chrisvoncsefalvay/vaers-outcomes huggingface dataset:
adverse reaction after my second Moderna vacination; 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 VACCINATION COMPLICATION (adverse reaction after my second Moderna vacination) 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 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 VACCINATION COMPLICATION (adverse reaction after my second Moderna vacination). At the time of the report, VACCINATION COMPLICATION (adverse reaction after my second Moderna vacination) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable  Concomitant product details was not reported.  Treatment details was not reported .
COVID PSYSR Vaccine observation area   1622 - 20 min after injection c/o itching inside of left ear / left face and left eye VS 150/102  HR 79 O2sat 97%   Doctor notified   1628 sx increasing - Benadryl 25mg PO given   1640 sx decreasing VS 157/91 HR 65   1650 face and ear itching resolved.... eye still feel heavy   1700 - feeling well. Left observation area
Fever, generalized body aches, and diarrhea from 4pm on 7/13 until 7/15.
Shortly after patient received both PNEUMOVAX and Tdap, experienced severe pain in right arm and shoulder, down his back, in the center of his chest. Stat EKG showed no changes from 2010 EKG. Patient denied radiating pain to left arm or jaw. After several minutes pain subsided and patient was released AMA.
Presents today with 50 mm by 50 mm flattened red rash at injection site. Warm to touch and c/o numbness and tickling in (L) arm. Referred to facility if seeks treatment. Also informed to let us know if she does seek tx.
Blood sugar increased; This spontaneous case was reported by a physician and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar increased) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001821A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar increased). At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar increased) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: constantly at around 200; (abnormal) constantly at around 200.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter reported that patient will not take his second dose if in case the sugar levels will not come down.
Headache, muscle aches, pain at injection site, flu-like symptoms, chills, achy joints Narrative:
Received shot at 3:45pm.  At approximately 6:45pm started shaking, muscles and joints started aching; became nauseated, got severe fever - could barely stand up - shaking uncontrollably for several hours.  At about 5:00am, started sweating for 2 solid hours - totally drenched!  Back hurt for 48 hours.  Did not go to emergency as husband was at work and I kept thinking it would pass.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose, route and frequency unknown. On 21-MAY-2012 the patient was vaccinated with improperly stored VARIVAX lot # 671861/1907AA, dose number 2. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of arthralgia in unspecified number of patients who received FLUARIX QUADRIVALENT. On an unknown date, the patients received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patients experienced arthralgia. On an unknown date, the outcome of the arthralgia was unknown. It was unknown if the reporter considered the arthralgia to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case was reported by a nurse via sales representative via call center representative. The reporter when speaking with a sales representative made the general statement that there have been more complaints of arthralgia from unspecified number of patients this year than in the past with the FLUARIX QUADRIVALENT vaccine. The reporter did not note the number of patients that had received the vaccine nor their identification. The representative called to report what little information he had been provided with. The representative tried to get more specific about the patients and the number of patients. He did note that the hospital had purchased 4000 doses of the vaccine.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 3:39 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 1:47 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 68.81 for dose administered on 31-Mar-2021, Vaccination time 1:47 PM. Age of patient was reported as 68.73  for dose administered on 03-March-2021, Vaccination time 3:39 PM.  Concomitant products were not provided.  On 03-Mar-2021 vials were moved to clinic. On 24-Feb-2021 the vaccines were moved to fridge. On 03-Mar-2021, the vial underwent the excursion. The vaccine beyond use date was reported as 26-Mar-2021.  On 31-Mar-2021 vials were moved to clinic. On 30-Mar-2021 the vaccines were moved to fridge. On 31-Mar-2021, the vial underwent the excursion. The vaccine beyond use date was reported as 29-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Patient was given the Pfizer/Biotech Covid-19 Vaccine on 10/11/2021. It was discovered that the product was dispensed and administered on the 33rd day of being in the fridge. VAERS will be updated and filled with all pertinent information.
ACUTE NON ST ELEVATION MI 4/27/2023 ACUTE NON ST ELEVATION MI ACUTE CORONARY SYNDROME, UNSPECIFIED 4/27/2023 ACUTE NON ST ELEVATION MI ACUTE NON ST ELEVATION MI 4/27/2023 RHEUMATOID DEFORMITY OF BILAT HANDS ACUTE CORONARY SYNDROME, UNSPECIFIED 4/27/2023 RHEUMATOID DEFORMITY OF BILAT HANDS
soreness in body, right arm at injection site, joint stiffness in body, long lasting joint stiffness in both hands, right hand is worse in right thumb, index finger, ring finger and pinky.  decreased grip strength in hands and achy.
Pt became very warm and began to sweat. Vision became blurry, lasted ~ 5min. Knees buckled and pt collapsed on floor. Erythema and swelling to the area of injection (~2/3 of upper left arm). Warm unable to bend or lie on the arm, lasted several hours into the evening. Nausea, but not vomiting. Lightheadedness. Consumed fluids to help manage once nausea resolved.
pt came into pharmacy to see if she was due for a covid booster.  She brought the last vaccine record card we had given her with last booster date of 10/31/21.  Looked as if she was due for a bivalent booster.  Pt was agreeable with receiving Pfizer version as that was all we had in stock.  After administering the vaccine, she handed me 2 vaccine record cards to see if I could consolidate them & it was then I noticed she had already had a Moderna bivalent booster while in 09/2022.   No adverse effects to report at this time--reporting as was given outside of guidelines
Due to a reaction to a Tetanus Toxoid Adsorbed injection 20 years ago, pt was given only a 0.25 mL dose of Tetanus Toxoid Adsorbed; Purogenated on 05/24/1999 when he sustained a small laceration to his hand.  Two days post vax, pt developed fever, chills and flu-like symptoms.
The top of the syringe broke when they were trying to put the syringe on.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "The top of the syringe broke when they were trying to put the syringe on.". Additional information: with one of the prefilled syringes and to the top of the syringe broke when they were trying to put the syringe on, but actually would this Prevnar more 'appropriately' to you, she just wanted to file report this and this syringe is not administer to patients when it broke.   The reporter considered "the top of the syringe broke when they were trying to put the syringe on." associated to pneumococcal 13-val conj vac (dipht CRM197 protein).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10/11/07 Red, raised area, 6x4 urticaria at injection site, reported by PCP - Dr.
Received Tdap and MCV4 in left deltoid of HPV 9 in right deltoid on 8-2-16. On 8-7-16 noticed on (L) deltoid red circle with induration. Area 2.5 x 2 inch diameter indurated red, sl. swelling on left deltoid. Reports mildly itchy. Office visit 8-8-16 tx with cool compresses and hydrocortisone cream to area.
Miscarriage; Vomiting; 103 fever (2 consecutive); Pregnancy at time of Vaccination: Yes; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Aug2021 (at the age of 28-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported and concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient was pregnant at the time of vaccination and had maternal exposure during pregnancy. On 14Aug2021, the patient experienced 103 fever (2 consecutive), vomiting and had miscarriage. The patient received ultrasound-complete miscarriage and treatment for other events. The adverse events resulted in doctor or other health care professional office/clinic visit. The outcome of the events was recovered with sequel.  No follow-up attempts are possible. No further information is expected.
NAUSEA AND VOMITING. SOME SORENESS AT INJECTION SITE EARLIER.
Patient obtained 3 immunizations. She was in mid-conversation, when suddenly, she fell back onto the exam table and displayed seizure-like symptoms for 30-45 seconds. She was rigid and shaking during the episode. She was not incontinent of stool or urine. When symptoms subsided, she was alert and oriented x4. She was provided water and crackers, as patient reported only having a Go-gurt for breakfast. PA was contacted and advised to have patient be evaluated by PCP or in the ER. Mother was contacted and notified of event. Mother then reported patient had a similar episode about 1 year ago, although she had not reported this when contacted for the contraindication questions. Mother was able to contact patient's PCP and they advised to follow-up in their office at a later date. Mother reported that PCP can order further workup, if indicated. Mother did come and pickup patient from school to be monitored for the rest of the day. Mother was provided letter with description of episode.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 68-year-old male patient who received SHINGRIX (batch number KB99G, expiry date 23rd February 2021) for prophylaxis. On 21st September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The patient experienced current episode of shingles after receiving SHINGRIX. The patient's date of birth is not encoded in the present case as the note in the classification keyword states that it is wrong.
Adult dose administered in errror; Adult dose administered in errror; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HAV (Havrix 1440 adult) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   On 17-AUG-2023, the patient received the 2nd dose of Havrix 1440 adult (intramuscular). On 17-AUG-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: Adult dose administered in errror) and adult product administered to child (Verbatim: Adult dose administered in errror).  The outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 6-Sept-2023 The reporter reprtoed that the encounter cashier marked adult dose and nurse herself grabbed the adult dose. EHR unavailable during administration (there was a safety message that would have alerted the patient to check the dose had it been working). The reporter was unable to read the patient's voicemail twice left asking for returned. The patient received an adult of Havrix in error, which led to overdose and adult product administered to child. Summary of changes: Suspect details, event details and narrative were updated.  Upon internal review, the case was updated on 14th September 2023: Summary of changes: The case was changes from invalid report to valid report.
blood pressure 110/74; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): EC-2022-121579 .  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; lenvatinib mesilate (LENVIMA), since Jul2022 (ongoing) (Lot number: 2612335) at 10 mg daily (10 mg, daily (started second week of July)), oral for endometrial cancer. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "blood pressure 110/74". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for lenvatinib mesilate was dosage not changed. Additional information: The patient had 3 missed doses (dates unknown) due to hospitalization (for 3 days - dates unknown) for unspecified reaction due to covid vaccine (query sent). Unknown if side effects or adverse reactions due to missed doses. Blood pressure at the time of the report was 110/74. MD was aware.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hospitalized 12/7/2021; COVID-19 positive 12/7/2021; fully vaccinated  BRIEF OVERVIEW: Discharge Provider: DO Primary Care Provider at Discharge: MD  Admission Date: 12/7/2021 Discharge Date: 12/10/2021 DETAILS OF HOSPITAL STAY:   HOSPITAL COURSE: Patient is a 90-year-old female with history of dementia, 1 diabetes mellitus, recurrent urinary tract infection, stage III CKD, diabetic neuropathy and paroxysmal atrial fibrillation who presented with increased weakness, decreased appetite and decreased LOC.  She resides at facility.  In the ED, she was hypoxemic and placed on 2 L oxygen.  She was hypertensive but otherwise hemodynamically stable.  She was noted to be COVID positive but is fully vaccinated.  She was lethargic and confused in the ED, with glucose 206, BUN 31 and Cr 1.34.  She underwent CT head without contrast, which showed no acute intracranial abnormality.  Due to her hypoxia and generalized weakness, with altered mental status, she was admitted to the hospitalist service for further management.   Upon admission, she was quickly able to be weaned back to room air.  By the following day, her mental status was markedly improved, and felt to be at baseline.  She remained afebrile, with normal WBC count.  She had minimal symptoms of COVID otherwise.  She was seen by PT and OT, who felt that she was appropriate for discharge back to her assisted living facility.  Her urine culture did return positive for Aerococcus urinae.  She was given a single dose of Fosfomycin on 12/9, which should be repeated on 12/12.  I suspect her altered mental status was either behavioral or due to underlying infection (COVID vs UTI), but had resolved by time of hospital discharge.   She was discharged back to her assisted living facility on 12/10/21.  She should receive a second dose of Fosfomycin on 12/12 to complete treatment for her UTI.  She should follow-up with Dr. in 1 week.
Dizziness, mild sweating, and a temporary loss of hearing a few minutes after the shot before brief LOC. Mother reported "eyes rolling up" and a respiratory gasp.   Rapid recovery with fully orientation on the floor. VS stable in observation.   No nausea or visual changes reported by the patient. No orthostasis.
Rapid heart beat; elevated blood pressure; cardiologist sent me to ER and I was later admitted and treated in hospital for 2 days.
EXPOSURE VIA BREAST MILK; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of exposure via breast milk was not reported. This report was non-serious.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with HepB (manufacturer unknown) (dose, route of administration, lot and expiry date were not reported). On an unknown date the patient experienced severe unspecified allergic reaction to a HepB (manufacturer unknown). The patient's outcome was not reported. The event was considered to be related to HepB (manufacturer unknown). Additional information is not expected because the reporter does not wish to be contacted.
I tested positive for Covid-19; I had ringing in my ears I lost my taste and smell still to this day I cant taste and smell also my pulse rate is irregular.
MUSCLE TENSION; MUSCLE CRAMPS IN THE LEGS, ARMS AND KNEES; TIGHTENING OF THE NECK; I DON'T HAVE ENERGY AT ALL; 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, and batch number were not reported) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced muscle tension, muscle cramps in the legs, arms and knees, tightening of the neck, and i don't have energy at all. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the i don't have energy at all, muscle tension, muscle cramps in the legs, arms and knees and tightening of the neck was not reported. This report was non-serious.
Discharge Provider: MD Primary Care Provider: DO Admission Date: 3/3/2023 Discharge Date: Mar 5, 2023   PRESENTING PROBLEM: Hyponatremia [E87.1] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Patient is a 73 y.o. male with past medical history significant for CAD with stents, DLD, HTN, PMR, kidney stones, possible RA, DM II, chronic neck pain and cervical spinal fusion who was recently found to have COVID-19. He scheduled outpatient remdesivir infusions and presented to his appointment on 3/3. Routine lab work before the infusion found acute hyponatremia to 120 and he was instructed to go to the ER for further evaluation.    He had been trying to keep up hydration with water. He was given IV fluids in the ER and admitted to medicine for further management. He was continued on fluid resuscitation with close monitoring of sodium to prevent overcorrection. His chlorthalidone was stopped. He had slow and appropriate increase in his sodium levels up to previous baseline of 130.    For his COVID he was started on remdesivir for 3 days. On 3/5 his COVID was improving. He was never hypoxic. His sodium returned to his baseline. After shared decision making he was discharged in stable condition. He will f/u with his PCP.
Approx. 10 minutes after receiving vaccines mom noted blanching small red macules on dorsum of feet; child otherwise well; given 8 mg of BENADRYL; after - 20 minutes post - BENADRYL doctor checked and almost completely resolved.