chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practical nurse concerning a 6 month old patient, gender unknown. There was no information about the patient's concurrent conditions, concomitant medication, or medical history provided. On 19-SEP-2016, the patient was vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported). No symptoms were reported. The administered dose of vaccine experienced a temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions and no further temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012794: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004976: US-009507513-1705USA004977: US-009507513-1705USA004978: US-009507513-1705USA004979: US-009507513-1705USA004980: US-009507513-1705USA004981: US-009507513-1705USA004982: US-009507513-1705USA004983: US-009507513-1705USA004984: US-009507513-1705USA004985: US-009507513-1705USA004942: US-009507513-1705USA004944: US-009507513-1705USA004945: US-009507513-1705USA004946: US-009507513-1705USA004947: US-009507513-1705USA004948: US-009507513-1705USA004949: US-009507513-1705USA004950: US-009507513-1705USA004951: US-009507513-1705USA004954: US-009507513-1705USA004955: US-009507513-1705USA004956: US-009507513-1705USA004957: US-009507513-1705USA004958: US-009507513-1705USA004959: US-009507513-1705USA004960: US-009507513-1705USA004961: US-009507513-1705USA004962: US-009507513-1705USA004963: US-009507513-1705USA004964: US-009507513-1705USA004966: US-009507513-1705USA004967: US-009507513-1705USA004968: US-009507513-1705USA004969: US-009507513-1705USA004970: US-009507513-1705USA004971: US-009507513-1705USA004972: US-009507513-1705USA004973: US-009507513-1705USA005007: US-009507513-1705USA005004: US-009507513-1705USA005005: US-009507513-1705USA005006: US-009507513-1705USA004894: US-009507513-1705USA004895: US-009507513-1705USA004896: US-009507513-1705USA004897: US-009507513-1705USA004898: US-009507513-1705USA004899: US-009507513-1705USA004893: US-009507513-1705USA004892: US-009507513-1705USA004890: US-009507513-1705USA004889: US-009507513-1705USA004888: US-009507513-1705USA004952: US-009507513-1705USA004887: US-009507513-1705USA004891: US-009507513-1705USA004975: US-009507513-1705USA004974:
Cough; Soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 80-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 01Apr2021 at 12:30 (at the age of 80-year-old), as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation, bypass surgery, mitral valve replacement, chronic obstructive pulmonary disease (COPD) and COVID-19 and hospitalisation (due to COVID-19) in Dec2020 and did not suffer as much pain and discomfort as the side effects. The patient was not aware of any known allergies to medications, food or other products. Concomitant medications included warfarin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and torsemide (TORSEMIDE), all medications received on unknown date for unknown indications. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient experienced cough and soreness at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events cough and soreness at injection site was resolving at the time of reporting.   No follow-up attempts are needed. No further information is expected.
he had pain associated with that; redness, streaking from injection site expanded almost into his right arm pit; redness, streaking from  injection site; streaking from injection site expanded almost into his right arm pit, he had pain associated with that; This spontaneous report was received from a medical assistant and refers to a 62-year-old male patient. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 08-FEB-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe, lot #W019533, expiration date: 30-SEP-2023, intramuscularly (exact dose, and administration site were not provided) administered for prevention of pneumococcal disease.   On 08-FEB-2023, the patient experienced redness, streaking from injection site expanded almost into his right arm pit, he had pain associated with that (vaccination site erythema, vaccination site pain, erythema, pain in extremity). The patient was treated with cephalexin (manufacturer unknown). The action taken with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not applicable. The outcome of the events was not provided.  The relatedness between the suspect therapy and the events was not provided.  This is one of several reports received from the same reporter.
Feeling sick/ not well; Not pleasant lasted 5 days, more intense in the beginning; Nauseated; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Feeling sick/ not well), FEELING ABNORMAL (Not pleasant lasted 5 days, more intense in the beginning) and NAUSEA (Nauseated) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 prophylaxis.     The patient's past medical history included Sickness, Eye colour change (Had pink eye), Chest pain and Difficulty breathing. Concurrent medical conditions included GERD (Reflux), Type 2 diabetes mellitus, Blood pressure high, Allergy to antibiotic (Erythromycin (throws up)), Allergy to antibiotic (Tetracycline), Contrast media allergy (was rigid) and Dust allergy. Concomitant products included METOPROLOL TARTRATE (LOPRESSOR) for Blood pressure high, FAMOTIDINE (PEPCID [FAMOTIDINE]) for GERD, ACETYLSALICYLIC ACID (BABY ASPIRIN) and CANNABIDIOL (CBD OIL) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MALAISE (Feeling sick/ not well), FEELING ABNORMAL (Not pleasant lasted 5 days, more intense in the beginning) and NAUSEA (Nauseated). In 2021, MALAISE (Feeling sick/ not well), FEELING ABNORMAL (Not pleasant lasted 5 days, more intense in the beginning) and NAUSEA (Nauseated) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. After receiving 1st dose, patient reported feeling sick, nauseated, not well, not pleasant lasted 5 days, more intense in the beginning. Patient's symptoms were improved. The adverse event had caused patient to seek medical care. No treatment medications were reported.   This case was linked to MOD-2022-630474 (Patient Link).
mom informed hosp that pt exp breathing difficulty on the way home from clinic pt had resp arrest; was adm to hosp;
This initial spontaneous case, was received on 24-Oct-2017, from other non-health professional, concerning a 01-year-old male infant. The patient had no relevant medical history and concomitant medications. On 19-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration, anatomical location, batch number: 195222, expiry date: 30-Apr-2018) and had no adverse event. The reporter assessed the event as non-serious. Significant case correction received with IRD 24-Oct-2017: One event (no adverse event) was deleted and narrative was amended accordingly. Non-significant case correction received with IRD 24-Oct-2017: Expiry date of the product was added and narrative was amended.
Initial information received on 12-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist by phone. This case involves a 65 years old female patient who was inadvertently vaccinated with FLUZONE QUADRIVALENT and 0.3 ml of FLUZONE HIGH DOSE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to wrong vaccine administered and wrong technique in product usage process. It was unknown if any adverse event occurred or not following the vaccination. 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. Follow up report received from a pharmacist on 13-Dec-2018. Patient detail and medication error event updated. Documents held by the sender: none.
Headache, Myalgia,  fever, did not record temperature, reports short of breath times 24 hours then resolved   Narrative:  Reports took tylenol 500 mg.
swollen and very sore lymph nodes in armpits, neck and groin area; bleeding gums; This is a spontaneous report from a contactable pharmacist (patient). A 46-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 at 10:30 as DOSE 2 (Age at Vaccination: 46), SINGLE for covid-19 immunisation. Medical history included mastectomy (2010 to an unknown date). The patient had no known allergies. There were no concomitant medications. The patient received dose 1 of bnt162b2 on 03Feb2021 for covid-19 immunisation (vaccine location: Left arm, lot number: EL9264). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced swollen and very sore lymph nodes in armpits, neck and groin area and bleeding gums on 25Feb2021 at 02:00. The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of both the events was not recovered.  Information about Lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Within 4 hours of vaccination, the site was swollen, red, and tender to the size of patient's fist around injection site. Within 24 hours, the swelling and redness had expanded to include his whole upper leg from hip bone to just above the knee and all around the thigh. The tenderness caused pain during any movement of the leg and discomfort at rest. 5 mL acetaminophen administered at bedtime to induce sleep. The morning of Jan 6, swelling and redness had not subsided. Itching at the site started.
I experienced at first a slight tingling and burning sensation on left side - mid chest and continued to my back. I consulted with Doctor and she confirmed shingles as I showed her the lesions on my side. I was prescribed an opioid which I refused. I used a topical spray with  lidocaine and capsaicin patches without relief. .Gabapentin was then prescribed which I did not want to take either. I used ibuprofen and after a few weeks it has gradually get better. I still have skin sensitivity, but it is gradually disappearing. I have been testing my self with a rapid COVID test once per week. I have never had a positive test. Sx are improving.
ARM WAS A LITTLE SORE; FEVERISH; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 subject experienced arm was a little sore, and feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm was a little sore and feverish was not reported. This report was non-serious.
Participant fainted after receiving vaccine/ ice pack was applied to neck and forehead/ no epi administered/ 911 called by company security, participant declined transport to hospital, left the room in stable condition.
Patient was inadvertently given the Moderna bivalent booster instead of the first dose of the Moderna primary series. This was recognized by the pharmacist  when the patient presented to the pharmacy a month later for her second dose. Patient reported no adverse effects from the bivalent dose that was given on 11/29. After consulting with the patient and referring to CDC recommendations for Moderna COVID19 vaccination schedule diversion, the patient was given a 0.5ml dose of the Moderna primary series on 12/27 in order to ensure full vaccination status against COVID19.
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 22-OCT-2015, the patient was vaccinated with a dose of unspecified HPV vaccine (unknown if it was GARDASIL or GARDASIL 9) "SDV; 10 pack" and lot number K010215 with expiration date of 05-MAY-2017 (dose, route of administration and anatomical location were unknown), which was stored at the lowest recorded temperature of 34 (1.111111111 Celsius degrees) for 36 hours. The storage criteria and the storage type were reported a "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sweling lymph node under left arm pit; swollen lymph node in left side of her neck; Arm soreness; Fatigue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Arm soreness), LYMPHADENOPATHY (Sweling lymph node under left arm pit), FATIGUE (Fatigue) and LYMPHADENOPATHY (swollen lymph node in left side of her neck) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history.). Concomitant products included LEVOTHYROXINE and AZILSARTAN for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness) and FATIGUE (Fatigue). On 19-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (Sweling lymph node under left arm pit) and LYMPHADENOPATHY (swollen lymph node in left side of her neck). At the time of the report, VACCINATION SITE PAIN (Arm soreness) and FATIGUE (Fatigue) outcome was unknown and LYMPHADENOPATHY (Sweling lymph node under left arm pit) and LYMPHADENOPATHY (swollen lymph node in left side of her neck) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details not reported by the reporter.; 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.
Liver enzymes were elevated. On the day of the vaccination (7/16/09), ALT was recorded at 17. On 08/26/09, ALT was recorded at 130. On 9/4/09, ALT was recorded at 158. On 9/11/09, ALT was recorded at 117. Ultrasound of the liver was performed on 9/16/09 with results pending.  8/5/09 PCP medical records service dates 716/09 to 9/11/09. Assessment: Gastritis Patient presented with abdominal pain, black stools, fever, nausea. Dizziness.
Acute worsening of Complex regional pain syndrome; This literature-non-study case was reported in a literature article and describes the occurrence of COMPLEX REGIONAL PAIN SYNDROME (Acute worsening of Complex regional pain syndrome) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Concurrent medical conditions included Complex regional pain syndrome Type I.    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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COMPLEX REGIONAL PAIN SYNDROME (Acute worsening of Complex regional pain syndrome) (seriousness criterion medically significant). At the time of the report, COMPLEX REGIONAL PAIN SYNDROME (Acute worsening of Complex regional pain syndrome) had resolved. Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COMPLEX REGIONAL PAIN SYNDROME (Acute worsening of Complex regional pain syndrome) to be related.    Patient was diagnosed with CRPS type I who presented with acute worsening of symptoms after mRNA-based COVID-19 vaccination and their medical management.  Patient reported severe worsening of the right lower extremity, burning pain, color changes and temperature changes within 24 hours of first dose of mRNA COVID-19 Vaccination(Moderna).  The acute clinical worsening after mRNA-based COVID-19 vaccination was transient and effectively managed with adjustment of individualized therapy in all patients. However, clinicians should be aware of the possibility that there may be a clinical worsening CRPS after mRNA-based COVID-19 vaccination  Concomitant and Treatment medications were not reported. COMPANY COMMENT: This is a Literature non-study case concerning a 49-years-old female patient with clinical history of Complex regional pain syndrome who experienced the unexpected event of COMPLEX REGIONAL PAIN SYNDROME (Acute worsening) 1 days after 1st dose of RNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-512201 (Patient Link).; Sender's Comments: COMPANY COMMENT: This is a Literature non-study case concerning a 49-years-old female patient with clinical history of Complex regional pain syndrome who experienced the unexpected event of COMPLEX REGIONAL PAIN SYNDROME (Acute worsening) 1 days after 1st dose of RNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Dark purple bruise about the size of a quarter; Worried about not getting the full benefit of the vaccine due to incorrect administration; This spontaneous case was received on 14-Sep-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-02224) and concerned a 63-year-old female patient.  The patient had no relevant medical history and was not taking any concomitant medications. The patient's historical vaccines included two shots of an unspecified Covid vaccine in the same arm.   On 08-Sep-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular and indication: not reported). The batch number was not reported.  On 09-Sep-2021, one day after receiving Flucelvax Quadrivalent, the patient developed a dark purple bruise about the size of a quarter.   On an unspecified date in Sep-2021, the patient was worried about not getting the full benefit of the vaccine due to incorrect administration (explicitly coded as 'Product administration error'). There were no treatment measures associated with the event.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A 63-year-old patient was administered Flucelvax Quadrivalent. One day after receiving the vaccine, the patient developed a dark purple bruise about the size of a quarter. Reportedly, the patient was worried about not getting the full benefit of the vaccine due to incorrect administration. Product administration error is assessed as unrelated per company's conventions.; Sender's Comments: A 63-year-old patient was administered Flucelvax Quadrivalent. One day after receiving the vaccine, the patient developed a dark purple bruise about the size of a quarter. Reportedly, the patient was worried about not getting the full benefit of the vaccine due to incorrect administration. Product administration error is assessed as unrelated per company's conventions.