chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Moderna product on 01/05/2021, 02/02/2021, and 11/09/2021. They tested positive for COVID-19 on 03/21/2022. They were hospitalized 03/19/2022-03/26/2022 and discharged to a hospice facility on 03/26/2022. They remained in the hospice facility until their death on 03/28/2022. They had terminal metastatic lung cancer and were found to have had complications of acute hypoxemic respiratory failure, hypoxic ischemic brain injury, septic shock, COVID-19 pneumonia, and a Type II myocardial infarction.
a 6 months old male patient was administered a dose of Menactra instead of Menveo/No AE; a 6 months old male patient was administered a dose of Menactra instead of Menveo/No AE; Initial information received on 06-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a six months old male patient who was administered a 0.5ml first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6347AA, expiration date: 30-Aug-2020 via intramuscular route in the right thigh on 06-Jun-2019 instead of MENVEO.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL), PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), HEPATITIS B VACCINE (HEPATITIS B VACCINE) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).   It was an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  No symptoms were reported.  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.  List of documents held by sender: none.
pt has had 3 spells according to mom, 12JAN94; pt was limp, awake but lethargic; eyes rolled back;  temp dec below nl, vomits & sleeps for 2-4 hrs;
pt vax dtp on 19sep90. pt devel inflammation and pain at the inject site, and abscess devel. and child hosp.  swelling on left thigh devel 3-4 dys aft vax.  sent to er on 10oct90 then to hosp. see worm...
08/18/2021 Covid19 Routine Testing = Positive Asymptomatic
Moderna COVID-19 Vaccine EUA  I had severe chills, bodyaches, headache and fever approximately 20 hours after receiving the vaccine. The chills, rigors  and teeth chatter were the worst of my symptoms. All symptoms lasted about 18 hours.
Face became flushed, red, felt cold. Temporal temp: 97.9. Denies any itching in mouth/tongue, breathing normal. Held for extra 15 mins, returned to class as 1030. Alerted school nurse staff.
Drew up 0.3 mL undiluted bivalent Pfizer vaccine for 5-11 year old patients and administered
Really sore throat, headache, dry cough, puffy eyes, knees, and and hands. I received my vaccine this past Saturday and felt better, but now it is tuesday and i am feeling worse.
Discomfort to Left Arm. Constant pain for over 2 weeks. Pain still there but not as intense. Patient believes nerve was hit during reciept of shot.
p/MMR approx 2 mins pt c/o difficulty breathing dec air movement & mild retractions noted; administered 60 mg Solumedrol IM w/immed response & recovery; No other tx required;
No other AE reported.; Pharmacist reported that VARIVAX which had undergone a temp excursion, had been administered to a patient.; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's pertinent medical history, and previous drug reactions or allergies were not reported.     On 03-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) vial, at a dose of 0.5 milliliters (ml) as prophylaxis (lot number S003447, which has been verified to be valid, and expiration date reported and validated as 04-FEB-2021) (product storage error) (dose number, vaccination scheme, route of administration, and anatomical site of vaccination were not provided). The suspect vaccine was reconstituted with 0.5 ml of Merck sterile diluent (lot number S003447, which has been verified to be valid, expiration date reported and validated as 09-NOV-2021).   The varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to a temperature of 18 degrees Fahrenheit (F), for a time frame of 5 hours, as recorded by the digital data logger. There was no previous temperature provided. No other adverse event was reported.
Felt fine the day of the shot but next morning woke up with severe brain fog and tired.  Was not able to work.  Brain fog was bad for 3 days then lessened but stayed for 5-6 days.  Yesterday, April 29th, 8 days after I received the shot the injection site swelled and the lymph node on my left armpit swelled.  Woke up to the swelling and it was about 3x's the size of my other side.  I took an anti inflammatory to relieve the discomfort.  It is slightly swollen still today and sore.  I am also continuing to feel a slight brain fog and tired.     The health department had listed me as a presumed positive for COVID in March of 2020.  There were not any tests at the time I was able to get to confirm the diagnosis.
I started with hot and cold chills. I was super sweaty. I didn't think anything of it really. The next day I felt I needed to lay down due to a horrible headache. It was an all over intense pain on the back of my skull. A few days later I had a fever of 100. I thought it was a sinus infection. I took an at home test, which was negative. I ended up talking with my family doctor, who prescribed amoxicillin. The following day I had a sore throat and a cough. I took another at home test which was again negative. I went to doctor to take a PCR, which was positive. My doctor said I had bronchitis secondary to COVID-19. I still have a lot of wheezing and high pitched cough. I also am experiencing shortness of breath when I try and do normal things. I am again on another round of steroids.
Throwing up x 1-week, Migraine x 1 week, Diarrhea v 2 weeks,  Cough,
feels short of breath mild sore /burning throat burning in chest like after a very, very hard sprint run any time of day when I'm relaxing lasts for a few minutes then goes away any time of day
First day felt fine except for arm hurting; second day headache and dizziness; third day felt really terrible, hurt to move my neck from side to,side and had chills and hurt all over; arm hurt more than the first time.
Initial literature report received on 20 Dec 2010: This report consisted of cases retrieved from the Vaccine Injury Compensation Program database. A query of the database was conducted to identify potentially relevant cases based on a claimed injury of shoulder pain, arm pain, shoulder dysfunction, frozen shoulder, adhesive capsulitis, or shoulder bursitis. Brachial neuritis was also included since this injury was frequently claimed when the arm was involved regardless of the actual diagnosis. Case histories of all submitted medical records were reviewed in detail to verify vaccination date, symptom onset and clinical course. This patient with no history of shoulder dysfunction, was vaccinated with influenza vaccine (manufacturer unknown, batch number: unknown) on unknown date. It was reported that the vaccine administration led to shoulder injury with significant shoulder pain and dysfunction. The symptoms lasted for more than six months. The outcome was not reported. The authors commented that they believe that this type of phenomenon is not due to a specific vaccine but results from injection of a vaccine antigen to which a person has previously been sensitized as a result of previous naturally occurring infection or past vaccination. This concept is consistent with the vaccines which were given in this case series, namely influenza and tetanus vaccines which are given repeatedly over time. This clinical case series provides additional evidence supporting the report that vaccine administration in the upper third of the deltoid area can have long-lasting consequences unrelated to the specific vaccine administered.
Patient recieved a dose of QUADRACEL that was too early with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Health Professional via Agency (Reference number- 00688223) and transmitted to Sanofi on 19-Jul-2021.  This case involves a one year old female patient who received a dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] that was too early (inappropriate schedule of product administration).  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  On 19-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5951AA and expiry date: 25-May-2023) via intramuscular route in the left thigh for prophylactic vaccination (inappropriate schedule of product administration).  It was an actual medication error case due to inappropriate schedule of vaccine administered (latency: same day).  At the time of reporting, the patient experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
she was diagnosed with MTHFR - a DNA condition; More than 35 days after the first dose without receiving the second dose; Pain in hand; discomfort in liver; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (discomfort in liver), PAIN IN EXTREMITY (Pain in hand), METHYLENETETRAHYDROFOLATE REDUCTASE GENE MUTATION (she was diagnosed with MTHFR - a DNA condition) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (discomfort in liver). On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in hand). On an unknown date, the patient experienced METHYLENETETRAHYDROFOLATE REDUCTASE GENE MUTATION (she was diagnosed with MTHFR - a DNA condition) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose). The patient was treated with CORTISONE at a dose of 1 dosage form. At the time of the report, ABDOMINAL DISCOMFORT (discomfort in liver), PAIN IN EXTREMITY (Pain in hand) and METHYLENETETRAHYDROFOLATE REDUCTASE GENE MUTATION (she was diagnosed with MTHFR - a DNA condition) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: follow up received added events More than 35 days after the first dose without receiving the second dose and she was diagnosed with MTHFR - a DNA condition
"Chills, couldn't get warm." Patient believes she had partial seizure possibly two partial seizures where "her spine arch up backwards and she had no control of it." No LOC or incontinence with episode. It happened during Friday night ; unknow time. Patient's muscles were sore next day and temp was 99.0 F on Saturday
I started feeling palpitation after 2 minutes then was placed in the observation room. Vital sign showed heart rate of 145 with normal blood pressure and oxygen. Then after few more minutes  I started feeling numbness and tingling in the mouth and started feeling dizzy and had cold sweats. Heart rate was 130s and BP was undetectable and my skin was severely pale.  I administered my Epipen and  rapid response team arrived after few minutes. I felt better 5-6 min after infection of the epipen but was still feeling dizzy and mildly short if breath.  I was transferred to emergency room when I was treated with IV  steroid, benadryl  , pepcid and IVF. I was observed for 4 hours and was discharged with improvement in symptoms .
Headache, Myalgia, Arthralgia, Fever, inj site swollen arm, throbbing, rash, itchy; fatigue, chills Narrative:
soreness at the injection site; fever of 101; shivering; fatigue; headache; stuffy nose; This case was reported by a consumer and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (for the tolerance of 1st dose, refer case- US2021AMR004190). Concurrent medical conditions included hashimoto's disease.   On 6th January 2021, the patient received the 2nd dose of Shingrix. On 6th January 2021, less than a day after receiving Shingrix, the patient experienced injection site pain. In January 2021, the patient experienced fever, shivering, fatigue, headache and nasal stuffiness. The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the fever, fatigue, headache and nasal stuffiness were recovering/resolving and the outcome of the shivering was recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever, shivering, fatigue, headache and nasal stuffiness to be related to Shingrix.  Additional information was provided as follows: The patient received 2nd dose and experienced soreness at the injection site in her left arm.  At 1 am, experienced shivering, fever (101 degree celsius), headache, stuffy nose and fatigue. The patient took Tylenol and the symptoms were resolving. The reporter did not consent to follow up. The case is linked with the case number- US2021003187, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021003187:same reporter
Swollen spot got bigger and bigger and bigger, 2 weeks later it was still there like a big nodule. When it went down I had a divot in my muscle, and it was very painful. And I ended up with a frozen shoulder and had to go to physical therapy for 6 months. Physical therapy began a month and a half later after this began. Went for an MRI right before I started physical therapy.
Pink eye with discharge that is getting more red everyday. I noticed her watery eyes  the day after the vaccine , but the redness was noticed 2 days after the vaccine. I (mother also got the same side effect with the vaccine, so now I know it is not a coincidence but a reaction  we have from the vaccine)
Fever (100.2), chills, body aches, joint aches, gastrointestinal pain, headache, pain at injection site, skin rash around/within 10" of injection site.
Hives and redness to both arms, given 25mg of Benadryl PO, after 30 minutes hives began to decrease.
right arm sore, headache, tired, lymph nodes swollen under arms, Narrative:
Information has been received from a healthcare worker concerning a 50 year old female patient with hypercholesterolaemia, hypothyroidism, CODEIDING hypersensitivity and wheat allergy who on 04-DEC-2008 was vaccinated with first dose of PNEUMOVAX (Lot #....), 0.5ml, intramuscularly. Concomitant therapy included PRAVACHOL, NEXIUM, SYNTHROID and OS-CAL. On 04-DEC-2008 after the patient received PNEUMOVAX developed left arm pain in the injection and a round red blotch about the size of a half dollar on her left shoulder and the same size blotch on the left side of her neck. There were no Laboratory or Diagnostics studies performed. At the time of the report on 05-DEC-2008 the patient was recovering. The patient sought medical attention office visit. Additional information has been requested.
Pretty sick yesterday; Flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 immunisation.  The following information was reported: ILLNESS (non-serious) with onset 20Mar2021, outcome "unknown", described as "Pretty sick yesterday"; INFLUENZA LIKE ILLNESS (non-serious) with onset 20Mar2021, outcome "unknown", described as "Flu like symptoms".  Additional information: Reporter stated, "he and his wife both had the second vaccine (Unspecified vaccine) on Thursday, and they came down pretty sick yesterday, flu like symptoms and stuff like that. Today he feel little bit better still following plans. He just want to know are we contagious to other people, want to go to church around old people.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021320630 same reporter/Vaccine , different patient
He received the first dose of the vaccine on 05Jan2021 and the second dose on 29Jan2021.; Rash on body; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He received the first dose of the vaccine on 05Jan2021 and the second dose on 29Jan2021.) and RASH (Rash on body) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced RASH (Rash on body). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He received the first dose of the vaccine on 05Jan2021 and the second dose on 29Jan2021.). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He received the first dose of the vaccine on 05Jan2021 and the second dose on 29Jan2021.) outcome was unknown and RASH (Rash on body) had not resolved.            Concomitant product use was not provided by the reporter. Treatment details included Steroid Shot. Action taken with mRNA-1273 in response to the events was not Applicable.
Woke up at 12:30 am with severe body aches/feeling light-headed, had near-syncopal episode with large amount vomiting and diarrhea. Also had chills, unsure if febrile. Symptoms lasted for about 1 hour. Felt better the next morning but still with body aches
Very sore arm beginning night of booster injection. Next day left flank became itchy. About a day later right flank became itchy. Thought it was dry winter skin. Over next few days redness with intermittent itching developed. Then a red, angry, bumpy measle type rash appeared on both sides. Then thought it was shingles. Went to General Practioner Friday 2/4/22.  He diagnosed as possible contact dermatitis. Prescribed course of Prednisone and Cortosteroid topical cream. Monday 2/7 rash was no better and extremely uncomfortable and itchy. I have not changed any lotions soaps etc. I have never had a rash like this in my life. Called my dermatologist Dr and was able to get in that day. She diagnosed as allergic reaction to something.! Continue with Prednisone and changed topical to stronger one called Clobetasol. It is now a little over 2 weeks and I still have the rash on both sides. It might seem to be getting a bit better. Follow up with dermatologist in 3 weeks.
Received GARDASIL #3 into (L) arm IM about 1100 on 8/13/13. About 1730 pt. had hives on chest, back, arms and face. Mom gave 50 mg BENADRYL. Had 2 emesis and 2 diarrhea that nite w/facial swelling. Facial swelling continued on 8/14 - gone by 8/15.
11/11/22- Pt developed bruise at vaccine site the day following the vaccines, and pt has seemed to be limping and saying "ouch". Mom reports there is a mild rash near vaccine site also. Pt developed fever last night, temp this morning around 100.2. It looks like both Proquad and Kinrix were given in RT by health staff on 11/05/22. Mom admits pt was fighting vaccines and had his legs flexed, etc at time of administration.  11/17/22- Mom reports pt actually developed RSV and she believes that may have caused fever and body aches as well. No further concerns regarding vaccine site.
So I had a breakthrough case of Covid-19 which started with a scratchy throat, stuffy nose, head cold cough and congestion as well.
Rash looks like little red dots; Rash at the injection site; Itching at the injection; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Rash looks like little red dots), VACCINATION SITE PRURITUS (Itching at the injection) and VACCINATION SITE RASH (Rash at the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood cholesterol abnormal (Statin for cholesterol) and Blood pressure abnormal (Blood pressure pills). Concomitant products included ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for Cholesterol, METOPROLOL, WARFARIN and VITAMIN D NOS for an unknown indication.    On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection). On 20-Apr-2021, the patient experienced RASH MACULAR (Rash looks like little red dots) and VACCINATION SITE RASH (Rash at the injection site). At the time of the report, RASH MACULAR (Rash looks like little red dots), VACCINATION SITE PRURITUS (Itching at the injection) and VACCINATION SITE RASH (Rash at the injection site) was resolving.            No Treatment was provided by Reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21-May-2021:event outcome (unknown to recovering) was updated.
Patient admitted to hospital on 12/02/2021 with bilateral leg wounds, edema and drainage.   Denies cough, fever, nausea/vomiting, diarrhea . no sore throat, no congrestion
Two days after the shot, I began to feel intense back pain with tingling in my arms and legs. I experienced facial numbness as well as arm numbness in the left arm. I visited the ER twice and had CT, MRI, EKG, and lab work done. All tests were negative. I had a follow up appointment with an internal medicine doctor for more blood work. I also have an appointment with a neurologist. I am being monitored for Guillain-Barre Syndrome.