chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling icy hot in his back/ it went down to the opposite arm (his left arm)/ then traveled to the forearm/ now it is back to his back; like heat/ can feel heat going down his arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (feeling icy hot in his back/ it went down to the opposite arm (his left arm)/ then traveled to the forearm/ now it is back to his back) and FEELING HOT (like heat/ can feel heat going down his arm) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (feeling icy hot in his back/ it went down to the opposite arm (his left arm)/ then traveled to the forearm/ now it is back to his back) and FEELING HOT (like heat/ can feel heat going down his arm). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (feeling icy hot in his back/ it went down to the opposite arm (his left arm)/ then traveled to the forearm/ now it is back to his back) and FEELING HOT (like heat/ can feel heat going down his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant product information was not provided.
I was asked about what additional vaccine I had w the booster. So I completed this because I had the flu vaccine the same day I had my 3rd COVID booster shot.
generalized body aches; localized arm pain; nausea; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (generalized body aches), PAIN IN EXTREMITY (localized arm pain), NAUSEA (nausea) and FATIGUE (tiredness) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced PAIN (generalized body aches), PAIN IN EXTREMITY (localized arm pain), NAUSEA (nausea) and FATIGUE (tiredness). At the time of the report, PAIN (generalized body aches), PAIN IN EXTREMITY (localized arm pain), NAUSEA (nausea) and FATIGUE (tiredness) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient had side effects as localized arm pain, nausea, tiredness, generalized body aches (heaviness feeling). The injection was on 28-Sep-2023 and today was 10-Oct-2023.Patient concerned that this was lasting too long.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Oct-2023: Live follow-up received: Reference number added.
Patient broke out in hives all over his left leg and left arm almost 2 hours after the vaccine was given. Mom was instructed by Dr. to give him 5 ml (10 mg) of hydroxyzine (10mg/5 ml) every 6 hours until hives resolved. First dose of hydroxyzine was at 4:45 PM on 10/01/2018 and the hives resolved by 6:45. No further doses of hydroxyzine given. Instructions on treatment and patient's follow up was all done over the phone with Dr. and triage nurse. No follow up appt. needed in clinic.
1/17 2 hrs post administration Rt. arm pain, could not lift it, broke out in a sweat and chilled during the night. Could not get out of bed throughout night at 6AM 1/18 rt. shoulder to elbow and around back under arm swelled up and red.
pt recvd vax;approx 3 hrs later,crying inconsolably,limp extremities;body felt hot;had fine red rash covering whole body;ped called & notified;next am,pt was fine;no problems or further rxn noted;
Metallic taste in mouth; Chills/hot spells; nausea; vomiting; body aches; hip and back pain; sharp pain in left upper chest; Chills/hot spells; This is a spontaneous report received from a non-contactable Other-HCP. A 40-Year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN9581 and Expiration date not reported) via an unspecified route of administration, in Arm right, on 13Feb2021 at 02:30 PM (at the age of 40 years) as 2nd dose, single for COVID-19 immunisation. The patient medical history included Known allergies was reported as pseudoephedrine, Cephalexin, eggs, melon and concomitant medications included Multivitamin, St Johns Wort (medications in two weeks). Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3246 and Expiration date not reported) via an unspecified route of administration, in Right arm, on 23Jan2021 at 02:30 PM as 1st dose, single for covid-19 immunisation. The patient didn't receive any other vaccine in four weeks. There was no covid prior vaccination. The patient was covid tested post vaccination. On 13Feb2021, at 02:45 PM, the patient had experienced Metallic taste in mouth and feeling hot initially, Chills/hot spells, nausea, vomiting, body aches, hip and back pain, sharp pain in left upper chest. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests which includes Rapid Antigen Nasal Swab test post vaccination on 15Feb2021 with the result of negative, on 17Feb2021 with the result of negative, on 19Feb2021 with the result of negative, on 22Feb2021 with the result of negative, PCR Nasal Swab test on 24Feb2021 with the result of pending. There was no treatment received for AE. Outcome of the events was reported as Recovered with lasting effects.  No follow up attempts are possible. No further information is expected.
Got a shot 8 weeks ago, just got shingles/Suspected vaccination failure; Got shingles saturday morning; It (shingles) hurts; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In October 2022, less than 2 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 12-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got a shot about 8 weeks ago and just shingles Saturday morning. The patient stated that they hurts. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As it was reported that just hot shingles Saturday morning it hurts, therefore conservatively onset for all events were captured as October 2022.
Patient has been feeling pain  and limited arm movement on her arm since she got the shot x 5 weeks. She went to see her md, md said she has bursitis, it's SIRVA. She will be getting cortisone shot next week, and maybe physical therapy.
Severe fatigue and body aches and day 4 a severe rash on my back that lasted two weeks.  Treated with OTC steroid lotions.
Information has been received from a physician concerning a patient who in "which the last month" in July 2006, was vaccinated with a SC 0.5 ml dose of of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  In July 2006, the patient developed a measles like rash.  Medical attention was sought.  subsequently, the patient recovered on an unspecified date.  There was no product quality complaint involved.  Additional information  has been requested.
Patient is a 69 y.o. male patient who originally presented to the hospital on 3/23/2021 due to shortness of breath.  Patient had 1 week of shortness of breath.  He starts experiencing 2 weeks of pain in edema right lower extremity.  Did notice increasing dyspnea on exertion.  Was noted to have bilateral PEs with evidence of RV strain on CT scan.  She admitted to the ICU on heparin drip he did undergo tPA.  Echocardiogram documented to be improving.  Patient now baseline ambulatory in the room without oxygen stable.
Diarrhea; Had persistent diarrhea which has gotten worse; Arm was sore; Tired; Swollen glands; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL1283 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 19Jan2021 (at the age of 69-year-old) as dose 1, single for COVID-19 immunisation.  Medical history included breast cancer female from an unknown date the caller was on a breast cancer drug trial and has been on it for 17 years. Concomitant medications included levothyroxine taken for an unspecified indication from an unspecified start date and ongoing, estriol, estradiol, testosterone, progesterone, dhea, estrone taken for breast cancer female, start and stop date were not reported. On 20Jan2021 after the first vaccine she noticed she had some swollen glands. About three days after the first vaccine caller started experiencing diarrhea. The caller has had persistent diarrhea and her doctor asked her when she got the vaccine and she realized she has had the diarrhea since about 3-4 days after the first vaccine. The caller has had persistent diarrhea which has gotten worse, and it didn't go away. The caller tried one prescription, diphenoxylate atropine 2.5 mg tablets and it didn't do it, it would slow down the diarrhea but would not stop it. This medicine was in a pharmacy bottle, unknown lot, expiration date 15Feb22. The second prescribed medication, prevalite, has been working well but as soon as she tries to wean off it, the diarrhea comes back with a vengeance. The caller has called around to get an appointment with a gastrointestinal specialist but 28Jul2021 is the soonest appointment she can get. The caller's doctor suspects the diarrhea is related to the vaccine.   Therapeutic measures were taken as a result of diarrhea. Outcome for the event lymphadenopathy was recovered, Diarrhoea was not recovered, condition aggravated, pain in extremity, fatigue was unknown.  No follow-up attempts are needed. No further information is expected.
CDC reports: 2 mo infant rec'd DTP/OPV 16JAN90 & experienced fever & screaming episode, 17JAN90 hospitalized for 4 days treated for Bronchitis & otitis media.
approx. 24 hours later, got light headed and faint, felt rapid heart beat.
Patient began to experience side effects on day following first dose 7/11/21 around 6am including temperature (103F), chest pain, lung and kidney inflammation, headaches, body aches including cramping and charlie horses for 3-4 days following first dose, symptoms then resolved. Patient stated she did seek treatment at the emergency room and was given a chest xray and a dose of toradol.  Patients symptoms were resolved within 3-4 days
Redness and warmth to the touch. Swollen. Painful, hard knot at site approx. 2 in in diameter.
10-9-16 Pt unable to walk, ascending paralysis. Went to ER was admitted with Guillain-Barre.
After I received both doses (shots) of moderna I then had a blood test for my high cholesterol. I received a PSA Blood test results of a 4.5 psa and second follow test 4K test 5.5psa. I had a MRI done of my prostate. Then I had a prostate biopsy done which provided negative results . I got a blood infection from the biopsy and had to be hospitalized for 5 days. I believe the moderna vaccine caused my psa blood test to have resulted in a higher psa blood result. I think this was all caused by my covid moderna vaccine.
Information has been received from a certified medical assistant concerning 12 patients who on an unknown date were vaccinated with a dose of PNEUMOVAX 23 (Lot number: 663888/0627Y or 662599/1076X). The certified medical assistant reported that the 12 patients had "reactions to PNEUMOVAX 23 ranging from fevers of 102F to 103F and cellulitis". Some patients had "cold like symptoms including muscle aches, fever, cough and congestion, starting the day after the PNEUMOVAX 23 was given". At the time of the report the patient's outcome were not reported. The certified medical assistant stated that 4 patients went to the emergency room and were placed on IV antibiotics but were not admitted to the hospital. The other patients sought medical attention at the physician's office. Follow up information was received from the medical assistant who stated that would like to return PNEUMOVAX 23 that caused patient reactions in the office. Nurse stated "she understands that routine reports had been noted with PNEUMOVAX 23 in the past but had never had reactions such as this in their office". Follow up information has been received from a nurse who reported that a patient who on unknown date was vaccinated with a dose of PNEUMOVAX 23 (Lot number not specified). On an unspecified date, the patient had adverse reactions to PNEUMOVAX 23. This is one of several reports received from the same source.
Localized, immediate swelling, heat and pain to forearm. Appearance of greater than 10mm (+) PPD.
1) Typical side effect after shot 2 - fatigue. 1 day 2)  Tendonitus Right Arm- tennis elbow, arthritis- onset 1 week after shot,  cortisone shot. Not effective. Reported to Dr who said research is inconclusive but there have been reports 3) Experiencing ? brain fog? loss of balance, innattentiveness, extreme fatigue since 2nd shot, ongoing
Initial information received on 07-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. It was linked to 2019SA038790.  This case involves a 11 years old male patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number U61552AA.  No other vaccines were given.  It was a case of actual medication error due to Inappropriate age at vaccine administration. Patient received first Menactra at age 11 and then a booster at age 15 year.  It was unknown whether patient experience any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
A non-serious, spontaneous report of inner-ear neuritis, chills and dizziness was received from a nurse concerning her son, a 20-year-old male subsequent to FLUMIST. The patient's medical history included mild, occasional dust allergy, attention deficit/hyperactivity disorder (ADHD) since he was eight-years-old, previous influenza vaccination with FLUMIST (11-Oct-2008), no adverse events following any prior vaccinations, non-smoker, no alcohol use and no surgical history. Concomitant medication included methylphenidate. On 02-Oct-2009, the patient received FLUMIST. On 05-Oct-2009, the patient experienced occasional chills, periodic feeling of dizziness and feeling like his "eyes kept moving" when he turned his head. He did not experience a fever or nasal congestion or other viral symptoms. On 08-Oct-2009, he experienced severe vertigo described as the "room spinning even with eyes closed while laying in bed." He was examined by his doctor who diagnosed him with inner ear neuritis (viral). He was treated with a steroid dose pack and meclizine for seven days. On 14-Oct-2009, the events resolved.
pt recv vax 4JAN99 & 12hr post vax pt devel a febrile sz;pt then had 5 more sz on 5JAN99;tx w/phenobarbital;pt had no recurrence of sz as of 29JAN99 & phenobarbital has been discontinued
pt recvd vax 17SEP92 & immed p/inject devel fever of 103 & cried incessantly; treated w/APAP; mom of child stated that pt passed out 3 times during dinner; 24 hrs p/vax pt was asymptomatic; no further details were provided;
Lymphadenitis; This is a spontaneous report from a non-contactable consumer. An adult male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 for COVID-19 immunization. The patient experienced lymphadenitis on Jan2021. It was unknown if the patient received treatment for this. Outcome of the event was recovered on Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Minor Tenderness; brief tiredness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Minor Tenderness) and FATIGUE (brief tiredness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Exercise induced asthma since 2010. Concomitant products included THERAGRAN M from 01-Jan-1978 to an unknown date for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Minor Tenderness) and FATIGUE (brief tiredness). At the time of the report, TENDERNESS (Minor Tenderness) and FATIGUE (brief tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information was provided.    This case was linked to MOD-2021-009251 (Patient Link).
Large rash/ hives at injection site started 48 hours post injection. Itches and burns; Large rash/ hives at injection site started 48 hours post injection. Itches and burns; Large rash/ hives at injection site started 48 hours post injection. Itches and burns; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12May2021 at 15:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no known medical history. The patient did not receive any other medications within two weeks of the vaccination. The patient did not have any allergies to medications, food, or other products. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021 at 15:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 14May2021 at 12:00, the patient experienced large rash/hives at injection site started 48 hours post injection, itches and burns. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the events large rash/hives at injection site started 48 hours post injection, itches and burns were unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
First 48 hours fever(102); Chills; Headache; Vomiting; Fatigue; Diarrhea; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 6203) via an unspecified route, administered in Right Arm on 22Feb2021 at 16:30 (53-year-old of age at vaccination) as a single dose for COVID-19 immunization. The patient's medical history included high blood pressure, known allergies to amoxicillin. The patient's concomitant medications included Emtricitabine, Tenofovir Disoproxil Fumarate (TRUVADA), propranolol (PROPRANOLOL), Olmesartan (OLMESARTAN) and diltiazem (DILTAZEM). The patient had not received any other vaccine in four weeks prior to covid-19 vaccine. The patient did not have covid prior vaccination. On 22Feb 2021, the patient experienced fever (102) for first 48 hours, chills, headache, diarrhea, vomiting, and fatigue. After day two (unknown date in Feb2021) diarrhea and extreme fatigue through day 6. The patient had not received any treatment medication for the resulted events. The patient was not covid tested post vaccination. The outcome of the events was not recovered.  No follow up attempts are possible. No further information was expected.
THERE WAS NOT AN ADVERSE EVENT ON 8-5-21.    ALTHOUGH MODERNA WAS GIVE TO A PATIENT UNDER THE AGE OF 18YRS OLD.  PATIENT WAS 16 YEARS OLD.   I SPOKE WITH PATIENT'S FATHER ON 8-6-21 AND NO ADVERSE EVENT WAS EXPEREIENCE AT THE TIME OF THE CALL THAT MORNING.
Spoke with CDC explained the error in detail error is as follows 10/03/2021 Pfizer was given as first dose, on 11/11/2021 Moderna was given for second dose. The statement is that it was an understanding that vaccine could be mixed matched however, he understood as the second dose could be mixed matched but has learned that this only applies to the 3rd or booster vaccine.
This spontaneous report as received from a healthcare worker refers to a 62 years old male patient. The patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # 672675/0068AE, expiration date 12-SEP-2013) SQ on 04-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 05-SEP-2012, the patient went to emergency room and was diagnosed with Bell's palsy. The patient was told the Bell's palsy was caused by ZOSTAVAX. The patient was treated with unspecified treatment and was released; he was not hospitalized. The healthcare worker stated that the doctor did not think the Bell's palsy was caused by ZOSTAVAX. At the time of the report, the patient had recovered. Upon internal review Bell's palsy was considered as medically significant. This is one of several reports received from the same source. Additional information has been requested.