chrisvoncsefalvay/vaers-outcomes huggingface dataset:
were left out of the refrigerator, might have been administered; This case was reported by a other health professional and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number 5Z4R7, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 was provided as follows: The age at vaccination was not applicable for this report. Occupational health specialist reported that they received a new shipment of Flulaval and the vaccines were left out of the refrigerator for about 5 days, the vaccines might have been administered after this excursion, although was not completely sure and had no registration of any patients at the moment, which led to incorrect storage of drug. The reporter consented to follow up.
Case number PHEH2012US023204 is an initial spontaneous report received from a consumer (she also a nurse) on 21 Nov 2012: this case refers to a 41-years-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1206101 and expiry date: 20 Jun 2013) at dose of 0.5 ml intramuscularly on an unspecified date. On an unspecified date after vaccination, she experienced fever, chills, body aches, dizziness, pus on back of throat, runny nose, cough, sore throat and over all fever like symptoms. She was treated with ROCEPHIN and DECADRON shots. She also stated that, she was missed a day work, she felt like she couldn't breathe in the middle of the night, had still sick, fever of 103 F and extreme body aches and then she was treated with TAMIFLU. The outcome, seriousness and causality of the events were not reported.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown 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 patient experienced Shingles after the first shot. The patient asked for how long she could wait to receive the 2nd dose. The patient left the chat, before any more information could be obtained.
No additional AE/PQC; vaccine was labeled expiration date was 8/20/2020 and it was administered to patient on 8/25/2020; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On 25-AUG-2020,post expiry date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 1.0 mL, non-valid lot #S0218729 with an expired date reported on 20-AUG-2020, for prophylaxis. No additional adverse event/product quality complaint was reported.
day 1: chills, nausea, fever day 2: same as day 1  day 3: felt ok day 4: numbness in mouth, face and legs was able to get into doctor 12/23 and was diagnosed with guillain barre
Received 1st AVA 4/17/2007 with flu like s/s in 1-2 days x 1 wk.  2nd AVA 5/12/07 with same s/s X 1 wk.  3rd AVA 2/6/08 with nausea, sore throat, flu s/s, fever, sweaty, myalgia, fatigue, arthralgia, slept alot X 1-2 weeks.  PRN numbness w/wt loss, sweating, dizziness, DOE over next 6 months.  8/22-26/08 admitted w/syncopal episode, 16 secnds asystole w/sz like activity.  Still under neuro/cardiac evaluation for ?dx new onset epilepsy. 12/10/08-records received-after each vaccine C/O worsening fatigue, nauseas, felt out of it, groggy, sore throat, flu like symptoms, muscle aches, fever, numbness, weight loss, dizziness, shortness of breath. 8/21/08-C/O tingling, numbness in bilateral arms, hands, increased dizziness, nausea, headache, increased thirst and urination.Admitted 8-23-8/26/08-vasodepressor epidsode in ER 8/22/08 while having blood drawn. DX: vertigo. Two events of asystole associated with seizure-like activity both assoicated with sinus tachycardia. Vasovagal episode.9/10/08-fever, dizzy, low blood sugar, felt lightheaded/dizzy with difficulty breathing, chest pain.presented on 10/31/08 C/O recurrent scrotal pain x 1.5 months. Treated for epidiymitis. Symtpoms returned 3 days ago. DX: inguinal groin pain, scrotal pain.
Within days of receiving an injection of Flu Shield, pt developed a hypersensitivity reaction manifested by severe hives and itching.  Pt was treated with unspecified antihistamines and topical preparations and recovered in 7 to 10 days.
pt recv vax 27SEP96 & 5OCT96 pt exp a low grade fever of 100 & devel a rash around whole body that was concentrated on trunk;5OCT96 pt also exp a bit of soreness throughout;
Swollen arm, pain in injection site, unable to move arm, high heart rate, difficulty breathing, body aches, dizziness, muscle tightness then falling over, double vision
Chalazion on upper right eyelid starting 5/31/2021 (1.5 months after vaccination). Removed surgically on 7/15/2021 (1.5 months after onset). Sharp, stabbing leg pain and hypersensitivity of skin on right thigh starting 7/19/2021 (3 months after vaccination). No treatment, problem persists to present day (7/28/2021).
Date and time adverse event started:  3/18/21  1520 immediately  1707 Caller states about 2 hours ago called was given Pfizer in the Left deltoid.  Felt slight pain then when needle withdrawn started bleeding. Pressure was applied for about 45 minutes dressing changed two times.  now has a band aid over the area. Area is starting to bruise and the patient is getting a headache.  Patient has a grape sized hard knot at the injections site.   Patient using ice indirectly for 10 minutes on 10 minutes off.  Caller questions if vaccine went into the blood stream will it be effective, or does the vaccine need to be placed in the muscle to have time to replicate to be effective.  . Does caller need another first shot.
Passing out shortly after waking up. First time was January 6, 2022 and then 4 more times in February. Went to the hospital 3 times and had 2 concussions.
12MAR w/in day fever 103 ax 7th day rash, anorexia;18th rash onset follow up 25MAR97;
body felt heavy; body felt achy; head felt heavy; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (body felt heavy), PAIN (body felt achy), HEAD DISCOMFORT (head felt heavy) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included VITAMIN D3 for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-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 FEELING ABNORMAL (body felt heavy), PAIN (body felt achy), HEAD DISCOMFORT (head felt heavy) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (body felt heavy), PAIN (body felt achy), HEAD DISCOMFORT (head felt heavy) and HEADACHE (headache) had resolved. Not Provided          Concomitant product also include Blood pressure medications. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-129741 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received and updated the Event out come updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-129741:First dose case
major stroke; This is a spontaneous report from a contactable consumer (patient's husband) via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was in the hospital due to a major stroke on an unspecified date. She can't move her right arm, right leg and she cannot talk. Patient's 2nd dose was due on 27Apr2021 and she can't continue to have the vaccine. Outcome of the event was unknown.
scars; shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included scar (has scars from her previous shingles outbreaks). Previously administered products included Zostavax with an associated reaction of herpes zoster (she had 4 to 5 shingles outbreaks in 2018.) and Shingrix with an associated reaction of pain in extremity (received 1st dose of Shingrix 6 months ago and experienced arm soreness and tiredness, refer case US2019129959).   On 1st July 2019, the patient received the 2nd dose of Shingrix. On 5th July 2019, 4 days after receiving Shingrix, the patient experienced shingles. On 12th July 2019, the patient experienced scar. On an unknown date, the outcome of the shingles and scar were unknown.   It was unknown if the reporter considered the shingles and scar to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. On 5th or 6th July 2019, the patient developed shingles. She has scars from her previous shingles outbreaks in addition to the most recent episode. There is a discrepancy regarding outcome on narrative as in source document mentioned as RECOVEREDRESOLVED WITH SEQUEL for shingles and in Database core mentioned as unknown.
Change in menstrual cycle; Increase in severity of endometriosis symptoms; Increase in severity of endometriosis symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. The patient's concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 19Jul2021, outcome "recovering", described as "Change in menstrual cycle"; ENDOMETRIOSIS (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 19Jul2021, outcome "recovering" and all described as "Increase in severity of endometriosis symptoms". The events "change in menstrual cycle", "increase in severity of endometriosis symptoms" and "increase in severity of endometriosis symptoms" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of menstrual disorder, endometriosis, condition aggravated.  Additional information: The reporter was reported about covid vaccine. The patient was reported and AE reported and Female and no had Pregnant. The patient Dose received: 2 and Product: COVID 19 its Pfizer brand. The lot not provided. The Administration date: 02Aug2021 11:00 AM at Vaccine location: Left arm and The previous dose history unknown. The Previous dose administration time: 11:00 AM and dose number: 1 .The Previous dose vaccine location: Left arm Facility type vaccine: Pharmacy or Drug Store and no other vaccine in four weeks. The reporter was reported about Adverse event: Change in menstrual cycle Increase in severity of endometriosis symptoms and adverse event start date: 19Jul2021. The AE resulted in: [Doctor or other healthcare professional office/clinic visit] and patient recovered: Recovering. The treatment was unknown and no covid prior vaccination. The covid tested post vaccination and covid test type post vaccination: Nasal Swab results was Negative . The related history had  known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Discharge Physician: MD Primary Care Clinician at Discharge: PA  Admission Date: 1/27/2023 Discharge Date: 2/2/2023   PRESENTING PROBLEM: COPD exacerbation [J44.1] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 60 y.o. female with medical history significant for inflammatory arthritis on methotrexate, chronic obstructive pulmonary disease not oxygen dependent, continued tobacco use, right upper lobe adenocarcinoma status post lobectomy/chemo, OSA on CPAP, chronic diastolic CHF, known AAA, hypothyroidism, bipolar 2 disorder, mild cognitive impairment.  Presents to ER for ongoing shortness of breath for several days.   Upon admission, noted to be tachypneic, desatted to 88% on room air.  EKG showing mildly prolonged QTC, otherwise unremarkable.  Labs significant for potassium 3.0.  ProBNP 1312, up from 312 yesterday.  Found to be COVID-19 positive.  CXR unremarkable.  Given nebulizer, IV Solu-Medrol, potassium replaced in in ER.  Was admitted to Medicine for treatment of chronic obstructive pulmonary disease exacerbation triggered by COVID19 infection.  She was not hypoxemic and required no supplemental oxygen.  She was started on bronchodilators as well as prednisone (dexamethasone was withheld due to no objective hypoxemia) overnight she improved substantially and was discharged home the following day in good condition.
Patient reports hard, red bump on VARIVAX location, which by the next day had doubled in size to %1/2 inches by 3 inches. She reported extreme itching and redness which had begun to fade by 1/2/18.
fever of 99.3, fever of 102.3 @ 2:30 PM
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 63-year-old male patient who received SHINGRIX (batch number BN9L9, expiry date unknown) for prophylaxis. The patient's past medical history included shingles. On 20th April 2018, the patient received the 1st dose of SHINGRIX. On 20th April 2018, less than a day after receiving SHINGRIX, the patient experienced fever. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the shingles was not recovered/not resolved. The reporter considered the fever and shingles to be possibly related to SHINGRIX. Additional details were provided as follows: In April 2018, fever resolved after lasting for a week. Less than a year after vaccination, the patient experienced a sensation which was described as, a reactivation of his shingles in the areas where he previously had shingles. The pharmacist was unsure if lot number was BN919 or BN9I9 for SHINGRIX, which did not exist and was updated to BN9L9, according to sales database. The batch number was unknown. This case has been linked to US2018140190, reported by the same reporter.
Contracted Covid-19 approx. four months after receiving Pfizer booster shot.   Symptoms started on 02/12/2022 and for first five days were headache, sore throat, lethargy and low energy, stuffy and runny nose, body aches.  On 03/02/2022, 18 days after first symptoms developed, I went to the hospital ER and was diagnosed with lung inflammation and a sinus infection.   Symptoms at time of ER visit were intense headache, lethargy and low energy, wheezing.
9/14 cranky maybe low grade fever - motrin  9/15 totally fine  9/16 Fever 102-104, shaking chills, peripheral cyanosis mom called EMS concerned seszure. Was NOT a seszure child alert whole time. Intermittent fever 9/17 + 9/18 with development nasal congestion.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2015, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
It was discovered that the patient was 3.5 months under 18 years of age and she was given the Moderna vaccine which has only been approved for individuals 18 and over.  The patient has had no adverse events due to this vaccine as far as we know.
Not sleeping well; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) and INSOMNIA (Not sleeping well) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016F22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Lot ER1742) on 03-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (Lot EW0221) on 05-Jun-2021, PFIZER BIONTECH COVID-19 VACCINE (lot FD0810) on 20-Nov-2021 and PFIZER BIONTECH COVID-19 VACCINE (FM7380) on 20-Apr-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 05-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INSOMNIA (Not sleeping well). At the time of the report, COVID-19 (COVID-19) had not resolved and INSOMNIA (Not sleeping well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Suspect product dosage text was reported as additional booster. It was reported that patient had a low grade fever, a touch of a headache and a bit of runny nose and fatigue and also patient checked chest and there was nothing in the lungs and sinuses. No treatment information was provided.
Information has been received from a registered nurse (R.N.) concerning an 8-year old patient who in October 2001, was vaccinated with a dose of varicella virus live (Oka/Merck). subsequently, in the summer of 2005, the patient developed shingles. Unspecified medical attention was sought. The patient's present status was unspecified by the reporter. No product quality complaint was involved.
14 hours after receiving vaccine chills for 24 hours, fever low grade 12 hours,  eyes burning, horrible headache that just doesn't want to go away not even tylenol helped, nausea, fatigue, arm pain , arm pits swollen and hurt, heart rate elevated for 48 hours. The first shot I had all of this but didn't have headache.  This second shot was much worse.
Approx 5 yr ago, pt recv IM Typhoid vax, and devel inj site rxn lasting more than 48 hr. Reporter indicated 8 pts exp this event, but are not identifiable.Also see comments.
cellulitis rt upper & forearm, red, warm, swollen;pt saw family MD & was put on ATB;
Redness of the eyes, sore throat, chills, vomiting. Later on after the chills subsided the fever set in and achy joints and severe headaches occurred.
Narrative: COVID infection following COVID vaccine series 07/01 Pfizer, dose #1 07/23, Pfizer, dose #2 07/31 pt cc: cough, dyspnea, exposure: unknown 08/01 - 08/16 pt symptoms continue 08/12 COVID swab, result: detected 08/12 SARS-COV-2 Variant Sequencing result: pending
G40.909 EPILEPSY, UNSPECIFIED 9/11/2022 SEIZURE, UNSPECIFIED I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 11/5/2022 SEIZURE, UNSPECIFIED G40.909 EPILEPSY, UNSPECIFIED 9/11/2022 BRAIN LESION I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 11/5/2022 BRAIN LESION G40.909 EPILEPSY, UNSPECIFIED 9/11/2022 HX OF DVT I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 11/5/2022 HX OF DVT G40.909 EPILEPSY, UNSPECIFIED 9/11/2022 BILAT DRY EYE SYNDROME I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 11/5/2022 BILAT DRY EYE SYNDROME G40.909 EPILEPSY, UNSPECIFIED 9/11/2022 HX OF DVT I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 11/5/2022 HX OF DVT
Headache, nausea and vomitting, fever, chills, aching and sore muscles.
This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. On 04-SEP-2013, the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot number and expiry date were reported as 671553/1138AA and 27-APR-2013 respectively, dose and route unspecified). No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
Pain in left collar bone, similar to pleurisy, nauseous, mouth watering, dizzy, shaky, buzzing in ears, ears ringing worse than normal.  Following day pain moved to left armpit.  2 days later, severe vertigo in evening, including vomiting. 3 weeks after vaccination, had another severe vertigo episode, with vomiting, numbness in hands and feet.  Continues to feel low energy, and non-specific ill feeling.