chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case involves a 77-year-old female patient who received an INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], intended vaccine was INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. No other concomitant vaccines. On 22-Nov-2021, the patient received a dose of suspect FLUZONE QUADRIVALENT (0.5 ml, total, once, lot UT7330JA and expiration date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error due to wrong vaccine administered (same day latency). No adverse event reported. 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 the Directive 2001/83/EC and Module VI. 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.
Left side of face ear area  fullness numbness progressed later to numb lip on left side and poor vision in left eye , chest pain in center of chest and walking imbalance
This spontaneous report was received from medical assistant and refers to a currently 77 years old female patient. The patient concurrent conditions were right lung non-small cell lung cancer and chronic obstructive pulmonary disease. The patient's medical history included right lung lobectomy. The patient was vaccinated with PREVNAR 13 on 19-FEB-2016. The patient's concomitant therapies included VENTOLIN, QVAR, PLAVIX, DUONEB, lisinopril, lovastatin, propranolol hydrochloride, sertraline hydrochloride, spironolactone, trazodone hydrochloride and ROBAXIN. On 20-OCT-2017, the patient was vaccinated with PNEUMOVAX 23, lot # M023460, expiration date: 12-NOV-2017 for prophylaxis. On 21-SEP-2018, the patient presented in physician's assistant office for cough, unspecified tremors, and unspecified urinary problems experienced since unknown dates. The patient had routine chest x-rays performed however no results were provided. The patient received unspecified treatment for the events. The outcome of the events was reported as not recovered. The causality assessment was not provided.
Immediately after receiving all vaccines, the patient became weak, lethargic, pale, and continued to nod off. Symptoms continued for 30 minutes.  After 30 minutes she stated she felt better but it was hard to breath. All vital signs normal, glucose 124, hemoglobin 13.1, orientated x3. Recommended ER via ambulance and mom refused transportation to paramedics. Mom stated would follow up with primary provider immediately.
VOMITING (NOTHING CAME OUT); DIZZINESS; HAND SORENESS; WEAKNESS; FEVER OF 104; NAUSEA; HEADACHE (FELT SHE COULD SCREAM); This spontaneous report received from a parent concerned an 18 year old female. 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: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced vomiting (nothing came out). On 09-JUL-2021, the subject experienced dizziness. On 09-JUL-2021, the subject experienced hand soreness. On 09-JUL-2021, the subject experienced weakness. On 09-JUL-2021, the subject experienced fever of 104. On 09-JUL-2021, the subject experienced nausea. On 09-JUL-2021, the subject experienced headache (felt she could scream). Laboratory data included: Body temperature (NR: not provided) 104. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 104, nausea, vomiting (nothing came out), weakness, headache (felt she could scream), hand soreness and dizziness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210724637.
Fever (highest 101 degrees), ?buzzy? and feverish feeling head; fatigue. About 6 days after shot I developed an itchy, hot to the touch, red rash that slowly moved from the shoulder to the elbow of the arm that had received the vaccine.  I had this same type of rash with my first Moderna shot.
COVID-19 confirmed with at-home rapid antigen self test; COVID-19 confirmed with at-home rapid antigen self test; This is a spontaneous report from a contactable pharmacist via Pfizer. A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269), dose 1 intramuscular, administered in Arm Left on 30Jan2021 (at the age of 29-years-old) as DOSE 1, SINGLE and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9266), dose 2 intramuscular, administered in Arm Left on 20Feb2021 (at the age of 29-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included exercise-induced asthma and sleep apnoea syndrome from an unknown date. There were no known allergies. Concomitant medications included cetirizine, esomeprazole (ESOMEPRAZOLE) and multivitamins taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccination within four weeks. On 12Nov2021, the patient experienced covid-19 which was confirmed with at-home rapid antigen self-test. On 12Nov2021, the patient underwent lab tests and procedures which included sars-cov-2 test/ Antigen self-test using nasal swab and tested positive. Therapeutic measures were taken as a result of the event of covid-19 with Ibuprofen Chlorpheniramine/phenylephrine. The outcome of the event covid-19 was not recovered.  No Follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
two days after the vaccine the patient started getting a hive like rash on her chest and stomach.  She did also start an antifungal for an unrelated issue.  It could be an allergic reaction to that as well.  It has now been 5 days and she is still having the rash and is no longer on the antifungal either.
Patient was recently adopted, with unknown immunization status.  DTaP #1 and Hib #1 were administered 1/06/04.  Later that evening, mom reports patient ran increased temp of 103 degrees.  Per mom, patient awoke morning of 1/07/04 with red, raised rash to majority of the body and bilateral swelling of the eyes.
Vertigo; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (Vertigo) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Corneal transplant in October 2018. Concurrent medical conditions included Gluten intolerance, Lactose intolerance, Vertigo (Benign positional vertigo episodic), Paresthesia, Coronary artery disease, Tinnitus, Constipation (Chronic idiopathic constipation), Osteoarthritis (Osteoarthritis in hands), Osteopenia, Osteoporosis, Hypothyroidism, Anxiety and Lichen sclerosis atrophicus (Lichen Sclerosis vaginal labia area). Concomitant products included LUBIPROSTONE (AMITIZA), LEVOTHYROXINE, ROSUVASTATIN from 20-Nov-2020 to an unknown date, CLOPIDOGREL from 15-Aug-2020 to an unknown date, ESTRADIOL and DIFLUPREDNATE (DUREZOL) for an unknown indication, LOTEPREDNOL ETABONATE (LOTEMAX).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo) and FATIGUE (Fatigue). At the time of the report, VERTIGO (Vertigo) had not resolved and FATIGUE (Fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided by reporter.   This case was linked to MOD-2021-104658 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: follow received  as updated outcome of the event
some of the vaccine leaked out near where the needle attaches to the syringe as he did not tightened the needle on tight enough/ No AE; While vaccinating with Fluzone High-Dose Quadrivalent vaccine  some of the vaccine leaked out near where the needle attaches to the syringe/ No AE; Initial information received on 18-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a patient (unknown demographics) who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number: UJ516AA, expiry date: 30-Jun-2021, dosing details, route and site of administration not reported) on an unknown date for prophylactic vaccination while some of the vaccine was leaked out as needle was not tightened enough (PT- wrong technique in product usage process and underdose).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   It was an actual medication error case due to wrong technique in product usage process and vaccine underdose (latency: same day).  Addition description of event: reporter states he did not think he tightened the needle on tight enough and as he was giving the injection, some of the vaccine leaked out near where the needle attaches to the syringe. Reporter did not think that a lot of the vaccine leaked out and asked if he should revaccinate the patient.  At the time of reporting, no adverse event was reported.  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.
Patient states she noticed itching and redness at the site of injections about 8 days after the injection. I recommended putting hydrocortisone cream on it and taking Benadryl for the itching,
Spontaneous Coronary Artery Dissection and Takotsubo cardiomyopathy    detected with severe chest pain, elevated blood pressure and arm pain.
Fever. Recurring seizures after immunization. Hospitalized. Failed hearing & hypsarrhythmia.
shot didn't work, got them now/suspected vaccination failure; got them now; 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.   On an unknown date, the patient received Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: shot didn't work, got them now/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got them now). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   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: 24-Mar-2023 The case was received from the patient's friend via interactive digital media. The reporter stated that the shot did not work for the patient and he/she got them now (at the time of reporting). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR059663, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR059663:Same reporter
A little less than 24 hours after getting vaccine at my place of employment (I work in an internal medicine outpatient facility), I started to feel lightheaded, feverish, achy and had a headache. These symptoms worsened over the next 24 hours. I developed a fever, profound diaphoresis, muscle aches that lasted another 12 hours. I treated with Acetaminophen, cool baths and the symptoms went away by day 3 after receiving the vaccine. To note, the area of injection is very large, red and firm.
probably had a sinus infection; overly fatigued; He keeps having extreme epistaxis after receiving the vaccine; This is a spontaneous report from a contactable consumer (patient).   A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on Feb2021 as dose 2, single for covid-19 immunization. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, on Jan2021 for covid-19 immunization. Patient had no known allergies. The patient had relevant medical history of multiple Sclerosis and trigeminal neuralgia. The patient concomitant medications were not reported. Both got the vaccine first dose in Jan and the second dose at the end of Feb. He had extreme epistaxis after receiving the vaccine, with the first episode occurring 12Mar2021 and then 2 times in Apr, once in May and 2 in Jun with the last episode on 22Jun2021. She states he was in the ER for over 6 hours during the first episode and they had a problem getting it stopped. He never had a nose bleed in his life. It was not a normal nose bleed, its like turning on a faucet and projectile out of his nostrils, a significant amount of blood. He saw the ENT in Apr was told he probably had a sinus infection and was given Augmentin, Afrin and nasal rinses. Their was no help and he went back to the ENT. He had two more scopes done. He was already scheduled for an MRI due to be overly fatigued from his MS and no tumors or an increase of plaques were seen. He had been given Augmentin 3 times in total and has also been given Astelin nasal spray. The ENT did not figure out what was causing it. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient states that two to three days after receiving his second dose, he developed swelling and bruising in the arm where the vaccine was administered. This reaction happened only on the arm where the vaccine was administered and no other part of his body. He states that after applying ice, the swelling went down but the bruising persisted weeks after the shot, until date. Upon review today, the patient still had the bruising but the swelling had gone down completely.
has a bruise further down on his arm/it is just a darker spot than his skin; This is a spontaneous report from a contactable consumer.  A 90-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on an unspecified date (at an unknown age) as a single dose for COVID-19 vaccination.  Medical history was not provided. Concomitant medication included an unspecified blood thinner. It was unknown if the patient has any allergies to medications, food, or other products. It was unknown if the patient had received any other vaccines within four (4) weeks prior to the vaccine. On an unspecified date the patient took his first shot and afterward he had a bruise further down on his arm. The reporter stated that it has lightened up on his arm. The reporter clarified that it does not hurt, it is just a darker spot than his skin and the reporter noticed it was there. Treatment information, if any, was not provided. The clinical outcome of bruising of arm was unknown.
Around 10 minutes after shot, began to feel throat irritation and some swelling while sitting. Elevated temperature, but was not measured. Left the facility after symptoms did not become worse, but did persist for a few hours. Patient did not seek any treatment or consultation from the health facility. Received 2nd dose in series 6 months later and had similar symptoms.
MIGRAINE HEADACHE; This spontaneous report received from a consumer 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 previously received covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse event post primary vaccination (dose number in series 1). The patient received additional (booster) dose of covid-19 vaccine ad26.cov2.s (dose number in series 2, unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date 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 migraine headache after covid booster shot and was on Tylenol (paracetamol) oral suspension for pain, also patient said did not touch the pain (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain, and the outcome of migraine headache was not reported. This report was non-serious. This case, involving the same patient is linked to 20220146616.
On unspecified dates an unspecified number of patients may have administered improperly stored GARDASIL 9.; No adverse events reported; This spontaneous report was received from a registered nurse regarding an identifiable patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis, lot number R020947, expiration date 04-MAY-2021 (strength, dose and route of administration was not reported). There was no adverse events reported. On 20-JUN-2019, the administered doses of vaccines experienced the temperature excursion of -13.33 Celsius degrees for 2 minutes. On 10-MAY-2019, the previous excursion of 9.12 Celsius degrees for 3 hours and 15 minutes was reported. No data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA001880: US-009507513-1909USA001305:
Narrative:  Per dermatology assessment 2/9: - Patient reports he received first covid vaccine Jan 19th - 3 days after vaccine, noted pain, swelling, and red raised rash on arm on which he received vaccine - over the next 1-2 days, red rash progressed to involve his b/l proximal and proximolateral LEs, anterior shins, and then dorsal feet - Over past few days, feels rash has also developed on back, waistband distribution, and abdomen, although is less confluent on the abdomen. during similar timeframe, also came to involve scrotum - presented to ER 10 days following vaccine, as was concerned this represented adverse reaction to vaccine - ED offered him triamcinolone and cetirizine, as they were concerned for an eczematous process, he has experienced no relief on this combination - presented today for 2nd covid vaccine but refused to have it administered and was offered an urgent appointment with derm to assess rash - patient reports rash is markedly pruritic plan: #Eczematous rash Widely distributed eczematous eruption. Patient reports onset 3 days following covid vaccine, unclear association with vaccine given we continue to learn about cutaneous events in association with covid vaccine. denies any skin condition or similar appearing rash ever preceding covid vaccine administration last month - Will initiate prednisone taper 50 mg x 5d, decr by 10 mg every 5 d - Continue triamcinolone ointment application to lesions - cont cetirizine 5 mg, can incr to 10 mg if patient tolerates incr dose w/o AEs - will see back in clinic in 3 weeks Holding off on vaccine #2 until dermatology evaluation is completed is complete and pending risk/benefit discussion with patient.
Redness, swelling and tednerness from the shoulder to elbow in the right arm Nausea Fatigue Loss of appetite Low grade fever (100 degrees F)
Muscle twitching in Right Arm; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN 6206), via an unspecified route of administration, administered in left arm on 09Mar2021 (at the age of 60-year-old) at single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Medical history included mitral valve prolapse, osteopenia, skin allergy. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included calcium citrate (CITRACAL); fish oil; sertraline; raloxifene; 'aspiri'. The patient's known allergies included erithomyicine, codeine, skin allergy, Propylene Glycol and other skin allergens. The patient experienced muscle twitching in right arm, not the arm vaccine was given in. Began on 13Mar2021. Since the vaccination, the patient was not tested for COVID-19. No treatment was received for events. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected
Muscles aches, severe headache, and a fever of 101 f.  Fever broke around six hours later. Muscle pain and headache also subsided gradually thereafter. No fever reducers were taken.
Pain at injection site and remainder of the arm.  Body aches and stiffness.  Joint aches and stiffness. Headache.
Discharge Provider: (name) Primary Care Provider: MD Admission Date: 7/9/2022 Discharge Date: Jul 12, 2022   PRESENTING PROBLEM: COVID-19   HOSPITAL COURSE:     Patient is a 79 y/o woman with PMH significant for diastolic congestive heart failure, hypertension, CKD stage 4, coronary artery disease with PCI presented to emergency department with nausea and vomiting.   On presentation to emergency department her blood pressure was very high 211/96 other vital signs were unremarkable.  She was tested positive for COVID-19 pneumonia  Patient is admitted to hospitalist service for COVID-19 infection.   Is on admission patient was started on fluids.  As patient was able to tolerate diet without any symptoms IV fluids were discontinued.  She did not require steroids or remdesivir given clinical stability.   As BP was high we increase Hydralazine to 50 mg TID ( was on 50 mh BID).   BP is improved. Renal functions are stable.   In stable condition patient is discharged home.
Face became red & c/o of itching of arms and back almost immediately after injection.  c/o nausea and stated that he threw up about 30 minutes after the injection.  Mother states that patient developed sparse macular type rash on his back and threw up twice in the evening.
7 days post vaccine developed lump in arm and rash to neck/arms/chest -fire burning