chrisvoncsefalvay/vaers-outcomes huggingface dataset:
they gave doses of Acthib and pentacel on the same day/no AE; Based on additional information received on 12-Jun-2019, case becomes valid as patient was identifiable.  Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 22 months old male patient who received vaccines HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL).  The patients past medical history family history were not provided.  No concomitant medication received.   On 10-Jun-2019, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (left thigh, second dose) and DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (right thigh, first dose) lot number not reported via intramuscular route.  It was an actual medication error due to extra dose administered.  It was reported that they gave 2 doses of Acthib and Pentacel on the same day.  It was reported that no adverse reaction was there after the injection.   Information on lot number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.  Follow-up information received on 12-Jun-2019 regarding an unsolicited non-serious case received from a Health Care Professional-Other.  Case becomes valid. Patient age was added. Suspect PENTACEL was added. Dosing details of both suspects added.   Information on lot number was requested.
she reports a lot of swelling and redness of her arm; she reports a lot of swelling and redness of her arm; This is a spontaneous report from contactable consumer (patient) via medical information team. A 55-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the Pfizer Covid 19 vaccine a week and one day ago. After it was administered, she said the provider massaged her arm. A day and a half later she reported a lot of swelling and redness of her arm that lasted for a day. The outcome of events was recovered on unspecified date.  Follow-up attempts were completed. No further information was expected.
Primary Smallpox vaccination on October 22, 2003. On October 31, at 2:00 am, he began to have chest pain. He describes the pain as sharp and stabbing in the center of his chest but also located at the bottom of his chest where his diaphragm is and in the area in front of his shoulders. The intensity initially was 5/10. The pain was worse when lying down and slightly better sitting upright. The most pain relief was when he was standing up, however, when standing, he would become light-headed. The pain would increase when he attempted to take a deep breath. The pain eventually eased and he was able to go back to sleep. When he woke in the morning he only felt only soreness in his chest that he rates 3/10. He reported to work and was running physical training when he began to have chest pain again. This time the pain was much worse and he also had difficulty breathing. This pain was rated 8/10. He became light-headed and was helped to the clinic. From there he was sent to the emergency room at the hospital. While in the ER he had an EKG and chest x-ray which were reportedly.  He was discharged home with Tylenol and Maalox. That afternoon, he reports that he felt better. He awakened at 4:00 am (Nov 1, 2003) with chest pain. This pain was the worst and rated 10/10. Again, he had difficulty breathing he became light-headed and passed out. He was transported to the hospital again and a repeat chest X-ray showed an enlarging heart when compared with the previous days x-ray. He was then transported by ambulance to the hospital. He was found to have a pericardial effusion. On Monday November 3, 2003 he had a pericardialcentesis performed and 600 ccs of serosanguineous fluid. The pericardial drain was left in place and he was put in the Intensive Care Unit. He reports that since having the fluid removed he finds that breathing is easier. The medical record received on 1/6/04 confirms pericardial effusion and states pericarditis and fever.
Large Bruise, aching pain/discomfort, some weakness in lifting arm and shoulder.
This spontaneous report as received from a healthcare worker refers to a 66 year old patient (second of 2 patients). On 20-NOV-2013 the patient was vaccinated with ZOSTAVAX vial of lot # J001729 and expiry date 20-OCT-2013, dose 0.65 ml, via subcutaneous route. The patient  had received an expired dose of ZOSTAVAX. No adverse effect was reported. This is 2 of 2 reports received from same reporter. Additional information has been requested.
She is dizzy at times it's worse than others but pretty constant, she had ringing in her ear and her stomach as been upset off and on.
Fussy and crying after imms. Inj site tender to touch and "puffy".
Sore arm starting around 1300hrs.  Approximately 1830hrs, felt like I couldn't get warm, took temperature and was at 100.1.  Went to bed and then start with serious chills and uncontrollable shivering.  By 1930hrs, temperature was 102.2.  Took two Extra Strength Tylenol around 2000hrs, shivering stopped about 30 minutes later and I fell asleep.  Woke up the next morning feeling tired, but without fever.  Felt fine by the end of the day.
monovalent Moderna Covid 19 bivalent vaccine booster dose instead of a bivalent booster dose on 1/17/2023; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent Moderna Covid 19 bivalent vaccine booster dose instead of a bivalent booster dose on 1/17/2023) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Lot number 037K20A, expiration date was 22-Jun-2021, route of administration: Right Arm ) on 29-Dec-2020, Moderna COVID-19 Vaccine (Lot number 043L20A, expiration date was 07-Jul-2021, route of administration: Right Arm ) on 26-Jan-2021, Moderna COVID-19 Vaccine (Booster dose, Lot number 047C21A, expiration date 7-Nov-2021, route of administration: Left Arm ) on 26-Oct-2021, Moderna COVID-19 Vaccine (2nd Booster dose, Lot number 066K21A, expiration date 7-Jul-2022 and route of administration: Left Arm ) on 25-Apr-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 17-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent Moderna Covid 19 bivalent vaccine booster dose instead of a bivalent booster dose on 1/17/2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent Moderna Covid 19 bivalent vaccine booster dose instead of a bivalent booster dose on 1/17/2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (monovalent Moderna Covid 19 bivalent vaccine booster dose instead of a bivalent booster dose on 1/17/2023).    No concomitant medicine were reported. It was reported that the patient received a 0.25ml Pediatric Dose instead of a 0.5ml Adult dose. No treatment medicine were reported.
Information has been received from a health professional concerning an 8 year old white female who on 22 June 1998, was vaccinated in the right arm with a first dose of varicella virus vaccine live (Oka/Merck) )lot # 625047/1574E). On 18 January 2006, the patient experienced red macules and a few vesicles. Treatment included acyclovir (Zovirax) for 5 days and symptomatic care. No lab work was done, but the patient was seen in the physician's office. The patient recovered on an unknown date. Additional information is not expected.
No egg or other allergy; Approx 15-20min p/shot c/o blurred vision, dizziness, dry mouth, feeling weak; BP 70/40 about 1120AM; 80/50 @ 1130; Given Epi SC @ 1150; @1155 BP 94/60; Pt had not eaten any breakfast or other food;
Patient developed chest pain late March.  Duration of 1-2 days.  No medical follow-up.  Patient developed chest pain and difficulty breathing 26 Apr.  He reported to a facility like Urgent Care.  HCP recommended CXR which revealed questionable findings.  HCP recommended hospital visit but patient did not go that day.  Instead patient called ambulance to home the next morning and was transferred to the local hospital. Chief complaint chest pain and difficulty breathing.  Bloodwork ruled out myocardial infarction.  Various other assessments done over the first three days of hospitalization, including a CT scan which purportedly showed about a pulmonary emboli.  Most (if not all) of the emboli were in the right lung and were small and fixed/immobile.  At least one was larger.   Patient was started on heparin .  Echocardiogram workup ruled out presence of DVT in the legs.  Patient was discharged after 13-14 days in the hospital.
Site injection soreness, pain, fatigue, loss of appetite,  gas (farts) , aches, pains, lower abdominal cramps,, chills, hot flashes, nausea, lower back pain, cold sore tingle on mouth, eye twitch, brathing issues, headache, sinus pain, runny nose
Approximately 3 days after receiving the vaccination pt began feeling achy with muscle stiffness.  She also felt "tender" and extremely tired.  Approximately 4 days after receiving the vaccination pt tried to do routine exercise and was unable to do so without resting at least twice during exercise.  Pt experienced back ache and soreness in her calf muscles.  These feelings gradually decreased over the next 10 days and pt felt about 90% better.
Swelling and soreness at area of vaccination. Swelling continued to spread from shoulder to wrist. Finally had to visit emergency room where cellulitis was diagnosed by Dr. and 10 days of antibiotics (Cephalexin) was prescribed. Doesn't have manufacturer or lot # info requested on ack letter.
Hive-like rash with pruritus 4-5 hours after MMR, VARIVAX. Intermittent rash for 2 days then resolved. BENADRYL helped rash. Photos emailed to PMD showed urticarial lesions on stomach and arms.
She works with us, she had vaccine at pharmacy 5/15, and reported this adverse reaction to me Monday 5/17/21 when she was at work.
BAD SIDE EFFECTS; SLEPT ALL DAY; SORE ARM; CHILLS; HEADACHE; FEVER; NAUSEAS; EXTREME FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 bad side effects, slept all day, sore arm, chills, headache, fever, nauseas, and extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, headache, fever, chills, nauseas, extreme fatigue, bad side effects and slept all day was not reported. This report was non-serious.
Patient's mother states child developed a fever on the evening of 2-6-13. She's not sure how high the fever was because her thermometer wasn't working. Mother said child developed an itchy rash during the day on 2-7-13 all over body. She brought child to Health Clinic. It was believed to be an allergic reaction and Prednisone was prescribed. Child took Prednisone for 3 days and it cleared the rash up.
occasional headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (occasional headaches) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and TREPROSTINIL SODIUM (IV drip) .165 microgram/kilogram. On an unknown date, the patient experienced HEADACHE (occasional headaches). At the time of the report, HEADACHE (occasional headaches) outcome was unknown.            No treatment medication was reported.   Reporter did not allow further contact
injection site hard; injection site a little red; injection site sore; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (injection site hard), VACCINATION SITE ERYTHEMA (injection site a little red), VACCINATION SITE PAIN (injection site sore) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Blood pressure (High blood pressure patient. On meds but unspecified.). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE INDURATION (injection site hard), VACCINATION SITE ERYTHEMA (injection site a little red), VACCINATION SITE PAIN (injection site sore) and HEADACHE (headache). At the time of the report, VACCINATION SITE INDURATION (injection site hard), VACCINATION SITE ERYTHEMA (injection site a little red), VACCINATION SITE PAIN (injection site sore) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicines also include water pill and medicines for cholesterol and high blood pressure.   No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI
Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown ages and gender. Information about medical history, concurrent condition and concomitant medication was unspecified. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX lot # L049536 with expiration date of 08-DEC-2017, strength, dosage, frequency and route unspecified). Temperature/ time frame was 10.8 F for 4 hour 48 minutes and previously temperature excursion was 30 F for 10 hours 45 minutes. This is one of two report received from the same reporter. Additional information has been requested.
Information has been received from a pharmacist concerning multiple patients of unknown age. On unspecified dates multiple patients were vaccinated either with VARIVAX (Merck) (lot # K002048, expiration date 10FEB2016) or ZOSTAVAX (lot# L011533, expiration date 03JUL2016) that was improperly stored. No adverse event was reported. Additional information has been requested.
My arm was burning to the bone, popping, snapping and very painful in left arm behind injection area. I started swelling up my arm and then into my neck area and then started having pain in my throat area. I also was having trouble breathing. This has continued.
Mild erythema noted around injection site.  Child c/o mild itching.  Informed by nurse who administered vaccine to follow-up with their medical doctor if symptoms worsen.  Informed of local reactions after vaccines.
MRI heart- injury to septum- PETSCAN =cardiac sarcoid; MRI heart- injury to septum- PETSCAN =cardiac sarcoid; 3 sec heart pause heart block 4 sec heart pause; This is a spontaneous report from a contactable other hcp (nurse). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Formulation: Solution for injection, Lot Number: EN51318) via dose 2 via an unspecified route of administration, administered in arm left on 22Mar2021 at 07:45 as single dose for COVID-19 immunisation. The patient medical history included asthma. The patient did not had known allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Lot Number: EL9269) via an unspecified route of administration in left arm on 03Mar2021 at 09.30 as single dose for COVID-19 immunisation. The patient did not had COVID prior to vaccination. The patient did not receive other medications in two and four weeks of vaccination. On 25Mar2021, COVID test (nasal swab) was negative. On 18Apr2021, the patient experienced chest, jaw and left arm pain went to the emergency department (ED). On 18Apr2021, troponins were elevated. On 19Apr2021 at 11:00, the patient experienced MRI heart- injury to septum- PET scan =cardiac sarcoid and 3 sec heart pause heart block 4 sec heart pause. The patient was treated with atropine. On 19Apr2021, the patient underwent lab tests and procedures which included computerised tomogram aorta (left/right bundle branch block(L/RBBB) for arrythmia): no aortic dissection/pulmonary embolism (PE), magnetic resonance imaging (MRI) heart: injury to septum and positron emission tomogram (PET): cardiac sarcoid. The events resulted in life threatening illness (immediate risk of death from the event). The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information currently available, the reported events of  cardiac sarcoidosis , intraventricular septum rupture and AV block  of the suspected vaccine BNT162B2 cannot be completely excluded. However, more information is required to assess the case properly. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Initial report was received from a health care professional on 29 March 2011. A 54 year-old female patient with a history of hypertension, allergic rhinitis and an allergy to sulfa had received a first dose intramuscular left deltoid injection of ADACEL, lot number U3874AA (sanofi pasteur Ltd. lot number C3823) on 25 March 2011 and an unspecified amount of time later developed pain down her arm and a large lump in her armpit region measuring 2 1/2 inches in length. The patient was evaluated by a physician on 29 March 2011. Treatments were not reported. Concomitant medications included Kozar and Hydrochloriothiazide. The patient received no other vaccines on 25 March 2011. Illness at time of vaccination, vaccines given within four weeks prior of suspect vaccine and adverse event following prior vaccinations were all denied. No further information was available at the time of the report. The patient's outcome was not recovered. Follow-up information received on 25 April 2011 from a health care professional. Additional medical history includes nausea when taking Sulfanilamides. Other concomitant medications that were listed included: NASALCROM for the eyes, Hydrochlorothiazide, COZAAR (previously reported as Kozar), RHINOCORT AQUA and EFFEXOR XR. Start dates for all concomitant medications were reported as 25 March 2011; and Indications were not provided. The patient was evaluated by a physician on 29 March 2011 at 8:15 am (4 days post-vaccination). Vital signs that day included blood pressure 149/84, temperature 98.3 degrees Fahrenheit and pulse 96 beats/minute. The patient had received the ADACEL vaccination the Friday before on 25 March 2011 and subsequently developed pain over the left arm with some radiation down her arm, but then noted swelling over the left axilla (anterior). Onset date was not provided. On the 29th the swelling had worsened, but there was not much pain, and no redness or fever. The left arm pain had resolved. Physical exam that day revealed no apparent distress, but left upper arm was positive for mild ecchymosis over the site of injection with no induration or erythema. The left anterior axilla had a 2.5 x 2 cm firm mass with no erythema or fluctuance. There were no signs of infection. The patient was prescribed warm compresses and Ibuprofen as needed. Final clinical assessment was suspect prominent lymphadenitis reaction. The patient was instructed to follow-up if symptoms worsened or if any redness occurred. At the time of this report, the patient had recovered (date not reported). Documents held by sender: Office visit doctor note.
My face had been growing increasingly hot and flushed since the vaccine on 10/21. However, it's not abnormal for me to feel a little under the weather after receiving my annual flu shot. When I went out into the sun on Sunday, 10/23, to let the dog out my face began to feel like it was on fire and when I blinked my eyelashes touching together was terribly painful.   When I got back inside and looked in the mirror I had a rash from the top of my chest, up my neck, on my chin and cheeks, up to the bottoms of my eyes where on the right side my eye was swollen above and below on the eyelid.
Patient reported swelling of left hand and forearm started 2 days after vaccination. Was evaluated by PCP on 3/11/21. Noted swelling left hand, wrist, forearm. few small areas of patchy erythema. u/s negative for DVT. inflammatory markers elevated, uric acid elevated. Given prednisone burst and taper with some improvement in symptoms, but not full resolution. Seen by rheumatology on 3/24/21 with broad differential and plan to monitor/close f/u. recommended against second vaccine dose for now.
The day of vaccination - Symptoms were: "Insolvable crying for more than 3 hours - High Fever - extremely high tactile, ete ? 104 and lower T (with simultaneous acetaminophen and Ibuprofen) was 101 degrees F - Not eating -No appetite - (L) Thigh - excessive Redness-Swelling.