chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my armpit is all swollen; low grade fever; A lot of pain in some of my joints, like my toes & knees; My arm is sore arm at injection site.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (my armpit is all swollen), PYREXIA (low grade fever), ARTHRALGIA (A lot of pain in some of my joints, like my toes & knees) and VACCINATION SITE PAIN (My arm is sore arm at injection site.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced PERIPHERAL SWELLING (my armpit is all swollen), PYREXIA (low grade fever), ARTHRALGIA (A lot of pain in some of my joints, like my toes & knees) and VACCINATION SITE PAIN (My arm is sore arm at injection site.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (my armpit is all swollen), PYREXIA (low grade fever), ARTHRALGIA (A lot of pain in some of my joints, like my toes & knees) and VACCINATION SITE PAIN (My arm is sore arm at injection site.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Dec-2021, Body temperature: high (High) HIGH.         Concomitant medication use was unknown Tylenol was taken between 6 and 7 am.   This case was linked to MOD-2021-406730, MOD-2021-406735 (Patient Link).
fever for 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever for 48 hours) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PYREXIA (fever for 48 hours). In April 2021, PYREXIA (fever for 48 hours) had resolved.            Concomitant drug details include none. No treatment information was provided after dose-2 events. Patient reports having allergies to tetracycline and medications allergies.   This case was linked to MOD-2022-438492, MOD-2022-438771 (Patient Link).
21SEP91 woke w/aching of lt arm, lt neck, lt jaw, feelings of generalized toothache; 22SEP91 onset of stiff neck; 23SEP91 to MD but not examined given meds;
Had to bring him to doctor on 3/10. Has shallow breathing. Had high temperature. Had febrile convulsion. Had spinal tap. Had low blood cell count. Was checked for meningitis. Had few red lesions on trunk.
SkinRash, Rash, NauseaVomiting, periorbital edema,scleral injection Narrative:
Fever of 103-104 x 2 1/2 days. Max temp 104.4 by pacifier thermometer. Fussy with fever.
Irritability/inconsolable crying since 5:30 PM. There are no further terms reported as per discharge summary rec'd 06/21/2005.
projectile vomiting; nausea; headache; Vomiting,unable to keep anything solid down; This spontaneous case was reported by an other health care professional and describes the occurrence of VOMITING PROJECTILE (projectile vomiting), NAUSEA (nausea), HEADACHE (headache) and VOMITING (Vomiting,unable to keep anything solid down) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced VOMITING PROJECTILE (projectile vomiting), NAUSEA (nausea), HEADACHE (headache) and VOMITING (Vomiting,unable to keep anything solid down). The patient was treated with METOCLOPRAMIDE (REGLAN [METOCLOPRAMIDE]) in April 2022 at a dose of 1 dosage form. At the time of the report, VOMITING PROJECTILE (projectile vomiting), NAUSEA (nausea), HEADACHE (headache) and VOMITING (Vomiting,unable to keep anything solid down) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that patient was okay for the first 2 days and then was unable to keep anything down, nausea, vomiting and headache. Patient was okay if she had electrolyte water and protein shakes.   On Friday, the patient visited ER where she was given fluids and Reglan.   This case was linked to MOD-2022-561892, MOD-2022-561891 (Patient Link).
Left deltoid redness, warm to touch 3 1/2" area. Warm compress, Advil or Tylenol 3-4 times daily per Dr.
Client was vaccinated 1st dose Pfizer at 1108, 2-3 minutes later, he stated felt his heart rate increasing. His BP 143/97 @1111, 126/88 @ 1125. He seemed calm.  Released at 1145. H=
This spontaneous report was received from a registered pharmacist concerning an approximately 62 year old female patient with no drug reactions or allergies. Medical history of the patient included an unspecified cancer. On 25-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as 5001690 and 08-MAY-2014 respectively, dose and route unspecified). No concomitant medications were reported. On 25-JUN-2013, the patient developed swelling around the injection site and a rash that extended from the elbow of the patient to her arm pit that was approximately 5 inch long after receiving ZOSTAVAX. The patient sought medical attention (contacted pharmacist). She was treated with an ice and hydrocortisone cream. No lab tests were performed. The patient was recovering from the events. The relatedness for the events was unknown for ZOSTAVAX. Pharmacist reported Varicella Zoster Virus Identification Program (VZVIP) packet. VZVIP packet was faxed. Additional information is not expected.
Severe fatigue, insomnia, severe irritability. Severe body aches and pain to touch, pain in all muscles  and pins and needles through the body.  Headache, lack of concentration and mood swings.  Body aches are better but irritability, mood swings and lack of concentration is still present to this day.
Swelling approximately 1-2 inches from site at the bicep area-rash did develop.
12/22/2021 I had routine bloodwork done and my platelet count was low: 25 10^9/L (normal 140-444).  I did not have any symptoms then or ever, blood tests were the only evidence of an issue. My PCP office told me to go to the emergency department for further testing. I was diagnosed with Acute Idiopathic thrombocytopenic purpura (ITP). I have been treated with 2 rounds of Dexamethesone (40mg/day for 4 days) and had several appointments at clinic. Currently (April 2022) my platelet level is in the normal range. Previous to this experience, I had not had any issues with platelets that I know of.
On March 11, 2021 I had two minor occurrences of vertigo.  On the morning of March 12, 2021 I had a serious case of vertigo and had to be transported to hospital.  The event lasted several hours and I was admitted overnight for observation.  The problem corrected itself within 12-18 hours.  I have had no follow-up  occurrences.  The episode occurred less than 10 days after my first Moderna COVID-19 vaccine shot.  I cannot confirm that the event was the result of a side effect, but I have never had vertigo before an all other heart, MRI, and CAT scans eliminated all common causes of vertigo.  An ENT doctor did not note any inner ear problem.  I don't know if this was a side effect, coincidence, or something unrelated, but wanted to report it just  in case.
Constant crying and screaming beyond 3 hours. Inability to move leg that received injection. Deep red rash from hip to knee and swelling of the leg that received injection.
Went to medical facility later in evening with SOB, screaming, grunting, T 99.2 Rectal, D/c with no sub, Color good, WNL
Patient says they had a rash and a slight swelling of the throat after they got the shot.
Patient came to a flu event asking for a Flu vaccine "for old people". Vaccine was given and later he returned with his wife and said he intended to receive a Covid Booster vaccine and that he had already received the Flu vaccine in September at his Doctor's office.
patient had 3 vaccines and still tested positive for covid; patient had 3 vaccines and still tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 15 year-old male patient received bnt162b2 (COMIRNATY) (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. The patient had no relevant medical history. The patient did not have COVID prior to vaccination. There were no concomitant medications. The patient did not have other vaccines in four weeks and no other medications in two weeks.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "recovered" (Jan2022) and all described as "patient had 3 vaccines and still tested positive for covid". The event "patient had 3 vaccines and still tested positive for covid" and "patient had 3 vaccines and still tested positive for covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Half an hour after vaccine my body started getting covered in hives, few hours later I has so many hives you couldn?t see unaffected skin, I started taking Benadryl which seems to move hives from one parts of body to another. Next day my lips swell up and I had difficulty breathing. I went to urgent care and was given prednisone plus Benadryl.  Two days later I developed chest pressure, and difficulty breathing still persisted. I went to ER and was given another steroid injection and more prednisone. My chest pressure still exist more than a week after vaccination, I get out of breath easily and get tired faster.
On 02/28/2021 @ 21:00 pm I felt chilly , hot and dizzy . When I got home and 24:30 am I took a shower, then I got freezing, chilly and body shaking, also I went to bathroom may time. The whole morning I felt so tired, then I went down to kitchen to  have breakfast, but I reacted with my food smell. Then I went back to my room because I couldn?t eat. During I went back to my room, I fainted at the stair. I hit my head against the wall. I did not realized I fainted after the fact. Sometime it is tough to breath and body aches. On day 2, I had headache and could not work. From then the vaccination until now (March 6th)  my heads feel heavy.
Patient presented with red rash and some swelling around elbow area of left arm (which is the same arm as vaccination). Patient reports the rash started approx. 2 pm on 6/24. He reports it is very itchy and warm to the touch. Upper and lower arm not affected rash and swelling was localized to the elbow area. Pt had a few scabs on the area which he reported were due to him scratching the affected area.  Patient reports no other symptoms occurred and is already scheduled to see PCP on Thursday to be evaluated.  Advised patient on OTC measures he could take at this time (benadyl and topical hydrocortisone) and if condition worsens to seek medical attention sooner.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.    No Medical History information was reported.   On 03-Nov-2021 at 2:35 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 2:35 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The patient was given dose from vial that were stored in an ultracold freezer which was colder than they should have been. The facility had a temperature excursion for the Moderna COVID-19 vaccine and the patient was administered the vaccine underwent temperature excursion.  Excursion duration was 1 month; on 19-Nov-2021, the vial moved from super cold freezer to the refrigerator; 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator; no vaccine state changes were noticed; none of the vials were punctured and no previous temperature excursions.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-402935 (Patient Link).
feel very weak; This case was reported by a consumer via interactive digital media and described the occurrence of feelings of weakness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feelings of weakness. On an unknown date, the outcome of the feelings of weakness was unknown.   It was unknown if the reporter considered the feelings of weakness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got shot for Shingles. The patient felt very weak. The patient asked whether it was side effect. Additional supportive information: The follow up would not possible as no contact details were available.
Possible flu-like side effects; incredible body aches; headache, and other torture; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11th October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced influenza-like symptoms, general body pain and headache. On an unknown date, the outcome of the influenza-like symptoms, general body pain and headache were unknown.   The reporter considered the influenza-like symptoms, general body pain and headache to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt date: 12-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient just got the shingles vaccine yesterday.  The patient sated that, he/she had possible flu-like side effects said by the nurse.  The patient further stated that, incredible body aches, headache and other torture. Additional Supportive Information: The follow up would not possible as no contact details were available.
Per pt: when got home, started feeling couldn't swallow, mucus build up, nauseous, SOB. Had to get up, spit, lay down. Threw up and diarrhea forcefully. Called EMS for ER. Lost a lot of potassium thru blood work. After giving the patient the flu shot, we talked for a few minutes, she went home and seemed ok as she left. She came back the next day saying she went to the ER.
Patient received second shot beyond 42 day window period; Cough; fever; chills; Muscle aches; shortness of breath; Loss of taste; Loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second shot beyond 42 day window period) and COUGH (Cough) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic respiratory disease NOS since 2001.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, 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 DYSPNOEA (shortness of breath), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second shot beyond 42 day window period), COUGH (Cough), PYREXIA (fever), CHILLS (chills) and MYALGIA (Muscle aches). The patient was treated with BAMLANIVIMAB (intravenous) 21-Jan-2021 for COVID-19, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second shot beyond 42 day window period), COUGH (Cough), PYREXIA (fever), CHILLS (chills) and MYALGIA (Muscle aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, SARS-CoV-2 test: (Positive) positive.         This case was linked to MOD-2021-014458 (Patient Link).
Patient tested positive after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested positive after getting the vaccine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced COVID-19 (Patient tested positive after getting the vaccine). At the time of the report, COVID-19 (Patient tested positive after getting the vaccine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided.  Treatment information was not given.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: No specific follow-up information recorded.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 28-AUG-2015 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB, (dose and frequency and route of administration were not provided), lot # reported as L020157, expiration date 12-MAR-2018. No concomitant medication was reported. At the time of this report, no adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Vaccine was given outside of expiration date for vial at room temperature:  vaccine given at 50 hours with vial at room temperature.   Pt contact info not vailid, unable to contact patient.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, unspecified patients were vaccinated with improperly stored VARIVAX lot # M009764, expiration date: 23-FEB-2018. No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Became lightheaded and dizzy at roughly 1pm, had an elevated blood pressure(138/99) when tested at 345pm. Continued to be lightheaded and dizzy, at 620pm blood pressure was 167/107. Twenty minutes later I was advised to sit by a fellow CNA, according to nurse became unresponsive, however still aware of surroundings, and eyes rolled to back of head. Vitals were taken and blood pressure was 193/147. Staff called 911. Paramedics came and accessed, blood pressure came down to 167/103. Blood pressure has been elevated since event.
(R) arm - injection site warm, swollen - red next day - treated for cellulitis 8-8-11.
Patient received 2 doses of Varivax and immunity level is not achieved; This spontaneous report as received from a physician via company representative, referring to a female patient of unknown age. The patient had no pertinent medical history neither drug reactions or allergies. Information regarding the patient's concurrent conditions and concomitant therapies was not provided. It was reported that the patient did not have previous varicella vaccinations and a titer was checked and was low.  On 11-JUN-2019, the patient was vaccinated with an initial booster of varicella virus vaccine live (oka/merck) (VARIVAX), subcutaneously (dose, route of administration, vaccination scheme frequency, anatomical site of vaccination, lot number and expiration date were not reported) as prevention of varicella. Subsequently, another titer was drawn and remained low. Therefore, on 30-MAY-2020, the patient was vaccinated with a second booster of varicella virus vaccine live (oka/merck) (VARIVAX), subcutaneously (dose, route of administration, vaccination scheme frequency, and anatomical site of vaccination were not reported; lot number S030244 as been verified to be valid, expiration date reported and validated as 26-SEP-2021).  On 22-AUG-2020, subsequent serologic testiong-titers was drawn after second booster of varicella virus vaccine live (oka/merck) (VARIVAX) and still remained low (antibody test negative). Additionally, it was reported that no treatment was given for the adverse event and the patient did not seek medical attention.  The outcome of antibody test negative was reported as not recovered. The causal relationship between the event and the suspect vaccine was not reported.
Before administering the vaccine the nurse with interpreter assistance asked  patient "is there any chance you may be pregnant". Patient replied no and the vaccine was administered. While walking the patient out to the lobby the patient turned to the nurse and stated " I think I'm pregnant". At that time nurse obtained urine to test for pregnancy and test was positive. Patient was immediately seen by an MD who referred her to an OBGYN.
pt recv vax & devel flare, splotchy red rash @ the inj site;pt recovered;