chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8 months old was given quadracel with no reported ae; Initial information received on 01-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 8 months old female patient who was given Quadracel (DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE ) with no reported ae (adverse event)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis b vaccine and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination.  On 16-Nov-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE  lot U7526AA, expiration date:07-Sep-2024, via intramuscular route in the left thigh for prophylactic vaccination.  On 16-Nov-2022 the 8 months old was given quadracel with no reported ae (product administered to patient of inappropriate age) same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE . The patient used the product for the first time.  Action taken was not applicable.  corrective treatment :None  At time of reporting, the outcome was Unknown for the 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 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.At time of reporting, the outcome was Unknown for the event vaccination complication
Severe panic / anxiety attacks. Rapid heart beat. Throat and chest tightening. Dizziness
This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On 07-MAY-2015, according to the reporter, the patient was inadvertently vaccinated with MMR II (LOT # J003002), (strength not reported), subcutaneously injection, 0.5 ml; that had expired on 14-MAR-2015. No adverse effects reported. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 18 year old patient of an unknown gender. On 26-JAN-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
syncope; POTS; orthostatic intolerance; autonomic dysfunction; dizziness; fatigue; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 23-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), autonomic dysfunction, orthostatic intolerance, syncope, fatigue, and dizziness. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of syncope was determined to be medically significant.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Approximately 8 hours post vax received on 08/30/99, the pt experienced fever of 102F. Two days post vax on 09/01, the pt developed approximately 100 fluid filled vesicular rash. It was noted that the pt was never seen or evaluated by a physician, she telephoned the clinic to report the events. No further information is available.
Within a few minutes of receiving vaccine, patient developed chills, headache, dizziness, nausea and agitation that lasted 30 to 45 minutes. She recovered with no treatment.
Narrative:  LUL DVT (subclavian and axillary vein) in same arm; received **JANSSEN** Covid-19 Vector-NR vaccine on 3/9/21; onset of LUL swelling ~4/22/21. NO thrombocytopenia associated with clot. Hospitalized for anticoagulation initiation. Stable for discharge 4/29. Heparinoids used for treatment of clot.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 02-JUL-2018, the patient was vaccinated with a improperly stored dose of ROTATEQ orally, lot # N030175, expiration date 16-JUN-2019 (strength and vaccination site were not provided) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion at of above 32 degrees Fahrenheit up to 35 degrees Fahrenheit for 84 hours. There was no previous temperature excursion. Information was received from a data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA010993: US-009507513-1807USA010994: US-009507513-1807USA010995.
I started experiencing severe pain in my knees/legs on the day I received the vaccine, which went away in a few hours, however, I started experiencing pain in my knees/legs again a few days later after I received the first dose  which never went away. The pain slowly started travelling to other body parts such as arms, shoulders, hips, wrists etc. i was tested for any auto immune diseases with blood work, MRI, x-rays and EMG, however, the results were normal. I was then diagnosed with fibromyalgia by a rheumatologist and was prescribed lyrica 75mg, which seemed to help for a little bit but it isn?t helping at this time and I am experiencing the same pain again and it?s mostly in my legs. I do have discomfort, soreness in my arms and shoulders but it is mostly in my legs. I am unable to complete my ADLs without difficulty. I was seen by a PM&r doctor, neurologist, rheumatologist, my PCP and I also received physical therapy for 5 weeks, however, I am still experiencing the pain.
42 year old with a suspected adverse reaction to Flumist.  He was vaccinated on 24 Sept 2013.  He has had the Flumist at least 5 other times in the past with no issues.  He states that the following mid-afternoon (about 24 hours after the mist) he noticed the development of a tingling sensation in his arms/legs/feet/face that started.  This lasted about 1 hour and resolved.  This tingling sensation occurs about 3-4 times throughout the day.  He denies any fevers/arthralgias/muscle aches/pains.  He states that he feels like this causes his skin to itch during these events as well.  He has had these sympoms for over 14 days and they have roughly stayed the same.  He has not tried any medicaitons to fix this.  He has never had this type of reaction ever in the past. He denies any shortness of breath/angioedema/hives/GI symptoms/light-headedness/dizziness.
Made aware on 2/27/23, that there was an extra diluent vial in the state Menveo box that did not have the counter part with it, the powder vial. As we are unable to narrow down who received the incorrect diluent (received list of 4-patients that got that lot number), so all are being asked to revaccinate.
Dizziness following injection, dizziness approximately 2.5 hours later with paleness and weakness.  Allowed to lie down.
Initial unsolicited report received from a Physician on 10 January 2016. This case involves two patient (onset age and gender were not reported) who was vaccinated with an unknown doses of DAPTACEL (batch number, expiry date and dose in series were not reported) in an unknown site on an unknown date. Concomitant medications were not reported. On an unknown date, unspecified timeframe following the vaccination, the patient had developed severe swelling and redness. The patient's emergency room (ER) or doctor visit was not reported. The patients Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as unknown. List of documents held by sender: none.
dose_received: 3; injection site pain; tiredness; body aches; chills; nausea; heartburn; pain in left armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Dec2021 (Lot number: FA8027) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955), administration date: 08Apr2021, when the patient was 47 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955), administration date: 18Mar2021, when the patient was 47 years old, for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021, outcome "recovering", described as "dose_received: 3"; VACCINATION SITE PAIN (non-serious) with onset 21Dec2021, outcome "recovering", described as "injection site pain"; FATIGUE (non-serious) with onset 21Dec2021, outcome "recovering", described as "tiredness"; PAIN (non-serious) with onset 21Dec2021, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 21Dec2021, outcome "recovering", described as "chills"; NAUSEA (non-serious) with onset 21Dec2021, outcome "recovering", described as "nausea"; DYSPEPSIA (non-serious) with onset 21Dec2021, outcome "recovering", described as "heartburn"; AXILLARY PAIN (non-serious) with onset 21Dec2021, outcome "recovering", described as "pain in left armpit". Therapeutic measures were not taken as a result of immunisation, vaccination site pain, fatigue, pain, chills, nausea, dyspepsia, axillary pain. No follow-up attempts are possible. No further information is expected.
Pt called clinic to report her right arm developed pain, swelling, and redness at site of injection, she also reported unable to move her right arm (lift it) after receiving injection. Spoke to pt on phone today, 08/28/17, she stated all symptoms resolved.
She reported pain at the injection site, headace, and fever of 101F. Symptoms resolved with Tylenol.
The pt experienced spots and rash on face, headache, discomfort and itchiness.
I received  my booster shot on November 22, 2021. I began experiencing urticaria/hives all over my body 12 days later on December 4, 2021. The rash is all over and has not stopped since it began. Zyrtec has offered some relief, although symptoms begin to restart after taking Zyrtec after about 12 hours.
fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2021US151492_NC.  A 54 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "not recovered", described as "fever".  Additional Information: Patient stated that the day prior to starting Entresto she got COVID-19 booster and had developed fever which is still continuing.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a registered nurse referring to an 11 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 18-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored (incorrect product storage). This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA008666:
Positive for mild covid-19 disease (confirmed by PCR); Positive for mild covid-19 disease (confirmed by PCR); This is a spontaneous report from a contactable pharmacist (patient). A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 11Jan2021 17:00 (Batch/Lot Number: Unknown, unable to locate or read the details) as dose 2, single; via an unspecified route of administration on 21Dec2020 18:00 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included omeprazole taken for an unspecified indication, start and stop date were not reported. The patient experienced positive for mild covid-19 disease (confirmed by PCR) on 09Apr2021. The patient had been tested for COVID-19 since the vaccination. The patient underwent PCR test: positive on 09Apr2021. No treatment was received for the adverse event. The outcome of the event was recovering. The event was reported as non-serious.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test positive and vaccination failure due to temporal relationship.  Case will be re-assessed upon the additional information provided.
Deep itching of fingers in left hand (shot given in left arm) followed by significant exacerbation of Raynaud's symptoms which have persisted to date.
I have pain in both hands, my thumbs are worse/My right thumb is worst, more painful/It's painful to use my thumbs; Had muscle spasms from my injection site shoulder & into my neck; I could hardly move my thumbs; I had so much pain in my joints; Arm pain / had muscle spasms from my injection site shoulder & into my neck; A severe headache for 24 hrs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (I have pain in both hands, my thumbs are worse/My right thumb is worst, more painful/It's painful to use my thumbs), MUSCLE SPASMS (Had muscle spasms from my injection site shoulder & into my neck), HYPOKINESIA (I could hardly move my thumbs), ARTHRALGIA (I had so much pain in my joints) and VACCINATION SITE PAIN (Arm pain / had muscle spasms from my injection site shoulder & into my neck) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Osteoarthritis, Arthritis (arthritis in left thumb) and Joint disorder (basil joint issues in left hand).On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced MUSCLE SPASMS (Had muscle spasms from my injection site shoulder & into my neck), HYPOKINESIA (I could hardly move my thumbs), ARTHRALGIA (I had so much pain in my joints), VACCINATION SITE PAIN (Arm pain / had muscle spasms from my injection site shoulder & into my neck) and HEADACHE (A severe headache for 24 hrs). On 02-Dec-2021, the patient experienced PAIN IN EXTREMITY (I have pain in both hands, my thumbs are worse/My right thumb is worst, more painful/It's painful to use my thumbs). The patient was treated with HYDROCODONE for Adverse event, at a dose of 2 unit; PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and DICLOFENAC (VOLTAREN [DICLOFENAC]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (I have pain in both hands, my thumbs are worse/My right thumb is worst, more painful/It's painful to use my thumbs), MUSCLE SPASMS (Had muscle spasms from my injection site shoulder & into my neck), HYPOKINESIA (I could hardly move my thumbs) and ARTHRALGIA (I had so much pain in my joints) outcome was unknown and VACCINATION SITE PAIN (Arm pain / had muscle spasms from my injection site shoulder & into my neck) and HEADACHE (A severe headache for 24 hrs) had resolved. For 5 days patient couldn't even put on her socks.Concomitant medication details were not reported by the reporter. Treatment also included patient soaked her hands in hot water, & used a heating pad neither worked.This case was linked to MOD-2021-403846, MOD-2021-403852 (Patient Link).
During observation period, patient developed itching in her throat that did not resolve on its own. Was given 50mg PO of Benadryl and observe for another hour. Sx resolved and patient went home.
Last one night and one day: body muscle pain, headache, belly pain, fever, chill.  Took Advil for painkilling.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included fibromyalgia. Concomitant products included hydrocodone. On 6th April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th April 2019, 1 days after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities, swelling arm and skin warm. The patient was treated with ADVIL and Ice Pack (NOS). On an unknown date, the outcome of the pain in arm, erythema of extremities, swelling arm and skin warm were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, erythema of extremities, swelling arm and skin warm to be related to SHINGRIX. Additional case details were provided as follows: The patient received concomitantly hydrocodone for fibromyalgia but, it did not help. The patient received dose of SHINGRIX on Saturday and on the next day the patient experienced arm was red, warm, swollen and very sore. The reaction on the patient's arm was about the size of a pickle jar top. The patient has given the consent for follow up.
Running a low grade fever , chills , muscle aches, runny nose, headache, lost taste or smell, fatigue, cough, wheezing, shortness of breathe, nausea and vomiting and diarrhea.
Syncope, nausea, vomiting for ~ 2 hours, kept pt for observation until vomiting subsided. Pt reported at next visit that after she got home continued vomiting until 8:00 PM that night.Pt reported she had H/A the next day, that lasted all day.
This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 11-year-old male patient who received FLULAVAL Quadrivalent (batch number XZ3SP, expiry date 30th June 2015). On 11th November 2014, the patient received FLULAVAL Quadrivalent (intramuscular). In November 2014, less than a day after receiving FLULAVAL Quadrivalent, the patient experienced injection site erythema, injection site warmth, injection site tenderness and injection site swelling. FLULAVAL Quadrivalent was continued with no change. In November 2014, the outcome of the injection site erythema, injection site warmth, injection site tenderness and injection site swelling were recovered/resolved. The reporter considered the injection site erythema, injection site warmth, injection site tenderness and injection site swelling to be probably related to FLULAVAL Quadrivalent. Additional information was provided: A clinic reported that 5 different patients have experienced pretty severe injection site reactions within 24 hours (not immediate) of receiving 0.5 ml of FLULAVAL Quadrivalent. All the patients have had flu shots before with no previous reactions. Specifically, the injection site reaction consisted of redness, swelling, and tender and warm to the touch. All reactions were the size of a small apple/orange. The reactions were quite large and not a normal reaction that the clinic would expect. All the patients were later seen by the doctor with an office visit and the events have since resolved. This is one of the 5 cases reported by the same reporter for the same vaccine and with the same events.
Approximately 54hrs post vaccine, patient developed L hip pain. Pt complained initially when we checked on him in the evening afte rhe had fallen to sleep. No medications or other therapies were given at that time. The following day we spent the day walking through a Christmas themed amusement park. Patient continued to limp and complaint of pain. We wheeled him around in a stroller most of the day. We gave him ibuprofen to help with the pain. On exam he had swollen lymph nodes in his L hip. He maintained full range of motion in the hip during episode. By the following morning he was no longer complaining of pain or walking with a limp. His swollen lymph nodes lasted for a couple more days - improving daily. During this time he had no other symptoms such as fever, rash, body aches, change in bowel habits, nausea, vomiting, headache, or pain at the injection site. Total time of symptoms 24-36hrs.
Severe itching at and around injection sites. This has gotten worse over the last 3 months.
At 5:30am, fever 100.5 F with chills, profuse sweating, severe headache, severe fatigue. Took Tylenol 650 mg, 2 tabs, after that temperature returned to normal (98.8 F at 2pm; 99.3 F at 5:30p). Because headache did not resolve, I had to take additional Aleve 2 tabs (around 1:30p), then Excedrin Migrane 2 tabs (around 5:30p), the mild headache is still present at the reporting time. The moderate fatigue is still present. In addition, there is mild pain at the injection site (left arm) with mild erythema.
Pt received the incorrect Hep A vaccine. Pt recieved the Adult dose of 1.0mL instead of the pediatric dose of 0.5mL. Pts parents were notified as soon as this was discovered. Per pts mother pt did not have any adviser reactions.