chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Boostrix administered first. Then Varivax.  Was talking to mom and patient, and patient said she didn't feel well, then head fell back (in chair) - she fainted. She came to quickly, but was pale, clammy and lethargic. Paramedics and Fire Department arrived shortly after, evaluated her vitals, watched her for a while, and advised mom it looked like she fainted, and was looking more back to normal.
feels real cold; feels lousy; her head feels hot; been sleeping pretty much all day; Soreness on arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness on arm), FEELING COLD (feels real cold), FEELING ABNORMAL (feels lousy), FEELING HOT (her head feels hot) and SOMNOLENCE (been sleeping pretty much all day) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SB21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (The patient's medical history was not provided.).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness on arm). On 01-May-2021, the patient experienced FEELING COLD (feels real cold), FEELING ABNORMAL (feels lousy), FEELING HOT (her head feels hot) and SOMNOLENCE (been sleeping pretty much all day). At the time of the report, PAIN IN EXTREMITY (Soreness on arm), FEELING COLD (feels real cold), FEELING ABNORMAL (feels lousy), FEELING HOT (her head feels hot) and SOMNOLENCE (been sleeping pretty much all day) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-101577 (Patient Link).   Reporter did not allow further contact
severe diarrhea several times during day and night, explosive most of the time; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in the left arm on 19Feb2021, 13:45 (Batch/Lot number was not reported) (at the age of 71 years old) as dose 1, single for COVID-19 immunisation. Medical history included diabetes which is under control. The patient has no known allergies and did not have COVID prior vaccination. Concomitant medications included metformin and venlafaxine hydrochloride (EFFEXOR). The patient did not receive other vaccines in four weeks. On 20Feb2021 (also reported as 19Feb2021, 12:00 AM) the patient experienced severe diarrhea several times during day and night, explosive most of the time. The patient stopped metformin but observed no difference. It was reported that the event started right after first shot. The patient was not tested for COVID post vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included endoscopy. The patient has not recovered from the events. The patient also received the second dose of BNT162B2 on 11Mar2021 (Batch/Lot number was not reported) for COVID-19 immunization.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Rash of small bumps has appeared on both shoulders this morning (2 days after vax).
Having just little mild ache at, where the shot was given; It is just mild pain; This is a spontaneous report from a contactable consumer (patient, self-reported). A 73-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0198 and expiry date was not reported), via an unspecified route of administration, on 10Jul2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that just had his first Pfizer shot this afternoon and he did not see anything in papers he got with that whether alcohol affects it. The patient reported that on 10Jul2021, he having just little mild ache at, where the shot was given; It was just mild pain. When clarified the concern consumer stated he had his first Pfizer shot this afternoon he did not see anything about if there was any interaction of alcohol with it. Outcome of the event was unknown.  Follow-up attempts are needed. Further information is expected.
Incorrect dose administered. A half dose  (0.25ml)  of the moderna bivalent booster was administered.  The mistake was discovered a 7 days after administration. The patient was notified and scheduled to receive the other half dose (0.25ml) as soon as possible based on CDC guidelines.  The package labeling on the Bivalent vaccine is confusing and most likely to blame for this error.
Information has been received from a physician concerning a 33 month old female patient who on 22-OCT-2009 was inadvertently vaccinated with a dose of GARDASIL instead of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD). There was no product confusion but a human error. The patient sought unspecified medical attention. Additional information has been requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE OBSTRUCTIVE SLEEP APNEA ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN ACUTE PULMONARY EMBOLISM
Received vaccine on 10/30/14 in (R) deltoid. Began to experience significant pain 5 days later. Patient complains of significant pain when moving/using her (R) arm. Situation has not improved as of today's date.
Dizzy, both legs felt heavy and not able to ambulate well, fever, right arm injection site was red, warm, swollen. The size of the reaction site was 6mm in length and 4.5 mm in width. The patient came back to the clinic on 9/13/2018 to complain about the symptoms.
Patient was diagnosed with Polymyalgia Rheumatica with symptoms appearing the weekend after the FLUZONE HIGH DOSE vaccine was administered. She was not sure if it had anything to do with the vaccine.
Arm hot and red. Whole left arm swollen to hsi wrist and experiencing numbness to his fingers. Saw physician who told him nurse probably hit nerve during shot.
A 6 month old male with fussiness, fever of 102.2 F, left leg pain, and a 2 x 5 cm elliptical rash distal to DTaP and Hib injection sites. Occurred within 24 hours of the injection. Remains fussy 48 hours later, now with URI, symptoms and rash on inner left thigh, left axillae and less confluent but more widespread around the injection sites. Mental status appropriate, leg still painful at 48 hours.
received 1st dose /in 2018 & 2nd dose not given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   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 were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The health care professional did not report patient's demographic details neither lot number nor expiration date of the 1st dose of Shingrix. The reporter consented to follow up.
Patient started feeling dizzy after the shot. After few minutes, she states that she could not see anything and lied down on the floor, which she felt little better. Blood pressure was measured around 85/57, pulse rate was 57 at which point ambulance was called for low blood pressure. Patient was helped by the EMS provider, went to the hospital, discharged, the parent called back later saying she was doing fine now.
Red, raised, warm circular area approx 7 cm in diameter. Rx: clindamycin x 10 days
Vaccine syringe leaked over half dose lost. Discussed with charge nurse and patient. Vaccine repeated.
Full body inflammatory response with old injuries (bone and soft tissue) being so inflamed and painful as to be debilitating; Full body inflammatory response with old injuries (bone and soft tissue) being so inflamed and painful as to be debilitating.; Menstrual period was very early for 2 cycles (16-day cycle followed by a 9-day cycle. Normal cycle length 24 28 days); Full body inflammatory response with old injuries (bone and soft tissue) being so inflamed and painful as to be debilitating; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 (Lot number: EW0179) at the age of 44 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Celiac disease" (unspecified if ongoing); "Gluten intolerance" (unspecified if ongoing), notes: known allergies: gluten and "Injury" (unspecified if ongoing), notes: Full body inflammatory response with old injuries (bone and soft tissue). Concomitant medication included unspecified supplements. Past drug history included: Fentanyl, reaction: "Drug allergy", notes: known allergies: fentanyl. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EW0161; Anatomical Location: Right arm; Route of Administration: unspecified), administration date: 15Apr2021, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: INFLAMMATION (non-serious), CONDITION AGGRAVATED (non-serious) and PAIN (non-serious), all with onset 26Jun2021, outcome "recovered with sequelae", and all described as "Full body inflammatory response with old injuries (bone and soft tissue) being so inflamed and painful as to be debilitating", POLYMENORRHOEA (non-serious) with onset 26Jun2021, outcome "recovered with sequelae" described as "Menstrual period was very early for 2 cycles (16-day cycle followed by a 9-day cycle. Normal cycle length 24 28 days)". The events "Full body inflammatory response with old injuries (bone and soft tissue) being so inflamed and painful as to be debilitating" and "Menstrual period was very early for 2 cycles (16-day cycle followed by a 9-day cycle. Normal cycle length 24 28 days)" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of inflammation, condition aggravated, polymenorrhoea and pain.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient had no history of abnormal menstrual cycles and has not had any additional abnormal cycles since then. Since the vaccination, the patient had been tested for COVID-19.
covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 07Feb2021 as dose 1, single (Lot number: EM9810), on 01Mar2021 as dose 2, single (Lot number: EN6202), on 24Sep2021 as dose 3 (booster), single (Lot number: 3013SBA), on 30Mar2022 as dose 4 (booster), single (Lot number: FK9894) and on 16Sep2022 as dose 5 (booster), single (Lot number: FP7137) at the age of 73 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: Retired registered nurse calling who thought they got the COVID bivalent today but they got a call from the pharmacy where her husband and she went to get it, which was around 3:30 their time. The pharmacy let them know that they had received an old booster dose and not the bivalent. They did tell her, which she was very upset as a nurse herself she doesn't understand how they could make the mistake to give the wrong vaccine, they would have to wait two months to get the bivalent. The only reason they went for vaccine today was for the Omicron booster, and now they have to wait two months, and it is prevalent in the (withheld) area. Caller would like to know if it is a packaging problem, if the bivalent and old booster are packed the same way. Fifth dose was 16Sep2022 of LOT: FP7137, which her card says it was bivalent but it wasn't. Their vaccine cards are handwritten and the only information provided on them was LOT and manufacturer name for each dose, no EXP/NDC. All five doses were Pfizer COVID shots. Caller says she doesn't want to have Omicron, and she thinks it is terrible they went there for getting the booster for Omicron and now have to wait two months, in a medium risk area with back to school. Her grandkids are just getting over COVID, they have been boosted, and she doesn't want to get Omicron because she has seen what the kids have gone through. Her husband had COVID at the beginning of Aug and was very sick. Caller clarifies getting the old booster instead of bivalent is not serious.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 (COMIRNATY) to the reported events Vaccination failure and COVID-19 cannot be ruled out.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 24-JUN-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL (strength: 0.5 ml) lot # L020162 and expiration date: 23-JUL-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 120 hours, with the highest recorded temperature of 53 degrees Fahrenheit (11.66 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
increasing weakness in R shoulder over the last two weeks. diagnosed with Parsonage Turner Syndrome.
cough Narrative: He notes having developed a dry/intermittent cough ~24 hours after the initial vaccination that persisted for ~ 7x days. He did not seek treatment for this cough, which was described as intermittent during the day and not waking him from sleep. He notes having h/o "getting the flu" from influenza vaccinations, which was described as previously getting flu-like sx s/p related vaccinations and has included cough in the past. No other common adverse effects were reported.
17 year old received a dose of the Flubok last year with no reported adverse event; Initial information was received on 25-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 17 year old male patient received a dose of the flubok last year with no reported adverse event..  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Nov-2022, the patient received a dose of 0.5 ml of suspect influenza quadrivalent recombinant vaccine (strength, expiry date: unknown) (lot UJ931AA) via intramuscular route in the left deltoid for Immunization.  On 22-Nov-2022 the patient developed a non-serious event of 17 year old received a dose of the flubok last year with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) following the administration of influenza quadrivalent recombinant vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event 17 year old received a dose of the flubok last year with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Approximately 10 days after the 1st vaccine I developed  a red rash on my upper left arm. (just below the site of the injection).  It started out as a bright red circular shape and got larger over the next day.  At it's biggest size, it was approximately 2  1/2 inches wide and 5 inches long.  The rash was slightly swollen and was mildly itchy.  Over the next three days it decreased in size and the redness faded.  At this time, it is almost gone.
Extreme Chills- took Tylenol & Ibuprofen for relief. Which did not return. Extreme Headache & moderate Body aches- took Tylenol & Ibuprofen, headache and body aches returned after about 8 hours, re-dosed with Tylenol & ibuprofen. Only a slight headache returned for a 4 hours.
Dull pain after receiving vaccination in L arm starting the day she received the vaccine on 8/20/18 stating that "it does not feel right" and the night of 8/24/18 patient stated that her L arm started swelling, pain got worse, redness and warm to the touch.
Severe pain in shoulder resulting in inability to complete physical therapy next day; Large red lump appeared day after injection, measured 12 cm across and about 3 cm raised. Was red rashy appearing without itchiness.
Pfizer-BioNTech COVID-19 Vaccine treatment under Emergency Use Authorization(EUA): The decedent received their vaccine and had no reaction. He was found dead in bed the next morning.
Myalgia, Arthralgia, Fatigue, Chills Narrative: Developed body aches, chills, and fatigue.
No additional adverse effects were reported; adult patient received a pediatric dose of VAQTA; This spontaneous report was received from a physician an adult patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions or concomitant medications.  On 17-DEC-2019 the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated(VAQTA) for prophylaxis (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided). No additional adverse effects were reported in the patient.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 15May2021 at 09:00 as dose 1, single (Lot number: EW0167), in left arm, on 07Jun2021 at 09:00 as dose 2, single (Lot number: EW0187), in left arm and on 07Jan2022 at 09:00 as dose 3 (booster), single (Lot number: FJ8757) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes type 2" (unspecified if ongoing); "Known allergy: Penicillin" (unspecified if ongoing); "Known allergy: Blue cheese" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "Known allergy: Erythromycin". The following information was reported: VACCINATION FAILURE (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: (unspecified date) Unknown results; (2022) Negative, notes: testing negative; (21Jul2022) Positive, notes: Covid 19 symptoms reoccurred with a positive test 3 days after finishing PAXLOVID. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient stated that Anti-viral details for COVID 19 Treatment, Paxlovid, Treatment start date: 13Jul2022, Treatment stop date: 18Jul2022, Covid 19 symptoms reoccurred with a positive test 3 days after finishing PAXLOVID and testing negative.
Developed fever about 1 hour after immunizations; temp 102.7 degrees on 821/12; lethargic, not eating and drinking as much. Fever remained until 8/22/12.
(L) upper arm w/ area of erythema and mild swelling, mildly tender, blanching use cool compress, Motrin prn or Benadryl prn.
Terrible nausea; Passed out; Dry heaves; Arm was a little sore; Chilled; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was a little sore) and CHILLS (Chilled). On 05-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant) and RETCHING (Dry heaves). On 05-Mar-2021 at 6:00 AM, the patient experienced NAUSEA (Terrible nausea). In 2021, the patient experienced FATIGUE (Fatigued). On 05-Mar-2021, LOSS OF CONSCIOUSNESS (Passed out) had resolved. At the time of the report, RETCHING (Dry heaves), PAIN IN EXTREMITY (Arm was a little sore), CHILLS (Chilled) and NAUSEA (Terrible nausea) outcome was unknown and FATIGUE (Fatigued) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: 4.13 (normal) reactive: 4.13. In 2021, Blood pressure measurement: decreased (abnormal) blood pressure drop.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported patient received  oxygen when the paramedics came to her on 05 Mar 2021. It was reported that patient had severe reaction in that she passed out, became unconscious and had to call the paramedics. She had dry heaves, then she passed out for about 5 to 10 minutes. severe reaction in that she passed out. She was fatigued for a couple days.  Company comment: This case concerns a 74 year-old female patient with no reported medical history who experienced the unexpected serious event of loss of consciousness. The event occurred approximately I day after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-369460 (Patient Link).; Sender's Comments: This case concerns a 74 year-old female patient with no reported medical history who experienced the unexpected serious event of loss of consciousness. The event occurred approximately I day after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.