chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fainted; Did not receive second dose; This serious case was reported by a physician and described the occurrence of fainting in a 12-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero (unknown arm) and did not receive the 2nd dose of Bexsero. On an unknown date, 1 day after receiving Bexsero and not applicable after receiving Bexsero, the patient experienced fainting (Verbatim: Fainted) (serious criteria GSK medically significant) and incomplete course of vaccination (Verbatim: Did not receive second dose). The outcome of the fainting was resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-jun-2023 This report was submitted via the online direct entry reporting system. The patient received first dose of Bexsero prior to going to sleep away camp due to outbreak.  She did not receive second dose.  She fainted the following day after getting vaccine. That happened about 4 to 5 years prior to the reporting. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Bexsero, which led to incomplete course of vaccination.
This spontaneous report as received from a Registered pharmacist refers to a 67 year old female patient with glaucoma and with no drug allergies/drug reactions. On 06-MAY-2013 the patient was vaccinated with ZOSTAVAX (0.65) (lot # H021459, expiration date 30-APR-2014) subcutaneous in the left triceps to prevent shingles. Concomitant therapies included COSOPT and BONIVA. On 07-MAY-2013, the patient experienced nausea. The patient also experienced a hard knot, redness "a little bigger than a half dollar", soreness, "a little bit of a tingling effect", "itched somewhat", swelling and a slight rash at the injection site, which worsened on 08-MAY-2013. The patient did not seek medical attention. The treatment was BENADRYL on an unspecified date. At the time of the report the patient was recovering. Additional information has been requested.
Patient was supposed to be given TDap, was given Kinrix DTap instead by mistake.  PCP made aware and made parent aware.
This spontaneous report was received from a pharmacist referring to a currently 74 year old female patient. Current conditions included hypertension. The patient's medical history was not reported. On 09-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 lot # M007768, expiration date: 27-JUN-2017, second dose, 0.5 ml, intramuscular in the left deltoid (concentration was not reported). Information regarding concomitant medications included enalapril maleate, hydrochlorothiazide (manufacturer unknown), amlodipine, atenolol and simvastatin (manufacturer unknown). On 09-SEP-2016, the patient experienced swelling below the injection site, trouble lifting the arm and soreness in muscle below the injection site. It was also stated that on 12-SEP-2016, the patient reported some improvement in the soreness and that she had taken BENADRYL, additionally, the pharmacist advised the patient to use ibuprofen and warm compresses to the site. At the time of the report, the outcome of swelling below the injection site, trouble lifting the arm and (musculoskeletal disorder) was unknown. On the other side, the outcome of injection site pain was reported as recovering. The causality between PNEUMOVAX 23 and swelling below the injection site, trouble lifting the arm and soreness in muscle below the injection site was unknown. Additional information has been requested.
Broke out again but "not as progressive"; She had residual redness; Bumps that don't itch or burn; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (She had residual redness), MASS (Bumps that don't itch or burn) and RASH (Broke out again but "not as progressive") in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040a21a and 024m20a) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ERYTHEMA (She had residual redness) and MASS (Bumps that don't itch or burn). On 14-Mar-2021, the patient experienced RASH (Broke out again but "not as progressive"). The patient was treated with HYDROCORTISONE (topical) at a dose of 1 dosage form. In March 2021, RASH (Broke out again but "not as progressive") outcome was unknown. At the time of the report, ERYTHEMA (She had residual redness) and MASS (Bumps that don't itch or burn) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD-2021-073770, MOD-2021-074842 (E2B Linked Report).; Sender's Comments:  MOD-2021-073770:First dose MOD-2021-074842:Second dose
12 hours after my 2nd dose of Moderna I felt somewhat nauseated and my abdomen felt sore. 18 hours after 2nd dose I started running a low fever of 100.7. The following day my fever jumped to 102.6 at 2pm and fever continued to return every 3 to 4 hrs. My abdomen aches when I have fever. The following day (Friday night) I went to sleep at 10:30 with a fever of 101, rooks some Tylenol and woke up at 12:30 to a 104.3 fever and severe chills. It took two hours, a cold bath and 4 Advil gel capsules to bring fever down to 101.5. This fever has continued and I still currently have a high fever, all day every day, every 3 to 4 hours.   My body is somewhat achy and I have mild to medium headaches off and on.  I met with a nurse practitioner and she ordered a RESPIRATORY PATHOGEN PANEL WITH COVID-19. I tested negative for all viruses.   I am managing the fever by setting alarms on my phone for every 3-4 hours so I don?t forget to take a fever reducer.  It?s a total nightmare. When will it end?  My appetite is also v small and I am weak. I am truly exhausted from this unending high fever.
body feels warm; Dry cough; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (body feels warm) and COUGH (Dry cough) 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 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (body feels warm) and COUGH (Dry cough). At the time of the report, FEELING HOT (body feels warm) outcome was unknown and COUGH (Dry cough) had resolved.            Concomitant product use was not provided. No treatment was reported.   This case was linked to MOD-2021-164589 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: TCR document was attached. Event was recovered.
dose were administered after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose were administered after the published expiration date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     Patient has no known allergies.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose were administered after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose were administered after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 28-Mar-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. Reporter does not know if patient had positive COVID test. No treatment information were reported.   This case was linked to MOD-2022-532912 (Patient Link).   Reporter did not allow further contact
Inflammation around the heart .; This is a spontaneous report from Non-contactable consumer female (patient). A 17-year-old female patient (not pregnant at the time of vacciantion) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 05Aug2021 (at the age of 17 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. 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. Since the vaccination, the patient hasn't been tested for COVID-19. On 26Aug2021 patient experienced inflammation around the heart. Therapeutic measures were taken as a result of inflammation around the heart with Computed tomography (ct), x-ray, electrocardiogram (ecg). The reported event led to patient's prolonged hospitalization on an unspecified date. The reporter considered events as serious. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Subject: Adverse reaction I received the Moderna vaccine at 3:30PM Friday, Jan. 22. Other than a sore arm, I was fine until the next night. About 8:00PM Saturday, Jan. 23 I was overcome with severe chills, hurting all over, nausea and a 101.3 fever. I suffered through the night with the chills ebbing by NOON Sunday, Jan. 24. By 5:00PM I was back to 95% except my arm remains sore and I occasionally feel nauseous.  Feel free to text or phone me.
Received shot at 2:30 pm.  No original pain, redness or swelling to arm.  Woke up next morning at 7:30 with urgent need to urinate.  developed into urinary tract infection.  Was drinking lots of water and cranberry juice for a week.  mostly urinating often and lots of urine.  Then on March 5, started having pain upon urinating and almost lack of urine .  Went to Urgent Care  .  Lab report showed E Coli .  Begin taking Cephalexin 500 .  Took this for one week.  Seems to have taken care of problem.
One week after receiving her annual influenza vaccination November 2017, patient experienced an acute onset of nausea and lightheadedness while standing, not associated with her usual groin/pelvic pain, eating, or sudden position change. Within 24-48 hrs she experienced lower extremity tremulousness "like a chill" affecting her from the waist down. Others were able to observe the shaking of her legs.  Over the next 8-10 hours, the tremors would last about 5-10 minutes, abate for 1-2 hrs, and then return without apparent stimulus.  She also noticed an icy-hot' sensation over various parts of her body at various times.  [Continued]  The distribution did not seem to follow a dermatomal pattern.  While the icy-hot' symptoms and pain seemed to slowly diminish in frequency, duration, and intensity over the 4-6 months, the bouts of nausea seemed to persist, with the additional onset of bowel and bladder symptoms.  Her stooling become irregular starting with explosive diarrhea then several days of constipation followed by several months of irregularity. She also experienced bouts of urinary urgency. During this time she lost over 15 lbs from anorexia due to her nausea.  Between Feb and Apr 2018, she experienced several bouts of "low blood pressure".  Her groin/pelvic pain seemed to diminish after a uterine infection was found and she was treated with Flagyl.  Her symptoms have been extensively evaluated by urology, rheumatology, neurology, urogynecology, and gastroenterology with no definitive diagnosis forthcoming. She began to experience an intense sandpapery', lightening-like sensation that radiated under her right ribs to her pelvic area, again not precipitated by movement or other identified activities.  This pain, and later lower back pain, decreased significantly with physical therapy.  She has been treated with magnesium and Vit D with some improvement. Bladder infusions with heparin, antibiotics, and lidocaine had only partial relief.  She underwent pelvic floor PT for several months, although does not complain of dyspareunia or other sexual dysfunction.  She has not experienced vaginal, ocular, or oral dryness.  Over the past two years, her symptoms have slowly improved, such that today, she experiences only an unusual transient (5-10 seconds) deep buzzing' sensation in her right abdomen if she lays on her right side or stomach and sharp pain in both her feet.  Working diagnosis: resolving small fiber neuropathy
Swelling in the arms; Swelling in the breast; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a adult female patient who received HAV (Havrix) (batch number E9G4E, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number ZMM22C ?, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Havrix and Shingrix. On an unknown date, unknown after receiving Havrix and Shingrix, the patient experienced swelling arm and breast swelling. On an unknown date, the outcome of the swelling arm and breast swelling were unknown.   It was unknown if the reporter considered the swelling arm and breast swelling to be related to Havrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received both Havrix and Shingrix and developed swelling in the arms and breast after that.  The reporter provided all patient identifiers and batch number but no expiration date, as it was not available.  The reported batch number for Shingrix ZMM22C was not available in sales data base, however it was captured as ZMM22C ?
104 fever for 45 hours, dizziness and nausua for 3 weeks.  4 days after shot my arm swelled up and was hot for a week
Headache, Myalgia, Arthralgia, FATIUE Narrative:
Itching, swelling, redness at site, headache, swollen lymph nodes in axilla.
Case of 57 year old female with history of RA treated with methotrexate 2.5mg 7 tablets weekly. Completed primary series with Pfizer mRNA vaccine; second dose administered 4/28/21 with the Pfizer mRNA vaccine. On 11/29/21 the patient was administered 0.25ml of Moderna mRNA vaccine. After this dose she experienced headache and pain at injection site 1 day of onset for a total duration of 2 days. She received 0.25ml of Moderna mRNA vaccine on 12/9/21 to complete the full dose of the additional primary dose. The patient was observed for 15 minutes with no adverse events to report within this time frame.
Following my second shot, I have been experiencing pain in my legs. I describe it as feeling like it's in my bones, not necessarily my joints. It requires numerous position adjustments when sitting and lying down. It wakes me up several times in the night. I had none of these issues prior to receiving the vaccine.
Local Rxn prox. left arm erythema, high temp to palpation; induration; edema.
The patient also received a booster dose instead of a third full; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (The patient also received a booster dose instead of a third full) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 041L20A and 025J20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Immunosuppression.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (The patient also received a booster dose instead of a third full). On 03-Dec-2021, ACCIDENTAL UNDERDOSE (The patient also received a booster dose instead of a third full) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter.  The patient had no adverse reactions after the first vaccine and booster dose.   This case was linked to MOD-2022-466204 (Patient Link).
dizziness; tingling legs; diarrhea; Headache; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PARAESTHESIA (tingling legs), DIARRHOEA (diarrhea), HEADACHE (Headache) and NAUSEA (nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CITALOPRAM for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), PARAESTHESIA (tingling legs), DIARRHOEA (diarrhea), HEADACHE (Headache), NAUSEA (nausea) and CHILLS (chills). At the time of the report, DIZZINESS (dizziness), PARAESTHESIA (tingling legs), DIARRHOEA (diarrhea), HEADACHE (Headache), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not reported.
This spontaneous report was received from a other health professional refers to a patient of unknown demographics. On 04-NOV-2014 the patient was vaccinated with M-M-R II lot # H014989; expiry: 10-AUG-2014 (dosing regimen unspecified). No concomitant medications were reported. Healthcare worker reports that an unspecified patient was inadvertently administered an expired dose of M-M-R II 04-NOV-2014. No adverse effect reported. No further information was provided. Additional information has been requested.
Patient remained asymptomatic throughout the course of the infection;; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ASYMPTOMATIC COVID-19 (Patient remained asymptomatic throughout the course of the infection;) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Morbid obesity. Concurrent medical conditions included Hypertension.   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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASYMPTOMATIC COVID-19 (Patient remained asymptomatic throughout the course of the infection;). At the time of the report, ASYMPTOMATIC COVID-19 (Patient remained asymptomatic throughout the course of the infection;) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.
Resident admitted on 3/22/22  at 20:00. COVID Negative. Resident arrived at 1935 from (Privacy) hospital on stretcher with Dx of Major Neuro Cognitive Disorder with Behavioral Disturbance. She was transferred into bed and oriented to her room and bed controls. She is A&O x0 despite numerous attempts. She has no vermin in her hair, hearing is WNL, pupils are a 6 and eyes are protruding, unsure if she wears glasses, there are none with her and she is unable to answer, nares are patent, mucous membranes are pink and moist, she has her own teeth in good repair, she is on a regular diet, no jugular distention, LS clear, no cough or dyspnea, nonpitting edema to BLE, pedal pulses +, capillary refill <3, abdomen is obese, BS+ x4, incontinent of B&B, has bruising to right flank, right lower anterior leg and right inner knee, left buttock has red area that blanches to her left buttock and nonraised reddened area to her right inner thigh, no rashes, attempted to call husband x2 to complete POLST and Psychoactive Medication form but his mailbox was not set-up and he did not return call, resident is combative and resistive to care, she is also delusional and hallucinates, the patient has orders for a CPAP machine that needs clarified in a.m., remaining orders have been reviewed and clarified with CRNP.  Care plan with husband and our facility team was held on 3/24/22. Husband noted that she has not ate or taken meds for some time.  see assessment from 3/24/22 9:20 am  Resident alert and responsive. Very confused. Oriented to self only. Speech mumbled most of the time. Skin warm and dry. Lung sounds diminished. No respiratory distress observed at this time. Abdomen obese. Soft. BS+ in all 4 quads. Incontinent of B&B. Trace pedal edema noted. V.S. 97.9 83 18 122/82 O2 sat 98% on RA. No s/sx of pain or discomfort observed at this time. 2 assist with hoyer lift for transfers. 2 assist with bed mobility. 1 assist with ADL's including eating. Meal and fluid intake poor. Resident encouraged to eat and drink fluids but most of the time either pushes staff away or turns her head away.
Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016134142) on 05 Jan 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Influenza virus vaccine) (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date.  Patient's medical history reported that the patient was a former smoker (reported as 0.26 ppd, 8.75 pack-years), never used smokeless tobacco and no alcohol. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed allergies to Influenza virus vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of the documents held by sender: none.