chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered at 11:30 am, noticed itching, swelling, redness from shoulder to elbow and burning at 2:00 pm, reported to nurse at 2:20 pm and she administered BENADRYL 25 mg per company policy, and instructed to apply ice and report if symptoms worsened. Instructed to take another 25 mg BENADRYL 4-6 hours later if symptoms returned. Instructed to seek medical care for any symptoms of itching or swelling of throat or difficulty breathing. Follow-up on 10/9/2018: All symptoms resolved later that evening with some slight soreness at the sight lingering a day or so.
Pfizer, pain in arm around the injection site, down into left breast, nausea could not sleep on the side of injection too painful
half an hour after the vaccination was given, patient experienced anaphylactic symptoms of swelling throat, difficulty breathing and rash. The symptoms lasted for about 1-2 hours.
This spontaneous report as received from a pharmacist (patient's husband) refers to a female patient (age not provided) with diabetes type II and deafness in left ear due to Meniere's disease. On approximately 25-OCT-2013 (reported as "two weeks ago") the patient was vaccinated with PNEUMOVAX23, 0.5 ml, intramuscular. Lot number was not provided. Concomitant therapies included metformin. On approximately 27-OCT-2013 (reported as "2 to 3 days after vaccination") the patient experienced hearing loss in right ear and ringing in right deaf ear. Lab diagnostics studies were not performed. Physician was called for medical attention. The patient took antihistamine and corticosteroid nasal spray to treat the events, but her hearing had not yet improved. Causality assessment was not provided. Upon internal review the event of hearing loss was determined to be medically significant. Additional information has been requested.
Left shoulder extreme soreness, inability to raise arm more than a 6 inches above the waist; general malaise.
Narrative: Patient reported sensation of dry mouth and scratchy throat following administration of 1st dose of Pfizer covid vaccine. Patient was able to be released with no intervention needed.
Redness, tenderness, swelling and induration in right deltoid began ~ 48hr after injection. Peaked at 72hr after immunization. Now appears to be resolving. Advised use Ibprophren with standard dose x 36 hrs and contact MD if condition worsens. (no prior treatment of any kind).
Patient was administered 5th DTAP .5cc right deltoid and 2nd MMR .5cc left deltoid SQ on 11/18/02. DTAP reaction vs. cellulitis to DTAD presented in our in our office on 11/20/2002 with redness, warm to touch on right deltoid.
The second day arm was red and hot but seemed to be getting better the next day. On Friday January 22 I woke up that morning my arm was 100.3 when I put the thermometer on it, red swollen about lemon size and VERY itchy. 1-23-21 go larger so I called my Doctor. She prescribed Keflex. I started the antibiotic on 1-24. On 01-24 and today 1-25 it has grown to grapefruit in size. Still very hot but not as itchy.  I did notice on 1-23 when running my finger across i felt little tiny bumps.
HIGH LIVER ENZYMES; LETHARGIC; SORE ARM; FEVER; FATIGUE; HEADACHE; This spontaneous report received from a parent concerned a 22 year old male. The patient's height, and weight were not reported. The patient's past medical history included: kidney disease, and fatty liver disease, and concurrent conditions included: penicillin allergy, non-smoker, non-alcohol user, and autistic, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient was on a very restricted diet, no sugar, no potassium, no red meat and very low salt intake. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, Laboratory data included: Magnetic resonance elastography (NR: not provided) Fine, SGOT (NR: not provided) 31, and SGPT (NR: not provided) 41. On AUG-2021, the patient experienced lethargic. On AUG-2021, the patient experienced sore arm. On AUG-2021, the patient experienced fever. On AUG-2021, the patient experienced fatigue. On AUG-2021, the patient experienced headache. Laboratory data included: Body temperature (NR: not provided) 102 F. On 16-AUG-2021, the patient experienced high liver enzymes. Laboratory data included: Blood test (NR: not provided) Not specified, Glucose (NR: not provided) 144, Hepatic enzyme (NR: not provided) High, SGOT (NR: not provided) 80, and SGPT (NR: not provided) 108. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on AUG-2021, had not recovered from fatigue, lethargic, and headache, and the outcome of sore arm and high liver enzymes was not reported. This report was non-serious.
tremor; insomnia; intense itching; loose stools; This is a spontaneous report from a contactable consumer (patient). A 76-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was reported as unknown) via an unspecified route of administration on 26Feb2021 at 10:30am (at the age of 76-years-old) in left arm as dose number unknown, single for covid-19 immunization at Hospital. Medical history included breast cancer and known allergies as IgG reactions to many substances both from an unknown date and unknown if ongoing. No other vaccine taken on same date. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks. Concomitant medications received within two weeks included pregabalin (LYRICA); ascorbic acid (VITAMINS C); colecalciferol (VITAMIN D [COLECALCIFEROL]); melatonin (MELATONIN) and fexofenadine hydrochloride (ALLEGRA) all taken for an unspecified indication, start and stop date were not reported. The patient experienced delayed reaction two days after vaccination which included intense itching, insomnia, loose stools, and tremor on 01Mar2021. The patient received treatment for the adverse events occurred. The outcome of the events was Recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
QUARTER-SIZED HARD KNOT AT INJECTION SITE. SITE BECAME RED AND INFLAMED. SITE WAS TENDER. SYMPTOMS PERSISTED UNTIL 5 DAYS LATER (TODAY), THOUGH SYMPTOMS HAVE BECOME LESS SEVERE.
He is acting well, eating well, no vomiting or fever but started with significant diarrhea, watery stools 3 x/hr, 24 hr after the vaccine and still is stooling that often on 11/22. by evening of 11/22 His diarrhea has slowed down to 2-3 times an hour from 4 or more times. Acting well otherwise. Getting plenty of fluids.
Decreased ROM (R) arm swelling, erythema, increased warmth (R) deltoid areas of induration (R) deltoid.
On third day after shot, I went to work in the er ( I?m a nurse).    Resting heart rate of 120, 150 active.   hypertensive 150s/108.  Sob- says 93% room air , Diaphoretic and dizzy.   Was checked into er.   EKG showed sinus tachycardia.   Labs run   D dimmer positive.   Pulmonary ct negative for pe.   Sent home for 2 days.  Came in   To work Friday 17th.   Same symptoms.   Checked in er again and sent home.   Sob and tachycardia improved 20th.
according to mom, pt was fine all day; around 9PM fever started to inc, gave non-aspirin product; all through the noc, had been crying & screaming @ times, high-pitched; when pt finally settled down, body had tremors;
COVID-19 PNEUMONIA; MEDIASTINAL DISORDER; COVID-19; COUGH; HILAR LYMPHADENOPATHY; ANGIOGRAM ABNORMAL; This spontaneous report received from a health care professional by a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS ID private) and concerned an 88 year old female of unspecified race and ethnic origin. 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, intramuscular, batch number: 1808980 and expiry: Unknown) dose was not reported, dose number in series was 1, 01 total administered in left arm on 02-APR-2021 for an unknown indication. No concomitant medications were reported.  On 07-NOV-2021 patient experienced corona virus disease pneumonia (COVID -19 pneumonia) and was hospitalized for 16 days, discharge information was not reported. She was given supportive care and remained stable on 3 to 5 liter nasal cannula (oxygen), while hospitalized her main complaint was cough so she was started on Mucinex (guaifenesin) and her Tessalon Perles (benzonatate) was increased. During her hospitalization her oxygen level had been ranging from 3 to 5 liters nasal cannula and was stable, mediastinal (mediastinal disorder) and hilar lymph node enlargement (hilar lymphadenopathy) were found on computed tomography angiography (CTA) and likely secondary to COVID -19 infection (dose number in series was 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the angiogram abnormal, covid-19, COVID -19 pneumonia, cough, hilar lymphadenopathy and mediastinal disorder was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000209403. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information was received from Central Complaint Vigilance department on 19-JAN-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.  Upon review following information was amended: Suspected clinical vaccination failure event removed.; Sender's Comments: V2: Additional information updated : Product quality complaint investigation result. Upon review following information was amended: Suspected clinical vaccination failure event removed. 20211255822-COVID-19 VACCINE AD26.COV2.S- angiogram abnormal, covid-19, covid-19 pneumonia, cough, hilar lymphadenopathy, mediastinal disorder. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Patient reported that she received the 1st dose of Shingrix 2 years ago and experienced flu like symptoms shortly after receiving the injection and the symptoms lasted for a week so she decided not to get the 2nd dose of Shingrix. The reporter consented to follow-up.
Felt a little tightness in chest, then a red swollen itchy spot appeared on my lower back the next couple hours 9 more itchy (hive) spots appeared.
covid vaccine breakthrough case  dose 1 3/5/21 Janssen 1802068
They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case contains information for the 9th patient of 24 patients reported by the reporter.  Concomitant medications were not reported.  The vaccination clinic received incorrect guidance from the DOH in regards to the vaccination, who instructed to order and administer the vials with pink top to patients. This resulted in 24 patients being undervaccinated.  It was reported that 24 pediatric patients were administered underdose bivalent vaccine doses for either their first or second doses. They received 0.2 ml dose from the pink vial instead of the 0.25 ml dose from the blue cap vial. The patients were aged between 6 months to 5 years. The patients were being contacted and revaccinated with the correct dose.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
Half dollar sized red inflamed area at inj. site. Impetigo/rash areas: A) Under nose, right nostril. B) Site RXN at inj. site. C) Various "pox" spots on left hand, forearm, and bicep.
COVID-19; COVID-19; Intraocular pressure high; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4237795-00, US-PFIZER INC-202200112374.  A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 09Apr2021 (Batch/Lot number: unknown) at the age of 62 years as dose 2, single and intramuscular, administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; INTRAOCULAR PRESSURE INCREASED (non-serious), outcome "not recovered", described as "Intraocular pressure high". The patient underwent the following laboratory tests and procedures: intraocular pressure test: high. The action taken for adalimumab was unknown.  The reporter considered "covid-19" related to bnt162b2.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Covid-19 and eye pressure is high was not provided. Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran): For Covid-19, Causality as per reporter (Drug/Vaccine) was possible and for Intraocular pressure high (Intraocular pressure increased): Causality as per reporter (Drug/Vaccine) was Not Reported.  The reporter's assessment of the causal relationship of the event Intraocular pressure high with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Dry nostrils; Headache; Chills; Slight fever; Upset stomach; Tiredness; Did not get a good nights sleep last night; Pain at the injection site after the shot.; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th May 2022, the patient received the 1st dose of Shingrix. On 19th May 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On 13th June 2022, the patient experienced poor quality sleep. On 14th June 2022, the patient experienced headache, chills, fever, upset stomach and tiredness. On an unknown date, the patient experienced nasal dryness. On an unknown date, the outcome of the injection site pain, headache, chills, fever, upset stomach, tiredness and poor quality sleep were recovering/resolving and the outcome of the nasal dryness was unknown.   It was unknown if the reporter considered the injection site pain, headache, chills, fever, upset stomach, tiredness, poor quality sleep and nasal dryness to be related to Shingrix.     Additional Information: GSK receipt date: 14-JUN-2022 Reporter's comment: The reporter was patient. The patient stated that experienced pain at the injection site after the shot of Shingrix. On 14th June 2022, 26 days after receiving Shingrix the patient began experiencing headache, chills, slight fever ((99.9), upset stomach, and tiredness. He admitted that he did not get a good night sleep last night from the date of reporting. The patient said he started to feel better.  The patient also stated during the call that he had dry nostrils.  The patient provided limited information, declined to provide date of birth, but gave age. patient gave. The reporter consented to follow up.
Headaches; This is a spontaneous report from a contactable consumer reporting for his mother. A 73-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medication was not reported. The patient suffered from headaches and took paracetamol (TYLENOL) on unknown date with outcome of unknown.  No follow-up attempts are needed. No further information is expected. Information about lot/batch number cannot be obtained.
Had headaches for a few days a  little dizziness right hip pain and left shoulder pain the hip has been an all  day affair the headaches 9am in the morning a couple days a week the dizziness when I stand up the shoulder pain was for a few nights at about 12 am
Patient express no contraindications prior to receiving the vaccination. She had severe lightheaded effects from an unknown vaccination in the 1970s, but had been given blood tests, flu vaccinations, and other shots since then without any problem. Post vaccination, the patient reported a lightheaded/dizzy feeling and thought she may need to "lay down". I talked with her to make sure breathing, speech were still ok. The lady she was with and I helped her remain calm and awake so she did not fall out of the chair. Over the course of the next 20- 30 minutes, I stayed with the patient to make sure she did not faint. She requested some water and chocolate which did make her feel better. I took her blood pressure which was normal but below her normal numbers. She eventually felt better and I had my tech walk her outside just in case.
Right ventricle is also enlarged; Left ventricle is has double the size; Eustachian tubes in left ear is flat and moved; Difficulty breathing; Pain all over the body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RIGHT VENTRICULAR HYPERTROPHY (Right ventricle is also enlarged), LEFT VENTRICULAR HYPERTROPHY (Left ventricle is has double the size) and EUSTACHIAN TUBE DYSFUNCTION (Eustachian tubes in left ear is flat and moved) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Cerebral palsy. Concomitant products included MAGNESIUM and IBUPROFEN for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced RIGHT VENTRICULAR HYPERTROPHY (Right ventricle is also enlarged) (seriousness criterion medically significant), LEFT VENTRICULAR HYPERTROPHY (Left ventricle is has double the size) (seriousness criterion medically significant), EUSTACHIAN TUBE DYSFUNCTION (Eustachian tubes in left ear is flat and moved) (seriousness criterion medically significant) and MYALGIA (Pain all over the body). 05-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing). At the time of the report, RIGHT VENTRICULAR HYPERTROPHY (Right ventricle is also enlarged), LEFT VENTRICULAR HYPERTROPHY (Left ventricle is has double the size), EUSTACHIAN TUBE DYSFUNCTION (Eustachian tubes in left ear is flat and moved), DYSPNOEA (Difficulty breathing) and MYALGIA (Pain all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient describes almost instant swelling at the site and the vaccine is in a pocket not being absorbed into the muscle. Typical soreness and soreness to touch. Patient was assessed on 10/26/2017 by the Director Of Nursing from the Health Department. Patient is concerned that the reaction to the vaccination will conflict with regularly scheduled infusions to the same arm. Patient reports receiving a Hep B vaccination from the Public Health Clinic within the last month.
Leg pain right and left, loss of appetite, asthma, bronchitis. Treatment:  Albuterol neb 12/24/09:  ER visit, lower extremity problems, knee pain.  DX:  Myalgias, viral syndrome.  RX:  Ibuprofen 12/29/09:  2:18pm  ER visit for weakness lower extremities.  CT scan, bloodwork.  CT head w/o contrast: Impression:  no acute intracranial abnormality is identified.  Maxillary, ethmoid, and sphenoid sinus disease. Impression:  Ataxia, areflexia.  Transfer to Medical Center.  Admitted 12/29/09  Disch: 1/6/10  Discharge finding:  impression, findings compatible with Guillian-Barre syndrome.  Received IVIG daily X 5 days., well controlled with Neurontin 5mg/kg/dose, BID. Transferred to Inpatient rehab.  Followed by PT/OT while in hospital.  Continue as instructed.  Follow-up with neurology