chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; expired vaccine was dosed to 4 individuals; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine was dosed to 4 individuals) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2023, 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. In July 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine was dosed to 4 individuals). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine was dosed to 4 individuals) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine was dosed to 4 individuals).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown.  It was reported that expired vaccine was dosed to 4 individuals on 10-Jul-2023, 14-Jul-2023 and 17-Jul-2023. The vial size was unknown. The vial was initially stored in the refrigerator on 10-Jul-2023. The vial did not undergo any temperature excursions.  No treatment medication was reported.   The NDC number given as 80777028299   This case contains information about patient 2 out of 4 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733819 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733819:Master case (Patient 1)
4/7 Day of shot approx 5 hours after shot - aches and pain from neck to knee on right side of body  (injection side), particularly in back of neck and lower back.  Difficulty lifting right arm.   4/8 (day after shot) tightness in chest and productive cough.  Pain in right arm at injection site.  4/11  (4 days after shot) - extreme fatigue and headache for entire day. 4/12 (5 days after shot) - extreme pain and swelling in right armpit.  Pain in muscles surrounding right scapula 4/14 (week after shot) - pain in armpit dulls but is still there.   extreme pain in muscles at based of neck on right side and muscles surrounding scapula.  Also pain in lower back may be due to not sleeping well.
Information has been received from a physician concerning a 15 female who on an unspecified date was vaccinated with the first dose of GARDISIL. On an unspecified date was vaccinated with the second dose of GARDISIL. The patient experienced fever and syncope after the first and second dose. The first incident was not as severe as the second. Subsequently, on an unspecified date, the patient recovered from fever and syncope. The patient sought medical attention at physician's office. Additional information has been requested.
Woozy/lightheaded; Sick to the stomach; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Woozy/lightheaded) and ABDOMINAL DISCOMFORT (Sick to the stomach) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     Concomitant products included LORAZEPAM for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced DIZZINESS (Woozy/lightheaded) and ABDOMINAL DISCOMFORT (Sick to the stomach). At the time of the report, DIZZINESS (Woozy/lightheaded) and ABDOMINAL DISCOMFORT (Sick to the stomach) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant product use included blood pressure and cholesterol medications for unspecified indications. Treatment information was not provided. Patient provided consent to follow up. Patient reported she was feeling well and does not have any symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Narrative updated.
Pains and pressure in chest 4 days, G.I. issue 5 days, Headache most days, nausea 4 days, joint pain 5 days, dizziness 2 days, loss of appetite 4 days, painful lump under vaccine arm 3 days, fatigue, loss of concentration 9 days. 15+ days with various symptoms
This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient. A 67-year-old patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for Covid-19 immunization; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunization. The patient's relevant medical history was not reported. The patient took concomitant medications, also reported as Patient took other medication in 2weeks (Unspecified). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19 included Paxlovid from 16Jul2022 to 21Jul2022. Clinical course: Patient had rebound of symptoms. If treatment received for symptoms was unknown and patient was recovering from symptoms. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Patient reported no vaccine site reaction but reported Nausea, achy feeling, sweating and headache. Patient says that they passed out in bathroom (syncope).
Little brown, purple, and red spots (lots of red spots) allover the body.  Little blood vessels broke.  Pt has not been feeling good since receiving the shot. Pt did not hit her legs but had a very painful legs and when she looked down she had blood vessels broking. Has red blood vessels on face and legs only.  Pt has been feeling tired and no energy and was not  able to work some days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test false positive: (11May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache, Fever, INJECTION SITE PAIN, CHILLS Narrative:  Other Relevant History:
Arthralgia  INJECTION SITE DISCOMFORT SORE,  INJECTION SITE REDNESS, FATIGUE  Narrative:
cough; headache; feel cold; fever; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller said he should get the second dose tomorrow 09Jan2021, asked if the date was correct. Caller said he received the 1st dose on 19Dec2020.At the end of the call he mentioned he "had symptoms", had a "headache, feel cold and fever". Caller confirmed he no longer had these side effects "but have cough".  The outcome of the event cough was not recovered on an unspecified date. The outcome of the other events was recovered on an unspecified date.    No follow-up attempts are possible; information about batch number cannot be obtained.
Rash, itching, similar in appearance to ringworm. Appearing in multiple locations: hands, arms, legs, feet. Treating symptoms with prednisone and antihistamines. Treatment started today (4/28) and as of now, the condition is ongoing and seems to be intensifying.
Had the shot then got the shingles\ Suspected vaccination failure; got shingles three times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shot and got the shingles three times. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Pt.'s mother began noticing several dirty diapers that contained blood and took baby to the emergency room at Hospital.
3-4 minutes post vaccination, patient had a syncopal episode x45 seconds and incurred a fall injury. Patient lost consciousness and fell forward into a wall while still in the clinical area. She had a soft tissue injury to her eyelid but had no other residual sx after regaining consciousness. After evaluation from a medical provider, she was referred to the ER/Urgent care to have her eyelid repaired. The soft tissue injury could possibly leave a permanent scar on eyelid.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EL9261), in left arm, on 12Mar2021 as dose 2, single (Lot number: EN6204), in left arm and on 14Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "History of DVT" (unspecified if ongoing); "May-Thurner's" (unspecified if ongoing). Concomitant medication(s) included: FLONASE ALLERGY RELIEF, start date: 11Mar2022, stop date: 13Jun2022; ZYRTEC ALLERGY, start date: 08Jun2022, stop date: 08Jun2022; ZARBEE'S ALL NATURAL COUGH SYRUP NIGHTTIME, start date: 20Feb2020, stop date: 13Jun2022; RAINBOW [LEVODROPROPIZINE], start date: 31Aug2020. Past drug history included: Ct contrast, reaction(s): "Allergy"; Demerol for Allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical Information: Other medications were given in 2 weeks were Fluticasone Propionate, Cetirizine, Elderberry Immune Support, Calcium Supplement with Magnesium and Vitamin D3 and Flonase. Paxlovid was prescribed as treatment for Covid-19. No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 03-FEB-2015, the patient was vaccinated with MMR II (lot number: K002816 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. The causality of the events with MMR II, live was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Patient tested positive for COVID on 9/14 - he was experiencing some coughs but overall felt symptomatically improved. However on 9/24 he was seen in the ED for right leg pain and some chest pain. He tested positive again for COVID while in the ED. He was found to have an occlusive right femoral DVT with scattered pulmonary emboli. Patient was admitted from 9/24-9/25 for vascular consultation due to acute DVT. Per vascular surgery consult, the provider felt the right femoral DVT was likely secondary to COVID-19 infection. Patient was started on Eliquis at discharge. Additionally, he has received the COVID vaccine and one booster.
Information has been received from a 62-year-old male with high blood pressure, type II diabetes mellitus and no known allergies who on 08-DEC-2007 was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck).  Concomitant therapy included lisinopril (MSD), GLUCOPHAGE and aspirin.  On 09-DEC-2007 the patient developed a "rash like shingles on chest" post vaccination.  The patient did not seek medical attention and did not have any diagnostic labs performed.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  No further information is available.
Pt recvd vax & 30 mins post vax exp lighthead, tingling & weakness in extremities, nausea, dizziness & h/a;
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Apr2021 (Lot number: EW0151) at the age of 53 years as dose 2, single and intramuscular, administered in arm left, administration date 13Mar2021 (Lot number: EN6204) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: Verbatim: High Blood Pressure; "metastatic breast cancer", start date: Jun2020 (ongoing), notes: She has metastatic breast cancer, monthly injections of Faslodex daily 100mg Verzenio tablets. Concomitant medication(s) included: LISINOPRIL taken for hypertension; VERZENIO taken for breast cancer metastatic (ongoing); FASLODEX taken for breast cancer metastatic (ongoing). The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "She has metastatic breast cancer, each time she takes the shot her tumor markers goes to normal"; TUMOUR MARKER DECREASED (non-serious) with onset 2021, outcome "recovering", described as "She has metastatic breast cancer, each time she takes the shot her tumor markers goes to normal". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tumour marker decreased. Additional Information: The patient said that it was a good sign for metastatic breast cancer, her tumor markers went to normal. Directly after what was in a week, just few week after and then the next month it went back up, my numbers went up but the vaccine obviously was having some kind of effect on. When she saw her doctor later that month her blood work showed that the tumor markers were normal. Well as close to normal as it had been since she was diagnosed. Dose 3 administered on 03Nov2021 Time: 08:00, Anatomical Site of injection: upper left arm, Route of administration: Intramuscular and Batch/Lot number: FH8028. Vaccination facility type was other. Vaccine was not administered at military facility. No prior vaccinations (within 4 weeks). No specific relevant test for thromboembolic events with thrombocytopenia. This was a positive event after each vaccine including booster my cancer antigen went down to almost normal range and then back up the following month. The vaccine killed off cancer cell in my blood. The patient would like to know why. She would be happy to donate any blood needed for research. Her oncologist checked records of his patients and she was the only one that had this reaction. No follow-up attempts are possible. No further information is expected.
Breast and nipple soreness; Breast and nipple soreness; sick; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) via a Pfizer sponsored program. A 70-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced breast and nipple soreness and sick. The treatment was received for the adverse event with antibiotic therapy for 10 days. It was further stated that she said that she did not get the 2nd dose of the vaccine that was scheduled last 23Apr because a few days after the 1st dose she was sick and experienced breast and nipple soreness and she went to antibiotic therapy for 10 days. She was asking if it is safe for her to take the 2nd dose of the Covid-19 vaccine. The patient underwent lab tests and procedures which included mammogram: negative, ultrasound breast: negative on an unspecified date in 2021. She added that she sought help from a cancer doctor then underwent mammography and ultrasound procedure and it was negative. The clinical outcome for all the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (side effects) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported.Treatment information was not reported.This case was linked to MOD-2021-398626 (Patient Link).
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 19-OCT-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose,  lot # R000554 with expiration date 08-JAN-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
temp inc 103 x 4 days;rash entire body rash started on face-vomiting;