chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; received the wrong booster/received booster from incorrect vial; got the pediatric 6 to 11 year old formulation; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (received the wrong booster/received booster from incorrect vial), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (got the pediatric 6 to 11 year old formulation) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR6965B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 06-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received the wrong booster/received booster from incorrect vial) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (got the pediatric 6 to 11 year old formulation). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received the wrong booster/received booster from incorrect vial), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (got the pediatric 6 to 11 year old formulation) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (received the wrong booster/received booster from incorrect vial) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (got the pediatric 6 to 11 year old formulation).    No concomitant medications were reported. Patient got second Moderna booster. Patient was supposed to get a booster, but got the pediatric 6 to 11 year old formulation. The box said booster doses on the outside. The pharmacist explained that HCP grabbed a vial of the vaccine for 6 to 11 year olds and administered to 3 adult patients who were going for their booster shots.The pharmacist reported that it was confusing because the vial states Moderna COVID-19 Vaccine for booster doses only. There was a purple border on the carton, but not on the vial. It did not mention an age group on the carton at all.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-642004, US-MODERNATX, INC.-MOD-2022-642009 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-642004: US-MODERNATX, INC.-MOD-2022-642009:
Information has been received from a consumer concerning a 66 year old female friend who in end of May or early June 2008, was vaccinated with single dose of ZOSTAVAX (Merck).  Concomitant therapy included blood pressure medication, antidepressant and high cholesterol medications which the names were unspecified by reporter.  During the first couple days of September 2008, the patient collapsed and emergency medical technician (EMT) was called.  The patient was taken to hospital.  At the hospital they had to intabate her and she was put on life support.  The patient was on hospital for about a week and she was home and doing better (recovering).  The patient was not diagnosed with anything at the time she was at the hospital.  Additional information has been requested.
I had a swollen left arm , red, warm to touch for the first 3 days.  arm was very sore on day #2.  I had my shot on a  Monday morning, by thursday my arm felt mostly fine, just a little sore. On Sunday evening, my arm started to react again at my injection site.  Monday morning, red, hard, felt hot, about a quarter size.  By Monday evening,  about 5 inches of swelling in my arm and the red warm area was a half dollar size.  By Tuesday morning it was twice that size. My arm and shoulder area are all sore at this point.   I am taking 800 of Ibuprofen,  Zyrtec and using  cortisone ointment on my arm.  Dr's at my hospital that I work with suggested that it meant i have had Covid recently,  and already had antibodies, therefore having a stronger reaction.  My Employee Health dept says that is not the case. They said to file a report here. They were also hoping  this site would be able to tell me if can or should get the second vaccine.  They aren't sure that I should.
G47.33 OBSTRUCTIVE SLEEP APNEA 4/21/2023 SEVERE OBESITY
Could hardly walk.; Again she experienced chilling, shivering and used 7 blankets and was still freezing; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Could hardly walk.), CHILLS (Again she experienced chilling, shivering and used 7 blankets and was still freezing) and MYALGIA (Body aches) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 025J202A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced GAIT DISTURBANCE (Could hardly walk.), CHILLS (Again she experienced chilling, shivering and used 7 blankets and was still freezing) and MYALGIA (Body aches). At the time of the report, GAIT DISTURBANCE (Could hardly walk.), CHILLS (Again she experienced chilling, shivering and used 7 blankets and was still freezing) and MYALGIA (Body aches) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2022-456330, MOD-2022-456359 (Patient Link).
Pt arrived with his grandmother to recieve a pediatric pfizer vaccination. Mother, ill at home, gave phone consent per policy. Pt inadvertantly was given an incorrect vaccination, receiving Moderna 025ml NOT Pfizer. When discrepancy was found, Medical Director was contacted and I called pt. Mother and explained the mistake. I also texted her the information for follow up with his PCP.  No reaction.
mom called in some day of listed vax stated pt devel temp of 104; was starring into space & had jerking movements; pt was seen by MD and & adm to hosp w/bronchitis, ear and throat infect;
Pt called 9/20 + said he has had a radiating pain down his arm + is now residing in wrist area. His gout medication (colchicine) didn't work. He will see PCP if it continues.
Redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th July 2019, 2 days after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The patient received Shingrix dose in left arm. At the time of reporting, the patient experienced redness at the injection site. The reporter did not consent to follow-up. No further details were provided.
patient was needing a Tdap per her age but was given the Pentacel(Dtap).  It was her 6th dose of the Dtap so according to CDC guidelines this will cover her Tdap needed.  I was advised by my Reg. Rep to submit this .  LPN
strong pain in the arm; was born on 21-Dec-1970, so he is 49 years old / received the first dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 49-year-old male patient who received Herpes zoster (Shingrix) (batch number 5CE54, expiry date 25th February 2022) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix. In February 2020, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received first dose of Shingrix a week ago, was suffering strong pain in the arm. The healthcare professional want to know how long it was going to last. The healthcare professional reported the patient was 49 years old, which led to inappropriate age at vaccine administration. The Shingrix was recommended for patients 50 years and older. The reporter consented to follow up. As per sales data sheet reported batch number was changed from 8-5CE54 to 5CE54.
Staff member approached us for her vaccination.  She filled out the VAR and she told us it was her second shot.  After she received it, she went to her purse and got her COVID CDC card and we learned that she already had 2 Moderna vaccines. As of now, no adverse reaction has taken place.
Received expired dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of vaccine) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired dose of vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
This spontaneous report was received from a licensed practical nurse concerning a to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 22-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, dose number, lot number and route were not reported) expiration date 25-SEP-2014. Co-suspect and concomitant therapies were not reported. Nurse reported patient was administered expired PNEUMOVAX 23 on 22-OCT-2014. No adverse effects reported. Additional information has been requested.
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated with the first 0.5 ml dose of GARDASIL (lot# not reported) in July 2011. On 05-OCT-2012 the patient was vaccinated with the second 0.5 ml dose of GARDASIL (lot# not reported) at physician's office. No adverse effects reported. Additional information has been requested.
Patient has end-stage renal disease and was felt to have fluid overload when he presented to the emergency room. Lasix was given and it was noted that the patient had discomfort in his prepubic area and has urine retention due to no urine output in his home Foley. The patient then vomited blood ( coffee ground emesis )  and was placed on Protonix with Carafate.        The patient's hemoglobin was around 7 so he was transfused 1 unit of blood there.  He came in with acute respiratory failure with hypoxia and hypercapnia: Pt has recurrent metastatic adenocarcinoma. Continue oxygen support. Discharged to hospice at a skilled nursing facility and passed away on 12/8/2021. Hospital admission was within 6 weeks of receiving the COVID vaccine.
patient pulled away and the full dose was not given. when the patient pulled away, the vaccine leaked out of the syringe and was not administered with no reported adverse event; Initial information received on 09-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of an unknown age and gender and reporter reported that the patient pulled away and the full dose was not given. when the patient pulled away, the Influenza Quadrival A-B Vaccine [Fluzone Qiv] leaked out of the syringe and was not administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection (strength: unknown, expiry date: Jun-2024 and lot UT8038MA) via unknown route in unknown administration site as Influenza and patient pulled away and the full dose was not given. when the patient pulled away, the vaccine leaked out of the syringe and was not administered with no reported adverse event (incorrect dose administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Began 7-25-09 with "mild achy".  Worsened on 7/27/09 -> fever (subjective), body aches, nasal congestion cough & chest congestion, arms & legs aches, fatigue.  No GI symptoms.
Pt felt that he had an irregular heartbeat which led to a bit of anxiety. He felt that he was having a tickle in his throat. After taking an alprazolam, pt was feeling better and did not need to call 911 or go to ER.
Received vaccine at 11:30 A.M. on 10/25/09, At about noon the next day, 10/26/09, I developed a fever, 100 degrees, with severe body aches & chills. I stayed in bed with heating pad & toll Aleve. I've never experienced body aches where I couldn't get comfortable or rest. It subsided about 6 p.m. that day. It was gone by the next morning.
Heart racing (HR average 120-130), bumbles, tingling/needle-like feeling in hands and fingers.
Flu shot Tues, 10/28/08 - Wed. morning 10/29/08 (+) redness and tenderness at injection site. (+) pain, redness, and spreading tenseness into today. No facial abscess or fluctuant mass noted. Tenderness, (-) induration.
Fever for 24 hours, welts, hives in various places and red spots on abdomen for 2 weeks.
Dose administered to 3 year old patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number n254c, expiry date 23rd November 2023) for prophylaxis.   On 18th February 2022, the patient received Boostrix. On 18th February 2022, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The patient was inadvertently administrated a dose of Boostrix, which led to inappropriate age at vaccine administration. No further events were reported. The reporter agreed to be contacted for follow-up The Vaccine Administration Facility is the same as Primary Reporter.
I had a rash that was itchy, red, and hot come on the  11th day after my first Moderna Covid shot. It spread quickly around my arm and was sore if it bumped into anything.
Grandmother stated she noted a heat rash type rash on childs back when she gave her a bath.  No respiratory distress.
Soreness at injection site on same day as vaccination.  Then by 2/2/08 symptoms increased.  Headache, mild stomach ache, arm achy, unable to lift higher than 90 degree angle.  No fever, no swelling or redness at site.  Symptoms lasted 2 wks.  Relieved slightly with Naprosyn every 12 hours for 2 days.
sore arm x 3 days.  (starting on night of injection) Chills (starting night of injection) following injection for 24 hours: fever 100.8 F muscle aches  extreme fatigue migraine mild shortness of breath
Inflammation, heat, swelling over injection site and down arm to elbow.  Patient complained of "tingling" in 4th /5th digits but sensation intact.  Treatment with medrol dosepak.
Pt ex cold sensation, shivering & feverish, teeth chattering, muscle stiffness, t102, restless following vax;
PT EXPEREINED FEVER OF 103, COMPLETE BODY CHILLS, ACHES, EXHAUSTION FOR UP TO 4 DAYS.. TYLENOL DID HELP REDUCE THE FEVER. BUT IT WAS TAKING A WHILE TO IMPROVE AND TO FEEL A SENSE OF RELIEF.
I had fever, chills, coughing from the beginning. I do have asthma. I did not expect to it continue with phlegm and cough everyday since the vaccine. I also have dizziness. I will see a heart specialist to see why I am still having certain issues. I took prednisone, antibiotics and I also drank herbal teas to help with the phlegm and asthma. I also used a nebulizer for my asthma. They had me on vitamin C, vitamin D, zinc and I am also taking a multivitamins. I still have symptoms today.
pt presented w/fever w/in hr of vax;hosp 48hr p/onset;eval revealed probable Kawasaki's disease w/coronary artery enlargement, inc ESR,  persistent T, myocarditis resolved w/IVIG/ASA;
Moderna COVID-19 Vaccine EUA - Tinnitus in right ear noticeable day after 2nd dose was administered. Has persisted for approximately 36 hours.
Symptoms began following the covid-19 vaccines, persistent at two following the injections. Patient complains of feeling unwell, run down since taking COVID injections. Treated at ER for vomitting, aching all over, dizziness and significantly worsened joint pain in knee.
Patient returned to pharmacy on 10/9/19 stating she was still experiencing painful soreness starting at the injection site in the deltoid and extending down to a point of pain in the elbow and then continuing down to the hand.  She described numbness and tingling on the dorsal surface of the hand.  These effects started after the vaccination.  She will be following up with her physician for evaluation.
Information has been received from a office manager concerning a 63 year old female with no medical history or drug reactions/allergies who on 21-MAY-2010 was vaccinated SC with a 0.65 ml ZOSTAVAX (Merck) (lot # 665430/1764Y, expiration 15-MAR-2011). Concomitant therapy included a hormone replacement therapy (therapy unspecified). On approximately 21-MAY-2010 (within 24 hours of being vaccinated) the patient developed redness and swelling in an area of 6 inches at the injection site. The patient called office to seek medical attention. The patient was prescribed DOXYCLIN. There was no laboratory test performed. Subsequently on an unspecified date the patient recovered. Additional information has been requested.
muscle pains; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MYALGIA (muscle pains) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Mar-2021, the patient experienced MYALGIA (muscle pains). At the time of the report, MYALGIA (muscle pains) outcome was unknown. Not Provided      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.   Treatment medication were not reported/unknown.
Pt developed pain in right arm/shoulder on 2/26/12. Within 24 hours developed blister like rash (R) arm c/w shingles area of mid forearm with secondary infection.
Five hr. post vax pt devel inject site rxn with redness,warmth & pain.Within 5-7 days,inject site size inc to that of a "50 cent piece". Inject site pain down arm with numbness in fingers. Tx w/ compresses & analgesics;
chills/sick; 101 temperature; Chills; Left side of face went numb about 20-30 mins; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 17:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included nocturnal epilepsy, fibromyalgia, asthma, sleep apnea, migraine, COVID-19 and CAT scan dye allergy. Concomitant medications included oxcarbazepine (OXTELLAR XR), omeprazole (MANUFACTURER UNKNOWN), vitamin C (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), vitamin B (MANUFACTURER UNKNOWN) and montelukast sodium (MONTELUKAST) all for unknown indication on an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 17:30, after vaccination the patient experienced left side of face went numb for about 20-30 mins. On 27Mar2021, 24 hours after vaccination, the patient experienced 101 temperature and chills/sick. Therapeutic measures were not taken as a result of the events. The adverse events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The clinical outcome of the events left side of face went numb, 101 temperature and chills/sick was recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recv vax 1pm; approx 4pm became nauseated, weak, dizzy; color pale; sx lasted approx 24 hr;