chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very sore and feverish at injection site. Arm and shoulder painful when movement occurs since time of injection. Neck and shoulders very painful 2 days later.
first dose/on 09/15/2018/never received one; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15th September 2018 on left arm into the muscle).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided were as follows: The age at vaccination was not applicable for this report. The reporter was the patient's wife. The patient received his 1st dose of Shingrix and did not know about the 2nd dose of Shingrix to complete the series, so till the time of reporting he did not receive the 2nd dose which led to incomplete course of vaccination. The reporter did not have lot number and expiration date for Shingrix. She had national drug code number (58160-0819-12). The reporter gave a consent to follow-up with health care professional. However, she did not have a fax number or an email address. The reporter consented to follow-up. This case had been linked with US2021156426, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021156426:Same reporter. Wife case.
Massive brain bleed; Product use for unapproved combination; Product use for unapproved combination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 03Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 03Oct2022, outcome "unknown" and all described as "Product use for unapproved combination"; CEREBRAL HAEMORRHAGE (death, hospitalization) with onset 03Oct2022 at 20:00, outcome "fatal", described as "Massive brain bleed". The event "massive brain bleed" required emergency room visit. Therapeutic measures were taken as a result of cerebral haemorrhage and included various per 911 first responders and ER (emergency room). The patient date of death was 04Oct2022. Reported cause of death: "Brain bleed". It was not reported if an autopsy was performed. The clinical course was reported as follows: the patient received a Covid-19 booster and flu shot on Monday 03Oct2022. Later that evening, she began a seizure in my kitchen. 911 was called; first responders took action. She was taken by ambulance to a hospital where she passed away overnight due to apparent massive brain bleed. The patient was not Covid tested post vaccination. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Brain bleed
On 2-21-11 AM. VARIVAX #2 administered (L) arm SQ and Hepatitis A #2 in (L) deltoid. At VARIVAX site area of red, painful lump noticed at noon on 2-22-11. Evening of 2-22-11 increased redness around lump. On 2-23-11, size of lump decreased, and size of surrounding redness increased. Positive itching.
Expired vaccine received; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021 at 12:57 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine received). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Expiration date of vaccine was 22 Sep 2021. Patient did not have any adverse events and did not require any medical attention. No problems were reported from the patient.
Adverse side effects; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (Adverse side effects) in an 8-year-old female patient 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 IMMUNISATION REACTION (Adverse side effects). At the time of the report, IMMUNISATION REACTION (Adverse side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was provided.
55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided
This spontaneous report was received from the physician and refers to a patient of unknown age (reported as 0) and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 27-APR-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# M000442; expiration date, dose, route of administration and anatomical location were not reported) and with an improperly stored dose of ROTATEQ orally (lot# M041181; expiration date, dose and anatomical location were not reported). The vaccine doses were exposed to a temperature excursion of 48 Fahrenheit degrees for 30 minutes. There were no digital data logger or previous temperature excursions involved. No adverse effects were reported.  This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA000587: US-009507513-1704USA001660: US-009507513-1705USA012992: US-009507513-1705USA012997: US-009507513-1705USA012998: US-009507513-1705USA012999: US-009507513-1705USA013000: US-009507513-1705USA013001: US-009507513-1705USA012986: US-009507513-1705USA012985:
Chills, body aches, very sore arm, generalized malaise, fatigue for 24 hours, resolved between 24-48 hours after rest Then was positive for Covid 19, (omicron), 12/31/2021. Symptoms, constant cough, fatigue. Received Sotrovimab on 12/31/2021
Sterile abscess from DTaP given in right anterior thigh 4/11/08.  Required incision & drainage 5/1/08.  No fever or tenderness.  Culture->only rare staph coag negative.
8 hours post vaccine I experienced weakness and "crumbling" feeling in my knees and legs. I was unable to walk without leaning on  something. I felt like I would drop to the ground. It was Not numbness or tingling. It lasted for about 5-5 1/2 hours.
Patient was administered with moderna covid-19 vaccine for ages 6-11yrs of age instead of the updated Moderna bivalent booster.
Redness, swelling, irritation and pain at and below injection site. Burning and throbbing from injection site to elbow.
Chronic headache since the day received 2nd vaccine.  Treated with Tylenol which just dulls the pain. Headache never completely goes away.  Was advised to start Magnesium and Vit B complex which has not improved the headaches. Seen by neurologist who prescribed Medrol and Topamax which I will be starting today.
Arm sore over night Sunday to Monday and began to itch.  Area still itches and is red and swollen area where shot was given
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around September 2011, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations and seriousness of his condition. As a result of the zoster vaccine live (ZOSTAVAX), he sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, he suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was considered to be not recovered. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of shingles was determined to be disabling.
Patient developed fever the day following vaccine, then developed some neck stiffness, then severe chest pain two days after vaccine and was found to have myopericarditis and currently hospitalized.
Approximately 2 days after vaccine was given, the patient stated the place where the vaccine was given became very red, hard, and slightly painful to the touch. The mark is approximately 1" by 2" rectangular with a larger red area about 5" in diameter.
Adverse event after 2nd dose; Fatigue; Headache; Nausea; Chills; Not feeling well; Fever; Some soreness in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (Some soreness in injection arm). On 29-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (Not feeling well), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse event after 2nd dose). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MALAISE (Not feeling well), HEADACHE (Headache), NAUSEA (Nausea), CHILLS (Chills), VACCINATION SITE PAIN (Some soreness in injection arm) and PYREXIA (Fever) had resolved and FATIGUE (Fatigue) had not resolved.            Concomitant product use was not provided by the reporter. The patient claimed that she did not experience any side effects from the first vaccination. The action taken for the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Non significant follow up On 12-Jul-2021: Non-significant follow-up case booked in; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pain; lymph nodes popping out under her left armpit and side of her left breast; injection site pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 29Jul2021 14:35 at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 30Jul2021 03:00 the patient experienced pain, lymph nodes popping out under her left armpit and side of her left breast, injection site pain. Reporter, female, aged 63, received first dose of the Pfizer BioNTech Covid 19 vaccine yesterday on 29Jul2021 at 2:35pm-2:40pm. This morning on 30Jul2021 around 3am she woke up with pain and noticed lymph nodes popping out under her left armpit and side of her left breast. She says the lumps her real bad. She received the shot on the right side but has no pain on the right side, just injection site pain if she presses on it but nothing severe. While on the phone she noticed she has a swollen one on her neck as well. Is this a side effect of the vaccine. Question: She has an upcoming biopsy bladder surgery on Wednesday, is it still okay to do. Outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (23Aug2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm.; 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm; 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm.; diagnosed Vestibular Neuritis; 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm.; unable to work for more than a few minutes without nystagmus; extreme fatigue and continued vertigo; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration, administered in the arm right on 21Apr2021 at 10:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing , sarcoidosis from an unknown date and unknown if ongoing , obesity from an unknown date and unknown if ongoing , seasonal allergy from an unknown date and unknown if ongoing , allergy to horse and cat dander from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162b2 on 31Mar2021 at 10:45 (Lot Number: EW0150) via an unspecified route of administration in the right arm for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 23Apr2021 at 16:00, the patient experienced vestibular neuritis (medically significant), 23apr2021 at 4pm sudden onset severe dizziness, 4:15pm severe vertigo, nausea, vomiting until 7pm, unable to work for more than a few minutes without nystagmus, and extreme fatigue. Clinical course: on 23Apr2021 at 4pm sudden onset severe dizziness. At 4:15pm severe vertigo, nausea, vomiting until 7pm. At 7pm, wife took patient to ER and received a CT and MRI to rule out a blood clot. Vomiting has resolved with medication. On 26Apr2021, patient was diagnosed vestibular neuritis. Symptoms are slightly better but patient have been unable to drive, walk without increase in symptoms, unable to work for more than a few minutes without nystagmus, extreme fatigue and continued vertigo. Treatment received for the events included diphenhydramine (BENADRYL), droperidol,meclizine, and methylprednisone. The patient recovered from the event, vomiting. The patient had not recovered from the events, vestibular neuritis, 23apr2021 at 4pm sudden onset severe dizziness, 4:15pm severe vertigo, nausea until 7pm, unable to work for more than a few minutes without nystagmus, and extreme fatigue.   No follow-up attempts are needed. No further information is expected.
Pt is covid + on 11/12/2021 and fully vaccinated. Pt says he has felt sick and tired with chest pain for 1 week. Positive for chills, fatigue, cough, chest pain, arthralgias, myalgias. Pt stable for outpatient care. Discharged
SkinRash & Tachycardia Narrative:  Staff member received the vaccine approximately @ 1030hrs. States she felt flush, tachycardic right after the vaccine. They developed a rash on her neck, chest and face.
Three days post-vax pt exp blisters on her feet.  Blisters inc in number and size and spread to pt hands.  One mon post vax, pt saw dermatologist who noted multiple bullae on erythematous bases.  Pt. treated with topical Cyclocort cream.
Itching; Swelling; At the vaccine it''s the area spread you know redness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: FF8841) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "Itching"; SWELLING (non-serious), outcome "unknown", described as "Swelling"; ERYTHEMA (non-serious), outcome "unknown", described as "At the vaccine it''s the area spread you know redness".  Additional information: patient received the Pfizer COVID-19 Vaccine had non serious allergic reaction, the itching and the swelling and at the vaccine it is the area spread you know redness wanted to know if it normal to have these allergic reactions.  No follow-up attempts are possible. No further information is expected.
Erythematous pap. pinpoint rash to MUNK, BUES and BLR, buttocks and cheeks, TMS flushed at LR PP eryth others, nose inflamed (+) post cervical lymphadenopathy, LS CTA, HR RRR - adverse reaction, exanthem to MMRV.
pt recvd vax & c/o feel like going to faint-flushed feeling, SOB, shaking like a sz & was incont of urine; passed out & tired;
PATIENT DEVELOPED LARGE HEMATOMA BEGINNING AT THE INJECTION SITE AND EXTENDING TO THE ELBOW OF THE RIGHT ARM.  PATIENT DOES TAKE BLOOD THINNERS.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (right leg) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (right leg). At the time of the report, pain in extremity (right leg) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported. Sender's comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Cellulitis resulting in antibiotics course, recurring reaction with second dose of Moderna as well as Flu Vaccine in the fall of 2021.
Patient presented to the ER with chief complaint of chest pain and shortness of breath.  Patient tested positive for COVID-19 and was tachypneic and tachycardic in the ER which improved with high-flow nasal cannula.  CT chest showed bilateral infiltrates in the lower lobes greater on the right side with areas of consolidation and some peripheral atelectasis bilaterally.  Small right-sided pleural effusion noted.  Also some right perihilar loculated fluid noted with no evidence of PE.  Patient was admitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia requiring HVNC 40L 60%. ID and pulmonology consulted.  Pt weaned down to room air and wanted to go home. Id recommended to discharge on 8 more days of dexamethasone and 5 days of doxycyline. Pulm cleared pt for discharge and asked to follow up outpt. Cardiology recommended two week event monitor on discharge and have pt f/u EP oupt. Discussed with pt and he agreed to follow up with everyone and stated he had someone to take him to the appointments. Pt was discharged home in stable condition.      Acute hypoxic respiratory failure secondary to COVID-19 pneumonia Weaned down room air  CTA chest showing bilateral infiltrates in the lower lobes, greater on the right S/p dexamethasone and remdesevir ID on consult, MRSA screen ordered, Currently on IV ceftriaxone and doxycycline. Discharged on 5 days of doxycyline. Continue Dexamethasone 8 more days; Pt refused remdesivir and baricitinib.
Information has been received from a physician concerning a 53 year old female patient who on 22-AUG-2007 at 3:11 pm, was vaccinated IM into the right deltoid with a first 0.5ml dose of PNEUMOVAX 23 (Lot# 656826/0308U). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid administered in a different site. On 22-AUG-2007, the patient developed pain, redness and swelling distal to the injection site of PNEUMOVAX 23. Unspecified medical attention was sought. A few weeks later in September 2007, the patient recovered. No product quality complaint was involved. The reporter considered pain, redness and swelling distal to the injection site to be other important medical events. Additional information is not expected.
Right arm pain, numbness, atrophy. Diagnosed with chronic degenerative disk disease. Permanently disabled and loss of normal routine. *Follow-up received on 02/13/2003: Chrinoc disc disease. The reporter has sent the vaccine lot # twice, and no longer has it in his records.