chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore Arm after second dose of vaccine; Almost felt like she was getting shingles again; Cold sores on and in mouth; Nerves tingling; This is a spontaneous report from a contactable consumer or other non hcp.   A 70-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 (Batch/Lot Number: ER8735) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included herpes from 1970 to an unknown date. Patient had been treated for Herpes on and off since the 1970s. Patient had undergone 3 surgeries in 2016 for knee revision. Patient had shingles three times in her life and received her shingles vaccine 3 years ago. Family history included that her husband had heart valve replacement in 2016. She stated that her husband had heart valve replacement in 2016 and they were both getting up there in age. Her daughter has one lung and she wanted to be able to be around her. They have been staying at home; would like to get out more. The patient's concomitant medications were not reported. Previously patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 (Batch/Lot Number: ER8734) as 1st DOSE, SINGLE for covid-19 immunization. On 02Apr2021, the patient experienced sore arm and felt cold after the first dose of the vaccine. It was reported that the patient had sore arm after second dose of vaccine from unknown date in Apr2021 till unknown date in Apr2021. On 06May2021, about three days after the second vaccine she noticed the cold sores on and inside her mouth and also had nerves tingling. It was stated she has had this before and has been being treated for herpes on and off since the 1970s. She started Valtrex for this on 10May 2021 and also had been using a topical cream. Stated the sores were improving before these medications and have continued to improve. It was asked if anyone else has had something like this happen after the vaccine. It was also stated that she thought it almost felt like she was getting shingles again. She has had shingles before and said that since then though she has had the shingles vaccine. Her arm was a little sore after the second vaccine and it wasn't bad. The outcome of the events Oral herpes and Paranesthesia was recovering. The outcome of the event pain in extremity was recovered. The outcome of the event Herpes zoster in extremity was unknown.  No follow-up attempts are needed. No further information is expected.
sore arm at injection site. I also got Flucelvax in the same left arm at the same time.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Oct2023 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 08Oct2023 at 10:30 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 02, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 03, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 04, Manufacturer: Unknown), for COVID-19 immunization; Flucelvax (Dose: 01, Manufacturer: Unknown), for immunisation; Flucelvax (Dose: 02, Manufacturer: Unknown), for immunisation; Flucelvax (Dose: 03, Manufacturer: Unknown), for immunisation; Flucelvax (Dose: 04, Manufacturer: Unknown), for immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 08Oct2023, outcome "recovering", described as "sore arm at injection site. I also got Flucelvax in the same left arm at the same time.". Therapeutic measures were not taken as a result of vaccination site pain.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
felt a little bit weird the night after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt a little bit weird the night after the first dose) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030120A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-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 FEELING ABNORMAL (felt a little bit weird the night after the first dose). At the time of the report, FEELING ABNORMAL (felt a little bit weird the night after the first dose) outcome was unknown.            Concomitant product use was not provided. No treatment reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-049863 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: patient said she is fine now.TCR document attached.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-049863:crosslink
Shortness of breath, severe edema and swelling in extremities, specially feet and legs. Extreme tiredness and fatigue.
pt recv vax; local rxn immed; gradually included systemic sym.; dph adm w/in 10 mins of vax; to er;
HPI: Patient is a 58-year-old female is here today for evaluation of right shoulder pain.  She states that this pain started after having a shingles vaccination.  She denies any injury or trauma but continues note quite a bit of pain in the right shoulder.  She likes to exercise regularly to include lifting weights in the gym and states that she is unable to do so because of the pain.  She has not had any prior problems with the right shoulder.  There is been no bruising.  She has tried some treatments to include cupping.  Hx provided by: patient Right shoulder films: Films demonstrate very minimal degenerative changes at the AC joint Treatment of her shoulder to include cortisone 3/13/2020. If no relief will have MRI.
Patient received vaccination on Saturday. On Sunday the patient experienced fever and chills and by Monday developed rash and itching. Itching still continued on Thursday.
A cough began 3 days after the vaccine. On the 4th day I woke up with a fever, heavy cough and heavy head cold. I slept the whole day. The fever was gone by morning of the 5th day, but I felt like a piece of "rubber"  the following 2 days. The cough has lingered until today (2 weeks after the first vaccine).
Very painful arm at shot site, but significant swelling and pain in armpit.  Malaise and headache as well
administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 025C21A and 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Apr-2021 at 1:28 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021 at 3:23 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2022 at 2:13 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 22-Feb-2022 at 2:13 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  It was reported that, the vaccines were initially placed in the refrigerator on 19 Jan 2022 . The vial did not undergo any temperature excursions.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow-up received contains non significant information.
Started 01/21/2020, red, hot, swollen, itchy and 3 inches in diameter.  Cortisone cream on site for two or three applications.  Site is still pink, but no swelling or itching and no other side effects.  Normal arm ache the night vaccine was administered and lasted for two days.
Patient presented to clinic with shot record that did not have most updated shots.  Gave VZV vaccine and found out after clinic that MMR vaccine was given at a different clinic 20 days prior to the VZV vaccine being given.
Pt came in with right leg swollen, feeling warm and red. Pt was seen by doctor and given Cephalexin 250mg/5m/4ml q12h X 7 days.
Rash occurring on 9/30/02 and 10/1/02 post vaccination on 9/19/02. No fever of other sx. Rash was erythematous, macular lesions of spots (1mm diameter) started on face and spread down trunk to extremity.
Bad arm pain from shoulders to elbow; arm was very itchy  from elbow to the shoulder; arm was red from elbow to shoulder; rash stayed for 2 weeks then went away; Sore at Injection site; red (4" radius) & itchy at injection site; slight itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Bad arm pain from shoulders to elbow), PRURITUS (arm was very itchy  from elbow to the shoulder), ERYTHEMA (arm was red from elbow to shoulder), RASH (rash stayed for 2 weeks then went away) and VACCINATION SITE PRURITUS (slight itching at the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient's medical history included No Adverse event,.  Concurrent medical conditions included Drug allergy (Macrodantin), Drug allergy (Demerol), Drug allergy (Dicyclomine) and Drug allergy (Cefpodoxime).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (slight itching at the injection site). On 03-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (red (4" radius) & itchy at injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (Bad arm pain from shoulders to elbow), PRURITUS (arm was very itchy  from elbow to the shoulder), ERYTHEMA (arm was red from elbow to shoulder), RASH (rash stayed for 2 weeks then went away) and VACCINATION SITE PAIN (Sore at Injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; HYDROCORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Bad arm pain from shoulders to elbow), PRURITUS (arm was very itchy  from elbow to the shoulder), ERYTHEMA (arm was red from elbow to shoulder), RASH (rash stayed for 2 weeks then went away), VACCINATION SITE PRURITUS (slight itching at the injection site), VACCINATION SITE ERYTHEMA (red (4" radius) & itchy at injection site) and VACCINATION SITE PAIN (Sore at Injection site) had resolved.            No concomitant medications were provided.      Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Additional doc 1 On 26-May-2021: Additional doc 2 On 28-Jun-2021: TCR: additional event reported (Bad arm pain from shoulders to elbow).
Tinnitis in both ears started the day after second dose (Lot EW0151 04/07/2021 at 08:00) and has gotten somewhat worse or remained constant.  All day, all night, 24/7.
This spontaneous report as received from a medical assistant refers to a 16-year-old patient of unknown gender. No information about the patient's medical history and concurrent conditions were reported. On 19-FEB-2016, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K008931, expiry date 04-MAR-2017, injected in the left arm (dose and route of administration were not reported). Concomitant therapy included meningococcal vaccine (unspecified). Administered doses were exposed to the following conditions, temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required correspondence was received.
Scalded Dermatitis on bilateral digits of hands, Full body muscle soreness and weakness, symptoms persistent for approximately a week since vaccination.
Within a few minutes of receiving her booster, she began to lose consciousness while seated. Over the next 15 minutes, she went in and out of consciousness and urinated on the floor. The school nurse was with her and stated that she has a history of similar vasovagal responses to injections, most recently with the 1st Pfizer Covid-19 vaccine. She tolerated the 2nd dose without incident. EMS was called and after about 15 minutes she began to fully regain consciousness. Though stable, she was transported because she is underage and a student.
Pt was only expecting flu vaccine and received covid vaccine instead. Was then given flu vaccine after mistake discovered.
After the vaccine my arm was a little sore at the injection site. 24 hours later I had a slight headache. Over the couple next days my arm was hurting more. I am taking medication for the swelling because it is still there.
Patient experienced brief fainting, and recovered quickly after 30 seconds. Then patient experienced nausea for around 10 minutes. Had patient remain in chair and provided supportive care and encouragement.
This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (I'mstarting to have some chest pain.) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (I'mstarting to have some chest pain.). At the time of the report, CHEST PAIN (I'mstarting to have some chest pain.) outcome was unknown.            No Concomitant product use was reported.  The patient had COVID shot from Moderna back on 26-Apr-2021 and had not been able to get in to get the booster shot. The patient was starting to have some chest pain and was asking were there any alternative that could do because there was no of that shot. The patient was quite concerned. The patient wanted to get the booster shot, and apparently the patient had difficulty finding a place to get that, and the only time the patient could get that was early in the morning. The patient had to stand in the line, so missed out two times. The patient further stated that they needed to get that shot because patient's neighbor just came down with COVID and was in the hospital. The patient just wanted to find out if they still had some protection.  The patient had COVID shot from Moderna back on 26-Apr-2021 and had not been able to get in to get the booster shot. The patient was starting to have some chest pain and was asking were there any alternative that could do because there was no of that shot. The patient was quite concerned.  The patient wanted to get the booster shot, and apparently the patient had difficulty finding a place to get that, and the only time the patient could get that was early in the morning. The patient had to stand in the line, so missed out two times. The patient further stated that they needed to get that shot because patient's neighbor just came down with COVID and was in the hospital. The patient just wanted to find out if they still had some protection.  Reportedly, the patient was going to be 81 years old.  No treatment information was provided.
Severe headache, chills, severe body aches, stuffy nose, bone / joint aches. All very severe. Debilitating. Could not work or care for my children.
This spontaneous report was received from a registered nurse refers to the patients of unknown age and sex. On an unspecified date between August 2015 and continued through October 2015, the nurse reported that unspecified number of patients were vaccinated with improperly stored oral, ROTATEQ (lot # K004795 and expiry date 11-FEB-2016). Concomitant medications were not reported. No symptoms were reported. No PQC were involved and No further information was provided. This is one of the several reports from the same source. Additional information has been requested.
Acute bilateral tinnitus developed within one day of receiving  the vaccine, also  associated with some acute hearing loss. Tinnitus is is present bilaterally daily, causing unrelenting and life altering hearing problems. Now causing emotional, mental and physical disruptions in my daily life. Difficulties sleeping, focusing, conversing with others and being present in all situations. 6 weeks post vaccine I was infected with COVID-19, the tinnitus and hearing loss worsened and on day 10 of infection I called for appointment of ENT. She prescribed hi dosage  dexamethasone taper and Acyclovir for 10 days. Repeat audiogram showed some mild improvement in hearing, no improvement in tinnitus.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Extreme pain on the tips of his toes on the left foot/On a scale of 1-10 it was 10) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 018B21A) for COVID-19 vaccination.     The patient's past medical history included Vasculitis (In 1984 and 1988 he had hospitalization for vasculitis in fingertips and toes) in 1984 and Cyanosis (Vasculitis resulted in cyanosis of just tips of toes and fingers(1984 and 1988).) in 1984. Concurrent medical conditions included Atrial fibrillation, Chronic lymphocytic leukemia since 2011, Cholesterol (Borderline cholesterol), Stroke (Previous minor stroke), Hypothyroidism, Blood pressure since 2005, Penicillin allergy, Allergy to antibiotic (Allergy to Cephalosporins) and Allergy to antibiotic (Allergy to Avalox). Concomitant products included METOPROLOL TARTRATE for Blood pressure, LISINOPRIL for Blood pressure and Atrial fibrillation, ATORVASTATIN for Cholesterol, LEVOTHYROXINE for Hypothyroidism, APIXABAN (ELIQUIS) for Stroke.   On 25-Feb-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021 at 3:00 AM, the patient experienced PAIN (Extreme pain on the tips of his toes on the left foot/On a scale of 1-10 it was 10). On 26-Feb-2021 at 3:10 AM, PAIN (Extreme pain on the tips of his toes on the left foot/On a scale of 1-10 it was 10) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported. Patient has stated that in 1984 and 1988 he had episodes with toe and finger tip it became infarcted and felled of dead tissues and he had resolved with residual effects of damage of finger and toe tips.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Added secondary reporter details, Added concomitant medication information. On 30-Jul-2021: Added patient details, patient's other relevant history were added, Added Concomitant medications and its indication.
Caller reports fatigue as adverse  event to her second Shingles vaccine. She was back to normal after three days.
Elevated heart rate Fever Rash Pain and swelling at injection site Seriously elevated blood pressure with pain in left arm and left side of body. Treated for allergic reaction at ER Given IV fluids, with medication to lower blood pressure, prednisone and benadryl. Given prescription for two days of prednisone upon release.  Advised to not work for 2 days.
Mistakenly received a third dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date received 1st dose) and Shingrix (on an unknown date received 2nd dose).   On an unknown date, the patient received the 3rd dose of Shingrix (intramuscular, unknown deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Mistakenly received a third dose of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 31-Jul-2023 The health care professionals (HCP) reported that a patient mistakenly received a third dose of Shingrix because he forgot that he had received 2 doses, which led to extra dose administered. Nothing else was reported. The reporter consented to follow up. This case is linked with US2023104119, by same reporter.; Sender's Comments:  US-GSK-US2023104119:Same reporter
LOWER BACK PAIN; Protocol: 21-0012: A Phase 1 2 Study of Delayed Heterologous SARS CoV 2 Vaccine Dosing Boost After Receipt of EUA Vaccines.  Manufacturer Receipt Date: 07-OCT-2021  A clinical investigator reported that a patient of unspecified age and sex (subject number and site number were not reported) experienced grade 1 lower back pain. The event occurred unknown days after COVID-19 vaccine  Ad26.COV2.S was administered intramuscularly for prevention of symptomatic SARS-CoV-2 virus infection. The action taken with study vaccine was not applicable. The outcome was recovering.  The subject's height, and weight were not reported. No past medical history or concurrent conditions were reported. No concomitant medications were reported.  On an unknown date, the subject was treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported.   On 24-JUL-2021, the subject experienced lower back pain due to an exercise related injury.   The subject was recovering from lower back pain.  Investigator's causality assessment:  The event of back pain was not related to the study vaccine.  Company causality assessment: The event of back pain was not related to the study vaccine.