chrisvoncsefalvay/vaers-outcomes huggingface dataset:
running a high fever with the shakes; running a high fever with the shakes/ slight fever; very sore joints; very sore muscles; sleep 16.5 hours; Initial information received on 15-Sep-2022 regarding an unsolicited valid  non-serious case received from a patient.  This case involves a 65 years old male patient who had very sore muscles, running a high fever with the shakes, running a high fever with the shakes/ slight fever, very sore joints and sleep 16.5 hours , after receiving vaccine MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE [H1N1 FLU VACCINE PACKAGED BY ].  The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.    On 14-Sep-2022, the patient received an unknown dose of suspect MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE, (with an unknown strength, lot number and expiry date) , given as topical injection in an unknown administration for prophylactic vaccination (immunization). Information regarding batch number has been requested.  On 15-Sep-2022, the patient woke up at 2:30AM and had running a high fever with the shakes (tremor) (pyrexia) , The patient also had very sore muscles/joints (myalgia), (arthralgia) ,  1 day following the administration of MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE. The patient went to work and left at Lunch, went home and sleep 16.5 hours (somnolence) , 1 day following the administration of MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE. Then, the fever finally broke around 11:30AM, and a slight fever came back and then was over with morning of the 16-Sep-2022. Patient did not experience any additional symptoms/events. There were no lab data/results available  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events (very sore muscles, running a high fever with the shakes, running a high fever with the shakes/ slight fever, very sore joints, sleep 16.5 hours).  Outcome: Recovered / Resolved on 15-Sep-2022 for all the events.
Hair loss; Sore arm; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 053E21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (MAY 14-27 2021, went to hospital with COVID.) from 14-May-2021 to 27-May-2021. Concurrent medical conditions included Penicillin allergy, Contrast media allergy and Allergic reaction to analgesics (Demoral). Concomitant products included CALCIUM for Supplementation therapy.   On 18-Aug-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Hair loss), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and CHILLS (Chills). On 10-Nov-2021, ALOPECIA (Hair loss) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: seems to be little off (abnormal) seems to be little off.         The onset time for events such as sore arm, fever and chills was provided as 10:00 pm.  No treatment medication were reported.   This case was linked to MOD-2021-304842 (Patient Link).
Papular rash outer thighs bilateral legs - No erythema, no nodules.
Headache, body aches, low grade fever (100.6), fatigue, injection site tenderness
Complained of "itchy" on stomach, arms, legs with "rash".  Denies swelling, SOB.
Reported dizziness after getting shot.  Helped to lay down on exam table.  Blood pressure 140/80.  Pulse 120.  Complained of some chest pain.  Transported via ambulance to emergency room.
pt recvd vax & devel hemiparesis sudden onset 2 wks after vax; weakness, spasticity of lt hand & foot; tx: pt, ot, massage, acupuncture, chiropractic manipulation;
COVID-19 vaccination - 2/2 in series.  Reportedly, patient fainted following first dose.  Approximately 5-6 minutes after patient received second dose, she become lethargic, progressing to non-responsive.  A rapid response was called and patient was transferred to the emergency department.  She was protecting her airway.  En route to the ED, patient's eyes rolled backwards and she began having generalized tonic-clonic movement indicative of a seizure.  Patient was turned onto her side until seizure activity subsided.   Post-ictal state lasted approximately 5-10 minutes after seizure activity ceased and patient became alert and oriented and able to answer all questions.  All lab tests and imaging were normal.
Severe back pain - 2 days Muscular pain throughout body - 3 days, subsided over time Headache - first 24 hours Hot red rash on arm of injection - day 2 - day 4 (present) and getting better but very hot and itchy
A nurse reported that a 17 month old male received his 2nd dose of Prevnar on 8/14/00. The next day, he could not bear weight on the leg into which the vaccine had been injected and he dragged the leg when he crawled.
She got her vaccine, had no reactions at all. The day after her arm was very swollen, sore, red and could not move it.  She took Tylenol for it.  The arm was swollen for about a week. She had body aches as well that went away after about a week.  She had a flu-like response.  She is now feeling well. She called her doctor and they told her to put ice on the arm, and monitor herself.  She had fever to 102.
pt recvd vax;8feb95 lt arm area 6 x 6cm erythematous,moderately indurated,warm to touch;9feb95 lt arm red, non tender;denies itching & pain;100x100mm (sl indurated);
Information has been received from a nurse concerning an 8 year old male with no medical history, no known drug allergies who on 18-SEP-2001 was vaccinated 0.5ml SQ with one dose of VARIVAX (Oka/Merck) (lot # 638251/0224L).  There was no concomitant medication.  On 11-JAN-2009 the patient developed "atypical VARICELLA".  The patient had 50 to 80 pruritic lesions on his arms, and ears.  He was still developing additional lesions.  The patient sought medical attention in the office.  The patient's "atypical VARICELLA" persisted.  Additional information has been requested.
Covid-19 infection; cough; tickling of the throat; This spontaneous case was reported by a physician and describes the occurrence of COUGH (cough), OROPHARYNGEAL DISCOMFORT (tickling of the throat) and COVID-19 (Covid-19 infection) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L22A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced COUGH (cough) and OROPHARYNGEAL DISCOMFORT (tickling of the throat). On 17-Mar-2021, the patient experienced COVID-19 (Covid-19 infection). At the time of the report, COUGH (cough), OROPHARYNGEAL DISCOMFORT (tickling of the throat) and COVID-19 (Covid-19 infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, SARS-CoV-2 test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. Treatment information was not provided.
Headache; Rash on arm; swollen arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache), RASH (Rash on arm) and PERIPHERAL SWELLING (swollen arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen arm). On an unknown date, the patient experienced HEADACHE (Headache) and RASH (Rash on arm). At the time of the report, HEADACHE (Headache) and RASH (Rash on arm) outcome was unknown and PERIPHERAL SWELLING (swollen arm) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PERIPHERAL SWELLING (swollen arm) to be related. No further causality assessments were provided for HEADACHE (Headache) and RASH (Rash on arm).    Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-056395 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Added VAER; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056395:patient 2- first dose
raised oval swelling at injection site with intense itching and rash as of  03/04/2021
This report from study was reported via Pregnancy Registry (initial receipt 18-Aug-2015) concerns a neonate patient. Concomitant medications, received via the mother in utero, included prenatal vitamins, cyanocobalamin, fish oil, calcium, cholecalciferol, clomiphene citrate, monoclonal antibodies, prednisone, esomeprazole magnesium, paracetamol, ibuprofen, loratadine, pseudoephedrine hydrochloride, docusate sodium, doxylamine succinate, lorazepam, folic acid and DTP vaccine. The neonate patient's mother had a medical history of rheumatoid/RA (rheumatoid arthritis) (diagnosed in 2001), infertility (received fertility treatment), hip replacement (in 2006), IBS (irritable bowel syndrome, resolved), ulcers from NSAIDS, Thyroid dysfunction - Graves (diagnosed in 2013), fibroids (that were removed in 2014), GI upset, stomach flu, diarrhoea, vomiting, respiratory infection/cold, headache, carpal tunnel, ulcers, and a carrier for CF (cystic fibrosis). The mother's date of conception was 09-Mar-2014 with twin pregnancy. At first ultrasound at 5.7 weeks, 2 sacs were seen, the first sac had a pole and heartbeat and the second sac had no pole or heartbeat. Twin B was spontaneously aborted at 6 weeks of gestation. At follow-up ultrasound on 6.9 weeks there was still heartbeat in the first sac but the second sac hadn't developed any further. (Refer to case 2015053273). The ultrasound scans (performed on 11-May-2014, 07-Sep-2014, 21-Jul-2014, 05-Oct-2014 and 09-Nov-2014), alfa-fetoprotein test (performed on 01-Jul-2014) and non-invasive prenatal tests (performed on 04-May-2014). On 25-Sep-2014, the patient received AFLURIA vaccine, (batch number: T58606) via the mother in utero. The patient was live born at 40.1 week gestation (weight: 2835 grams, Apgar score at 1 min: 9, Apgar score at 5 mins: 9). The patient was born full term and diagnosed with congential chordee which was diagnosed and confirmed by paediatric urology medical records. The outcome was not reported.
Three weeks after receiving injection had severe back ache.   Broke out in a rash, went to doctor and was diagnosed with shingles. And two medication?s, valacyclovir and gabapentin. Also taking Tylenol for back pain. Only in first week of diagnosis, severe rash, pain.  Told by the doctor that this would last at least 3 to 5 weeks.
Began with complaint of sore throat and progressed to runny nose and mild coughing.  Currently giving DayQuil and/or NyQuil.
Redness, swelling of injected arm, elbow to shoulder, medial & lateral.  Fever > 101 degrees F.
Date and time adverse event started: Patient started to experience symptoms on her drive home after taking the vaccine on 4/8/21 around 12:15pm-12:30pm. Patient stated she started to experience and feel symptoms on her drive home after the vaccine was given. Complains of soreness in arm at injection site, blurry vision, extreme headache and nerve pain, complete numbness in right leg (caused car accident), fever, body aches, chills, sweats increased neuropathy pain, left shoulder pain, n/v, extreme weakness and tiredness. No bowel movement since morning of 4/8/21. Appetite decreased tremendously due to n/v feeling. She has vomited twice on Thursday on 4/8/21 and once on 4/9/21. BP ON 4/8/21 around 4pm it was 178/122  and then at 7pm after taking bp medication it was 176/120. Patient experienced SOB and chest pressure/heaviness not painful on 4/8/21. Didn't take BP on 4/9/21.  She took her normal medications for the day before the vaccine. When patient arrived at home she took Oxycodone, Buspar, Potassium tabs and Methocarbamol at 2pm on 4/8/21 (due time for her meds). On 4/8/21 at HS the muscle relaxer and pain killer was taken and it hasn't helped with the pain.   As of 4/9/21 @2:19pm her neuropathic pain is 12 (on a scale of 1-10), she is breathing better today but still feels pressure, but still feeling all of the above symptoms.   Recommended patient to go to an urgent care or ER, if she can't go then to make her PCP aware of what shes feeling. Advised her to take Tylenol for the fever, body aches, chills, and stay hydrated and eat light.    4/13-patient did not follow up with the ER/primary/urgent care as advised by prior entry. Patient states she has increased neuropathy from her baseline and continued nasal congestion. She took her rx medications but no additional medications for treatment. we will follow up with her next week to see how she is feeling. she is appreciative of the follow up call.
Patient became nervous , after about 10 minutes said he had headache and felt ill. After a few moments he told RPh  that he had not eaten or drank anything all day.  We observed patient for about 45 minutes he was given a water as well as a slice of pizza. He ask that we call his mom who came and picked him up. She seemed calm and mention that patient was nervous and took him home.
Swelling, hardness and pain at vaccination site extending through shoulder and neck. Treatment includes physical therapy, acupuncture, cupping, application of medical marijuana gel and wan hua (a chinese oil to relieve pain), and soaking with epsom salts. I continue to have the pain.
This spontaneous report as received from a nurse refers to an unspecified amount if patients. Concomitant medication and pertinent medical history were not provided. The nurse reported that LIQUID PEDVAXHIB (injection, dose, route, frequency and indication were not provided) that underwent a temperature excursion had been administered. No adverse effect reported. This is one of several reports received from the same source (MARRS# 1406USA009879). Additional information has been requested.
Patient stated that he got a shingles rash from the Shingrix. Patient will follow up with physician. I reviewed the rash. It resembles a sun rash. I am uncertain of what causes the rash.
HPV 3 administered on 12/22/16 and documented in EMR but not state registry. Records were not reconciliated and HPV was readministered on 2/20/17.
ADMINISTRATION OF EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced administration of expired vaccine. On 22-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and off label use was not reported. This report was non-serious.
Redness and itching at vaccine site 2/18/21 Lethargy 2/15/21
About 8 hours after the shot, I started to get a fever. At first it was about 101, I took tylenol (6 hours pill) but after 4 hours I spiked a 101 fever again. I took tylenol at the scheduled time and my fever went down, but then spiked up again  after 4 hours, this time to 103 degrees. I called my doctor's office emergency line, and was told to take advil, and be scheduled for a covid test. This was about 24 hours after the shot. Upon beginning advil and tylenol at the same time (2 hours apart) my fever reduced. I continued taking this regimine for another 24 hours with no breakthrough fever. By 48 hours after the shot, I felt totally fine fever wise. I had a covid test about 36 hours after my shot and was negative. I had redness and itchiness  with some swelling for 72  hours on my arm after the shot. My whole body was really sore and achy for about 4 days after the shot.
SWOLLEN THROAT; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced swollen throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of swollen throat was not reported. This report was non-serious.
Information has been received from a county health registered nurse concerning a 6 year old female who on 20-APR-2002 was vaccinated with varicella virus vaccine live (Oka/Merck). On 23-MAR-2007 the patient developed varicella, < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the same source. No further information is available.
Information has been received from a nurse practitioner, for the Pregnancy registry for GARDASIL, concerning a baby boy whose mother was vaccinated with a first 0.5 ml IM dose of GARDASIL on 06-Aug-2008 and on 16-Dec-2008 was vaccinated with a second dose of 16-Dec-2008 (Lot # 659962/1740U). The baby's mother LMP was on 16-NOV-2008. On 26-MAY-2009 the mother delivered a 2 lb baby boy. It is unknown if the baby was given medical attention. At the time of the report, the outcome of the baby was unknown. Upon internal review low birth weight (2 lb) and baby born on week 27 of pregnancy were considered other important medical events. The mother's experience has been captured in WAES# 0812USA03338. Additional information has been requested.
fever 104 R 6PM 30OCT92 dec w/APAP; clear nasal discharge, lung congestion, cough seen by MD 2NOV92 recvd oral ATB;
started to have chills; low grade fever / higher this morning (100 F); This case was reported by a consumer and described the occurrence of chills in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 30th May 2020, the patient received Shingles vaccine. On 4th June 2020, 5 days after receiving Shingles vaccine, the patient experienced chills and fever. On an unknown date, the outcome of the chills was unknown and the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the chills and fever to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingles vaccine, the patient started to have chills and a low-grade fever. His temperature was slightly higher on the day of reporting which was recorded 100 degree F. The reporter reported onset of side effect was about 5 days, and asked was that normal. The patient asked if this could be related to the vaccine.
sharp chest pain on the left side of her body; arm is swollen; 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 30-year-old female patient received BNT162b2 (BNT162B2), on 24May2022 as dose 1, 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: PERIPHERAL SWELLING (non-serious) with onset 25May2022, outcome "unknown", described as "arm is swollen"; CHEST PAIN (non-serious) with onset 25May2022, outcome "unknown", described as "sharp chest pain on the left side of her body".  Additional information: Patient wanted to know if this is a side effect of the vaccine and does not want to get her 2nd dose as she doesn't know what will happen.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PRODUCT STORAGE ERROR; This spontaneous report was received from a licensed practical nurse regarding a 1 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On 15-JAN-2021, the patient received improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S037501, expiration date of 12-NOV-2021, subcutaneous in the right thigh , varicella virus vaccine live (oka/merck)(VARIVAX) lot # T017686 with expiration date of 21-MAY-2022, subcutaneous in the left thigh, hepatitis a virus vaccine inactivated(HAVRIX) lot # ZJ3G3 with expiration date of 12-JUN-2022, intramuscular in the right vastus lateralis and pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) lot # D57723 with expiration date of 30-SEP-2022 intramuscular in the left vastus lateralis, all for prophylaxis The vaccines experienced temperature excursions with a total of 29.5h.  This is one of several reports from the same reporter(US-009507513-2101USA011364).
Pt is a73y.o. year old female from a facility presents to HCF due to progressive shortness of breath s/p testing positive for COVID 11/5. Reports of abdominal pain and diarrhea prior to arrival which appear to have resolved. The patient appears comfortable on 4 L O2/NC. She denies abdominal pain at this time. She admits to cough. Decadron/Remdesivir initiated (recognize there may be minimal benefit of remdesivir as 10 days since diagnosis) Leukocytosis noted. CXR/CTA with multifocal pneumonia consistent with COVID. Clinically doubt superimposed bacterial pneumonia. DC antibiotics. Charting reflects patient had 1 dose of Moderna in February 2021 cannot confirm additional dosing at this time COVID 19 INFLAMMATORY MARKERS:
Pt was being placed into car seat, crying. As per father, pt went limp and unaware; Pt taken out was pale not blue, although questionable blue lips; Pt still unresponsive and limp. 911 called. When ambulance arrived pt was aware; much less active than nl, but was returning to normal self. As being taken to ER pt acting normal.
9/12/03 received IPV #3 (Friday). Monday 9:15 AM phone call from Mom "bad rash head-toe". Low grade fever, then developed rash. Cranky. "Welt like" for 48 hours. Now resolving 9/15 AM.
Patient was seen and evaluated at urgent care for periorbital cellulitis of right eye and dermatitis.  Given prednisone and Keflex.