chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse indicating that a patient's mother contacted the physician's office concerning her daughter, who completed the series for GARADSIL in July 2007 (unspecified vaccination dates and lot number). Within 4-5 months of completion, the patient developed rheumatoid arthritis and fibromyalgia. The patient had sought unknown medical attention. At the time of report the patient's status was unknown. Follow-up information was received from a nurse indicating that a 24 year old female patient with obesity, hypothyroidism, allergic to sulfa and PERCOCET, and a history of multiple surgeries on left ankle and heel (condition and dates not provided), gastric bypass surgery (in December 2008). The patient had no family history of rheumatoid arthritis and fibromyalgia. The patient was vaccinated with the first dose of GARDASIL (Lot #654389/0961F) on 26-JAN-2007, the second dose of GARDASIL (Lot#653736/0014U) and the third dose of GARDASIL (Lot# 0469U). There were no other vaccines given at the time of GARDASIL administration. Concomitant therapies included levothyroxine sodium (manufacturer unknown), VICODIN and cyclobenzaprine hydrochloride (MSD). In April 2009 (previously said "within 4-5 months of completion") the patient developed rheumatoid arthritis and fibramyalgia. The patient had sought medical attention, see a rheumatologist. At the time of the report the patient's status was not recovered. The nurse did not know or any hospitalization information and did not feel that the events were disabling or life threatening. Additional information has been requested.
(L) thigh 3x5cm induration, surrounding skin is mild red. Observation and warm compress.
Immediately after the shot my arm started hurting. The next day I started getting a headache and nausea, chills and muscle ache. My bottom lip was swollen by the third day and I was not feeling right. I had numbness going up to my right eye and I could not speak clearly.
expired FLUZONE QIV HD being administered with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from Nurse via Regulatory Authority (Reference number- 00801096) and transmitted to Sanofi on 06-Oct-2021.  This case is linked to case 2021SA333475 (same reporter).  This case involves an 82-year-old female patient who vaccinated with a 0.7 mL (total) dose of expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ454AB and expiry date 30-Jun-2021) via intramuscular route in the left deltoid on 06-Oct-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event 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.
Initial misuse case was received from a healthcare professional on 30 OCT 2013. The cases were received at GPV on 21 March 2014. A patient whose demographic details, , medical history and concomitant medication were not reported received, a dose of TETANUS TOXOID vaccine on an unspecified date (ROUTE, site dose and Batch number not reported). It was reported that on an unspecified date patient received expired dose of vaccine. Laboratory investigations were not reported. No adverse event was reported. List of documents held by sender were none.
A report received from a health professional on 11/05/2002, concerning a 38 month old vaccinee who was inadvertently administered Fluvirin. On 10/29/2002, the vaccinee was inadvertently administered Fluvirin. No adverse event occurred. There was insufficient information to determine the reporter's causality assessment
A pharmacist reported the occurrence of an injection site reaction in a 5 year old female who received Infanrix for prophylaxis. The subject's medical history included allergies to amoxicillin and possibly sulfa. The subject experienced no adverse events following previous immunizations. On 4/1/02, the subject received his fifth injeciton of Infanrix (538A2) into the left deltoid. On the same day, the subject also received injections of MMR II and IPOL. One day later, the subject developed an injection site reaction characterized by soreness and a 4cm by 5.5cm area of redness with a raised, hard urticarial border at the site of Infanrix adminsitration. On an unspecified date, the injection site reaction resolved. The reporter considered the injection site reaction to related to Infanrix administration. This report has been linked to reports A0389698a, A0389699a, A0389700A, and A0365783A due to same reporter.
Information has been received from a health professional concerning a 63 year old white menopausal female with asthma, hypertension, allergy to naproxen, allergy to aspirin and allergy to most anti-inflammatories and a history of acute sinusitis, urinary incontinence, irritable bowel syndrome, osteoarthritis and allergic rhinitis who on 06JAN2004, at 9:30 , was vaccinated IM in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included Vioxx, Nasacort, Clarinex, Detrol, Diovan HCT, Norvasc, Vitamin C and Vitamin E. On 07JAN2004 the pt was seen in the office with pain and redness of the arm. There was a large wheal around the injection site that went around the arm in a four inch band. It was described as red, warm and raised with no petechiae. It was painful to touch and with movement. She was afebrile. The pt was treated with Benadryl and Tequin for 7-10 days. No product quality complaint was involved. Follow up information from the health professional indicated that the pt came to the office with complaints of pain and redness in the right arm at the site of the dose of pneumococcal 23v polysaccharide vaccine given in the office. The pt was seen and was noted to have a large 3-4 inch band around the upper right arm that was red, raised and warm to touch. The pt complained of pain to touch and pain with movement. It was reported that a physician examined the patient. Treatment included Benadryl and Tequin. It was reported the pt recovered on approximately 13JAN2004. Additional information is not expected.
Initial information received on 22-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a six years old patient who received 0.5 ml ADACEL (lot: C5556AA, expiry date: 12-Mar-2020) via unknown route in the right deltoid, on 22-Mar-2020. The ADACEL PI stated that it is indicated for ages 10 to 64 years. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error inappropriate age at vaccine administration. It was unknown whether the patient had any adverse event. 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. List of documents held by sender: none.
Numbness, lack of sensation and weakness. Inability to walk. Hospitalized 10-2-11.
accidentally administered a Moderna booster dose to an 11 year old patient instead of a Pfizer pediatric dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally administered a Moderna booster dose to an 11 year old patient instead of a Pfizer pediatric dose) in an 11-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally administered a Moderna booster dose to an 11 year old patient instead of a Pfizer pediatric dose). On 11-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally administered a Moderna booster dose to an 11 year old patient instead of a Pfizer pediatric dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The patient did not experience any known symptoms and not received any treatments.
Adacel was given too soon at age 10 yr. 8 mo. instead of age 11 yr.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6204), administration date: 16Mar2021, for COVID-19 immunization, reaction(s): "Adrenal disorder", "Urine analysis abnormal". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional Information: Patient states she is to have MRI/radiology with contrast and asking about concomitant use. Patient states she received second dose and experienced no adverse event other than a sore arm. Asking if that indicates less efficacious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt's entire upper arm became inflamed, red and hot to touch. Pt complained of itching in affected area.
Patient reported that eye, jaw on right side of face feels weird.  Itching since 6 am on face and chest.  Patient took benadryl and advil and denies need to be seen by physician.
Lips are little bit swollen; I am having rash on back of the body and on arms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (I am having rash on back of the body and on arms) and LIP SWELLING (Lips are little bit swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced RASH (I am having rash on back of the body and on arms) and LIP SWELLING (Lips are little bit swollen). At the time of the report, RASH (I am having rash on back of the body and on arms) and LIP SWELLING (Lips are little bit swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
After receiving my 1st dose of the Moderna vaccine, I missed a period.  After 2nd dose of the vaccine, I completed the menstrual cycle I was in (meaning I had a period), but I have not had one since.  It's been 5 months.  My doctor has run test to make sure it is not early menopause or some other issue.  All tests came back in the normal range.
1st vaccine 2/19/21; developed fever, SOA, and chills same day; seen in ED on 2/20/21 for continued symptoms.  Had a lithotripsy 2/18/21.
Developed hives and dermatographism. Taking 25mg of hydroxyzine daily - relieves the itching but not the marks on my skin.
Fever; severe body aches; chills; headache; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 at 00:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. If other medications in two weeks were not reported. Prior to the vaccination, the patient was not 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 06Apr2021 at 03:00 the patient experienced fever, severe body aches, chills, headache and head kind of swimming. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fever, severe body aches, chills, headache was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Post-vaccine symptoms were typical for week 1 but continued into week 2 with nausea, severe headaches and exhaustion/lethargy off and on. It felt like when I was a covid long hauler. Week 3 persistent mild headache.
Erythema, Slight edema, tender, the erythema ranged in size approx radius 5 in to 16 in treated with Benadryl and ice packs
Headache, Myalgia, Arthralgia, Fever, Diarrhea, STOMACH CRAMPS Narrative: STAYED HOME FROM WORK
Approximately 8 hrs. after shot, became tired. Experienced chills and low grade fever about 100.5* for rest of and through night. Very achy in joints. Uncomfortable feeling in chest lasting few hours. Next day completely tired. Bad headache. Rest in bed all day.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 ". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 27May2023 to 01Jun2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective , Covid-19 and the use of suspect product BNT162b2, BNT162b2 omi ba.4-5 cannot be fully excluded.
Inj. site swelled hot to touch - as evening came - very fatigue feeling ill. Arm at site swelled double size. By 9 PM couldn't use arm at all - 9/26 sweling and redness moving down arm. Still have inf. and redness.
Attendee received Johnson & Johnson vaccine at 14:20 in the left arm.  Lot# 205A21A. Attendee was directed to observation area.   At 14:35 voiced complaints chest tightness and anxiety.  Attendee's skin was warm and dry.  Attendee's respirations were not tachypneic or dyspneic. Attendee refuse to go to the cot.   14:47  Reported being anxious and that he is going on a flight out of the country later today. Did not want 911 to be called. HR:  77   BP:  125/70   RR:   19   O2Sat%:  99      14:55 - Attendee decided that he was leaving. He did let them get another set of vital signs, before he left.
Redness and swelling at site extending up to elbow; Fever, chills, bodyaches, and severe fatigue day following vaccine
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 10:12 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 78.85. No concomitant medication was provided. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.   The BUD date was reported as 27-Jan-2021, and the date of vaccine moved to fridge was reported 05-Jan-2021. No treatment medication was provided.
Oblong, raised, erythematous, pruritic lesion surrounding injection site measuring 4 cm x 9.5 cm.
cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cancer".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 16OCT95 & devel a sore arm,occasional numbness in the hand,a fever of 102 & h/a w/in 1 hr of vax;pt had recovered;
Severe chills with chattering teeth for about an hour, then gradually lessening chills for the next 40 hours. Lightheadness for the first 24 hours (I couldn't stand up for long). Redness and tenderness at the injection site for about 4 days.
Patient came for a Pfizer Covid 19 IMZ with his husband. I gave the IMZ at in her right Deltoid around 4:45pm. She was asked along with her husband to stay for 15 minutes to observer and make sure there was no reaction before leaving. In a few minutes husband notified us that she is having a seizure (4:55 pm). I immediately came out to check on the patient, she was sitting in a chair in front of the immunization room. We called 911 (4:58 pm) right away and notified store manager immediately Patient was alert with no seizure reaction, She was able to talk to me. She complained being dizzy. I asked if she had any breathing difficulties and she said no and that she could breathe fine. I used wet paper towel to rob her forehead and back of her neck. Then I checked her BP (around 5:00 pm) which was 174/124 and HR 85. I continued to monitor her BP and HR every few minutes. Patient stated since the immunization room was too bright and when she left the room her eyes had to adjust for the light differences, that's why she went through that situation. EMS called me on my cell phone and stayed on the line with me while I was with patient. EMS arrived around 5:10pm .  They took her BP (160/116) and recommended her to go to hospital for observation, but she did not accept. She signed the form to not go to hospital. She and her husband left on their own power around 5:34pm
I received the Shingrix vaccine September 3, 2019 / been diagnosed with Pulmonary Fibrosis; Lung Inflammation; This case was reported by a consumer and described the occurrence of pulmonary fibrosis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2019, the patient received the 1st dose of Shingrix 50 ug. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pulmonary fibrosis (serious criteria GSK medically significant) and lung inflammation. The patient was treated with mycophenolic acid (Mycophenolate). On an unknown date, the outcome of the pulmonary fibrosis and lung inflammation were unknown.   It was unknown if the reporter considered the pulmonary fibrosis and lung inflammation to be related to Shingrix.  Additional details were reported as follows: The age group was not reported but it was selected as adult as per vaccine indication. The patient was taking 1500 mg Mycophenolate daily. The patient delayed starting the Mycophenolate until he or she could receive both the Shingrix and flu vaccines and allow 2 weeks for them to take effect. Now, the vaccinator advised the patient that they have the 2nd Shingrix available. The patient's doctor did not want the patient to discontinue the Mycophenolate to receive the 2nd vaccine. The doctor said that the patient could receive the 2nd dose while continuing the Mycophenolate. The patient asked an opinion on same. The patient further reported the purpose of this medication was to tone down the immune response to reduce inflammation in the lungs. It was working. The patient asked about the efficacy of Shingrix while on the Mycophenolat and asked if there were any other problems that the patient should be aware of.