chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Health Professional concerning an 8 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 01-Oct-2013. The patient experienced Fever, Acting sleepy, Lazy and Headache which started on 01-Oct-2013. The patient recovered from the event of Fever, Acting sleepy, Lazy and Headache on 04-Oct-2013. The report was considered to be non-serious. Summary of follow-up information received by MedImmune on 24-Oct-2013 from Health Professional: New reporter added. Details of the reporter administered by updated. County where administered updated. Lot number and expiration date of the suspect drug added. Corrected Report 15-Nov-2013: Stop date of all the events added.
Vaccine expired on 06-Sep-2021 and removed from the fridge on 04-Jan-2022; administered vaccines past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered vaccines past the expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 06-Sep-2021 and removed from the fridge on 04-Jan-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered vaccines past the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 06-Sep-2021 and removed from the fridge on 04-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered vaccines past the expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 06-Sep-2021 and removed from the fridge on 04-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  On 04-Jan-2022, the vial was removed from fridge.  Reportedly, By Used Date was 06-Sep-2021. The vaccines were stored in the freezer and only removed as needed to thaw and then administered. It was mentioned that vials were taken out at a time and thawed as they did not thawed an entire box.  No treatment medications were provided.
Recieved shots at approximately 10 a.m. 7/13.  Was fine only sleepy.  2:00 a.m. he woke up with a fever of 102.2.  Nursed him throughout the night.  Woke up at 7 a.m. with a fever of 102.5.  Fever then gradually went down over the morning finally returning to normal.  Over the morning he started getting red bumps over his back and arms.  The next day the fever was completely gone but his bumps are spreading.  That's the current situation.
Client was vaccinated around 1710, fainted at 1715 and hit posterior aspect of her head. One small approximately 1cm laceration present on posterior head. Client placed supine,  BP at 1716 was 100/64, improved to 110/78 after 5 minutes. Advised client and mother to go to the ER but refused due to lack of insurance. approximately 1730 client felt nauseous and 911 was called and client was transported to the hospital.
Patient/guardian inadvertently attested eligibility for Moderna despite being younger than 18 when administered.
Rash on top of right thigh day after. Rash on left ankle and injection site 2 days after
Patient states that he is paralyzed on whole left side of body. Was told he has slurred speech as well. Patient could not move.
Started with sore arm. By morning next day most of arm swollen unable to move much. Swelling  under arm and down side to waist.  Nodes in arm pit swollen. Dizzy unable to walk straight,  nausea vomiting low grade fever 100.9. Weak and barely able to get up out of bed. Headache. Symptom lasted 4 days. Started to itch everywhere.  Had taken motrin for pain day 2- 3. Reglan from day after shot through 4.  Benadryl day after shot. Was unable to work till monday. Shot was given on Wednesday.
The pt was in error give 2 doses of booster dose. This is a misadministration. No symptoms so far.
Case number PHEH2014US019128, is an initial spontaneous report from a nurse received on 22 Sep 2014, with a follow up received from other health professional on 16 Oct 2014. This report refers to a 12-year-old male patient. Historical conditions were not reported. Vaccination history included administration of DTP (batch number: not reported) on 22 Apr 2002, 14 Jun  2002, 15 Aug 2002, 09 Sep 2003 and 23 Feb 2007; hepatitis B vaccine (manufacturer unknown batch number: not reported) on 25 Feb 2002, 28 Mar 2002, and 15 Aug 2002; haemophilus influenza type B vaccine (manufacturer unknown, batch number: not reported) on 22 Apr 2002, 14 Jun 2002, 15 Aug 2002, 19 Mar 2003; measles, mumps, and rubella vaccine (manufacturer unknown, batch number: not reported): on 17 Jun 2003 and 23 Feb 2007; pneumococcal vaccine (manufacturer unknown, batch number: not reported): on 22 Apr 2002, 14 June 2002, 15 Aug 2002, 17 Jun 2003; polio vaccine (manufacturer unknown, batch number: not reported): on 22 Apr 2002, 14 Jun 2002, 09 Sep 2003 and 23 Feb 2007; varicella vaccine (manufacturer unknown, batch number: not reported): on 19 Mar 2003 and 23  Feb 2007. He was concomitantly vaccinated with human papilloma virus vaccine (manufacturer unknown, batch number: not reported), DTP (batch number: not reported) and meningococcal vaccine (manufacturer unknown, batch number: not reported) on 22 Sep 2014. He was administered Men A lyophilized conjugate component of MENVEO (batch number: A14044) reconstituted with a diluent from Merck instead of Men-CYW-135 liquid conjugate component intramuscularly into the right deltoid on 22 Sep 2014 at 14:30. The patient was contacted and notified of the error and patient did not report any signs or symptoms of adverse reaction. No adverse reaction was noted in the patient following the maladministration (wrong solution used in drug reconstitution). The patient was scheduled for revaccination with MENVEO on 18 Nov 2014 at 03:00 PM. It was reported that the patient was due to receive Flu vaccine and hepatitis A vaccine. Follow up received from other health professional on 16 Oct 2014: updated patient demographics (gender), vaccination history, concomitant vaccines, site and time of vaccination of MENVEO and other clinically relevant information in the narrative.
TWO DAYS OF SINTOMOS,PAIN INJECTION SITE, HEADACHE,MUSCULAR PAIN,FEVER,ABDOMINAL PAIN, DIARREA,SUETING AND INFLAMATION OF THE GANGLIOS.
I had severe chills, fever and was very weak.  A few weeks later, I started having serve chest tightness and pain.  I also had shortness of breath. These lasted for a few months. I went to the doctor about this.  They did EKG, ECG, stress test, lab, and CT scan.  I had a heart Cath done on Oct. 12th. I am still waiting to have an MRI done.  My doctor said that my heart is enlarged.
vaccines admin 01/08/09, pt started with fever 01/09/09 3:00am - Mom states pt was "burning up" and guessed fever at 100 (did not measure it). Gave Tylenol. Then "spiked" fever at 5:00am, had a seizure and squad was called. Taken to Emergency room, and admitted for 3 days. Had a total of 3 seizures, but none after fever controlled with alternating Tylenol / Motrin at the hospital. Mom unsure if she was giving the appropriate dose of Tylenol at home. Mom stated "tests all came back fine but the doctor at the hospital said pt should have never gotten 8 shots".  4/21/09 MR received for DOS 1/9-11/2009 with D/C Dx: Acute Febrile seizure. Acute febrile illness. Bacteruria.  Metabolic acidosis 2' to seizure or dehydration. Pt presented on the morning after vaccines with fever and several episodes of seizure.  Pt initially seen by parent shaking with eyes rolled back.  EMS called and pt had another episode in ambulance and one in ER.  Tx with IV abx for ? UTI with improvement.  No further seizures. D/C on po abx.
The pediatric Pfizer vaccine was given prior to dilution (undiluted) which resulted in patient receiving double the dose than intended. The patient was contacted regarding the issue the same day. patient was doing fine. No symptoms/adverse events were reported at the time. The patient was contacted 3 times all together (the next day, and fourth day from the day of vaccination). Patient was doing completely fine and no adverse events were reported. Patient had no symptoms of fever, muscle pain, arm soreness or headache.
Tiredness, achy-ness, high fever (102.7°), mental fogginess, shivering/tremors from feeling cold, this went on for over forty minutes before I fell asleep still shaking. I had not taken Tylenol or any other forms of medication at this time to alleviate symptoms. That night I took two Tylenol 500 mg and symptoms from fever began to subside. Following day still experienced fatigue , low energy, and achy-ness.
Moderna  COVID-19  Vaccine EUA localized pain - arm painful and extremely hot to touch.  Still hot after 3 days Fever/Chills for 48 hours.  Temperature ranging  from 100.5F to 101F oral. Loss of appetite for approximately 36 hours Extreme fatigue and weakness, muscle and joint pain pounding headache for 2 1/2 days
Headaches, dizziness, myalgia, joint pain, short-term memory loss, difficulty concentrating, depression.  Followed up with provider 9/15/21
this is 1 of 4 hosp employees to exp hypotension w/nausea, dizziness, shakiness, weakness, & flushing immed p/vax;
Dizziness and mild headache. 2:24pm. States that dizziness and HA have some what subsided; alert and oriented x3 appears to be apparent distress or discomfort.
Fever (102F) for 24 hours, extreme headache for 24+ hours, chills and body aches for 24 hours, fatigue and arm pain for 24 hours.
The day following the 2nd dose of Moderna Covid-19 vaccination extreme pain in the side began, on 3/11/2021 patient saw PCP regarding pain nothing was determined however BP was elevated and losartan dose was increased.  Hypertensive urgency requiring hospitalization occurred on March 19 2021 clonidine was prescribed to control BP and is being taken to date however BP is still erratic.
Administered vaccine at 7:00 pm by 10 pm pt began feeling dizzy. By AM felt nausea & vomited X 2.
felt flu-ish" for a day and a half; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt flu-ish" for a day and a half) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included DULOXETINE HYDROCHLORIDE (DULOXETINE HCL), LAMOTRIGINE, LITHIUM CARBONATE, PANTOPRAZOLE, ROSUVASTATIN CALCIUM, LEVOTHYROXINE and CLONAZEPAM (CLOZEPAM [CLONAZEPAM]) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt flu-ish" for a day and a half). On 24-Apr-2021, INFLUENZA LIKE ILLNESS (felt flu-ish" for a day and a half) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Seroquil were the concomitant medications.  No Treatment information  were reported   This case was linked to MOD-2021-290906 (Patient Link).
I had the Covid arm and extremely swollen. I had a fever of 102, body aches and chills, As well as headaches. I also kept getting shingles after getting vaccinations and my doctors have confirmed my suspicions that it may have some connection with the vaccinations.
Decreased appetite; lethargy; decreased responsiveness; decreased urine output; LUQ mass. Abdominal US done showing abnormal gas pattern concerning for intussusception.  Pt transferred for further evaluation and treatment.
I experienced the same reaction after the 1st dose of covid vaccine.  Temporary VAERS E-Report No: 219515 I was instructed to premedicate prior to 2nd dose of vaccine by allergist.  Approximately 24 hours after vaccine administration,  developed rash localized to abdomen above belly button.  No hives, pruritis, shortness of breath noted.  Rash resolved within 24 hours.
consistent: brain fog, muscle aches, joint pain, headaches, difficult in concentration, losing words and tongue tied. poor and restless  sleep.   sporadic : cold sweats, neck stiffness, chest tightness, fevers.
Within 90 minutes, headache and fatigue. 4 months later, profound fatigue with daily unrelieved headaches, and joint pain and swelling
Right arm was immobile for 2 days- seemed paralyzed - still have extreme soreness and do not have full mobility
Patient having Heart Palpitations 15mins after getting the flu shot ( High Dose)- FLUZONE HD. This is her first year getting the High Dose vaccine. FYI: Patient has had a mitral valve repair done in the past.
pt recv vax 29MAR96 & 4APR965 days later pt had sz @ daycare;during nap time pt appeared to be asleep-when pt did not wake up provider went to pt & pt was non-responsive;eyes were rolled back when lids were pried open, was stiff;taken to MD
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 51-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 11-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    Concomitant medications were not reported.  113 Bivalent doses administered after the BUD to patients 12 and up. Breakdown of doses were as 51 doses from Lot AS7140C and 60 doses from Lot AS7148B.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689946 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689946:Case
NAUSEA, WEAKNESS, FEVER OF 99 (NORMAL FOR PATIENT IS 96) EVENING AFTER VACCINE AND CONTINUED THE MORNING AFTER. TOOK ASPIRIN TO TREAT SYMPTOMS
Caller reported vaccine administered after temperature excursions.  No other information provided.  No PQC reported. Previous AE filed 02236682 was updated with new excursion information. Related AEs filed 02237157, 02237190, 02237201, 02237212, 0223; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 12-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #W017567, expiration date: 29-NOV-2023, administered subcutaneously as prophylaxis (strength was not provided), after a temperature excursion of 1 hour and 30 minutes at a temperature of 10.9 Fahrenheit degrees (product storage error). No previous temperature excursions were reported.   This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2209USA000235: US-009507513-2209USA000438: US-009507513-2209USA000179: US-009507513-2209USA000350: US-009507513-2209USA000177: US-009507513-2209USA000361: US-009507513-2209USA000255: US-009507513-2209USA000374:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included arthritis (in spring 2017, had surgery on wrist to cut the nerves to his hand to control severe arthritis pain). Previously administered products included steroid injections (got 5 injections in his hands prior to the surgery where the nerves were cut). Concurrent medical conditions included injury at work (had caused a lot of physician problems and led to 8 surgeries), multiple allergies and biceps tendon rupture. On 5th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 5th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 6th July 2018, the patient experienced stomach cramps and bloating. On 7th July 2018, the patient experienced swelling arm and pain in arm. On 13th July 2018, the patient experienced erythromacular rash. In July 2018, the patient experienced localized itching and fatigue. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain, swelling arm and pain in arm were recovering/resolving and the outcome of the stomach cramps and bloating were recovered/resolved and the outcome of the localized itching was unknown and the outcome of the fatigue and erythromacular rash were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, stomach cramps, bloating, swelling arm, localized itching, fatigue, erythromacular rash and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient had many allergies. The patient reported that he got SHINGRIX on 5th July 2018 (Thursday) in the muscle of his left arm, about 2 inches below his shoulder (left deltoid).  On the same day, in the evening the patient started experiencing pain at the injection site, at the time of reporting the pain was minimal but initially he could not touch it, it was so painful. On 6th July 2018 (Friday), in the evening, the experienced cramping in his stomach muscles. Not the intestines, but on the surface and also felt bloated. On 7th July 2018 (Saturday) morning, the patient woke up at 4 AM and his right hand was swollen to twice the size of his left hand and was very painful. Since then the patient has had some episodes of swelling, but it usually resolves after a short period of time but this time he had been compressing and icing his hand and taking ibuprofen, but his hand was still swollen at the and it was getting better, at the time of reporting. The patient could see his knuckles again, but this was longer than usual, but he feels like he was itching more than usual, and he had also been more tired than usual. On the day of reporting, the patient noticed a red dot on his left arm, below where his bicep would be. The patient did not had a bicep because it was ruptured.
This spontaneous report as received from a pharmacist via company representative refers to two (2) anonymous patients of unknown age and unknown gender. The patients pertinent medical history was unspecified. On an unknown date, the anonymous patients were concomitantly vaccinated with ZOSTAVAX, PNEUMOVAX 23 and unspecified Flu vaccine (manufacturer unknown). Concomitant medications were unspecified. On an unknown date the patients experienced extreme lethargy. The patient sought medical attention with the pharmacist and the treatment given was unspecified. The outcome of extreme lethargy was reported as recovered on an unknown date. The causality of the lethargy was not reported. No product complaint was reported for ZOSTAVAX, PNEUMOVAX 23 and unspecified Flu vaccine (manufacturer unknown). This case is linked to case # 1411USA012872 (same reporter link). Additional information has been requested.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed multiple vesicles on right cheek, back of neck, both arms, legs, chest and back. On day 3 pt was seen by a physician and diagnosed with varicella. There were no complications and there were no treatments administered.
No additional AE's/PQC's were reported; reporting a temperature excursion for VARIVAX/ have been administered to several patients since the escursion; This spontaneous report has been received from an office manager and refers to patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 18-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose or frequency 1 (units not provided) (route of administration, vaccine scheme, anatomical site of vaccination were not reported; lot number T041685 has been verified to be valid, expiration date reported and established as 10-DEC-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 11.3 Fahrenheit degrees (°F) during a time frame of 15 minutes. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA006576:
had a mild fever; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no. was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient who got the covid vaccine and over the weekend had a mild fever and was tested negative with covid. Reporter wanted to know if it is safe for patient to get the second shot of the covid vaccine. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
No fever, diarrhea and vomiting, has not resolved at this time. Son had diarrhea on the morning of 11/10/2009.
Shortness of breath  Redness, swelling, hotness, and itchiness at injection site 7 days after receiving the vaccine
MISSED DOSE ON SUNDAY; This spontaneous case report (PVX2019-1722) was received from a pharmacist on 01-Jul-2019. It describes a 16-year-old adolescent female consumer who "missed dose on Sunday", while being on Vivotif for an unknown indication.  Case report: The consumer took only two doses of Vivotif on 26-Jun-2019 and 28-Jun-2019, respectively. Then, she went out of the town and missed her dose. She would not return until 04Jul-2019.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed dose on Sunday" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed dose on Sunday" was considered as not applicable.
Blisters on her arm, and thigh, also a hard lump apx 1 inch above injection site.  Scaly patches appears in subsequent days on her face.
Information has been received from a female consumer (age not reported) who on 15-MAY-2007 was vaccinated with the first dose of Gardasil.  Concomitant medication was not reported.  On 16-MAY-2007, the day after the patient received her first Gardasil, she experienced vaginal spotting.  The outcome of the event was not reported.  Additional information has been requested.