chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a consumer (patient's grandmother) and refers to 13 months old male patient. The patient had no pertinent medical history and concomitant medication. The patient had allergies to fish, egg, sesame, pistachios and cashews. On an unknown date in February 2019, the patient underwent skin allergy test with M-M-R II via intradermal route (dose, lot# and expiration date not reported). The reporter stated that the patient had a significant reaction which included a red, swollen rash (rash erythematous and swelling), developed after the test. The patient did not receive any treatment. On an unknown date in February 2019, the patient recovered from the events of swelling and rash erythematous. The patient sought medical attention and would be receiving vaccination with M-M-R II vaccine on an unspecified date in the near future at the allergist's office. No product quality complaint (PQC) was involved. Causality assessment for the events was not reported.
Child received Dtap on RT arm, afterwards developed red warm swelling, mom described as 6-7 cm diameter; no fever. Pt treated with Hydrocortisone 1% TID
approx 1hr p/vax started w/refusal to drink & progressing to being limp, not alert, sleeping a lot, eyes glassed over, & not crying;not usual behavior;
No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 15 month old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 18-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023503 and expiry date 16-AUG-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 at 13:15 as dose 1, single (Lot number: EN5318), in left arm, on 03Mar2021 at 14:30 as dose 2, single (Lot number: EM9810), in left arm and on 23Aug2021 at 10:00 as dose 3 (booster), single (Lot number: FC3182) at the age of 55 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 at 11:00 as dose 4 (booster), single (Lot number: 045L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "high Cholesterol" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; IRBESARTAN; PROZAC; WELLBUTRIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that, no known allergies. The patient received Paxlovid from 23Aug2022 to 27Aug2022 for treatment of Covid-19 . Rebound covid symptoms 6 days after stopping Paxlovid. Fever, sneezing and congestion. Other medications received in 2 weeks.
01/05/22: COUGH, ST, HA, NC, BODY ACHES
Muscle aches, prickly  lower lip and tongue, swollen and small amount of blistering to the lower lip, redness and slight swelling to the tip of my tongue.  Took Tylenol 1000 mg, Liquid Benadryl 50mg. Improved symptoms and was able to sleep but currently the prickly sensation to lips and tongue are returning.  Therefore, I took another does of Tylenol 1000 mgs and Liquid Benadryl 50mgs by mouth.
pt recv vax;mom called to report T of 104 PO;apap given & T dec to 102;children advil & T dec to 100; had no oth sx; lasted 1 day;
Inflammation of joints. Arthritic symptoms.  Went to personal physician. The follow up states, "I wasn't told that; she didn't come to me with this but her PCP."
At approximately 1108 am, It was reported to Dr in post vaccination that the patient had and issue with the vaccinations given.  Dr. Rushed to the vaccination are to see what was going on with the patient. It was reported that the patient had 2 vaccination at @ 1105(Tdap, MenB).   Report received that patient lost loc for less than 1 second.  I arrived at pts side to discover that pt was lethargic and Dr. had placed an ice pk on pts forehead.  However, pt is able to state her name.  Pt taken to the post vaccination via wheelchair at 1113 after making sure pt was stable.  Pt placed on a cot by school staff and me.  Upon assessment pt noted to have a blood pressure of 99/62, P: 65 O2 sats: 98% and temp of 98.8 at 1115.  Pts mom at her side.  Pt;s mom states she had not eaten breakfast this morning and that she had a previous hx of syncope with vaccination at the age of 8 yrs old.  Pt able to squeeze my hand.  Strong grips noted bilaterally.  No weakness noted.  Pt remained on the cot.  Vitals at 1120: B/P: 100/65, P; 65, O2 sats 99. 1125 Patient moved to sit up in a chair.  Patient able to self-ambulate.  vitals: B/P: 102/65, P: 66, O2: 98% Dr. gave patient a snack at 1130.  Pt tolerated her snack well lips pink, Pt able to chew, and is sitting up.  Patient states she feels ok.  Patient's mom remained at her side. Vitals B/P:116/79, P: 87, O2: 98% 1135 vitals:  115/75, P:75, O2 99%.  Patient A&O x 5. 1140 Vital B/P: 104/67, P: 61, O2 sats:99% 1152 patient able to walk out of clinic.  Patient states she feels good not issue noted while ambulating.  Patient's mom advised to monitor patient and makes sure she drinks plenty of fluids today and tomorrow.  Advised mom to seek medical attention if pt experience any side effects from vaccines
Injection site has a 3.5 inch diameter circular rash. The site is warm to the touch, red, itchy, painful, and swollen. Patient has also experienced fatigue, malaise, a cold sore and overall not feeling well.
3 months after recieving my 2nd vaccine I started having seizures. I was having unprovked seizures every 3 weeks.  Seisure Medication did not help. I added CBD oil to my seizure medication and i went 6 months with out a seizure. Had another unprovked seizure November 29, 2022 and now latest seizure January 9, 2023.  I've been a very healthy person until i got the pfizer covid 19 vaccine. I am no longer allowed to drive, I lost my grant money for college due to my attendace as i was having seizures every 3 weeks! 2 seizures accured in the college. Lost my job also because of attendance and no longer able to leagally drive. This vaccine is NOT SAFE for everyone and the public people deserve to know the truth. Stop pushing the vaccine on everybody it does NOT stop you from getting covid and it can most deffenitly ruin your health. I need to know if this vaccine will ever leave my system? Will i ever be healthy and normal again? Can it be reversed? Or am i to suffer from epilepsy , and these horrible grandmall seizures the rest of my life?
The vaccine was reconstituted with "sterile diluent"; sterile water instead of co-packed 0.4% saline with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via physician via (Reference number- 00607391) and transmitted to Sanofi on 19-May-2021.  This case involves a 2 month old male patient who was vaccinated with 0.5 ml first dose of HIB (PRP/T) VACCINE [ACT-HIB], which was reconstituted with sterile diluent; sterile water instead of co-packed 0.4% saline (lot UJ357AAA, expiry; 25-Jan-2022) via intramuscular route in left leg for prophylactic vaccination on 18-May-2021 (Product preparation error)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  It was a case of an actual medication error due to Wrong diluent used (latency same day)  The caller stated that they used the incorrect dilute for ACTHIB and administered it to a patient. The caller would like to know what steps to take now. But the nurse who prepared the vaccine reconstituted it with sterile diluent; sterile water instead of co-packed 0.4% saline. The vaccine will be repeated  No adverse effects 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
rash on my arms and a little on my neck and shoulders. Called the pharmacy and was told to just take Benadryl for a couple of days
Patient states that  around six hours after second COVID vaccine, she developed chills and fever x 1 day.  Also around 6 hours after vaccine, she developed tachycardia (around 120 BPM, then up to 180 BPM with little exertion).    She visited her OBGYN Dr.  one week after symptoms started and an EKG was performed to show left ventricular swelling.  She was referred to a cardiologist and a stress test was performed around one month later to show normal results.   The tachycardia lasted for 2-3 weeks after initial symptoms started.  Granted, the patient notices mild tachycardia currently and premature heartbeats, to date.   She is scheduled to followup with cardiologist.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitants medication were provided.  No treatment medication were provided.   This case was linked to MOD-2021-393535, MOD-2021-393537 (Patient Link).
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with PROQUAD (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up has been received from a physician and a licensed practical nurse (LPN) regarding a 4 year old male patient (child). On 07-JUL-2014 at 4:47 pm, the patient might have been immunized with a dose of PROQUAD lot number J015596, expiration date 05-JUN-2015, in the right thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Severe headache, sharp stabbing pain on top right side if head- stabbing in 20-30 sec increments, pain I right arm  Muscle pain throughout body  Joints extremely inflamed ( ankles, knees , hip & wrist /hands   Nausea  Sweating  Freezing
Patient reported dry throat, then was observed for an additional 10 minutes. Patient had normal vitals when monitored.
PARENT REPORTS REDNESS ITCHYNESS AND PAIN TO INJECTION SITE.
temperature excursion; This spontaneous report was received from a registered nurse and refers to a 5-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-DEC-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), lot# T021638, expiry date: 21-FEB-2021 (formulation, strength, dose, dose number, route of administration, anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of -13.3 degrees Celsius for 4 hours and 15 minutes. There were no previous excursions related. Data logger was involved.
Pain in upper left arm where vaccine administered later in evening same day. Pain continues now 3 weeks with decreased Range of Motion Left shoulder.
3-4 days post Tdap pharynigitis, fever, erythematous rash and arthralgia lasting 5-8 days.
This case was reported by a healthcare professional and described the occurrence of an adult female subject not responding to therapy following vaccination with Engerix B for prophylaxis.  On 26 July 2007, 27 April 2007 and 26 March 2007 the subject received 3rd dose, 2nd dose and 1st dose of Engerix B (unknown).  At an unspecified time after completion of the Engerix B three dose series, the subject was tested and the titer test showed to be only equivacol.  The subject had not responded to therapy.  At the time of reporting the event was unresolved.
This vaccine was given by error to a 61 year old female while it is approved 65+ patient with no adverse reaction.
Blood in urine; Urinary Tract Infections after first and second shots.; Also skipped period after first shot. Got second shot 4 weeks later, till no period; Also incredibly painful cramps after second shot, lasted 1 hr and happened 12 hrs after second shot.; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 38-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0167) via an unspecified route of administration, administered in Arm Left on 02May2021 14:30 (at the age of 38-years-old) as dose 2, single for COVID-19 immunization. Medical history included urinary tract infection from an unknown date and unknown if ongoing. Concomitant medication/other medications in two weeks included ciprofloxacin (CIPRO [CIPROFLOXACIN]) taken for urinary tract infection, start and stop date were not reported. No known allergies. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0151) via an unspecified route of administration, administered in Arm Left on 05Apr2021 12:00 PM (at the age of 38-years-old) as dose 1, single for COVID-19 immunization. No other vaccine in four weeks. No COVID prior to the vaccination. No COVID tested post vaccination. On 03May2021 02:30 AM, the patient experienced blood in urine, urinary tract infections after first and second shots; but negative culture tests. Also skipped period after first shot. Got second shot 4 weeks later, till no period and incredibly painful cramps after second shot, lasted 1 hour and happened 12 hours after second shot. Concerned with taking antibiotics after second shot with fear of interaction. The patient underwent lab tests and procedures which included culture urine: negative and urine analysis: blood in urine on an unspecified date. Therapeutic measures were taken as a result of adverse events. Adverse event treatment: Cipro antibiotics for 10 days. None for second UTI. The outcome of the events was recovering.
This was the 23-24 new vaccine.  I had only had moderna b4, including the bivalent one in Sept. 2022.  I also had the flu vaccine in the same arm on same day.  Today at work I had skin incident that lasted about 30 mins.  Started in my face and then ears, neck, arms and finally legs.  Felt hot and dry, painful and tingling.  My skin was visibly red and swollen.  It resolved without intervention bit was unnerving.  Hope it doesn't come back.
This vaccine caused my menstrual cycle to be (so far) at least 7 days late (my cycle is typically regular with no variation).  Pregnancy tests are negative. I know it?s a minor AE, but I felt the need to report this because its important to be transparent about the vaccine affecting women?s cycles for those that are trying to conceive (not me).
The formal illness began when he was seen in peds clinic with a fever, lethargy and all over BODY WEAKNESS, which started that morning.
Within 12 hours of receiving the reported vaccines I had flu like symptoms and wheezing with breathing difficulties. I returned to the doctor on 3/11/13, 3/14/13, 4/3/13 and was finally hospitalized on 4/7/13.
pt recv vax 13MAY96 & 1MAY97 pt exp chickenpox;
Headache, left arm numbness, mild left arm pain Injection site, moderate Myalgia, severe migrating  joint pain, chills leading to rigors. No fever. Incapacitating.
I have severe left shoulder pain. It has been 10 months now and has not gone away or got any better. I went to the doctor about this. I was referred to do physical therapy. Which has not helped.
pt devel acute rapid increase of temp;pt had rigors, devel febrile sz lasting approx 30 to 60 seconds;pt was post ictal p/sz;T104 R;
devel fever on 7/30/99 PM;woke up 4AM 7/31/99 w/trembling then had generalized stiffening & stopped breathing for few seconds;second sz, t103;rx APAP, amoxil;
Information was received from a 58 year old female patient, who on 01-DEC-2014, was vaccinated with ZOSTAVAX "1 single shot" (route of administration not provided). The patient reported that on 01-DEC-2014, after receiving ZOSTAVAX, "I developed a red spot on my arm that has since doubled in size and has traveled down my arm." The patient sought medical attention and was treated with BENADRYL. The outcome of the event was reported as not recovered. No further information was provided. Additional information is not expected.
Information was received on 15-AUG-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 13-SEP-2015 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-JUN-2016, the patient was treated by a physician, for the onset of a severe vesicular rash accompanied by weakened immune system which was diagnosed as herpes zoster, or shingles. The patient has been prescribed valacyclovir (VALTREX) and hydrocodone (manufacturer unknown), for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
female friend who has had the same "sympathetic" pain and rash in both arms; female friend who has had the same "sympathetic" pain and rash in both arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), RASH (non-serious), outcome "unknown" and all described as "female friend who has had the same "sympathetic" pain and rash in both arms".  Additional information: Reporter also had some weird sympathetic arm pain and rash on the other arm in the same place. It was weird because since he heard other friends say the same things. No other information about his friends provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccines were stored after beyond use date and expiry date; Vaccine was administered after beyond use date and expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after beyond use date and expiry date) and PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and expiry date) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after beyond use date and expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after beyond use date and expiry date) and PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and expiry date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   The date and expiry date was reported as 22-Sep-2021.   The vial was stored in standard freezer for the lot 031B21A with 2 degrees F high -1 degrees Flow on 31-Mar-2021.  No treatment medication were reported.  This case contains information for the eleventh of 45 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-571126 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-571126:Master case
She didn't feel well; This is a spontaneous report from a contactable consumer or other non hcp.   A 50-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. No medical history and no concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunization. It was reported that She did not feel well after her second dose either but only for 1 day. It was also reported that patient received her Pfizer COVID-19 booster on 26Oct2021. And today on 30Oct2021 she is finally feeling better. About 12 hours post booster dose, age felt fatigued, nauseous and had a headache. The outcome for the event did not feel well after her second dose was reported as resolved on an unspecified date.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.