chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RN that was calling to report temperature excursion that was intermittent beginning 7/28/2020, but not previously reported, involving PROQUAD states that there have been administered doses.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  It was reported that temperature excursion was intermittent beginning 28-AUG-2020, but not previously reported, involving Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD).   On 11-AUG-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S031882 with expiration date of 07-APR-2021, 0.5 milliliter, for   It was stated that the vaccines underwent a temperature excursion of -14 degrees Celsius (°C) to -10 °C (max -9.5°C) for a total of 38 hours and 30 minutes. No previous temperature excursion occurred. The call was because of a "data logger".  ; Sender's Comments:  US-009507513-2008USA014788:
patient came looking for Covid vaccine. Patient was informed pharmacy only carries Moderna booster.  Patient confirmed this was the vaccine needed.  After administration, patient said this was the first covid vaccine they had received.  Booster was given in error
medication error due to temperature excursion that exceeded the stability data  and administered to patient with no reported adverse event; medication error due to temperature excursion that exceeded the stability data  and administered to patient with no reported adverse event; Initial information received from on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 42 years old and unknown gender patient and reporter stated that there was a medication error due to temperature excursion that exceeded the stability data  and administered to patient with no reported adverse involving 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 DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TENIVAC). It was reported regarding a medication error due to temperature excursion that exceeded the stability data and administered to patient with no reported adverse event (product storage error) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On 22-Sep-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (strength, formulation was unknown, lot UJ899AA and expiry date: 30-Jun-2023) via unknown route in unknown administration site for Immunization.  On 22-Sep-2022 the patient developed a non-serious event of medication error due to temperature excursion that exceeded the stability data and administered to patient with no reported adverse event (poor quality product administered) (Latency: same day)following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken : not applicable.  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 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.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75-year-old male patient received BNT162b2, on 24Sep2021 as dose 3 (booster), single (Lot number: 301308A), in left arm and on 31May2022 as dose 4 (booster), single (Lot number: FN2g0B) at the age of 75 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), 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) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: COVID-19 Treatment (Treatment of COVID-19) with Paxlovid treatment start date on 01Oct2022 to treatment stop date on 05Oct2022.
patient ended up in the hospital from an allergic reaction; Initial information was received on 11-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-healthcare professional (patient) via social media.   This case involves a patient of unknown age and gender who ended up in the hospital from an allergic reaction (hypersensitivity), after patient receiving INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced an allergic reaction (hypersensitivity), (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event (seriousness).  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  Information on the batch number was requested for this case.; Sender's Comments: This case concerns a patient of unknown age who presented with allergic reaction (latency: unknown) after vaccination with INFLUENZA VACCINE. The time to onset is compatible. There is, however, no information regarding patient's condition at time of vaccination, history and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
A non-serious spontaneous report of body aches, fever, sore throat, and vomiting has been received from a nurse practitioner concerning a 19-year-old female subsequent to H1N1. The patient's medical history and concomitant medications were not provided. The patient received H1N1 (date not provided). On 22-Oct-2009, the patient experienced "reactogenic effects including fever, body aches, sore throat and vomiting from the administration of the H1N1 Mist vaccine". The reporter indicated "some of the reactogenic effects continue". The outcome of each event was not provided.
This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Severe Pain in the neck; Severe Pain in the neck; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Severe Pain in the neck), PAIN IN EXTREMITY (sore arm) and ARTHRALGIA (Severe Pain in the neck) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 19-Apr-2021, the patient experienced NECK PAIN (Severe Pain in the neck) and ARTHRALGIA (Severe Pain in the neck). On 10-Apr-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, NECK PAIN (Severe Pain in the neck) and ARTHRALGIA (Severe Pain in the neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-092524 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092524:Cross linked case
This spontaneous report as received from healthcare worker refers to an unknown number of patients of unknown age and gender. The healthcare worker reported that the unknown number of patients might had received with a dose of RECOMBIVAX HB (lot#, expiration date, dose and strength not reported) that was exposed to a high temperature of 47 degrees F., 7 different times since January 2014, 5 minutes for each excursion, for a total of 35 minutes. No adverse effect reported. It was unspecified if the patient sought medical attention. This is one of four reports received from the same source. Additional information has been requested.
Woke with fever. Fever all day. Maxed out at 102.2. Chills. Took 2 Extra Strength Tylenol every 6 hours. Slept MANY hours.  Woke the next morning feeling fine, just a little tired. No fever.
Information has been received from a registered nurse concerning a 29 year old female with no past medical history of allergies who in 1995 was vaccinated with two doses of varicella virus vaccine live. On 05/04/2001, the pt experienced loss of effect when a serum varicella zoster virus antibody test revealed a negative titer. The pt sought medical attention. Additional information has been requested.
On July 19 I woke up at 2 AM with severe pain on my left shoulder right on the injection site. The pain was so much that I was unable to lift my arm.  My arm felt numb and heavy. I lasted with the pain for about 3 weeks before I decided to go to the hospital. I was taken by my wife to hospital. Where I was told I've had multiple strokes, I had High Blood Pressure, and had a blood clog in my left arm. I was in the hospital for 5 days was discharged on Sunday night with multiple medications for my blood pressure and blood thinners for my blood clog. I was not told what the cause of the pain in my shoulder was. To this day the pain is so severe I am unable to sleep.
pt was diagnosed with cellulitis of the Left deltoid two days after Adacel was administered.  pt was started on Keflex.
SLEEPING ALOT; RACING HEART; ABDOMINAL PAIN; STILL NOT GETTING HER ENERGY BACK/FEELING BETTER; DIARRHEA; FATIGUE; FEVER; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included thyroid irradiated, and concurrent conditions included aneurysm, and hyperthyroidism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced sleeping alot, racing heart, abdominal pain, still not getting her energy back/feeling better, diarrhea, fatigue, and fever. Laboratory data (dates unspecified) included: Investigation (NR: not provided) NOTHING WAS FOUND, and X-ray (NR: not provided) NOTHING WAS FOUND. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sleeping alot, and still not getting her energy back/feeling better, and the outcome of fever, diarrhea, abdominal pain, racing heart and fatigue was not reported. This report was non-serious.
First dose given was Moderna on 3/9/2021. Second dose was Pfizer on 4/8/2021
Guillain Barre diagnosed 11/25/13 - patient admitted to MICU and intubated for respiratory difficulties one week later (still in hospital - seems to be improving but no update yet today).
CHILLS; FEVER; This spontaneous report received from a patient concerned a 48 year old male. 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, and batch number: 1808980 expiry: not reported) dose was not reported, administered on 06-APR-2021 at 13:00 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021 12:00, the subject experienced chills. On 07-APR-2021 12:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and chills. This report was non-serious.
Pt came in to facility 08/13/2019 with reports of itchy raised, reddened area at injection site that started 08/12/2019. Pt applied hydrocortisone cream to site at home with minimal effectiveness. Pt was prescribed  DiphenhydrAMINE HCl Tablet, 25 MG, 1 tablet as needed, Orally, every 8 hrs, 3 days and Amoxicillin-Pot Clavulanate Tablet, 875-125 MG, 1 tablet, Orally, every 12 hrs for 5 days.
I'd like to report a side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I'd like to report a side effect) 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 VACCINATION COMPLICATION (I'd like to report a side effect). At the time of the report, VACCINATION COMPLICATION (I'd like to report a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
I had a reaction on my arm 2 weeks after the first dose of Moderna. It was cleared up by the second dose. I mentioned it to the nurse who gave me the second dose on 4/2/2021 and he said "that's odd." I guess he hadn't been watching the news or was an informed professional in his field. Anyways, I had the second injection in my left arm as well. The skin reaction has now covered my entire upper arm. It is red, hot, and swollen. It is now 5 days later and the rash continues to grow.
The patient is an 8-year-old female who received the COVID-19 Moderna vaccine on 4/05/2021. At this time, there are no reported symptoms by the patient or guardian.
Tingling sensation in hand of vaccinated arm for approximately 30 minutes after vaccination, ongoing upper arm pain of varied severity throughout the day and between multiple days, mixture of achy pain, sharp pain, and feeling of tightness, occasional muscle twitching; treatment of gabapentin for potential nerve irritation ongoing
Felt chilly all night; This is a spontaneous report from a non-contactable consumer or other non-health care professional (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient felt chilly all night after receiving second dose of the COVID vaccine on an unspecified date. The outcome of the event was reported unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
had a headache for 3 weeks on the left side along the occipital bone; had a headache on the left side along the occipital bone; This non-serious case was reported by a nurse via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-SEP-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: had a headache for 3 weeks on the left side along the occipital bone) and bone pain (Verbatim: had a headache on the left side along the occipital bone). The outcome of the headache and bone pain were resolved (duration 3 weeks).   It was unknown if the reporter considered the headache and bone pain to be related to Shingrix.     It was unknown if the company considered the headache and bone pain to be related to Shingrix.   Additional Information: GSK receipt date: 11-OCT-2023 The reporter was a GSK representative who was reporting on behalf of an HCP (nurse).  The HCP was the patient, and she received her second dose of Shingrix. In 2023, she had a headache for 3 weeks on the left side along the occipital bone.  Headache had resolved in 2023. The reporter consented to follow up.
Pt, has pain in his right leg and he can no longer walk without a walker , his leg continues to give out with weight bearing .
aching pain all over the body;h/a, low grade fever 99.8-100.8;
Twenty-six hours post vax, developed red rash on both soles of feet. No other symptoms or fever. Rash macular and blanching and non-tender.
Immediately, as nurse pressed plunger, vision became 'dreamlike', eyes felt like Jell-o, and eyelids were very heavy.  Lasted approximately 25 mins.  Hand movements were slow, heavy
At about 18 hours my body and muscles started ache. Before that I had zero side effects. By 24 hours afterwards I was cold and shaky. Had to take a hot bath abs went to bed with an electric blanket on for the rest of the day.   I have not had the normal energy or appetite since and it?s been three days.
Patient miscarried in the 11 days following vaccine administration.  Patient does have a history of miscarriage.
STARTED WITH HEADACHE THAT NIGHT, ON 11/17 I WOKE UP WITH CONGESTION AND SNEEZING, BY EVENING I WAS COUGHING 11/18 WOKE UP WITH WORSENED COUGH, CHEST TIGHTNESS AND BODY ACHES
This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of no adverse event (Patient received first Shingrix dose 7 months ago). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were reported as follows: Age at vaccination was not applicable for this report. The patient received first dose of Shingrix 7 months before reporting and went for second dose. The reporter wanted to know if they need to restart the series. Consent to follow up was not possible as no contact details were available.
No adverse effect; Inappropriate schedule of vaccine administered; This spontaneous report was received from a pharmacist referring to a 19-year-old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy details were not reported.  On an unknown date in 2011 (when the patient was 11-year-old), patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) first dose (dose, frequency, route, lot# and expiry date were not reported) for prophylaxis. On 09-AUG-2019, (reported as after 8 years) the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (inappropriate schedule of product administration). No adverse event was reported. No additional information was reported. No product quality complaint (PQC) was reported.
Patient complained at time of injection that he felt as if injection was going right through his arm, major pain at time of injection.  Following this as patient left, arm felt as if he was punched very hard in the arm.  Since then, patient has lost the use of his arm, patient cannot pick up a gallon of water, range of motion is limited, still extremely painful at site of injection as if someone is sticking a knife in his arm.  Patient had an EMG test for nerve issue as well as MRI on same arm due to discomfort.
Redness, swollen, hot to the touch, hardness of area, approx. 3 inch diameter, purple streak injection site.
At the time of administration of vaccine the exp. date of 10/31/2022 was given to me on the LOT# FL2757. At a later date, 3wks. I was made aware that  the true exp date was shortened by the manufacturer and should actually have  been 9/30/22.
Pt recv vax on unspecified day; 2 hr later pt exp vomiting, chest tightness, wheezing w/ inspiration, X 3 hr.  Pt exp decreased motion LA, fatigue, left hand cold.
Extreme arm pain, diarrhea, Extreme headache, fever over 100, extreme body aches, jaw pain, chills, sensitivity to light
This case was reported by a consumer via call center representative and described the occurrence of rash in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. But it could be 78 or 79 years old. The patient did not know the date of administration, but stated that she received SHINGRIX a few weeks ago. The patient experienced a rash on the front of her body. She stated that the rash was interspersed and did not completely cover the area of her skin. The patient declined to give phone number or other personal information.
Red, round, flaky, itchy nodules progressing from injection site across the whole body of the period of months. Using over the top steroid cream, and salicylic acid cream with minimal relief in symptoms and no reduction in progression. Currently no health insurance and unable to afford paying for doctors visits.  The problem is ongoing.
Large area of redness, size of grape fruit, with itchiness, hot to touch, and very, very hard to touch.