chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fatigue; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (fatigue) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 22-Apr-2023, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Batch number for vaccine was reported as 066H22A OR 0S5FF22B. Patient had completed fatigue. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
Expired Havrix administered; Dose given over 12 months after dose 1; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 70-year-old male patient who received HAV (Havrix) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (first dose was received on an unknown date).   On 9th February 2023, the patient received the 2nd dose of Havrix (intramuscular) .5 ml and Havrix Pre-Filled Syringe Device. On 9th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used and drug dose administration interval too long. On an unknown date, the outcome of the expired vaccine used and drug dose administration interval too long 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: 09-FEB-2023 Reporter's comments: The nurse reported that a patient had received dose of the Havrix vaccine in left deltoid on the day of reporting The vaccine expiration date was 6 February 2023. This dose was also late- given over 12 months after fist dose. Nurse had been transferred to Medical inquirer (MI) for more information. The reporter had consented to follow-up. Additional supportive information: At the time of reporting, the patient had received an expired dose of Havrix vaccine, which had led to expired vaccine used.  At the time of reporting, the patient had received the second dose of the Havrix vaccine later than the recommended interval, which had led to lengthening of vaccination schedule. This case was linked with US2023021173, reported by the same reporter.; Sender's Comments:  US-GSK-US2023021173:Same reporter - female patient
No adverse event - just received vaccine that he should not have received. He should have gotten the Pneumovax23 and instead got PREVENAR 13.
Baby has rash at left leg before the vaccine shots, then 2 hours after receiving the shot rashes were observed by mom to the face then to the whole body. Then at 8 PM baby had fever of 103.7 F. Baby was taken to clinic and treated with Benadryl. C-Pap. Baby is receiving amoxicillin for 4 days now for ear infection.
VZV--Right leg--erythema and induration--28mm X 22 mm with bruise at 1609. MMR--Left leg--19mm X 21mm at 1609. No respiratory distress noted. Observed until 1620 and released. A follow up report received 9/18/2002 adds: Child's legs had resolved when checked in ofice 3 days later. No meds, only observation.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On an unknown date the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 that had been improperly stored (dosage, route and lot# not reported). No adverse effects reported. The outcome of event was unknown. Additional information has been requested.
PARESTHESIA; WEAKNESS IN LEGS; This spontaneous report received from a consumer concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-APR-2021, the subject experienced weakness in legs. On 18-APR-2021, the subject experienced paresthesia.  Treatment medications included: methylprednisolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paresthesia, and weakness in legs. This report was non-serious.
I have had Crohn's Disease since 1978, almost 43 years. I had a right hip replaced on 7/10/20, and my left hip replaced on 10/16/20. After my first vaccine, right arm on 2/18/21, my arm hurt horribly for at least a week. I also had severe pain, muscularly, in my left hip area for about 5 days. It was very difficult to walk. After my second vaccine, left arm on 3/19/21, my arm did not hurt at all, but I had the same hip pain as mentioned above, for about 3 days this time. I also had a horrific headache (only after the second shot) for at least 24 hours.
Developed a Right lower extremity deep vein thrombosis, and bilateral pulmonary embolism
Swelling, redness, warmth, vomiting, redness from shoulder to about an inch above elbow as of right now
She reported that she began experiencing chills, muscle aches and respiratory symptoms last night.  She went to see her physician today and was given a Covid test.  Her results will probably not be in until next week
On day after vaccines, infant developed erythema multiforme like rash on face, trunk, and extremities. no fever, no uri sxs. No h/o fever blisters. no mucus membrane involvement. He was treated with Benadryl.
Rash all over the body; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of RASH (Rash all over the body) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced RASH (Rash all over the body). At the time of the report, RASH (Rash all over the body) outcome was unknown. 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 used unspecified allergic medication as treatment for symptoms.
Duull, achy pain from scapula to wrist. Noticeable, palpable lump at site of injection. No redness, streaking or bruising
Pain to left thigh and thigh area. Stiffness. Increased over all pain to body. No redness. 2-3 doctor visit and one emergency visit. Reduce fitness class to just mat pi and the stopped all fitness class. Warm water therapy pool exercises currently  about one hour ever other day. Lately added time hot pool (tub) to relax body.
Fever - Unverified by Medical Treatment Facility Dizziness Sitting & Standing Vomiting Psychosis - Inability to Communicate Properly Major Anxiety Allergic Reaction - Unverified by Hospital CT - Scan Not Performed Psychological Evaluation Not Performed
injection site was red ,  hot and swelled  for 10 days, on day 6 rash appeared  and was itchy .  Took antihistamines (zyrtec)for 4 days rash ,itchyness  and swelling subsided.
Vesicular rash in clusters on left upper arm in area where MENACTRA and TRUMENBA vaccines were administered on 05/04/2018. Differential might be herpetic rash, skin reaction to secondary to immunizations, pohtodermatitis.
Fever over 102, whole body aches and weakness, nausea and vomiting, headache, sore throat, injection site pain that radiates into a sharp pain across my back.  These symptoms are not mild like everything online says and were way worse than expected.  I don't remember the last time I was ever this sick.
Fever 103.9. MOTRIN 400mg q 6-8h pm.
Gave birth on the 6th of August, 10 days after the vaccination at 37 weeks 0 days.
At 1545 patient c/o tingling lips.  At 1600 patient c/o trouble swallowing and Epi 0.3mg administered at 1605 in R thigh.  At 1613 patient reported trouble swallowing wasn't improving, 25mg po Benadryl given without difficulty and 911 called.
Body aches and fever of about 99.5 the next day.  General fatigue and some nausea.
Hardened, swollen, red, sore reaction at injection site. Approx 2? diameter
Information has been received from a Licensed Practical Nurse referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored VAQTA (lot # M021124 with expiration date 02-FEB-2018, strength 25/0.5 (unit not provided), lot# M022531 with expiration date 23-FEB-2018, dose and route were not reported). There was no previous temperature excursion. Digital data logger involved. The vaccine had been stored under the lowest temperature of 0.8 Celsius degree for cumulative 2 hour and 41 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
During 15 minute observation period after vaccination, person asked to use the restroom where he was escorted to the restroom.  En -route, he blacked out and fell into the wall and onto the floor.   Immediately responsive to verbal stimuli and assisted to room for assessment. VS stabilized after 5 minutes and he was alert and oriented.  Later admitted previous similar episode from receiving a vaccine. Refused further care and returned to normal state after monitoring.
Patient complained of tingling in and around the mouth ten minutes after receiving her Pfizer Covid 19 Vaccine booster dose. Patient has experienced reactions to previous first and second doses of Pfizer Covid 19 Vaccine, but was told after being seen  by medical staff that she did not experience an anaphylactic reaction. Her physician advised her to continue on with the series and to bring her prescribed Allegra 180mg to take. Patient refused any other pharmaceutical intervention. Patient vitals collected, water and ice pack provided, staff closely observed patient for 30 minutes before patient voluntarily left stating her symptoms had improved.
fever 104;shaking-questionable febrile sz called same by fire dept witness;shrill loud unconsolable crying
Information has been received from a physician concerning an approximately 12 months old patient, with no known medical history, who on approximately 19-AUG-2011, was vaccinated with a dose of RECOMBIVAX HB Lot number 0596A is an invalid lot number for RECOMBIVAX HB (route not reported) 0.5 ml. Concomitant therapy included PENTACEL. The physician reported that on approximately 19-AUG-2011, the patient experienced a high fever lasting more than 24 hours. The patient did not seek medical attention and was not given any treatment for the event. No laboratory tests were performed. On an unspecified date, the patient was recovered. This is one of several reports received from the same source. Additional information has been requested.
Same day, was shaking and had fatigue. Next day, extreme fatigue and weakness. Next day felt sick, weakness, slight shaking. Coming back,  to work, feel nauseous and foggy minded.
Swelling and bruising of the joint at the base of the  little toe on the right foot. Pain lasted approximately 12 hours. Bruising lasted about 7 days. The joint still feels tender when walking 12 days later.
Eyes burning and swollen Heat and dramatic swelling at injection site ace swollen  Prednisone 10 mg qd x 3 days
14JUN94 pt c/o weakness, sweating, joint pain, fever 103 orally & passed out for 20 mins; c/o nausea, aching had 12x18mm pinkish red-purple lesion on rt deltoid area approx 3" from inject site;
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE PERICARDITIS, UNSPECIFIED MYOCARDITIS 12/22/2021 -- RECURRENCE OF SAME SYMPTOMS
Information has been received from a physician's assistant concerning an 18 month old female who on 09/09/2004 was vaccinated with a dose of varicella virus vaccine live.  Subsequently, in 2004, the patient experienced breakthrough chickenpox with about 10 lesions.  Unspecified medical attention was sought, no hospitalization was required and at the time of this report the patient's status is unknown.  No product quality complaint was involved.  Additional information has been requested.
Developed a large amount of swelling in the armpit of the arm the injection was made.  Less than 24 hours later developed chills, sweat, aches and pain.  By 30 hours after the injection I developed pain in my lower back that spread to my right ground.  In 48 hours I was now experience excruciating  pain in my groin with a constant and intolerable pain down my leg into the knee area which continued for hours.  I was unable to find a position of comfort and was taken to the ER .  I was immediately given a morphine drip which was not successful and then administered Dilaudid for the pain which was able to calm it down but not end it.  At the time of this writing (About 72 hours after 2nd injection) I am unable to stand or walk without pain in my groin and knee area.  Part of my thigh and Knee are have developed numbness and extreme discomfort.  I can finally only sit with much pain.  This Moderna Vaccine was administered through my employer.
SHORTNESS OF BREATH; NOT BEEN ABLE TO WORK; DRY COUGH; VOMITING; DIARRHEA; NAUSEA; FATIGUE; ARM SORENESS; REDUCED APPETITE; FEELING WORSE; VACCINATION REACTION; SHOULDER SORENESS; BODY ACHES; MILD FEVER/FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. 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 14-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-JUL-2021, the patient experienced body aches. On 14-JUL-2021, the patient experienced vaccination reaction. On 14-JUL-2021, the patient experienced shoulder soreness. On 14-JUL-2021, the patient experienced mild fever/fever. On 16-JUL-2021, the patient experienced reduced appetite. On 16-JUL-2021, the patient experienced feeling worse. On 16-JUL-2021, the patient experienced arm soreness. On 16-JUL-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 99-100.4. On 19-JUL-2021, the patient experienced dry cough. On 19-JUL-2021, the patient experienced vomiting. On 19-JUL-2021, the patient experienced diarrhea. On 19-JUL-2021, the patient experienced nausea. Laboratory data included: Body temperature (NR: not provided) 99-100.6, and COVID-19 virus test (NR: not provided) Negative. On 29-JUL-2021, the patient experienced shortness of breath. On 29-JUL-2021, the patient experienced not been able to work. Laboratory data included: Blood test (NR: not provided) Negative, COVID-19 virus test (NR: not provided) Negative, and CT scan (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shoulder soreness, mild fever/fever, body aches, arm soreness, fatigue, reduced appetite, dry cough, nausea, vomiting, diarrhea, shortness of breath, not been able to work, feeling worse, and vaccination reaction. This report was non-serious.
Pt. with weakness and GI bleed.  Admitted to hospital after being seen in the ER
Influenza shot given 10/05, a viral process with bronchitis starting 10/05 & continuing till 10/14, when a gastrointestinal process started. This continued until admitted to Stringfellow Hospital by Dr. PT evaluated when admitted 10/27/07 for c/o ascending numbness in feet by Dr. Given Immunoglobulin x5 days after + Spinal Tap for protein. Not at present--still has numbness in feet. 11/26/07-records received for DOS 10/21-10/26/07 DC DX: Guillain-Barre syndrome, status post intravenous IgG therapy. Presented to ED with C/O right lower extremity and right upper extremity numbness associated with facial numbness that started distally and was progressing centrally. Per 60 day follow up: "Still have residual weakness and numbness in right leg."
Red rash the size of a lemon, hot to the touch, lasted 9 days. Then took 1 Benedryl and it subsided. Gone after 11 days.
Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant in the US (UT) reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. This report is for patient 10 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 10 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Burny; Redness; Feels bumpy underneath the injection site; Quite warm; Arm soreness; Itchiness in the injection site; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), FEELING HOT (Quite warm), THERMAL BURN (Burny), ERYTHEMA (Redness) and VACCINATION SITE MASS (Feels bumpy underneath the injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE, PROPRANOLOL, CLOZAPINE and ZOLPIDEM for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and VACCINATION SITE PRURITUS (Itchiness in the injection site). On 13-Mar-2021, the patient experienced FEELING HOT (Quite warm), ERYTHEMA (Redness) and VACCINATION SITE MASS (Feels bumpy underneath the injection site). On an unknown date, the patient experienced THERMAL BURN (Burny). At the time of the report, PAIN IN EXTREMITY (Arm soreness), FEELING HOT (Quite warm), THERMAL BURN (Burny), ERYTHEMA (Redness), VACCINATION SITE MASS (Feels bumpy underneath the injection site) and VACCINATION SITE PRURITUS (Itchiness in the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were reported.
Fever 100-101, vomiting starting approximately 12 hours after vaccines, vomiting lasted approx. 12 hours no treatment other than oral rehydration and TYLENOL/MOTRIN was needed.
flare-up of Herpes; tender at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex (flare-up of a pre-existing case of Herpes on her lower back).   On 13th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 13th August 2021, less than a day after receiving Shingrix, the patient experienced injection site tenderness. On 15th August 2021, the patient experienced herpes simplex aggravated. On an unknown date, the outcome of the injection site tenderness and herpes simplex aggravated were not recovered/not resolved.   It was unknown if the reporter considered the injection site tenderness and herpes simplex aggravated to be related to Shingrix.  Additional details provided were as follows: This case was reported by patient himself/herself. The patient received dose of Shingrix in left arm and stated that her arm was tender at the injection site from the day she received the Shingrix. Patient also experienced a flare-up of a pre-existing case of Herpes on her lower back. The patient was referred to health care professional. The patient did not gave permission to contact.
Fever; chills; aches; headache; sinus pressure; diarrhea that lasted 5 days; This is a spontaneous report from a contactable other HCP (patient). A 29-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0169), via an unspecified route of administration, administrated in Right arm on 20Aug2021 11:15 (age at the time of vaccination 29-years-old), as a single dose for COVID-19 immunization. The patient's medical history included COVID, covid prior vaccination. The patient's concomitant medications included gabapentin, Metformin, Effexor xr, and Birth control. No other vaccine in four weeks. No covid tested post vaccination. No known allergies. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0158), via an unspecified route of administration, administrated in Right arm on 30Jul2021 14:00 (age at the time of vaccination 29-years-old), as a single dose for COVID-19 immunization. On 21Aug2021 12:00, the patient experienced Fever, chills, aches, headache, sinus pressure, and diarrhea that lasted 5 days. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient took Tylenol and immodium for the treatment of adverse events. The outcome for all the event was not recovered.  Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected.
11cm x 6cm painful erythematous plaque at vaccination site. Mildly pruritic. No systemic symptoms. Treated with ice, ibuprofen, and diphenhydramine.
Patient was asked to come back in one week instead of 1 month; This non-serious case was reported by a nurse via sales rep and described the occurrence of drug dose administration interval too short in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO).   On 18-JUL-2023, the patient received the 2nd dose of Bexsero. On 18-JUL-2023, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: Patient was asked to come back in one week instead of 1 month). The outcome of the drug dose administration interval too short was 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: 18-Jul-2023 The patient was asked to come back in one week instead of 1 month and staff did not realized until after patient was vaccinated. The reporter did not consent to follow-up. The patient received 2nd dose of Bexsero earlier than the recommended interval, which led to shortening of vaccine schedule.
Left upper arm swollen and red and warm. Erythema multiform and urticaria pruritus.