chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Painful arm; Pain at injection site; can not even lift his arm to put a shirt on; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number M9P52, expiry date 18th December 2021) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 2nd October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. In October 2019, the patient experienced injected limb mobility decreased. On an unknown date, the patient experienced pain localized. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site pain was unknown and the outcome of the injected limb mobility decreased and pain localized were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and pain localized to be related to Shingrix.  Additional details were provided as follows: The patient received dose of shingrix in the left arm. The batch number of Shingrix was updated from M9PS2 to M9P52, as per sale's data sheet. The reporter stated that on the day of vaccination, the patient had injection site pain and about a wek later pain was present from shoulder down to the elbow.  Less than 3 months after vaccination, the patient could not not even lift arm to put a shirt on. The patient visited the primary care physician. The patient performed an ultrasound test, but did not show anything. The patient tried putting ice on the arm and it was not helping and the arm was still painfull. No further details were provided The reporter consented to follow up.      Lab Comments: Lab test performed on an unknown date
pt c/o inc pain & swelling in lt deltoid area;MD dx severe local rxn, warmth inc;
Since the above date, she has had a constant 24/7 headache, constant fatigue, and short term memory problems. We have been to several doctors, but have not had anyone who can help us yet.
Patient fully vaccinated.  Patient COVID positive 11/19/2021.  88-year-old female with significant known history for atrial fibrillation/coronary artery disease, depression, who presented for shortness of breath.  In the emergency department, she is alert/oriented, states she is not sure how she ended up here, cannot recall exactly who brought her and/or why she is here and is asking to be discharged home.  Denies chest pain.  BP 96/62.  Admission dx:  acute respiratory failure, SOB, Hypoxia, COVID pneumonia.  CSR: multipfocal bilateral airspace opacities. Treatment: remdisivir, decadron, lovenox.  On 15/15NRB.  Progressive pulmonary infiltrates. broad spectrum ABX  CRP 301.1-242.7; D-dimer 1021--769; procalcitonin 0.51.  AKI: Cr 1.11--0.98-- 1.06--1.02--0.95--0.89--0.82-0.99--1.64-1.19.  Patient expired.
17 YEAR OLD INADVERTENTLY GIVEN JANSSEN VACCINE  NO ADVERSE EFFECTS REPORTED
FOLLOWING SECOND COVID-19 SHOT PATIENT REPORTED FEELING LIKE SHE WAS GOING TO PASS OUT. SHE WAS TAKEN TO THE MEDIC AREA FOR FURTHER ASSESSMENT. AFTER APPROXIMATELY 30 MINUTES SHE RECOVERED AND LEFT THE PREMISES.
pt recv vax & devel redness & exp itching @ the inj site, which lasted for 2 days; the pt also devel a 1inch by 1 inch brown, discolored area @ the inj site which persisted 1mo p/the inj; No further details were provided;
arm was sore; fever of 101 F; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm and fever. On an unknown date, the outcome of the pain in arm and fever were resolved with sequelae.   It was unknown if the reporter considered the pain in arm and fever to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The reporter stated that the patient received vaccine 2 weeks ago from the time of reporting and experienced pain in arm and had a fever of 101 F. Next day after receiving vaccine the patient experienced fever. The reporter did not consent to follow up. This case has been linked with case US2019125908, reported by the same reporter.      Lab Comments: On an unknown date body temperature was recorded
started itching Wed noc 17FEB93; 18FEB93 skin became blotchy; still has blotchy area from waist down; pain @ inject site;
mom called office pt got up from nap screaming & crying not able to calm baby down advised mom to give APAP to pt;
BLOOD CLOTS; LOW PLATELETS; This spontaneous report was received via social media from the parent of a patient via a company representative and concerned a female of unspecified age, race and ethnicity. The patient's weight height and medical history were not reported. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration, batch number and expiry date not reported), dose not reported, administered on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request the batch number. No concomitant medications were reported. On an unspecified date, the patient was reported to have experienced blood clots and low platelets. The patient visited an emergency room/department or urgent care center for the events on an unspecified date. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The patient had not recovered from blood clots and low platelets. This report was serious (other medically important condition).; Sender's Comments: V0: This spontaneous report received from the parent of a patient via social media platform concerns a female of unspecified age, race, and ethnicity who visited the emergency department for blood clots and low platelets an unknown period of time after receiving the Janssen Covid-19 vaccine. Medical history, concomitant medications, clinical symptoms and signs, diagnostic testing, and corrective treatment were not reported. As of the time of the report, the patient had not recovered. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (per definition from Brighton Collaboration), the relationship of the events to vaccination is considered unclassifiable due to insufficient information. Additional information will be requested if contact information becomes available.
She was seen on 2.23.2018 and given PREVNAR 13. Initially had some pain at site of infection but yesterday, she noticed red bumps in area and this morning larger area involved. Tenderness with some pruritus. Did have T 99 when she had PREVNAR but no further fevers/chills. No CP, SOB. No tongue swelling. Tx: prednisone, betamethasone topical cream.
severe chills day one loss of consciousness day two (passed out in shower and was out for under one minute) Brain fog with loss of energy daily starting one month after second dose Pulsatile Tinnitus (swishing or pulse sound in ear) with a plugged feeling where it feels like ears need to pop accompanied by having a harder time hearing on average once a week starting one month after second dose Average of two severe headaches per week accompanied by occasional nausea and/or diarrhea starting four months after second dose.  Sometimes severe enough to prevent regular daily tasks. Times of dizziness especially when turning head to one side or the other or bending down daily starting two months after second dose
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; 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) and NO ADVERSE EVENT (No adverse event) in a 73-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date).    No concomitant information was reported. BUD reported as 17Feb2022. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Non significant Live Follow up; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
myasthenia gravis; This is a spontaneous report from a contactable physician. An 86-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) intramuscular on 23Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included atorvastatin, pantoprazole, clopidogrel and melatonin. On 08Feb2021 patient developed new onset myasthenia gravis 2 weeks after her first dose of the COVID vaccine, antibody confirmed disease. The event resulted to a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized for 2 days. Treatment was received for the event which included oral steroids and pyridostigmine. The facility where the vaccine was administered was in the patient home. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient is not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the event was not recovered.   Information about lot/batch has been requested.; Sender's Comments: A causal relationship between the event "myasthenia gravis" and suspect product BNT162B2 is possible based on the information provided, drug profile and a temporal association in this 86-year-old female patient. This case will be reassessed should additional information become available.  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 RAs, Ethics Committees, and Investigators, as appropriate.
This spontaneous report as received from a Registered Nurse who stated a unspecified number of "children" were vaccinated with improperly stored vaccines. Nurse stated their data logger were blinking from 2 refrigerators from last May 2012. Multiple excursions, as high as 14C, and low -0.5C. M-M-R II, GARDASIL, PEDVAXHIB, PNEUMOVAX 23, stored inside, (merck) VARIVAX stored in 2 freezers that also went out of range, since last May 2012. Nurse stated she was still researching the freezer temperatures. Nurse stated no adverse events reported at this time. Additional information has been requested.
0927 Patient c/o itching on trunk area. No redness or rash observed. Benadryl 50mg po given.  0937 Patient states itching improved.  0945 Patient states itching has stopped.  Informed to continue Benadryl 25mg po at home as needed. Verbalized understanding
Left arm numb from shoulder down thru fingers. Numb along left jawline below eye to left side of mouth.  Began about 1 2/2 hours after vaccine.  Began to subside about 24 hrs. after vaccine. 48 hrs. after vaccine- no numbness in arm, only a small spot of numbness on face at cheekbone. No treatment given but hydrate, rest.  Return if symptoms continue for evaluation by neurologist.
Patient presented with redness, swelling and heat in the arm in which vaccine was given.  She reported symptoms starting on 6/3 after vaccine and had not gone away on 6/5.  Dr gave antibiotic.  Patient also reported redness on stomach that the doctor thought may have been due to a tick bite.
Approx 35minutes after vaccine i experienced sneezing ,scratchy throat and itchy yes, took Allegra with good effect. Arm soreness developed about 8 hours after vaccine, woke next morning with fever 100.9, severe body aches, headache, nausea, weakness and fatigue, decreased appetite. In addition, as the  day went on I experienced a shallow cough, high pulse rate (130), tongue twitching and just felt aweful. Slept on and off all day, sx lasted the entire day. Took Tylenol throughout the day for the the fever. I awoke 3:30 am today, 1/10/21 with fever 101.5, took more Tylenol, still headache and feel tongue twitchiness  however muscle aches, body aches, nausea, decreased appetite and fatigue have subsided. I took 600mg Advil around 9am today and have been gradually feeling much better as of now 1:30pm. As a side note, I did have COVID 19 illness mildly in March 2020. It was dx'd with PCR testing and my sx were loss of taste/smell, nausea, weight loss, bursted eye vessel, slight respiratory sx, I recovered well and had a follow up negative test 2 weeks after. Thank you.
This spontaneous report was received from a physician assistant refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL (lot#, expiration date and route not reported) on the buttocks. No concomitant medications were reported. The reporter could not confirm if GARDASIL was administered intramuscularly. No adverse symptoms reported. No further information provided. Additional information has been requested.
07/21/2021 0733: 31 y/o received J/J vaccine at 0731am, escorted to observation area at 0733am exhibiting profuse diaphoresis, dizziness; Denies CP, dyspnea, nausea. Encouraged to lie down post initial BP 84/p with HR 44bpm. Prompt improvement in dizziness. Fan provided. Moist cloth to forehead.     0735: 109/53 64BPM 0740: 124/9 72BPM 0747: 142/72 74BPM 0752: 135/54 74BPM 0800: Dc'd home, symptoms resolved .  Documentation by RN
The morning after receiving Covid-19 vaccination I fainted.  I was sitting, working on an i-pad and got up to go to another room. I walked through the house to another room. I noticed my arms and legs felt kind of rubbery and that I didn't seem to have control of them. I fell to the bed and lost consciousness for 5-10 seconds. This was all observed by my spouse. I  recovered quickly. The remainder of the day I had a slight headache and felt slightly nauseous. I took acetaminophen before going to bed and woke up the following morning with no complaints .
SICK; VOMITING; DIARRHEA; SNEEZING; MUSCLE ACHES; FEVER; This spontaneous report received from a consumer concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and no relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821267, and expiry: UNKNOWN) dose was not reported, administered on 27-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUN-2021, the subject experienced fever. On 04-JUL-2021, the subject experienced sneezing. On 04-JUL-2021, the subject experienced muscle aches. On 05-JUL-2021, the subject experienced vomiting. On 05-JUL-2021, the subject experienced diarrhea. On an unspecified date, the subject experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting, diarrhea, muscle aches, and sneezing, and had not recovered from fever, and sick. This report was non-serious.
erythematous, warm wheal 2/4 cm in size at injection site in right subcutaneous area
Area below inject site was sore, red, raised and warm to touch. Dx: cellulitis.
Pt came in to get a Janssen covid vaccine, Pre-vaccintation checklist was completed at which time he denied having received any other COVID vaccine. After the Janssen vaccine was administered the patient stated  "I have to be honest with you ladies I already got the Moderna Vaccine, when are you giving the Pfizer vaccine I want that one also". i looked in his EHR and he did not receive Moderna vaccine from us.
Administered 11/2009 after motor vehicle accident. Pt then developed myositis.
Information has been received from a consumer concerning her 23 year old daughter who on an unknown dates was vaccinated with the three doses of GARDASIL was given in April 2007. There was no concomitant medications. On approximately 23-Sep-2008, the patient had a Papanicolaou test positive. As of 29-Sep-2008, the patient had not recovered. Further testing must be done pertaining to positive PAP test. The patient sought unspecified medical attention. No additional information is expected.
pneumonia; This spontaneous case was reported by an other caregiver and describes the occurrence of PNEUMONIA (pneumonia) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes and Pacemaker insertion (cardiac). Concurrent medical conditions included Heart disorder.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion hospitalization). At the time of the report, PNEUMONIA (pneumonia) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. Patient's husband received his 1st vaccine on 1Mar2021. Her husband have pace maker and heart problem, diabetes and he admitted to ER on Sunday on 28Mar2021 for pneumonia and he is still in the hospital. No treatment information provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD21-065334 (Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD21-065334:
Anca Vasculitis, acute kidney failure.  Patient had no previous kidney issues, normal creatine levels prior to being given the Covid booster.  Patient went to her family care physician following release from hospital for routine lab work.  Lab work showed Creatine of 6.4 and acute kidney failure.  Patient went to the ER and was admitted into the hospital.
pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 35-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, Full-term  birth) on 23-May-2019, Pregnancy (Live, Full-term  birth) on 23-Aug-2015 and Pregnancy (Live, Full-term  birth) on 24-Feb-2013. Concomitant products included NITROFURANTOIN for UTI.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 17-Sep-2020 and the estimated date of delivery was 25-Jun-2021. On 04-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 04-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2020, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Estimated date of conception reported as 10-OCT-2020. Mother is surrogate. Previous pregnancies included three live full-term birth without complications on 24-Feb-2013, 23-Aug-2015 and 23-May-2019 respectively. Fetal anatomy scan performed on 10-Feb-2021 was normal.  No treatment medication details was reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: EP7533), in left arm, on 19Apr2021 as dose 2, single (Lot number: ER8735), in left arm and on 15Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "RA" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Prediabetic" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST, start date: 31Jan2003; METFORMIN, start date: 31Dec2017; HYDROXYCHLOROQUINE SULFATE, start date: 31Dec2017; PANTOPRAZOLE SODIUM, start date: 31Dec2013; EVENING PRIMROSE, start date: 31Dec2001; CHROMIUM PICOLINATE, start date: 31Dec2015; ALLER-ITIN, start date: 30Apr2017; TURMERIC CURCUMIN, start date: 01May2018; PROBIOTICS, start date: 30Apr2018; OMEGA-3 NOS, start date: 31Dec2016; SAMBUCUS [SAMBUCUS NIGRA], start date: 30Apr2021; AIRBORNE, start date: 30Apr2020; ZINC, start date: 28Feb2022. Past drug history included: Codine for Known allergies: Codine; Wellbutrin for known allergies: Wellbutrin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Return of Covid Symptoms 3 days after finishing doses. Symptoms were worse then before medication. Symptoms lasted 10 days. with the cough continuing now. day 23. The patient treatment received Albuteral Inhaler. Antiviral details product COVID 19 Treatment, Paxlovid, treatment start date 07Jun2022, treatment stop date=11Jun2022,  lot number=FY7026, indication=Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.