chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MORE TIRED; WEAKER THEN EVER BEFORE; This spontaneous report received from a patient via company representative through social media concerned a patient of an unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (form of admin, route of admin, and batch number were not reported) dose, start therapy date were not reported 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date (after the patient received two shots), the patient was more tired, and weaker then ever before (dose number in series 2). It was reported as "agree ever since got the two shots I have become more tired and weaker then ever before so I believe Covid shot has something to do with it long term effects got shots in April". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from more tired, and weaker then ever before. This report was non-serious. This case, involving the same patient is linked to 20221131316 (dose number in series 1).
Reports shortly after leaving health department noticed metallic taste in mouth (which is still present}. Doesn't remember well where went but did some shopping - thinks was in store. Was confused and unable to prepare meal and do usual chores last evening.  Today is felling better. Thinking is clearer. Does have headache today. Says does not remember doing chores yesterday afternoon but can tell did them.  There is stress in personal life at this time. Feels disorganized.
Initial information received on 07-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 15 months old male patient who received an expired DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE for Immunisation; and FLULAVAL for Immunisation. On 07-Dec-2018, the patient received a 0.5 ml fourth dose of DAPTACEL (lot number: C510BA and expiry date: 04-Dec-2018) via intramuscular route in the thigh NOS. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event or not. 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 and Module VI of the 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. List of documents held by sender: none.
Systemic: Rash (other than injection site)- Mild, Systemic: Nausea- Mild, Systemic: Vomiting- Mild, Systemic: Other- pt had itchy eyes, arms, neck and numbness around eyes
Pt got the shot at around 5 PM on 11/2/14. Approached the pharmacy counter about 5 min after complained of dizziness and as time passed she mentioned having headaches. She was very cold and pale looking. Paramedics were called in. She rested, lying down about 15-20 mins - stabilized, left.
Sudden total hearing loss in R ear.  R ear is completely dead.  Has not responded to oral steroids or steroids injections.  R ear is a dead ear.  Pressure and ringing is present in L ear due to L ear overcompensating for the total hearing loss in the R ear.
patient developed area of redness on right cheek initially then had red spots in his diaper area.  Has progressed to bilateral cheek redness, trunk rash and hives.
After my 2nd dose, I ran a slight fever and had some soreness in mt arm. I felt fatigued. At the end of April, I got diverticulitis and was treated with antibiotics. I never felt like I got over the diverticulitis and I still had the fatigue. At the end of June, I was experiencing shortness of breath and continuing fatigue. August 11, I was diagnosed with diverticulitis again. I was put on different antibiotics, cipro and flagellin. My iron saturation was also noted as low, so I was put on iron as well. I was beginning to feel better but then I had an episode of severe abdominal cramping, nausea etc. On 9/3 I went in and had a COVID test which was negative. I then had a CT scan on 9/9/2021 to rule out continued diverticulitis. I was put on Bentil for the abdominal cramping which has helped a lot. I will be having a stomach emptying test with a GI specialist. I had a 7-day heart monitor which showed intermittent runs of sinus tachycardia. It was short runs so my doctors suggested it was not something to follow up on. I have never had this before. I also ran a 100 deg fever which I have never experienced with any vaccine before and I have had many vaccines since I am a nurse.
breathing issues; This is a spontaneous report from a contactable consumer. A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0185) at single dose for COVID-19 immunisation on 04Jun2021 (61-year-old at vaccination). Relevant history included Lyme Disease. Relevant concomitant drug was unknown. The patient previously received the first dose of BNT162B2 (Lot number: EW0176) at single dose for COVID-19 immunisation on 14May2021 with not reaction. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced breathing issues on 04Jun2021. The event caused to Emergency room/department or urgent care visit, and the patient was hospitalized. The outcome of the event was not resolved. Unknown if treatment received or not. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient has not been tested for COVID-19.   Information on Lot/Batch number was available. Additional information has been requested.
Neck pain radiating into head starting at 2300.  By 2330 full body ached, severe pain, chills, nausea, and temperature of 101.4.  Took 1000mg of Tylenol and 200mg of Celebrex but nothing touched the pain.  This lasted until September 18, 2021 at 0400.  Nausea continued through the day of September 18, 2021
Product temperature excursion issue; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was an excursion from their freezer on 01-Oct-2021.   They used the excursion tool but there was no option for the excursion they experienced.   The tool only gives options for excursions above one hour and not less than, so she does not knowhow to do the analysis.   She states that her team already knows the recommended temperatures and wants to know if the vials were still okay to be used because they were administered to 118 patients.  No concomitant medication was provided.  No treatment medication was provided.
After my 1st vaccine I just got tired but 3 days after my 2nd vaccine I got Meniere's disease for the 2nd time and cannot get rid of it. The only other time I had Meniere's disease was in 2018 a few days after a flu vaccine where I ended up in the ER. I spent a lot of time, doctor visits room 2GP's, ENT and tge best help was by Dr. to clear it up but now it's back ever since March 20. I'm going to Dr., a Chiropractor.
raised bumps/rash; redness at injection site; injection site pain; headache; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 14th January 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site pain and headache. On 16th January 2020, the patient experienced raised rash. On an unknown date, the outcome of the injection site erythema, injection site pain and headache were recovered/resolved and the outcome of the raised rash was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, headache and raised rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. Within 12 hours after vaccination, the patient experienced pain at injection site of left arm, headache, and redness at injection site. Two days after vaccination, the patient began to develop a rash, described as raised bumps, on her chest. Outcome for adverse events injection site redness, injection site pain and headache was reported as recovered in database while discrepantly mentioned as recovered resolved with sequeale in the source document. The reporter consented to follow up.
After 2 hours after getting vaccine on my left arm. It started to get more sore then usually after getting a shot on your arm.  I started to think maybe the nurse gave me a shot to close to my shoulder bone. But that was not the case. By the following hours I could bearly move my left arm. I could not raise my arm above my chest with out sharp pain on left shoulder.. I left work early to work from home and it was hard to drive with the pain. By 7:00pm 1/27/2021 The pain was unbearable I had to take 2 ibuprofen 800 mg and a muscle relaxer.  I could not sleep all night the next day I called out from work. I woke up with still sharp arm pain and muscle soreness all over my body, tight muscles on both back shoulders and my back.  felt body aches.
Pt called to report that approximately 20-30min after receiving vaccine, she began to feel dizzy, had a headache, and could "feel her heartbeat."  Recommended patient sit, rest, drink some fluids and if symptoms persisted, she should have someone drive her back to the Health Center for evaluation by a medical provider.  Pt did return to the  Health Center and was evaluated by NP.
RASH ALL OVER FACE ONLY; SLIGHT FEVER; CHILLS; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's past medical history included Asian flu, and concurrent conditions included GERD, high blood pressure, arthritis in hands, gout, tuna fish allergy, allergic to tarte/acidic foods., allergic to bread, and no alcohol use, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 09:00 for prophylactic vaccination on left deltoid. Concomitant medications included allopurinol for gout, and atenolol for high blood pressure.  On 12-MAR-2021 21:00, the subject experienced chills. On 12-MAR-2021 21:00, the subject experienced slight fever. On 13-MAR-2021, the subject experienced rash all over face only. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and slight fever on 13-MAR-2021, and had not recovered from rash all over face only. This report was non-serious.
Redness, pain, swelling. Injection site is approx 2" below deltoid area. Arm has been painful since injection, swelling and redness developed soon after injection, reported this to spouse on 1/31/2013. Swollen area is about size of half-dollar. MD office called morning of 2/1/13, msg left for phone nurse with above info.
I was hospitalized for difficulty breathing.  Stayed 5 dayd in ICU and 2 in regular.
Itching all over body. Currently still itchy, I?m taking Benadryl. No other issues
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were recovered/resolved. It was unknown if the reporter considered the injection site pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The adverse events were lasted for at least a week. The patient had denied permission to contact their physician. No further details were provided. For tolerance to 2nd dose, refer case US2018GSK153648, for same patient.
Immediately after the vaccine I had a metallic taste in my mouth that went away.; After 20 minutes it felt like I had just received a novocaine injection in the left side of my jaw. It's sore and feels like very mild numbness and tingling.; After 20 minutes it felt like I had just received a novocaine injection in the left side of my jaw. It's sore and feels like very mild numbness and tingling.; After 20 minutes it felt like I had just received a novocaine injection in the left side of my jaw. It's sore and feels like very mild numbness and tingling.; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 22Apr2021 at 10:15 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and obesity. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN), omeprazole (PRILOSEC) and ubidecarenone (COQ10); all from unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 25Mar2021 at 12:45 (at the age of 38-years-old) as a single dose for COVID-19immunisation. 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 vaccination. On 22Apr2021 at 10:45, immediately after the vaccine, the patient had a metallic taste in her mouth that went away. After 20 minutes it felt like she had just received a novocaine injection in the left side of her jaw. It was sore and felt like very mild numbness and tingling. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event had a metallic taste in her mouth that went away was resolved on 22Apr2021, while that of after 20 minutes it felt like she had just received a novocaine injection in the left side of her jaw; it was sore and felt like very mild numbness and tingling was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
9pm-2 am Severe shivering; 2 am-8 am Fever
swollen area; redness; area of the injection was much lower than the first shot; arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), INJECTION SITE SWELLING (swollen area), ERYTHEMA (redness) and INJECTION SITE REACTION (area of the injection was much lower than the first shot) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE and METOPROLOL for blood pressure and thyroid. On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm sore). On 11-Feb-2021, the patient experienced INJECTION SITE SWELLING (swollen area), ERYTHEMA (redness) and INJECTION SITE REACTION (area of the injection was much lower than the first shot). At the time of the report, PAIN IN EXTREMITY (arm sore), INJECTION SITE SWELLING (swollen area), ERYTHEMA (redness) and INJECTION SITE REACTION (area of the injection was much lower than the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: SEVERE DROP IN BP TO 90/52 AND EXCESSIVE SWEATING - TSHIRT SOAKED WITHIN A FEW MINUTES INTENSE THIRST-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Shakiness-Mild, Additional Details: PATIENT HAD IMMEDIATE DROP IN BP , EXCESSIVE SWEATING, EXCESSIVE THIRST AND SLIGHT SHAKING.
0 hours: Injection (~3 PM) +6 hours: Malaise,  +7 hours: Chills, slight fever +8 hours: Chills, fever, nausea, vertigo  +12 hours: Fever, awake every 60 mins from chills, headache +18 hours: Fever, chills, nausea, los s of appetite, migraine, fatigue + 24 hours: Fever broken, headache, fatigue, vertigo on movement + 30 hours: Malaise, mild headache, fatigue +36 hours: Malaise, mild headache, fatigue +48 hours: Slight malaise, Headache +54 hours: Baseline
Cannot move bowels.  It like my rectal muscles cannot contract.  No urges any more signaling movement coming.
Said his arms was kind of sore; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Aug2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 73 years for COVID-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (primary immunization series complete; lot number: unknown), for COVID-19 immunization; BNT162b2 (dose number unknown, single; lot number: unknown), administration date: 2022, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16Aug2023, outcome "unknown", described as "Said his arms was kind of sore". Additional information: The patient reported that he went to the pharmacy at the time of the report and told them he wanted the new Pfizer COVID-19 vaccine. He said on TV they said to get your new COVID shot. So he was given a COVID shot and said his arms was kind of sore. He then learned that he was given the Pfizer COVID vaccine, bivalent for adults and told them that it's not the one he wanted. He was told he was given another dose of the vaccine he got by the end of last year. So patient was wondering if the new vaccine comes out in September or October, the fact that he had that shot, if he can get the new one by then. Of note, he said all his COVID vaccines are Pfizer's. He also shared that his wife died due to COVID, mentioned she was his high school sweetheart and said that he was okay however due to depression, he's on medication he said.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Within 12 hours, right leg started to hurt and within 24 hours, marked swelling of entire thigh to knee. Hot, red, tender to touch. Fever (low grade) 24 hours after shot.
Fever of 103 for 3 days - crying and fussy for 3-4 days unconsoleably. Local reaction to right thigh.
Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. The patients' medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated unknown doses of improperly stored VAQTA (25/0.5, dose, frequency and route were not reported, data logger was involved), lot # was L041676 with expiration date 15-MAR-2017. The VAQTA was improperly stored at 9 centigrade for 30 hours and then was back in range. No adverse effects reported. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
My normal heart rate of 45-50 shot up to 72! It stayed that way for a couple of days.  At first it was very scary since I didn't know when it would slow.
Within 24 hours, arm was very red, hot to touch, and swollen. Redness was spreading down/around arm, continuing to get worse as time went on. Went to doctor 10/5/22 and was prescribed triamcinolone 0.5% ointment and prednisone 20mg tablets.
One of two pt's who recvd the vax w/in 48 hrs exp fever, chills, nausea, vomiting, diffuse muscle aches & a large local rxn consisting of redness & tenderness;
rash under skin 3 days of fever 100-101;shaky, balance off, all started at about 9 days p/shot;
Hospitalized 9/23/22-9/27/22 Weakness, malaise, nausea, headache, cough, tachypneia, debility,
I've got the second dose of Pfizer Covid vaccine on 5/6/21 evening. About a day and a half later on 5/8/21 around 1 am, my symptoms started. It has been 4 days and i am still having side effects. First it was pain the arm them throughout my body. Later my bones were all in pain while being very weak. Last 2 days, the pain has subdued by my entire body is burning up from the inside. Currently, in still weak, tired, but mainly feeling of burning inside my body. The vaccination site which is my left arm still feels kinda sore and hot.  I have been taking 2 Tylenol 500mg tablets every 6 hours, vitamin c every day, vitamin d 5000ui every day, and ibuprofen 800mg twice a day only for 2 days.