chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4-month old patient was accidentally given Fluzone Quadrivalent WIth no reported adverse event; Initial information received on 10-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves a 4 months old female patient who was accidentally given fluzone quadrivalent with no reported adverse event while receiving vaccine influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR).  On 10-Nov-2022, the patient received a dose of suspect influenza quadrival A-B vaccine Suspension for injection at a dose of 0.5 ml with lot UT7683KA and expiry date- 30-Jun-2023 via unknown route in unknown administration site for influenza.  On 10-Nov-2022, 4-month old patient was accidentally given fluzone quadrivalent with no reported adverse event (product use issue) following the administration of influenza quadrival A-B vaccine (latency unknown).  Action taken: not applicable  It was not reported if the patient received a corrective treatment for the event   Outcome: Unknown   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 guidelines. 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.
Received call mom stated that child woke up with Wheals on stomach, arms, legs, hands and one on face. Received 2nd HepA yesterday. no reaction to previous dose. Mom states child acting fine. Denies any wheezing, SOB, or respirations. Consulted with RN who administered Benadryl Elixir. T.C. back to mom, instructed to given Benadryl Elixir. Advised if no improvements, symp worsen, or more severe to go to Dr or ER mom agrees
extreme tenderness; extreme swelling; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (extreme tenderness), SWELLING (extreme swelling) and VACCINATION SITE PAIN (pain at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007-M20A and 023-M20A) for COVID-19 vaccination.     The patient's past medical history included Lymphadenectomy. Concurrent medical conditions included Cancer, Hypertension, Diabetes and Cholesterol. Concomitant products included LETROZOLE for Cancer, ROSUVASTATIN for Cholesterol, GLIMEPIRIDE for Diabetes, CARVEDILOL for Heart rate abnormal, CHLORTHALIDONE for Hypertension.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced TENDERNESS (extreme tenderness), SWELLING (extreme swelling) and VACCINATION SITE PAIN (pain at injection site). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency. On 14-Mar-2021, TENDERNESS (extreme tenderness), SWELLING (extreme swelling) and VACCINATION SITE PAIN (pain at injection site) had resolved. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-096459 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-096459:Second dose case
Patient received Moderna COVID-19 vaccine instead of Pfizer COVID-19 vaccine for his second dose. Patient was informed of the error and was told next steps and was promised a follow-up phone call from the Doctor in charge of the vaccination efforts).
Chickenpox looking red bumps all over body, stomach, back, neck, armpits, and face. Fever of 102.5.
A spot on left hand that looks like bleeding under the skin; blood under the nail of left hand; A spontaneous report was received from a consumer concerning a 71-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a spot on left hand that looks like bleeding under the skin (Bleeding spot subcutaneous) and blood under the nail of left hand (Subungual hematoma).  The patient's medical history include Blood Pressure and Cholesterol issues. Products known to have been used by the patient, within two weeks prior to the event, included unspecified blood pressure and cholesterol medications.  On 04 Mar 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 05 Mar 2021, the patient noticed blood under the nail of the left hand.   On 15 Mar 2021, the patient noticed a spot on his left hand that looked like bleeding under the skin. The second dose of mRNA-1273 shot is scheduled for 01-Apr-2021.  No treatment information was provided.  Action taken with mRNA-1273  due to the events was unknown.  The outcome of events, a spot on left hand that looks like bleeding under the skin and blood under the nail of left hand was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Vomited for two days. Muscular aches. Migraine for 3 days. Joint pain. Very tired. Didn't feel "normal" for a week.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L017146, expiration date 13-MAY-2017, exact doses and route of administration were not reported). The vaccines were exposed to temperature of 8.1F for 30 minutes. Previous temperature excursion was reported and doses reached then 8.6F for 30 minutes (date was not provided). No adverse events were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
SLIGHT SORENESS AT THE INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry : UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included vedolizumab for ulcerative colitis. On an unspecified date, the subject experienced slight soreness at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slight soreness at the injection site was not reported. This report was non-serious.
Terrible myalgia & tight muscles in left leg, making it hard to sleep for several nights. It has been worse at night or when my leg is straight; a little of same in right leg. Also some tingling in my leg down to my toes, and a few tingling spells on left side of face.  Also stabbing pains? once in top of left foot & once in side of left leg. Treatment: ice packs and heating pad;  a few doses of naproxen & acetaminophen which didn?t really help.  It has been 2 weeks since my 2nd vaccination & I am still experiencing these side effects although they have lessened.
Thirty seconds after receiving vax, pt noted to be sneezing a lot. His eyes became red and swollen with swelling of the face. This was followed by respiratory distress and wheezing. Pulse oximetry was 96% on room air. Pt given epinephrine, Benadryl, and Prelone. He was also given Albuterol nebulizer treatment.
I have COVID. I have done all the shots and boosters. I am coughing, runny nose. I am on paxlovid. Is this normal; I have COVID. I have done all the shots and boosters. I am coughing, runny nose. I am on paxlovid. Is this normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have COVID. I have done all the shots and boosters. I am coughing, runny nose. I am on paxlovid. Is this normal". Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid. Clinical course: Reporter had COVID. Reporter had done all the shots and boosters.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300288281 Same patient, different drug/AE;
10 hours after vaccination at place of employment, patient experienced rigors, fever of 101 degrees, dizziness, fatigue, myalgias, and shortness of breath. Patient's symptoms resolved two days after vaccination, self-administration of acetaminophen, and plenty of sleep.
Aching in arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR105288   Additional Information: GSK Receipt Date: 10-JUL-2022 Reporter's comment:This case was reported by a patient via interactive digital media. The patient received 2 doses of shingles vaccine. Both the doses were month apart. Patient would not ever forgot aching in arm which lasted for days. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105288:Same reporter
Facial numbness on right side Extremely sore joints in the neck, arms, hands, legs, feet Headache Fever
History (no PII): HPI: 21 y/o F HX of vasovagal syncopial episode approximately 3 minutes s/p J&J vaccination.  PT was in sitting position and did not sustain a fall or trauma during this time.  PT began to lose consciousness and was unresponsive < 10 seconds.  Airway, breathing and pulse were intact. Vitals given above.  PT was laid down, feet elevated, alcohol swab placed under her nose to assist in revival.  PT returned to a responsive state and was aware of place, day and situation.  PT was able to reiterate the situation prior to the syncopial episode.  PT stated this is something she has experienced in the past.  PT denies any other medical issues. PT stated she had not eaten anything at all earlier in the day.    Medications administered:  None. PT given water and lollipop (sugar)   Disposition:  Transfer of care to EMS secondary to loss of consciousness < 10 seconds.  PT was not transferred to hospital, PT signed AMA.  PT had friend pick her up and take her home.  PT was A&OX4, gait stable.  PT expressed that she was no longer feeling any of the symptoms that she had at the time of the syncopial episode.
p/recv vax pt exp fever, malaise & generalized myalgia, localized erythema & edema devel. symptoms worsened 1/16 & 1/17/97, starting feeling better 1/21/97
Started with nausea (recipient vomited after the 1st dose on 4/8/21). Reported "spaced out" feeling and pain on left side of neck.  Progressed into a headache.
Severe  arm soreness, unable to lift or touch arm without severe pain. Dizzy spells accompanied with ?brain zaps?. Nausea. Fatigue
About 1 hr after vaccination patient felt sick to her stomach, chills, and shooting pain in head. All symptoms she had with an active case of shingles previously. Took 3 days for symptoms to resolve completely.
Bones and Muscles have been affected; Bones and Muscles have been affected; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISORDER (Bones and Muscles have been affected) and BONE DISORDER (Bones and Muscles have been affected) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE DISORDER (Bones and Muscles have been affected) and BONE DISORDER (Bones and Muscles have been affected). At the time of the report, MUSCLE DISORDER (Bones and Muscles have been affected) and BONE DISORDER (Bones and Muscles have been affected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was 50 something years old.  Patient was healthy.  No concomitant medications were reported.  Patient said that she had Moderna vaccine and after that her bones and muscles had been affected. It was scary.  Patient was walking with a cane and was half her weight. Patient was skinny already.   No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Moderna was stored in the fridge on 17Aug2022 and beyond use date was on 17Sept2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Moderna was stored in the fridge on 17Aug2022 and beyond use date was on 17Sept2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 053B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Nov-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna was stored in the fridge on 17Aug2022 and beyond use date was on 17Sept2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Moderna was stored in the fridge on 17Aug2022 and beyond use date was on 17Sept2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Moderna was stored in the fridge on 17Aug2022 and beyond use date was on 17Sept2022).    No concomitant medications were reported.  It was reported the Moderna vaccine was stored in the fridge on 17-Aug-2022 and beyond use date was on 17-Sep-2022. Individual vials or unbroken cartons was 2 vials. The product was expired on 24-NOV-2022.  It was reported Vial size 5.5 mL with 10-dose vials.  The vial did not undergo any temperature excursions.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-679876 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-679876:Case for patient who received dose on 28Nov2022
HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge, 2 patients on 9FEB2022 ( 1 booster and 1 primary dose )./ vaccine 3 days after use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge, 2 patients on 9FEB2022 ( 1 booster and 1 primary dose )./ vaccine 3 days after use by date) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2022 at 3:06 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge, 2 patients on 9FEB2022 ( 1 booster and 1 primary dose )./ vaccine 3 days after use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge, 2 patients on 9FEB2022 ( 1 booster and 1 primary dose )./ vaccine 3 days after use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided. HCP called to ask about a box of vials that they received on 7JAN2022. There is one vial who was been administered after 30 days on fridge (30 days were on 6FEB2022). The LOT NUMBER of that vial was 022J21A and they administered a Moderna COVID-19 vaccine to 5 patients. HCP stated that she don´t have the Personal information of those patients. The vaccines were administered in the pharmacy: 3 patients on 10FEB2022 (1 Booster dose and 2 primary doses) and 2 patients on 9FEB2022 ( 1 booster and 1 primary dose ). The expiration date of the vial affected is 24APR2022. On 10FEB2022 the patients received the vaccine one hours after first puncture and on 9FEB2022 the patients received the vaccine almost 3 hours since the first punctured. HCP stated that there is no temperature excursion during the administration of that vial ( the vials were in the fridge).   This case was linked to MOD-2022-480636 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Feb-2022: Follow up received contains Non significant information. Fax no. updated. On 01-Mar-2022: Report type changed from invalid to spontaneous, drug start date and details, patient and reporter details and event start date updated.
Information has been received from a registered nurse concerning a 61 year old female who on 23-MAR-2007 was vaccinated SC with a 0.5 ml dose of Zostavax. It was noted that the patient was vaccinated by a retired nurse. The patient experienced pain at the injection site. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Patient had flu shot on Fri 10/4, came in today, has been to the Dr and had a red line (they think infection) appear on his hip. Dr gave injection of ROCEPHIN and measured for growth.
Pt recv vax on 12/8/98; on 12/16/98 pt exp tight bronchi, body aches, muscular aches in hips, thighs, back to 12/19; fever x 2 day; cough to 12/31; tx= acupuncture
Stroke on 07/192021 at ~05:30am of unknown cause.  Rushed by ambulance to hospital ()   Was in hospital for 3 days and was administered many tests.  Please contact Hospital for detailed records
Sore arm day of, continuing into day two. Woke at 9am day 2 feeling very achy and tired but with an upset stomach and shortly after vomited. He has a fever of around 101 and still has all other symptoms but stomach ache & nausea has subsided.
This was unwitnessed by medical professional and not followed up via appointment by mother.  Mom and Dad both state that after 2mos shots pt had "seizure" activity without fever.  2-3 short episodes that parents found very concerning.  Resulted in delay of subsequent vaccines until age 5.
COVID-19 Treatment; COVID-19 Treatment; Pfizer / BioNTech dose number=4; Pfizer / BioNTech dose number=4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "Psoriatic Arthritis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: COSENTYX; AIMOVIG. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed, Manufacturer unknown), for Covid-19 immunization. The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 19Jan2022, outcome "unknown" and all described as "Pfizer / BioNTech dose number=4"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt was vaccinated then about 7 minutes was taken to lab for HLT.  Upon arriving at the lab it was noted that child had a red welt on the Rt lower thigh where MMR vaccine was given.  Pt given 1 tsp of PALGIC.  Welt was 2cm in size.  After waiting 20 min pt was seen by Dr. welt had decreased in size and no other problems noted.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "headache". Additional information: The patient experienced minor side effects such as headache after receiving the Pfizer BioNTech vaccine which resolved after few days. The patient would like to know if they can get another booster dose on March. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.