chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA311665 and 2018SA314360 (same reporter). This case involves an 11 months old female patient who received an expired dose of 0.25ml of vaccine FLUZONE QUADRIVALENT (batch number: UT5897MA, expiry date: 30-Jun-2018) (dose in series not reported) via intramuscular route in the left thigh on 11-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. It was a case of actual medication error due to expired vaccine used. It was not reported that if any adverse reaction was experienced or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Erythema and swelling measuring 5 x 6 cm, hot to touch. PCP ordered KEFLEX for possible cellulitis.
Long lasting shoulder pain that began well after receiving the shot. Pain is constant and does not respond to OTC pain medications.
shot#2 on 2-2-2021 @ 9:45 AM, At3:00PM became very tired,chills joints began aching. 2-3  symptoms continued 2-4 symptoms  continued 2-5chills began again at 3:00 PM 2-6 chills dizzines
a little sore arm; lightheadedness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Feb-2021 and was forwarded to Moderna on 17-Feb-2021.    This spontaneous report from was received from a 67 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lightheadedness and sore arm.  The patient's concomitant medications included unspecified medication for blood pressure, cholesterol and acid reflux.  On 09-Feb--2021 the patient received his dose of mRNA-1273 (Lot number: 015M20A) solution injection  intramuscularly in his arm for  prophylaxis of COVID-19 infection.   On 12-feb-2021, the patient started experiencing this lightheadedness. Now it was mild but it was still there. The patient said that the vaccination was well executed. The patient had a little sore arm.  Treatment information was not provided.  Action taken with the suspect drug mRNA-1273 was unknown.  The outcome of the event of lightheadedness was recovering and that of event of sore arm was not recovered /not resolved.
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 a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 2:51 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 2:51 PM, 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 76.42 .  Concomitant products were not provided.  On 07-Jan-2021, excursion time was 09 AM and 10 AM  and temperature was 34 respectively, total doses given for the day was 96, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 07-Jan-2021. 06 vial was moved to clinic on 07-Jan-2021. Vaccine BUD date was 27-Jan-2021.  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.
Fever of 101.0, severe chills, severe body aches (joint and muscle pains including pain in wrists, hands, neck, arms, shoulders, back and legs), severe headache, for 48+ hours, loss of appetite and even pain behind my eyes.  Administered Advil and Tylenol on a rotation schedule every 4 hours (taking the medications 1 hour a part from each other) to no avail for more than the first 24 hours.  Arm pain from injection site lasted 4-5 days. It took more than 48 hours for the fever to break and for severe muscle and joint pains to calm down.  Felt fatigued and weak for another 2 days following.
Numbness in lips, tongue, pallet, gums. and left side of face.  Hives over body
the full dose instead of the half dose; pregnant teachers got it; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (the full dose instead of the half dose) and MATERNAL EXPOSURE DURING PREGNANCY (pregnant teachers got it) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (the full dose instead of the half dose) and MATERNAL EXPOSURE DURING PREGNANCY (pregnant teachers got it). At the time of the report, ACCIDENTAL OVERDOSE (the full dose instead of the half dose) and MATERNAL EXPOSURE DURING PREGNANCY (pregnant teachers got it) had resolved.            Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter. Company Comment: This case concerns a female patient of unknown age, with no relevant medical history, with maternal exposure during pregnancy and the additional event of accidental overdose with the third (booster dose) dose of Moderna COVID-19 vaccine. No associated adverse events were reported. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-366021 (Patient Link).; Sender's Comments: This case concerns a female patient of unknown age, with no relevant medical history, with maternal exposure during pregnancy and the additional event of accidental overdose with the third (booster dose) dose of Moderna COVID-19 vaccine. No associated adverse events were reported. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Swollen and very tender/sensitive knuckles in fingers. Painful. Excessive swelling to the point that wedding band doesn?t even come close to fitting on finger (which has been worn for 15 years).
Storage unit temperature excursion, vaccines deemed non viable by manufacturer, contacting patients for re-vaccination.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE DVT OF RIGHT POPLITEAL VEIN
At an unspecified time, the pt received his 1st dose of Lymerix, with no untoward effects. The physician reported the pt received the 2nd dose, and the pt reported to his physician he experienced joint pain. The most recent information received on 6/13/00, reported the joint pain resolved.
Sore Arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and PYREXIA (Fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Sep-2021, received third 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) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Sore Arm) and PYREXIA (Fever) had resolved.            Concomitant product use was not provided by the reporter.  On an unknown date, the patient had sore arm and fever. No treatment information was provided. The reporter's causality for the event(s) sore arm and fever with humira(adalimumab) was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.      Reporter did not allow further contact
Experienced some soreness during night, but by morning I could not raise my arm in front of me or to the side past my waist.  Ability to move my arm returned within 72 hours but certain movement, especially anything cross-body or around my back continued to be extremely painful for over 10 weeks.
Patient was administrated with a 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number mr75g, expiry date 13th July 2023) for prophylaxis.   Previously administered products included Shingrix (received 2 doses on an unkown date).   On 16th June 2022, the patient received the 3rd dose of Shingrix. On 16th June 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 21-JUN-2022 Reporter's comment: The patient was administrated with a 3rd dose of Shingrix on 16th June 2022. The vaccine administration facility was the same as primary reporter. The reporter was consented to follow up. No adverse event was reported. Additional Supportive Information: The patient received 3rd dose of Shingrix, which led to extra dose administered.
Dizziness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and HEADACHE (Headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Headache). On 12-Apr-2021, DIZZINESS (Dizziness) and HEADACHE (Headache) had resolved. Not Provided      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.
Patient develop rash to both arms and legs on 9/111/18 one day after receiving vaccine. She has been taking Benadryl but no improvement in rash yet.
Patient reports he 1st noted this ?lump? in his chest yesterday when he took off his sure to take a shower in the morning and saw swelling in the mirror.  He felt around the area and noticed a small area of swelling superior and lateral to his nipple.  He notes the swelling went up throughout the day and the area became tender.  When he woke up this morning he noted swelling had diminished.  There is also some mild erythema over the area, but he is uncertain if this is secondary to him poking and prodding at the area frequently over the past 36 hours.  Of note he did get his COVID booster 11/06/2021 in the shoulder on the same side (Left), and his influenza on the right.  Patient notes as above, the area has reduced in size overnight and throughout the day today, but still feels there is a ?lump? present.  He denies any systemic signs such as fever, chills, nausea vomiting.  Denies any nipple discharge, or recent irritation to the nipple site.  He is a never smoker, denies any environmental exposures, he works as a psychology professor locally.  Family history includes a mother diagnosed with breast cancer 25 years ago and a father with prostate cancer.
Fever; chills; aches; Constant headache; This is a spontaneous report from a contactable consumer (patient). A 68-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EM9809), via an unspecified route of administration, administered in Arm Right on 12Mar2021 at 08:15 as DOSE 2, SINGLE for covid-19 immunisation (at the age 68 years). Medical history included hypertension, high cholesterol, covid-19 (Covid-19 prior to vaccination). Patient reported known allergies to penicillin, erythromycin. Concomitant medications included metoprolol succinate; HCTZ; iron, Pravastatin. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6201) via unspecified route administered in right arm on 19Feb2021 at 08:15 (at the age of 68 year old) for covid-19 immunisation. The patient experienced fever 102, chills, aches and constant headache on 12Mar2021 at 16:00. No covid tested post vaccination. The patient underwent lab test which included fever (body temperature): 102 on 12Mar2021. No treatment was received. No other vaccine in four weeks. The clinical outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected.
3 hours follow administration of vaccine, patient developed tonic/clonic seizures without the presence of fever. After hospitalization, patient was diagnosed with new onset Epilepsy. Per annual report- Pt. has been seizure free since November '04 after 5.5 months of up to 30 seizures a day.  He is still on antiepileptics, Zonegram.  The doctor will try to take him off this coming November.  He will not receive any vaccines that have seizures listed in the possible side effects.
I did not have an adverse reaction to the Covid vaccine.  On April 1, 2023, I woke with a severe sore throat, headache, and general aches and weakness, and then tested positive for Covid.  After a telemedicine visit with my doctor's office, I started taking a 5 day course of Paxlovid on April 2, 2023.  My Covid symptoms abated quickly.
Within 24 hrs of shot had expected chills and muscle aches. Then within a week of shot began to develop mild tingling and/or squeezing sensation primarily in arms/hands. Comes and goes throughout the day and has appeared daily since within a week of the shot. Occasionally the same feeling is felt in feet, but primarily/regularly felt in arms. Not overly painful, but noticeable.
Got Sick; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient's friend) via social media.  This case involves patient (unknown demographic) who got sick (illness), while received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received free dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site at 1st Aid Department.  On an unknown date, the patient got sick (illness) (non-serious, unknown latency) after administration of INFLUENZA VACCINE.  Miss several days of work after just receiving a free vaccine.  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting the outcome of event was unknown
soar arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soar arm / pain in extremity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the event the patient received both planned doses of mRNA-1273 (lot/batch: unknown) (unknown route) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) soar arm.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of event(s), soar arm was unknown.
Moderna COVID-19 Vaccine EUA. Left arm rash developed on Day 8 ( Wednesday, January 13, 2021). I noticed the rash when I got home from work at 7:00pm. Rash is mildly itchy around border. I continue with left arm rash on Day 9 (Thursday, January 14, 2021)   Rash is red and hard and mildly itchy around border.
Child was vaccinated 11/16 at 5:30pm. The next morning at 7:00 am the mother found what looked like a "lacey" rash, purple and mottled. The rash continued to develop throughout the day to redness on the child's cheeks. It extended throughout the entire body including back, belly, arms, and chest after a warm bath was given. Rash came and went but resolved itself completely after 48 hours. The mother suspected "Fifth disease." Subject had both seasonal flu shots in mid-September and late-October with no reactions.
Hallucinations; Double vision; This is spontaneous report from a contactable consumer (patient). An 85-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Feb2021 (at the age of 85 years) (Batch/Lot Number: EL9267) as a single dose for COVID-19 immunization. Medical history included high blood pressure, thyroid disorder, allergic to penicillin, and ongoing glasses wearer. Concomitant medications included losartan for hypertension; metoprolol for hypertension; and levothyroxine for thyroid disorder. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 (Batch/Lot Number: EL9263) for COVID-19 immunization. The patient also previously took epinephrine and experienced allergy. Since Mar2021, the patient had double vision which was already for 5 months at the time of report. When the patient first had it, had hallucinations and it was very weird that patient never tied it to the shot until started hearing that other people had double vision too. Patient saw how bad it was on 06Mar2021 as patient have not driven since 06Mar2021, everything was looking double, the cars were coming at patient instead of going straight. It took a while for patient to get an appointment with the ophthalmologist. Patient finally went and have been going every single month to see him and there was no change. Patient still had double vision. The patient thought that the adverse event has gotten worse. Patient told the doctor and he is going to send the patient to another doctor. Patient also went to a neurologist. They took a brain scan and had an angiogram, everything in patient's brain was ok. The doctor is going to send patient to another one that might prescribed prisms in glasses because patient did not want surgery. It is surgery or prism. Patient have not had any treatment. Outcome of the event hallucinations was recovered on an unspecified date in 2021 and of the event double vision was not recovered.  Follow-up attempts are completed. No further information is expected.
No adverse event; reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 32030BD, EN6203 and EN6198) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022).    No concomitant product reported by reporter. Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medication was reported.   This case was linked to MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-704260:(Master case)