chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TENIVAC and Infanrix were administered to patient with no adverse event; Initial information regarding an unsolicited valid non-serious case received via medical assistant on 15-Mar-2023 processed along with live follow-up of same. number: 01534286, 01533938.  This case involves 16 years old female patient who experienced Diphtheria and Tetanus Toxoids (Tenivac) and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Infanrix) were administered to patient with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Last menstrual period was 26-feb-2023.  Concomitant medications included Polio Vaccine INACT 3V (Vero) (Ipol) for Prophylactic vaccination; Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Prophylactic vaccination; Varicella Zoster Vaccine (Varicella Vaccine) for Prophylactic vaccination; and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 5-Component, Tetanus Vaccine Toxoid (Adacel) for Prophylactic vaccination.  On 03-Mar-2023, the patient received suspect INFANRIX not produced by Sanofi Pasteur at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination and on same day, the patient received suspect Tenivac vaccine Suspension for injection at dose 0.3ml once (lot: U7092AA, expiry date: 24-Jun-2023) via intramuscular route in the left deltoid for prophylactic vaccination with no adverse event (extra dose administered) at same day latency.  Action taken with was not applicable.  No corrective treatment was received for the event.  At time of reporting, the outcome was Unknown for the event extra dose administered.   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 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.
Feel the burning sensation on her lips and tip of her tongue; This spontaneous case was received on 10-Dec-2021 from pharmacist via regulatory authority (reference number: SEQW21-05997) and concerned a 68-year-old, female patient.  The patient's medical history was not reported. The patient's current condition included high blood cholesterol, hypertension, gastric reflux and unspecified thyroid condition. The patient's concomitant medications included unspecified medications for cholesterol, blood preasure, thyroid and gastric reflux.  On 10-Dec-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml; route of administration: intramuscular (IM); anatomical location: deltoid) for influenza prophylaxis. The batch number was reported 312850 and expiry date 08-Jun-2022.  On the same day, 15 minutes after vaccination the patient experienced burning sensation on her lips and tip of her tongue.  The outcome of the event 'Oral discomfort' was unknown.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A 68-year-old female patient experienced oral discomfort on the same day after vaccination with Fluad Quadrivalent. Based on plausible temporal relationship, causality for the reported event is assessed as possibly related.; Sender's Comments: A 68-year-old female patient experienced oral discomfort on the same day after vaccination with Fluad Quadrivalent. Based on plausible temporal relationship, causality for the reported event is assessed as possibly related.
Prolonged seizure w/o documented fever, but probably w/fever; started approx 6 hrs post DTP administration; Subsequently, pt has had a difficult to control sz disorder;
In upper (R) leg; 11 x 10 cm area of erythema; mild swelling, warmth surrounding injection site. Patient prescribed with ATARAX 10mg/5mL; 3/4 tsp every 6 hours for itch/swelling.
Narrative: His other prompting for his emergency department visit today revolves around the symptoms of nausea vomiting fatigue, headache, and generalized malaise, approximately 72 hours after receiving his second Pfizer vaccine. This is in context of PCR positive Covid approximately 3 months ago with no long-haul symptoms. He's had mild nausea, with nonbilious non-bloody emesis, generalized fatigue, and mild shortness of breath, without diarrhea or rash or presyncope.
Patient did not have any symptoms; Caller is a medical assistant who reports that an expired dose of VARIVAX was given to a patient.; This spontaneous report was received from the medical assistant and refers to a 48-year-old patient of an unknown gender. The patient's medical history, concomitant medications, and concurrent conditions were not reported.  On 01-JUN-2022, the patient was administered varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter once, lot #T010298, expiration date: 24-MAR-2022 (expired product administered) (strength, and route of administration were not provided) for varicella immunisation. The vaccine did not have any previous temperature excursions, and was used with the sterile diluent (lot number and expiry date not reported). The patient received varicella virus vaccine live (oka/merck) (VARIVAX), because had titers drawn and was not immune to varicella. It was unknown whether the patient was vaccinated against varicella before. On 06-JUN-2022, the medical assistant confirmed, that the patient did not have any adverse reaction to the expired vaccine. No further information was available.
Patient came in asking for covid shot. After Pfizer shot given, found patient had already J &J, Moderna, and Pfizer in past  at multiple pharmacies. We found out through Database. Customer had trouble remembering when I questioned him if he knows he has already gotten covid shot.  Told him do not come back for 2nd shot and he is finished with covid vaccinations. Gave him a piece of paper written "DO NOT GET ANY COVID SHOTS -DONE !! "  to keep in his wallet as a reminder.
improperly stored administered ROTATEQ; This spontaneous report was received from a customer (reported also as "other") and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-JUN-2023, the patient was vaccinated with improperly stored (Product storage error) dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, administered orally, lot # reported and confirmed as: 1968385, expiration date reported and confirmed as: 22-MAY-2024 from prophylaxis. Temperature excursion details: 34.9 degree Fahrenheit for 6 hours 34 minutes (20-JUN-2023); no previous temperature excursion.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA009292:02429442
Blood test two weeks after vaccine shows blood platelets clumping; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET AGGREGATION ABNORMAL (Blood test two weeks after vaccine shows blood platelets clumping) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis (Patient is dealing with psoriatic arthritis for 3 years.) and Autoimmune disorder. Concomitant products included TOFACITINIB CITRATE (XELJANZ), ADALIMUMAB (HUMIRA) and ETANERCEPT (ENBREL) for Autoimmune disorder, ATORVASTATIN and VERAPAMIL for an unknown indication.    On 05-Aug-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 PLATELET AGGREGATION ABNORMAL (Blood test two weeks after vaccine shows blood platelets clumping). At the time of the report, PLATELET AGGREGATION ABNORMAL (Blood test two weeks after vaccine shows blood platelets clumping) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet aggregation test: abnormal (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Follow up document contains no new information.
03/31/23 presents to ED for "syncope". PMHx of "hemochromatosis"
pt recvd vax 13JUN95 & 27JUN95 pt devel 8 lesions on face, chest, & arms;f/u MD added that the pt had devel gen pox marks;
Erythematous rash/pox-like lesions on chest and back, generalized vaccinia. Pt given Benadryl and Tylenol.
Itchy, burning and tingling skin with no rash.  No treatment given from doctors. Hydrocortisone cream doesn?t work and neither does Benadryl or Claritin.
Pt came in 12/16/16 to report her arm was red and some around site where vaccine was administered. Viewed arm and verified arm has circle (diameter approximately 2 inches) around vaccine admin site.
3wk p/vax c/o joint aching;mom describes almost every joint in body hurt;could hardly walk;legs would go out;pt ran a fever for couple days 99-100, was very tired, ended up in bed, sleeping a lot & developed; pneumonia for which hosp;
I've developed a dull achy pain in my neck and between my shoulders blades. It is not constant, but it comes and goes somewhat like a cramp. I also have developed a cramp sensation in the left side of my chest cavity.
Dizziness, Headache, Myalgia, Fever & NauseaVomiting Narrative:
Pt stated that on 4/15/18 they noticed redness that burns warm on right buttocks that appeared separately from vaccination.
I had the vaccine on my left arm. I was advise of being thirsty symptom   the next day as a side effect. I got up as usual. I did my daily physical exercise routine as usual ( lift weight 80 lbs), Went to clean my face and look the mirror, and I notice I have my LEFT EYE bloody AND RED. Second day is more. I am using eye drops to remove this problem.  Never had this situation happened before and I have never had any shot for 55 years.
Itch at the injection site from the shoulder to the elbowon her left arm/ injection site itching; Headache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itch at the injection site from the shoulder to the elbowon her left arm/ injection site itching), HEADACHE (Headache) and FATIGUE (Tiredness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Morphine) and Drug allergy (Allergic to Codeine). Concomitant products included SIMVASTATIN, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL+HIDROCLOROTIAZIDA), MULTIVITAMINS [VITAMINS NOS] and MAGNESIUM for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Tiredness). On 23-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itch at the injection site from the shoulder to the elbowon her left arm/ injection site itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 26-Feb-2021, VACCINATION SITE PRURITUS (Itch at the injection site from the shoulder to the elbowon her left arm/ injection site itching) had resolved. At the time of the report, HEADACHE (Headache) and FATIGUE (Tiredness) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up received on 29-APR-2021 included: Added patient's demographics, Allergies (morphine and codeine), on 24-Jan-2021 patient received 1st dose (Lot# 030L20A) and on 21-FEB-2021 patient received 2nd dose (Lot# 023M20A), Concomitant medications added, The event (Injection site itching) outcome changed (from unknown to recovered on 26-FEB-2021).
as per patient her throat was closing... oxygen was taking BP and everything was in normal ranges , Dr examine 30 minutes  . Patient was discharged home after 2nd examination .  10 minutes after patient received covid vaccine stated her throat was closing.... patient was breathing well. she was talking oxygen was at 100% , well. Dr monitor patient in office for 30 minutes until she was stable.
No signs or symptoms reported; PEDVAX HIB was administered to patients after the excursion occurred; This spontaneous report was received from a licensed practical 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 26-OCT-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced temperature excursion with 35.0 Fahrenheit degrees (F), 35.1 F, 35.3 F, 35.2 F, 34.9 F for 53 minutes (cumulative). There was no previous temperature excursion. On an unknown date in 2021, after the excursion occurred, the patient was vaccinated with the improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (1 time dose, lot # U003873, expiration date 15-APR-2023; strength, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No signs or symptoms reported. No other adverse event (AE) or product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2111USA004277: US-009507513-2112USA003883: US-009507513-2112USA003884: US-009507513-2112USA003885: US-009507513-2112USA003881:
FIBROMYALGIA; GUILLAIN BARRE SYNDROME; COUGHING; BECAME AFRAID; ALARMED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry; Unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination (Dose number series 1). The batch number was not reported and has been requested. No concomitant medications were reported. Shortly after patient received the vaccine, In APR-2021, developed strange numbness and pain in arms, legs, neck and had tingling, cough and other symptoms throughout body. Guillain Barre Syndrome was the reason for which the patient was instructed to go to the emergency room at a Hospital. The patient became very alarmed and afraid as took that shot and a woman died of Guillain Barre Syndrome. The patient was unemployed due to Fibromyalgia and needed a complete shoulder replacement. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the guillain barre syndrome, coughing, became afraid ,alarmed and Fibromyalgia was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211233584.; Sender's Comments: V0: 20211233505- Covid-19 vaccine ad26.cov2.s -Guillain-Barre Syndrome. This event(s) is labeled and is therefore considered potentially related.
Had more issues than ever before; Had more infections than ever before; Ill for 3 days; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Had more issues than ever before), INFECTION (Had more infections than ever before) and ILLNESS (Ill for 3 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Thyroidectomy in 2000. Concomitant products included ZINC, VITAMIN C [ASCORBIC ACID] and VITAMINS NOS (MVI [VITAMINS NOS]) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had more issues than ever before), INFECTION (Had more infections than ever before) and ILLNESS (Ill for 3 days). At the time of the report, VACCINATION COMPLICATION (Had more issues than ever before) and INFECTION (Had more infections than ever before) outcome was unknown and ILLNESS (Ill for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.  Patient stated that they worked with COVID-19 patients for 1 year before taking the vaccine and did not get COVID-19.   This case was linked to MOD-2022-455745 (Patient Link).
Sore arm about 2 hours after injection; in 12 hours, severe headache; 24-72 hours were chills and body aches. About 48 hours after receiving the vaccine in my left arm, the same arm became exceptionally sore, both on the bicep and the inside of the arm. I could not let it relax at my side, since that was painful, and I couldn't rotate my shoulder in any way without extreme pain. The next day, the pain cleared up but there was a large visible bruise around where the Nexplanon implant was located in my left arm. I think the immune response in my left arm affected the implant and created a more painful experience than usual.
Arm was sore day 1 as expected and then dissipated. About 2 weeks later, noticed pain upon raising arm, crossing arm over body, or pulling off t-shirt over head. Seems worse at night. Pain in upper arm near shoulder originating near injection site. Concerned how long this condition will continue. Not getting better.
in 12 hours, I had a sore arm where the injection, weakness and shortness of breath, Normal routine with my  specialist in blood leukemia  did bloodwork two weeks after the 1st dose.
Severe pain in left arm. Swollen for months after the shot. Some nerve damage. Sometimes I can't move my left arm because of pain. Treatments: TORADOL, ADVIL, heat, a little exercise, etc.
NUMBNESS RANDOMLY IN THUMB INDEX AND MIDDLE FINGER/IN HAND JUST ABOVE WRIST/HAND WERE LIKE THEY FALL ASLEEP; TINGLING RANDOMLY IN THUMB INDEX AND MIDDLE FINGER/IN HAND JUST ABOVE THE WRIST; PAIN IN HANDS; PAIN IN SHOULDER/WRIST; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (NUMBNESS RANDOMLY IN THUMB INDEX AND MIDDLE FINGER/IN HAND JUST ABOVE WRIST/HAND WERE LIKE THEY FALL ASLEEP), PARAESTHESIA (TINGLING RANDOMLY IN THUMB INDEX AND MIDDLE FINGER/IN HAND JUST ABOVE THE WRIST), PAIN IN EXTREMITY (PAIN IN HANDS) and ARTHRALGIA (PAIN IN SHOULDER/WRIST) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis aggravated.    No Medical History information was reported.   On 04-Feb-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) (Intramuscular) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced HYPOAESTHESIA (NUMBNESS RANDOMLY IN THUMB INDEX AND MIDDLE FINGER/IN HAND JUST ABOVE WRIST/HAND WERE LIKE THEY FALL ASLEEP), PARAESTHESIA (TINGLING RANDOMLY IN THUMB INDEX AND MIDDLE FINGER/IN HAND JUST ABOVE THE WRIST), PAIN IN EXTREMITY (PAIN IN HANDS) and ARTHRALGIA (PAIN IN SHOULDER/WRIST). At the time of the report, HYPOAESTHESIA (NUMBNESS RANDOMLY IN THUMB INDEX AND MIDDLE FINGER/IN HAND JUST ABOVE WRIST/HAND WERE LIKE THEY FALL ASLEEP), PARAESTHESIA (TINGLING RANDOMLY IN THUMB INDEX AND MIDDLE FINGER/IN HAND JUST ABOVE THE WRIST), PAIN IN EXTREMITY (PAIN IN HANDS) and ARTHRALGIA (PAIN IN SHOULDER/WRIST) outcome was unknown.            No concomitant medications were provided by the reporter.  Patient had taken Humira product in the form of Solution for injection in pre-filled pen.  No treatment information was provided.   This case was linked to MOD-2022-596094 (Patient Link).
This spontaneous report received from a consumer via company representative through social media (J&J Corporate) 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced shingles. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles was not reported. This report was non-serious. This case, from the same reporter is linked to 20220231933.
Injection site pain; Extreme Exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 10:15 (Lot number: EW0150) at the age of 44 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Known allergies: sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: SLYND; ALLEGRA 24 HOUR; IBUPROFEN. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 31Mar2021 14:00, outcome "recovered" (2021), described as "Injection site pain"; FATIGUE (non-serious) with onset 31Mar2021 14:00, outcome "recovered" (2021), described as "Extreme Exhaustion". Therapeutic measures were taken as a result of vaccination site pain, fatigue.  Additional information: Patient occupation: None of the above. If other vaccine in four weeks: no. Other medications in two weeks: Slynd 4 MG, Allegra 24 HR, Ibuprofen as needed. Adverse event country:  resulted in: None of the above. If treatment  No.  treatment: Tylenol and ice. If Covid prior vaccination: No. If Covid tested post vaccination: No.  No follow-up attempts are needed. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-2021529341 Same patient/product, different dose/event
approx 30hr p/vax pt became stiff, arched back for approx 1min & held breath;pt has had no further episodes;
Breakthrough case admission after 3 vaccines Pfizer 4/14/2 Lot# Ew0164;  Pfizer 5/5/21 Lot# Ew0179;  Pfizer 11/21/21 lot# FH8030