chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In the right arm, the patient experienced swelling, tenderness and warm to the touch for 4 days following the vaccine administration. Patient did not report having a temperature.
Vomiting suddenly & severely about 30hrs after receiving injection. Felt warm but did not take temperature vomiting & diarrhea x7 hrs. 1st 4 hrs after 15mins. After 1st 2 vomiting episodes much was stomach juices. Absorbed sinus headache. Did not take any medications entire Sunday early evening 20hrs after 1st started vomiting, took Theraflu.
This case was reported by a nurse via sales rep and described the occurrence of vesicular rash in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown. It was unknown if the reporter considered the vesicular rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient received SHINGRIX and presented with a rash that appeared to look like shingles outbreak (not confirmed). The reporter agreed to follow up from GSK.
shakes; stiff neck; muscle pain; headache; fatigue; nausea; chills; shivers; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), MUSCULOSKELETAL STIFFNESS (stiff neck), MYALGIA (muscle pain), HEADACHE (headache) and FATIGUE (fatigue) in a 92-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (1st dose and lot number 028L20A) on 05-Feb-2021, COVID-19 VACCINE (2nd dose and lot number 023M20A) on 05-Mar-2021, COVID-19 VACCINE (3rd dose and lot number 071F21A) on 04-Nov-2021 and COVID-19 VACCINE (4th dose and lot number 057M21A) on 05-May-2022. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE and COVID-19 VACCINE. Concurrent medical conditions included Seasonal allergy (Allergies), COPD and Skin disorder.    On 13-Feb-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 13-Feb-2023, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck), MYALGIA (muscle pain), HEADACHE (headache), FATIGUE (fatigue), NAUSEA (nausea), CHILLS (chills) and CHILLS (shivers). On an unknown date, the patient experienced TREMOR (shakes). At the time of the report, TREMOR (shakes), MUSCULOSKELETAL STIFFNESS (stiff neck), MYALGIA (muscle pain), HEADACHE (headache), FATIGUE (fatigue), NAUSEA (nausea), CHILLS (chills) and CHILLS (shivers) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Fainting (Syncope) at home while teaching piano to student. Fell into corner near furniture, woke up after 30 seconds; husband transported to ER at hospital.
Headache; I can't get up; Coughing; booster; Giving the fever like for 3 holidays, after I got the booster I can''t get up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date Dec2021 (Lot number: 33130BA) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine ("The first one is on the 22Apr (Clarified as 22Apr2021) this year., dose 1 , MANUFACTURER UNKNOWN), administration date: 22Apr2021, when the patient was 28 years old, for COVID-19 Immunization; Covid-19 vaccine (Second one is on the May 17May (Clarified as 17May2021) this year.", dose 2 , MANUFACTURER UNKNOWN), administration date: 17May2021, when the patient was 28 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Dec2021, outcome "unknown", described as "booster"; PYREXIA (non-serious) with onset Dec2021, outcome "not recovered", described as "Giving the fever like for 3 holidays, after I got the booster I can't get up"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; DYSKINESIA (non-serious), outcome "unknown", described as "I can't get up"; COUGH (non-serious), outcome "unknown", described as "Coughing". Therapeutic measures were taken as a result of pyrexia. Therapeutic measures were not taken as a result of headache, dyskinesia, cough.  Additional information Consumer stated, "I have some question, I on the Sunday of this Dec I got the  booster Pfizer and after got that being, giving the fever like for 3 holidays, I don't know what to do with that, like before I get the booster I was everything was fine but after I got the booster I can't get up and I have a headache, I have fever, I have coughing and I don't know what is going on here, I don't know." Start of adverse event: Consumer stated, "Like after I take the booster on that night I was on the 'service' like at around  6 O'clock that was on 'light' I started to get fever, my fever continues on today I still having fever and it was such dull and 'light'."  Treatment: Consumer stated, "I don't took any medications, in general it doesn't seems right." When again probed for the treatment, Consumer stated, "I take Advil to lower my fever because I have been keeping having fever for three days and it still continues on, I don't know what to do with that, I feel so helpless. That's why I call you." When probed if the, Consumer stated, "The Advil helps me just temporarily like I take it I feel  little better and few hours later and then it comes back."
This spontaneous report as received from a pharmacist refers to a 64 year old female patient with no pertinent medical history and no drug reactions/allergies. On 11-DEC-2013 the patient was vaccinated with a dose of PNEUMOVAX23 lot # J009827, Expiration Date 10-AUG-2014 (dose and route unknown) and an unspecified influenza vaccine administered (1 vaccine administered in each arm). The patient called the pharmacy on 17-DEC-2013 to notify that "over the weekend" (on approximately 14-DEC-2013) her "entire arm swelled up." Pharmacist stated that it was determined that the arm that "swelled up" was the arm that PNEUMOVAX23 was administered. The patient went to see her unspecified physician on an unspecified date, who diagnosed the patient with cellulitis. The outcome of cellulitis was unknown. The patient visited physician office to seek medical attention. This is one of several reports received from the same source. Additional information has been requested.
The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 30-JUL-2014 was vaccinated with (Oka/Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and does schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Local swelling and fever at injection site (radiating 5 inched from injection), lethargy, decreased appetite.
Patient passed after HAVRIX (second vaccination was given), 911 and the Clinic Nurse was notified, pt was sitting down and we propped legs up in a chair, patient started to seize and came back. Patient came back before ammonia inhalent could be used. The Clinic nurse came straight over to assess the patient, upon assessment she said it was a vasovagal response (patient indicated he has a fear and anxiety of needles, also stated he passes out after giving blood).
Pt was flushed, nausea and vomiting, felt heaviness in chest, c/o arm pain (left arm). Advised pt to go to ER because no Drs were present in clinic. Red area on left arm 5 1/2 cm across.
calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 02-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
Had a migraine headache everyday; This is a spontaneous report from a contactable nurse, patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 08Apr2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the left arm on 15Mar2021 at (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient previously took meloxicam (MOBIC) and experienced drug allergy. On 01May2021, the patient experienced had a migraine headache every day. The patient had seen a neurologist and an MRI was ordered, that confirmed a new diagnosis of migraines. The patient did not have migraines prior to the vaccination. On an unknown date the patient underwent an magnetic resonance imaging (MRI) and the result was a new diagnoses of migraines. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of event which included an unspecified treatment and was ongoing at the time of this report. The clinical outcome of the event migraine headache was not resolved at the time of this report.
some confusion affecting life activities; some confusion affecting life activities; Having fatigue considerably; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Apr2021 11:00 (Lot number: ER8729) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sleep Apnea" (ongoing), notes: Pertinent details : N/A; "Schizophrenia" (ongoing), notes: Pertinent details : N/A; "High Blood Pressure" (ongoing); "Mental illness" (ongoing). Concomitant medication(s) included: CLOZARIL taken for tension (ongoing); LAMICTAL taken for tension (ongoing); KLONOPIN taken for tension (ongoing); DILTIAZEM taken for hypertension (ongoing). The following information was reported: CONFUSIONAL STATE (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset 2021, outcome "unknown" and all described as "some confusion affecting life activities"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Having fatigue considerably".  No follow-up attempts are possible. No further information is expected.
I woke in pain on the left side of my leg and hip including tingling and generalized pain, fatigue had actually begun two days before this. It felt like nerve pain as though I had pulled something like neurological nerve endings were aggravated. It felt like an inflammation reaction.
Day 1: Odd-sounding, high-pitched cry. Days 1-5: Somnolence (began 15 minutes after vaccination), gradually resolving; irritability, gradually resolving. Days 1-7: Injection site pink and hot, gradually resolving. Days 1-18: Fever - temperature "yo-yo'd" up and down, with lowest temperatures always above normal; gradually returned to normal over a period of about 2.5 weeks; entire head very hot to touch, even when fever at lowest points and rest of body felt much cooler; gradually returned to normal over a period of about 2.5 weeks. Days 2-17: Severe diaper rash (with red swollen areas on Days 5-10). Days 4-6, 19-20: Upper respiratory congestion (runny/stuffy nose, cough). Days 4-13: White rash, whole body (so severe skin became "scaley" with bumps by Day 6). Days 7-19: Diarrhea (foamy, bright yellow stools several times daily; sometimes "explosive"). Days 8-10: Vomiting and projectile vomiting. Days 9-17: Red rash, whole body. Days 11-14: Episodes of severe crying beginning suddenly, usually in conjunction with breastfeedings. Days 15, 20: Odd, repetitive, seizure-like movement of left arm. Days 18-40: Mild diaper rash. Days 21, 25, 28: Hives on trunk, unknown cause. Days 22-23: Fever and green diarrhea. Days 22, 32-34: Sneezing (without other upper respiratory symptoms). Days 31-34: Sleeping much more than usual, normal alertness when awake. Day 35: Painful intestinal gas. Days 33-66: Green, semi-digested, very liquid stools (with occasional days of normal-colored, well-digested stools - Days 48, 49, 55, 58-63); over a period of about 10 days beginning Day 66, stools gradually returned to consistent normal color and consistency. Note: What was striking about this period of illness following the DTaP vaccination was the contrast with the baby's previous good health. In her first 5 months, previous to this vaccination, her health had been good except for (1) an episode of severe diaper rash, along with very infrequent stooling - both apparently due to GI candida related to antibiotics and well resolved by about 2 months with minimal treatment; (2) 2 mild and brief "colds"; (3) an occasional greenish stool, and (4) mild allergy symptoms traced to dairy and soy. Before this vaccination, she had never had an odd-sounding, high-pitched cry; somnolence; significant fever, a "hot head", whole body red rash; severe whole body white rash; foamy yellow diarrhea; odd, repetitive, seizure-like arm movements; or hives; and she hasn't had any of these symptoms since the period immediately following this vaccination.
Experienced chest pain and chest burning; Weak; Felt dizzy; Felt very sick; Ear pain; Shivering; Experienced pain all over her body; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Experienced chest pain and chest burning), ASTHENIA (Weak), DIZZINESS (Felt dizzy), ILLNESS (Felt very sick) and EAR PAIN (Ear pain) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced CHEST PAIN (Experienced chest pain and chest burning), ASTHENIA (Weak), DIZZINESS (Felt dizzy), EAR PAIN (Ear pain), CHILLS (Shivering) and MYALGIA (Experienced pain all over her body). 06-Mar-2021, the patient experienced ILLNESS (Felt very sick). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and ESSENTIAL OILS NOS at an unspecified dose and frequency. On 12-Mar-2021, EAR PAIN (Ear pain), CHILLS (Shivering) and MYALGIA (Experienced pain all over her body) had resolved. At the time of the report, CHEST PAIN (Experienced chest pain and chest burning), ASTHENIA (Weak), DIZZINESS (Felt dizzy) and ILLNESS (Felt very sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Blood pressure measurement: normal (normal) Reported to be normal. On 06-Mar-2021, Body temperature: normal (normal) Reported to be normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Left deltoid region: red, swollen and warm to the touch.  Mother giving tylenol and applied ice last night.  Denied temperature.
An expired Pentacel was given to a 15 month old as a 4th dose, no AE; Initial information was received on 07-May-2021 regarding an unsolicited valid  non-serious case from a consumer/non-health care professional.  This case involves a 15-month-old female patient who was administered 0.5 ml fourth dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot: DTAP/ IPV: U6395AA, ActHIB: UJ160AA, expiry date: 24-Apr-2021) via intramuscular route in thigh for prophylactic vaccination on 07-May-2021.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA) for prophylactic vaccination.  It was a case of an actual medication error due to Expired product administered (latency same day).  At the time of report, no adverse event was reported  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
This case was reported by a pharmacist via sales rep and described the occurrence of stroke in a adult male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced stroke (serious criteria GSK medically significant) and numbness of upper extremities. On an unknown date, the outcome of the stroke and numbness of upper extremities were not recovered/not resolved. The reporter considered the stroke and numbness of upper extremities to be unrelated to SHINGRIX. Additional information was received as follows: The patient's arm became numb, and he was referred to emergency room,  where  the  physician  believed  that  the  patient  suffered  a  mild  stroke.  On  an  unknown  date,  the  patient  went  to  the  emergency  room and was sent to a rehabilitation facility. Neither the physician nor the patient's wife were attributing the stroke to the  SHINGRIX vaccine. The reporter searched the literature, and did not found anything concerning stroke. The incident had been reported VAERS. The reporter imagined that the numbness was due to the stroke and not due to the SHINGRIX vaccine.
his leg started to itch; a big rash the size of a hand,; "raised bumps/raised area; exhaustion; asthma got worse; soaked in sweat; itching and it was completely red; high blood preasure; This case was reported by a consumer via call center representative and described the occurrence of blood pressure high in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) powder for solution for injection for an unknown indication and cefuroxime unknown for an unknown indication.   Concurrent medical conditions included asthma. Concomitant products included prednisone.   On 1st April 2019, the patient received Shingrix and Nucala at an unknown dose and frequency. On an unknown date, the patient started cefuroxime at an unknown dose and frequency. On 1st April 2019, less than a day after receiving Shingrix, immediately after starting Nucala and not applicable after starting cefuroxime, the patient experienced blood pressure high. On an unknown date, the patient experienced itchy legs, rash, papular rash, exhaustion, asthma aggravated, hyperhidrosis and erythema. On an unknown date, the outcome of the blood pressure high, exhaustion, hyperhidrosis and erythema were unknown and the outcome of the itchy legs, rash and papular rash were recovering/resolving and the outcome of the asthma aggravated was not recovered/not resolved.   It was unknown if the reporter considered the blood pressure high, itchy legs, rash, papular rash, exhaustion, asthma aggravated, hyperhidrosis and erythema to be related to Shingrix and Nucala. It was unknown if the reporter considered the itchy legs, rash and papular rash to be related to cefuroxime.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that he had CBID (patient did not define acronym), and chronic asthma.  The patient reports that he has been taking Prednisone, and Cefuroxime off and on for five years. The patient was prescribed the medication Nucala subcutaneous injection once monthly. On 1st April 2019, the patient received Shingrix vaccination while taking Nucala. He reported immediate high blood pressure after the Nucala injection, but it passed. He also reported that about two weeks after Nucala he was sitting at the piano and all of a sudden, his leg started to itch. He looked down and soaked in sweat. he looked at leg where it was itching and it was completely red, a big rash the size of a hand, and a raised area. The patient reports that a rash, raised bumps, was developing on his arms as well. He also reported exhaustion directly after the Nucala injection. He reported that the rashes had not resolved, he stated the rash started at a 10, it was 2.5 now. It was getting better. The patient reported that he had been taking Prednisone, and Cefuroxime off and on for five years. He reported his doctor discontinued his Cefuroxime due to his current reactions. As a result of discontinuance, the patient stated the rash was half gone. The patient reported that stopping the Cefuroxime had resulted in his rash getting better. The patient stated, as got older by asthma got worse