chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE. No PQC. No further information available.; Patient was administered expired MMRll on 04/16/2021; This spontaneous report has been received from a nurse practitioner, referring to a 41-year-old female patient. Information about her pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions and allergies was not provided.  On 16-APR-2021, the patient was vaccinated with and expired dose (expired product administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (Therapy type: rHA), lot number S007814 and expiration date 14-MAR-2021, for prophylaxis (dose, frequency, route of administration and anatomical location were not provided).  The nurse practitioner requested medical information for expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccines and was provided with outcome response. No additional events were reported.
Injection site reaction 1-2" redness and swelling and pain x 4 days then injection site reaction returned post injection day 8 for 3 days.  Fatigue for 2 weeks following injection, GI upset
itching; pain at injection side (right arm); Swelling of entire arm (right side); Hives; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), VACCINATION SITE PAIN (pain at injection side (right arm)), VACCINATION SITE SWELLING (Swelling of entire arm (right side)) and URTICARIA (Hives) in a male patient of an unknown age 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 PRURITUS (itching), VACCINATION SITE PAIN (pain at injection side (right arm)), VACCINATION SITE SWELLING (Swelling of entire arm (right side)) and URTICARIA (Hives). At the time of the report, PRURITUS (itching), VACCINATION SITE PAIN (pain at injection side (right arm)), VACCINATION SITE SWELLING (Swelling of entire arm (right side)) and URTICARIA (Hives) had resolved.            Patient was an older gentleman. No concomitant medications were reported. The events resolved on their own and the patient did not take any medications.
Received 1.0 ml Flu vaccine IM, injection site "sore" for 2 days.
the vial was initially stored in the refrigerator after expiration date; inadvertently administer the vaccine 11 days after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator after expiration date) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 033C21A and 033C21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  After expiration date and date 31-May-2022, patient took Moderna first booster.  The patient had no known allergies. It was unknown whether the patient had been diagnosed with/ tested positive for COVID 19. Acute and Chronic illness at the time of vaccination and up to one month before was reported as none.  Dose administered after 30-day use by date or after manufacturer date of expiry. On 27-May-2022, the vial was initially stored in the refrigerator. Number of doses/vials administered were reported as one vial. The vial had not undergone any temperature excursions.  No treatment medication was reported.
On 9/30, agency was notified by an out-of-state health services company that a nurse had reused syringes for multiple persons earlier that day at an employee influenza vaccination clinic where the health services company had been contracted. The nurse contracted by the health services company brought three multiple-dose vials of vaccine that were intended for another event (and stored in her personal fridge without temp monitoring). The nurse reported using two syringes she found among her supplies to administer vaccine to 67 employees of the business. She reported wiping the syringes with alcohol and using the new needle for each of the 67 persons. Only 2 multiple dose vials of vaccine (10 doses/vial) were used for 67 adult participants. Participants were offered bloodborne pathogen testing (hep B, hep C, HIV), hepatitis B vaccine, and flu vaccine.
4OCT96 or 5OCT96 noticed soreness & swelling in lt shoulder;7OCT96 noticed a localized red rash where vax had been given;10-15 sore on upper lt arm;no systemic complaints;11OCT96 to company MD for eval;30OCT96 raised pink areas on arm
This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737, also reported as EW0170) via an unspecified route of administration in the arm left on 01Apr2021 at 16:00 as a single dose for COVID-19 immunisation. Medical history included high blood pressure and anxiety. No known allergies were reported. Concomitant medications included venlafaxine hydrochloride (EFFEXOR) and metoprolol (MANUFACTURER UNKNOWN); both since an unknown date for unknown indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 02Apr2021 at 02:00, the patient experienced flank pain on left side after first vaccine. Constant went to emergency room(ER) and received CAT scan and result was no finding for upper left quadrant. The patient also reported that pain was still present after 6 weeks. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of flank pain on left side after first vaccine and included CAT scan on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event flank pain on left side after first vaccine was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Mtr called to report child c/o left arm pain ( 3AM 12/7/04) vomiting, leg pain, temp 102, medicated with Tylenol, cool compress to arm, seen by pediatrician 10:30 AM, steroid and antibiotic rx'd, couns. on cool compress to left arm.
Developed hives after receiving the booster.  Intense itching and hives after hot showers, eating spicy food and when sleeping at night.  Moderately controlled with Xyzal and Benadryl. Never had an issues with hives until now. Also joint aches. Bones in the knees and hands aches since the booster .
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Jun2023 at 13:15 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Shingrix (Shingrix #2 vaccinations half day before original symptoms), for Herpes zoster immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was treated with Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300249663 same patient, different drug/event;
I experienced all of the listed risks on my paper from the pharmacy, but also had some visual hallucinations.  I wanted to be sure and report it since it wasn't listed and was a bit frightening.
Hep A IGM antibody was negative; Hep A IGM antibody was negative; This case was reported by a physician via call center representative and described the occurrence of hepatitis a antibody negative in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Twinrix, the 2nd dose of Twinrix and the 3rd dose of Twinrix. On an unknown date, unknown after receiving Twinrix, Twinrix and Twinrix, the patient experienced hepatitis a antibody negative and therapy non-responder. On an unknown date, the outcome of the hepatitis a antibody negative and therapy non-responder were unknown.   It was unknown if the reporter considered the hepatitis a antibody negative and therapy non-responder to be related to Twinrix, Twinrix and Twinrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated there were 4 to 5 patients who received complete Twinrix series but no patient details were available. Their blood test for Hepatitis B (antibodies to Hepatitis B surface antigen) were positive but Hepatitis A IGM antibody was negative, which led to negative titer. The reporter also asked whether they did the wrong test for Hepatitis A or should they be testing IGG and not IGM.  The reporter consented to follow up.      Lab Comments: On an unknown date the patient performed blood test for Hep B and Hep A
soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). On 26-Feb-2021, VACCINATION SITE PAIN (soreness at injection site) had resolved. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-079463 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079463:Dose 2
got sick; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (got sick) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     Concurrent medical conditions included Renal failure (The patient was hospitalized starting on 17Sep2021.).    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick). At the time of the report, ILLNESS (got sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ILLNESS (got sick) to be possibly related.    Concomitant medications were not provided. No Treatment information was provided.  The patient received the first dose on 29Jul2021 and got sick. He is in the hospital currently for renal failure (unrelated to the vaccine) and would like to get the second dose. The reporter (nurse) would like to know if they should proceed to give him the second dose or start the series over. The patient was hospitalized starting on 17Sep2021.; Sender's Comments: This case concerns a 60-year-old, male subject with a medical history of renal failure, who experienced the unexpected event of illness. The event start date following administration of the first dose of the Moderna COVID-19 Vaccine was not provided. The rechallenge was not applicable as the event occurred after the first dose. The medical history of renal failure, which may cause the potential complication of decreased immune response that makes the patient more vulnerable to infection, remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.
pt recvd vax; rt sided sz for 20 mins w/ fever of 39; tonic clonic movements; post ictal for 15 mins; rt leg weakness for hours (less than 24 hrs);probable todd's paralysis;also local swelling w/ erythema 4-5 cm in diam;
Seizure activity-stiffening of bilateral arms and legs, eyes rolling in back of head, periorbital cyanosis lasting 60-90 seconds; unknown temp-1.5hours after motrin given, T-100.3 rectally.
I went to bed around 10:30 and felt completely normal.  Around 1AM I woke up with the chills that lasted for about an hour or so.  I could not get warm.  My body would go from hot to cold and shiver/spasm in a pattern that lasted about a minute or so.  this pattern of hot cold and shiver/spasm lasted approximately an hour.    when that subsided I started to experience relatively extreme fever and flu symptoms.  I completely sweat through my pajamas.  My entire body ached and hurt like a normal fever flu but more extreme.  Around 2:30AM I took three 500mg acetaminophen, 2 mg Xanax and a 10 mg Valium.  I fell back asleep some time between 3:30 and 4:00AM.  I woke up at 8:30 with most of the symptoms having dissipated.  It's now 10AM.  I still feel groggy and a little achy in my body, but the fever seems to have subsided.  For now that is about it
Received the 1st dose of Pfizer Covid Vaccine on 3/18/21. Patient was scheduled for and received the 2nd dose on 3/30/21. When charting the dose the nurse noticed that the dose was received early.  Should have received the 2nd dose on 4/8/21.  Patient stated he was going out of town next week, so scheduled it early.
Swollen and painful lymph nodes under arm and along clavicle starting approximately 12 hours after vaccine administration.; Swollen and painful lymph nodes under arm and along clavicle starting approximately 12 hours after vaccine administration; The patient received BNT162b as booster dose; The patient received BNT162b as booster dose; This is a spontaneous report from a non-contactable pharmacist, the patient. A 29-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the right arm on 19Oct2021 at 15:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included influenza vaccine inact sag 4v (FLUCELVAX QUADRIVALENT) on 11Oct2021 taken for an unknown indication on an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration in the left arm  on 17Dec2020 at 14:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0142) via an unspecified route of administration in the right arm on 07Jan2021 at 14:15  (at the age of 28 -year-old)  as a single dose for COVID-19 immunisation. On 20Oct2021 at 03:00, the patient experienced swollen and painful lymph nodes under arm and along clavicle starting approximately 12 hours after vaccine administration. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. 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 swollen and painful lymph nodes under arm and along clavicle were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Patient was given vaccination as usual and vaccine was confirmed and accurate.  No previous reactions were reported prior to administration.  Patient expressed the vaccine hurt more on her arm that dose 1 as she was returing to her mother in the waiting area.  She began to state she was passing out as she reached her chair in which her mother was attending to her and had her in chair safe.  Pharmacist was alerted immediately and patient was moving and responsive when he arrived but past out shortly after arrival.  technician retrieved blanket and bottle of water as patient was safely lowered to ground by pharmacist and mother after assessing she was safe but unconscious.  patient was responsive to name and mom state
Arm began hurting within an hour to the point where it can barely be moved. My back, chest, and ribs ache when I breathe or move. Shooting pains in my upper back. Nausea. Fatigue.
On the day after my first dose, I had the following side-effects / symptoms: Strong headache, muscle aches, fatigue.; On the day after my first dose, I had the following side-effects / symptoms: Strong headache, muscle aches, fatigue.; On the day after my first dose, I had the following side-effects / symptoms: Strong headache, muscle aches, fatigue.; This is a spontaneous report received from a contactable consumer (patient), who reported for herself. A 28-year-old female patient received the first dose of Bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534), via unspecified route of administration in left arm on 01Apr2021 at 08:00 AM (at the age of 28 years) as single dose for covid-19 immunization. The patient medical history included asthma and allergies to penicillin and cephalosporin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 02Apr2021, (on the day following her first dose of covid vaccine), the patient experienced the side-effects / symptoms including strong headache, muscle aches and fatigue. The patient did not receive treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in 2021.  No follow-up attempts are needed. No further information is expected.
PATIENT COMPLAINS OF HIVES AND RASH 4 HOURS POST VACCINATION, RECOVERED WITHIN 2 DAYS.
Initial report received on 1/31/2006 from a health care professional. A 17 month old female patient with no significant medical history had received an administration (route not reported) of Fluzone SV 2005 2006 USP, lot number U1915AA, in the left thigh and an administration (route not reported) of Tripedia, lot number U1345BA, in the left thigh on 1/25/2006. At an unspecified time later, the patient developed an injection site abscess with redness and edema. The abscess was verified by ultrasound and the patient was evaluated by a physician and treated with antibiotics. At the time of this report, the patient had recovered from these events. The reporter for this case is the same as for case 200600227. Follow up information received on 4/10/2006. The patient has a past medical history of recurrent otitis media with myringotomy and tympanostomy tube placement in Oct 2005. The patient received her Fluzone and Tripedia vaccine intramuscular on 1/25/2006. One day post immunization, she developed severe left leg redness, swelling and pain at the injection site. She was seen by her physician the following day. On examination, her left proximal thigh had a large area of erythema, induration, tenderness and warmth around and distal to the injection site. She was also found to have an ear infection, earache, rhinitis, intermittent fever and cough. She was diagnosed with acute upper respiratory infection and ear infection. Per the physician, there was a small risk for cellulitis/abscess, and she was admitted to the hospital for treatment. She was to have a CBC with platelets, influenza swab, and RSV test. No laboratory results were provided.
Twisted mouth, one nostril was drooping left nostril, left eye running & can?t blink eye.
The vaccine this patient received was determined to have had a temperature excursion below the recommended storage temperature prior to administration. There was no recommendation to repeat the dose from the vaccine manufacturer.
Mom had left message Re: child had reaction to DTaP on 08/12/02. Arm was red, swollen, itchy. Fever at 100.0 - 101.0 degrees F. Headache, I left message on pt's answering machine to try Tylenol, cold compresses and to call back if fever persisted. Never heard back from mom.
Patient received Hep A vaccination on 5-11-07, not red swelling starting 5-12-07 gradually increased swelling to 6 cm Diameter-injection site below Deltoid (L) upper Arm
-Rash, swollen eyes  -Given: Prednisone 30mg BID x 5 days Zyrtec 10 mg QD Benadryl 25 mg PRN HS -outcome: Patient shows improvement;  no complications
46 yo F with NKDA was vaccinated with Moderna Covid-19 vaccine in her left deltoid on 8/20/21 at ~1444. The patient was monitored 15 minutes. At 1519, patient was in the facility lobby and reported she didn't feel well. Complained that her throat felt funny and it was hard to breath. Emergency helicopter team presented and took VS which showed patient was hypertensive 164/90 with good O2 sats and RR 16. Patient refused further offers of care by EMS and did not want to go to the ED. After drinking some ice water, she felt better and called her husband to pick her up.