chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist referring to a 56 year old female patient, who was no pregnant. The patient had no drug reactions or allergies. Concurrent condition included losartan (manufacturer unknown). On 31-AUG-2016, the patient was vaccinated with a dose of VAQTA (dose unknown, frequency: reported as "once", lot # L017757, expiration date: 08-APR-2018) intramuscularly. On 31-AUG-2016, the patient had 3/4 inch nodule on left shoulder under skin which moved with palpation and was not too hard. No treatment was given for the event and no lab was performed. The outcome of the event was unknown. The causal relationship between the event and VAQTA was unknown. Additional information has been requested.
Tingling in the left jaw; Left side of her face felt weird; Swelling of The Face; Itching in her Face; Tingling in the Tongue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in the left jaw), FEELING ABNORMAL (Left side of her face felt weird), SWELLING FACE (Swelling of The Face), PRURITUS (Itching in her Face) and PARAESTHESIA ORAL (Tingling in the Tongue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PARAESTHESIA (Tingling in the left jaw), FEELING ABNORMAL (Left side of her face felt weird), SWELLING FACE (Swelling of The Face), PRURITUS (Itching in her Face) and PARAESTHESIA ORAL (Tingling in the Tongue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency. On 08-Feb-2021, PARAESTHESIA (Tingling in the left jaw), FEELING ABNORMAL (Left side of her face felt weird), SWELLING FACE (Swelling of The Face), PRURITUS (Itching in her Face) and PARAESTHESIA ORAL (Tingling in the Tongue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Steroid. The patient indicates that had never used Dermal Fillers in face.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 15-JUN-2018, the patient was inadvertently vaccinated with an expire dose of PNEUMOVAX23 via intramuscular (dose and anatomical location were not reported) lot # M042324 and expiration date: 10-JUN-2018, indicated for prophylaxis. No adverse effects were reported.
Day of immun high pitched scream, not consolable, 6 hrs duration; Consulted MD by phone; No treatment; Notified 14MAY91;
Shortness of breath and chest pressure over several days. Found to have Constrictive Pericarditis requiring pericardiocentesis.
A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer/health care professional concerning a 34-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, FLUMIST was given via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot number of the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot number of the other supply of FLUMIST with expiration date of 25-Dec-2008. The expired lot of FLUMIST was given to 17 adult individuals including this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not application, and the event is considered resolved. Based on the results of the investigation, the root cause for 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. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
102 temp the day following vaccine administration only; swelling at injection sites since the date of vaccine adminstration.  During nighttime bath on 3/30/13 mother noticed, blotchy spots on leg and torso.  Also noticed a half-dollar sized swollen area on right thigh which was red, hot and firm to the touch.  Phoned primary care provider on 4/1/13 to report the reaction.  Instructed by primary care provider to monitor site and use ice intermittently to area.  If no improvement by Wednesday 4/3/13, client was to be brought in to provider's office for examination.  As of 4/3/13 at 9:00 am, area was without redness and heat; no appointment made to see primary care provider.
pt recvd vax; w/in 24 hrs after vax, pt devel runny nose & a cough; cough was severe & lasted for 8-10 days; tx dilaudid;
Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approx. when temperature data logger registered 22 degree F; Dose administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approx. when temperature data logger registered 22 degree F) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 3:16 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 3:16 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approx. when temperature data logger registered 22 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approx. when temperature data logger registered 22 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 71.08.  No concomitant medication was reported by reporter.  On 17-Feb-2021, Excursion time was 9 AM, temp was 22, total doses given for the day was 62, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 11-Feb-2021, vial was moved to clinic on 17-Feb-2021. Vaccine BUD date was 13-Mar-2021.  Vial was stored on cooler 2, on 17-Feb-2021, Excursion Temp at 8 AM: 20, 9 AM: 22, 10 AM: 37, 11 AM: 41, 12 PM: 42, 1 PM: 39, 2 PM: 40, 3 PM: 42, 4 PM: 41.  It was reported that patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Vial was punctured right before administration.   No treatment medication was reported by reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Within 35 minutes I began experiencing mild to moderate lower abdominal cramping, along with a metallic taste in my mouth. The metallic taste lasted a few hours. The cramping calmed down to very intermittently but did last around 24 hours.  I had 1 incident of loose stools around 20 hours after the shot.
Pain is so severe; Joints are aching/ Shoulders ache/ Knees ache/ Hips ache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Pain is so severe) and ARTHRALGIA (Joints are aching/ Shoulders ache/ Knees ache/ Hips ache) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Pain is so severe) and ARTHRALGIA (Joints are aching/ Shoulders ache/ Knees ache/ Hips ache). The patient was treated with MORPHINE for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (Pain is so severe) and ARTHRALGIA (Joints are aching/ Shoulders ache/ Knees ache/ Hips ache) outcome was unknown.            Treatment medications were not provided.
Pt had swollen nodes & low grade fever, the wk following imun on 21JUL91 about 5PM pt spiked fever of 103.8; convulsed was taken to ER; tx for convul Phenobarb; Seen by MD poss URI & viral infect;
Sore arm for 3 days at the injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: Sore arm for 3 days at the injection site). The outcome of the injection site pain was resolved (duration 3 days).   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 30-JUL-2023 The case was received via interactive digital media. The reporter stated sore arm at the injection site for 3 days with no side effects.
Received vaccine 4/19. Was fine that night, slept okay. Woke 4/20 at 8:00 and was fussy with low grade fever (100.0) all day. Tylenol did not help. Taken to ER by family 4/21 at 1:00 am. No treatment. No findings. Seen back here by pediatrician. Baby consolable. Vaccine sites all without redness, warmth or edema. Possible pertussis reaction. To get Dx in future.
It has been 37 days from 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It has been 37 days from 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (It has been 37 days from 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (It has been 37 days from 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 14-OCT-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K024036 exp 26-NOV-2016) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
jaw pain x 3 min 5 minutes after vaccine administration, then had two episodes of chest pain after 15 minutes measuring a 2/10 last 2-3 seconds each.
I woke up with full body aches, a slight cough, extreme fatigue, sore throat, and nasal congestion. The symptoms lasted 4-5 days. I tested positive for COVID-19 1/28/2022. I was directed to go to and went to ER to check my oxygen levels and they were normal.
I had a fever and a headache for a few days.  The headache did not go away.  It traveled to my ear.  When, I went to my doctor.  It had turned into an ear infection in my middle drum. I was prescribed antibiotics.
Chills lasted 2 hours. Soreness at injection site became painful for 6 1/2 hours. Insomnia, was not able to sleep at all from 10:30 pm until 6:00 Am when my alarm went off. Low grade fever. My normal temperature is 98.6. My low grade fever temperature was 99.4. No treatment at this time.
Post vax, the pt had extreme soreness in the arm, into the shoulder and down to her waist. No redness or hot to touch. Was better within 24 hours. We reported 3 other pts with the same vial with similar reactions.
Patient is a 86 y.o. female patient of MD with history of HTN, DM, hypothyroidism, CKD  presented to a local Hospital with weakness and  sob.    COVID-19 Infection Generalized weakness Vaccinated without booster Symptoms onset 11/25/22, positive test date 11/29/22 No current oxygen demand  Trend inflammatory markers - CRP 3.4 LDH 386 Fibrinogen 385 D-dimer 1.85 MAB: Not indicated Steroids: Not indicated Anticoagulation: Heparin Consider discontinuation of isolation 12/8/22  Consult PT/OT - recommends skilled therapy  Consult case management - discharge needs    Stage 3b CKD Historical baseline: Cr 1.7 & GFR 32 Cr 1.78 Renally dose medications and avoid nephrotoxins   DM2 Resume home medications    Hypokalemia - resolved  2.8 on presentation Replace and recheck    Hypothyroidism  Continue supplement     HTN  SBP >200 in the ED  Restart home medication - stopped meds several days ago due to not feeling well Prn hydralazine  SBP 150s-  change metoprolol to coreg 12.5mg BID to achieve better BP control  Follow up with PCP    Elevated trop in setting of COVID 19   Initial troponin 89 Repeat troponin 80 EKG NSR  NT proBNP 4610 STT 2020 NLVFX EF 74% possible small mild area of ischemia the inferolateral segment. Medically managed
Headache, Myalgia, Pain at L arm and tired, Chills, body ache Narrative:
The patient received the correct vaccine and dose appropriate for his age, however he received a dose that had been left out at room temperature and exceeded the beyond use time of 12 hours. The vaccine was out in room temperature in the morning the day before and the vaccine was given around 1pm the next day, so the vaccine had expired by just a few hours.
Elevated blood pressure readings after 1st Moderna Vaccination. BP reading elevated:5/20/21 BP=210/118, 5/21/21 BP=209/104, 5/22/21 BP=206/117, 5/23/21 BP=174/89, 5/24/21 BP=211/89 on this day the pt was had also vomited numerous time. 911 called. EMS came in and evaluated the pt. BP was still high at 200/100 however the pt refused to go to the hospital. On 5/25/21 BP=149/82 and pt reporting felling completely normal. 5/26/21 BP=139/81.
Pt had near syncopal episode approx. 20 mins after the vaccines. Was treated with snack and returned to baseline. Approx 5 hours after the vaccinations developed fever, nausea and vomiting that mother reported continued throughout the night. He was back to baseline in the morning, no fever and no nausea/vomiting.
extreme sick; achy; very tired; extremely chilly; very nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (extreme sick), PAIN (achy), FATIGUE (very tired), CHILLS (extremely chilly) and NAUSEA (very nauseous) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced ILLNESS (extreme sick), PAIN (achy), FATIGUE (very tired), CHILLS (extremely chilly) and NAUSEA (very nauseous). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (extreme sick), PAIN (achy), FATIGUE (very tired), CHILLS (extremely chilly) and NAUSEA (very nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test positive: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
This spontaneous report was received from a healthcare worker concerning an approximately 25 year old female patient. It was reported that the patient was given the third dose of GARDASIL early. On 25-FEB-2013, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified). On 23-APR-2013, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, dose and route unspecified). On 21-MAY-2013, the patient was vaccinated with the third dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Redness, swelling, and pain in left upper extremity near the injection site. Tx: TYLENOL, BENADRYL.
SORE ARM X 2 DAYS AFTER INJECTION, BRUISING AT INJECTION SITE X 1 WEEK Narrative:
Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I also began to test positive again; Negative, notes: 5 successive days of negative tests; Negative, notes: 5 successive days of negative tests; Negative, notes: 5 successive days of negative tests; Negative, notes: 5 successive days of negative tests; Negative, notes: 5 successive days of negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
started with c/o "feels weird in my chest like a pulled muscle",  few days later slight short of breath with fatigue, May 2 11:45 cardiac arrest when paramedics placed O2, rounds of CPR and med's, pronounced dead at hospital after attempts of CPR.  Out come on death certificate Bilateral Pulmonary Thromboemboli. Coroner stated there were multiple PE's in bilateral lungs. Positive for Covid 19 (Had in Feb, vaccine in April 20)
FLU LIKE SYMPTOMS FOR 3 DAYS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not 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 MAR-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 MAR-2021, the subject experienced flu like symptoms for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms for 3 days on MAR-2021. This report was non-serious.
Patient received two doses of the Moderna Covid-19 vaccine within 2 days; A spontaneous report was received from a other healthcare professional concerning a patient (age and gender unknown) who received two doses of the Moderna's Covid-19 vaccine within 2 days (Inappropriate schedule of product administration).   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    On an unknown date, the patient received their first of two planned doses of mRNA-1273 and within two days of the first dose the patient received their second dose of mRNA-1273 for prophylaxis of COVID-19 infection. They wanted to know what should be done with the official second dose of the vaccine. No further details were provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event received two doses of mRNA-1273 vaccine within two days was considered resolved.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot # unknown with no associated AEs.
swollen lower lip; body ache; Fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swollen lower lip), PAIN (body ache), PYREXIA (Fever) and CHILLS (chills) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 26-Mar-2021, the patient experienced PAIN (body ache), PYREXIA (Fever) and CHILLS (chills). On 27-Mar-2021, the patient experienced LIP SWELLING (swollen lower lip). On 26-Mar-2021, PAIN (body ache), PYREXIA (Fever) and CHILLS (chills) had resolved. At the time of the report, LIP SWELLING (swollen lower lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.    Reporter did not allow further contact
I had a sore arm 12 hrs that lasted three day.  Two days after I noticed a rash on my chest, neck and face that was itchy red and raised. The next day, spread down my stomach, back, thighs and both arms.
Information has been received from a healthcare provider concerning a 13 year old female with no drug allergies, who was vaccinated with a series of GARDASIL. The last dose was given about one and a half years ago. "3 months ago" (on approximately 14-FEB-2010) the patient had been losing hair. It was unknown if the patient sought medical attention. At the time of the reporting, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.