chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hashimotos disease flared; increase in her blood pressure; increase in her heart rate; fatigue; forced to quit her part time job because of the brain fog; quit her part time job; she slept for 2 weeks; This case was reported by a consumer via call center representative and described the occurrence of hashimoto's disease in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of back pain (1st dose received in september 2019 for further tolereance refer US2021053291).   In December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced hashimoto's disease (serious criteria GSK medically significant), increased blood pressure, heart rate increased, somnolence, fatigue, foggy feeling in head and activities of daily living impaired. On an unknown date, the outcome of the hashimoto's disease, increased blood pressure, heart rate increased, somnolence, fatigue, foggy feeling in head and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the hashimoto's disease, increased blood pressure, heart rate increased, somnolence, fatigue, foggy feeling in head and activities of daily living impaired to be related to Shingrix.  Additional information were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of shingrix and experienced hashimotos disease flared, causing her to have an increase in her blood pressure and an increase in her heart rate. The reporter stated that slept for 2 weeks, fatigue, and was forced to quit her part time job because of the brain fog. All the Symptoms were resolved. The reporter did not want to share health care professional information. The reporter did not  consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021053291:same patient,1st dose
Dizziness within 2 hours after getting Pfizer Injection. It's been 4 days and I'm still have the dizziness, it's almost like having Vertigo.  I haven't been able to get to my physician because we have had lots of ice and snow. The city is basically locked down due to inclement weather until further notice.
At 3:00 A M the next morning Sep 3, Dizziness, Light Headed, Nausea,  Blacked out and fell on the fioor trying to throw up
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 17-year-old patient who received Hepatitis A vaccine (batch number LY35X) for prophylaxis.   On 13-JAN-2023, the patient received the 2nd dose of Hepatitis A vaccine. On an unknown date, an unknown time after receiving Hepatitis A vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
TASTE BUDS AFFECTED; METALLIC TASTE; This spontaneous report received from a patient concerned a female of unspecified age. 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, batch number: Unknown and expiry: unknown) dose was not reported, administered on 09-MAR-2021 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 subject experienced taste buds affected, and metallic taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the taste buds affected and metallic taste was not reported. This report was non-serious.
sore arm at injection site, headache, stiff neck, body aches all over, fever 102 degrees Thursday night, chills, shakes  Symptoms began Thursday (04/01/2021) evening and continued throughout the night to Friday (04/02/2021) afternoon about 5 pm when fever broke
THESE SIDE EFFECTS FOLLOWED MY 4/8/21 SECOND PFIZER VACCINE: 36 hours post second Pfizer vaccine I experienced debilitating full body pain; 48 hours post vaccine a 101 degree fever; 60 hours post-vaccine debilitating sharp pains in right thoracic region (difficulty drawing breath); 72 hours post-vaccine experienced  swelling and tenderness in right underarm (right deltoid was site of injection); 72 hours post vaccine swelling and tenderness in neck on right side.
After shot arm was sore. Woke up felt not herself, tired achy.  Took Tylenol went to sleep. The next day she couldn't move. Was in bed in a ball.  Today she can walk a little bit. Went to pharmacy to get more Tylenol. Cannot concentrate.  Chills and fever. Bolt of electricity down spine. Very tired.
Day 2:  flu like symptoms. W/o fever. Confined to bed Day 3:  same but part time in bed Day 4:  reduction in flu like symptoms but disoriented and lethargy and headache  Day 5:  disoriented and lethary Day 6:  same Day 7:  shakey and lethargic Day 8:  same
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 23-SEP-2013 the patient was vaccinated with MMR II (lot # H015829, expiration date 24-AUG-2014). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes and on 20-SEP-2013 for 40 minutes. No known adverse effects. Additional information has been requested.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender with drug hypersensitivity to Astelin, Astepro, Augmentin, cephalexin clindamycin, erythromycin, MACROBID, penicillin, prednisone (reported in MARRS case #1712USA000871) Flagyl, Bactrim, rhinitis and hypercholesterolaemia as concurrent conditions.  On 06-NOV-2017, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis. Concomitant therapies included influenza virus vaccine (unspecified), rosuvastatin calcium (CRESTOR), levothyroxine sodium (LEVOXYL), omega-3 marine triglycerides and cholecalciferol. The reporter stated that approximately on an unspecified date in November 2017 (reported as after administration of ZOSTAVAX), the patient experienced injection site "tingling and dryness" (injection site paresthesia)(injection site dryness), also experienced tingling in her arms and through the rest of her body (paresthesia). Furthermore, the reporter stated that the patient experienced dryness of skin (dry skin) and itching of throat (throat irritation). The outcome of injection site paresthesia and injection site dryness was unknown. The outcome of paresthesia was reported as recovering. The outcome of throat irritation and dry skin was reported as not recovered. At the time of this report, the causality between the events and ZOSTAVAX was not reported.; Sender's Comments:  US-009507513-1712USA000871:
nights of hard sweating; fever`; This spontaneous case was reported by a patient and describes the occurrence of NIGHT SWEATS (nights of hard sweating) and PYREXIA (fever`) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (symptoms were tiredness, abrupt changes in pulse and shortness of breath.) and EBV infection (when patient was 24 years old which left me ailing for over 2 years.).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (nights of hard sweating) and PYREXIA (fever`). At the time of the report, NIGHT SWEATS (nights of hard sweating) and PYREXIA (fever`) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Immunology test: (Positive) positive.         No concomitant medication was reported.   Patient have been reading that the coronavirus could possible reactivate the EBV in the body and patient was convinced that the symptoms patient suffered were related to this. Unfortunately, no medical test has been able to prove this, only the fact that patient showed a positive Ig-G test and no antibodies after the fever from Covid-19 receded. Patient took second dose of Moderna vaccine and after a few nights of hard sweating and fever, patient situation improved dramatically. Patient could now run and cycle without any problems in pulse. Patient also have no signs of tiredness.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) CHEST PAIN
On day of admission patient was extremely weak and lethargic, patient normally ambulates however today he was not able to ambulate and was noted to have a fever, nonproductive cough and generalized weakness Sepsis related to COVID Hypotensive, hypoxic ,tachycardic, fever, however normal white blood cell count Chest x-ray unofficial interpretation negative for acute infiltrate Inflammatory markers elevated CRP 14.5
pt devel periorbital cellulitis @ 14mos of age p/receiving vax x 3 on 21MAR94, 29JUN94 & 15AUG94;
Breakthrough case admission after 3 vaccines Pfizer 3/11/21 Lot# En6207;  Pfizer 4/1/21 Lot# ER8737;  Pfizer 8/28/21 Lot# Ew0198
1. Immediate sore arm; at 24 hours: red, inflammed circular area approx 2inx3in @ site of injection and currently Persisting  65 hours post injection and itching.  2. Generalized Fatigue and body aches and joint aches and stiffness with tingling sensation throughout body. Onset 8 hours post injection; worsening from 12-36 hours post-injection; slowly decreasing and currently continues at 65 hours with generalized moderate fatigue and aching. 3. Low-grade fever 14 hours post injection lasting approx 8 hours. 3. Diarrhea started 36 hours post injection lasting until 48 hours, currently 65 hours lower GI discomfort. 4. Brain -fog 12 hours post-injection...continuing.  No treatment: just resting .
Extreme fatigue and muscle ache throughout body, fever, chills and shaking, intense headache. Vaccine was administered at 9:30 am. Symptoms began around 3:30 pm and lasted until approximately 5:00 am the next day.
fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Treatment medication not provided. Concomitant medication not provided.   This case was linked to MOD-2021-020592 (Patient Link).
Patient received two immunizations in the same arm. Her arm is swollen with hives, painful to move, and hot to the touch. She was prescribed prednisone from her provider.
I currently have Hashimoto disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Immunocompromised" (unspecified if ongoing), notes: an immunocompromised person; "Childhood asthma" (unspecified if ongoing); "Autoimmune condition" (unspecified if ongoing), notes: more than one autoimmune condition, my mother also has an autoimmune disease. The patient's concomitant medications were not reported. The following information was reported: AUTOIMMUNE THYROIDITIS (medically significant), outcome "unknown", described as "I currently have Hashimoto disease". clinical information: Caller was an immunocompromised person caller have had childhood asthma and more than one autoimmune condition, caller currently have Hashimoto disease". Caller did not specify whether this diagnosis was prior to her vaccination with the Pfizer-BioNTech COVID-19 vaccine for 12 years and older formulation (purple cap). Caller's age was not requested. Patient's demographic information: Female, age unknown.Caller provided information on additional potential AE's. Caller stated: "My husband that has asthma, my children also have autoimmune diseases and my mother also has an autoimmune disease. Wil they qualify to receive a third primary series vaccination and a booster dose?" Caller did not specify whether these diagnosis were prior vaccination with the Pfizer-BioNTech COVID-19 vaccine for 12 years and older formulation (purple cap). Responded as per attached. Informed caller: "COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older. COMIRNATY and the Pfizer-BioNTech COVID-19 Vaccine are also authorized under EUA to provide a 2-dose primary series to individuals 5 years of age and older; a third primary series dose to individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise; a single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA); and a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Left upper arm shows large area of redness and swelling from deltoid down to slightly above elbow on 8/4/04.  Instructed mother to apply ice to site.
pt recv vax 6AUG97 & 11DEC97 pt exp a patchy breakthrough of chickenpox;
No additional AE details; patient was admnistered her second dose of PNEUMOVAX 23 on 07-OCT-2021 that had expired on 01-OCT-2021; This spontaneous report was received from a pharmacist and refers to a 59 year old female patient. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.     The pharmacist reported that on 07-OCT-2021 (also reported as "today"), the patient was vaccinated with her second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, lot number T003597 that had expired on 01-OCT-2021, for prophylaxis (dosage, route of administration and anatomical location were not reported). No additional adverse event (AE) details.
She also is diabetic and has high eye pressure.; The pain is going to her neck and does not let her raise her arm. She also mentions that she also have a sharp pain in her belly and she did not have it before.; Feeling that her shoulder is killing her.; The pain is going to her neck and does not let her raise her arm. She also mentions that she also have a sharp pain in her belly and she did not have it before.; she also have a sharp pain in her belly; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 30Apr2021 as a single dose for covid-19 immunization. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) via unspecified route on an unspecified date. The patient's medical history included diabetes. The patient's concomitant medications were not reported as single dose. It was reported that the patient felt that her shoulder was killing her. The patient stated that the pain was up to her neck and does not let her raise her arm. The patient also stated that she also had a sharp pain in her belly which did not had it ever before all on 19May2021. The patient also stated that she was also a diabetic and has high eye pressure. Patient called her doctor this morning and could not find him so she she left a message. Patient did not want to go to the ER and she wanted to know why she was having these adverse reactions after 20 days of taking the vaccine. The patient was explained about the reports of muscle pain and pain in the injection site, the possible duration and being more intense after the second dose. The patient was recommended to consult her physician to determine the cause of her pain. Therapeutic measures were not taken as result of AE. The outcome of the events was unknown.  Information on lot number/batch number was requested.
Fever 101 ax & rash following immun on 8OCT91; fever lasted 2 days; fine red rash covering body began 9OCT MD visit stated rxn to immun;
I received one (1) shot of the HPV vaccine Gardasil on 09/25/09.  Two months later, on 11/19/09, I went into my doctor with petechiae (red blood dots) on my legs, excessive bruising on my legs and arms, and mouth lumps (inside lower lip). I took a blood lab and when the results came in, I was at 8,000 platelet count and told to go to the ER right away.  Treatment (steroids alone) lasted for 2 days, and had to go back to the ER, this time with arm numbness/temporary paralysis added to the issue.  Treatment with a stronger medication (Anti-D) was administered, but again, two days later, I was back in the ER.  A third treatment was administered (IVIG), and it lasted two weeks.  Now I am scheduled to go back to the hospital for admission to do another dose of this.  Aside from pain at the injection site for over a month, I have also now been diagnosed with the autoimmune disease thrombocytopenia (low blood platelets) which I have been dealing with for over a month at an aggressive level, and it shows no signs of getting better.  During this condition, I have had arm numbness/temporary muscle paralysis, as well.  12/23/09 PCP medical records received. Service dates 11/19/09 to 12/21/09. Includes ED visit 11/21/09. Assessment: Idiopathic Thrombocytic Purpura. Patient c/o feeling warm, fatigue. Cough, congestion. Oral contraceptive use. Hematochezia. Paresthesia. Bruising on forearms. Presents at ED with petechiae. Multiple bruises thighs and feet. Bright red blood from nose. Tired. Diarrhea. Bumps in lower lip. Thrombocytopenia.  12/28/09 Discharge summary, hospital records received. Inpatient Service dates 12/8/09 to 12/11/09. Includes Labs from 11/23/09 to 12/22/09. Assessment: Thombocytopenia, Idiopathic Thrombocytopenic Purpura.  Prior hospital admissions 11/19/09 to 11/23/09 for Thrombocytopenia / Idiopathic Thrombocytopenic Purpura. 12/2/09 to 12/3/09 for Thrombocytopenia, weakness, heaviness. Patient presented after follow up labs showed a platelet count of 20. (R) arm subjective weakness, headache, nose bleed, petechiae on chest. Shortness of breath. IVIG and steroid administration. Migraine headache. Oral contraceptive use.
My body and spescifically back hurt a lot and was somewhat impossible to focus 2-3 day from the vaccine
Pain in vaccinated arm, all the way to palm, Neck pain & headache since vaccine received, Hot flashes (many per day).
Patient states her arm became sore, red and swollen with a welt like lesion at the site where varicella injection was given. Area also became itchy.
Pt complained of left arm pain after 4 hours Pneumovax vaccine was given in left deltoid with swelling.
Weakness; Diarrhea; Red knot two inches around arm; Red knot two inches around arm; Arm swelling; got up and felt heat up legs into entire body; lightheaded,thought I was going to faint; Vommiting; arm itching; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), DIARRHOEA (Diarrhea), FEELING HOT (got up and felt heat up legs into entire body), DIZZINESS (lightheaded,thought I was going to faint) and VACCINATION SITE PRURITUS (arm itching) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Broken bones (22 broken bones due to car accident) and Brain injury (due to car accident). Concurrent medical conditions included Non-Hodgkin's lymphoma. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), DULOXETINE HYDROCHLORIDE (CYMBALTA), PANTOPRAZOLE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), LAMOTRIGINE (LAMICTAL), ALPRAZOLAM (XANAX), LACTOBACILLUS ACIDOPHILUS (ACIDOPHILUS [LACTOBACILLUS ACIDOPHILUS]), BIOTIN and COLECALCIFEROL (D3) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (arm itching) and NAUSEA (nausea). On 19-Feb-2021, the patient experienced VOMITING (Vommiting). On 28-Feb-2021, the patient experienced FEELING HOT (got up and felt heat up legs into entire body) and DIZZINESS (lightheaded,thought I was going to faint). On an unknown date, the patient experienced ASTHENIA (Weakness), DIARRHOEA (Diarrhea), VACCINATION SITE INDURATION (Red knot two inches around arm), VACCINATION SITE ERYTHEMA (Red knot two inches around arm) and VACCINATION SITE SWELLING (Arm swelling). At the time of the report, ASTHENIA (Weakness), DIARRHOEA (Diarrhea), FEELING HOT (got up and felt heat up legs into entire body), DIZZINESS (lightheaded,thought I was going to faint), VACCINATION SITE PRURITUS (arm itching), VACCINATION SITE INDURATION (Red knot two inches around arm), VACCINATION SITE SWELLING (Arm swelling) and VOMITING (Vommiting) outcome was unknown and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
headache; fatigue; weakness; joint pain; pain and redness at injection site; pain and redness at injection site; fever; fogginess; This is a spontaneous report from a contactable consumer (patient). A 52-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6198 and Expiry date were not reported) dose 1, via unspecified route of administration, administered in left arm on 03Mar2021 at 17.30, single for COVID-19 immunization. The patient's medical history included a Covid-19, ankylosing spondylitis, hashimoto's thyroiditis, seasonal allergies, dander allergies, indoor allergies, chronic sinusitis, asthma. The patient had allergies with medication prochlorperazine, food chocolate. The patient did not receive any treatment. The patient was not Covid tested post vaccination.The patient took unknown concomitant medications in two weeks. On 03Mar2021 at 07:00 PM(1.30 mins after vaccination), the patient experienced a headache, fatigue, weakness, joint pain, pain and redness at injection site, fever, fogginess. The outcome of events were not recovered.   No follow-up attempts are possible. No further information is expected