chrisvoncsefalvay/vaers-outcomes huggingface dataset:
two Fluzone Quadrivalent doses were given to a 21 month old child 5 days apart/ no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (MI) (Reference number- 00337530 ) and transmitted to Sanofi on 29-Oct-2020.  This case involves a 21 months old male patient who received two doses of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (strength- standard, presentation- multidose vial) 5 days apart on 24-Oct-2020 ( lot number UJ477AC expiration date: 30-Jun-2021) via intramuscular route in the right thigh and again on 29-Oct-2020 (lot number UJ452AB expiration date: 30-Jun-2021) via intramuscular route in the left thigh for prophylactic vaccination (Extra dose administered).  It was reported as the patient had received 2 doses of vaccine last year.  Medical history, medical treatments, and family history were not provided.  Concomitant therapy was reported as none on 24-Oct-2020 and Hepatitis A vaccine on 29-Oct-2020 (batch number and dosing details not reported) for prophylactic vaccination .  It was a actual medication error due to Extra dose administered.  It was reported as the patient was supposed to get only one dose this year. Reported wanted to know about to side effects if any to look for.  At the time of this reporting, patient had no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Expired Twinrix vaccine administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 48-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th January 2023, the patient received the 2nd dose of Twinrix 1 ml and Twinrix Pre-Filled Syringe Device. On 4th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 11-JAN-2023 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the patient received an expired dose of Twinrix vaccine on 4th January 2023. The reporter stated that the Twinrix vaccine was expired on 1st January 2023. The vaccine administration facility was the same as the primary reporter. The reporter did consent to follow up. Additional supportive information: The patient received a Twinrix which was already expired, which led to expired vaccine used.
WHOLE BODY SORE; WEAK; 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced whole body sore, and weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the whole body sore and weak was not reported. This report was non-serious.
Johnson & Johnson COVID-19 Vaccine EUA Patient is a 36 year old female who was in her usual state of health until 4/13 where she went to urgent care and received antibiotics and diagnosed with a UTI. She went to the Emergency department on 4/14 for bilateral lower extremity weakness and urinary retention. Approximately 1 liter of urine removed by foley catheter. PMH of oophrectomy and migraines. Patient reported she received J&J vaccine approximately 12 days prior (~ 4/2/2021). MRI findings of acute transverse myelitis of unknown etiology. Urinary retention likely due to neurogenic bladder from spinal lesion. Three of 5 plasmapheresis sessions have been completed.Patient has been treated with methylprednisolone 1g every 24 hours (4/15-4/18).  Patient has been able to walk with physical therapy. Patient still in the hospital. Discharge plans for either home or rehabilitation program
Caller stated that on 8/19/2020, the patient was administered improperly stored V ARlVAX (reconstituted with properly stored Merck STERILE DILUEN); This spontaneous report was received from a registered Nurse referring to a 5 years old female patient. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.   On 19-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002848, expiration date 23-JAN-2022 for prophylaxis (reconstituted with properly stored Merck sterile diluent) lot # S008566 expiration date 16-NOV-2021 (dose, frequency and route of administration were not reported) (Product storage error).  The improperly stored suspect vaccine experienced multiple temperature of - 14 Celsius degrees (°C) to 10°C (average -12.1°C) for 3 hours (multiple excursions); -9°C to 8°C ( average -7.5 °C )  for 8 hours and 30 minutes (multiple excursions).  The call was made due to a digital data logger. No previous temperature excursion was reported.
off label use; Dose: 3; Date: 29Oct2021; Tinnitus in the right ear, still ongoing after 1 week; This is a spontaneous report from a non-contactable consumer (patient).   A 48-years-old non-pregnant female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 3 via an unspecified route of administration, administered in Arm Left on 29Oct2021 (at the age of 48-Years-old) (Lot Number: FG3529) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. (Booster and off label use). The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 21Mar2021 (at the age of 47-Years-old) (Batch/Lot Number: ER2613) as DOSE 1, SINGLE for covid-19 immunisation and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 (at the age of 47-Years-old) (Batch/Lot Number: E0102) as DOSE 2, SINGLE for covid-19 immunisation and experienced Migraine headaches on day 2 and Severe vertigo approximately 5 days after. On an unknown date in 2021, the patient experienced tinnitus in the right ear, still ongoing after 1 week. The event resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Seriousness was reported as non-serious. At the time of this report, the outcome of event tinnitus was not recovered.  No follow-up attempts are possible. No further information is expected.
Patient received a bivalent dose for his 1st dose in the primary series. Was charted as a 5-11 peds dose because that was what was on the patients covid card. Parent has been spoken to and advised patient will have to come back in for his primary series doses.
Patient claims she felt pain and limited range of motion that is ongoing that she believes is caused by the immunization.
localized reaction to infection site, redness, itching , warmth, swelling x 7 days Felt confused/ head fog x 4 days post shot
Vaccine given Tuesday (07/22/08).  Father noticed hives, swollen eyes early Thurs. morning (07/24).  Given ZYRTEC & BENADRYL.
Headache, Myalgia & NauseaVomiting Narrative: nauseous, headache, body aches.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccine on 05/20/2021 and 06/17/2021. Presented to ED on 8/14 with complaints of shortness of breath and coughing. Noticed symptoms of chills, nausea, and abdominal pain on 8/11.  In ED pt was febrile, tachycardic, and tachypneic. CXR showed bilateral infiltrates. Patient required HFNC at 75-90% and Non-rebreather. Patient was proned. During stay, patient received zosyn, vacomycin,prednisone, ceftriaxone, and decadron. Renal disease precluded use of remdesivir.  Patient continued to decline and expired on 8/28/21.
My tongue started having a strange tingly sensation.  Slight metallic taste.  This also occurred after my second dose.  Sensation went away over the course of a couple of hours.
Large red area on arm; Large painful area on arm; This case was reported by a consumer via sales rep and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities and pain in arm. On an unknown date, the outcome of the erythema of extremities and pain in arm were unknown.   It was unknown if the reporter considered the erythema of extremities and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was unknown, but patient's age was about over 50 year. The patient received Shingrix in an unknown arm. After receiving Shingrix, the patient had a large red painful area from shoulder to almost elbow and it was unknown on which arm. The reporter did not agree to follow up from GlaxoSmithKline.
10/1/09 afternoon developed swelling, heat and redness at site of injection. Feels general mailaise, sinus tenderness,L arm feels heavy and painful.Erythema and induration L upper arm at site of injection. One small blister at injection site.Is using ice at site of imflammation. To force fluids, use antipyretics and started on cefzil. diagnosis cellulitis/vaccine reaction moderate.
Dizziness when getting up after lying down. Did not have prior to receiving the vaccine. It continues to occur every day.; This is a spontaneous report from a non-contactable nurse (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: Eh9899/expiration date unknown), via intramuscular route of administration, on 24Dec2020 at 07:15 AM (at the age of 67 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included hypertension and known allergies to chocolate, strawberries. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Ramipril, Atorvastatin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Ramipril, Atorvastatin within 2 weeks of vaccination. On 25Dec2020, at 07:00 AM, the patient experienced dizziness when getting up after lying down which she did not have prior to receiving the vaccine. It continues to occur every day. No treatment was received for the event dizziness when getting up after lying down. The outcome of the event dizziness when getting up after lying down was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
Injected vaccine that was prepared into syringes that may be expired based on 5 hour rule
had Shingles after having the vaccine/ suspected vaccination failure; Shingles around eyes; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included cancer.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had Shingles after having the vaccine/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles around eyes). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-APR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced Shingles so it was not horrible. The patient stated that the shingles are around his or her eye so that was scary. The patient reported that the cancer treatment was the most painful and it goes on for months. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
In all 4 covid vaccines I had severe Rheumatoid arthritis flares that lasted for 2 weeks each; bad headaches; bad nausea; extreme fatigue; no energy; bad pain at injection sites; joint pain throughout my body.
Left shoulder injury.  Unable to reach behind back with left arm. Started approximately 2/4/21.  Still have pain & hard to reach behind back on 2/14/21.  Noticed small dime-sized red spot on left shoulder on 2/11/21. On 2/14/21 red spot had grown to approximately 3 1/2? long & 2 1/2? wide.  Is warm to the touch, but doesn?t seem to be swollen & not painful.  Intermittent problem finishing a sentence without taking an additional breath.  Started about 2/5/21. Not sure if heart murmur is related.
Out of work two days.  11-13-09 - Pain in arm and tiredness.  11-14-09 - Body aches, tiredness - arm soreness.  11-15-09 - stomach ache, tiredness, body aches, arm soreness.  8:30-9:00 PM - Nausea, stomach ache, tiredness, chills (hot to cold), vomiting - called EMS - weakness, out of work for two days - to weak to work.
On Saturday, September 18th, I started experiencing what felt like heart palpitations in the mid-afternoon. I only felt a few at that point, so I was not concerned. On Sunday, September 19th, I felt the palpitations were becoming more frequent and thought about reporting to the emergency room at that time, but chose not to as my only symptom was the heart palpitations. After these same events occurred on both Monday, September 20th and Tuesday, September 21st, I decided to call my doctor who encouraged me to go to the emergency room. On the EKG monitor, PVCs were recorded and I was then made an appointment to go to the cardiologist after I was discharged from the emergency room (the appointment was made for 15 minutes after my discharge time). I was then set up with a holter monitor. The holter monitor did pick up additional abnormal activity which is why I was referred to get an echocardiogram after the test was resulted. I am still in the middle of this process of getting a diagnosis, I will be seeing a cardiologist as well as my primary doctor for this issue that is still continuing almost 60 days after my first initial covid vaccine. Current, my diagnosis is a new onset of heart palpitations
Patient developed 103 Fever 12/08/2017. Cephalexin prescribed 12/12/2017. Patient has red area with undefined shape for past week.
Pfizer 4/22 and 5/13. Positive on 12/10
Feeling inflammation in back, stomach, neck, lymph nodes aching/hurting and headache on left side all after 4 days to current.
In about 12 hrs I felt fevered,  then went to cold, then I started trembling.  So hard, I still felt cold, but this wasn?t shivering,  I wanted to go to get in warm water.  I was shaking so bad I couldn?t take my clothes off.   I got in with clothes on, I was getting delirious.   My whole body was contracting so hard I couldn?t sit in the tub flat, my but cheeks contracting with all muscles.   I found myself in the night with a sticking hat soaked in water to cover my face.  I could not have called for help when the muscle contractions  were going on.  That lasted I think 30-45 minutes.  I was groggy on the 20th all day but getting much better.   I was very excited for vaccine and would do it again, but wanted to report what I consider pretty rough side effect, so you could make note of it. And I still thank you for the vaccine,  but dang I truly thought I was dying.
measles type rash; This spontaneous report was received from an office manager via company representative referring to a non-pregnant female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) at a local health department for prophylaxis.         On an unknown date in August 2022, the patient experienced a measles type rash. No treatment was given for the event. The outcome of the event was unknown.       The causality between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
Ankle Swelling; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Ankle Swelling) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 031B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced JOINT SWELLING (Ankle Swelling). At the time of the report, JOINT SWELLING (Ankle Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment product details not provided.
Extreme pain X 8 hrs at right shoulder to arm, could not raise arm. Better now - No nausea.
Lips, eyelids, and ears swelled. Palms and soles of feet became very itchy (used ice packs for relief). Ringworm type of rash spread over body since May 2021.
Sore arm 2 days after vaccine with red rash.  Soreness and itching on arm on day 3
Mild case of shingles, tiny vesicles on flank area, rash & itching at site of reaction. Showed up the following 2 weeks, received triamcinolone 0.5% cr. on 6/5/12.
Experienced blindness after first shot in right eye after first shot; TIA; headaches; This is a spontaneous report from a contactable consumer.  A 70-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in  the left arm on 21Jan2021, 13:00 (Batch/Lot Number: EL 3249) as a single dose for covid-19 immunization. The patient's medical history included diabetes from an unknown date and unknown if ongoing. The patient was generally in good health. Concomitant medications included apixaban (ELIQUIS); pravastatin (PRAVASTATIN); and vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) all taken for an unspecified indication, start and stop date were not reported. The patient previously took morphine and ceclor and experienced allergies. On 24Jan2021 at 13:00, the patient experienced blindness after first shot in right eye after first shot for about 20 minutes (Most likely a transient ischemic attack (TIA)). Have had headaches every day since the first shot. The patient underwent lab tests and procedures which included negative test for Covid-19 on 11Feb2021 (via nasal swab). The outcome of the event was not recovered.
No additional AE reported; an expired dose of GARDASIL 9 was administered to a patient; This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 18-JAN-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml, lot # S010729; expiration date 01-DEC-2021; strength, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). It was confirmed that the expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) did not experience a temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) was reported.
Began with pinkish neck and chest approximately 15 minutes post vaccine administration.  Within 10 minutes of further observation, more reddened splotches noted on chest, and c/o tightness in chest.  Taken to ED via wheelchair immediately.  Treated with Benadryl, solumedrol and famotidine.  Pt discharged to home within 2 hours.
PATIENT HAD NO ADVERSE REACTION VACCINE WAS ADMINISTER TO PATIENT UNDER AGE OF 18 PATIENT WAS 17 YEARS OF AGE
Patient in office for Moderna Monovalent #1 for ages 6mo-5yr.  Moderna Bivalent for ages 6mo-5 yr was given instead.
Rash; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and FATIGUE (Fatigue) 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 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 RASH (Rash) and FATIGUE (Fatigue). At the time of the report, RASH (Rash) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.