chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) had resolved.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications were reported. Treatment information was not provided.Expiry date of the vaccine is on 11-Oct-2021. As of 15-Nov-2021, at least 30 patients were administered by this expired vaccine. It was reported that the no Adverse events occurred after administration of any of the vaccines that were reported as being expired.Most recent FOLLOW-UP information incorporated above includes:On 17-Nov-2021: Follow up received. Updated Batch/lot number and expiration date of Suspect and updated Action taken, De challenge as Not Applicable, Updated event outcome as Recovered/ Resolved. Updated company causality as Not Applicable from Initial version.
Received her PPD on 4/24 = 10mm (Prev. neg) Repeated PPD on 5/2/02 = 3mm
Enlargement of lymph nodes near both mastoid processes on 10/3/06.  She was seen & examined on 10/12/06. Buccal mucosa sores opposite anterior mandibular teeth on 10/3/06.  Resolved on 10/12/06. Onset of L ankle pain on 10/8/06.  Not tenderness & full AROM without pain.  Onset of L knee pain on 10/11/06.  C/o popliteal fossa pain with supine flexion to 90/135.  Gait is slightly antalgic.  Onset of L hand & wrist pain on 10/12/06.  C/o wrist & ring F pain with wrist flexion, radial & ulnar deviation.  Onset of numbness over L upper arm & forearm on 10/12/06.  Light touch sensation intact over these areas.
Red splotches the entire length of injection arm.  Inside the red splotches are small blisters.  The arm has continued to be sore.
patient did not have any reaction after receiving the dose, but patient and father provided the incorrect date of birth at time of vaccination, so patient was under 12 years of age at vaccination
Redness & swelling at injection site. Pain & pressure in both ears. Temporary loss of hearing. Subsequent ears noise.
Approximately 5 minutes after the injections he suddenly lost consciousness, fell to the floor, and lacerated chin.  No abnormal movements or incontinence.  Was very dazed for about 30 minutes, with normal pulse and B.P. during that time.  After another hour of lethargy, he returned to normal.  5 stitches.
Pt. states: "I have intense burning pain and inflammation in my left leg. Within hours of the vaccine, I felt the same kind of pain in my left wrist - where I had broken a bone many years ago. Over the last 2 weeks, the pain only worsened and spread all the way to my elbow and into my hand. I saw my pain doctor on Monday (April 12th) and he said we needed to wait and see how this plays out. On Tuesday, the same kind of pain developed in my other arm, and it became as painful as the left and both my hands became swollen and weak. For lack of a better description, Thursday night my whole body started vibrating and became worse on Friday, so I went to the ER, based on the recommendation of my primary doctor.
?Pfizer-BioNTech COVID-19 Vaccine EUA. My Left Leg (entire leg) was swollen & Numb) I received my vaccine and when I arrived home about 1pm that day My leg felt odd.  when walking, standing I felt an odd sensation in my left foot/lower calf area.  I had body aches mild which progressed at night especially pain running down my left side of my body.   The next morning I put on my clothes for work and my body still mild aches but the pant leg was tight especially around the calf.  My My left foot was swollen as well as my shoe fit tighter.  I also had a numbing sensation through the leg.  I had an ache behind the calf and the heel of my foot as well as the left foot of my left foot.  The swelling remained and I worried I might have a DVT.  I called my primary care DR office and they said I should go to the ER.  I called employee health at my job and they told me go to the ER.  So on 12/29/2020 I went to the ER.  The providers there also thought I had a DVT especially after examining my leg and recognizing the significant swelling.  My US venous doppler showed negative for DVT however a significantly enlarged lymph node.  As of today the swelling is much improved however still slight.  The sensation in my left foot is still not the same as before.  I have a numbness and tingling sensation that runs from my Left lateral calf down to the sole of my foot.
Feeling cold; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feeling cold), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VITAMINS NOS for an unknown indication.    The patient's past medical history included Pacemaker insertion (cardiac) (They stated that she has pacemaker/stent and that she doesn't have a spleen.). Concurrent medical conditions included Hypertension. Concomitant products included LATANOPROST, OMEPRAZOLE, LISINOPRIL and ALIROCUMAB (PRALUENT) for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started VITAMINS NOS (unknown route) 2000 milligram. On 03-Jun-2021, the patient experienced FEELING COLD (Feeling cold). 03-Jun-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING COLD (Feeling cold), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with the product mRNA-1273 was not applicable.   This case was linked to MOD-2021-247127 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received and contains no new information.
Felt he had a lump in his throat right after vaccine given and tingling in his throat.  oral benadryl given with resolution of symptoms.
Lip swelling; Chest tightness; Itching; Urticaria; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Urticaria), LIP SWELLING (Lip swelling), CHEST DISCOMFORT (Chest tightness) and PRURITUS (Itching) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 09-Mar-2021, the patient experienced URTICARIA (Urticaria) and PRURITUS (Itching). On 11-Mar-2021, the patient experienced LIP SWELLING (Lip swelling) and CHEST DISCOMFORT (Chest tightness). The patient was treated with PREDNISONE at a dose of 40 mg once a day; FAMOTIDINE at a dose of 40 mg once a day and DIPHENHYDRAMINE at a dose of 25 mg. At the time of the report, URTICARIA (Urticaria), LIP SWELLING (Lip swelling), CHEST DISCOMFORT (Chest tightness) and PRURITUS (Itching) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable
pt recv vax 22MAY98 & 12JUN98 pt exp hair loss;pt recovered p/3 months;pt was advised to have titer drawn to determine whether 3rd dose is indicated;
5 minutes after initial injection I became increasingly lightheaded, nauseous, dizzy, disoriented, and fatigued. 10 minutes after initial injection I experienced a short fainting event in passenger seat of vehicle. Immediately after regaining composure I began sweating profusely and became very pale/flushed color in face at which point I exited the vehicle and flagged EMS to assist me. EMS monitored blood pressure and blood saturation before releasing me on my own recognizance approximately 25 minutes later. Tingling sensation felt in left arm after fainting approximately 10 minuets after initial injection. Next 48 hours after injection I experienced severe body chills, body aches, headache, nausea, loss of appetite, and night sweats. 72 hours after injection I am close to fully recovered but still experience fatigue and night sweats.
Patient complained of slight swelling, pain, and a localized rash at the injection site of the ZOSTAVAX over the phone. Patient was instructed to use cold compresses, acetaminophen OTC as needed for pain/discomfort, and diphenhydramine OTC as needed for itching. Patient has annual doctor appointment where she will show area to doctor if reaction has not improved.
she inadvertently gave a 35 year old male the vaccine 1.5 hours after the 6 hours dilution period; she inadvertently gave a 35 year old male the vaccine 1.5 hours after the 6 hours dilution period; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program .  A 35-year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) and all described as "she inadvertently gave a 35 year old male the vaccine 1.5 hours after the 6 hours dilution period".  Additional information: The reporter stated that she diluted the vaccine, drew up 6 syringes and placed the syringes back into the refrigerator. The reporter stated that she inadvertently gave a 35 year old male the vaccine 1.5 hours after the 6 hours dilution period. The reporter confirmed diluted, Pfizer Covid-19 vaccine with a purple cap, stored in a syringe, in the refrigerator. The reporter queried if she would need to give the patient another dose. The reporter was seeking stability information for diluted Pfizer Covid-19 vaccine with a purple cap that was stored in the syringe.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-APR-2022.; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-APR-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-APR-2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-APR-2022.) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 10:24 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 10:24 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-APR-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-APR-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-APR-2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-APR-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. Patient's Ethnicity was reported. The time of vaccine administration was reported as 10:24:37. No treatment medication was reported by reporter.
lightheaded; extreme stomach pains; low grade fever; chills; body aches; full blown nausea; dizziness; This is a spontaneous report from a contactable other healthcare professional, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 27Mar2021(at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and penicillin allergy. Concomitant medications included olmesartan (MANUFACTURER UNKNOWN) and chlortalidone (CHLORTHALIDONE) all from an unknown date for unspecified indication. The patient previously took first dose of  BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 06Mar2021 at 10:15 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. 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 28Mar2021 at 02:00, the patient experienced low grade fever, chills, body aches. Woke up from sleep with full blown nausea, dizziness, lightheaded with extreme stomach pains. Symptoms have continued for the last 8 days since getting second vaccine. Visited medical provider on 05Apr2021. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events and included treatment with meclizine 12.5 mg / blood work. The clinical outcome of the events low grade fever, chills, body aches, full blown nausea, dizziness, lightheaded and extreme stomach pains was not recovered.   No follow-up attempts are needed. No further information is expected.
Debilitating headache from evening after shot and persisting for 5 days and counting; nausea and vomiting throughout night; nausea persisted 5+ days; fatigue for 5+ days. Could not get out of bed or partake in daily activities until the following Monday (shot was Wednesday)
Pt reports receiving dose #1 of the COVID-19 vaccine (Moderna) on 1/26/21. She reports feeling intense abdominal cramping that evening into the next morning, and she reports starting her menstrual period that morning. The pt continued to have 2-3 days of heavy menstrual bleeding then 2-3 weeks of intermittent passage of menstrual blood and clots with continued cramping. The pt has been receiving depo provera injections on time for approximately two years, and she reports that she has not had her period during this time. After receiving the COVID-19 vaccine was when she resumed her menstrual period after a long time. She reports to her primary care clinic today to receive her depo injection on time, and she reports having some menstrual bleeding today. This RN consulted with a provider on site who encouraged use of tylenol for abdominal cramping, maintaining hydration and rest.  This RN asked pt to call back next week after her 2nd dose of the COVID-19 vaccine to report status of menstruation and any side effects from depo injection or covid vacccine. It is also important to note that the pt has a hx of dysmenorrhea, but the two years of depo injections have suppressed her regular menstrual cycle.
No adverse event; Patient is Immunocompramised and Received 1st booster instead of 3rd dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is Immunocompramised and Received 1st booster instead of 3rd dose) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066021A, 026L20A and 013M20A) for COVID-19 vaccination.     Patient had no allergies.  The patient's past medical history included Transplant (2 transplants). Concurrent medical conditions included Immunocompromised, Diabetes and Gastroparesis (Stomach Gastroparesis).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is Immunocompramised and Received 1st booster instead of 3rd dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is Immunocompramised and Received 1st booster instead of 3rd dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            It was reported that patient had received antibodies to protect her against COVID 19.   The dose patient received  on 15-Aug-2021 was first booster dose.  No concomitant drug was reported.  No treatment drug was reported.   This case was linked to MOD-2022-660003.
Case number PHEH2012US022817, is an initial spontaneous report received from a medical assistant on 15 Nov 2012 and a follow up report from the health care professional received on 17 Dec 2012. This report refers to 29 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated intramuscularly with MENVEO (batch number: M11071, expiry date: Dec 2013) and received only Men CYW-135 liquid component on 14 Nov 2012 at a dose of 0.5 ml into the left deltoid region. No adverse event was reported following the maladministration. Follow up report from the health care professional received on 17 Dec 2012. The patient details, dose of the suspect drug and region of vaccination were updated.
fever of 102 degrees Fahrenheit; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 102 degrees Fahrenheit) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (fever of 102 degrees Fahrenheit). At the time of the report, PYREXIA (fever of 102 degrees Fahrenheit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
My cousin has Myocarditis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: MYOCARDITIS (medically significant), outcome "unknown", described as "My cousin has Myocarditis".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nausea, diarrhea, HA, fatigue, lightheadedness, general malaise, hives.
I started getting ''parasites''; This is a spontaneous report from a contactable consumer (patient). A patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date: not reported), via an unspecified route of administration in Jun2021 as single dose (dose number unknown) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. In July2021, the patient started getting parasites. The patient stated that must have got like a bad dose because of some rumor species which was never ever seen before. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (01Nov2021) follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.  Follow-up attempts completed. No further information is expected.
extreme itching; inch diamond shape round which is hard and warm to touch; Lower arm is swollen; Flushing feverish; nausea; fatigue; severe pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain in arm), PRURITUS (extreme itching), SWELLING (inch diamond shape round which is hard and warm to touch), PERIPHERAL SWELLING (Lower arm is swollen) and PYREXIA (Flushing feverish) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 01B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (severe pain in arm), PYREXIA (Flushing feverish), NAUSEA (nausea) and FATIGUE (fatigue). On 31-Mar-2021, the patient experienced PRURITUS (extreme itching), SWELLING (inch diamond shape round which is hard and warm to touch) and PERIPHERAL SWELLING (Lower arm is swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 29-Mar-2021, PAIN IN EXTREMITY (severe pain in arm), PYREXIA (Flushing feverish), NAUSEA (nausea) and FATIGUE (fatigue) had resolved. At the time of the report, PRURITUS (extreme itching), SWELLING (inch diamond shape round which is hard and warm to touch) and PERIPHERAL SWELLING (Lower arm is swollen) outcome was unknown.            Treatment  drugs used Benadryl cream, cold moistened washcloth Action taken for  mRNA-1273 vaccine t was not applicable. no concomitant medication was given by the reporter   This case was linked to US-MODERNATX, INC.-MOD-2021-065017 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up included no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065017:1st dose case
10 hours after: fatigue, headache and injection site pain/redness 30-36 hours after:  mild fever (100), increased heart rate (90-100bpm), chills, hot flashes, skin pain, increased injection site pain/redness, headache, muscle/joint pain 36 hours +: Injection site pain/redness, swollen lymph nodes in arm pit under injection-site arm - other side effects have subsided.
Localized swelling about 7 inches, redness, and pain.  Gave her a benadryl tablet.