chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bruise at the injection site about an area of 1.5 to 3 cm; The site was firm; Injection site a little tender; Injection site a little sore; Warm at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE BRUISING (Bruise at the injection site about an area of 1.5 to 3 cm), VACCINATION SITE INDURATION (The site was firm), VACCINATION SITE PAIN (Injection site a little tender) and VACCINATION SITE PAIN (Injection site a little sore) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Allergy (Had allergies when he was a boy. Fifty years from now.). Concurrent medical conditions included Renal disorder (Mild) and Hypertension. Concomitant products included HISTAMINE, LISINOPRIL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 13-Jan-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm at the injection site). On 14-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Bruise at the injection site about an area of 1.5 to 3 cm), VACCINATION SITE INDURATION (The site was firm), VACCINATION SITE PAIN (Injection site a little tender) and VACCINATION SITE PAIN (Injection site a little sore). On 13-Jan-2021, VACCINATION SITE WARMTH (Warm at the injection site) had resolved. At the time of the report, VACCINATION SITE BRUISING (Bruise at the injection site about an area of 1.5 to 3 cm), VACCINATION SITE INDURATION (The site was firm), VACCINATION SITE PAIN (Injection site a little tender) and VACCINATION SITE PAIN (Injection site a little sore) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
SIDE EFFECTS WERE EXAGGERATED; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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, administered on 14-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On JUL-2021, the subject experienced side effects were exaggerated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from side effects were exaggerated. This report was non-serious.
This case was reported in a literature article and described the occurrence of uveitis in a 20-year-old female subject who was vaccinated with Hepatitis B (manufacturer unspecified). On an unspecified date the subject received 2nd dose and 3rd dose of Hepatitis B (unknown). Three days after vaccination with 2nd dose of Hepatitis B and 4 days after vaccination with 3rd dose of Hepatitis B, the subject experienced uveitis and headache. 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 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.
1. Bronchitis  2. Cough  3. Nasal congestion  4. Suspected COVID-19 virus infection   Symbicort
Slight swelling of throat; Heart rate went up to 103 bpm then 159 bpm. For the next 8 hours bpm rates ranged from 103 to 179; Had small increase in temperature by 1 degree; No events other than slight soreness of injection site until 24 hours after injection; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 62-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in Arm Right on 18Mar2021 12:00 (age at vaccination: 62-years-old) as single dose for covid-19 immunization. (Vaccination facility: Other). Medical history included covid-19, heart rate increased from Jul2020 to an unknown date (I did have COVID the last two weeks of July2020 and increased heart rates were very common during that time). had a 50% collapsed left lung from 2020 to an unknown date (I had a 50% collapsed left lung shortly after contributed to the COVID infection and also contributed to COPD-like lung conditions). chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient did not receive any other vaccine four weeks. It was reported that on 19Mar2021 12:00 patient experienced no events other than slight soreness of injection site until 24 hours after injection. Had small increase in temperature by 1 degree and slight swelling of throat. Main issue was heart rate went up to 103 bpm, then 159 bpm. For the next 8 hours bpm rates ranged from 103 to 179. After taking Tylenol and a nights sleep, bpm back down to 79 bpm and temperature/throat are now normal. Therapeutic measures were taken as a result of events. Patient did not tested for covid post vaccination. The patient underwent lab tests and procedures which included body temperature: increase in temperature by 1 degree on 19Mar2021, body temperature: normal on 20Mar2021, heart rate: 103 on 19Mar2021, heart rate: 159 on 19Mar2021, heart rate: 103-179 on 19Mar2021, heart rate: 79 on 20Mar2021. The outcome for the events was reported as resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
First noticed redness and swelling after receiving shot on 6/16/10 progresses redness, swelling, itchy L upper arm on 6/18 approximately 12.5 x 9 cm area of erythema.
AdmissionDate: 1/29/2022; Hospital Day: 3    Attending: DO ID Attending: DO   Date of Consultation:  1/31/2022  Time of Consultation:  2:16 PM    Reason for Consultation: Covid + 1/27   History of Present Illness: Patient is a72y.o. year old female who tested positive for COVID 1/27/22.  ( Moderna vaccine 3-4-10/2021)She noted increasing shortness of breath and chest pain and called EMS.  D Dimer >10,000. CT at BRO 1/27 reported uncomplicated sigmoid diverticulitis. Patients niece reported patient had been complaining of diffuse abdominal pain prior to presentation to Hospital.  The niece also reported recent lethargy and difficulty finding words. Patient was noted to have progressive mental status changes and concerns for protection of airway and was subsequently intubated. AKI on CKD CT/CXR with bibasilar airspace disease Neutrophilic leukocytosis Patient still meets criteria for Remdesivir. Decadron 6 mg daily. Empiric Zosyn was initiated due to concerns for possible Diverticulitis.
15" p/vax pt devel tingling in fingers & rt hand * then numbness throughout rt hand & arm up to deltoid/shoulder area;
patient reported today via phone that she is still having a throbbing and burning sensation at the injection site but it is not a visible reaction, and its been past the 7 to 10 days that usually these types of symptoms resolve so i advised her on that and to contact her pcp to see if they want to see her or have any suggestions for her.
Patient passed out after receiving Vaccine.  I called the paramedics they observed the patient and released him to his father.
Patient began feeling like she was having panic attacks. She was nauseous and went to the ER. ER ran tests including Ct scan, ekg and blood work. All tests came back normal. A couple of hours later patient became delirious and oxygen started to drop. Then patient was intubated at which point she had a major heart attack and died.
This spontaneous report has been received from a healthcare professional concerning an unspecified number of patients of unknown age and gender. Since January 2015, the unspecified number of patients was vaccinated with doses of GARDASIL 9 (Lot number: L000610, expiration date: 31-JAN-2017 and Lot number: L011846, expiration date: 16-JUN-2017) (dosage schedules were not reported) which underwent temperature excursions. This report is one of the reports from the same reporter. Follow up information has been received from a Medical Assistant (M.A) during a phone call on 25-NOV-2015. She stated that information on patients was not available over the phone and asked to send her a written request. Additional information has been requested.
Information has been received from a consumer concerning her 7 month old daughter who on 08/14/2001, 11/19/2001, and 01/09/2002 was vaccinated with a first, second, and third dose of Hepatitis B virus vaccine RHBSAG (yeast) (lot number 640323/0753L0 , 640323/0753L, and 641449/1230L respectively).  The patient's vaccination history was noted to include a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, a dose of poliovirus vaccine inactivated (Vero) (IPOL), and an "RV shot" on 02/27/2001, a first, second, and third dosse of Hib conj vaccine (OMPC) (MSD) on 02/2001 (lot # 638138/1548K [also reported as "1548KO"]), 05/01/2001 (lot # 639437/0929L0, and 01/2002 (lot #639437/0929L) respectively, a dose of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) on l04/01/2002 (lot # 638706/0745L [also reported as "0745LO"]), and a dose of varicella virus vaccine live (Oka/Merck) (MSD) on 01/09/2002 (lot # 638244/0466L).  The mother reported that each time the patient ' had a shot (any shot)" she experienced a rash around the diaper area and a fever [Hib conj vaccine (OMPC) (MSD) (WAES # 0401USA01373), measles virus vaccine live (Moraten) (+) mumps virus 0401USA01517), and varicella virus vaccine live (Oka/Merck) (MSD) (WAES# 0401USA01518)].  The mother eas told to "just wait through the fevers."  Subsequently, the patient recovered.  A product quality complaint was not involved.  Additional information was received from a physician who indicated that the hepatitis B virus vaccine RHBSAG (yeast) was not administered in his office. No further information is expected. The mother also reported that the patient developed a severe urinary infection after therapy with Hib conj vaccine (OMPC) (MSD) (WAES# 0401USA01373).
Pt states she had been "rubbing" her chest  after the vaccine administration because her chest "felt ache and sore."  She denies nausea, vomiting, diaphoresis, dyspnea, dizziness, lightheadedness, or radiating pain to jaw, arm or shoulder blades.  She denies dysphagia, or feeling like her throat is closing, facial, lip or tongue swelling. She states "I just hate hospitals because she has had to have brain surgery and states " I am sure I am fine" and think it is related to the stress of being at the hospital.
Body aches; injection site soreness; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Dec2021 17:00 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021, outcome "unknown", described as "booster"; PAIN (non-serious) with onset 14Dec2021 07:00, outcome "not recovered", described as "Body aches"; VACCINATION SITE PAIN (non-serious) with onset 14Dec2021 07:00, outcome "not recovered", described as "injection site soreness". Therapeutic measures were not taken as a result of pain, vaccination site pain.  Additional information: Serious: No. Patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Other medications the patient received within 2 weeks of vaccination: Nikki birth control. Prior to vaccination, the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Known allergies: N/a.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Parent of child called me on 6/4/08 to state that unbeknown to her patient was pregnant when she received shots on 4/24/08. No known ill effects reported per parent.
Within 20 minutes post injection the following occurred:  Dizziness, light headedness,  hives, feeling excessively hot, throat tightness w/feeling of needing to clear my throat
Starting several hours after the vaccine she began experiencing chills. The chills continued into the next day and she began having body aches, nausea, vomiting and diarrhea. No fever. Symptoms were completely gone by 1/31/21
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 43-year-old female. Neither medical history nor concomitant medications were reported. On 02-Mar-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009: product complaint investigation results.
Fever; 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) 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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. No treatment was reported.
death; shortness of breath; Nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jun2022 at 11:15 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Heart failure" (unspecified if ongoing); "acute kidneyfailure" (unspecified if ongoing); "covid " (unspecified if ongoing), notes: prior vaccination. No other vaccine in four weeks. The patient took prescribed concomitant medications in two weeks. Past drug history included: Tramadol, reaction(s): "Allergy"; Levaquin, reaction(s): "Allergy". The following information was reported: NAUSEA (non-serious) with onset 04Jun2022 at 17:30, outcome "not recovered"; DEATH (death, medically significant) with onset 04Jun2022 at 17:30, outcome "fatal"; DYSPNOEA (non-serious) with onset 04Jun2022 at 17:30, outcome "not recovered", described as "shortness of breath"; VOMITING (non-serious) with onset 04Jun2022 at 17:30, outcome "not recovered". The events "death", "shortness of breath", "nausea" and "vomiting" required emergency room visit. Therapeutic measures were not taken as a result of death, dyspnoea, nausea, vomiting. The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Covid was not 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: death
TERRIBLE ACHES AND PAINS; CHILLS; HIGH FEVERS; HEADACHES; 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, and batch number were not reported) dose, (Dose number in series:1) start therapy date were not reported 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 terrible aches and pains, chills, high fevers, and headaches. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) over 102 for 4 days. (Dose number in series:1 )  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high fevers, and the outcome of chills, headaches and terrible aches and pains was not reported. This report was non-serious.
Postural orthostatic tachycardia syndrome (POTS); Autonomic Dysfunction; Orthostatic Intolerence; Dizziness; Headache; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 23-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination postural orthostatic tachycardia syndrome (POTS), headache, dizziness, orthostatic intolerance and autonomic nervus system imbalance.  The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007498:
Fever > 104 degrees, anorexia, fussiness starting 6/25/03 pm. Rash started on trunk 6/29-pruritic pink mostly on trunk. Return of appetite by 6/29; defervesced to low grade. Fever < 101 by 6/27/03. Papular rash on trunk 6/29 through 7/3/03.
Cold symptoms; COVID-19; Covid-19 on 00-Dec-2021; Vaccination site pruritus; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold symptoms), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE SWELLING (Vaccination site swelling), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Covid-19 on 00-Dec-2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, first dose. In 2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling). In December 2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Covid-19 on 00-Dec-2021). In April 2022, the patient experienced NASOPHARYNGITIS (Cold symptoms). In 2021, VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved. At the time of the report, NASOPHARYNGITIS (Cold symptoms), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Covid-19 on 00-Dec-2021) outcome was unknown.            No concomitant medication information provided. No treatment medication information provided.  Company Comment: This is a Spontaneous case concerning a 60-year-old female patient, with concurrent condition of Psoriatic arthritis treated with Adalimumab (HUMIRA), who experienced the non-serious unexpected AESI of COVID-19. Also, the special situation of Drug ineffective was added to this case. The event occurred approximately 4 months after the administration of the 3rd dose of the mRNA-1273 vaccine (in an appropriate schedule of administration). The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness assessed as non-serious.; Sender's Comments: This is a Spontaneous case concerning a 60-year-old female patient, with concurrent condition of Psoriatic arthritis treated with Adalimumab (HUMIRA), who experienced the non-serious unexpected AESI of COVID-19. Also, the special situation of Drug ineffective was added to this case. The event occurred approximately 4 months after the administration of the 3rd dose of the mRNA-1273 vaccine (in an appropriate schedule of administration). The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness assessed as non-serious.
SEVERE RASH FROM NASAL AREAS, UNDER NOSE,  AROUND MOUTH AND CHIN.   IT WAS RED, WEEPING, SORE AND ITCHED.  I WENT TO DERMATOLOGIST AND  WAS PRESCRIBED METRONIDAZOLE, IVERMECTIN, AND  FLUOCINOIDE.
Loss of hearing in right ear on 3/25/21, ringing in ear on 3/25/21, Vertigo on 3/26/21
The caller also stated that her friend got expired vaccine too but had no reactions.; 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 EXPIRED PRODUCT ADMINISTERED (The caller also stated that her friend got expired vaccine too but had no reactions.) 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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The caller also stated that her friend got expired vaccine too but had no reactions.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The caller also stated that her friend got expired vaccine too but had no reactions.) had resolved.            No concomitant medications were reported.  No treatment information was reported.