chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from Health care professional on 29-May-2018. This case involves female patient (age not reported) who was vaccinated with an expired dose of MENACTRA (batch number, expiration date, dose, dose in series, route, site of administration was not reported) on an unknown date. Medical history was not reported. Concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event occurred. 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. Documents held by sender: none.
Patient received Pfizer vaccine + booster - 2/24/21, 3/17/21, booster 11/23/21. Patient asymptomatic except fever spike of 101 on 2/5/22.  Patient admitted 12/3/21 for NSTEMI.  12/5/21 suffered acute CVA.  Patient currently aphasic and placement to a facility pending.   Any information omitted from this report was purposeful and due to information availability at report submission.   Choice to say none of the above on item 21 is due to the identifier -(vaccine received during existing hospitalization).
sore arm; This spontaneous case was reported by a patient and describes the occurrence of TENDERNESS (sore arm) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (sore arm). At the time of the report, TENDERNESS (sore arm) 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.   Concomitant medications were not reported.   Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-737570 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737570:Same patient (Booster dose)
Fatigue, Dizziness, Fever, Severe Aches, Headache; Starting Gradually several hours after receiving the shot and continuing for several days. Hair loss was observed soon after and has not subsided.
Redness, swelling, itching. Patient presented to the pharmacy on 4/15/23 to show us her arm, which had a large red patch covering approximately 1/3 of her bicep area. She stated that it has continued to spread since Tuesday when she received her vaccine. She said that she was taking benadryl to reduce itching. Stated that there was no trouble breathing, etc. just localized reaction. Recommended that she follow up with PCP early this week when they are open to get a recommendation on any additional treatments required and  whether or not to receive second vaccine.
Swelling, redness, and heat at injection site; Redness, and heat at injection site; Heat at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. HCP did not provide how many patients were involved. No date of birth or any demographics for the other patients involved were reported. The patients experienced swelling, redness, and heat at injection site following a dose of Shingrix.  The events lasted for 4 to 5 days following administration. No additional information provided. The case has been linked with the case US2020161263 and US2020161260, reported as same reporter. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020161260:same reporter US-GLAXOSMITHKLINE-US2020161263:reporter's case
menstrual cramping; breakthrough hot flashes; This is a spontaneous report from a contactable consumer (patient). This 57-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6200) via an unspecified route of administration in the left arm on 02Mar2021 at 11:15 (at 57-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to anticonvulsants from an unknown date; and post-menopausal for 7-years from an unknown date. Concomitant medications were unspecified. Prior to vaccination the patient had not received any other vaccines in 4 weeks and had not been diagnosed with COVID-19. On 02Mar2021 at 20:00 the patient experienced menstrual cramping and breakthrough hot flashes; she reported she was post-menopausal by 7 years and was on hormone replacement therapy. No treatment was received for the events. The patient received the second dose of BNT162B2 (ER87340) in the left arm on 23Mar2021 for COVID-19 immunisation. The outcomes of the events were recovering. Since vaccination the patient had not been tested for COVID-19.
Stinging, numbness neck to elbow, local redness and swelling, diarrhea.
PNEUMOVAX 23 injected at L deltoid 2/13; pain immediately, swelling and decreased use of arm due to pain. Examined at office 2/17; she reports it resolved by 2/21/17.
Diagnosed with nummular eczema; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. The patient had history of known allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and multivitamin from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 09Feb2021 at 18:45 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient also took erythromycin (MANUFACTURER UNKNOWN), tetracycline (MANUFACTURER UNKNOWN) and doxorubicin (ADRIAMYCIN) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 01May2021, the patient had been diagnosed with nummular eczema about six weeks after the vaccination. She never had eczema before. Since the vaccination, the patient had not been tested for COVID-19. The adverse event resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures were taken as a result of reported events which included treatment with topical steroid cream (MANUFACTURER UNKNOWN). The clinical outcome of the event nummular eczema was not recovered at the time of this report.
Client received 0.3 ml of the pediatric vaccine instead of 0.3 ml of the adult vaccine
Dizziness/ light headed; Brain fog; Temperature of 99; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness/ light headed), FEELING ABNORMAL (Brain fog) and PYREXIA (Temperature of 99) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure fluctuation. Concomitant products included PANTOPRAZOLE and HYDROXYCHLOROQUINE for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DIZZINESS (Dizziness/ light headed), FEELING ABNORMAL (Brain fog) and PYREXIA (Temperature of 99). At the time of the report, DIZZINESS (Dizziness/ light headed), FEELING ABNORMAL (Brain fog) and PYREXIA (Temperature of 99) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: 99 (Inconclusive) 99.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-046395 (Patient Link).
Pt recvd vax & c/o pruritis, swelling & redness in area of circular bandaid; pt's condition was resolved & will cont w/vax series;
Patient had her second covid vaccine on 6/2/21 and had a lot of gi symptoms (like bloating and gas and feeling hungry even though she had eaten).  Then she suddenly had the pancreatitis on 6/8/21.  She had never had any issues with her gallbladder prior.  Pt ended up having cholecystectomy.  Patient is currently recovering.
This spontaneous report as received from a nurse via the representative refers to a 18 year old female patient. In June 2008 the patient was vaccinated with the first dose of GARDASIL (lot#, strength, dosage and route unknown). The patient received the second dose in June 2014, and then got a third dose of GARDASIL in August 2014. The outcome of the event was unknown. Additional information has been requested.
Patient developed fever, arm pain, vomiting, headache, and abdominal pain the morning after vaccination. Improved after 24 hours. Symptomatic care only.  Has sick contacts currently with gastroenteritis symptoms.
Initial symptom , nausea 6 hours later pain, itching and chills began (late afternoon). Woke up in night 2300, 0230 and 0600 with heat, swelling, itching and pain below injection site and radiation down arm.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. During 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 01-MAY-2016, the patient was treated by a physician and was diagnosed with herpes zoster or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This is a spontaneous report from a contactable consumer. A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Jan 26, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On Feb 14, 2021, patient experienced cough and fatigue. On an unspecified date in 2021, patient felt sick. Patient has been sick for two or three days now. Patient didn't know if it was safe to get the COVID-19 vaccine as her immune system was down. Cold started on Sunday. The second dose was scheduled Feb 16, 2021. The outcome of events: unknown. Follow-up attempts completed. No further information expected.
In addition to a sore arm and flu-like symptoms, I developed a swelling in my groin area.  This was discovered 2 days post injection.  I called my primary care physician who directed me to wait a week to see if the swelling went down.
Patient reports that one week after the Td, he developed cramping all over his body, no rash, no difficulty breathing, was seen by an Urgent care doctor who gave him a steroid injection and told him that the combination of heat and the tetanus one week earlier, gave him an allergic reaction. I have seen him for this complaint on 6/18/18, no rash and not complaint of cramping.
woke up the following morning with "itchy bumps on her injection arm that spread over the following 5 days down the right side of her body then to the rest of her body".  Gone now.
received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 46-year-old female patient who received HAV (Havrix) (batch number EK59B, expiry date 26th February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th March 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 7th March 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that a patient received an expired dose of Havrix, which led to expired vaccine used. The reporter consented for follow up.
Progressive rash extending from abdomen to thorax and upper extremities. Rash is dry scaling with mild erythema. No papules or vesicles. No obvious itching, fever, vomiting, or diarrhea. No rash at injection site. Rash present for 1 week and patient placed on topical hydrocortisone today. Patient seen at both and urgent care and physicians office
Medication was mixed with the incorrect diluent and then administered to the patient intramuscularly in the left arm
24 hour fever after booster which did not happen after my first two shots Pain in right knee  started 3 weeks after booster shot. Diagnosed with osteonecrosis of medial condyle left femur of unknow cause. Was not there one year prior on another radiograph
Dizziness, HYPERtension, Extreme fatigue, increased pain in areas that were already hurting which lasted for 30 days; increased blood pressure which required increased in meds; increased anxiety ; nightmares;difficulty sleeping
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB lot # L030864, expiration date: 07-JUN-2018 (exact dose and route of administration were not reported) and lot # L033690, expiration date: 14-JUN-2018 (exact dose and route of administration were not reported). There were no concomitant medications provided. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 120 hours. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information is not expected as reporter refused additional contact.
About 2 hour after receiving my second dose of the pfizer vaccine, I continued to do strenuous work outdoors in the hot evening. I began to feel very slight stabbing pain into the late evening. It was almost unnoticeable at first but continued throughout the night as I had trouble sleeping (I took approximately 800mg of ibuprofen at 2am that night). The next day I continued to do strenuous activity and by the afternoon I became fatigued by the vaccination and the sharp pain in the left side of my chest continued on and off until Monday afternoon and which by then the pain had moved towards the center of my chest. By Tuesday the stabbing sensation has stopped but the entire left side of my chest feels like a sore muscle.
Patient received vaccine at 3:45. The patient came back to the facility to be monitored at 4:14. The patient relayed to Paramedic that when she left the facility she said that she was starting to feel like her throat was closing. Paramedic walked the to sit down and obtain vitals which were in normal limits. The patient relayed to Paramedic that she did not want to take Benadryl because it makes her too drowsy too drive. Paramedic contacted Dr. and was informed to give the patient 40 mg of Pepcid + Benadryl. Paramedic gave patient 40mg of Pepcid. The patient relayed to Paramedic that she no longer having symptoms. Paramedic informed the patient to call 911 if any other symptoms occur. Patient declined Benadryl.
Vaccine received 1-22-21 - sore arm at injection site but "fine" after 48 hours. 1-29-21 arm was slightly swollen, red, warm, painful, itchy.
Erythema, warmth,edema in 10cm x 13cm area around injection site.
19SEP95 pt devel rash w/itching;mom states looks like hives;T100-101 (o);similar episode p/1st Hep B but NP told mom was not vax because sxs occurred 2 wks later; saw MD 22SEP95
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Lot number: AS7143C) at the age of 49 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
This initial spontaneous report was received from a healthcare professional referring to multiple unspecified patients of unknown ages and genders. there was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on multiple unspecified dates, the patients were administered improperly stored doses of ROTATEQ oral solution (lot # L022447 with expiration date 26-FEB-2017; dose was not reported). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from a physician (Pediatrician). This case involves an unknown demographic patient who was vaccinated with a dose of ACT-HIB (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to patient was administered ACTHIB without the DTaP-IPV diluent (product preparation error). No information about adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
redness, pain, swelling (approx 3" in diameter), and pruritus after both vaccines, two to three week duration. Injection site erythema 5> cm,subcutaneous nodules, at site within 24 hrs.
w/in 1 day of vax a few  pt devel redness & a nodule @ the inj site;no further info was available @ the date of this report;
Triaged by nurse; ice and ibuprofen. No indication for antibiotics. Pain posterior upper arm.
Chest pain  & rapid palpitations, shortness of breath , headache , swollen at the left side of my armpit & pain in sore in the area of administration
Patient with myasthenia gravis (33yr history) received Pneumo-Vac.  8 days later began to  experience exacerbation of symptoms with increased weakness and decrease of oropharyngeal strength.  Eventually required plasmapheresis and increase in pyridostigmine.  Nurse follow up on 08/19/04 states: "Complete." Per annual report-Partial recovery with residual increased requirement for pyridostigmine.
Part of the face started to clench a little, don't know if that's part of Bell's palsy or that was just; Heart palpitations; Chills; This is a spontaneous report from a contactable consumer, who reported for himself. A 50-years-old male consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EN6206), via an unspecified route of administration, on 03Mar2021 at 3:15 pm (at the age of 50-years-old) as a single dose for COVID-19 immunization, in left arm. Relevant medical history included cholesterol. Concomitant medications included: Rosuvastatin 20mg, once a day for cholesterol, started a year ago and Vitamin C. On 03Mar2021, the patient had heart palpitations that lasted multiple days. I went to a cardiologist and he wasn't sure whether I should do a second vaccine dose, given that was one of the side effect. He gave me metoprolol which took down the heart rate. But I had the chills, I had part of the face started to clench a little. I don't know if that's part of Bell's palsy or that was just, I just don't know. It wasn't strong, it went away relatively quickly, within 4 hours. Treatment for heart palpitation: Metoprolol Tartrate, 25 mg, one. No treatment received for chills. The clinical outcome of the events Heart palpitations and chills was recovered on 11Mar2021, the outcome of the event face started to clench a little was recovered on 03Mar2021.
Patient experienced fever of 101-103, night sweats, chills, body aches, headaches, increased urinary urgency,  burning upon urination, dark colored urine, rash on left thigh, and gained 4 lbs in course of 1 week after vaccine.  Patient had visit with primary care provider  1 week after vaccine.  Primary care provider communicated that patient's symptoms are now 80% better.  Provider is going to follow up with patient for further monitoring and treatment.
Pt presented to Immunizations clinic on 03/31/15 with small bump like rash under both axillaries, and left groin area. Pt denied any other symptoms at this time. Consulted with Provider and placed the pt on quarters for 48. Pt returned to clinic on 04/2/15 with bigger bumps to aforementioned areas and had spread to both hands of the patient. Provider consulted with regional rep, who then passed in on to another Provider. Both providers agreed that no further action at this time is required. Pt is to keep area covered when in public areas. Pt being sent to a dermatologist for further eval of rash.