chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had a very bad reaction and I have a lifetime deformity on my arm; Got a golf ball size bump; I am stuck with this bumps on my arm, its awful; Had a very bad reaction and I have a lifetime deformity on my arm; Got a golf ball size bump; I am stuck with this bumps on my arm, its awful; I have allergies; Allergic to the something that is in the shot, in the vaccine; Lipoma; Got a big bump it looks like a golf ball sticking out where the injection site was; This is a spontaneous report from a contactable consumer. This consumer (patient) received pneumococcal 13-val conj vac (dipht crm197 protein) (Prevnar 13, Solution for injection in pre-filled syringe) via unspecified route of administration on an unspecified date as dose number unknown, single for Immunization. Medical history and concomitant medications were not reported. Consumer stated, "I got this shot (Prevnar 13), I had a very bad reaction and I have a lifetime deformity on my arm and I already have talked to someone at your place maybe last year (further clarification unknown). So, I do not recommend this to anybody, and I have got a golf ball size bump. Regarding Lot# of Prevnar 13: Consumer stated, "I don't know what you mean a LOT number, I don't have this, I don't know where the LOT number would be. The doctors, they just give you the shot they don't tell you the numbers or anything. I am not the nurse or the physician, I am just the patient who received the Prevnar 13 three years ago and I got, my doctor said that I have a very bad rare, very rare reaction. I have allergies, he said that you probably were allergic to the something that is in the shot, in the vaccine and then he sent me for ultrasound, MRI and they both said, it is a lipoma and I have got a big bump it looks like a golf ball sticking out where the injection site was and I tell you doctor said no more vaccines for you, it's too risky. So, I didn't take Covid vaccine, I take no flu vaccine, I have to live with this now, I tell you I am very angry that this happened, I am very angry that the side effect with the vaccines is terrible and I am so upset with myself that I probably, like you know when you are at the doctor's office for your annual check-up and they say you are over 65 you want the, we can do it and then he want to mail and then a year later you get the 'Prevnar 26' (not clarified further, hence captured as-Unspecified Medication) and all this. So, you trust the doctor and they you say I am here now and will talk to it and it was the worst experience that I ever have." Consumer further stated, I am angry, but you know it may have saved my life in one respect because of this Prevnar 13 reaction that I got, I will never get another injection, another vaccine and I am seeing with the Covid vaccine and all the reactions like people dying (further clarification unknown). So, in a way it may have saved my life because I am not taking the Covid vaccine (not clarified further). Outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
4 weeks after received vaccine, pt couldn't raise arm without it being sore and very uncomfortable. Pt went to physician. No treatment at this time. MD wants to wait to see if body will reabsorb at site. Office visit Oct. 22.
Initial report was received 26 January 2011 from a health care professional. A cluster of eight to ten children, ages six months through eight years, had previously received either PENTACEL or DAPTACEL (lot numbers, routes, sites and dates of administration not reported) and subsequently developed pertussis. No further information was provided at the time of the report. Documents held by sender: None.
Arm was killing him for two days/ arm hurt when he moved it for two days/that is how bad it hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was killing him for two days/ arm hurt when he moved it for two days/that is how bad it hurt) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059D21A, 001B21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was killing him for two days/ arm hurt when he moved it for two days/that is how bad it hurt). At the time of the report, PAIN IN EXTREMITY (Arm was killing him for two days/ arm hurt when he moved it for two days/that is how bad it hurt) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, Antibody test: 0 antibodies (Negative) 0 antibodies.         No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-294807 (Patient Link).
Developed sudden vertigo, dizziness, tinnitus, anxiety, heart palpitations. Have had it ever since.
The patient is over 3 months late for second dose of vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (The patient is over 3 months late for second dose of vaccine) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (The patient is over 3 months late for second dose of vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (The patient is over 3 months late for second dose of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Expired product used; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 92-year-old female patient who received Herpes zoster (Shingrix) (batch number 5592T, expiry date 12-OCT-2023) for prophylaxis.   On 24-OCT-2023, the patient received the 1st dose of Shingrix. On 24-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Expired product used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 31-OCT-2023 The pharmacist reported his pharmacy sent out a Shingrix vaccine to a nursing facility who administered it to a patient and then realized that the vaccine was expired. This was the patient's first dose in the series.  At the time of reporting, dose had not been repeated.  The reporter consented to follow up.
5-5-08 MENACTRA 3:30 pm.  5-6-08 awake with headache, sore left arm site of injection.  5-7-08 painful, red, warm to touch, swollen left deltoid site of injection.
11/07/21 presents to EC ED with "1 day history of fever, cough, fatigue. No shortness of breath". PMHx "of CKD with recent right IJ permcath placement and right UE AVF placement"
Transverse myelitis - started after receiving  unknown COVID 19  vaccine in 4/2021.
Pain in deltoid muscle that radiates to upper shoulder, upper back and neck. Difficulty lifting arm. Symptoms present for 4 weeks. No signs of infection.
soreness & pain in rt arm down to wrist;no redness, edema or fever;pt reported by telephone;
Reporting feeling ill the day after receiving second dose of Pfizer COVID vaccine, which lasted approximately 48 hours. Four days after vaccine, she presented to ER with acute onset right sided abdominal pain and was found to have right anterior inferior kidney infarction (1.9 cm) extending through cortex
About 11 days after the third dose (booster), I suddenly developed profuse itching and burning all over the body, but notably at the palms of the hands, armpits, groin, ears, and scalp. I've never had these symptoms before. There is general erythema and occasional splotching, but no raised rash or clear pattern. Initiation of daily fexofenadine (which I had on hand for seasonal allergies) provided mild relief.
The incorrect vaccine was administered.  The Moderna (not approved for minors) was administered opposed to Pfizer.
Patient felt flushed and experienced shortness of breath (history of anxiety, panic attacks). Drank water and felt better in 10 minutes.
Hepatitis A; This case was reported by a pharmacist via call center representative and described the occurrence of hepatitis a in a 23-year-old male patient who received HAB (Twinrix adult) (batch number 3597P, expiry date 12th March 2022) for prophylaxis.   Concomitant products included HAB (Twinrix adult).   On 30th August 2019, the patient received the 2nd dose of Twinrix adult (intramuscular). On 26th September 2019, less than a month after receiving Twinrix adult, the patient experienced hepatitis a. On an unknown date, the outcome of the hepatitis a was unknown.   It was unknown if the reporter considered the hepatitis a to be related to Twinrix adult.  Additional details were provided as follows; The pharmacist reported that a patient got Twinrix vaccine 1st dose and Twinrix vaccine 2nd dose on left arm. On 26th September 2019, the patient had some blood works done at the doctor's office and the doctor's office informed the pharmacist. In 2019, the patient tested positive for hepatitis A. The reporter was consented to follow up.
(Fever, rash) (Serum sickness) (Headache, joint pains) x 7 days.
Diaphoretic, clammy, unresponsive for brief time, loss of muscle tone- occurred approximately 5 minutes post vaccination.  Patient verbalized history of "passing out" with vaccines in the past.  Blood pressure 102/64, HR 90, O2 98%.  Assisted to floor with feet elevated and cool packs applied to forehead, neck and wrists.  Slowly became more alert within minutes.  Parent notified of incident as this occurred at a school-based flu vaccine clinic.
I received my second dose of the Moderna COVID vaccine at approx. 10:40 AM on Friday, January 29 at clinic. By 12:00 PM, I noticed that I developed facial swelling, which was most significant around my eyes, and I felt lethargic. Between 12:00 PM and 2:00 PM, I  developed hives on my neck, chest, stomach, and arms, which prompted me to take 1/2 of a dose of 25mg Benadryl.  Nonetheless, the symptoms persisted and I began to experience dizziness and tightness in my throat around 4-5 PM, which was when I was advised by a nurse to go to the emergency room for treatment. I arrived at Hospital's Emergency Department around 6:00 PM and I was treated for "Possible Allergic Reaction Major." I received diphenhydrAMINE (BENADRYL) injection 50 mg, famotidine (PF) (PEPCID) injection 20 mg, methylPREDNISolone sodium succinate (PF) (SOLU-MEDROL) injection 125 mg, sodium chloride 0.9 % iv bolus, and acetaminophen (TYLENOL) tablet 650 mg. I was discharged after 10:00 PM and sent home with a prescription for predniSONE 20 mg and famotidine 20 mg. My facial swelling and hives have gone down but neither have completely resolved since being discharged. I am also experiencing full body aches and fatigue at this time (3 PM on Saturday, January 30).
Shot given 5/4 - Fever immediately during night/next day which continued prolonged high Temp of 102/103 for several days, Injection site discoloration kept spreading out, very hot to touch and pain worsened, Discoloration dark purple and a ring formed which turned into Blisters like a 3rd Degree burn. Resulted in needing to take to the ER within 48hrs of shot. Site still not healed up.
An 18 cm X 14 cm red, warm to touch rash developed 24 hrs after injection to HIB & DTAP.
Developed redness at injection site (left thigh) about 3 cm diameter with induration about 1.5cm diameter at 24 hours after administration of vaccine.  No fever.  Treated with ice, cool packs.
PT HAS A SORE ARM THAT IS STILL SORE BUT IS SLOWLY GETTING BETTER. SHE FEELS THAT SHE IS HAVING A REACTION BECAUSE THE SORENESS IS STILL LINGERING.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. The patient stated that, Shingles vaccine could give shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
He is a little achy today; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (He is a little achy today) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN (He is a little achy today). At the time of the report, PAIN (He is a little achy today) outcome was unknown.            No relevant concomitant medications were reported. The patient did not take any treatment medication. Action taken with mRNA-1273 in response to the events was not applicable.
Constant Chest pain/discomfort. Increasing pain during deep inhalation. No change or relief after 2.5 weeks.
Reconstituted vaccine with bacteriostatic Sodium Chloride 0.9%. Customer is understands error and is not interested in revaccination. VAERS (copy in folder).
I had a headache for about 48 hours after receiving the vaccine.  Drinking water, taking ibuprofen and sleep id not help.  I also had the typical sore arm.
RIGHT FACIAL SWELLING, DIFFICULT TO SAY IF IT IS A CELLULITIS OR ALLERGIC REACTION BUT THERE IS ASSOCIATED FACIAL DROOPING ALSO C/W BELLS PALSY.   TREATING FOR ALL OF THE ABOVE.  HOPEFULLY SHE RECOVERS WITHOUT ANY PERMANENT FACIAL NERVE DAMAGE.
Information has been received from a registered nurse referring to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates, the patients were vaccinated with improperly stored VAQTA (lot # M017982, expiration date: 13-SEP-2017; lot# M022924, expiration date: 24-JAN-2018; dose and route unknown) for prophylaxis. From 14-OCT-2016 to 04-NOV-2016, the VAQTA of lot# M022924 was stored under temperature between 32 Fahrenheit and 36 Fahrenheit for totally 45 hours. The VAQTA of lot# M022924 was stored under temperature between 46 Fahrenheit and 77 Fahrenheit for totally 31.5 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of three reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA005337: US-009507513-1703USA005338:
I woke up with major pain in my shoulder and neck on the side of my body that the shot was administered. It is still very painful two days later. I can not raise my arm above my shoulder without extreme pain!
Arm swelling to forearm, elbow pain, redness, limited range of motion of arm due to pain and swelling. Symptoms/swelling resolved spontaneously and was resolved 11/14 when seen in clinic.
5 days after vaccination on 12/20, patient developed a mild, erythematous rash on left hand (dorsal) and forearm. The character of symptoms is redness, no pain, no itching, and no swelling.  Radiating symptom(s): spreading proximally.  The degree of symptoms is minimal.
patient was inadvertently given two flu vaccines on their first administration/no AE; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious case from an other health professional via Medical Information (with reference number :00311985).  This case involves a patient with unknown demographic who was inadvertently received two doses of influenza vaccine (lot and expiry date: not reported) via an unknown route at an unknown administration site on an unknown date for prophylactic vaccination on their first administration (Extra dose administered).   Medical history, medical treatment, vaccination, family history and concomitant medication were not provided.  It was case of actual medication error due to extra dose administered (same day).  Reporter had a query regarding 2nd dose of flu vaccine as this was first season to receive flu.  At the time of reporting, patient had no adverse event.   Disclaimer: 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 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.      There will be no information available on the batch number for this case.
"Fever, chills, and pain 11/10". Pt was admitted 2/3/11 to Hospital and hospitalized x 7 days.  Pt states currently on prednisone 25mg and titrating. Pt states was dx with myalgia due to vaccine.
T103.2 max;pain, redness, mild edema arm; beginning 10-12hr p/vax;
Chest pain, ankle swelling, nausea,  vomiting, abdominal pain, change in appetite, muscle aches, joint pain, joint swelling, back pain, dizziness, headache, DVT
Rash on both ankles, both elbows, both hands. Rash is raised bumps that are red and itchy and clustered in groups.
12/28/21 presents to ED for "right facial numbness". PMHx of "HTN"
sz on 29APR92; no know fever; temp in ER 100.6 R; had serous otitis; tx w/Augmentin; referred to ENT 7 neuro; seen @ ER;
Tightness in chest shortly after receiving shot, currently persistant Strange flavor in mouth persisted several hours but has ceased.
Flu-like symptom beginning 48 hours after injection and lasting 10 days.  Fever, chills, body aches, lethargy, loss of appetite, diarrhea, loss of strength.  Initially unable to sit up in bed without assistance.  Walking un-steady for 2 days.
Bruising - Muscle throbbing deep in injection site into neck area. All over body aches and throbbing muscle aches. Lightheaded. All over malaise.
Major fatigue, light headed/dizziness, missed period , extreme nausea and fatigue
pt recv vax & exp rash same day;+ pruritic, purpuric lesions on both arms progressed to legs-few lesions on chest;
Patient experienced rash and tachycardia after receiving vaccine. Patient was given  Benadryl 50 mg and Epinephrine 0.3mg. Patient responded well to medications and sent home with Prednisone Rx.
she experienced her arm was itching all up and down, not on the side where she took the shot, the other arm the other arm It's really bad, it's like under your skin it's itching; I was rubbing my arm and I broke out in little welt, I broke out with the welt on each arm.; Sick of the discomfort I am having because I am itching; Sick of the discomfort I am having because I am itching; I don't know what's happening with me and I didn't like feeling I feel with this side effects. So, that's what I am trying to figure out; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0185) via an unspecified route of administration on 03Jun2021 at 09:00 (at the age of 72 years) as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Jun2021, patient took the COVID shot morning about 9 O'clock and just a minute ago right after the vaccination, her arm was itching all up and down, not on the side where she took the shot, the other arm. Well at both of them at the bottom, she was rubbing her arm and broke out in little welt on each arm. And it's real bad, it's like under the skin its itching. Patient was really trying to find out about her arm as she was sick of the discomfort she was having because of itching. Patient enquired that she does not know what's happening with her and she didn't like feeling she felt with this side effects. Patient just wanted to know what was wrong, why she was having side effects, why does she have to go through all of that. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse referring to a 18 year old female patient. Information about medical history, concurrent condition and concomitant medication was not reported. On 20-OCT-2015 the patient received a dose of ZOSTAVAX (lot# L015417 with expiration date of 01-AUG-2016, 0.5 ml, subcutaneous, instead of (Oka/Merck) VARIVAX (wrong vaccine administered). No adverse effects were reported. Additional information has been requested.
Within hours, swelling of arm above elbow -- red, tight, warm; on second day, swelling extended below elbow. No fever, but general sense of malaise for 3 days.
SPENT ALMOST 30 HOURS IN BED; EVERYTHING HURT FROM TEETH TO TOES; MASSIVE HEADACHE (THINK ELECTRIC PINK HAND GRENADE); FEVER OF 101 (F); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) 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 19-MAY-2021, the subject experienced spent almost 30 hours in bed. On 19-MAY-2021, the subject experienced everything hurt from teeth to toes. On 19-MAY-2021, the subject experienced massive headache (think electric pink hand grenade). On 19-MAY-2021, the subject experienced fever of 101 (f). Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from spent almost 30 hours in bed, fever of 101 (f), and everything hurt from teeth to toes, and had not recovered from massive headache (think electric pink hand grenade). This report was non-serious.
pt with acute onset of AMS, unable to form words or sentences- last 1.5 hours then resolved  nl CT scan, MRI brain, LP abnormal with leukocytosis, lymphocytic predominance