020, the patient received improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) which was administered via unspecified route,  lot # S033516 (verified to be a valid lot number), expiration date reported and established as 29-JUN-2021, for prophylaxis. The call was because of a data logger and no additional adverse event was reported. The vaccine was improperly stored during a time frame of 15 minutes and highest temperature above 47°F/9°C 47.6°F. The following was the previous temperature excursions reported: temperature total time and highest temperature above 47°F/9°C 52.5°F, time frame 15 minutes, temperature total time and highest temperature above 47°F/9°C 46.7°F, time frame 15 minutes, temperature total time and highest temperature above 47°F/9°C 47.1°F, time frame 15 minutes.
Pt c/o itching over right arm, chest and back. It progressed to itching all over and large wheals appearing over back, chest and right arm by 21:00. Mother called ER and was instructed to give pt Benadryl 50mg. Pt's signs and symptoms did not resolve so went to ER. Rash and itching resolved by 22:30. Pt's mother notified private MD and was instructed to notify health dept.
Pt developed a bruise at the injection site that spread up the arm and down towards the elbow, characterized by lines of black, blue and yellow. Symptoms lasted for over one week.
Vaccine was administered after vaccine sat at room temperature for 2 hours and 40 minutes prior to administration.
Extreme non stop aching.   Nausea Temperature that ranged from 99 to 103 Chills Headache Very Sore throat Burning when taking a deep breath
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52-year-old male patient received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EN5318), in left arm, on 22Feb2021 as dose 2, single (Lot number: EN6200), in left arm, on 08Nov2021 as dose 3 (booster, single) (Lot number: FF2593), in left arm and on 23May2022 at 11:00 as dose 4 (booster, single) (Lot number: FJ4989) at the age of 51 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "High Blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aripiprazole, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) Positive; (10Jun2022) Negative, notes: completed 5 day course of paxlovid; symptoms had resolved; covid antigen home test negative; (14Jun2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Localized reaction (10 x 12 cm erythema) at injection site mild edema.
Headache, fever, leading to severe aches, headache, fever of 101 degrees, hot and cold flashes, clamminess, racing heartbeat by 7:00 AM 1/13/13. As of 1/14/13 at 5:00 PM headache and hot flash and chills continue.
Patient describes soreness on the arm that is hot to the touch, headache, she took Tylenol, body sweats and nausea and also reports sore throat. Patient reports she is having all symptoms except arm soreness.
Received Pfizer for his second dose.  Was vaccinated with  Moderna for his 1st dose. Did not hvae his vaccine record at the time of vaccination and instructed the vaccinator that he received Pfizer initially. Reports no complications at this time.
He had a positive SARs CoV-2 PCR on 1/6/22. Patient called to ask about his recent positive COVID test. He states he still has shortness of breath and it may be getting worse over the last two days
Continued pain on left arm / shoulder where injection was given. Pain with movement and at times decreased ROM due to pain. Usually relieved with OTC pain meds.
acting like his whole body hurts. The leg the injection was in he won?t pick up while I?m changing his diaper. He is clenched to my arm when I?m holding him. Crying /whimpering when moved.
Patient believed to have received 0.30mL of the 0.45mL undiluted covid-19 vaccine.
No Adverse event; Extra dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022 at 6:18 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Dec-2022 at 6:18 PM, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Extra dose administered).    No concomitant medications were reported.  Pharmacist called to report that the patient received a 2nd Bivalent booster on 16-Dec-2022, 2 months after the first Bivalent booster. All vials thawed on 16-Dec-2022.   No treatment drugs were reported.  This case contains the information of 10th out of 13 elderly patient who received the vaccine as described by the reporter.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2021 at 1:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Heart rate: fast heart rate (High) Fast heart rate. Action taken with mRNA-1273 in response to the event was not applicable. No relevant concomitant medications were reported. No treatment information was provided.
Neck pain felt like a pinched nerve couldn't turn to the right. Fever 101.4. Took ADVIL and kepta heating pad on my neck.
Pt exp erythema, edema, warmth, pain & localized rash; tx w/DPH & hot compresses; Resolved w/in 48 hrs;
After receiving the flu vaccine the patient developed a rash. He has had flu vaccines in the past and has never had a reaction. He reported the reaction to the pharmacy on 11/25/20. He stated the rash has resolved. He only received one vaccine on that day and didn't start any new medications or encounter anything out of the ordinary that could lead to the rash.
Patient described instant pain with vaccine injection then called me back at the pharmacy 7 hours later and described intense pain in the arm of injection and pain with movement of her arm. She described the pain as "burisitis-like pain." I advised the patient to let myself or a doctor know if they pain does not improve in a few days.
Patient indicated about a week after the vaccine her optic nerve became inflamed, resulting in MRI and steroids for 4 weeks.  MD advised that it could be related to the vaccine and to hold off on getting second dose.  Patient did not notify me of the AE until I called to schedule her second dose.
If she should vaccinate the patient today 17Aug2021 even though it is 42 days past the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (If she should vaccinate the patient today 17Aug2021 even though it is 42 days past the first dose) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (If she should vaccinate the patient today 17Aug2021 even though it is 42 days past the first dose). On 16-May-2021, PRODUCT DOSE OMISSION ISSUE (If she should vaccinate the patient today 17Aug2021 even though it is 42 days past the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Maculopapular rash, generalized, including trunk, arms, legs, palms, soles, neck. Started the evening of the 5th day, and lasted for 9 days, then resolved. No fever, seizures, or other adverse events occurred. Child did well, and fully recovered from the rash. Follow-up office visit on 8/8/2022.  Infectious Disease Specialist consult on 8/10/2022
Pt has localized rash that is red and warm to touch on her left arm where she received her Moderna Covid 19 booster shot on Thursday, 11/18/21 . Rash is itching with mild pain. Ppt is reporting that rash came up on Saturday morning.   Size of rash is 14 X 8 cm.   Pt had Pfizer 2 shot COVID 19 series and did not have this kind of reaction when she took that vaccine.
This spontaneous initial report was received from a Nurse referring to an unspecified number of patients with not ages and genders reported. Patients' medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that since 05-SEP-2017 the patients were administered Improperly Stored PEDVAXHIB (strength, route of administration and dose were not reported) lot # N003537 indicated for prophylaxis. The temperature of storage was reported as 32 Fahrenheit degrees to 35 Fahrenheit degrees, for a time frame of 9 hours and 12 min. Previous temperature excursion was not reported. Digital Data logger was involved. No adverse event was reported. The outcome of the improper storage was reported as Supported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008048.
With shot #1, my arm became red and swollen a bit. I felt tired  but both symptoms passed within a few days. I noticed a slight rining in in my right ear, but thought I must have an aspirin which sometimes does that. With shot 2, I also felt very tired but Became physically sick: ache all over, especially my right arm which swelled up and turned red and hot for more than 2 weeks. The ringing min my ear became so loud and bothersome that I finally went to our Urgent care doctor, who told me it was from the SHINGRIX shot and sent me to an ENT doctor who confirmed the same information about the shot.
This is a breakthrough case. I got COVID-19. I had a very sore throat and fever. I tested positive at home then went to the doctor and they confirmed that I had COVID-19 and prescribed me PAXLOVID. My symptoms were over in 3 days.
This spontaneous report was received from a licensed practical nurse, regarding a current 19 year old patient (gender not provided). Pertinent medical history, drug reactions/allergies were not provided. On an unspecified date, the patient received series of RECOMBIVAX HB, (number of doses, lot number, expiration date, and route of administration were not provided). On an unspecified date, when the patient was a child, the patient was tested for titers and had found to be not immune. The patient was given a booster dose of pediatric RECOMBIVAX HB on an unknown date, and tested again and found to be not immune. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness of the event with RECOMBIVAX HB was not provided. Additional information has been requested.
Rash; Leg pain; Knee pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), PAIN IN EXTREMITY (Leg pain), HEADACHE (Headache) and ARTHRALGIA (Knee pain) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate Free. In 2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced RASH (Rash), PAIN IN EXTREMITY (Leg pain) and ARTHRALGIA (Knee pain). At the time of the report, RASH (Rash), PAIN IN EXTREMITY (Leg pain), HEADACHE (Headache) and ARTHRALGIA (Knee pain) had not resolved.            On unknown dates, the patient experienced rash, leg hurts and knee pain. In 2021, the patient experienced headache after the covid vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna    Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Significant follow up: event added.
Pfizer-BioNTech COVID-19 Vaccine EUA  tiredness, headache, chills, nausea, vomit, feeling unwell, dizziness and weakness
Expired Moderna COVID19 Vaccine/ Inadvertently used a lot that looks like it had expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID19 Vaccine/ Inadvertently used a lot that looks like it had expired) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Oct-2021 at 2:53 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Oct-2021 at 2:53 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID19 Vaccine/ Inadvertently used a lot that looks like it had expired). On 24-Oct-2021 at 2:53 PM, EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID19 Vaccine/ Inadvertently used a lot that looks like it had expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment drugs were reported. Seven patients were inadvertantly  administered with booster shots, Moderna,  lot 049E21A. None of the seven patients had reported any adverse reactions till  11/19/2021. Did not have any information on their past corona history.   This case was linked to MOD-2021-363223 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Significant follow-up received and included patient's details (initials, DOB, age, gender, race), Suspect's details (start date, time, anatomical location, route of administration, dose number, expiration date), vaccine facility information, event onset date and stop date were updated.
Sickness; Hypertension; Bone disorder / Bone felt like they were disintegrated; Mobility decreased / Could not move; General body pain / Evrything hurt; low energy; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), HYPERTENSION (Hypertension), BONE DISORDER (Bone disorder / Bone felt like they were disintegrated), MOBILITY DECREASED (Mobility decreased / Could not move) and PAIN (General body pain / Evrything hurt) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphoid leukemia.    No Medical History information was reported.   On 10-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. In June 2022, the patient experienced ILLNESS (Sickness), HYPERTENSION (Hypertension), BONE DISORDER (Bone disorder / Bone felt like they were disintegrated), MOBILITY DECREASED (Mobility decreased / Could not move), PAIN (General body pain / Evrything hurt), ASTHENIA (low energy) and PYREXIA (Low grade fever). At the time of the report, ILLNESS (Sickness), BONE DISORDER (Bone disorder / Bone felt like they were disintegrated), MOBILITY DECREASED (Mobility decreased / Could not move), PAIN (General body pain / Evrything hurt) and ASTHENIA (low energy) outcome was unknown and HYPERTENSION (Hypertension) and PYREXIA (Low grade fever) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: not reported Not reported. On an unknown date, Body temperature: 101 101.         No concomitant medications were reported  No treatment medications were reported
CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/3/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
after the first shot I came home and slept for 5 hours; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 69-year-old female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "after the first shot I came home and slept for 5 hours". Additional Information: The patient had the vaccine and the only side effect she had was after the first shot she came home and slept for 5 hours which is a good thing. It went really well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
sensitive to I guess you would say supernatural events, after I received your shot, and it went away; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (sensitive to I guess you would say supernatural events, after I received your shot, and it went away) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (sensitive to I guess you would say supernatural events, after I received your shot, and it went away). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (sensitive to I guess you would say supernatural events, after I received your shot, and it went away) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient was very sensitive to supernatural events. After the patient received Moderna shot about a year prior to the date of this report, it went away, which was great. It was not schizophrenia. The patient was ready for any testing which would really help a lot of people.  Treatment information was not provided.
Employee received the 1st dose in the series on 12/30 and she woke up 12/31 with a fever of 101.5 F and an increase in heart rate. Employee stated it was about 113.
entire Right upper arm was red, swollen, tender,  painful to move; Seen on Friday, today, area improved but site still red, swollen sore approx 7 cm diameter
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 20-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F; In September of 2015, the coldest temperature was 34 for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1, 031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.