chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle pain; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder pain) and MYALGIA (Muscle pain) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced ARTHRALGIA (Shoulder pain). On an unknown date, the patient experienced MYALGIA (Muscle pain). At the time of the report, ARTHRALGIA (Shoulder pain) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was reported.
Initial unsolicited report received from nurse on 21-Sep-2018. This case is linked to cases 2018SA267265, 2018SA267283, 2018SA267295, 2018SA267294, 2018SA267293, 2018SA267304, 2018SA267305 and 2018SA267274. This case involves a [60 years old] male patient who was vaccinated with a single expired dose 0.5 ml dose of FLUZONE QUADRIVALENT expiration date: 30-Jun-2018, site of administration: left deltoid and route was not reported) on 17-Sep-2018. The patient's medical history and concomitant medications were not reported. On 17-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI997AB via unknown route in the left deltoid. It was a case of actual medication error due to expired vaccine used. No reaction 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 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.
Within one hour, bright red, hot skin down left arm; extremely sore at injection site; weakness.  Approximately 17.5 hours after injection, woke up with severe headache and eye pain, trouble focusing eyes; more than normal ringing in ears; weak and somewhat dizzy; extreme muscle aches all over body; neck pain and neck stiffness; unable to hold head up in one position - would fall over to one side or the other; shivering, but not cold; stomach pain.  Symptoms lasted approximately seven hours, then, just weakness and sore muscles for another day.  The first dose of Shingrix produced only soreness at injection site.
rheometoid artheritis, phsoratic artheritis, body aches and pains, swollen feet and toes
This case was reported by a consumer via call center representative and described the occurrence of abnormal sensation of limbs in a 58-year-old male patient who received Shingrix for prophylaxis. In July 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced abnormal sensation of limbs. On an unknown date, the outcome of the abnormal sensation of limbs was recovered/resolved. It was unknown if the reporter considered the abnormal sensation of limbs to be related to Shingrix. Additional details were received as follows: The age at vaccination was not reported. The reporter was a patient, who received Shingrix 2 months ago in left arm. The patient noted arm sensitivity for 2 days and planned plans to get the second dose. The reporter declined to provide patient's demographics and follow up.
24 hours after shot-12/10, approximately 2 pm,started feeling sick to my stomach, body aches, went to bed.  The next day, 12/11, had diarrhea, body aches, chills, headaches, felt nauseated, felt like vomiting, but couldn't. These symptoms continued until 12/18 at which time I started feeling better.  On Thrusday, 12/15/, went to the employee health center to see if they could give me anything for the nausea, they could not, they told me I should go home if I had diarrhea.  This was around 10:30 am, I finished out my shift, around 2 pm.  The next day, 12/16, went again to employee health, again the same, could not give me anything, told me to go home or see my doctor. This was around 8:15 am, went and made an appointment with my doctor for 10:00am.  Went to my doctor at that time, was told there wasn't much to do, just rest and take tylenol, which I did.
Post vaccine pt started feeling light headed and dizziness on the way out of the facility. Pt was transferred to med obs via wc. Accompanied by daughter. Pt reported feeling better after lying down on stretcher. Vitals obtained and monitored. Pt started feeling better after several minutes of resting on the stretcher. Pt released at 1408 with daughter. Vitals as follows: 1359 LYING BP 155/86 HR 99 RR 14 SpO2 99% 1406 SITTING BP 146/107 HR 81 RR 14 SpO2 100% 1407 STANDING BP 163/79 HR 81 RR 14 SpO2 100%
died from cancer; kidneys shut down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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 (death), outcome "fatal", described as "died from cancer"; ACUTE KIDNEY INJURY (death), outcome "fatal", described as "kidneys shut down". The patient date of death was unknown. Reported cause of death: "died from cancer", "kidneys shut down". It was not reported if an autopsy was performed. Clinical course: As per reporter, he had lost 3 friends in the last 45 days, kidneys shut down. All 3 of them died from cancer.  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: Linked Report(s) : US-PFIZER INC-202200354728 same reporter, different patient/drug/event;; Reported Cause(s) of Death: died from cancer; kidneys shut down
PATIENT REPORTED DIZZINESS, LIGHT-HEADEDNESS, AND FEELING FEVERISH FIVE MINUTES AFTER VACCINATION. EMS ARRIVED TO CHECK ON PATIENT; AFTER EXAMINATION THEY DID NOT FIND ANY CONCERNING SYMPTOMS AND CLEARED HER TO DEPART THE PHARMACY.
Information has been received from a nurse referring to multiple, unspecified patients of unknown age and gender. On unknown date the patients were vaccinated with doses of improperly stored ZOSTAVAX (lot# reported as L001536 with expiration date of 03-JUL-2016, lot # L016283 with expiration date of 07-AUG-2016, dose, strength and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pruritis, erythema, and edema to injection site and arm, measurements: 10x12 cm. pt went home. no s/s of anaphylaxis or any life threatening reaction. no labored breathing or swelling anywhere but injection site.
Yesterday, I took 20,000 steps and my second shot feels like I'm on a caffeine buzz of energy.; My leg skin is starting to sag from losing weight quickly; My leg skin is starting to sag from losing weight quickly; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 10:00 (Lot number: ER8731) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: PROPOFOL; PROZAC; LISINOPRIL. Vaccination history included: Bnt162b2 (lot number:Er8727, administration time:10:00 AM, vaccine location:Left arm, dose number:1), administration date: 01Apr2021, when the patient was 40 years old, for Covid-19 immunisation, reaction(s): "Increase in energy". The following information was reported: ENERGY INCREASED (non-serious) with onset 21Apr2021, outcome "not recovered", described as "Yesterday, I took 20,000 steps and my second shot feels like I'm on a caffeine buzz of energy."; WEIGHT DECREASED (non-serious), CUTIS LAXA (non-serious) all with onset Apr2021, outcome "unknown" and all described as "My leg skin is starting to sag from losing weight quickly". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:The patient had Increase in energy, that was a stretch for him to hit 2,500 due to a mixture of pain, fatigue and other concerns over the years. Yesterday(21Apr2021), he took 20,000 steps and his second shot felt him like on a caffeine buzz of energy. He Heard about people had an awful experience, but he had zero pain and aside from the change in energy levels nothing negative. His leg skin was starting to sag from losing weight quickly. He had no known allergies also no other vaccine in four weeks and but received fish as medication in two weeks. No treatment was received for adverse events. He had no COVID-19 prior to vaccination and post the vaccination was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
04:50 p. Here for PNU and Flu requested per M.D. PNU RD and Flu Ld. ppeared pale and both arms started jerking 10 minutes after imm. given. 5:00  BP 113/67 P 104 R20  5:05p all called. 05:08  BP 107/58 P 97 R 18 Skin warm and dry. Alert still pale but a little greenish in appearance. EMT's arrived 05:10p BP 113/64 P 100 R 20. Mother agreed to have EMT transport child to ER for evaluation. Child walked out with assistance. All info. sent with pt.
She states that the patient has not reported any symptoms; female patient was administered Varivax 0.5 ml subcutaneous and ProQuad 0.5 ml subcutaneous on 20Feb2023; This spontaneous report was received from healthcare professional and refers to a 30-year-old female patient. The patient's concurrent conditions, pertinent medical history, and drug reactions or allergies were not reported. Concomitant therapies included sterile diluent.  On 20-FEB-2023, the patient was inadvertently administered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) 0.5 milliliter, lot #W020549, expiration date: 26-DEC-2023, administered subcutaneously (SQ); and with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #U015684, expiration date: 18-MAY-2023, administered SQ; both for prophylaxis (Overdose). The patient had not reported any symptoms. This issue was noticed upon after discharge of the patient, and she was not notified.
This report describes injection site redness and swelling in a 19-month ol female who received DTaP. In 04/00, the vaccinee received her first dose of Infanrix; No adverse events were reported. On 02/26/01, the vaccinee received her second dose of Infanrix. She also received IPv IM, ACTHIB IM. Post-vaccination, on 02/26/01, the vaccinee experienced redness and swelling at the site of the injection. The pt was taken to the local hospital following the incident, where an unspecified intravenous antibiotic was administered.  The vaccinee recovered on 02/27/01 w/out complications. The vaccine provider considered these events to be posssibly related to the administration of IPOL and ACTHIb. As of 03/06/01, the outcome of the events were recovered. The Infanrix dosing schedule was interrupted.
migraine disorder/Migraine headche; sensitivity to the light; moderate to severe white matter T2 hyperintensities; head tremor/shaking sensation of head; This case was reported by a lawyer and described the occurrence of migraine in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received via medical record.(This case is medically confirmed now).As per medical record the patient had concurrent medical conditions included hypertension.On 30 July 2018, the patient received Shingrix. The patient visited on 9 July 2019 and the patient had head tremor began 2 weeks after getting shingrix last year per patient on 13 August 2018. Also the patient had migraine headache. The patient had sensitivity to the light sound and nausea and shaking sensation of head.She had been taking Topamax 75 mg 2 times daily. MRI of the brain which showed no acute abnormality, mild cerebral and cerebellar volume loss, moderate to severe white matter T2 hyperintensities, nonspecific due to microvascular ischemia dated 4 December 2018.      Lab Comments: MRI of the brain which showed no acute abnormality, mild cerebral and cerebellar volume loss, moderate to severe white matter T2 hyperintensities, nonspecific due to microvascular ischemia dated 4 December 2018.
This is a spontaneous report from a contactable consumer via a sales representative. This consumer reported on behalf of her 4 year old daughter who received a single dose of PREVNAR13 on an unknown date. Relevant medical history and concomitant medications were unknown. The reported mentioned that only PREVNAR13 was administered to the patient. On an unknown date, at an unknown time, the patient experienced 102 degree F fever for 8 days. Relevant lab data was unknown . Emergency room or doctor visit were not required. At the time of the report the clinical outcome of above mentioned event was unknown. Follow-up (06DEC2012): Follow-up attempts completed. No further information expected.
no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 05-APR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002463:Original Case : 2104USA002463
SEVERE INJURY; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced severe injury. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe injury was not reported. This report was non-serious.
High Blood Pressure, Jaw Pain !0/10, headache, nausea, involuntary leg movement  We are deeply concerned about getting patient the care she needs.  There is a lack of urgency on the part of the hospital staff in acknowledging a connection to her receipt of vaccine and onset of adverse symptoms.
Symptoms: flu-like symptoms running nose, coughing progress to itchy rashes behind my right ear and my jawline areas
Patient presented to PCP office today with c/o skin sensitivity, chills, parathesia to the abdominal area and back area, reporting a "goosebump like sensation" on abdominal wall. Denied this sensation anywhere else.  Reports that he received travel vaccinations on 6/11/19 including MMRII, Typhoid and Yellow Fever.
covid 19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (covid 19) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Cholesterol.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: not go down 96.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took some medication for Cholesterol.   No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-741466 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741466:Same reporter Wife case
Severe fatigue and body aches all over.  Chills, nausea. Could not get out of bed morning after vaccine.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On unspecified dates, the patients were vaccinated with improperly stored VAQTA (unknown strength and route). Concomitant medications were not reported. No adverse symptoms were reported. The outcome of the event was unknown. There was no product quality complaint involved. This one of the several reports from the same reporter. Additional information has been requested.
Initial and follow/up information has been received from a Certified Medical Assistant (C.M.A) concerning a 16 year old female patient who on 29-MAR-2007 was vaccinated with a first dose of Gardasil lot #656050/0245U. On 29-MAR-2007 the patient developed headache, nausea and general achy feeling. Unspecified medical attention was sought. The patient was reported as not recovered. Additional information has been requested.
Patient reported feeling dizziness few minutes after getting the COVID-19 vaccine. She denies nausea and SOB. Patient admits that she has history of anxiety and panic attack especially after getting vaccines. Patient stated that she takes ativan 0.5mg bid as needed for anxiety and she did not take the medication prior to getting the vaccine. Patient was monitored in the medical bay. She reported felling well after 20 minutes. Patient left the vaccination site in a stable condition.
The patient  had tingling of her fingers, toes, and arm after both vaccinations. It lasted about five days.
12 days, post vax, the pt experienced severe thoracic herpes zoster, consisting of 100 lesions. Pts pain was reported to be a 6 on a scale of 0 - 10. Pt was treated with acyclovir for herpes zoster and Keflex for cellulitis and susequently recovered, according to follow-up information.
Diagnosed with shingles on 11/14/14. Prescription was given for Valacyclovir hcl1 g tablet.
On 1/6/2021 rash, redness, hot, itching, hematoma to injection site. Night sweats. Nausea. Side effects have not resolved at this time.
administered pentacel, only the dtap/ipv component was given. caller with question on whether she could order the hib diluent in order to administer the hib portion of pentacel with no reported adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 1-year-old female patient who administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)], only the DTAP/IPV component was given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza Vaccine for Prophylactic vaccination.  On 08-Sep-2023, the patient received a dose of 0.5 ml (frequency: once) suspect Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection of standard strength (lot: UJ877AA, Expiry date: 22-Mar-2024) via intramuscular route in the right thigh, only the DTAP/IPV component was given, the HIB diluent was not given and with question on whether she could order the HIB diluent in order to administer the HIB portion of Pentacel with no reported adverse event (product preparation error) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   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.
25 minutes after administrating the 2nd  moderna vaccine. , patient  started complain of tongue swelling .  BP 183/101 , Pulse 81. symptom wasn't getting worse . Called 911. they evaluate patient. Bp was still high,  There are no signs of anaphylaxis. Recommend to go to hospital for follow up . Patient stayed in the pharmacy for 20 minutes after 911 left and felt good and left home.