chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No adverse event) in a 33-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (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 assessment was provided for ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose).    Concomitant medications were not reported.  It was reported that 19 patients received half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022 and 06-Oct-2022.  For the past month, the reporter had been giving 0.25 ml dose instead of 0.5 ml dose of bivalent vaccine.  Treatment information was not reported.
Fluzone HD QIV was administered to 5 years old patient with no reported 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 is linked to cases 2023SA317318 and 2023SA317312.  This case involves a 5 years old male patient who was administered with influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Oct-2023, the patient received a 0.7 ml, once dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (lot U8138CA, expiry date: 30-Jun-2024, strength: standard) via intramuscular route in the left deltoid  for Immunization (product administered to patient of inappropriate age) (Latency: same day).  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 and Regulatory Authority 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.
SEVERE PERSISTENT MIGRAINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced severe persistent migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe persistent migraine was not reported. This report was non-serious.
This case was reported by a healthcare professional and described the occurrence of hepatitis B antibody negative in an adult female subject of unspecified age who was vaccinated with ENGERIX B. There were no concurrent medications. The subject had no relevant medical history and experienced no adverse events following previous vaccinations. The subject had an unclear vaccination history. On an unspecified date the subject received 2nd dose of ENGERIX B (20 mcg, unknown, unknown deltoid). A titer was drawn following the 2nd dose because the subject was stuck by a dirty instrument, The titer following the 2nd dose was negative. The reporter did not know exact time frame around the doses given or when the titer had been drawn. At the time of reporting the outcome of the event was unspecified.
Fatigue; Nausea; didn't sleep very well; lot of pressure on her chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 18 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 14:00 (Lot number: FD8448) at the age of 18 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mild gastritis", start date: Nov2020 (ongoing), notes: Verbatim: Mild gastritis. Concomitant medication(s) included: PROTONIX [OMEPRAZOLE] taken for gastritis. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 13Aug2021, outcome "recovering", described as "lot of pressure on her chest"; FATIGUE (non-serious) with onset 14Aug2021, outcome "not recovered", described as "Fatigue"; NAUSEA (non-serious) with onset 13Aug2021, outcome "recovering", described as "Nausea"; SLEEP DISORDER (non-serious) with onset 13Aug2021, outcome "unknown", described as "didn't sleep very well". The events "lot of pressure on her chest", "fatigue", "nausea" and "didn't sleep very well" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient did not visit to Emergency Room.  Follow-up attempts are completed. No further information is expected.
This non-serious listed case involves use of a cluster of two, (identical twins) out of two vaccinees who had received DAPTACEL, lot number C4050AA. Information regarding the other patient is captured in non-serious case number 2012-06012. Documents held by sender: None. Follow up information received on 28 June 2012: It was reported that the patient had no known drug allergy and had apnea of prematurity. The weight of the patient at the time of report was reported as 4 pounds and 5 ounces. The time of vaccination of dose one of DAPTACEL was reported as 3:18 pm. The patient had received subcutaneous dose of IPOL (lot number: H1305, on right thigh on 18 May 2012 and intramuscular dose of PREVNAR 13 (lot number: F88044, on left thigh on 25 May 2012. The patient's concomitant medications included caffeine citrate.
Patient flushed, dizzy - left ear flushed.  Patient felt very hot, then chills.
Positive chills; left arm healing smallpox wound to upper humeral area; tenderness.
inadvertently administered 2 FLUZONE QUADRIVALENT vaccines instead of a PENTACEL with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from Physician via Medical Information (Reference number- 00786914) and transmitted to Sanofi on 27-Sep-2021.  This case involves an unknown demographic patient who received 2 doses of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] inadvertently (lot number and expiry date not reported) via unknown route at an unknown administration site on an unknown date for prophylactic vaccination (extra dose administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to extra dose administered (latency was on same day).  It was reported "Sales rep states the he was told by Dr that she intended to administer a FLUZONE QUADRIVALENT and a PENTACEL vaccine, but inadvertently administered 2 FLUZONE QUADRIVALENT vaccines instead."  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.  There will be no information available on batch number for this case.
My father received both the Pfizer booster (#5 shot which was the annual booster that was promoted as good for a year).  He was given this booster in the arm.  At the same time, he received the annual flu vaccine.  Two weeks later, my Dad had multiple strokes on 9/23/2022.  After strokes lead to him being bed-bound and paralysis on his left side.  He eventually died on 2/14/2023.  Immediately after the strokes, he was hospitalized for two (3) months straight, with a brief period on rehab, then ICU, then into hospice.   After being in for two months (while being hospitalized at hospital, he was transported.  He was hospitalized at Hospital.  He died in Hospice Care at Hospital
Type 1 Diabetes. This was his diagnosis date, but I found out later he had been experiencing symptoms since the GARDASIL Vaccine.
large red tender spot on left arm from 12 hours after vaccine (still continuing), fatigue, chills, weakness, body aches, severe headache from 20 hours until 38 hours after vaccine
03/23/21 -sore arm  -body aches -headaches  -weakness -fatigue  -chills   7:00pm  -102.5 fever  -rash surrounding injection site  -slight swollen armpit  -cold sweats  -headaches -body aches  03/24/21 -101 fever -body aches -chills -cold sweats
Patient called and reported that she was having body aches in half of her body.  She reported no rash, itch, or any swelling/inflammation.  Patient was counseled that these were side effects that can happen and the reaction after the second dose can be stronger.  Was counseled she could take some Tylenol or ibuprofen and if aches are not going away or getting worse to contact doctor.
Overwhelming exhaustion; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6206), via an unspecified route administration in the left arm on 08Mar2021 at 16:30 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure and obesity. Concomitant medications included multivitamin, simvastatin (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN), both for an unknown indication from an unknown date. Patient reported that he had known allergy penicillin, erythromycin, gluten sensitivity. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced overwhelming exhaustion, dizziness on 08Mar2021 at 19:15 (three hours after the vaccination). The patient reported that he was remained very tired for at least 24 hours longer. Therapeutic measures were not taken for the event. The clinical outcome of the exhaustion and dizziness was recovered on 08Mar2021.  No follow-up attempts are needed. No further information is expected.
all over itchiness, no rash or bumps, intermittently itchy all over body when L arm is itchy, a mosquito bite size bump appears but subsides within 30 minutes after itching area
Pt c/o knot to left deltoid after receiving tetanus shot. Since then has been complaining of pain and edema in left arm. Patient has had an MRI and U/S of arm with no significant findings.
it was hurting so bad she can hardly move it; big swollen node in her left arm (injection site); it was hurting so bad she can hardly move it; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (it was hurting so bad she can hardly move it), VACCINATION SITE LYMPHADENOPATHY (big swollen node in her left arm (injection site)) and VACCINATION SITE PAIN (it was hurting so bad she can hardly move it) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 26-Sep-2022, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (it was hurting so bad she can hardly move it), VACCINATION SITE LYMPHADENOPATHY (big swollen node in her left arm (injection site)) and VACCINATION SITE PAIN (it was hurting so bad she can hardly move it). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (it was hurting so bad she can hardly move it), VACCINATION SITE LYMPHADENOPATHY (big swollen node in her left arm (injection site)) and VACCINATION SITE PAIN (it was hurting so bad she can hardly move it) had not resolved.            Concomitant medications included blood pressure medications. Patient had no allergies to medications, food and other products. Patient never had COVID positive test or diagnosis. Patient had no history relating to adverse event and had no acute and chronic illnesses at the time of vaccination. Patient received first two doses on an unknown date (lot number and expiration date- unknown). Patient did not seek any medical care. Patient stated she did not experience any side effects with previous doses of the vaccine. No treatment was given.
Covid vaccines given on:(Pfizer 2/18/21, 3//7/21, 9/22/21 and Moderna 2/15/22 Each vaccine has caused fever for 3-4 days, High of 104.6, body aches, eye pain, joint pain, headaches, extreme thirst, gastro bubbles.  I drank a lot of water, took tylenol, cool head compresses, showered when it was staying at 104.6,  From what I can tell, my reactions are much stronger and longer than other people. I assume it's because of my auto-immune disease.
her arm was hurting and still continues to hurt; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 08Mar2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknown date for COVID-19 immunisation. On an unspecified date in 2021, a couple days later patient arm was hurting and still continues to hurt when the air hits, like the air conditioning. Consumer stated that she has an old scar on her arm where nobody usually gives her a shot in there, but the nurse gave the second shot of the Pfizer COVID-19 Vaccine in there and she can see where the needle went in. Consumer stated that she put alcohol on it, "I don't think that would hurt". Caller added that it does not hurt all the time, only when she was close to an air conditioning. She did not have any medical condition. Consumer asked if it was okay that the vaccination provider administered the shot in that scar. The outcome of event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101064375 same reporter/vaccine/AE different patient.
Excessive crying irritability, no eating x 6 hrs before calling office.  Appt scheduled immediately.
Shoulder is really red; Shoulder is real hot; Kind of itchy on her right shoulder; Shoulder has a Hump on it and look like it is swollen; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Shoulder is really red), BURNING SENSATION (Shoulder is real hot), PRURITUS (Kind of itchy on her right shoulder) and SWELLING (Shoulder has a Hump on it and look like it is swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061B22A) for COVID-19 prophylaxis.     No Medical History information was reported.  Concomitant products included GABAPENTIN and CELECOXIB (CELEBREX) for an unknown indication.    On 15-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2022, the patient experienced ERYTHEMA (Shoulder is really red), BURNING SENSATION (Shoulder is real hot), PRURITUS (Kind of itchy on her right shoulder) and SWELLING (Shoulder has a Hump on it and look like it is swollen). At the time of the report, ERYTHEMA (Shoulder is really red), BURNING SENSATION (Shoulder is real hot), PRURITUS (Kind of itchy on her right shoulder) and SWELLING (Shoulder has a Hump on it and look like it is swollen) outcome was unknown.            Concomitant medication include 2 pain pills at 10 mg.  The dose patient received on 15-Aug-2022 was first booster dose.  Patient did not took any medication for side effects.
After the vaccination, I started noticing muscle spasms at night, waking up with tightness, and twitches frequently.   I started having chest pains that became chronic.  After a well visit with my NP, we attributed it to stress and anxiety although my BP was higher than normal.  I started an anxiety medication but it did not help.  I started monitoring my BP only to show readings that were very concerning.  I contacted my doctor and made an emergency appointment.  She started me on some BP meds; her initial thought was I had had Covid.  I was tested for antibodies but came back negative.  I should note that I had not been sick prior to this and no one else in my family had Covid.  I went for two more rounds of bloodwork, which all came back fine.  An EKG and chest Xray also came back fine.  I started on more meds to help manage BP, eventually changing one of them because of negative side effects.  My doctor suspected the vaccine caused a Covid-like response in me.  This has also happened to 5 of my colleagues.
Pt.'s girlfriend states that after receiving the 1st dose of J&J 06/07/2021, started experiencing symptoms 06/14/2021 of soreness of the arm, radiating arm pain, pain in the leg/hip, and difficulty lifting left arm. Primary visit 06/27/2021 with Recommendations of further testing. Still continuing to have symptoms. Cervical Spine X-Ray, Shoulder X-Ray, and Left Femur performed 06/29/2021. No noted fractures. Degenerate change in the noted joints.  Neurologist appt. scheduled (MRI cervical spine-without contrast)
Lightheadness and nose began to run. Last night had problems breathing, nose severly stuffed up, sore throat started, fever and headache.  Throat, nose, and headache continue today along with eyes watering (1/07/10).
pt w/developmental delay, speech delay & past hx of Henoch-Schonlein purpura APR91 recvd vax 6OCT; mom reported purpura lesions;
10/6/12-10/7/12 Abdominal pain. 10/8/12 Migraine. 10/9/12 Fatigue. 10/10/12 Chest pain (L) arm tingling to ED. Potassium 3.5. 10/11/12 Everything hurt on her body. 10/12/12 Nerve pain. 10/15/12 Shooting nerve pain both arms. 10/16/12 Chest pain slight & tingling arms.
13:20 received IM injection of fluzone. 13:25 pt told husband she was going to pass out. 13:30 pt not responsive to sternal rub to floor legs in air, pt then responded. A and O x3, pt flushed. 13:35 pt sitting up, nausea noted. 13:37 transferred to stretcher, BP 156/90. 14:00 pt sitting up. 14:04 DC'd ambulatory. Refused wheelchair. Instructed to call PCP.
Mother reports patient had hives scattered throughout body, was pale and clammy. Patient responded well to oral Benadryl.
1/20/00, 7 days post vaccination, pt c/o rash to body for 2 days.  Has fine m/p rash from head to toe.  Little pruritus, Temperature of 99.4.  Returned 1/21/00 with bilateral knee pain, no heat or edema.  Tx with Anaprox and Zyrtec.
Dizziness; Fatigue; Achy all over; fever; Chills; Nauseated; This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 4SN3Y, expiry date 21st January 2022) and (batch number 4F7B4, expiry date 15th January 2021) for prophylaxis.   On 18th September 2019, the patient received Shingrix. On an unknown date, the dose was an unknown dose. In September 2019, less than 2 weeks after receiving Shingrix, the patient experienced dizziness, fatigue, general body pain, fever, chills and nausea. On an unknown date, the outcome of the dizziness, fatigue, general body pain, fever, chills and nausea were unknown.   It was unknown if the reporter considered the dizziness, fatigue, general body pain, fever, chills and nausea to be related to Shingrix.  Additional details were provided as follows: The reporter asked any information on this type of reaction lasting 12 days. The health care professional stated the patient experience dizziness, fatigued, achy all over, fever, chills, nauseated. The adverse event was collected The reporter consented to follow up.
Initial misuse report received on 07 October 2013 from a health care professional. A 66 year old patient, whose medical history and concomitant medications were not reported, received a intradermal dose of FLUZONE ID (lot number and expiry date was not reported). It was reported that the patient whose age was 66 years, which falls outside the products indication was given the vaccine. No reaction was reported. List of documents held by sender: none.
mild muscle aches; fatigue; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (mild muscle aches) and FATIGUE (fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 MYALGIA (mild muscle aches) and FATIGUE (fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MYALGIA (mild muscle aches) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Started having lightheadedness and dizziness and nausea on 7/11/03. Little non-itchy, non red bumps appeared on 7/15/03. Began yellow (light stool color) on 7/18/03. Pt referred to her Dr for f/u to R/o WNV and for f/u care and management.