chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant refers to unspecified patients of unknown age and gender. No relevant medical history of the patients was reported. On 19-MAY-2014 the unspecified patients were vaccinated with 5 doses of PEDVAXHIB, intramuscularly (strength, dose, lot number and expiration dates were not reported). No concomitant medications were reported. It was reported that these vaccine doses had reached a low temperature of 32.9 Fahrenheit for 9.5 hours and were supported. No adverse effects were reported. There was no product quality complaint involved. The outcome was unknown. This case is linked to Case # 1405USA014111, Case # 1405USA014112, Case # 1405USA014113 via the same reporter link. Additional information has been requested.
Information has been received from a physician concerning a 10 year old male who was vaccinated with one dose of hep b vaccine recombinant. Approximately two weeks after the vaccination, the child developed an unexplained case of hives over his body. Unspecified medical attention was sought. Additional information has been requested.
Pain in arm; decreased range of motion in the arm; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number G7KX2, expiry date 31-MAR-2024) for prophylaxis.   Previously administered products included Bexsero (1st dose received on 9th February 2023.). Additional patient notes included patient did not had a history of arm pain.   On 16-OCT-2023, the patient received the 1st dose of Bexsero (left arm) .5 ml. In OCT-2023, 1 week after receiving Bexsero, the patient experienced pain in arm (Verbatim: Pain in arm) and mobility decreased (Verbatim: decreased range of motion in the arm). The outcome of the pain in arm and mobility decreased were not resolved.   The reporter considered the pain in arm and mobility decreased to be possibly related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the pain in arm and mobility decreased to be possibly 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: 25-OCT-2023 It was stated that the patient received 2nd dose of Bexsero and on the day of the visit did not had any other complaints, nor did she receive any other vaccines during the visit.  The healthcare professional did not know when the adverse event began following vaccination, but said one week later, the patient called complaining of arm pain and decreased range of motion. The patient made an appointment to see the physician on 26 october 2023. The adverse event had not resolved. When asked, the healthcare professional said she thought this adverse event was likely due to the vaccine and would categorize it as moderate severity since it had lasted so long. The patient did not had a history of arm pain. This case was linked to US2023AMR148934, same reporter.; Sender's Comments:  US-GSK-US2023AMR148934:Same reporter different patient
Approximately 45 after injection a migraine began with visual disturbance. Wavy lines across field of vision obscuring eyesight. This was accompanied by fatigue. That night racing thoughts throughout the night. I felt as if I was awake all night cataloging my daily life. The following day only sore muscles and muscle weakness in left arm.
Fatigue for the first few weeks, panic attacks, low body temperature, difficulty swallowing, unable to digest food properly, regurgitation, circadian rhythm disorder symptoms, shortness of breath, extreme irritability, constant headache and head feeling heavy, weakness, eyes became sensitive to light, blurry vision, dizziness.  8/11/09 PCP records received.  Seen 8/27/07 with c/o panic attack sx since 8/8/07 :tachycardia, difficulty swallowing, scared, throat tightness, also feeling sleepy, cold and with tightness in neck and shoulders.  Assessment:  Panic attacks, tachycardia, constipation.  Encouraged meds for anxiety.
pt recv vax 23JUl & exp extensive urticaria, fever, anxiety & marked orthostasis latter initially refractory, despite 4 liters; hospitalized & placed on hydrocortisone, DPH, Zantac & Epi
Moderna 100nRNA  Lightheaded, fever for 3 weeks, pins and needles in left arm, leg, cheek.
Patient immediately felt light headed and hands started shaking.  She ate a banana and drank orange juice.  B/P 118/72, HR 80, Oxygen Saturation 98%.  Patient laid down on a cot for 30-45 minutes before going home.
asthma attack/ prednisone-requiring exacerbation following administration of Shingrix; This case was reported by a physician via call center representative and described the occurrence of asthmatic attack in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma and immunosuppression.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced asthmatic attack. The patient was treated with prednisone. On an unknown date, the outcome of the asthmatic attack was recovered/resolved.   It was unknown if the reporter considered the asthmatic attack to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-March-2022 and 24-March-2022 Additional Supportive Information: The age at vaccination was not reported. The patient was in his 60's. The patient's age and initials, date vaccine given, batch and expiration was unknown. The patient was a known asthmatic. The physician stated that a patient in received his dose of Shingrix several years ago and had an asthma attack (severe, prednisone-requiring exacerbation) and now a similar occurrence after third Covid vaccine dose.  Duration of effect was known. The patient was immunosuppressed and a fourth booster of Moderna was now recommended.  The patient was hesitant to receive because of reaction to last Covid dose. The physician had nothing else to report. The reporter had limited information at the time of reporting. The physician was trying to determine if there was a common ingredient between Shingrix and Moderna Covid vaccine. The components of the latter were listed on website, but physician unable to locate component list for Shingrix. The physician was asking for help and asking if we aware of any similar components between the two vaccines. The reporter consented to follow up.
Information has been received from a Licensed Practical Nurse concerning a female patient who was vaccinated with 2 doses of ROTATEQ (lot # not reported) when she was 2 months at the first dose and was 4 months old at the second dose. No other co-suspects were reported. No concomitant medications were reported. Nurse informed that after each dose, the patient developed symptoms of reflux disease. The patient did not finish the third dose in the series and the symptoms resolved after dosing. Additional information has been requested.
This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave a Moderna 2nd dose and the vaccine expired yesterday) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave a Moderna 2nd dose and the vaccine expired yesterday). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Gave a Moderna 2nd dose and the vaccine expired yesterday) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided. It was reported that the vial was initially stored in the refrigerator on 08-Oct-2021 and did not undergo any temperature excursions. The reporter wasn't sure if they had concomitant medications but saw that they marked "no medical history" on the form
Patient received an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A, 001C21A and 020C21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, TERBINAFINE, HYDROCHLOROTHIAZIDE and FLUTICASONE for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. On 07 December 2021 the vial was taken out of freezer and placed into fridge. Expiry date of vaccine was on 06 December 2021. It was unknown that if patient was experiencing any symptoms.   This case was linked to MOD-2021-408558, MOD-2021-408476, MOD-2021-408490, MOD-2021-409258, MOD-2021-408598, MOD-2021-408547 (Patient Link).
22OCT91 non productive cough & irritability; 23OCT91 pulling @ ears in PM; 24OCT91 sz in AM, lasted 1-2 mins, t100 ax; seen @ hsop admitted for observation x 1 day; dc'd 25OCT91 12PM;
Large (3 cm) painful supraclavicular lymph node on the left side.  Same side as vaccine given.
Patient returned to vaccine clinic at 11:47 a.m. and stated she had chest pain, that was 6/10 under right breast. RRT called. VS obtained. B/P 121/71 P 78 R 18 O2SATS 99%RA. RRT arrived and patient was agreeable to got to ER for evaluation. Patient remained alert and verbal. Patient was later discharged from the ER.
Developed Bell's Pausly after third (booster) Maderna shot.  Patient has never tested positive for moderna nor had the virus, but completed all three Moderna shots.  1. Moderna 01/09/21.  2. 02/06/2021  3.  01.13/2022.  Experienced flu/cold ;like symptoms (worse reaction of the three) with booster Moderna shot.
NO ADVERSE EVENT OCCURED.  DOSE WAS DRAWN UP CORRECTLY (0.5ML.)  THERE WAS A MALFUNCTION OF THE SYRINGE/NEEDLE.  MOST OF THE DOSE WAS EXPELLED DOWN THE ARM OF PATIENT.  THE NEEDLE DID PENETRATE THE ARM.  THERE WAS NO WAY OF KNOWING HOW MUCH ACTUALLY WENT INTO THE PATIENTS RIGHT DELTOID.   MY RECOMMENDATION WAS THAT MOST DID NOT GET IN THE MUSCLE.  MOM DID NOT WANT US TO REDOSE UNTIL SHE HAD A CHANCE TO DISCUSS WITH PEDIATRICIAN.  SHE WILL BE IN CONTACT WITH ME ON MONDAY 11/6/2023 TO GIVE ME A NAME OF A PEDIATRICIAN TO CONTACT AT HOSPITAL.  PATIENT WAS VERY NERVOUS AND TENSE BEFORE GIVING THE VACCINE AND BOTH PARENTS WERE ATTEMPTING TO HOLD PATIENT WHILE THE SHOT WAS ADMINISTERED.  THE ISSUE SEEMED TO BE A FAULTY SYRINGE/NEEDLE.  WE WERE NOT AWARE OF HOW MUCH OF THE VACCINE WAS ACTUALLY GIVEN THROUGH THE IM NEEDLE.
Injection site became swollen; Joint pain; Chills; Fever up to 100.8; Hive covering the entire site; Tiredness; Joint stiffness; Injection site became warm; Injection site became red; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208) via an unspecified route of administration in the left arm on 01Apr2021 at 12:30 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included high BP (blood pressure high), cholesterol, osteoarthritis, asthma, allergies to cats, molds, trees, grasses, pollen and ragweed. Concomitant medications included triamterene (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN), latanoprost (MANUFACTURER UNKNOWN) and colecalciferol (VITAMIN D3), all started from an unknown dates and for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6204) via an unspecified route of administration in the left arm on 11Mar2021 at 09:30(at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient previously received simvastatin (ZOCOR) and hydroxyzine hydrochloride (VISTARIL) on an unknown date and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 01Apr2021 at 14:30 two hours post injection, the patient's injection site(vaccination site) became red and warm. On 02Apr2021 at 12:00 approximately 24 hours post injection, the patient developed joint pain and stiffness, chills, fever up to 100.8, tiredness, injection site swollen(vaccination site swelling)and had what appears to be a hive covering the entire site, approximately 6 inches diameter. The patient did not receive any treatment for the reported  events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests on 02Apr2021 which included body temperature and the result was temperature of 100.8(unspecified units). The clinical outcome of the events injection site warm, injection site red, injection site swollen and hive was not resolved at the time of this report, while that of joint stiffness, joint pain, chills, fever up to 100.8 and tiredness was recovered on 03Apr2021 at 12:30.   No follow-up attempts are needed. No further information is expected.
urticaria onset < 48 hours after vaccine administration; no systemic signs; went to ER on 6/20; follow up office visit 6/23. Treated with benadryl and claritin and referred to pediatric allergy
Severe dizziness, weakness, lethargy and loss of appetite.  Dizziness continued for two days.  26 hours after injection, one welt appeared 2 inches below injection site.  Within minutes, several welts began to appear.  Arm began to throb and became hot to the touch.  Visited Urgent Care, was told the welts were "droplets of medicine under the skin." By the next morning, welts had formed into four large bands around arm, and arm was swollen, hot, and hurt from shoulder to elbow.  Visited ER, blood work-up was done, no infection found, doctor concluded the welts were just a bad reaction to the vaccine itself.  Patient is still dizzy and weak more than two days after the injection.
Fullness in head feeling, lack of balance, room spinning, slight ringing in ear. Symptoms were moderate to slightly severe. Lasted approximately 1.5 weeks in full force 24-7. Starting to finally taper off now, but still have somewhat heavy head feeling. Lack of balance has not been an issue the past 3 days.
DEVELOPED RASH, ITCH AND WARMTH AT INJECTION SITE DAY 14 POST VACCINATION
pt recvd vax 23SEP94 & mid OCT exp swelling & joint pain in fingers & rash on lt hand;sx of itching,rash,swelling,joint pain & discoloration (redness to purple) in distal phalanges of both hands;Raynaud's phenomenon;itching,redness
Arm pain; injection site pain; Arthralgias; Headache; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Arm pain), VACCINATION SITE PAIN (injection site pain), ARTHRALGIA (Arthralgias) and HEADACHE (Headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunosuppression.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2020, the patient experienced PAIN IN EXTREMITY (Arm pain), VACCINATION SITE PAIN (injection site pain), ARTHRALGIA (Arthralgias) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain), VACCINATION SITE PAIN (injection site pain), ARTHRALGIA (Arthralgias) and HEADACHE (Headache) had resolved.        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.   Concomitant product use included immunosuppressant medication.   This case was linked to MOD-2021-314740, MOD-2021-314741 (Patient Link).
Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 07-Feb-2022; Received its 30-days Exp date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 07-Feb-2022) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2022 at 2:36 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Feb-2022 at 2:36 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 07-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 07-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Vaccine was in thaw state (2 to 8 degree Celsius) from about 24-Dec-2021. Dose was given at 07-Feb-2022 14:36:49.  No treatment medication was reported by reporter.   This case was linked to MOD-2022-542869 (Patient Link).
Vaccination failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 13Jan2021 at 14:00 as dose 1, single (Lot number: EL3247), in left arm, on 03Feb2021 at 14:00 as dose 2, single (Lot number: EL9769), in left arm, on 23Sep2021 at 14:00 as dose 3 (booster), single (Lot number: FW0183), in left arm and on 08Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Other medical history: Hypertension; "Hypercholesterolemia" (unspecified if ongoing), notes: Other medical history: Hypercholesterolemia; "GERD" (unspecified if ongoing), notes: Other medical history: GERD. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that, the patient received Paxlovid from 20Sep2022 to 25Sep2022, (batch/lot: 6E8702) for treatment of COVID-19. The patient did not received other medication in 2 weeks. No known allergies and other medical history: Hypertension, Hypercholesterolemia, GERD.
vomiting, passing out; 5-10 min post vaccination, pt became diaphoretic, pale, thready -palpable pulse, began to lose consciousness, ems called to eval. pt. RN/EMS lowered to the floor-pt put on side and he vomited. regained consciousness after vomiting- EMS transported hospital
Cellulitis at injection site 6 x 3" 2 days after injection ER with IV fluid and antibiotic. Fever 102-103 2 days after inj. ER with 24 OBS for IV fluids. 1/24/06 Medical records reviewed stated patient experienced pain & redness at injection site, fever and was diagnosed with cellulitis.  Patient was pregnant.
On1/13/05, fever 102.7 degrees and urticaria of the right thigh,1/15/05, increasing in size until 01/17/05 when it was 6 cm in diameter.
Swelling, pain, redness, at injection site. Fatigue. Started 11 days after injection.
several, 24 hours after 1st dose sudden fatigue and muscle soreness. 36 hours after 1st dose repeat vomitting and cramps for 8 hours. 1 week after 1st dose my arm swelled, I lost some movement in are and loss of sensation in fingertips(no feeling).  16 hours after 2nd dose chills fever fatigue and loss of some movement in arm. 20 hours after 2nd dose, spontanious diahrria and vomitting.
Information has been received from a pharmacy technician reporting on her son who was vaccinated at a clinic with a dose of varicella virus vaccine live (Oka/Merck). In 1996 (11 years ago) the patient had an adverse experience with varicella virus vaccine live (Oka/Merck). A product quality complaint was not involved. This is one of two reports received from the same source. No further information is available.
Irritation of the under eyes; Irritation of eyelids; Symptoms containing redness and dryness, and slight swelling of lids.; Symptoms containing redness and dryness, and slight swelling of lids.; Slight swelling of lids; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EM9809) via an unspecified route of administration in the arm left on 10Mar2021 at 19:15 (at the age of 22-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8737) via an unspecified route of administration in the arm left on 31Mar2021 at 19:00 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. The medical history was not reported. 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 vaccination. The concomitant medication were not reported. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced allergy. On 16Mar2021, about a week after first dose, the patient experienced irritation of the under eyes and eyelids, symptoms contained redness and dryness and slight swelling of lids. It was off and on- will be very irritated for 2- 3 days, then got better before become irritated again. It was not subsided before or after the second dose. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events irritation of the under eyes, irritation of eyelids, redness, dryness and slight swelling of lids were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.