chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist, referring to a 20 year old female patient. The patient did not had medical history, concurrent conditions or concomitant medications. On 28-DEC-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # N019921, expiration date on 05-JUL-2018, subcutaneously in the left arm for prophylaxis. On 30-DEC-2017 (reported as "2 days later"), the patient developed "shooting pain that extended up into her clavicle 2 days later, the pain became progressively worse and was intermittent. When the left arm was raised at a 20 degree angle the arm hurts and when raised at a 45 degree angle there was a shooting pain down the arm and across her clavicle." The reporting pharmacist stated that the pain was more like "nerve pain" and reported that the patient "had not been able to go to the gym and had difficulties performing her activities of daily living". It was confirmed that the patient did not receive any treatment for the events. The outcome of all the events was reported as not recovered/not resolved. The causality between the vaccination with ZOSTAVAX and the aforementioned events was not reported. Upon internal review, the events were considered as serious due to the disability for the patient.
Vaccine Error: Patient was administered an undiluted dose of the pfizer covid booster, therefore receiving 3 times the normal dose. Parent made aware, has not reported any symptoms
dizzy spell; driving; dizziness; dizziness; sore; blood pressure; light headedness; bedridden; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of DIZZINESS (dizziness), PAIN (sore), BLOOD PRESSURE MEASUREMENT (blood pressure), DIZZINESS (light headedness) and BEDRIDDEN (bedridden) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Dec-2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jan-2021, the patient experienced BEDRIDDEN (bedridden). On 27-Jan-2021, the patient experienced the first episode of DIZZINESS (dizziness), PAIN (sore), BLOOD PRESSURE MEASUREMENT (blood pressure) and DIZZINESS (light headedness). On 28-Jan-2021, the patient experienced DIZZINESS (dizzy spell), IMPAIRED DRIVING ABILITY (driving) and the second episode of DIZZINESS (dizziness). At the time of the report, PAIN (sore), BLOOD PRESSURE MEASUREMENT (blood pressure), DIZZINESS (light headedness), BEDRIDDEN (bedridden), DIZZINESS (dizzy spell), IMPAIRED DRIVING ABILITY (driving) and the last episode of DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
insomnia, visual and auditory hallucinations, (unable to sleep the night of the sixth); slept most of the seventh; severe nausea when awake on the seventh; also severe chilling the seventh. No treatment was sought so no treatment rec'd; full recovery on the eighth. The insomnia lasted for one night only; as did the hallucinations; the nausea & chilling were worse on the seventh; but ended by the eighth.
No adverse event at time of vax. Symptoms within 24 hours of myalgia, malaise, transient nausea. Used over-the-counter anti-inflamatories, prescription zyrtec / medrol dose pack (steroid). Tapering prednisone 11/99. Referred to rheumatology.
Client sat on chair, RN began to give HPV - IM (L) deltoid - before all vaccine adm - client pale face - slumped - limp - 2 RNs assisted clt to floor - knees elevated. P - weak 68-89 - cool clothes forehead, behind neck - sleepy "co dizzy - weak" cool to touch. PO2 92-99%. Never lost consciousness - 15 min able to sit up on floor. Color pink - PO2 98-99%. 2nd injection given Rt deltoid again as soon needle pierced skin - pale - cool - pupils dilated - RNs laid her down again recover with lying flat - cool clothes. Walked to car by mom - nurse.
Fever after 2nd shot; Chills after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after 2nd shot) and CHILLS (Chills after 2nd shot) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced PYREXIA (Fever after 2nd shot) and CHILLS (Chills after 2nd shot). On 19-Apr-2021, PYREXIA (Fever after 2nd shot) and CHILLS (Chills after 2nd shot) had resolved.            No concomitant drug details were reported. No treatment details were reported.   This case was linked to MOD-2021-407230 (Patient Link).
PATIENT PRESENTED WITH TREMBLING, SWEATING, NAUSEA AND DRY MOUTH. RECEIVED OXYGEN AND OTHER MEDICATIONS ORDERED BY THE MD. WAS TRANSPORTED TO THE EMERGENCY ROOM.
After HPV #3 reported acute behavior change, angry, confrontational, confused, trying to leave house.  Had resolved by the time she reached ER.
Headache Sore arm 3 days, Headache every 3 days. Narrative:
arm started getting warm; itchy; turned red; swollen from the top of their shoulder down half way into their mid arm; A spontaneous report was received from a healthcare professional concerning a 74-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events started getting warm, it was itchy, it's turned red, swollen from the top of their shoulder down half way into their mid arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 004M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 6 Feb 2021, the patient experienced the event(s) started getting warm, it was itchy, it's turned red, swollen from the top of their shoulder down half way into their mid arm.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), started getting warm, it was itchy, it's turned red, swollen from the top of their shoulder down half way into their mid arm was unknown.
Would consider this a vaccine failure for him to be fully immunized and get pertussis at age 7
Phone call from mother, stating that child had a flu shot on 11/15/05 at about 9am, the next morning she noted child had a rash on his cheek and ear.  The rash now covers his face.  Child may have a "slight fever" or 99 (mother states she is having problems with her thermomater). Denies any other symptoms.   Researched Fluzone package insert, and discussed with manufacturer.  Informed mother that we would report as a possible vaccine reaction, but she should monitor the child for increasing symptoms and if she has any concerns, he should see his pediatrian. Also advised her to keep child home from daycare.
On waking the morning after the shot, the area on my right upper arm  around the shot location is red, slightly raised, and sore in an area of approximately 2 inches wide and 1.5 inches long (tall/down the length of the arm).  The pain is not severe; I don't want to lie on it or be punched in the arm. Most of the redness is below the shot location.
Headache; Chills; Joint pain; My fever went up to 102.7; This is a spontaneous report from a contactable nurse. A 54-year-old female patient receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration in Left Upper arm on an unspecified date at a single dose for covid. The patient medical history was not reported.  Concomitant medication included magnesium hydroxide (MILK OF MAGNESIA).  The patient called in to report side effects. The patient received the vaccine at 9 am then woke up in the middle of the night with the headache and chills, joint pain, fever that went up to 102.7. Treatment included Tylenol. The nurse considered the events as related to the vaccine. The outcome of the events was unknown.
pt had fussiness & onset of crying; cried for @ least 5 hrs-fever up to 105; states went to local hosp w/fever & crying; pt had 2 convuls; 22JUN94 OM
Developed rash on day of vaccination administration which worsened over next 2 days. Mother concerned and brought him to the clinic. Diagnosed with urticaria (hives). Had redness at site of PREVNAR shot, developed into a bit of a knot prior to full rash on body.
A non-serious report of administration of H1N1 to a patient over 50 was received from a consumer concerning a 59-year-old female subsequent to the administration of H1N1. Relevant medical history and concomitant medications were not reported. On 30-Oct-2009, the patient received H1N1. There was no adverse event reported with this vaccination error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved.
Second Pfizer shot- 3/31/2021 Booster Pfizer- 10/30/2021  With both my second shot in March and the booster I received this past Saturday 10/30/2021, I experienced flu-like headache, body aches and joint pain 18 hours after the shot. At 36 hours after each shot (nearly exactly), I experienced an unusual painful sensitivity in all of my teeth, which was like the pressure and sensitivity felt from a terrible sinus infection. I do not have a sinus infection now. With both the second shot and this booster I had/have ?Covid arm?  characterized by a big hard lump at the injection site and a big round itchy hot circle around the injection site at least 4-5 inches in diameter. It appeared 48 hours after the vaccine and persists today? now 4 days post-booster.
10/262021  SHORTNESS OF BREATH, FATIGUE,  11/18/ 2021 FINAL DIAAGNOSIS AFTER TESTING: INTERSTITIAL PULMONARY  EDEMA PATIENT REFERRAL TO PULMONOLOGIST
Parents noticed a 50 cent size red area on left arm on 03/15/05. Now on 03/16/05, redness, warmth, swelling and itching from shoulder to left elbow.
Patient admitted to hospital 9/20/21 for sepsis due to COVID pneumonia. Tested positive for COVID 9/20/21. Discharged and readmitted 9/24/21. Deceased 9/27/21.
Information has been received from a female staff member in a physician's office but not healthcare professional concerning her 14 year old daughter who on 16-MAY-2008 was vaccinated with a first dose of GARDASIL.  The patient experienced numbness on the whole arm where she had the injection, headache and vomiting after receiving the first dose of GARDASIL.  The reporter was not sure if her daughter would received the second dose.  Additional information has been requested.
Mild to severe headache behind her eye and sinus area; Mild to severe headache behind her eye and sinus area; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 21Dec2020 at 10:15 AM, at single dose, for COVID-19 immunisation. Medical history included peanut allergy, penicillin allergy and nut allergy (unknown if ongoing). Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient experienced mild to severe headache in Dec2020, days after the COVID-19 injection. Main complaint was headache behind her eye and sinus area. The event required physician office visit on 29Dec2020. It was unknown if the event required any treatment. The events was considered as non serious. The patient was unsure if this was related to the vaccine but informed the reporter.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Whole body itching & predominantly in legs, extreme swelling of arm extending below elbow and into neck area swollen areas hot, tight, and pink to reddish colored, fever, tiredness, cramping in stomach, aching pain below ribcage and lower left rear lung area. No appetite.
Patient had swelling and warmth in area. Also felt tired and feverish. Dr. told her to ice and notified her that she already got vaccine in 8/2013.
Initial case received from a physician on 09 October 2009. A female patient in her mid-30's experienced arm pain after receiving a right deltoid injection of ADACEL (lot not reported). The patient had received the injection eight months prior to the report, and the pain was still ongoing. No additional information was reported. Documents held by sender: None.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (No drug name was reported.).   On 21-Jan-2021 at 11:15 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021 at 1:00 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021 at 10:00 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022 at 11:00 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Still testing positive after 15 days..         No concomitant medications were reported. It was reported that patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that patient had previously received COVID-19 vaccine. The event reported was Four days after completing Paxlovid COVID symptoms of fever, headache, congestion, muscle aches, chest pressure with cough and exhaustion returned and lasted for another 6 days. Still testing positive after 15 days. The  Device Date was reported as 29-May-2022  Company comment- This is a spontaneous case concerning a 70-year-old female patient with no relevant medical history, who experienced the unexpected COVID-19 after four doses of mRNA-1273 vaccine were administered. It was reported that four days after completing Paxlovid COVID symptoms of fever, headache, congestion, muscle aches, chest pressure with cough and exhaustion returned and lasted for another 6 days. Patient is still testing positive after 15 days. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 70-year-old female patient with no relevant medical history, who experienced the unexpected COVID-19 after four doses of mRNA-1273 vaccine were administered. It was reported that four days after completing Paxlovid COVID symptoms of fever, headache, congestion, muscle aches, chest pressure with cough and exhaustion returned and lasted for another 6 days. Patient is still testing positive after 15 days. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
He received his vaccination 1/2/21 at 1100. He experienced a racing heartbeat up to 150 when sitting in the monitor room that did return to normal during 15 minutes and he was asked to wait 30 minutes to continue to be monitored. He was feeling better but, when he went to walk up the stairs he began to feel light headed again. He was taken to the ER at 1218 for lightheadedness and racing heartbeat.  Vitals taken in the Emergency Department - Temp 97.7F, Heart Rate - 78,  Resp Rate 16, Blood pressure 127/63.  EKG - normal sinus rhythm.   He felt fine and was discharged at 14:06 .
Mid DEC noted weakness in all extremities;weakness progressed to pain & stiffness;reports no pain, soreness or cont weakness in legs but sx cont in both arms;denies having had redness or swelling;myalgia;upper leg pain;
Pt has decreased range of motion, numbness and pain in arm approximately 2 weeks after flu shot.
SCRATCHY EYES; ACHY EYES; JOINT ACHES; GENERAL MALAISE; FATIGUE; HEADACHES; MINOR SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: 21-SEP-2021) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-AUG-2021, the subject experienced scratchy eyes. On 04-AUG-2021, the subject experienced achy eyes. On 04-AUG-2021, the subject experienced joint aches. On 04-AUG-2021, the subject experienced general malaise. On 04-AUG-2021, the subject experienced fatigue. On 04-AUG-2021, the subject experienced headaches. On 04-AUG-2021, the subject experienced minor soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint aches, general malaise, fatigue, headaches, minor soreness at injection site, scratchy eyes, and achy eyes. This report was non-serious.
101.5 Fever, body aches, couldn't sleep or eat. Felt exactly like having COVID but more intense in a shorter time frame. Also felt numb and tingling in my arms and legs.
A tingling and prickling sensation in the left arm /and left leg; This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced tingling of extremity. On an unknown date, the outcome of the tingling of extremity was not recovered/not resolved.   It was unknown if the reporter considered the tingling of extremity to be related to Shingrix.  Additional details were provided as follows:  The case was reported by patient herself. The patient received Shingrix vaccine in left arm and experienced tingling and prickling sensation in the left arm and left leg, approximately 2 weeks to a month after receiving vaccine. The reporter reported that the tingling and prickling sensation comes and goes and seems to worsen when lying down at night. The tingling and prickling sensation seems to subside with physical activity. The patient did not yet receive their second dose of Shingrix. The reporter did not consent to follow up.
technician drew up 0.5 mls instead of 0.3 mls and administered vaccine
Patient was initially admitted to the hospital due to a syncopal event he was diagnosis COVID-19 positive. Patient was trying to get out of the bed according to records and per his recount and had gone to the bathroom felt dizzy and passed out. Patient was evaluated in the EC seen by cardiology and also recommended 3 doses of remdesivir. Noted cardiology input regarding need for TEE with his recent coronary artery disease with PCI and stent in March 2022 and a TAVR in 2022 however patient was very anxious to be discharged so the nurse did help me get ahold of cardiology who did clear him for discharge. As clinically patient is better his symptoms have resolved he has not required any O2 he would be okay for discharge without the third dose of remdesivir. Patient does understand that the recommendations for CDCR for 3 days if he has any issues he would need to return to the hospital.
This spontaneous report was received from a physician via a company representative concerning two patients of unknown age and gender. On an unknown date, patients were vaccinated with 0.65 millimeter (ml) ZOSTAVAX (route and lot number unspecified), once. No concomitant medications were reported. On an unknown date, after the vaccination, both the patients experienced a very mild case of shingles. Patients sought unspecified medical attention. Both the patients were given VALTREX as a treatment. The outcome of shingles was unknown. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
patient was only injected the adjuvant component; patient was only injected the adjuvant component; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: Age at vaccination was not reported. The pharmacist reported that, the patient was only injected the adjuvant component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  No adverse event was reported . The reporter consented to follow up. No patient's identifiers provided,no LOT number and expiration and no vaccination date were provided.
Information has been received from a nurse practitioner and a 26 year old female consumer for the Pregnancy Registry for GARDASIL concerning herself who on 19-MAY-2008 was vaccinated intramuscularly in the deltoid with her first dose of GARDASIL (lot# not reported) and became pregnant. There was no concomitant medication. The patient's LMP was 19-MAY-2008 and EDD was 23-FEB-2009. Subsequently the patient experienced no adverse symptoms. The patient sought medical attention with an office visit on an unspecified date. The patient had blood work and a urine pregnancy test to confirm the pregnancy. The patient's outcome was not reported. Follow-up information was received from the consumer who stated that she had a baby boy who is now nine months old; healthy and normal with no problems. She also said her pregnancy was "very good", and she was one week overdue when she went into labor. Additionally she reported an "emergency" cesarean section during labor because the baby "wasn't coming down" and had the umbilical cord wrapped around his arm and after a while" he couldn't take it any more". The reporter stated the baby was fine after he was born and she recovered very well from the surgery. Upon internal review, umbilical cord abnormality was considered an other important medical event. Additional information is not expected.