chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 04-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff). This case involves a 11-years-old female patient who received a 0.25 ml dose of vaccine FLUZONE QUADRIVALENT (prefilled syringe) batch number: UT6315TA, expiration date: 04-Jun-2019 via intramuscular route in the right deltoid on 01-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included was ADACEL, MENACTRA and HPV-9 VACCINE. It was an actual medication error due to vaccine underdose. A 11 year old female patient was administered a dose 0.25 ml FLUZONE QUADRIVALENT vaccine instead of 0.5ml. It was unknown whether patient experienced any adverse event following vaccination. 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.
On 6/2/03 Shania was given a shot (DTaP) in her right thigh (upper). Mom called 6/4/03 to inform us that her leg was red at site of shot. Was treated with Benadryl and Keflex (antibiotics).
This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 26-AUG-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
I had the normal side effects of arm soreness and fatigue after the vaccine, which resolved after 24 hours. Then 2 weeks afterwards, I noticed my blood sugar readings were 100 points higher than normal. My readings were in the 200-300 range. I was not doing anything different or eating anything different. I changed my diet and decreased my intake of carbs and sugar. My diet change did not normalize my reading and only brought it down to the 200 range.   I did go see my doctor and brought the concern that the vaccine had raised my blood sugars. The doctor increased the dosage of metformin, which did not bring down my sugar readings. I started drinking herbal tea with stevia, dandelion and camomile and increase my exercise. This did help normalize my sugar readings after 3 days. My range now is 165-170  in the morning and 119 prior to eating.
pt recv vax 22JAN96 & 22JAN96 pt exp pain in back;23JAN96 pt exp lt arm numbness & tingling;pt pain in back persisted;MD determined that pt had a muscular strain/pulled muscle unrelated to vax;
I had already taken my loratadine and I am glad.  My arm started really aching at about noon and moved into my neck and head with the pain, making me unable to concentrate, dizzy and spacey.  When my work shift was done I got on the bus and almost fell asleep but I thought it was the cold outside.  I got home got out of my coat, snowpants and boots and crawled into bed with a monster headache, an arm I couldn't lie down on and chills so bad that my bed shook and I couldn't get warm for about 6 hours about 11:00 pm.  I was dizzy and the room was spinning so I just had a glass of water and went back to bed.  I didn't wake up the next morning until 9:00 am and was still dizzy.  The room stopped spinning about 12:00 noon and I was not nauseous any more, but still dizzy and my whole body ached.  It wasn't like this with the first dose, I just felt a little like I had the flu then.  Good thing I had the day off so I went back to bed until about 6:00 am and went to work.  It took me most of today to feel like usual and well enough to submit this.   I didn't go to the hospital or bother trying because I got both the shingles booster and my tetnus shots on the last day my insurance was active.  No need to call the doctor since my throat did not close.  My face did swell up though, but not enough to warrant going back out in the cold and rack up a hospital bill I can't pay.
This spontaneous report as received from a nurse via Company Representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (start date, lot#, route and dosage not reported). Nurse reported that expired ZOSTAVAX was administered to a patient. No adverse effects were reported. Additional information is not expected since it is not able to connect caller due to technical difficulties.
Myalgia, Arthralgia, NauseaVomiting, feeling hot, arms feeling heavy Narrative:
Patient felt spacey/unable to focus. High BP initially but resolved upon arrival to ER. Symptoms resolved within one hour and patient was discharged from ER.
Later in evening after shot, patient started having arm soreness over entire length of arm that lasted about 24 hours. Next morning patient had swelling, redness, and heat entire length of arm. Also experienced headache, neck pain, and felt "funny". Swelling is reduced and patient managing pain with acetaminophen.
mom reports pt w/persistent, inconsolable crying following visit began around 130PM;pt refused bottle seen in local ER approx 9PM;t100.9R;vaccination site very red & swollen;
Dizziness, Headache, Arthralgia, NauseaVomiting, Vertigo symptoms Narrative:
Shingles (varicella-like) rash along left mid back to left abominal area
Large (approximately 8 centimeters around) red patch on left arm near injection site. The red area is hard, warm, and itchy.  The redness appeared  2 days after receiving the vaccine. The rash has not resolved as of 3/8/21.  Reaction to vaccine also included severe headache, low grade fever, muscle aches, fatigue beginning about 8 hours after vaccination and lasting for 2 days.
LARGE LOCALIZED REACTION AROUND INJECTION SITE & REDNESS IT WARM TO TOUCH, X 1 DAY, ADVISED TO USE BENADRYL CREAM OR TABLETS
I woke up itching on my stomach  n had hives , ghis also happened with my 2nd dose
Information has been received from a physician concerning a 12 year old female with family history of seizure who on unspecified dates was vaccinated with the first, second and third doses of GARDASIL. The patient did not have any problems after the first and second dose of GARDASIL. The patient had a seizure 30 days after receiving the third dose of GARDASIL. The patient sought unspecified medical attention. On an unspecified date, the patient recovered. The physician did not feel the seizure was related to GARDASIL. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested. 8/8/08-records received- ED report 1/4/08-presented to ED first seizure 12/26/07-C/O feeling tired. Seizure generalized tonic-clonic lasting 5 minutes. Postictal. Abrasion to tongue. Headache after seizure. Confusion lasting half hour. Neurology consult 1/10/08-the two seizures occurred while playing karaoke.   Subsequent seizure with forced eye closure while on the computer. Impression-cryptogenic generalized seizure disorder with multifocal and generalized discharges on EEG. Indeterminate staring spells probably atypical absence seizures. Depression.
Headache, fatigue and full body, body aches for 3-1/2 days
Case number PHEH2015US001175, is an initial spontaneous report from a pharmacist received on 14 Jan 2015. This report refers to a 60-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with MENVEO (batch number: M14024) intramuscularly on 13 Jan 2015. No adverse event was reported following the maladministration.
Arm was very sore and patient can still feel some light aching that is annoying; annoying; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was very sore and patient can still feel some light aching that is annoying) and IRRITABILITY (annoying) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 VACCINATION SITE PAIN (Arm was very sore and patient can still feel some light aching that is annoying) and IRRITABILITY (annoying). At the time of the report, VACCINATION SITE PAIN (Arm was very sore and patient can still feel some light aching that is annoying) and IRRITABILITY (annoying) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant medication was not provided.
On Friday afternoon 4/16, i went to leave from work and put my seatbelt on and i noticed my breast was sore. I got changed and looked and it looked enflamed. it was red and tender on the nipple and around it. I actually almost felt like there was something in there that didn?t feel right. So i called the doctor Monday morning and went to the doctor later that week. Thursday or Friday. by then the symptoms were gone and i still went to the doctor just in case. he told me that he didn?t think it had anything to do with the shot. but i thought it had to because it was too close of a time span. i also read that other women were having the same problem. We didn?t do anything then. The symptoms went away. I knew I had a OBGYN for later that summer. So I just waited. I went for my regular exam in august. Over the course of the summer, the right nipple had completely inverted. I went for my mammograms and it came back normal. And I went to see my doctor and he was worried and he ordered an MRI. And he noticed a milk duct and another area that was suspicious. They did an ultrasound and an MRI done. And then I went back to get a biopsy done with an ultrasound as well and it came back negative as well. So the doctor decided, since my breast turned back and blue, to just hold off for 6 months and do another MRI then.   Weird rash on foot several weeks after the shot ? finally went to the doctor and took anti fungal cream.   I was afraid to get the next vaccine but I didn?t have any new or worsening symptoms other than what I?ve already explained. I didn?t get a sore breast or new rashes with the second shot.
Vaccine Administration Error: Pharmacist administered second vaccine dose into my left upper arm, via subcutaneous route 2/16/21.He pinched up the skin on arm as he administered  vaccine.I felt him pinch up skin and felt nothing as the needle went into arm.Needle did not go into my arm muscle.Shocked by the administration technique error,I had no time to react as the injection happened quickly.After Moderna vaccine dose#1, 1/19/21, I had had strong immune response for 30 hours (chills,aches,low grade fever,extreme fatigue).After 2nd dose,I had NO side effects.Available med literature indicates subcutaneous injection route is ineffective--done in error.How do I ensure I am now adequately protected?
Patient developed pink splotchy rash on hands and arms approx 15 min after injection during observation period. States rash felt "stingy" States this is a normal reaction after vaccination for her. Patient was given 50mg of Benadryl po. States she felt improvement and rash was fading after another 20 min of observation.
Information has been received from a licensed practical nurse concerning now a five year old male pediatric pt who on 01/29/1997 was vaccinated SC in his left arm with the first dose of varicella vaccine. Concomitant therapy included tuberculin purified protein derivative. On 05/22/2001, the pt developed chicken pox (30 lesions). The pt sought medical attention and was treated with Zovirax. Subsequently, the pt recovered from his chicken pox. The licensed practical  nurse also discussed the experience of two other children after vaccination with varicella virus vaccine. No further info is available.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified dates in approximately 2014 (also reported as since 2014), an unspecified number of patients were administered ROTATEQ, oral (dose, lot # and expiration date were not provided) that fell to a temperature of 33F. This excursion was supported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Tired; Diarrhea; Sweat on forehead; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea), NAUSEA (Nausea), HYPERHIDROSIS (Sweat on forehead) and FATIGUE (Tired) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 011A21A)) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nausea) and HYPERHIDROSIS (Sweat on forehead). On 01-Apr-2021, the patient experienced FATIGUE (Tired). On 04-Apr-2021, DIARRHOEA (Diarrhea), NAUSEA (Nausea) and HYPERHIDROSIS (Sweat on forehead) had resolved. At the time of the report, FATIGUE (Tired) outcome was unknown. Not Provided          concomitant  drug : Blood Pressure Medication treatment drugs  : Ciprofloxacin 500mg BID X 10 Days Started on 15MAR2021 Tylenol Gatorade Pedialyte Water   This case was linked to MOD21-070095 (E2B Linked Report).; Sender's Comments:  MOD21-070095:MOD-2021-068586 -1st dose of Vaccine US-MODERNATX, INC.-MOD-2021-068586:MOD-2021-068605 -2nd dose of vaccine
Fever 100.5degree F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100.5degree F) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included PRIMIDONE and ESOMEPRAZOLE for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PYREXIA (Fever 100.5 degree F). At the time of the report, PYREXIA (Fever 100.5 degree F) outcome was unknown. Not Provided.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Body temperature: 100.5 F.     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.
usually with all 4 doses I was a little off the next day; with maybe a little bit of achiness; The only symptom that lasted for a couple of weeks was the fatigue associated with COVID; came down with a very, very mild Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (came down with a very, very mild Covid), MALAISE (usually with all 4 doses I was a little off the next day), PAIN (with maybe a little bit of achiness) and FATIGUE (The only symptom that lasted for a couple of weeks was the fatigue associated with COVID) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 011J20A, 024M201 and 026D21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 25-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2022, the patient experienced COVID-19 (came down with a very, very mild Covid). On an unknown date, the patient experienced MALAISE (usually with all 4 doses I was a little off the next day), PAIN (with maybe a little bit of achiness) and FATIGUE (The only symptom that lasted for a couple of weeks was the fatigue associated with COVID). At the time of the report, COVID-19 (came down with a very, very mild Covid), MALAISE (usually with all 4 doses I was a little off the next day), PAIN (with maybe a little bit of achiness) and FATIGUE (The only symptom that lasted for a couple of weeks was the fatigue associated with COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, COVID-19: Positive.         Patient had scheduled 3rd Moderna booster vaccine on 07Nov2022 at the pharmacy. Patient had moderna for all vaccinations and came down with a very, very mild Covid in late August, 2022 which was short lived perhaps partly due to his active lifestyle and partly due to the Moderna COVID-19 vaccine. No Concomitant medication was reported by reporter. No Treatment drug was provided by reporter.   This case was linked to MOD-2022-669831 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Nov-2022: Follow-up received: Event added, Dosage information added and Narrative updated.
Information has been received from a physician concerning a female who was vaccinated with a 0.5 ml dose of GARDASIL. The patient fainted after receiving the GARDASIL dose. The sought unspecified medical attention. The patient recovered on an unspecified date. Additional information has been requested.
Itchy red bumps all over her body!  Given steroid pills, shot, creme for itching.  Still on her body and it has been 1 month.
Information has been received from a 57-year-old female with a history of shingles (prior to vaccination) and no known allergies who in 2006 (a year ago) was vaccinated with a dose of zoster vaccine live (Oka/Merck). On an unspecified date the patient developed shingles. The patient sought unspecified medical attention. No diagnostic labs were performed. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. No further information is available.
Localized fluid filled vesicles were 1.5 cm circulum erythematous patch no other lesions or reactions noted.
Fever 99 to 102, nauesous, body aches allover, headache with congestion, chills, fatigue
high blood pressure; fast heart beat, fast blood stream; fast heart beat, fast blood stream; weak; shaking; very uncomfortable horrible feeling; very uncomfortable horrible feeling; faint; adrenaline rush; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 15Apr2021 15:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included low TSH and high blood pressure. Patient was not pregnant at the time of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium; losartan potassium (LOSARTAN "AGP"); vitamin D3; cissus quadrangularis (CQL); all taken for unspecified indications, start and stop dates were not reported. On 15Apr2021, the patient had three times adrenaline rush at 16:10, 16:30 and 18:20. It came automatically at 16:15 (as reported) with high blood pressure, fast heart beat, fast blood stream, faint, weak, shaking, very uncomfortable horrible feeling. Usually, this feeling will come after something happen and impact the brain, but now it came just by itself. Patient has feeling that she might die. She wanted to know if this vaccine affected her nerve system and if she should take the second dose or not. No treatment received for the adverse events. The patient underwent lab tests and procedures which included on 08Jan2021, colonoscopy: none, nucleic: none and nasal swab: negative; on 08Apr2021, colonoscopy (received within 2 weeks of vaccination): unknown results; and on an unspecified date (since the vaccination, the patient been tested for COVID-19) nucleic acid test: unknown results. Outcome of events were recovered on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Death; This is a spontaneous report from a contactable other healthcare professional (HCP). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in right arm on 27May2021 at 09:00 as single dose for COVID-19 immunisation. The relevant medical history included atherosclerosis from unspecified date. Concomitant medications included rosuvastatin calcium (CRESTOR). No other vaccine in four weeks. The patient experienced death on 07Jun2021 at 04:45. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The patient died on 07Jun2021. It was unknown if an autopsy was performed. The outcome of the event was fatal.  The Lot number for the vaccine [BNT162B2] was not provided and will be requested during Follow-up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death
Site: Bruising at Injection Site-Severe, Systemic: Other- Brusing down patients hand and wrist-Medium
Acute onset shortness of breath and profound weakness.  Taken to ER and admitted with pneumonia.  During hospital stay myasthenia gravis was diagnosed. On reflection, patient had had some weakness for several years but no severe symptoms.
Redness at sight of injection, (left arm),  in a large circle and very itchy.  This began after about 5 days after receiving the vaccine.
w/in 12 to 18 hrs p/immun, pt was lethargic 7 had hypotensive episode based on perfusion appearance; This was reported by mom who is a peds nurse; pt never seen in office p/immun; no tx initiated;
On 01/05/21: Numbness, pins and needles, tingling to the right side of body: arm, legs, torso, hands, feet, face, tongue, lips. Arms felt like it was going to explode. If standing on two feet, cannot feel right foot on ground.  On 01/13/21: - Cannot feel texture or sense of touch from elbow to fingers and from knee down to toes.