chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rib area painful,  cage & sternum pain; tingling; This non-serious case was reported by a consumer and described the occurrence of musculoskeletal chest pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included levothyroxine and lovastatin.   On 20-MAR-2023, the patient received Shingrix. On 25-MAR-2023, 5 days after receiving Shingrix and an unknown time after starting levothyroxine, the patient experienced musculoskeletal chest pain (Verbatim: Rib area painful,  cage & sternum pain) and tingling (Verbatim: tingling). On 04-APR-2023, the outcome of the musculoskeletal chest pain and tingling were resolved (duration 10 days).   It was unknown if the reporter considered the musculoskeletal chest pain and tingling to be related to Shingrix.     It was unknown if the company considered the musculoskeletal chest pain and tingling to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-Apr-2023 The reporter said should he/she get the 2nd vaccine. The patient's rib area was painful enough to take pain relievers. The rib cage and sternum pain and tingling symptoms were not treated. The reporter gave permission to contact.
Patient's mother states that he started to feel sick Friday night, approx. 5hours after vaccine was administered with vomiting 3x, decreased appetite, abdominal pain, chest pain started after vomiting. Mom reports pt. is still c/o chest pain intermittent since Friday. Denies any other medical symptoms. Patient was evaluated today 11/15/2021. Vitals: Temp 98.8, BP:90/60, HR: 80 , RR: 18,  PO: 97% ra , WT:118lbs. Pt is alert, no distress, hydrated, cooperative. Physical exam with in normal limits. Pt referred to ER for further evaluation for Myocarditis.
Pt. fainted while walking from counseling room to observation area. Was able to get up and walk to chair, but did develop sweating, blurred vision, difficulty hearing for 5-10 minutes. Pt improved after drinking water, apple juice, and doing deep breathing. Paramedics called to assess pt. Pt. had past vaccine syncope reactions and BP was <120/80 when taken by paramedics. Pt was fine after 30 min and was picked up by his girlfriend to go home together.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (rHA, lot # M006106, expiry date 01-AUG-2017), subcutaneously. The vaccine was stored at 37.2 degrees F for 16 hours with no previous excursions. No adverse event was reported. The outcome of incorrect product storage and no adverse event was unknown. The reporter consider incorrect product storage and no adverse event to be not related to PROQUAD. Additional information has been requested. Lot # M006106 is a valid lot # for PROQUAD.
pt recv vax 5FEB96 & 16FEB96 pt exp a rash @ the inj site;rash described by pt mom as 2 pea-sized bumps, pimple-like in appearance;later that day, pt devel 8-10 bumps on rt arm & back;bumps were gone by the following morning;
Complained of not feeling well, collapse to the floor while walking, rapid sweating, pale skin, dizziness and nausea, loss consciousness for about 10 seconds
dT given on 10/9/03 about 6-7 hours later pt began complaining of irritation/pain at injection site. F/U on 10/15/03 showed area of erythema about 4cm x 5cm and some induration about 2 x 2cm. Counseled pt to take Ibuprofen for pain and swelling.
This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. Concurrent conditions or pertinent medical history were unspecified. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot# reported as K007976, expiration date: 03-JUN-2016) subcutaneously (dose and frequency were unspecified) (prior to its expiration date) which was exposed to a temperature of 13.4 Fahrenheit degrees for a time frame of 4 hours, then, it was back in range. Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
Hx of seeing her endocrine specialist before vaccination, blood sugar at 1400 was 250, was advised to take insulin dose, but she didn't because she couldn't eat a meal at that time.  Also hx of anxiety with injections/vaccines. 38mins post vaccination pt c/o dizziness, nausea, and HA. Vitals: 17:38 BP 160/83, HR73, RR 18, SpO2 99% -- > @17:45 165/94, 80, 18, 99% -- > @17:55 155/86, 76, 18, 98 -- > @18:05 153/86, 73, 18, 99% -- > @18:20 153/86, 75, 18, 98%. @17:45 pt c/o palpitations sensation, dizziness, nausea, HA, and tingling in hands.  Pt given water. @17:55 pt noted that dizziness has improved @1825:  Escorted off unit via w/c to car.  Husband driving.  Advised to check sugar at home, take her BP meds and insulin if needed.  If worsens to call emergency services or urgent care
Brain fog for a total of 2 days after receiving vaccination, starting on day 1 post-vaccination
Information has been received from a registered nurse concerning a male patient who on an unspecified date was vaccinated I.M. with a dose of PNEUMOVAX 23 (lot # 665300/1314Y). Subsequently, the patient experienced swollen right and 103 degrees F the next day after receiving a dose of PNEUMOVAX 23. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. At the time of the report, the patient's status was unknown. Follow-up information has been received from the registered nurse concerning a 72 year old non-smoker retired physician with asthma, chronic rhinitis and no known drug allergies. On 14-DEC-2009 the patient was vaccinated with the first 0.5 mL dose of PNEUMOVAX 23 into his right deltoid in the morning. At the time of vaccination the patient was experiencing asthma exacerbation, deep cough and stuffy nose. On 15-DEC-2009 in the PM, the patient complained of temperature of 100.3 F (previously reported as 103F), soreness and slight swelling at the right deltoid area of injection. On 14-DEC-2009, the patient's spirometry of pre and post bronchodilator showed no FEV1 match and no FVC match. On 16-DEC-2009, the patient recovered from these events. This is one of several reports received from the same source. The nurse has requested a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center of Biologics Evaluation and Research and was released. No further information is available.
This is a spontaneous case, initially received from other non-health professional on 09-Jan-2019 (processed together with follow-up received on 10-Jan-2019), concerning a 38-year-old, adult, female patient. The patient had no historical or current condition. The patient did not receive any concomitant medications. On 21-Dec-2018, the patient was administered FLUCELVAX QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture-derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252685 and expiry date: 30-Jun-2019) for influenza prophylaxis. On 05-Jan-2019, 15 days after vaccination, the patient was diagnosed with H1N1 influenza. On the same day, the patient was hospitaliszd. At the time of this report, the patient was in intensive care unit (ICU) and was diagnosed with fulminant myocarditis. The reporter was concerned about the quality of the product the patient was given (explicitly coded as suspected product quality issue). The patient had not recovered from the events. The reporter assessed the case as serious (hospitalization).; Reporter's Comments: A 38-year-old, female patient was diagnosed with H1N1 influenza, 15 days after administration of FLUCELVAX QIV followed by fulminant myocarditis. Considering the implausible temporal relationship, the event of H1N1 influenza was assessed as not related to suspect vaccine as vaccination usually requires minimum 2-3 weeks to provide immune protection against influenza. Despite temporal association between vaccination and event of fulminant myocarditis, the clinical course suggests the reported H1N1 influenza as a more plausible explanation for the event. Hence, the company assessed the causality as not related to suspect vaccine. There is lack of information with respect to nature/cause of the reported event of suspected product quality issue and the company assessed the event as unassessable. The case will be further assessed upon receipt of follow up information. The company assessed the case as serious (medically significant).
Cell mast disorder; hives; Headache; rash/starts as small spots/it creates a full body rash; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 45-years-old, via an unspecified route of administration, administered in arm left on 08Aug2021 11:00 (lot number: FA7485; expiry date: unknown) as dose 1, single for COVID-19 immunization. Medical history included food allergy (any foods that increase histamine). Concomitant medications included over the counter (OTC) anti-histamines within 2 weeks of vaccination. The vaccine was administered in a pharmacy or drug store. The patient did not receive other vaccines within 4 weeks prior to the vaccine. Patient has not tested positive for COVID-19 since having the vaccine. On 09Aug2021, at 11:00 am, the patient experienced cell mast disorder, hives, headache and rash/starts as small spots/it creates a full body rash. The patient did not receive treatment for the events. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of the events was recovering.
This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. On 20-JUL-2011, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified) and the patient was in the office on 08-AUG-2013 (reported as today) to receive the second dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Dysphagia began on 3/10. Episodes of trouble breathing. Leg weakness. Weight loss. All symptoms are ongoing.
The following morning, grandma woke up with right wrist pain, mild swelling, and skin temperature is hot to touch.  Sign and symptoms got worst for the next three days and up till today sign and symptoms are still evident.
During visit in April with me, he reports having received Zostavax at local pharmacy in December 2012. States next day had eye pain and leg weakness lasting about one day.
pt revd vax & w/in 24 hrs p/vax exp arthralgia, weakness & myalgia; reporter has limited info on this case since pt is no longer @ the reporter's facility;
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date/lot 042J21A should have been reported with a BUD of Feb 17, 2022) and NO ADVERSE EVENT (No adverse event) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.     Concomitant medication was not provided.   It was reported that there was a mistake given during my phone call regarding lot 012H21B. That lot was not affected, but lot 042J21A should have been reported with a BUD of Feb 17, 2022.  Treatment information was not reported.
Incorrect interval between doses:  Dose 1 was administered on 03.26.21.  Dose 2 on 03.31.21.  No known adverse reaction, but will continue to follow up.
4 hours after COVID moderna second vaccine, she developed tachycardia, lightheadedness, palpitations, weakness., cough. Progressed to sinus pressure/discomfort, hacking cough, shortness of breath.  Symptoms of cough/sinus pressure have improved over time but she still has tachycardia, lightheadedness, palpitations and weakness.  We did recommend obtaining a covid diagnostic PCR test at the time but this was not completed by patient, so an actual COVID infection cannot be ruled out.
There is an allergy to where sticky areas of Band-Aid touched her skin, possible latex allergy, but patient said no allergy to latex. There was no allergic reaction to shot.
patient occasionally faints after shots. layed down on mat for 20-25 minutes after short fainting spell. BP 102/70
Immune Mediated Bulbar Myasthenia Gravis; This is a literature report.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for covid-19 immunization, reaction(s): "Immune Mediated Bulbar Myasthenia Gravis". The following information was reported: MYASTHENIA GRAVIS (hospitalization, medically significant), outcome "recovering", described as "Immune Mediated Bulbar Myasthenia Gravis". The patient underwent the following laboratory tests and procedures: Antibody test: non-reactive; without explanatory pathological findings; Magnetic resonance imaging head: without explanatory pathological findings; without explanatory pathological findings; Nerve stimulation test: decrement in facial nerve-nasalis CMAPs with low f, notes: repetitive stimulation, consistent with a post-synaptic neuromuscular disorder; post-exercise and, notes: repetitive stimulation-induced decrements in median-abductor policus brevis and spinal accessory trapezius CMAPs, confirming a systemic post-synaptic neuromuscular disorder; Serology test: non-reactive; without explanatory pathological findings; AChR binding and blocking antibodies were, notes: ultimately detected. Therapeutic measures were taken as a result of myasthenia gravis.  No follow up attempts are needed. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the event myasthenia gravis and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200023773 Same article/ drug/patient and different event;
Varivax vaccine failure. Patient developed hundreds of chicken pox lesions about 2.5 years after the vaccine was given.
pt recv vax JUL or AUG 1995 post vax whole arm swelled;sx resolved w/in 24hr;
Patient did not have any adverse reaction. The error was that she was administered a Pfizer Bivalent Orange Cap 0.2 mL dose for 5 - 11 years of age instead of the Pfizer Bivalent Gray Cap 0.3 mL  for 12 years and over.  Patient was monitored for 20 minutes post administration, no adverse reaction noted nor reported by patient or accompanying grandmother.   MD was notified as soon as dosage error discovered. Patient was given the appropriate dose of Pfizer Bivalent Gray Cap for 12 yrs + after vaccine error was discovered, per CDC Interim recommendations.
10 minutes after receiving my 2nd shot I felt a hot within my entire body and also felt similar to going under anesthesia. I was taken to another area.  My BP was extremely high 220/??.  (I remembered my sister in law who mentioned to hydrate). I keep drinking water (about 4 bottles in an hr). After about 15 mins, kept walking. It took about 1 1/2 hours for BP to drop to 165/90. I was asked how was I feeling. I was feeling better and I was sent home.  Today (4/27/21, I went to the dentist an had a similar event. the ambulance was called - they told me to go home and visit my doctor. My doctor asked that I come in on Thursday 4/29/21. BP came back down2 hrs ago but felt woozy a few mins ago, checked at it is at 1176/101. Waiting to hear from her if I should take another Losartan tablet.
I was diagnosed with COVID-19 after experiencing fever, cough, sore throat, headache, congestion, and diarrhea.
Patient with swelling of most of upper arm (injection given R deltoid) and additionally swollen in R hand (had to remove rings).  Swelling lasted x 3 days.  No treatment was given--he used ice and elevated it.
Adult patient received doses after its expiration date 13-Jul-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022).    No concomitant medications were reported.  It was reported that, the patient received vaccine from expired vial. Further it was stated that, there were no remaining vials unused of expired lot number.  The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 17th of 56 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case (1 of 56 patient)
chills; temperature of 100.4 ºF; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (temperature of 100.4 ºF) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VITAMIN D 3), VITAMIN C [ASCORBIC ACID], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and ZINC for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (chills) and PYREXIA (temperature of 100.4 ºF). At the time of the report, CHILLS (chills) and PYREXIA (temperature of 100.4 ºF) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Blood pressure measurement: 141/76 (Inconclusive) unknown. On 04-Mar-2021, Body temperature: 100.4 (Inconclusive) Patient had temperature of 100.4 ºF. On 04-Mar-2021, Heart rate: 111 (Inconclusive) Patient had pulse of 111. On an unknown date, Body temperature: 100.3 (Inconclusive) Patient's temperature  was 100.3 ºF but still not normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient also took blood pressure medications and aspirin (they stopped taking aspirin to take the vaccine).Patient also took lemon with ginger tea and Tylenol. He was walking and taking water.  Concomitant medication include Omega 3.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: TCR added(Fax number).
Information has been received from a health professional concerning a female with a latex allergy, penicillin allergy, augmentin allergy, amoxicillin allergy and prednisone allergy who on 01-AUG-2007 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 657737/0522U). Concomitant therapy included and eczema drug. On approximately 01-AUG-2007 the patient experienced redness and warmth at the injection site. On 20-DEC-2007 the patient was vaccinated intramuscularly with her second dose GARDASIL (lot# 658488/1264U). On approximately 20-DEC-2007 the patient experienced redness and warmth at the injection site and peeling of the skin in a 3 inch area at the injection site. Subsequently, the patient recovered from redness and warmth at the injection site, and peeling of the skin at the injection site. Additional information has been requested. 02/17/2010 Subsequently, the patient recovered from redness and warmth at the injection site, and swelling of the skin at the injection site.
Mother stated that 10 minutes after the patient received the GARDASIL vaccine, the patient reported to have a tight feeling in her throat and the patient started to feel hot. Patient was told by doctor to wait 10 minutes and symptoms should go away.
Swelling of lips and cheeks 3 hours after Hep B vaccine, resolved with Benadryl
he was angry at everyone and committed suicide; whole personality changed.; He became so hositle; he was angry at everyone and committed suicide; bipolar, it exacerbated it.; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included bipolar, it exacerbated it. The patient had covid prior vaccination. No known allergies. No other vaccine in four weeks. The patient received other medications in two weeks. Adverse event start date reported as 20Mar2021. From receiving second dose whole personality changed. All of a sudden he was picking fights with everyone. He went from being passive aggressive to arguing over politics religions and anything he could find. It did not matter. It got to the point his own family did not know him. He became so hostile that he by the end of the summer he was angry at everyone and committed suicide 29Aug2021. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care.  The events were reported as life threatening illness (immediate risk of death from the event) and disability or permanent damage. The events received treatments. The patient did not test covid post vaccination. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Heart Palpitations developed a couple of weeks after vaccine. They have continued into time of submission of this report.
the next night she had a rash on her arm.  not bad but just obvious. no pain or itching. like the diameter of maybe a baseball
Induration and erythema upper part of leg 2.1cm X 4cm and lower part of thigh, .5cm X 1cm.
Complained of pain and tingling at site. Tenderness at site , redness and swelling 60.5 mm posterior on the right tricep. No complaints of fever, chills, SOB. Was not there last night, woke up this morning. Was half the size this morning. Temp 100.4. Treated 5x5 with HC 2.5% top and Keflex 250 mg qid x 10 days. Did not take oral MGB. Aviation off run.
Headache and fatigue that lasted 7 days. Elevated temperature on day 3. Used Excedrin for the headache.
Vaccines given 7/9/19, redness, warmth and induration noted 7/10/19 in the evening, redness spreading on 7/11/19, no pain, itching, or fevers. No known insect bites, no tick bites.  Treating for cellulitis with augmentin.