chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tender lymph node on the side of the injection; Chills; Very mild fever; Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), LYMPH NODE PAIN (Tender lymph node on the side of the injection), CHILLS (Chills), PYREXIA (Very mild fever) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for Blood pressure high.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 13-Feb-2021, the patient experienced LYMPH NODE PAIN (Tender lymph node on the side of the injection), CHILLS (Chills), PYREXIA (Very mild fever) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and LYMPH NODE PAIN (Tender lymph node on the side of the injection), CHILLS (Chills), PYREXIA (Very mild fever) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included prelioxac to treat high blood pressure.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
3rd dose administered on 19Oct2022; 1st Flulaval dose 15Sep2022, 2nd 26Sep2022; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 8-month-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis and flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT).   On 19th October 2022, the patient received the 3rd dose of Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 26th September 2022, the patient received the 2nd dose of FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 26th September 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On 19th October 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and drug dose administration interval too short 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: 25-Oct-2022 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received second dose of Flulaval QIV earlier than the recommended interval, which led to shortening of vaccine schedule. The patient received third dose of Fluarix QIV, which led to extra dose administered.
pt recvd vax & exp rash appeared from shoulder to mid-form arm for 2 wks; c/o itching;
was diagnosed with covid on Saturday 20Mar2021/ symptoms started on Thursday, 18Mar2021; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age (age reported as Age: 64; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in right shoulder (reported as "he assumes it was in the muscle") on 10Mar2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. Medical history included non-Hodgkin's lymphoma diagnosed 10 years ago (in 2011). He was never treated the Non-Hodgkin's Lymphoma and is on a watch and wait. There were no concomitant medications. The patient had first dose of the Pfizer vaccine on 10Mar2021 Wednesday, due to have the 2nd dose this coming Wednesday. The patient was diagnosed with COVID on Saturday 20Mar2021. His symptoms started on Thursday, 18Mar2021. The patient was pretty much through Covid at the time of report but was not 100% but feeling much better. The patient asked if there is any data on side effects after having COVID and getting the vaccine. The patient underwent lab tests and procedures which included COVID test: positive on 20Mar2021. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Headache, Myalgia, Pain/Discomfort at injection site, chills, fatigue or tiredness Narrative:
Seated patient refers to itching and redness of face. Doctor ordered to administered 50mg of intramuscular BENADRYL.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed the vaccine vial,  and advised that lot  007B21A maintained activity necessary to protect  against Covid 19  regardless of expiration date.  Patient did not call in to report any adverse event.  This is an administration error without adverse event.
Case number PHEH2015US009658 is an initial spontaneous report from nurse received on 14 May 2015. This report refers to a patient of unspecified age and gender. Medical history and concomitant medications were not reported. The patient was vaccinated with RABAVERT (batch number: unknown) on an unknown date. The patient came for the repeat dose but it was held for 1 day because the blood pressure was elevated. The outcome, seriousness and causality was not reported.
15MAY95 pt recv vax @ 1045, pt phoned 3 hr later c/o shakiness & tightness in throat; had nuts on sandwich @ lunch (stated allergy to nuts as a child); took DPH; seen in ofc that evening; had fever, chills & rapid HR; t102.7, h/a; sepsis
elevated thyroid levels/thyroid numbers are out of range; This is a spontaneous report from a contactable consumer or other non hcp.   A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  on an unspecified date the patient experienced elevated thyroid levels/thyroid numbers are out of range. The patient underwent lab tests and procedures which included thyroid function test: elevated thyroid levels. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Received her TDAP vaccine on 12/16/11. No initial pain at injection site. 12/17/11 am began to have pain in upper left arm. Pain continued to be present. Week after Christmas she was unable to lift arm and pain continued. She saw her PCP 1/31/12 after being advised to by our office. Was treated with NSAIDS. Seen again 2/9/12 and pain is achy to sharp. Still unable to raise left arm over head. Now treated with steroids and physical therapy.
pt was vaccinated with no reported issues.  pt waited required 15 minutes in pharmacy area with no reported issues.   when pt sat up from chair and began walking to care they experienced the following: tremors, flushing, sweating, near fainting like symptoms, muscle weakness.  symptoms lasted approximately 5-10 minutes and were resolved completely after given cold water and after sitting for an extra 15 minutes.
Pt presented to hospital with high fevers and was later found to have atypical Kawasaki's Disease given echo findings of L coronary artery dilatation.
BODY ACHE/BODY PAINS; SLEEPING; SEVERE CHILLS; FATIGUE; 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: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced body ache/body pains. On APR-2021, the subject experienced sleeping. On APR-2021, the subject experienced severe chills. On APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache/body pains, sleeping, severe chills, and fatigue on APR-2021. This report was non-serious.
Information has been received from a health professional concerning a 10 year old male who on 06/10/99 was vaccinated with a dose of varicella virus vaccine live. The pt was DX with varicella  on 02/01/05 with 20 lesions and blisters occurring. It was reported that the pt has not recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other additonal information was provided.
12/30/12: tingling numbness in feet & hands. 12/31/12: began falling down. 1/1/13: ER visit / admitted to hospital / diagnosed with Guillain-Barre Syndrome - 1/24/13 D/C.
Cough; He had no energy; Low grade fever; was feeling fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), ASTHENIA (He had no energy), PYREXIA (Low grade fever) and FATIGUE (was feeling fatigue) 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 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced COUGH (Cough), ASTHENIA (He had no energy), PYREXIA (Low grade fever) and FATIGUE (was feeling fatigue). At the time of the report, COUGH (Cough), ASTHENIA (He had no energy), PYREXIA (Low grade fever) and FATIGUE (was feeling fatigue) outcome was unknown.            No Concomitant product use was reported.  The patient post receiving their Moderna booster was having low grade fever and cough the next day. The patient had no energy and was feeling fatigue. The patient had not been seen by a doctor although they were planning to.  No treatment information was provided.
Patient had fever after second dose for 1 week associated with right shoulder pain and limited range of motion. He was neutropenic and found to have MSSA Bacteremia. MRI of right shoulder with no drainable collection, no septic arthritis. No procedures, lines, dental work, nothing else that could explain it.
Moderate pain and redness at injection site for about 5 days After day 8 redness, pain, itchiness returned but more intense.
Patient reported feeling dizzy and short of breath. Went to walk-in clinic next morning after developing rash and no improvement in previous symptoms.
Atrial fibrillation and accelerated heart rate one week after vaccine. Now on beta blocker and blood thinner
About 24 hours after receiving my second COVID-19 vaccination (Pfizer) on 4/30/21, I began feeling intense pain in my lower back. It was so painful that I could not even sit down or lie down without intense discomfort. I was unable to sit for periods longer than 10 minutes. I did not do anything physically demanding after getting the vaccine, so I'm convinced the vacccine caused the pain. I have had lower back soreness for several years and two doctors have diagnosed it as a possible torn disk. It took a full 30 days for the pain to subside.  I also got severe flu-like symptoms from the shot beginning 12 hours after the second shot. These cleared up after about 8 hours.  I also began feeling heart burn about 10 days after my first shot. It intensified after my second shot. I've never had heart burn before. I had to go on Omeprazole prescribed by my physisican.  Abo
Information has been received from a health professional concerning females who were vaccinated with GARDASIL (lot# not provided).  Subsequently 2 out of 3 patients experienced pain at the injection site that lasted for several days post-vaccination.  There was no prevalence in the series of the doses in terms of pain intensity.  Subsequently, the patients recovered from pain at the injection site.  The patients sought unspecified medical attention at the doctor's office.  A phone call was placed on 22-APR-2008 to obtain more information.  Additional information has been requested.
Started having redness, water blisters, puffiness around eyes & lips 1 1/2-2 weeks after vaccination. Very itchy & painful. Sought tx at urgent care. Given steroid shot & tablets.
Initial and follow up information has been received from an office manager for the physician and a physician concerning a 65 year old retired female with no known adverse drug reactions, no known allergies and no pertinent medical history reported.  On the morning of 27-JUL-2005, the patient was vaccinated into the right arm with a 0.5 ml, first dose of pneumococcal 23v polysaccharide vaccine (lot650453-0791P).  There were no concomitant medications reported.  That same day, following vaccination, the patient developed pain and redness at the injection site was warm to touch at injection site and had difficulty moving her arm.  The patient sought unspecified medical attention.  The office manager reported that she believed the patient had recovered from the events (date unknown).  The physician reported a concern regarding the lot.  The records of testing prior to release of this lot have been checked by the Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.  Additional information is not expected.
PATIENT COMPLAIN WITH SORE ARM SINCE 10-29. SHE EXPERIENSE PAIN WHILE SHE CHANGE CLOTHING.  I RECOMENTED MOTRIN AND TO CALL PRIMARY.
This was a booster shot for just one shot before (J&J in April). Approximately 3 hours after shot, noticed shortness of breath while talking and raised heart rate. Had a raised heart rate (still do) for many days, with some episodes taking it about 100 bpm for multiple days. Shortness of breath continued while talking, and eventually (three days later) started noticing minor chest pain. Went to a doctor who suggested going to ER immediately on Dec 13th.
Fainted (Vasovagal syncope) within one minute of the vaccine injection. Regained consciousness quickly but felt very groggy. Drank orange juice and rested in place for 25 minutes until feeling well enough to slowly get up. Continued to rest sheet getting home and felt fine again within an hour.
Initial case report received from a physician and registered nurse via Vaccine Adverse Event Reporting System (VAERS), on 06 NOV 2009. A 2-day-old female patient experienced a seizure-like episode and was transferred to a neonatal intensive care unit (NICU) on 03 JUN 2009. The outcome was unknown at time of this report. Medical history: The patient's mother was vaccinated with FLUVIRIN (batch no. unknown) on 1 MAR 2008. A caesarean section due to non-reassuring fetal heart rate was performed on 01 JUN 2009. The baby's apgar scores were 7 at one minute, 8 at five minutes and 9 at ten minutes.
pt devel pain in lt arm that radiated to neck, lasted 2 days;pt was not evaluated by MD;
The "adverse event" I now have is COVID-19.   I was advised by the caller from your agency to report having COVID as an adverse event.  In 2021, I received both vaccination shots and both boosters.  On 7/11/2022, I contracted COVID.  My symptoms are relatively mild and I am currently quarantining for 5 days.   My doctor has prescribed PAXLOVID over a 5 day period.    The reason I've noted that I haven't recovered (Item 20 below) is I am still fighting off the virus.
This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unkonwn age and gender. Information regarding the patients' relevant medical history and concomitant medications was not reported. On unknown dates, the patients were vaccinated with a dose of ROTATEQ (oral, dose, lot# and expiration date were not reported) that was stored improperly. No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Low grade fever, moderate body aches, moderate fatigue, constant headache.  Required bed rest (2 days) and restricted activity for an additional 4 days, along with OTC pain relievers.  Site of injection was swollen, hot, and red for approximately 48 hours.
Initial report received from a nurse on 10 Dec 2009: This patient received initial vaccination with FLUVIRIN (batch no 102136P1A) on 20 Nov 2009. The second dose was give on 03 Dec 2009 which was only fourteen days after the first dose. No adverse event was reported.
Experienced vaginal bleeding on the 5th day after receiving booster vaccine. I bled for a total of 11 days. This was not when I was due for my regular menstrual cycle.
I got the vaccine, 5 mo later I blew up with Shingles/ suspected vaccination failure; shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 5 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingles vaccine and 5 months later blew up with Shingles. In less than 6 months after vaccination the patient ever experienced most incredible pain. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. Note-For pain time to onset considered as less than 6 months as pain might occurred before shingles and shingles experienced 5 months later Shingles vaccine.
Diarrhea, Nausea, Headache, Fatigue, Body Aches started at 4am Tuesday 1/26 and still ongoing today presently. Cough is starting today.
Mother stated baby had bumps on him, looked like ant bites.  Mom took him to E.R. and MD said it was chicken pox.  No treatment given.  Rash started on 10/2/99, saw MD on 10/4/99.
6/28/04 - 2 hrs after Td symptoms began. Experienced difficulty concentrating, aching all over, especially legs and nausea. Muscle contractions up & down from head to toe, unable to sleep, chills, blurry vision, neck stiffness, weak muscles, sensitive to touch, fever off and on, lower back aches, constipation.
No additional adverse effect reported; inadvertently administered a dose of PROQUAD on 1/20/2020 that had been improperly stored; This spontaneous report was received from a nurse practitioner regarding a 5-years-old patient of unknown gender. The patient's pertinent medical history , concurrent conditions and drug reactions or allergies were not provided.  On 20-JAN-2020, the patient was inadvertently vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA))(PROQUAD) injection (strength, dose number, and anatomical site of vaccination were not reported; lot number S027461 has been verified to be valid, expiration date on 02-MAR-2021) as prophylaxis.  The improperly dose experienced a temperature of -13 degrees Celsius (C), for a time frame of 5 minutes and 4.69 degrees C for a timeframe of 1 hour 45 minutes; without a previous temperature excursion. The temperatured was recorded by a data logger. It was reported that the sterile diluent (DILUENT MERCK) injection and used for reconstitution of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was properly stored.
Did not seek treatment went to family Dr. Received PT/meds-Doruocet/Lodeine-(inflam). Localized swelling at site/ lower arm within one day. At home initially tx with motrin/ice and heat alternating and exercise.
Large, red, swollen right upper arm to elbow on 8/3/15. Very sore. BENADRYL/ice.
Patient states the vaccine was administered too high, above the deltoid. She states she does not have any symptoms of nerve damage, but is worried of long term effects. She reports extreme] soreness.
Pt had localized reaction to Trihibit injection with swelling from shoulder down to/including elbow area and red hot--Right arm.