chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information had been received on 14-APR-2017 from a field representative who reported from a physician that about four weeks ago (unspecified date), a 65 year old female patient came into the office to receive her ZOSTAVAX subcutaneous injection for prevention of shingles (dosage not reported). The physician stated that the patient came back to their office about two weeks later (unspecified date) with complaints of "a rash" at the injection site and on her other arm (did not specify which arm was the injection site arm). The physician stated that it was concluded that the patient "developed chicken pox" as a result of the Zoster Vaccine Live (ZOSTAVAX) injection. The physician stated they instructed the patient to take diphenhydramine (BENADRYL) and use calamine lotion. Outcome of chicken pox was not reported. No other information was given on this matter. Additional information has been requested.
Hx of hives with flu vaccine- recommended 30 minutes wait - approximately 22 minutes in client alerted nurse to hive to left elbow. Cold pack applied to affected area. Client denies sob, difficulty breathing etc. Client refuses administration of epinephrine. Agreed to diphenhydramine 50mg PO. Administered medications as ordered Diphenhydramine HCl 50mg Lot- P122481  Exp: 07/22. at 1101am by RN per Emergency Medical Protocol got Management of Anaphylactic Reaction in Adults. Client advised not to operate heavy machinery or drive after taking this medications. Client states "I can make it to the high school". Client ate crackers and drank a bottle of apple juice during visit.  Assessed for signs/ symptoms of anaphylaxis through out 30 minute observation period. Client denies concerns Client reports only symptoms of localized reaction- hive to left posterior elbow. Client authorized nurse to contact Dr. to inform of this encounter. RN contacted medical Director for further instructions. RN informed client per Dr. instructions to repeat bendryl 50mg PO in 6 hours. Directed to seek emergency medical attention with s/ s of anaphylaxis. Educations of s/ s provided. Client agreed. Departed clinic at 1138. This nurse to file a VEARS report. Assessment and Plan
Teach from his college called and stated pt had "hives and his face was red and puffy". Was told by health dept. nurse to call ambulance or have someone take him immediately to ER. Nurse called pt about 45 min later - he stated that the ER was giving him "something IV". Unable to contact since. Assume he is out of country.
sore arm; feeling weak; dizziness; joint pain; headache; muscle pain; Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ASTHENIA (feeling weak), DIZZINESS (dizziness), ARTHRALGIA (joint pain) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Depression, Migraine, Anxiety, Incontinence, Pain, Sinus disorder, Gastrointestinal disorder and Eye disorder. Concomitant products included CALCIUM and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second 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 (sore arm), ASTHENIA (feeling weak), DIZZINESS (dizziness), ARTHRALGIA (joint pain), HEADACHE (headache), MYALGIA (muscle pain) and FATIGUE (Feeling very tired). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), ASTHENIA (feeling weak), DIZZINESS (dizziness), ARTHRALGIA (joint pain), HEADACHE (headache), MYALGIA (muscle pain) and FATIGUE (Feeling very tired) outcome was unknown.            Patient had lab work done and result was good.  Patient was on some concomitant medications for anxiety, depression, pain, sinus, migraine, asthma, eye medication, GI medication, calcium, vitamin-d and other supplements, incontinence medications, muscle relaxer.
pain in the right side of the stomach; got headache; vomiting; high temperature; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (pain in the right side of the stomach), HEADACHE (got headache), VOMITING (vomiting) and PYREXIA (high temperature) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Dec-2021, the patient experienced ABDOMINAL PAIN UPPER (pain in the right side of the stomach), HEADACHE (got headache), VOMITING (vomiting) and PYREXIA (high temperature). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (pain in the right side of the stomach), HEADACHE (got headache), VOMITING (vomiting) and PYREXIA (high temperature) outcome was unknown.            Concomitant product use was not provided by the reporter.
her arm is very sore, difficult to move and she is unable to lift it much.; Arm twice as big as other arm; Cannot pick up anything with arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 16-year-old female patient received bnt162b2 (BNT162B2), administration date 17May2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 18May2021, outcome "not recovered", described as "her arm is very sore, difficult to move and she is unable to lift it much."; PERIPHERAL SWELLING (non-serious) with onset 18May2021, outcome "not recovered", described as "Arm twice as big as other arm"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 18May2021, outcome "not recovered", described as "Cannot pick up anything with arm". Therapeutic measures were taken as a result of pain in extremity, loss of personal independence in daily activities.  No follow-up attempts are possible. No further information is expected.
Blisters Day 3 developed blisters of left nare and a  single 3 cm blister to area above left upper lip. Healed after about  a week
Itching & small blisters the day following the vax. Disappeared w/Benadryl. The next day developed diarrhea, slight fever & felt bad. Able to follow normal schedule p/3 days.
pain at the injection site; fever of 101 degrees F.; fatigue; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (receved 1st dose on an unknown date).   On 17th February 2021, the patient received the 2nd dose of Shingrix (intramuscular). In February 2021, 12 hrs after receiving Shingrix, the patient experienced fever, fatigue and headache. On 17th February 2021, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the fever, fatigue and headache were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. Within 1 second after receiving Shingrix, the patient experienced pain at the injection site. On 18th February 2021, about 12 hours after receiving Shingrix, the patient experienced a fever of 101 degrees F, headache and fatigue. The formulation of Shingrix was not known. The reporter consented to follow up.
Cough for two weeks, no fever. Treated today (10/18/2010-first visit for cough) with albuterol and prednisone.
Day 1 Wednesday 4 hours after shot  headache severely cold. Could not get warm. 4am woke up.in pain. Aches, chills, severely dehydrated, and nausea. By 8am 99.9 fever. Regular temp 97.8. All day couldn't function.  Whole body hurt and nauseous. Advil didn't help at all but Tylenol cut the pain. Rested all day by the night had fever of 101.6. Friday felt better just really tired and sweaty. Oke up in wet clothes.. Couldn't stop sweating. Not cold or hot. Just sweating through my clothes. Saturday woke up took a few steps and grabbed a counter to hold myself up. Felt a weight on my chest and everything heavy. Extreme exhaustion and struggling to catch my breathe. Felt like swimming in quicksand.  Sunday fine.
Sore throat and throat swollen, fever, severe chills, headache, diarrhea,. Symptoms started within 1 hour.
Imovax Rabies having a delay in dose due to the vaccine not going into the skin, no AE; leak occurred while injecting into the right deltoid; that a new needle was placed on the end of the syringe, no AE; Initial information received on 25-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse via other health care professional and additional information received on 29-Jun-2020 from quality department.  This case involves a 25 year old female patient having a delay in dose RABIES (HDC) VACCINE [IMOVAX RABIES].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.  On 24-Jun-2020, the patient received a 0.5 ml dose of suspect RABIES (HDC) VACCINE (lot P1E22M and expiry date: 30-Oct-2020; Injection, liquid solution) via an intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of actual medication error due to inappropriate schedule of product administration.  It was also the case of needle issue.  It was reported that nurse reporting on behalf of a consumer on Imovax Rabies having a delay in dose due to the vaccine not going into the skin but the vaccine leaking from the luer lok connection. The nurse reported that the leak occurred while injecting into the right deltoid; and that the consumer was administered another Imovax Rabies dose that was successful.  Number: 100049631 Issue Status: In Process Sample Status: Requested and Awaited  Batch number: P1E522M Expiry date: 30-Oct-2020  At the time of report, no adverse event was reported.  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.
Headache, Myalgia, Arthralgia, Fever, fatigue and chills Narrative:  Other Relevant History:
Patient reported to her friend that she felt nauseous.  According to the friend she then slouched to her right and fell off her chair.  She came to within a minute.  911 was called at 12:45.  She stayed on her right side on the floor for approx 3 minutes before being assisted to sitting on the floor.  She was alert and oriented.  She was given juice.  She reports she had eaten that morning before getting vaccine. She reports that she has not ever "passed out" after an injection or vaccine before.  She was assisted to the chair then to a wheelchair.  She was wheeled to the ambulance.  EMS checked her blood sugar and it was 65.   She did not go to the ER, she was treated and released.  She reported that she went for lunch after leaving vaccine site.
This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar event for 2 patient (Herself and her husband). This is 1 of 2 report. A contactable consumer reported that a male patient of an unspecified age received BNT162B2 (COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got COVID-19 virus (COVID-19) on an unspecified date. The patient underwent lab tests included sars-cov-1 test: positive on an unspecified date. Outcome of the event was unknown. Information on lot/ batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021223614 same drug and event, different patient
24 hrs. following receipt of 2nd Covid-19 vaccine, patient developed gross hematuria. This was confirmed during office appointment on 2/8. Gross hematuria resolved after 3 days, microscopic hematuria still present on day 4. BP, CREA, BUN, normal, C3, C4, ANA neg. Renal ultrasound neg, urine culture neg, patient not menstruating. ESR, CBC normal. By history patient had first vaccine 5/26/21 and same happened. Teen did not report to parent at that time and resolved over few days. She told her parent when happened again. No other personal HX of hematuria, no family history of nephropathy. Patient will seen nephrologist 2/28.
The adverse event was that the patient was given a Covid 30 mcg dose for 12+ yrs but was only 10 yrs of age at time of administration. Patient should have received the recommended  the recommended Covid 10 mcg dose for 5-11 yr olds.  Follow up with the family was done on 1/3/2022 by speaking to mom on phone. No adverse events regarding symptoms were noted.
9/09/12 07:50 (R) arm 8 x 8 cm redness at injection site, increased temp and soft tissue swelling - Rx KEFLEX 500 TID x 7d, 9/10/12 - 20:00 - edema of (R) arm - mid-humerus to below elbow - skin hot/swollen - 1 gm ROCEPHIN IM. 9/11/12 - 8:11 AM - increased swelling. Prednisone - 30/20/10 each x 2d. 9/13/12 10:00 - marked improvement - no heat to arm, decreased swelling.
9/16 - received VARIVAX vaccine Friday night. (L) arm red swollen painful.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age or gender who administered the second dose of GARDASIL late. The dates of administration was unavailable. No adverse effect reported. It was unknown if the patients sought medical attention. At the time of report, the patients status was unknown. Additional information has been requested.
Patient was administered vaccination on 10/01/21 at 230 PM; she reported that her arm was sore on 10/5.  No further information of adverse events, treatments or negative outcomes have been reported since.
On the first - third day, after the shot, I felt like I was injected w/ crystal meth. My heart raced, could not sleep, super anxious, then it subsided. Roughly, two weeks after the first dose and only dose, I began having severe gastric issues. Then got a vaginal ulcer that still has not fully healed. It's evident that this vaccine has inflamed my body beyond belief. It's also obvious that hormonal and/or perimenopause females are playing a role with my side-effects. If I were to start all over, I would NOT get this vaccine at all.
Immediate swelling of jaw. Focal seizure of hand. Temp to 105.7, 9 days of fever up and down.
Narrative:  COVID infection following COVID vaccine series 02/24, Pfizer, dose #1 03/17, Pfizer, dose #2 12/24 COVID swab, result: detected 12/24 pt cc: exposure: unknown
Tingling and numbness in left arm.  Shortness of breath.  Neck pain and back head pain.
1 hr following vaccine, face and neck flushed (very red), later on about an hour became achy, very sleepy, chills no fever, no rash. Nausea.
Pt recv vax on 2/3/99; on 2/5/99 pt exp unable to bend left knee, crying, fever; dx=inflamed muscle tissue of knee; tx=IV antibiotic & Advil
soreness in the injection arm; tingling sensation in lip; little blisters in mouth; swelling in the lower lip; This case was reported by a consumer via call center representative and described the occurrence of tingling lips in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2019, the patient received the 1st dose of Shingrix. In June 2019, 7 days after receiving Shingrix, the patient experienced tingling lips, blistering of mouth and lip swelling. On an unknown date, the patient experienced pain in arm. The patient was treated with antibiotics nos. On an unknown date, the outcome of the tingling lips, blistering of mouth, lip swelling and pain in arm were recovered/resolved.   It was unknown if the reporter considered the tingling lips, blistering of mouth, lip swelling and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix on left arm. Approximately 1 week after receiving the vaccine, patient developed swelling in the lower lip, a tingling sensation in her lips and little blisters in her mouth. The patient stated that these symptoms lasted for approximately 1 month before resolving. The patient stated that she went to see her doctor and the doctor prescribed an antibiotic and the antibiotic resolved the symptoms. The patient stated that she also developed soreness in the injection arm after receiving the vaccine. The reporter was consented to follow up.
Patient received a dose of Moderna on 10/13/21. The vial in which the dose came form expired on 10/12/21.
fainted 5-10 mins p/inject; came to & then fainted again; fainted a third time the next afternoon; seen by both MD & immed care MD; Bloodwork & EKG were nl; did have BP drop on standing up; 2AUG93, still cont has malaise & dizziness
Could hardly walk; Her hair is still falling out (practically bold); Taking a lot of naps; Pain in muscles; Pain in joints; Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Could hardly walk), ALOPECIA (Her hair is still falling out (practically bold)), SOMNOLENCE (Taking a lot of naps), MYALGIA (Pain in muscles) and ARTHRALGIA (Pain in joints) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 056AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Hair loss (Her hair was falling out at that time and continues to be falling out).   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (Could hardly walk), ALOPECIA (Her hair is still falling out (practically bold)), SOMNOLENCE (Taking a lot of naps), MYALGIA (Pain in muscles), ARTHRALGIA (Pain in joints) and FATIGUE (Feeling very tired). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (Could hardly walk), SOMNOLENCE (Taking a lot of naps), MYALGIA (Pain in muscles), ARTHRALGIA (Pain in joints) and FATIGUE (Feeling very tired) had resolved and ALOPECIA (Her hair is still falling out (practically bold)) had not resolved.      No concomitant medications were reported.  Treatment details also included hair growth products.   This case was linked to MOD-2021-214932 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Events outcome was updated from unknown to recovered.
14 x 12cm area of induration & erythema/warmth w/2.5cm area of clear vesicles;
Patient reports at her second COVID vaccine appointment to the nurse the she had red blotchy, itchy rash on Lt deltoid area x 4-6 days. started feeling itchy over whole body in 1hour after her first COVID vaccine injection.
Generalized weakness and fatigue  Sore throat  Nausea for 3 weeks Hyper-pigmented lesion hands dorsum first finger
11/3 HS: Patient with abrupt abd pain. Went to ER next morning where a CT done. Patient's diaphragmatic hernia used to just contain a small amount of fat, now on CT today shows herniated segment of colon coming through hernia with concern for bowel obstruction. Transferred to larger hospital to have surgery to repair hernia. At time of this report, it is 11/5 & patient is inpatient recovering from surgery with left sided chest tube, dilaudid PCA, IV medications while waiting for bowels to wake up.
On day 6 after first dose I started getting welts and a burning itch at injection site.  It 's the fourth day now and I still have the same issues.  Otherwise I feel fine.  Just intense redness, heat, itching and welts.
This study case was received from the investigator on 13 April 2012. A 28-year-old male subject who had no significant medical history was found to have unspecified disease of pericardium 16 days after receiving an injection of ACAM2000 (lot number, route and site of administration not reported) on 04 April 2009. The subject received the following vaccines on 27 March 2009: Anthrax vaccine (manufacturer and lot number not reported) and Influenza Vaccine (manufacturer and lot number not reported). On 15 April 2009 the subject had a troponin I performed which was normal and an electrocardiogram (ECG) which was normal. An echocardiogram was performed and the results were not available. On 20 April 2009 the subject was diagnosed with unspecified disease of pericardium. The outcome was not reported. Additional information will be requested from the investigator. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Anaphylaxis; A spontaneous report was received from a hospital CMO concerning a patient who was a frontline worker and received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date in Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 29 Dec 2020, it was reported that the frontline healthcare worker experienced anaphylaxis. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, anaphylaxis, was not reported.; Reporter's Comments: This case concerns a patient of unreported age and sex. The patient's medical history is not provided. The patient experienced anaphylaxis after receiving their first of two planned doses of mRNA-1273 (Lot unknown) on an unknown date.  The event is possibly related to the vaccine, and additional information including temporal relationship between dosing and event and whether patient has previous history of anaphylaxis could provide details needed for medical assessment.