chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seriousness criteria other medically significant (OMIC). Initial report received on 10/24/06 from the pts daughter who is also a health care professional. A male pt, age not specified, had received an injection of influenza vaccine, manufacturer not reported, lot number not reported, on an unspecified date in 1995. Two weeks post vaccination, the pt developed peripheral vision loss. Recovery status was not reported. This event was reported secondary to an inquiry, and the reporter stated, he is now suffering from pulmonary fibrosis and needs flu vaccine. Additional details were not provided.
About 8 1/2 x 15 raised rash that was red to the touch.
After injection into left deltoid, had pain, burning, all the way down arm into hand. Two weeks later arm still hurts, sharp pain when lifted certain way, arm constantly burns.
Patient awoke the next morning with some pain in the arm and redness near the injection site. Patient is unsure if she ?slept wrong?. Redness was still present when she came into the pharmacy three days later.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient states that area is warm to the touch & there is a knot the size of silver dollar coin in the location of injection.
No adverse event; patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 29-Sep-2022, the patient experienced UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine).    Concomitant medications were not reported. It was reported that patient did not report any adverse events. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-654894, US-MODERNATX, INC.-MOD-2022-654906, US-MODERNATX, INC.-MOD-2022-654910 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654894:Patient No-1 US-MODERNATX, INC.-MOD-2022-654906:Patient No -3 US-MODERNATX, INC.-MOD-2022-654910:Patient No-4
Painful  left vaccine site. Chills and swollen left ancillary lymph node.
09/17/2021 I noticed lymph notes. Had a CT and then  they wanted me to have a  Pet Scan.  Cancer had returned. Then had lung surgery in December of 2021.
Patient came back to clinic after lunch complaining of Difficulty breathing and severe pain in left arm and chest. Patient said it felt like he was having a stroke.
This spontaneous report was received from a registered nurse via an office manager and refers to a 12 month old male patient. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 28-APR-2016, the patient was vaccinated with his first dose of VARIVAX injection, lot # L035127, expiry date 14-SEP-2017 (dose, route of administration and anatomical location were not specified) which underwent a supported temperature excursion. Other suspect therapies included the fourth dose of ROTATEQ oral solution, lot # K023532, expiry date 21-JUN-2016 (dose was not specified) on 28-APR-2016, which previously underwent an unsupported temperature excursion. Concomitant therapies included one dose of MMR II. It was unknown if there was any relevant laboratory data. This is one of several reports received from the same reporter. Additional information has been requested.
Approx 31 hrs after injection, severe  uncontrollable diarrhea, mild stomach pain. Diarrhea 5-6 times over the next 24 hours.  Mild stomach pain continuing 72 hours.
Pt vax w/ 3 hepta B; 3rd dose given on 02May90.  Pt failed to produce adequate antibody titers.
Vaccinating nurse mixed partial doses from 2 vials of Moderna (same LOT #) to give 0.25ml dose.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021 at 10:08 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 10:08 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 39.31. Concomitant products were not provided. Treatment medications were not reported.  Batch number 019B21A underwent temperature excursion on 30-Mar-2021 with temperature 33 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 30-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.   This case was linked to MOD-2022-566976 (Patient Link).
The day after I had a fever and was really nauseous with lots of body aches that lasted about 2 days.  Woke up 2 days later with a horrible migraine and vomited and experienced sensitivity to light.  I wasn't able to see anyone until 4 days.
No additional AEs; Caller reported vaccine administered after temperature excursions.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug allergies or reactions, concurrent conditions, and concomitant drugs were not reported.   On 03-AUG-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) injection (0.5 ml, lot#: W038809, expiration date: 04-JUN-2024; strength was not provided) administered intramuscularly (IM) for prophylaxis. The vaccine administered experienced temperature excursion before of 18.3F for 1 hour and 5 minutes (product storage error). No additional AEs (adverse events) (no adverse event).
No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 20-JAN-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: S022599, expiration date: 25-FEB-2022, dose, strength and route were not reported) for prophylaxis.   The vaccine underwent temperature excursions and was stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported.   This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022599; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002972: US-009507513-2104USA002973: US-009507513-2104USA002974: US-009507513-2104USA002975: US-009507513-2104USA002976: US-009507513-2104USA002971: US-009507513-2104USA002978: US-009507513-2104USA002963: US-009507513-2104USA002944: US-009507513-2104USA002970: US-009507513-2104USA002981: US-009507513-2104USA002982: US-009507513-2104USA002983: US-009507513-2104USA002984: US-009507513-2104USA002985: US-009507513-2104USA002986: US-009507513-2104USA002987: US-009507513-2104USA002988: US-009507513-2104USA002989:
elevated temp 103.7 R; uncontrollable shrill cry; 8PM devel rectal temp 103.7; shrill cry from 8PM; seen by MD 9PM;
About 30 mins after vaccine throat felt tight. Hard to swallow. Went away after about an hour. Next day 04/18/21 had muscle and joint pains all morning. On 04/19/21 developed two bumps on the right of my neck on my lymp node.
No additional AE/ No PQC/. Patient did not have any side effects; a patient that was administered ROTATEQ that had been improperly stored. Patient did not have any side effects; This spontaneous report was received from a nurse and refers to a 3-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. There was no information regarding the patient's drug reactions or allergies.  On an unknown date, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2ml, administered orally, lot #W004501, expiration date: 20-APR-2023, (strength, and dose number were not provided) for prophylaxis.   For rotavirus vaccine, live, oral, pentavalent (ROTATEQ) the temperature excursion was reported as 34.4 Fahrenheit degree (F) for 20 minutes. The previous temperature excursions was not occurred. Patient did not have any side effects. No additional adverse event (AE) was reported (no adverse event).
I got inflammation of the rib cage Costochondritis. I've had nightmares since this as well.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical  history and concurrent condition was not reported. On 02-APR-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K003520 with expiration date of 20-NOV-2016, dosage and route unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sore arm. Bump. Then became red itchy hot rash about the size of a quarter. This gradually increased in size until it was about 5x7? covering a large portion of upper arm. Get hot to touch, very sore. Took about 2 weeks to go away. Still have lump and residual itchiness.
This spontaneous report as received from a 73-year-old male patient refers to himself. The patient had none pertinent medical history and no drug reactions/ allergies. On 20-DEC-2017 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiry date not reported) in the left arm. Concomitant therapies included LIPITOR, ELIQUIS and TOPROL XL TABLETS. On 18-SEP-2018, the patient went to emergency room with his left arm completely numb and was diagnosed with transient ischaemic attack. The patient was admitted and stayed overnight (1 day), received unspecified treatment and underwent various unspecified lab tests and blood work. The patient stated that all health conditions he experienced since his administration of ZOSTAVAX were related to the above mentioned adverse event, and therefore did not feel as though he had recovered fully from his adverse event (specific symptoms were not clarified). No further symptoms or specifics were provided. The outcome of transient ischaemic attack was reported as recovering/resolving. The causality assessment was not provided. Upon internal review event of transient ischaemic attack was considered to be medically significant.
arm around inj site reddened, warm to the touch, somewhat tender x 2-3 days
Dose administered over12hs after thawed; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered over12hs after thawed) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered over12hs after thawed). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered over12hs after thawed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. The year of birth of patient was reported. Reporter stated that the pharmacist administered a dose of the Moderna vaccine over 12 hours after thawed to patient who requested a booster shoot. Treatment medications were not reported.
Two weeks after receiving a tetanus shot I became ill.  I woke up and the left side of my face was numb, ached and had severe headaches.  My face became numb and then the next day the whole left side of my body became numb.  The numbness and headaches lasted for 6 months.  I started by going to my family doctor and had an open view MRI, bloodwork and x-rays done.  After no results i then went to a chiropractor and after 4-5 adjustments I regained all feeling.  Now according to the neurologist which the chiropractor sent me to the feeling coming back after the chiropractors readjustments may have been just coincidental.  He feels there is more to it than that.  So, today, I had a closed MRI with contrast.  The neurologist is suppose to get the results back from that by monday OCT. 23rd.
terrible reaction that lasted almost a week, 5-6 days; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (terrible reaction that lasted almost a week, 5-6 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical Conditions were Reported.).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced ADVERSE REACTION (terrible reaction that lasted almost a week, 5-6 days). At the time of the report, ADVERSE REACTION (terrible reaction that lasted almost a week, 5-6 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Ongoing low blood pressure hovering around 100 systolic and as low as 95/59. Also quite a lot of fatigue.
flu-like symptoms; head ache; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on Jan2021 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced that after her first dose on Jan2021, about 4 weeks ago, she experienced flu-like symptoms and head ache for about 4 days. The outcome of the events was recovered on Jan2021.  Information on the lot/batch number has been requested.
I was not able to stand; dizzy spells; got Covid Just out of quarantine this Monday.; It attacked the muscles in my body and was in a lot of body pain; This spontaneous case was reported by a patient and describes the occurrence of DYSSTASIA (I was not able to stand), DIZZINESS (dizzy spells), COVID-19 (got Covid Just out of quarantine this Monday.) and MYALGIA (It attacked the muscles in my body and was in a lot of body pain) 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 DYSSTASIA (I was not able to stand), DIZZINESS (dizzy spells), COVID-19 (got Covid Just out of quarantine this Monday.) and MYALGIA (It attacked the muscles in my body and was in a lot of body pain). At the time of the report, DYSSTASIA (I was not able to stand), COVID-19 (got Covid Just out of quarantine this Monday.) and MYALGIA (It attacked the muscles in my body and was in a lot of body pain) outcome was unknown and DIZZINESS (dizzy spells) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. The patient had been treated with infusions, steroids, antibiotic, anti-inflammatory shot with nausea medicine in a IV.   This case was linked to MOD-2021-114938 (Patient Link).; Sender's Comments: This case concerns a patient of unknown age and gender with no relevant medical, who experienced the unexpected event of COVID-19. The event occurred on an unknown date after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Symptomatic anemia, syncope event, suspected upper GI bleed secondary to NSAIDS, chronic headache following Covid infection.
DTaP/Infanrix given 4/12/04. Patient returned 4/14/04 with swelling, redness to injection site and painful. Started on Keflex/Motrin. Followed up on 5/5/04; erythema.
c/o weakness, dizziness BP 170/92, P60 reg, rested; 4 hrs post inject c/o dizziness when stands only, otherwise states OK BP 160/88, P66 reg reported next day felt very cold p/initial reaction on 20APR93; advised by MD to seek personal med
accidentally administered Fluzone High Dose to 7 patient's between the ages of 36-54/no AE; accidentally administered Fluzone High Dose to 7 patient's between the ages of 36-54/no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a male patient age ranging from 36-54 years (adult)  who received a 0.5 ml dose of vaccine  INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE lot: UJ285AA, expiry date: 02-Jun-2020), (prefilled syringe) via intramuscular route in the left arm  accidentally, on 21-Oct-2019.  The patient past medical history, medical treatments, vaccinations and family history were not provided.  No other vaccine was given.  It was a case of actual medication error due to overdose and product administered to patient of inappropriate age It was reported that patient was accidentally administered Fluzone high dose to patient between ages of 36-54   At the time of reporting, the patient had no adverse event.  No further relevant information was reported.  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 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.
Dec 17th noted silver dollar size redness at site of injection. Dec 18th worse extending from elbow to shoulder, redness, warm and itching. Dec 19th the redness remains with itching but feeling better. Advised to cover and use calamine lotion or oatmeal packs to relieve itching. Also BENADRYL. See dr. if breathing issues.
expired Daptacel was given to a 1 year old; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 12 months old patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and reported that expired Daptacel was given to a 1 year old.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any 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 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.  Information on the batch number was requested.  List of documents held by sender: none.
Severe shoulder and upper arm pain that has lasted over two weeks post vaccine.  Lost Range of motion in affected arm.  Pain so severe at times I am unable to sleep.
The injection site was swollen/hard/red/tender to touch; patient treated with ice pack on Sunday.  Patient now has cold like symptoms (sinus/allergy - sore throat. Redness and tenderness have decreased today 4/6/15.