chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got my my last moderna shot a month ago and my arm still hurting where the injection was given.Is this normal?; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (I got my my last moderna shot a month ago and my arm still hurting where the injection was given.Is this normal?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 VACCINATION SITE PAIN (I got my my last moderna shot a month ago and my arm still hurting where the injection was given.Is this normal?). At the time of the report, VACCINATION SITE PAIN (I got my my last moderna shot a month ago and my arm still hurting where the injection was given.Is this normal?) outcome was unknown.            Concomitant and treatment medications were not provided by reporter.
Recalled Lot  Product was administered; Recalled Lot  Product administered; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.     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: 26-May-2022 Reporter's Comments: The vaccine coordinator reported a dose of Engerix-B from recalled Lot Product was administered to patients. The patients were administered this lot number but no adverse event reported. The reporter inquired what information should they send to patient regarding Engerix recall from back in October 2021. The reporter did not consent to follow-up. Additional Supportive Information: The patient received engerix B from recalled Lot which led to recalled drug administered and drug dispensing error. This is one of 10 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR085031:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085025:Same Reporter US-GLAXOSMITHKLINE-US2022084603:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085030:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085029:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085026:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085027:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085028:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085032:Same Reporter
outbreak of herpes zoster; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The health care professional stated that the patient got an outbreak of herpes zoster shortly after getting vaccinated with Shingrix. The reporter did not consent to follow up.
patient received the adjuvant part of Shingrix only (without reconstitution with powder vial); patient received the adjuvant part of Shingrix only (without reconstitution with powder vial); This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 86-year-old male patient who received Herpes zoster (Shingrix) (batch number 5XP9M, expiry date unknown) for prophylaxis.   On 17th May 2021, the patient received the 1st dose of Shingrix. On 17th May 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received only the adjuvant part of Shingrix (without reconstitution with powder vial), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  The reporter did not consent to follow up. The reported batch number (5XP9M) belonged to adjuvant part of Shingrix.
After administration of vaccine, we were notified by local Authority that the vaccine had experienced a temperature monitoring event outside of our facility.  Patient was notified of CDC guidelines that recommend revaccination.  Patient returned on 10/13/2022 for revaccination.
Acute intraparanchymal hemorrhage centered within the right basal ganglia with left side affected October 12, 2021.
Headache, fever nausea--PCP and Allergist visit.  Allergy added to profile in chart.
Pt states she has a feeling of a rock in the arm, slightly bruised, but has full mobility in the arm.
Initial spontaneous report received from a physician on 23 Dec 2010: This patient was vaccinated with FLUVIRIN (batch number 1145906) on an unknown date. Within 2 minutes after vaccination, the patient "felt peculiar" and was a little confused. The reporter stated that the patient wanted to wander around and declined sitting down but agreed to sit in the consulting cubicle. The ambulance service was called and the patient was taken to the local accident and emergency department due to increased systolic blood pressure of 200. Value of diastolic blood pressure was not reported. At the time of reporting, the patient outcome was unknown. The reporter did not provide a causality assessment.
pain in the right breast; sensitivity of the nipple; sensitive and tender; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BREAST PAIN (pain in the right breast), SENSORY DISTURBANCE (sensitivity of the nipple) and TENDERNESS (sensitive and tender) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product SPIRONOLACTONE for an unknown indication.    No Medical History information was reported.   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 SPIRONOLACTONE (unknown route) dosage form. On an unknown date, the patient experienced BREAST PAIN (pain in the right breast), SENSORY DISTURBANCE (sensitivity of the nipple) and TENDERNESS (sensitive and tender). At the time of the report, BREAST PAIN (pain in the right breast), SENSORY DISTURBANCE (sensitivity of the nipple) and TENDERNESS (sensitive and tender) had not resolved.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-101841 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up information received on 03-JUN-2021 contains non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101841:cross linked case
On 11/18/2021 in the evening around 09:00 PM- warm and muscle joint aches, dry heaves and intestinal problems. I did not vomit but I came close a couple of times. At that point it did not seem bad. At 01:00 AM I took my temperature, and it was 102. I took some Tylenol. In the morning my temperature was 101, I called my PCP and he suggested I take a COVID-19 test. I went to the Emergent Care. The doctor evaluated me and then administered a fast COVID-19 test and it was negative they took a PCR COVID-19 test. A couple of days later I received the results, and they were also negative. All my symptoms resolved in 2 days.
3 days after receiving the vaccine, patient lost all physical mobility and had mental status changes.  He states he was violent toward Police and EMS.  He doesn't remember the first week in the hospital.  He was told he tested positive for COVID but other than receiving his vaccine he had very limited exposure to anyone or anywhere.  He said the only people he was around were not sick and they always wore a mask and washed their hands.  He feels the vaccine is what gave him COVID.
Large redness around injection site. Lasting for an extended amount of time, (Fri. 10/09/2009) and enlarging in size & soreness.
Immediately after, patient stood up and fainted. He vomited twice. Gave juice and water, laid down, doctor called and checked BP. Patient discharged by doctor in stable condition.
This spontaneous report as received from a nurse refers to a 10 months 22 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. 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 is not expected, no contact details were provided.
Itching, swelling, and 3.5 by 5 cm area of erythema and induration.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX23 for prophylaxis (route, lot # and expiration date were not reported). It was stated that the temperature was between 47 to 77 Fahrenheit degrees with a time frame of 5 days. No previous temperature excursions were reported. No adverse effects were reported in the patient. A product quality complaint was not involved. Additional information is not expected because the reporter refused additional contact.
Inability to swallow food to my stomach/ Inability to drink over 1/2 cup; Inability to swallow food to my stomach. Much discomfort. Inability to drink over 1/2 cup. Much discomfort; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: ew0171, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 29Apr2021 at 12:15 (at the age of 65 years old) as second dose, single for COVID-19 immunisation in a Pharmacy or Drug Store. The patient has no other medical history. The patient has no known allergies and prior to vaccine the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (lot number: er8737), via an unspecified route of administration administered in left arm on 08Apr2021 at 12:15 (at the age of 65 years old) as single dose for COVID-19 immunisation. The patient's concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has no list of any other medications the patient received within 2 weeks of vaccination. On 02May2021, the patient experienced inability to swallow food to his stomach with much discomfort and inability to drink over 1/2 cup with much discomfort. At the time of report, it was the second week the patient experienced the events. The patient stated that he needed to eat. The patient was able to eat only ice cream slowly. No treatment was received for the adverse event. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was not recovered.
got the 2nd vaccine (20May2021) 39 days after the 1st one (11Apr2021); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the 2nd vaccine (20May2021) 39 days after the 1st one (11Apr2021)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, 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 experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the 2nd vaccine (20May2021) 39 days after the 1st one (11Apr2021)). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the 2nd vaccine (20May2021) 39 days after the 1st one (11Apr2021)) had resolved.            Treatment medications included Steroids   This case was linked to MOD-2021-255602 (Patient Link).
Agitation, Headache, Palpitations & HYPERtension Narrative:
difficulty moving the shoulder; This non-serious case was reported by a physician via sales rep and described the occurrence of mobility decreased in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy (intramuscular). On an unknown date, an unknown time after receiving Arexvy, the patient experienced mobility decreased (Verbatim: difficulty moving the shoulder). The outcome of the mobility decreased was resolved (duration 8 weeks).   It was unknown if the reporter considered the mobility decreased to be related to Arexvy.     It was unknown if the company considered the mobility decreased to be related to Arexvy.   Additional Information: GSK Receipt Date: 25-OCT-2023 A GSK MSL Field Representative reported that a physician stated in his office that 3 female patients (no distinguishing factors provided), all received the Arexvy vaccine, and had difficulty moving the shoulder the vaccine was administered in for 6 to 8 weeks after administration. The GSK MSL Field Representative did not have any further information about this event, nor any information about lot/expiry or date of administration. The reporter consented to follow up. This case is linked with US2023AMR152006, same reporter.; Sender's Comments:  US-GSK-US2023AMR149219:3rd FEMALE PATIENT US-GSK-US2023AMR152006:
nausea; headache; calf-muscle pain under the knee; chills; cough; She is worried about the duration of this side effects.; muscle weakness; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 13Feb2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included abdominal discomfort; she said that even before the vaccine she was feeling sick of the stomach from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that, she received the first dose of the COVID vaccine on 13Feb2021 and still seven days later of this on 20Feb2021 she was having nausea, headache, calf-muscle pain under the knee, chills and cough. Nausea was still there along with muscle weakness. She was calling to get recommendations on what to do or what to take for this symptoms. She was worried about the duration of this side effects. Additionally to this, caller has scheduled her second dose on 05Mar2021 and according to the count that would be 20 days from her first dose. The outcome nausea and muscle weakness was not resolved while outcome of other events was unknown.  Information on lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
7AM, APRIL 11,2007, MOM NOTICED RAISED,RED,HARD,WARM LUMP ON UPPER LEFT ARM. LUMP IS 3" IN DIAMETER. NOT TENDER TO THE TOUCH.
ENTIRE BODY FEELING HOT AND FELT LIKE ON FIRE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was not reported and height was 64 centimeters. The patient's past medical history included difficulty breathing, and hurting around heart, and concurrent conditions included alcoholic (40s per day beer), and smoker, and other pre-existing medical conditions included the patient did not have any known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUN-2021, the subject experienced entire body feeling hot and felt like on fire. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of entire body feeling hot and felt like on fire was not reported. This report was non-serious.
HIVE LIKE RASH TURNED INTO BRUISES ON BUTTOCKS AND LOWER EXTREMITIES (BOTH) AND THESE SYMPTOMS RECURRING EVERY COUPLE OF WEEKS; SYMPTOMS STARTED LIKE A SPIDER VENOM BITE AND DEVELOPED A HIVE LIKE RASH; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was a former occupational therapist. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the patient experienced suspected covid-19 infection. On 15-MAR-2021, the patient experienced hive like rash turned into bruises on buttocks and lower extremities (both) and these symptoms recurring every couple of weeks, and symptoms started like a spider venom bite and she developed a hive like rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from symptoms started like a spider venom bite and she developed a hive like rash, and hive like rash turned into bruises on buttocks and lower extremities (both) and these symptoms recurring every couple of weeks, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Change in taste. Sweet and salt taste diminished to about 50% of normal. Condition continued about 10 weeks then taste returned to normal.
approximately 1/7/2021 I developed a small rash at the injection site that I noticed around 8:30 pm. This rash was spotty and irregular in shape and did not itch, but was hot to the touch. The following morning the rash had grown into a 2 inch wide and 2 in long bright red rash that was raised and swollen. Still hot to the touch but no itching. As of today the rash is no longer fully red on the inside but has left a small red raised ring of the outline of the initial rash which appears to be spreading outward. Another coworker of mine also reported the same symptom 2 days after the onset of my rash developed. I  attended a virtual visit with a physicians  assistant to take an oral antihistamine for a few days to see if the rash subsides.
Dosing error. Patient came to a mobile clinic we were performing at stating that she needed her second shot. This shot was given at 14 days from the first shot instead of 21 days. No adverse reaction to the shot, just a dosing error in timeline.
PT SAID HER TIP OF TONGUE WENT NUMB AND HER LIP BEGAN TO SWELL
Weak; feel awful; Fever; Muscle pain; Tiredness; Nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), FEELING ABNORMAL (feel awful), PYREXIA (Fever), MYALGIA (Muscle pain) and FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weak), FEELING ABNORMAL (feel awful), PYREXIA (Fever), MYALGIA (Muscle pain), FATIGUE (Tiredness) and NAUSEA (Nausea). At the time of the report, ASTHENIA (Weak), FEELING ABNORMAL (feel awful), PYREXIA (Fever), MYALGIA (Muscle pain), FATIGUE (Tiredness) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported. No treatment information was reported.
I received my second covid-19 booster of Moderna at 4:00 p.m. Thursday, April 28th, 2022 At 7:00 a.m. I woke up with a three and a half inch diameter circle right beside the band-aid that was covering the injection site. It was swollen, raised, hard, hot, (765) 832-3622 red, and itching intensely. There is no pain or soreness involved, just horrible itching.This morning it had increased to a diameter of 5 in. My initial vaccination took 11 days before the exact same thing occurred. The following three  occurred within 12 hours.