chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received an invalid dose of 0.25 mL instead of 0.5 mL of Fluzone QIV/no AT; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.   This case was linked to 2019SA293392.  This case involves a 14 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Oct-2019, the patient received a 0.25 ml instead of 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6653BD via intramuscular route in the right deltoid.  It was of actual medication error due to vaccine underdose..  It was unknown whether adverse event was noted or not.  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.
kidney pain; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RENAL PAIN (kidney pain) and HEADACHE (headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included Kidney pain and Headache.    On 20-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced RENAL PAIN (kidney pain) and HEADACHE (headache). At the time of the report, RENAL PAIN (kidney pain) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Pt describes as "light nausea/vomiting/diarrhea."  Pt reports self-resolving, starting this morning (10/11/17).  Awaiting call back from prescriber to notify them of reported reaction.
diarrhea, nausea, headache, chills, muscle aches, joint pain, weakness
several days after receiving the second vaccination I felt very tired....the tiredness did not go away it only lingered. Two weeks after second dose I began feeling dizzy and went to the hospital for a check up. That is when they discovered I had A-Fib.
Pfizer-BioNTech COVID-19 Vaccine EUA: two days after vaccination patient reports in clinic visit pain on right side of hand and leg, diarrhea, chills, difficulty urinating, and fever one day after vaccination. By the time of clinic visit symptoms resolved except for diarrhea. No rash or respiratory symptoms reported. Patient able to manage symptoms at home.
Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion.  Exact date of administration not provided. Patient is asymptomatic. No additional AE. No PQC.  Names of vaccines involved (including lot/exp) VARIVAX W; No additional AE.; This spontaneous report was received from a nurse, concerning to a patient of unknown gender an age.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, (lot #W031812 has been verified to be a valid lot, expiration date: 05-OCT-2024) for prophylaxis (strength, and route of administration were not provided), while the vaccine had a temperature excursion at 24.4 Fahrenheit grade during 5 hours and 51 minutes (Product storage error). There was not previous temperature excursion. No additional adverse event, and the patient was asymptomatic.
Left deltoid pain intermittently lasting for past 2-3 months. No redness, swelling, bleeding, discharge.
Red welts all over stomach, legs, chest, and bottom that itched just like the spot around injection site. Head aches and fatigue.
I experienced inability to do range of motion in my left arm and shoulder, pain at the injection site (whole deltoid muscle was extremely sore), neck pain, and headaches. I was seen at my doctor's office by his assistant who examined me, saw that I had range of motion issues with my left arm, pain in my neck and he scheduled physical therapy.
Reaction started with dizziness and weakness in the shower, followed by intense shivering and chills for 1.5 hours. Then I developed a fever of 100.8, which lasted 2 hours. During this time, I experienced nausea and vomiting, along with muscle pains and body aches, particularly in my back and legs. The nausea lasted 5 hours. The muscle pains lasted 8 hours.  I also experienced headache and thirst that lasted 10 hours.
On 3/1/2023 I had the pulse rate  problem  of 40 bpm at office. I had not been feeling well for several days with a severe runny nose that I attributed to pollen.  Then on 3/10/2023 from 8-10 pm I had multiple urinations about 3 times the Normal Volume, ?A flushing of the system?.  This was identical to a reaction after my fourth covid moderna vaccination on 4/12/2022. I did not feel good, but since it felt similar to heat prostration, I just had 3 bottles of Gatorade and felt ok the next day.  I felt the same but I did not take my pulse rate at that time.
Day of vaccine troubles allowing. Next day migraines everyday, severe muscle and joint pain that I could barely move and fever.   I am having uncontrollable movements throughout my entire body and facial drooping. I am having trouble with brain fog, memory and cognition. I did not do well on my neurological MOCA test. I am having trouble breathing. These things have gotten much worse since my second vaccine.  I have been to the ER because I was barely able to walk and was not able to speak. My speech is severely impaired at times.
Woke early AM 5/19/09 with frequent vomiting and fever.  Frequent vomiting lasted until 0700, then final, isolated emesis at 1700.  Temp max 103.  Fever and fatigue continued 5/20.  Did not go to school 5/19-5/20.  Felt better 5/21- no fever, returned to school.  Only symptomatic care given.
Symptoms 5/21/2022 began with allergy type symptoms, runny nose; coughing; congestion; sneezing, The next day her symptoms were worse and she was running a fever. The highest was 101F. They continue to get worse and on 5/22/2022 we tested at home and it was positive. 5/23/22 I contacted her rheumatologist and PCP. PCP wanted her tested again, and asked us to come in for the test. It was positive. She also started having confusion; loss of taste; nauseous. Because of her symptoms and that she is immunosuppressed he wanted to her get remdesivir infusion, which needed to be done at the hospital. Her PCP had her directly admitted. They did blood work on her the basic lab and to check her kidneys before the infusion. She was in from 5/23/2022- 5/25/2022. While in hospital, her nauseous and fever subsided. They cold like symptoms gradually improved. Her confusion, memory loss lasted for about 2 weeks.
Adverse Event: rheumatoid arthritis flare / Brand Name: Shingrix; This case was reported by a consumer via other manufacturer and described the occurrence of rheumatoid arthritis in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles shot (has received regular shingles shot).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant). The patient was treated with prednisone. On an unknown date, the outcome of the rheumatoid arthritis was unknown.   The reporter considered the rheumatoid arthritis to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix which was terrible for her and experienced rheumatoid arthritis flare up. Due to medical reason the patient did not want to take the 2nd dose as it may put her back into a rheumatoid flare. The patient had been taking Prednisone as a treatment and was getting better. No further details were provided. The reporter consented to follow up.
It started with chills and body aches. They started the night after the booster shot. I woke the next day 1/8 with chills, body aches, and swollen lymph nodes. As the day progressed nausea and headaches began. I slept restlessly that entire day. The next day the symptoms continued with me barely able to eat a handful of grapes without feeling nauseous.  When the symptoms first began I took Tylenol every 8 hours. Day 2 I took 2 doses of Tylenol. By the evening of 1/9 chills subsided but all other symptoms remained. The evening of 1/9 the headache resulted in needing a room fully in blackout. On 1/10 appetite began to return  but swollen lymph nodes and nausea were still prevalent. Finally on 1/11 swollen lymph nodes was the only symptom that continued.
after my second shot in Apr2021, my psoriasis cleared right up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "after my second shot in Apr2021, my psoriasis cleared right up".  Additional information: Patient just wanted to know about an exciting side effect patient had from your shots: after my second shot in Apr2021, my psoriasis cleared right up! It lasted through my first booster patient received in Oct2021. In May2022, the psoriasis returned. patient just got second booster yesterday and am hoping for the same psoriasis remission. Obviously, the shot is boosting my immune system. Seems like this is something that would be of great help to us psoriasis suffers Cheers.   Follow-up attempts are completed. No further information is expected.
Brain pressure, migraine headache and severe dizziness first night after vaccine. Dizziness and headache lasted for up to a week (though not as severe). Fatigue. Barely able to keep up with daily tasks.
Breakthrough case admission after 2 vaccines  Pfizer 3/27/21 Lot# ER8732;  Pfizer 4/17/21 Lot# Ew0169
Pt recvd DTP/OPV/HIB & was given APAP for fever; mom lost APAP & gave pt few doses of pedicare; pt found dead in crib next morning 10AM;
Need for NSAIDs for pain. C/O headache, joint pain, chills, and site soreness
On 10/26/15 at 0835 patient was given the flu vaccine. She then walked without incident until her lab draw (fasting). Pt then lost consciousness, fainting in lab chair. Nursing and PCMN notified. Legs were elevated and VS taken. Pt was observed in clinic. Dr. indicated pt. had low blood sugar. OJ and snacks provided. Pt c/o vertigo sx. Rested until left clinic with friend at 1110.
Irregular heartbeats for 8 hours after vaccine administration; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE IRREGULAR (Irregular heartbeats for 8 hours after vaccine administration) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE IRREGULAR (Irregular heartbeats for 8 hours after vaccine administration). At the time of the report, HEART RATE IRREGULAR (Irregular heartbeats for 8 hours after vaccine administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Mom states the patient became very pale, dizzy and passed out in car on the way home. Once in house, became nauseated, pale, ongoing. Doctor notified 2 days later. Patient developed red rash on arms/stomach. Doctor notified.  Mother called and reported to us on this day.
Narrative:  04/08/21 COVID vaccine dose #1 (of1) ~12/2021 Received COVID booster at another location 01/20/2022 Patient calls, reports ~ 24 hours after his J&J booster he developed right hand tingling, pain and numbness that is starting to radiate up the arm; duration of 5 weeks no further information available at this time
Patient called on Jan 3 2013 for unrelated matter she related developing an "egg" at site of injection and later, "swelling from above my collarbone and up the side of my neck" on 12/30/12. As of Jan 3 2013 all symptoms resolved per patient.
Information has been received from a pharmacist concerning a patient who "recently", in 2010 was vaccinated with PNEUMOVAX 23 (lot # not reported). Subsequently, in 2010 the patient experienced an infection at the injection site with "infection below the elbow to the forearm". The patient sought unknown medical attention. The patient's outcome was unknown. Additional information has been requested.
J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/17/2021 PULMONARY ARTERY HTN J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/17/2021 BACTEREMIA
Hives on face, antihistamine and prednisone dose pack. (continue to take antihistamine as symptoms remain although not as severe.
Woke with extreme pressure on left side, painful. Lasted five after first shot. Activity , stress, and laying increased pain.  Never any heart issues or lung issues before. Run 15 miles a week for 30 years and never any issues until now.
Received their first dose of Comirnaty on 13Nov2021 and got the 2nd dose 6 days ago, 19Nov2021; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 5 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 5 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1), administration date: 13Nov2021, when the patient was 5 years old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Received their first dose of Comirnaty on 13Nov2021 and got the 2nd dose 6 days ago, 19Nov2021"; PYREXIA (non-serious) with onset Nov2021, outcome "unknown", described as "Fever".  Additional information: Patient received the second dose from school by accident 6 days after first vaccine dose. Lot number of suspect vaccine was reported as KF5127 which was not clarified appropriately.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101640262 same reporter/product/event, different patients.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 09-NOV-2016, the patient was vaccinated with an expired dose of ZOSTAVAX injection, lot # K020185, expiry date 27-JAN-2016 (dose, route of administration and anatomical location were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
No other AE; temperature excursion; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 05-NOV-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) lot # U019289, expiration date 15-DEC-2022, at a dose of 0.5 milliliter for prophylaxis (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). No other adverse event reported.  The vaccine was stored in a temperature of 20 degree Fahrenheit for 17 (unspecified time unit). There was no previous temperature excursion reported.
Shoulder pain became severe approximately 2 hours after influenza vaccination, with inability to raise arm; active range of motion severely compromised, passive range of motion moderately compromised. Mild chronic pain; moderate to severe night pain. Consistent with adhesive capsulitis. Tx: Naproxen 500 mg bid, steroid injection at shoulder, daily physical therapy.
Arm went numb within first hour after dose, continued up through neck. Next morning I felt flu-like symptoms, Achy muscles and joints, fever that varies between 100° and 101.6°,  bad headache,  severe fatigue.
Chills, sweats, dizziness, vomiting, headache, shaking,  fatigue for about  21 hours . I began to feel better about 7pm on 2/19/2021
SUSPECTED CLINICAL VACCINATION FAILURE; SICK WITH COVID/ SUSPECTED COVID-19 INFECTION; This spontaneous report received from a health care professional and concerned multiple patients of an unspecified sex, age, race and ethnic origin. The patients heights and weights were not reported. No 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: unknown and expiry date: unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date post vaccination, the patients developed sickness with Covid (suspected Covid-19 infection and suspected clinical vaccination failure) and were hospitalized (number of days unspecified). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and sick with Covid/ suspected Covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000194197.; Sender's Comments: V0:20211000706-covid-19 vaccine ad26.cov2.s - Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.  20211000706-covid-19 vaccine ad26.cov2.s -Sick with covid/suspected covid 19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
05Apr90 pt vax;  devel blotchy rash at inject site on upper left arm.  W/in 15 min rash spread to neck & chest.  Tx included Benadryl & rash resolved in 30 min.
Patient received both vaccinations on Monday 10/22/12 9:30 am. On Tues eve, patient noticed a red rash where his short sleeve touches his arm on the right arm. On Wed, the rash and swelling traveled down halfway->.
pt recvd vax 1215PM & devel redness around inj lt thigh w/3 bumps in middle;each cleared w/DPH; pt later started vomiting & vomited 7 times between 1PM & 730PM;
Pt is a 36 y.o. female that began having COVID symptoms on 12/1. She is vaccinated. She has had f/c/sweats. Cough/SOA. Notes chest tightness. Anorexia. Notes myalgias/arthralgias/HA. Admitted 12/7 with hypoxia to 90%.
Aching, chilling to point of shaking, fever, inability to get comfortable to sleep.
Throat itchy after vaccine; Coughing; Hives each day after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Throat itchy after vaccine), COUGH (Coughing) and URTICARIA (Hives each day after the vaccine) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced THROAT IRRITATION (Throat itchy after vaccine), COUGH (Coughing) and URTICARIA (Hives each day after the vaccine). At the time of the report, THROAT IRRITATION (Throat itchy after vaccine), COUGH (Coughing) and URTICARIA (Hives each day after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a pharmacist refers to a 61 year old female patient with no known drug allergies. On 28-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J000432, expiry: 10-APR-2014) subcutaneously. Late on 29-JUN-2013 to early 30-JUN-2013, the patient experienced a small mosquito type bump, which was warm to touch. Patient called pharmacist to report and did not seek medical attention. Pharmacist suggested patient use TYLENOL, for discomfort, to which patient replied that it was not that bad. Laboratory diagnostics studies performed were none. The outcome of patient experienced a small mosquito type bump, which was warm to touch was unknown. Additional information has been requested.
Moderna Covid-19 vaccine EUA  Pain on left side of abdomen in underarm area for 72 hours.   99.1 degree fever the day after the shot for about 12 hours
Muscle aches, headache, sore neck/throat, joint pain, very sore arms (both), chills
Patient was sitting in waiting area after vaccination and slid out of chair in a state of dizziness/passing out, but did not lose conciousness.  We talked with her, offered her water and snack.  She sat for about 15 minutes, then appeared to be recovered.  She states she passed out with her last vaccine when  she was 15 years old.
I had nausea, fever, swelling of left arm and armpit. Pain and discomfort in the arm where shot was given came on and off. On May 26, 2021, I develop a strong pain from the left side of my neck to my elbow.  Decided to see my physiatrist because I couldn't stand the pain.  Got X-Rays and an MRI  of the area but nothing came out in them.  My physiatrist recommended therapy and medicine and after about a month, I started to feel some relief.  About a week later, i noticed I had a rapid heartbeat and was feeling  more tired than usual, and went to see Dr., he ordered a battery of tests.
1/3 of arm red, swollen, warm  from site of vaccine towards elbow.
Telephone call - Describes bruising to right forearm and shoulder.  Denies any known trauma to area.  Has not sought medical attention.
Patient stated that after receiving the vaccine her arm felt hot, sore and became swollen.  Then she developed red splotches that were itchy.  This lasted about 72-96 hrs. and slowly resolved.
8 days p/vax pt ran a t101 over the weekend; 10 day p/vax had a rash across chest & groin area; pt was notified by mom;