chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse described the occurrence of injection site cellulitis in a 4 year old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On 08/18/2004, the patient received the 5th dose of Infanrix in the right thigh (lot DTPA 598A2).  On 08/18/2004, the patient also received injections of measles, mumps and rubella virus vaccine and poliomyelitis virus vaccine.  Approximately 48 hours after the administration of Infanrix, on 08/20/2004, the patient experienced an injection site reaction at the site of Infanrix administration.  The patient was seen by a physician, who noted a reaction local to the injection site, but larger and more red and hot than normally seen.  A diagnosis of injection site cellulitis was made.  The patient was prescribed cephalexin (Keflex).  The event resolved on an unspecified date.  The nurse considered the injection site cellulitis to be related to vaccination with Infanrix.
some scarring marks on her back; did not receive her second Moderna dose; "too sick"; "pinching" feeling in the left arm/still has pain in her left arm; terrible pain in her left shoulder; red blotches; looks like shingles/diagnosed with shingles/shingles rash spread on her back, fingers, and arm/shingles rash spread on her back (left side)/shingles rash spread on her fingers (left side)/shingles rash spread on her arm (left side); right arm became a little sore; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotches), HERPES ZOSTER (looks like shingles/diagnosed with shingles/shingles rash spread on her back, fingers, and arm/shingles rash spread on her back (left side)/shingles rash spread on her fingers (left side)/shingles rash spread on her arm (left side)), SCAR (some scarring marks on her back), PRODUCT DOSE OMISSION ISSUE (did not receive her second Moderna dose) and ILLNESS ("too sick") in an 84-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 was reported.     On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced MYALGIA (right arm became a little sore). On 20-May-2021, the patient experienced RASH MACULAR (red blotches) and HERPES ZOSTER (looks like shingles/diagnosed with shingles/shingles rash spread on her back, fingers, and arm/shingles rash spread on her back (left side)/shingles rash spread on her fingers (left side)/shingles rash spread on her arm (left side)). On an unknown date, the patient experienced SCAR (some scarring marks on her back), PRODUCT DOSE OMISSION ISSUE (did not receive her second Moderna dose), ILLNESS ("too sick"), VACCINATION SITE PAIN ("pinching" feeling in the left arm/still has pain in her left arm) and ARTHRALGIA (terrible pain in her left shoulder). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for Shingles, at a dose of 1 gram three times a day. At the time of the report, RASH MACULAR (red blotches), HERPES ZOSTER (looks like shingles/diagnosed with shingles/shingles rash spread on her back, fingers, and arm/shingles rash spread on her back (left side)/shingles rash spread on her fingers (left side)/shingles rash spread on her arm (left side)), SCAR (some scarring marks on her back), PRODUCT DOSE OMISSION ISSUE (did not receive her second Moderna dose), ILLNESS ("too sick"), VACCINATION SITE PAIN ("pinching" feeling in the left arm/still has pain in her left arm), ARTHRALGIA (terrible pain in her left shoulder) and MYALGIA (right arm became a little sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow Up information received on 23 Jul 2021, contains events added
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 in 01/2023. I was exposed to COVID-19 from a friend about two days prior. I had a sore throat, headache, tired and some congestion. I previously tested positive for COVID-19 in 07/2022. I took PAXLOVID during both COVID-19 infections. I tolerated the medication without any complications. As of today, I am feeling good with no lingering symptoms.
pt recv vax 3AUG98 & 6AUG98 began exp chest & shoulder pain;went to ER to r/o MI;cardiac exam negative;discharged to home PMD gave percocet PRN for pain & heat to site;
HEADACHE; Rash (chest and neck); Fatigue; Chills; Dizziness; Tingly skin; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via unspecified route of administration in left arm on 18Mar2021 at 16:30 (at the age of 64 years old) as a single dose for COVID-19 immunisation. Medical history included immune thrombocytopenic purpura (ITP). Concomitant medication was not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205), via an unspecified route of administration in left arm on 27Feb2021 at 16:45 (at the age of 64 years old) as a single dose for COVID-19 immunisation. The patient had a history of allergy to Bactrim DS (Anaphylaxis) and Amoxicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine.  On 18Mar2021, the patient experienced headache, rash on chest and neck, fatigue, chills, dizziness and tingly skin. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, rash on chest and neck, fatigue, chills, dizziness and tingly skin were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, dose number, route of administration, lot# and expiration date were not provided). On 16-JAN-2018, the the patient was re-vaccinated with a dose of GARDASIL 9 (dose, dose number, route of administration, lot# and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001550: US-009507513-1806USA001555: US-009507513-1806USA001552: US-009507513-1806USA001553: US-009507513-1806USA001554: US-009507513-1806USA001556: US-009507513-1806USA001557: US-009507513-1806USA001558: US-009507513-1806USA001559: US-009507513-1806USA001560: US-009507513-1806USA001561: US-009507513-1806USA001547: US-009507513-1806USA001548: US-009507513-1806USA001549: US-009507513-1710USA003103.
This spontaneous report was received from a pharmacist concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.     From 01-SEP-2016 to 17-JAN-2017,  the unspecified patients were vaccinated with improperly stored doses of ZOSTAVAX 19400 plaque forming units (PFU) lot # M019646, expiration date: 18-JUL-2017, as prophylaxis (Dose was not reported), which experienced a temperature excursion between -15 and -10 Celsius degrees for 15 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 at 16:00 as dose 1, single (Lot number: EN6202), in right arm, on 26Mar2021 at 16:00 as dose 2, single (Lot number: ER8730), in right arm and on 28Feb2022 at 16:00 as dose 3 (booster), single (Lot number: FJ8757) at the age of 59 years, in right arm for covid-19 immunisation. The patient had no relevant medical history (no known allergies). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
severe headache, low grade fever, severe abdominal pain, emesis X 1, pallor
Narrative: 86yo male patient had received covid vaccines on 1/15/2021 & 2/12/2021. Pt admitted and treated for covid pneumonia on 12/25/2021. Per admitting MD note: "Principal diagnosis: # AHFR 2/2 COVID & superimposed aspiration PNA, POA REVIEW OF COMORBIDITIES AND COMPLICATIONS: # has acute hypoxic respiratory failure with PaO2 <55mmHg,  POA #Hx of SCC of lung s/p RUL lobectomy 2016, POA # asbestos related interstitial lung disease, POA # Dysphagia s/p PEG, POA # Barrett's esophagus, POA # Anemia of chronic disease, POA # HTN, POA # Hypothyroidism, POA # Hx of skin cancer (melanoma), POA" Pt was discharged from this admission on 1/13/2022 to a nursing facility; Facility was notified pt had deceased on 1/20/2022, location & cause of death unknown. Failure of covid vaccines leading to covid pneumonia infection may have contributed to this death.
Patient received her first dose of the Pfizer/BioNTech today at 0850. She reports intense dizziness and syncope soon after (5 minutes after) at the location where she received it. She was bought to the ER by EMS and received some continuous NS via IV by medics which she reports helped her feel normal again.
A non-serious spontaneous report of H1N1 LAIV was administered to 59 year old female was received from a office manager/other health professional. Neither relevant medical history nor concomitant medication have been reported. H1N1, Intranasal was administered on 14-Nov-2009. There was no adverse event associated with medication error therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Pt stated that her arm started to fell heavy and then her chest, throat felt "itchy".    Heart rate was 96-104, blood pressure 140/100, SpO2 100%.  Rested with legs elevated.  Benadryl 25 mg 1 tab given.  Nurse Practitioner evaluated pt.  Lungs clear,  symptoms improved and was sent home after 1 1/2 hours.
Pt recvd vax 830AM sx of rash behind legs, itching in hands & mouth & tongue; pt taken to clinic 1115AM hives on face & back of legs;
This case was reported in a literature article and described the occurrence of uveitis in a 36-year-old male subject who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified). On an unspecified date the subject received unspecified dose of Hepatitis B vaccine (unknown). At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced uveitis and ankylosing spondylitis. This case was assessed as medically serious by GSK. This is one of the 32 reported cases (B0662264A till B0662297A) of uveitis which occurred after hepatitis b vaccine between 1982 and 2009. It appeared that all subject's recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
Within 2 hrs - wheezing X 10 hours w/cong, clear mucous and eye drainage. No SOB
Patient Covid + on 10/12/2021. Hospitalized. Patient fully vaccinated per H & P: 68 yo female with h/o HTN / CHF, hyperlipidemia, asthma / sleep apnea, glucose intolerance, PUD / colon polyps / elevated liver enzymes / ulcerative colitis, chronic fatigue syndrome, depression / family stress, cervical dysplasia - S/P LEEP / post-menopausal vaginal bleeding, arthritis / back pain / L knee ACL tear / L thumb tendon neuroma - post-op / L hand osteomyelitis / fibromyalgia and overweight. Patient was seen in ER for complaints of shortness of breath after testing positive for COVID-19. For about the past 10 days, patient has had a worsening shortness of breath. Patient tested positive for COVID-19 on a COVID test which she took at home. Patient has had progressively worsening dyspnea but there were no complaints of severe cough or wheezing. There was no definite reported history of fever or chills. There were no reported other URI symptoms such as sore throat or sinus congestion. Patient has had a known family member / sick contact who was positive for COVID-19. Outpatient treatment was attempted for patient's COVID infection with PO Cipro and PO Decadron but patient continued to have worsening dyspnea. Per patient's family, pulse ox readings on patient were in the 80%'s - in the range of 81%-87%. Patient was instructed to go to the the emergency room due to hypoxia. Patient did not have any complaints of loss of taste or smell. Patient had shortness of breath but there was no complaint of chest pain, palpitations or diaphoresis. There were no complaints of nausea/vomiting, abdominal pain or diarrhea. There were no complaints of dysuria, urinary frequency or hematuria. In ER, patient's oxygen saturation was 87% on room air. CXR showed poor inspiratory chest with new bilateral pulmonary infiltrates consistent with pneumonia. CT angiogram of the chest showed bilateral pulmonary infiltrates with areas of atelectasis and consolidation consistent with pneumonia and a small gallstone within a contracted gallbladder but there was no gross central pulmonary embolism identified. Labs were significant for elevated ProTime/INR = 15.0/1.24, elevated D-dimer = 880, elevated AST = 40, low albumin = 3.3, elevated LDH = 536, elevated C-reactive protein = 70.5 and elevated ferritin = 335. COVID-19 PCR was positive. Venous blood gases were significant for elevated PCO2 = 51. Patient was admitted for COVID-19 infection / hypoxia which failed outpatient treatment.
Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) in a male patient of an unknown age 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 SITE PAIN (Pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.  The patient was not clear if the injection site pain happened with Moderna vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: TCR-No new information
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 21-JUL-2015 and on 19-NOV-2015, the patient was vaccinated with a dose of GARDASIL 9 (via intramuscular route, dose and lot # were not reported). There was no known adverse events. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Relevant medical history was not provided. On an unknown date the patient was vaccinated with PNEUMOVAX23, 0.5 ml, intramuscular. Lot number was not provided. Concomitant therapies included either FLUZONE or FLUVIRIN. On an unknown date, reported as over 18 months ago, the patient experienced red rashes and itchiness which pharmacist determined was hives. The outcome of red rashes and itchiness which pharmacist determined was hives was reported as recovered/resolved. The reporter causality was unknown. Additional information has been requested.
Multiple erythematous macules with central small papules and papulovesicles on trunk, none on arms, rare on upper legs, none on hands or feet, palms or soles.
BLOOD CLOGS IN LUNGS  AND ARMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clogs caught in lungs and arms, and was hospitalized for unspecified days. The patient was just released from the hospital (date unspecified). The patient was concerned that it was because of the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clogs in lungs and arms was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210860637-covid-19 vaccine ad26.cov2.s- blood clogs in lungs and arms.This event is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Case number PHEH2017US001062, is an initial spontaneous report received from a nurse on 05 Jan 2017. This report refers to a 58 years old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186866, expiry date: May 2017) intramuscularly at a dose of 0.5 ml on 22 Dec 2016. On 23 Dec 2016 (next day) after vaccination, the patient experienced soreness in arm which has extended down to elbow. It was reported that, the event was not resolved for 02 weeks. No redness, swelling or fever was reported. The final outcome of the event was reported as condition unchanged. The seriousness of the event was reported as non serious and causality was not reported.
1 of 4 pts vaxed from the same lot exp an adverse event; pt exp flu-like sx (chills, h/a, malaise) w/in 24 hrs following vax; treated w/APAP & bed rest; pt recovered;
Tdap erroneuosly administered ID instead of IM. Local reaction noted on forearm on 17 Oct 2014.
vaccine was given at the local high school (not by her doctor, the physician who is placing this report with mother's information)  She told mother she did not feel right 10pm the night of the vaccination, felt hot and cold, sweating, could not sleep, rose up from bed at 4am to get a glass of water, mother heard a noise from kitchen, and found patient passed out on floor. She was out for 2minutes at the most Mother got her up and made her drink a lot of water.  She continued to feel bad. Temp was close to 102.  Around 5pm that evening she was feeling better.  So this report is because of a syncopal episode about 19 1/2 hours after the Covid Pfizer vaccine #2.
Narrative: Headache, Myalgia, Fever, Swelling, Chills, tiredness.
This spontaneous report as received from a registered nurse refers to a 12 year old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 14-OCT-2016, the patient was vaccinated with improperly stored GARDASIL 9, (dose and route not reported) from lot # L036301 with expiry date: 20-DEC-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA014705:
High fever, (103.7), chills, body aches for 1st few days developing walking pneumonia. Antibiotics administered.
Rash, chills, shakes, temp 101, fall. Urgent care on 6/25/14 - dexamethasone sodium phosphate 10mg and Hydroxyzine HCl 25mg oral tablet.
Information has been received from a physician concerning a patient who was vaccinated with a dose of MMR II (lot # 653626/0426F). Subsequently, the patient experienced an adverse reaction. No product quality complaint was involved. No other information was provided. Additional information has been requested.
CHEST PAIN , SOB,  SEVERE VERTIGO TINNITUS, HEADACHE PRESSURE IN HEAD SHOOTING PAIN 15MIN. AFTER INJECTION UP THE SIDE OF MY NECK, WHITE FLASHING IN MY LEFT EYE.  FATIGUE . STILL HAVE FATIGUE EYE PROBLEM  DIZZINESS
Sensation in arm immediately after injection. Approximately 2 1/2 hours after receiving influenza vaccination developed throat burning, wheezing, eyes itching and excessive tearing with mucous production in eyes and throat. Developed fever and swollen glands in the evening. Took Benadryl 50 mg po. Took Nyquil 10/31/07 Continues with some eye and throat increased mucous.
Information has been received from a physician concerning a "very old" female who was vaccinated with MMR II. The patient recently received MMR II and came down with measles and was hospitalized. Unspecified medical attention was sought. Additional information has been requested.