chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extra dose of Pediarix; was supposed to get a flu vaccine; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 2-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number J953N, expiry date 11th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were provided as follows: Medical assistant reported that she accidentally administered a 2 year old an extra dose of Pediarix which led to extra dose administered.  Patient was supposed to get a flu vaccine but got the Pediarix which led to wrong vaccine administered. Consent to follow up granted.
Sx's 2 hours after injection: Left shoulder pain, headache, nausea, Left arm and neck pain. Patient had taken Advil Tylenol for pain.  Patient had Telehealth with PCP on 12/16/21 since sx's were not better. Rx: Vicodin and Medrol Dose pack.
Information has been received from a physician concerning a 10 year old male who on 01/02/2002 was vaccinated in the left arm with a first dose of hepatitis B virus vaccine rHBsAg(yeast). One week later, on approximately 01/09/2002, the patient developed lumps under the left armpit and a slight tremor in right hand when raised. The mother told the reporter that the swelling under the armpit lasted for one year. The patient was never brought into the office to be examined and there was never a specific visit for that issue. The physician stated that the child is "fine now". A product quality complaint was not involved. Additonal information has been requested.
Gave patient 2 shots and had sit in lobby. She fainted. Was unconscious for approx. 30 seconds then came back. She recovered quickly. No long term reaction noted.
My hair is thinning and falling out, my heart is beating differently, I?m more tired, my periods are longer and they keep changing start dates. My hair was healthy and grew with no problems until I got vaccinated. I also experience head aches and migraines daily
Symptoms started 01/07/21 I woke up with a lump on the right side of my jaw that is closing off half of my windpipe.  I also have a second lump on the back of my neck; both are tender to the touch. I had a fever of 101.3 yesterday and today it has gone between 102.6 and 103.6. I have full-body chills.
ADVERSE EVENTS: LOCAL SWELLING AT INJECTION SITE, DIFFUSE WELTS ESPECIALLY AROUND NECK AND UPPER BODY, REPORTED INCREASED PAIN AT INJECTION SITE WITHIN 15 MIN, CLAMMY HANDS AND FEET, TACKYCARDIA AND ELEVATED BP. TREATMENT: 02, CONTINUOUS MOINTORING OF VS, IV NS, SOLU-MEDROL AND BENADRYL INJECTION; EVALUATION BY MEDICAL PROVIDER. OUTCOME: PATIENT VS AND CONDITION STABLE WITHIN 25 HRS, PER MEDICAL PROVIDER NOT DEEMED NECESSARY TO TRANSPORT TO HOSPITAL.
Temperature: 10.3 C Time of excursion: 15 minutes with no reported adverse event; was the product administered to a patient? Yes with no adverse event; Initial information was received on 12-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and gender patient to whom IPV (VERO) [Ipol] was administered after temperature: 10.3 c time of excursion: 15 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Sep-2023, the patient received an unknown dose of suspect IPV (VERO) (Suspension for injection) (lot W1A191M, expiry date: 16-Feb-2025, strength: unknown) via unknown route in unknown administration site for Immunisation (poor quality product administered) (Latency: same day).  On an unknown date, temperature: 10.3 c time of excursion: 15 minutes with no reported adverse event (product storage error) (unknown latency).  This situation is due to human error. Reason: while moving the rack to accommodate the FLUZONE vaccines, and the not the data logger did not register it   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.
Admitted to  Medical Center w/ acute resp failure on 9/17/21. Worsening O2 requirements led to xfer to ICU on 9/21. Remain on high-flow  at this time (9/30/21)
Patient received HAVRIX vaccine and a few minutes later he lost consciousness and collapsed for a few seconds.
Mother called  office 8/6/20 to say that patient began having a bad headache, blurred vision and nausea the eve of August 5 a few hours after the injections were given.  Patient does have migraine headaches, however "this isn't the same feeling".  I called to check on child today, mom said that she hadn't seen her this morning because of parent work schedule, but the child was able to eat without nausea evening of 8/6/20,  and no further complaints of blurred vision. She did mention still having a headache and had been very tired.  No other complaints.  Reported per my request yesterday to family practitioner, who said it was an adverse reaction to vaccine.
Muscle ache, low fever (100.2), headache, weakness, some dizziness.
Administration site: Right leg; Major rash and swelling that started with shot and continued.; Major rash and swelling that started with shot and continued.; This is a spontaneous report from a contactable consumer, the patient. An 86-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 right leg on an unknown date in Mar2021 (at the age of 86-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure and diabetes. The patient had known allergies to procaine hydrochloride (NOVOCAINE). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified blood pressure and diabetes medicines from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient experienced major rash and swelling that started with shot and continued. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events major rash and swelling was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from another health professional refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. It was reported that on 03-SEP-2013, GARDASIL went out of range as it was exposed to 31.2 F for 6 hours. On 12-SEP-2013, the patient was administered with this improperly stored GARDASIL (route of administration unknown) for an unknown indication. Lot number was reported as H021861 with an expiration date of 09-OCT-2015. No adverse effects were reported. No further information was provided. This is one of 16 reports from the same reporter. Additional information has been requested.
Pt passed out after receiving vaccine.  Patient had gone to the restroom post vaccine and passed out.  Patient was given two glucose tablets and water.  Rested at pharmacy for 30 minutes and was fine.
Wife reports that patient went to see his cardiologist on 6/7/21 for a follow up to the aortic valve replacement on 10/1/20. He received a good report from the cardiologist and was going to be taken off Warfarin the following week. On the way home he complained of a headache and felt like it was sinus headache. When he got home he went to bed as the headache had worsened.  His wife assisted him up to the bathroom and back to bed and he went to sleep. She could hear him breathing from the other room. Later in the evening she became aware that she could not hear him breathing and upon checking on him she found him unresponsive, not breathing and he was blue in the face. She call 911 and they attempted to resuscitate him without success. Wife also reported that after the aortic valve replacement in 10/20, her husband went to the hospital with a fever and was diagnosed with covid and sepsis on 12/14/20. He was admitted and started on IV antibiotics and was hospitalized for 5 days. He had home health care coming into his home for 6 weeks of IV antibiotic therapy. He made a good recovery and was followed by an infectious disease doctor who put him on Amoxicillin po tid until the end of May. She states that he was doing very well physically and was playing golf, walking and felt better than he had in a long time.
I had been experiencing extreme joint point for several months and didn't know what was going on. I had seen my family doctor and they didn't know what was going on so I was referred to a Rheumatologist.  I had several test done and blood work. I was diagnosed with an auto immune  disease Psoriatic Arthritis. I am currently on medicine to help relieve my symptoms. I have had 27 shots in my joints to help allow me to move.
Rash began around 9PM on Sunday 5/6/18. Rash covered her back from one shoulder to the other.  Also developed rash on both legs. Rash caused itching. She took Diphenhydramine which helped with the itching. On Wednesday(5/10/18), rash still present on front shin of left leg. On Thursday (5/11/18), rash still present but not as red. Pt. also said she had a headache from Thursday 5/3/18 to Sunday 5/6/18.
This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), PRURITUS (itching), SWELLING (swelling) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient rceived first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness), PRURITUS (itching), SWELLING (swelling) and FATIGUE (fatigue). At the time of the report, ERYTHEMA (redness), PRURITUS (itching), SWELLING (swelling) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication details was reported. No treatment medication details was reported.
Child rec'd three vaccines on 2/23/04 ret'd to clinic 2 days later with swelling and redness (x2) arm with early cellulitis.
Diarrhea; Stomach hurt; Neck hurt; Shoulders hurt; Nausea; Very weak; Lethargic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Very weak), LETHARGY (Lethargic), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach hurt) and NECK PAIN (Neck hurt) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ASTHENIA (Very weak) and LETHARGY (Lethargic). On 09-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach hurt), NECK PAIN (Neck hurt), ARTHRALGIA (Shoulders hurt) and NAUSEA (Nausea). At the time of the report, ASTHENIA (Very weak), LETHARGY (Lethargic), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach hurt), NECK PAIN (Neck hurt), ARTHRALGIA (Shoulders hurt) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 83-year-old female subject who was vaccinated with Influenza vaccine (unspecified), manufacturer unspecified. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, site of injection and batch number). Two weeks after vaccination with Influenza vaccine (unspecified), the subject experienced anti-neutrophil cytoplasmic antibody positive vasculitis (myeloperoxidase) and microscopic polyangiitis. This case was assessed as medically serious by GSK. The subject was treated with cyclophosphamide and prednisone. At the time of reporting, the subject was in remission. This case is linked to 7 cases coming from the same publication.
THE MEDICAL ASSISTANT DID NOT VERIFY PT'S IDENTITY NOR THE CORRECT VACCINE. RETRAINING OF THE STAFF WILL BE IMPLEMENTED, TO ENSURE BETTER QUALITY AND CORRECT ADMINISTRATION IS DONE.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received treatment with Paxlovid. The patient had not taken any medication within two weeks.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
patient is saying he has left shoulder pain a year later after the flu shot.  We have documented that the flu shot was given in the right arm on the consent form.  We document immediately after administration.   Patient wants us to alter the consent form to say left arm as he mentioned it was on his tattoo arm.
3AUG93 to 6AUG pt felt warm to touch, had a mild infrequent cough was fussy & cried more than usual; had some inc crying & threw up p/APAP; pink dots appeared on the stomach & legs; t99.8 & irritable & viral rash;
Pt recvd vax 22SEP92 & w/in 1/2 hr of receiving vax pt exp spastic movements of arm followed by numbness & tingling from shoulder to fingertips; 15 to 20 mins later sc recurred; numbness spread from back of shoulder, down back & to waist;
Hives and swelling R thigh at inj site improved with BENADRYL.
Pt states that she had soreness at the injection and "all over" that day and night and it got worse the next day. She also complaned of chills and fever and abdominal cramping. She continues to have abdominal cramping with some nausea. Soreness has gone.
I experienced extreme fatigue within 24 hours of the shot. I didn't feel 'with it' and very irritable. I felt this way for about 4-days.
Developed shingles on the left side of my torso, 3 days following the COVID-19 vaccination.
Initially just tingling in fingers but as this went away a new sensation appeared in palm of my left hand. Sensation was sometimes minimal but also at times was rather painful and was felt up into the forearm. Sensation/pain persisted and led me to see my doctor (Jul 26). Hand also X-rayed that same day but no breaks of fractures identified. Referred to neurologist.
I had tingling and tightness in my face from my sinuses to my chin that lasted 30-45 minutes. It didn't seem as bad as the first time after the first dose. I also wasn't as worried the second time because it went away the first time and maybe that's why. For the next two days after that I was really sick in bed with terrible nausea and just stayed in bed and couldn't really get out of bed.
Rt. upper leg has a 1 cm red raised area with blister-like bumps around it. No fever. No increase warmth to area.
OnMonday 6/13/22, I woke up from a nap around 4pm with severe itchiness R side of neck. I looked in mirror and saw 3 small red bumps on side of neck about one inch apart in straight line. I thought a bug bit me. The next few days my skin itched badly and noticed another red bump about 4 inches away. By Thursday of that week, my right side of chin, neck spot on right forehead and few spots were visible on R  upper chest with blisters weeping, severe itchiness. I thought it was poison ivy. I had it 20 years ago, but nothing since. I applied hydrocortisone cream for the itch.I had no pain, just discomfort, and headache all week.  By Friday evening I was very uncomfortable. The rash was in some clusters, reddened and some weeping of fluids. I followed up with my neurologist on Monday 6/20/22.  I have shingles. Started me on Acyclovir 800mg 2 times a day. Prednisone 60 mg for 3 day, then 40 mg for 3 days, then 20 mg for 3 days. I began the antiviral med on6/20/22 at 4pm and Prednisone 60 mg on 6/21/22 at 1pm. I noticed a few hives are now on my left lower chin, one on left neck. Itchiness is better, but reddness persists with welts appearing
High fever, chills, body aches, Tremendous leg pain and discoloration (purple), Passed out, vomited, nausea, migraine, loss of feeling in right thumb.
RAPID HEART RATE; HEADACHE; MUSCLE ACHE; FEVER; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, allergy to polyethylene glycol (peg), and thermerisol allergy, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. the patient had no medical history.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: 06-JUN-2021) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced rapid heart rate. On 28-APR-2021, the subject experienced headache. On 28-APR-2021, the subject experienced muscle ache. On 28-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rapid heart rate, headache, muscle ache, and fever. This report was non-serious.
Patient received V-vax booster on 8/16/07. Next day reported redness, swelling and itching at site. Tylenol/ Motrin as needed pain relief. Benadryl as needed itch, swelling.
tinnitus, hypercussis, loss of hearing, fullness in ear, fever, chills.  tinnitus symptoms still there over a month later
ring in ears; headache; nausea; soreness; fatigue; shaking; breathing problems; painful needle-like ear-aches; rib and chest pain; rib and chest pain; unable to sleep; BOOSTER; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Nov2021 10:00 (Lot number: 3203080) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Intramuscular, lot#EW0164, expiry date: Aug2021), administration date: 14Apr2021, when the patient was 58 years old, for COVID-19 immunisation, reaction(s): "Ear pain", "Dizziness", "Chills", "Fever", "Soreness", "Haemoptysis", "Dyspnoea", "Tremor", "Headache", "Nausea", "Chest pain"; Comirnaty (Dose 2, Intramuscular, lot#EW0179), administration date: 05May2021, when the patient was 58 years old, for COVID-19 immunisation, reaction(s): "Ear pain", "Histamine level increased", "Dizziness", "Chills", "Fever", "Soreness", "Haemoptysis", "Dyspnoea", "Tremor", "Headache", "Nausea", "Chest pain", "Malaise", "Skin fissures", "Chapped lips". The following information was reported: On 06Nov2021, after 3rd jab of Pfizer patient experienced ringing in ears/headache within 24hrs and proceeded by nausea, soreness, fatigue, shaking, and breathing problems. Very painful needle-like ear-aches and extreme headaches. Rib and chest pain within 48 hrs and lasted approx. 27 days. unable to sleep due to standing position being only tolerable one. Seriousness Criteria for events: Important medical event. Treatment was not received for all events. The outcome of events was Recovering.   No follow-up attempts are possible. No further information is expected.
On May 17, 2022 I traveled for business, the company used a bus to transport us around the city for meetings, dinners, lunch, etc. Late afternoon on Wednesday, May 18, 2022, I started to feel off by Thursday morning May 19, 2022 I felt bad but couldn't put a finger on it. I started my drive back home that day, I had to stop to spend the night. By Friday I went to work on Friday, I could not think so I left early and came home. I took a home COVID-19 test on Saturday that come back positive extremely fast. I went to the emergency room right after I tested positive to make sure it had not gotten into my lungs. They did a chest x-ray and gave me an oximeter. Saturday, May 28, 2022 I took a home COVID-19 Test that came back negative.
This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender.. No information regarding patients' concurrent conditions, medical history and concomitant therapies was reported. Since 09-DEC-2016, those patients received improperly stored doses of PROQUAD (rHA) (dose and route of administration were not provided) lot#M029595, expiration date: 10-DEC-2018. Sterile diluent (manufacturer unknown) (lot# and expiration date were not provided) was used to reconstitute the vaccine. No adverse effects were reported. Time frames for the temperature excursions were as listed: - 6 degrees Fahrenheit (F) to 14 degrees F for 1,203 hours, - 15 to 46 degrees F for 5 hours. There was no previous temperature excursions. Additional information has been requested.; Sender's Comments: US-009507513-1704USA006388:
There was no adverse reaction. Pt came in with Moderna for 1st and 2nd dose at 2:25pm on Jan 5, 2022. Pt was given Moderna for Booster with consent from father , but was too early to receive booster due to age of 16yrs old.  Pt and father was made aware. Pt was observed for 15mins. No signs or symptoms. Pt was okay to leave.