chrisvoncsefalvay/vaers-outcomes huggingface dataset:
40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication of the patient was not reported.  It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 30-Jun-2021 and best used date was reported as 30-Jul-2021.  The patient did not report any side effects. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master case ID
Pain in hips, shoulders, knees, neck, back, rips, wrists, feet. Pain was mostly at night and wore off during the day then came back at night (when inactive like when sleeping).
Underarm pain and swelling at 5 days-present Red welt (3 in diameter) at injection site at 6-8 days Nausea, vertigo, loss of appetite at 6-14 days
Information has been received from a consumer concerning her daughter who was vaccinated with the first dose of GARDASIL on an unspecified date.  Subsequently, the patient "felt achy and not well, and her arm hurt" after vaccination.  No problems were reported regarding the second and third doses of GARDASIL.  At the time of the report, no additional AE information reported.  This is one of several reports of siblings.  Additional information has been requested.
Systemic: Fainting / Unresponsive-Mild, Additional Details: shortly after pt received her pfizer booster she fainted, she regained consciousness within 20-30 seconds and the police and EMS were called onsite, they evaluated pt and escorted her out, after patient regained consciousness she did mention that she had fainted in the past after receiving a vaccination in her teens
This case was reported by a consumer and described the occurrence of autism in a 1-day-old male subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  There were no concurrent medications.  On 26 June 2003 at 09:15 the subject received 1st dose of ENGERIX B (10 mcg, unknown, unknown thigh).  On 26 June 2003, the same day after vaccination with ENGERIX B, the subject experienced autism.  On an unspecified date, an unspecified time after vaccination with ENGERIX B, the subject experienced elevated blood mercury level.  The subject's mother called to question the lot number of ENGERIX B given a day after her son was born.  She called to find out what was in that particular product.  She stated that her son has been diagnosed with autism at the age of six and she just wanted to address some of her fears.  She stated that the subject has alot of mercury in his system and was concerned that her consent had caused this problem.  She was curious as to the potential of the vaccine causing autism.  This case was assessed as medically serious by GSK.  At the time of reporting the outcome of the events was unspecified.
The symptoms were mild and started out with a sore throat. Very congested with a bit of a cough, achy. It started on a Monday and by Thursday the sore throat went away, the only thing that stayed was the congestion and the cough. Today I'm still a bit stuffy but not bad. It was all very mild.
tiredness; fever; headache; muscle pain; injection site swelling; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support via a contactable Other-HCP (Patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on 20Feb2021 as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history were not reported. On an unspecified date in 2021, patient experienced tiredness, fever, headache, muscle pain, and injection site swelling. Outcome of the events were unknown.  Follow-up attempts completed. No further information expected.
COVID-19 positive on rapid antigen test after receiving 3 doses of Comirnaty; COVID-19 positive on rapid antigen test after receiving 3 doses of Comirnaty; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 13-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) for 1 day, as dose 2, single (Batch/Lot number: unknown) for 1 day and as dose 3 (booster), single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19 positive on rapid antigen test after receiving 3 doses of Comirnaty". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.COVID-19 positive on rapid antigen test after receiving 3 doses of Comirnaty. He is 13 and otherwise in good health.Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Drug ineffective and COVID-19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Approx 1 wk p/flu vax/pnu imune, pt exp redness swelling of hands, wrist, knees; dx acute polyarthritis; seen in ER 13NOV91; ESR 45; tx w/Clinoral; 19NOV still having pain, clinoral discontinued, txthen w/Darvocet & Ansaid; hospitalized;
He got his vaccines, he didn't notice it until a couple of days later when he was getting out of the shower that both injection sites were bubbly and scabbing.  The scab is still present on both of them as of today.  He did not put anything on the arm.  It's healing on it's own.
Unable to sleep on (R) side for 2-3 days after the shot d/t pain. A sharp pain - radiating from the injection site to neck. Muscle twitching on (R) forearm - now happens more frequently.
having a reaction some breaking out(like rashes) (Arm+Upper body+legs); This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on 05Feb2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient had the 1st dose vaccine yesterday, having a reaction some breaking out(like rashes) (Arm+Upper body+legs). Wanted to know if she can take Benadryl or go to emergency room. The outcome of the event was unknown.   Information on the Lot/Batch number has been requested
Patient developed 2 inch red circle around injection site.  Did not look to be a rash, although patient reported irritation and minor itching.
Red swollen area on arm less than 4 inches. Low grade fever 99 degrees F.
"Felt drained for better than a week" and the day after the vaccine, he got cold sores in his mouth under his lip. Had never had cold sores before. No treatment sought/given. (Pt just mentioned this at appt on 2/7/17).
Patient stated he wasn't feeling well on January 25, 2021, wasn't eating and complained of abdominal pain.  Patient noted to have indigestion and was constipated.  Meds provided and labs ordered.  On morning of January 26, 2021, patient became weak, lethargic and hypoxic and was sent to emergency department around 0700 hours on January 26, 2021.  At approximately 1100 hours, emergency physician notified this writer that patient was not going to overcome his illness and would be placed on comfort care.  At approximately 1130 hours, this writer was notified that patient had passed away from multi-organ failure.
Day after redness, hot and large lump.   Benedryl and Tylenol taken.   Few days later, continued redness.  Tylenol taken Day 7  redness subsided but injection site still warm, itchy and sore Day 14 no more redness but injection site still warm and itchy Day 15, injection site still warm and itchy.  Today a red ring about an inch around the entire injection site appeared.
At approx 5 p.m. on 3/25/03 mom noticed redness and swelling at inject site. Worse? on 3/26/03. Brought PT into see MD on 3/27/03 at 11:00. Left lat / anterior thigh 7 x 7.5 cm round erythema around vax site.
After receiving the first dose of Gardisil HPV, I felt dizzy and then fainted. I woke up and did not know where I was. Dr. had me lie down and watched over me for about 30 minutes until I felt better.
Redness and swelling at injection site, dizziness, fever, nausea. Symptoms began about 24 hours after I received the injection. I took Ibuprofen, iced the injection site and slept. The symptoms seem to have subsided although I am still a bit weak (time now is 9 am on 8/27/18). There were no adverse effects with the first vaccine in the series.
5/17 - Episodes of bloody diarrhea intermittently - did not draw to med attention until 7/5/16. Denies abdominal pain. Referred to gastroenterology.
Patient's upper extremities and face swelled up. Eyes were also swollen shut. Injection site on left arm was the size of a half dollar coin.
A little itchy; Hard to the touch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (A little itchy) and VACCINATION SITE INDURATION (Hard to the touch) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026c70a) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PRURITUS (A little itchy) and VACCINATION SITE INDURATION (Hard to the touch). At the time of the report, PRURITUS (A little itchy) and VACCINATION SITE INDURATION (Hard to the touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (A little itchy) and VACCINATION SITE INDURATION (Hard to the touch) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026c70a) for an unknown indication.     No Medical History information was reported.   Concomitent medications includes antidepressants.  On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PRURITUS (A little itchy) and VACCINATION SITE INDURATION (Hard to the touch). At the time of the report, PRURITUS (A little itchy) and VACCINATION SITE INDURATION (Hard to the touch) outcome was unknown. Not Provided          Reporter did not allow further contact
difficulty swallowing, tongue swelling  was administered epi-pen .30 mg IM, VSS, 911 called and transported to ER
At one week after my 1st COVID vaccine shot, a red warm circle appeared on left arm below injection site midway between shoulder and elbow.  It was about 4 inches across and very red.  Almost no itch, no blistering, no weeping.  It grew each day until it covered 3/4 of the circumference of my arm. A week later, it spawned a second bright red circle in crook of left elbow. Then original lesion faded away.  For a couple of days as it faded, I could see 'purple' tracery beneath my skin at the site of the former redness.  The second lesion in the elbow crook has no itching, but is prone to scaling and weeping.  I use a drying gel agent over it.  It has not grown beyond the 3-4 inches it was at the beginning and is now beginning yesterday to fade.
He said when he swallows, he has pain radiating from the breast bone to the back of his shoulder blade.  He said it feels like the hernia pain he had two years ago.
Info has been received from a registered nurse concerning a female with an allergy to cefpodoxime proxetil, lactose (VANTIN) who on 11/06/2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (lot #644103/0710M). On 11/07/2002 the pt was seen in the doctor's office with "a local reaction to the (pneumococcal vaccine 23 polyvalent)." It was also reported that 3 other patients had a similar reaction following vaccination (WAES #0211USA00663, 0211USA00880 and 0211USA00881). Additional info has been requested.
weakness; dizziness; stomach pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (dizziness), ABDOMINAL PAIN UPPER (stomach pain) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced ASTHENIA (weakness), DIZZINESS (dizziness), ABDOMINAL PAIN UPPER (stomach pain) and HEADACHE (headache). At the time of the report, ASTHENIA (weakness), DIZZINESS (dizziness), ABDOMINAL PAIN UPPER (stomach pain) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. No treatment was received by the patient.
I never have two periods a month I just ended mine over a week ago and today I am bleeding again and not a normal amount. This has never happened before and I was perfectly healthy doing 75 hard before these ridiculous shots that were forced on us.
sever headache; This is a spontaneous report from a non-contactable consumer (nurse, patient). A 35-year-old female patient received second dose of BNT162B2 (Comirnaty, Solution for injection, lot/batch number: FF2590 and expiry date was not reported), via an unspecified route of administration in arm left, on 10Oct2021 at 01:30 PM (age at vaccination: 35 years), as a dose 2, single for COVID-19 immunization. The patient's medical history includes allergies to sulfa and multiple Sclerosis. The concomitant medications include ocrelizumab (ocrevus), carbamazepine (tegretal), gabapentin, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (adderall), vitamin D[vitamin D nos] (vitamin D) all from an unknown date for an unknown indication. It was reported that the patient had covid prior vaccination and was not covid tested post vaccination. Reportedly the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient historical vaccine includes BNT162B2 (Comirnaty, Solution for injection, lot/batch number: 301358A and expiry date was not reported), via an unspecified route of administration in arm left, on 19Sep2021 at 04:30 PM, as a dose 1, single for COVID-19 immunization. On 14Oct2021, 4 days after second dose a severe headache that was persisted for 4 days. The headache was constant and was located on the right side behind her right eye. It was reported that the headache was not responding to ibuprofen or Tylenol. Noticed hcp and as a treatment of adverse event the patient was prescribed with a steroid dose pack starting at 80mg. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Left cervical adenopathy with torticollis, redness and warmth, 5 cm.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2010, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2013, the patient was treated by a physician/DO at an eye and laser healthcare facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, 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, and pain and suffering, and other damages.  The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Imm. given 10/31/07.  My arm started to swell the next day, had hard knot the size of an orange on it.  Got red and hot.  After 8 days, there is still some redness, bruising and slight swelling.  Tx with cold packs, Benadryl & Advil.
Ringing in ears. A year and a half later the ringing continues. Sometimes it is so loud it is hard to hear other and hard to sleep in the quiet.
19APR95 mom states pt had t107 & 35 hr post vax 8FEB; 10PM 9FEB95 pt's t101, then 4 hr later pt sleeping & very hot w/t107; tepid bath & APAP given; taken to ER to have temp rechecked per mom; cont APAP;t101.5 R in ER;
Moderna booster of 0.25 mL that resulted in this visit. Pt previously required observational stay after 2nd dose of Pfizer COVID-19 vaccine in June 2021. Now pt is admitted after reaction to Moderna COVID-19 booster dose. Pt woke up following morning with hives. Pt was given  epinephrine, benadryl, and dexamethasone.
Case number PHEH2015US019749, is an initial spontaneous report received from a healthcare professional on 02 Oct 2015. This report refers to a 14 year old pregnant female patient. Medical history and concomitant medication was not reported. Nurse reported that she administered FLUCELVAX (batch number: 173988) intramuscular to this pregnant patient on 01 Oct 2015. No adverse event was reported. No further information was provided.
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 24-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On an unspecified date, the vaccine had a temperature excursion for 40 hours in which the highest recorded temperature was 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Vaccination and Adjuvant Suspension Component were not mixed.  Patient given Adjuvant Suspension Component only
SORE/FEELING OF SOMETHING IN THROAT, BODY ACHES, TIRED, HEADACHES, POSSIBLE SLIGHT FEVER, EARS FEEL FULL, SENSE OF TASTE AFFECTED, WILL GO TO DOCTOR TOMORROW (MON) IF STILL FEELING ILL.
Patient was given 2nd dose Pfizer IMZ, 10 minutes after administering patient passed out and hit his head on another chair. EMSA was called took him to hospital for evaluation because he continued to feel dizzy multiple times, along with having a pain in his upper abdomen.
Pt. recieved vaccine past 12 hours expiration. MD contacted pt. No adverse event. Pt. declined revaccination
Pt became listless then cried persistently for > 3 hrs; Also was listless x 2 hrs p/immun;
had the vaccine and felt bad and went to bed and the next day was fine; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (had the vaccine and felt bad and went to bed and the next day was fine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (had the vaccine and felt bad and went to bed and the next day was fine). At the time of the report, FEELING ABNORMAL (had the vaccine and felt bad and went to bed and the next day was fine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  Treatment medication was not provided by the reporter. for mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment.
Extreme fatigue.  Hypertension delivery into a rash, continued itching over all the body!
Total body red rash not pruritic 8 hours after flumist. No fever.
Left arm was slightly sore last night (day of injection).  Provided 400 mg Advil.  Woke up at 5:30 am with a 102 fever, headache, queasiness, and all over body ache.  Provided 400 mg Advil as of 6:00 am and monitoring.
Low grade fever on Sunday night (100.5) progressed to high fever Monday morning at 102.8. Fever was not responsive to medications and remained around 101 until 5pm when it started to come back down.  Patient also had diarrhea on Saturday and Monday
Diffuse rash lasting over 36 hours. Pt given Tylenol by parents.
Localized 10 x 15 cm erytherma same day of injection, in the left deltoid. Treatment Claritin and Ibuprofen.