chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The number of doses/vials was 22. The date of the vial was initially stored in the refrigerator was unknown. The vials did not undergo temperature excursion.  No treatment medications were reported.
Then days after first dose, arm was itchy and red.  It went down after a couple of days, but there is still a diagonal striation across upper arm which is visible and almost black and blue.  On Monday, March 1, I noticed a little puffy circle  slightly smaller than a penny and slight puffiness in armpit.  Did not even feel or see until shaving underarms.  No changes since.  Going to doctor Monday to let her check.
DOSE 1- AUG 6 DOSE 2- AUG 27 *THE FOLLOWING INFORMATION IS FROM AN EMAIL THE PT SENT THIS RN: Shot 1 - COVID Arm about a week after the shot Shot 2 was given Friday 8/27/21 - Friday evening I was having trouble catching my breath and my arm swelled up immediately.  I also have itching, irritation and swelling in my lymph nodes under my arms and neck.  I woke up yesterday with random bruising up and down my arm and below my elbow is very painful.  I also have hives which turned into blisters on my neck, arms, and face.   I have never had a fever ever (even when I had appendicitis) so I cannot monitor anything with temperature.  I was not sick at all but after the shot just very irritated.  My face is still beat red. Wanted to let you know what I have going on in case you needed to track it.   I am allergic to so much that I cannot take anything unless I know that I am not going to cause more trouble to myself.
Few minutes after getting the shot, Mom knocked on the Pharmacy door. The child was on the floor and the Dad's hand was supporting his head. Patient was totally alert and spoke perfectly fine. He demonstrated and said that he has some tingling in his hand and something in his stomach. Child slightly diaphoretic. We called 911- vitals normal and  "everything checking up good" paramedics left. When leaving patient said he is feeling anxious, nothing else.
Initially had a sore shoulder at injection site for approx. 3 days.  Now 1 week out the lymph node under that arm is  aching, sore and swollen, and I am having numbness, tingling and electrical type buzzing in my 2 middle fingers.  Both wrists ache.
INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a health care professional and concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced inappropriate age at vaccine administration, and off label use. The action taken with covid-19 vaccine  was not applicable. The outcome of the inappropriate age at vaccine administration and off label use was not reported. This report was non-serious.
FLUBLOK had been administered to a 8 years old patient/ No AE; Initial information received on 04-Jan-2021 regarding an unsolicited valid non-serious case received from a nurse via Medical Information (Reference number- 00414025).  This case is linked to case 2021SA002575 (same reporter).  This case involves an eight-years-old male patient who was administered a 0.5ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] Prefilled Syringe, Strength: Standard (batch number: UJ509AA, expiry date: 10-MAY-2021) via intramuscular route in the left deltoid on 22-Dec-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration (latency: same day).   Nurse with question regarding administration of FLUBLOK to patients under 18 years of age. Caller reports FLUBLOK had been administered to 11 pediatric patients and would like to know if they are covered for Influenza vaccination for the season.  Adverse Event symptoms: None reported.  First time product used and still using product: No.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Patient came into pharmacy and showed me a picture she took (on 1/16/18 Tuesday) of her left arm where she received the PNEUMOVAX 23 and FLUZONE High Dose immunizations on 1/15/18 (Monday). The picture showed her left arm was red, swollen and puffy and covered most of her upper left arm.  She told me she woke up on Tuesday and had a fever and then realized her arm was red, puffy, swollen and warm to the touch. She said laid on the couch all day Tuesday and Wednesday. She said she never felt that way before and had a hard time lifting her arm and it hurt. She said she started feeling better on Thursday and came in today 1/19/18 (Friday) to show me the picture of her arm.  I asked her to come in the immunization room so I could look at her arm today and it was still a little swollen and slightly red but looked a lot better than the picture. I told her next time to call if she ever has any kind of reaction and I recommended that she take some benadryl. I told her I would report this reaction to pharmacy and Vaers and I would be calling her this weekend to make sure she was feeling ok and to make sure her arm was improving.
Within two days I had a sore throat, fever and , chills set in also, and malaise. Angioedema of both eyes occurred on 5,6,&7. I also had a rash on my face, complete loss of appetite, wheezing when breathing, massive mucous drainage.  I had the shot on Monday, Nov 3 and some of the symptoms are still ongoing! I have never had the flu shot in my life and will never get another one.  I am not allergic to eggs - I am allergic to Penicillin.
After a week, I developed very large bumps that scabbed over after 2 days.  Then the vaccination area became red, rash formed and after two weeks, it's still red, itchy and the injection site is blue/blackish in color and the skin is peeling.  I still have about 4 of the larger bumps with scabs.
Within 45 minutes of receiving the 2nd Pfizer vaccine (right arm) I became extremely ill. Believing this would pass I did not keep a medical journal. However I immediately became extremely ill with diarrhea, nausea, dizziness, pretty hard  heart palpitations, difficulty breathing; and my symptoms progresses throughout the following months to include tremors, a full on attack throughout my entire central nervous system, extreme fatigue,  loss of balance, brain buffer resulting in my inability to speak without sounding like I had suffered a stroke or severe brain injury, inability to walk without aid, extreme over the top anxiety and panic attacks like nothing I?ve ever experienced before, torturous pain throughout my entire body feeling as if my body had been plunged in to a raging fire, more recently the extreme pain throughout my hands, my joints. Mornings and nights are the absolute worst. Brain fog. I lose myself. Zone out in the middle of conversation. Inability to follow a movie and comprehend and retain much of what I read. Percocet, neurontin, pregabin, tizanidine, amitriprylene we?re prescribed. More recently, out of desperation to escape the inhumane pain, I opted for alternative medicine EBO2 plus NAD drip plus Vitamin IV. THAT seems to be the only treatment to have relieved me iof the burning pain until today which I believe yesterday?s physical therapy may have exacerbated my ongoing condition.
This spontaneous report as received from a pharmacist refers to a 56 year old female patient. On 20-NOV-2013, the patient was vaccinated with PNEUMOVAX23 lot # J007786 (expiry date: 25-SEP-2014), intramuscularly. No concomitant medications were reported. On 21-NOV-2013, the patient experienced injection site reactions. The reporter also reported that 3 other patients also experienced injections site reactions following the vaccination with PNEUMOVAX23. The patient sought medical attention and contacted the pharmacist. The reporter described reaction as red swollen upper and lower arm at the injections site. Approximately on 26-NOV-2013 (reported as within 5 to 6 days), the patient recovered from the event. Causality was not provided. This is one of the four reports from the same source. Additional information has been requested.
p/vax pt devel inj site rxn characterized by redness, tenderness & swelling extending to the elbow;
Immediate burning from neck to entire head and down both arms. Still suffering from intense pressure in head and weakness and tingling in arms and legs. Very terrible.
Odd taste in mouth started soon after (on drive home) and persists 5 days later (at time of report). Feels like bad breath but other people can't smell and it seems to only be taste. Nickel, coppery, and metallic in flavor. Brushing and flossing mask it for a bit but it returns, even without eating or drinking anything. No adverse impact to eating or other activity, just odd. Very very similar to an effect I had one time after eating pine nuts.
Rednss, inflammation and itching. Started , to my knowledge, on 7th day after injection
pt recv vax; had tulosa-hunt synd; cluster HA & diplopia;diplopia resolved gradually over six wk period;MRi in dec was nl;all lab tests nl'
Patient had a second HPV 9 shot on 8/18/16 and a wk after the second shot is when the cataplexy set in. We were not supposed to have the sleep study until 11/29/16. But I called them crying telling them I could no longer wait.
Midday on February 7, 2023, I lightly scraped the car to the right of me. On February 9, 2023, I had an episode of Atrial Fibrillation. It was my first episode since my initial episode on July 12, 2020. Then, on February 13, 2023, I was in a parking lot pulling out to leave, and I bumped into the rear bumper of another car. On February 13, 2023, I went back into Atrial Fibrillation while talking to the insurance agent about the accident. Each of those episodes were about 1.5 to 3 hours long. I saw my doctor on February 15, 2023. One thing we discovered was that my right eye, which had a near vison contact in it, was 2200 for far vision. In July of 2022, when I saw my eye doctor, my left eye was near vision and right eye was far vision. Throughout most of my life, I had distance vision in my left eye, and it was dominant. I asked if I could switch it back to have my dominant eye continue to be my dominant eye. He said my prescription would be pretty much the same for both eyes, so he suggested I wear my driving glasses upside down. I stopped wearing my driving glasses for short distances months before these accidents. What I've noticed since February, particularly in latter March and in April, is some increased clumsiness. I drop things and trip over things without dizziness, double vision, lightheadedness, or loss of strength. One episode was last week. It took me several tries to remember the last few digits of my own phone number. It doesn?t appear that poor right distance vision with a contact is a change. I have an appointment with an ENT on May 17, 2023.
Felt bad right after getting the shot. Had pain in the arm, my ears felt hot, I got a very bad headache, and became nauseated.  I broke out in a cold sweat. The headache and nausea continued all day. To this day my arm itches.
Body aches; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Fever) and CHILLS (Chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN (Body aches), PYREXIA (Fever) and CHILLS (Chills). In March 2021, PAIN (Body aches), PYREXIA (Fever) and CHILLS (Chills) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-393289, MOD-2021-393303 (Patient Link).
Day 1-3,: injection site/ rt arm soreness, palpable "mass"  rt deltoid, erytema- pain resolved with motrin  Day 3-7: persistent erythema, fatigue, dizziness Day 7 to present: worsening erythema/ warm to touch/ pruritus hive like at injection site, erytema/ palpable "mass"  increased from 0.5in to 1.5-2in in diameter
I couldn't stay awake the whole day I slept constantly throughout the night, this morning I took a Tylenol
Vaccine administered 9/16/09 at 12:45 pm.  Patient noticed slight swelling of upper lip that evening.  It got progressively worse.  He sought medical attention the following day.  Patient was prescribed PREDNISONE + BENADRYL.   Patient back to normal at this time.
A non-serious spontaneous report of two patients administered expired FLUMIST was received from a health professional concerning a six-year-old female. Neither past medical history nor concomitant medications were reported for this patient. The product expired on 22-Nov-2010. On 10-Dec-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Grade 1 severity soreness in arm where vaccination was administered.; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the parent.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Apr2021 15:30 (Lot number: EP6955) at the age of 16 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Apr2021 07:00, outcome "not recovered", described as "Grade 1 severity soreness in arm where vaccination was administered.". Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. Adverse event reported grade 1 severity soreness in arm where vaccination was administered. Onset 1 day after administration. Date of first awareness is 13Apr2021. No prior to vaccination, was the patient diagnosed with COVID-19. Patient tested and result is negative other medical history reported as none. No known allergies. Vaccine Facility information, Ethnicity, Race information available.  No follow-up attempts are possible. No further information is expected.
Injection site reaction; Fogginess; High fever; Chills; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 05Apr2021 at 16:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). Concomitant medications were not reported. The patient did not have a history of allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 14:30, the patient experienced vaccination site reaction, high fever, chills, nausea and fogginess (fuzzy).  The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken. The clinical outcome of the event vaccination site reaction, high fever, chills, nausea, fogginess was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a 13 year old female patient who on 09-AUG-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 658282/0929U). On 10-OCT-2007 the patient received the second dose (lot # 1265U). Five days after both doses the patient experienced nausea and vomiting. Unknown medical attention was sought. Subsequently the patient recovered a day after. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a physician concerning a 13 year old white female patient with an allergy to peanuts, who on 09-AUG-2007 was vaccinated with the first dose og GARDASIL (lot # 658282/0929U). On 10-OCT-2007 the patient received the second dose (lot # 659435/1265U). Vomiting began five days after both doses in association with stomach pain. "Self limited" occured after both doses. No fever and no rash. Missed 2-3 days of school. Unknown medical attention was sought. Subsequently the patient recovered. No product quality complaint was involved.
Initial report was received from a health care professional through another manufacturer on 21 June 2012. A male patient with a reported age of 12-years-old had received an injection of TRIPEDIA, sanofi pasteur Inc. (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced a fever of 105 degrees Fahrenheit (40.5 degrees Celsius). Past medical history and concomitant medications were not reported. The patient's outcome was not reported. Documents held by sender: None.
6 Months after I received the booster shot, I started feeling changes in my breast.  I started feeling swelling underneath my boob and underneath my armpit. It started itching really bad and I started feeling a lump soft at first but then it started growing rapidly.  I took Bendryl and it kind of helped. I have to get surgery now and recently I had a boob drainage.
I received the Moderna Bivalent booster on 12/27/2022. On about 1/1/2023, I noticed that I had lightheadedness and chest tightening. I didn't think anything of it at the time, though. Within a week, I noticed I was having heart palpitations, which would always cease whenever I rested. This continued, and I went to the urgent care on 1/15/2023. When I got to the urgent care clinic, I was sent directly to the emergency room. I underwent blood work, an EKG, and a chest X-ray, plus my vitals were taken. I was then given baby aspirin and advised to go to a cardiologist as soon as possible. I saw the cardiologist on 1/17/2023. The cardiologist prescribed TOPROL and 81 mg of aspirin, which I am to take daily. I underwent another EKG and had my vitals taken. I am now scheduled to undergo heart catheterization on 1/23/2023.
Headache; Muscle soreness; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 01Apr2021 at 12:30 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic back pain. Concomitant medications included vitamin D3 (MANUFACTURER UNKNOWN), oxycodone (MANUFACTURER UNKNOWN), paracetamol (ACETAMINOPHEN) and multivitamin (MANUFACTURER UNKNOWN), all taken for unknown indications from unknown dates. The patient had no allergies to medication, food and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 08:00, the patient experienced headache, muscle soreness and fatigue. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events headache, muscle soreness and fatigue were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Patient received the PREVNAR 13 vaccine on 7/26/17 at our office. That night, she did have pain to her Right upper arm and the next day she didn't feel well. She has contacted our office several times earlier in the week stating she had a really bad headache, chills, stiffness, and no appetite, as well as feeling really nauseated and fatigued. She was concerned it was all in relation to the vaccine. She was instructed to continue with supportive measures. Patient states that she took a shower the morning of 8/3/17 and noticed a rash to her trunk.