chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administration of an expired Bexsero dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXC05AA, expiry date 31-MAR-2023) for prophylaxis.   On 06-JUL-2023, the patient received Bexsero. On 06-JUL-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: administration of an expired Bexsero dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-AUG-2023 The pharmacist reported that the administration of an expired Bexsero dose to a patient. The reporter asked for guidance on this situation. The reporter consented to follow up. The patient received a Bexsero vaccine which was already expired, which led to expired vaccine used.
BREAKTHROUGTH COVID: FULLY VACCINATED WITH VIRAL COVID PNUEMONIA. 91-year-old female who presented with worsening renal function and significant electrolyte abnormalities as well as acute on chronic CHF exacerbation all likely related to renal declined.  She was adamant in opposition to dialysis.  Cardiology Nephrology were consulted for medical management.  Patient received Lasix drip, Lokelma for fluid electrolyte management.  Ultimately patient stated she would prefer hospice in the GI P setting so that she can "die peacefully."  Patient seems competent to make medical decisions.  Now transitioning to IP hospice.
Pt experienced a burning sensation at the injection site for 1 hour. 6-7 hours post vax pt experienced a fever, 7-9 hours post vax, the pt developed a headache, and fever was 102. Pt woke up on the following morning with sore muscles and flu like symptoms, a general skin rash (full body) with injection site red. Flu symptoms increased, and lasted over 2 weeks.
Pt called requesting appt.  Pt states the site she received her Tdap injection the other day has become red, hard and warm.  Pt states it is slightly painful.
Information has been received from a nurse referring to a patient of unknown age and gender, who completed 3 dose series of GARDASIL on 24-JUL-2013, 26-AUG-2013 and 29-JAN-2014, respectively. On an unknown date in July 2016, the patient was inadvertently vaccinated with a dose of GARDASIL 9 (lot # L023230 with expired date 28-JUL-2017, dose and route were unknown. No adverse effect was reported. Additional information is not expected since the reporter refused further contact.
Inflammation under my tongue and on my tongue.  Swelling under my tongue swelling  on my lips (upper and below)
TC received from client at 3:44 pm on 2/5/2021.  Reports receivng COVID 19 vaccine at Fairgrounds today at approximately 1:15pm.  About 3:15pm she developed tingling in her fingers on both hands.  Otherwise feeling well.  No dizziness, Shortness of breath, wheezing, rash, swelling, hoarseness, tightness of throat or chest, sneezing, coughing, tor other signs of anyphylaxis. She thought she should call to report it to use.  Advised to speak with her physcian or go to urgent care if symptoms worsen or persist.     TC check of client at 16:30 on 2/5/2021.  Feels symptoms are improving. Just felt she needed to report it.  Again advised to seek medical attention if symptoms worsen or persist.   Underlying medical includes essential tremors of the hands.  She takes Propranolol and Gabapentin for this.  No other medications reported.  Verbalized understanding of instructions.
Mother called on 8-17-11 at 330pm to report arm swollen "size of baseball" area feels feverish. Mother to apply cool compress to site give MOTRIN. Appt to be seen 8/18/11 - 16x9cm red, firm area on left upper arm warm to touch. Moves arm with ease. Treated with loratadine 10mg by mouth, use cool packs prn, ibuprofen prn, BENADRYL 12.5mg at bedtime re - am if worse. 8-23-11 called pt mother states arm is better no swelling no pain.
Left under armpit x at least 2 lumps swelling, pain (intense burning sensation) radiates to Left side of check and Left of back. Pain is constant at 8/10 at rest and 10/10 with palpation on post vaccination day #1. Pain gradually decrease to 5/10 at rest and 8/10 with palpation on post vaccination day #4.   Something to note:  1) I have been getting flu vaccine yearly (with records that dates back to 2011) and never had swelling to my armpit in the past.  2) I did have swelling to my Left armpit with pain (not as intense as this time) back in Jan 2021 about 1 week after I got my my 1st dose of Moderna Covid vaccine.
No adverse event; Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster).    No concomitant medications was reported. No treatment drug details was reported. The reporter reported that they called the CDC and were instructed to go ahead and administer the other half of the dose (0.25ml) on the same day.  This case contains information for the 7th adult patient out of 15 adult patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2022-658139, MODERNATX, INC.-MOD-2022-658159, MODERNATX, INC.-MOD-2022-658149, MODERNATX, INC.-MOD-2022-658161, MODERNATX, INC.-MOD-2022-658162, MODERNATX, INC.-MOD-2022-658154, MODERNATX, INC.-MOD-2022-658160 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-658139:Adult patient 1 MODERNATX, INC.-MOD-2022-658149:Adult patient 2 MODERNATX, INC.-MOD-2022-658159:Adult patient 10 MODERNATX, INC.-MOD-2022-658154:Adult patient 5 MODERNATX, INC.-MOD-2022-658161:Adult patient 12 MODERNATX, INC.-MOD-2022-658160:Adult patient 11 MODERNATX, INC.-MOD-2022-658162:Adult patient 13
I was 4 weeks pregnant (with a PGS normal embryo) at the time of vaccination. In addition to the usual IVF transfer related medications (estradiol & progesterone), I was taking prednisone to suppress my immune system (based on a high ANA value). The baby stopped growing at 6 1/2 weeks, which would be shortly after the first vaccine reached its maximum effect. While I don't believe that the vaccine directly harmed the fetus, I do believe that by stimulating my immune system, it overrode the prednisone I was taking to suppress my immune system. In all the research I did prior to vaccination, I never saw this mentioned. It would help the many women taking prednisone for an auto-immune issue during pregnancy if you advised them to wait until after the first trimester, when auto-immune issues have less impact on the fetus.
At exactly 20 minutes after the injection and I had already left the pharmacy, I had sudden hives/welts on both arms. My tongue started tingling and it became hard to swallow. My lower lip became numb. I felt hot internally and could not think straight, my brain was foggy. I immediately took two benedryl and got myself to Emergency Room.
Fever to 102 48-72 hrs after vaccines. Vomit, mild rash.
I had a really nasty cold that got into my ears, my ear is now perforated, I am not hearing as well as I should out of it now. I went into the Urgent Care after taking a home COVID-19 test that came back negative. I was given a Z-pack, prednisone to help clear up the infection. I went back to the Urgent care because my ears were still hurting me, I was prescribed ofloxacin ear drops to help clear up any infection that may be in my ears. I was advised to take a decongestant like MUCINEX to help.
nausea; severe Vomiting; continued severe lethargy; general flu-like symptoms (fever,chills, shaking, unable to eat); fever; chills; shaking; unable to eat; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date: not reported), via an unspecified route of administration, administered in Left arm on 04May2021 10:00 at the age of 44-years-old as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient historical vaccine includes first dose, BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date: Not reported), via an unspecified route of administration, administered in Left arm on 13Apr2021 at the age of 44-years-old as single dose for covid-19 immunisation. The patient previously took amoxicillin family of medications and experienced allergy. The patient did not receive other vaccine in four weeks of vaccination. The patient did not receive other medications in two weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 04May2021 at 22:30, the patient experienced Nausea followed by severe Vomiting (40-50 times in several hours) which began about 12 hours after the vaccine and lasted around 5 hours and continued severe lethargy and general flu-like symptoms (fever, chills, shaking, unable to eat). No treatment was received for adverse events. The outcome of the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient reported that his arm has been in pain and feels the pain is moving from one spot to the other every few days. His elbow was hurting really bad today.
Myalgia pain at sige, redness, fever, chills and fatigue Narrative:  Other Relevant History:
Patient states woke up 9/9/2021 (morning after vaccination) with a headache.  Patient had nausea and 1 time episode of vomiting.  Patient took OTC cold/flu med, drank fluids and slept.  Patient states symptoms gone within 4 hours.
Tested positive for COVID-19; Horrible pain in her arm that did not let her move it, she could not rise her hand; Did not let her move it, she could not rise her hand; Nor sleep well; Fever in the mornings but not at night; Chills; She could not walk.; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), GAIT DISTURBANCE (She could not walk.), COVID-19 (Tested positive for COVID-19), PAIN IN EXTREMITY (Horrible pain in her arm that did not let her move it, she could not rise her hand) and MOBILITY DECREASED (Did not let her move it, she could not rise her hand) in a 49-year-old female 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 Nasal congestion (Congestion) on 04-Mar-2021, Anosmia (The patient can't smell well because of the congestion) on 04-Mar-2021 and Cough on 04-Mar-2021.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced CHILLS (Chills), GAIT DISTURBANCE (She could not walk.), PAIN IN EXTREMITY (Horrible pain in her arm that did not let her move it, she could not rise her hand), MOBILITY DECREASED (Did not let her move it, she could not rise her hand), INSOMNIA (Nor sleep well) and PYREXIA (Fever in the mornings but not at night). On 07-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, CHILLS (Chills), GAIT DISTURBANCE (She could not walk.), COVID-19 (Tested positive for COVID-19), INSOMNIA (Nor sleep well) and PYREXIA (Fever in the mornings but not at night) outcome was unknown and PAIN IN EXTREMITY (Horrible pain in her arm that did not let her move it, she could not rise her hand) and MOBILITY DECREASED (Did not let her move it, she could not rise her hand) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature increased: 100.4 (Inconclusive) Reached a temperature of 100.4°F, then 99.4°F. On 07-Mar-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment for the events included medicine for fever.
Narrative: COVID infection following COVID vaccine series 03/09 Janssen dose #1 08/06 pt cc: exposure: unknown 08/06 COVID swab, result: detected
pt recvd vax; severe HA, sore throat, productive cough & diff breathing (due to swollen throat); T 100; to er & tx w/ inject of rocephin; as of 16nov94 HA & sore throat persist;
pt recv vax & inadvertently recv ID inj instead of PPD;pt devel brief inj site rxn characterized by mild swelling & erythema lasting minutes;
Began having joint pain and stiffness in thumbs and big toe, the left thumb began catching and popping and eventually became stuck and unable to bend. Right thumb continues to catch and pop periodically. I'm experiencing same type of pain and catching in big toe on my right foot. After weeks of pain and stiffness I was referred to a hand specialist for cortisone zone injection that didn't work and later scheduled for surgery Aug 27, 2021. Prior to vaccine I have never experienced these symptoms and strongly believe the vaccine may have contributed.
w/in 30min of vax pt devel an allergic rxn characterized by gen hive & facial angioedema;pt recovered spontaneously;
Patient called pharmacy on 10/08/09 complaining of arm pain due to flu vaccination. Pharmacist called Physicians Assistant and told them the problem.  The patient was seen in office on 10/12/09.  Patient said that she was going to have to go the physical therapy because a nerve had been hit. Later pharmacist spoke with pa and pa stated there is no permanent damage.
pt got an itchy rash all over body around 5 hours after getting her shot. red welts all over body and very itchy. pt has no such rxn the forst dose. pt did not have trouble breathing.
After the initial SHINGRIX immunization, my right arm at the inside of my elbow broke out in an itchy rash.
Site with redness + tenderness 2 1/2cm diameter.  S/S with in 24h of vaccine site hot to touch.
The day after, I was tired and ache. I had a headache. My arm was sore and got worst. I could not lift my arms. I went to my doctor. She referred me to an Ortho doctor. He did x-ray of my arm and shoulder.
Ringing in ear with increasing volume; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ear with increasing volume) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 09-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 TINNITUS (Ringing in ear with increasing volume). At the time of the report, TINNITUS (Ringing in ear with increasing volume) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Severe pain and swelling at injection site; Severe pain and swelling at injection site; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration (right arm) on 05Feb2021 12:00 (at the age of 51years) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EL3247) on 15Jan2021 (10:00AM) (at the age of 51years) at right arm for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Feb2021, the patient experienced severe pain and swelling at injection site. There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.  No follow-up attempts are possible. No further information is expected.
Nausea; Pain in legs, back and arms; Pain in legs, back and arms; Headache; Low blood pressure; pregnant at the time of vaccination; This is a spontaneous report received from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 31Mar2021 at 14:30 at single dose for COVID-19 immunization. The relevant medical history was reported as none. Concomitant medications were not reported. The patient experienced nausea, pain in legs, back and arms, headache, low blood pressure on an unspecified date. The patient was pregnant at the time of vaccination. The patient last menstrual period was 15Nov2020. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
COVID vaccine given to patient under 18 years old.  Unknown adverse effects, was unable to reach parent to discuss.
After dose 4 of the Pfizer vaccine I was diagnosed with Anemia and hair loss.
Possibly inadvertently injected with empty syringe with vaccine and ml vanish point syringe.
Pt recvd 3 doses of Hep B vax on 16AUG85, 16SEP85, & 21FEB86 & following a blood donation on 28JAN87 pt was notified of pos test for Hep B core antibody; On 4FEB88, donated blood again & was notified of pos results for Hep B core antibody;
Aside from the expected sore arm, the morning after the vaccine (about 20-ish hours after injection) I started feeling unsteady and weak, with cold limbs and achy joints. It felt like my blood pressure might be a bit low so I checked it. Per my machine, it was 102/69. My last dose of Losartan had been at least 24 hours before. I subsequently skipped my Losartan dose for today and will resume when my BP returns to baseline.  I drank a quart of water, thinking I might be dehydrated, but then looked up the vaccine side effects on the CDC website and determined this is likely due to the vaccination. The link to your reporting site was on the CDC website so I am filing this report.
Cellulitis left foot  Treatment: Oral Cephalexin 500 mg twice a day for 7 days
PT RECEIVED THE SMALLPOX/MONKEYPOX VACCINE ON 09/19/2022. THIS RN MADE AN IMMUNIZATION ERROR BY ADMINISTERING LIVE VACCINE TO PT ON 09/30/2022, WITHIN 28 DAYS OF PREVIOUS LIVE VACCINE. NO ILL EFFECTS WERE REPORTED BY PATIENT, NO ADVERSE EFFECTS WERE OBSERVED BY THIS RN.
Administered expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 10-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.            Concomitant medication use was unknown Treatment information was unknown   This case was linked to MOD-2021-347953 (Patient Link).
Pt very fussy for 1 week, screaming 15 min at time 2 days. Loss of appetite, spitting up, tired.
On 9/10/2021 received my first shot of Pfizer at work 1:30pm, 5 mins later felt a shooting sensation left arm all the way to my finger tips. On 9/11/2021 tinggling sensation left arm. On 9/12/2021 tinggling sensation on left arm, left side of face, lip, and left side of head went to ER. Ct and labs came back normal. On dates 9/13 thru 9/17, still having tingling sensations on and off on both arms, head, and legs. On 9/17 saw pcp and MRI was ordered.
Constant, persistent, dry cough after COVID-19 vaccine. I developed a cough shortly after the vaccine and still continue to have a cough daily.
Left upper arm pain after 1st dose; Unable to lift and continues to be frozen shoulder; Unable to lift and continues to be frozen shoulder/my range of motion is very limited; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 13:00 (Lot number: EW0162) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: if Covid prior vaccination: Yes. Concomitant medication(s) included: LAMICTAL.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 24Mar2021 13:15, outcome "not recovered", described as "Left upper arm pain after 1st dose"; PERIARTHRITIS (non-serious) with onset 24Mar2021 13:15, outcome "not recovered", described as "Unable to lift and continues to be frozen shoulder"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 24Mar2021 13:15, outcome "not recovered", described as "Unable to lift and continues to be frozen shoulder/my range of motion is very limited". The events "left upper arm pain after 1st dose", "unable to lift and continues to be frozen shoulder" and "unable to lift and continues to be frozen shoulder/my range of motion is very limited" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site pain, periarthritis, joint range of motion decreased.  Additional information: Dose received: 2. The patient did not receive any other vaccines within four weeks. Left upper arm pain after 1st dose. Unable to lift and continues to be frozen shoulder. She have been to 3 doctors which all concur frozen should joint was because of the Covid shot. She have been in physical therapy for 6 months. It was 50% better nine months after the first injection. The pain was horrible and range of motion was very limited. Treatment received was 3 steriod injections, 3 months of physical therapy. The patient did not been tested for COVID-19 post vaccination. No known allergies. device time stamp was 08Jan2022.  No follow-up attempts are possible. No further information is expected.