chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myalgia; This case was reported by a physician via call center representative and described the occurrence of myalgia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2018, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was not recovered/not resolved.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician was trying to determine if the problem was associated with the vaccine that was given to the patient in October.  The physician inquired if there would be an elevation in Varicella Igm post, vaccination if so, then how long it would be there. The physician also inquired that how long does the Myalgia last and where was it mostly localized. No additional data was supplied. The physician refused to give data due to accountability act.
my armpit started hurting; I had a lump about the size of a ping pong ball in my armpit; Felt a little achy; tired; chills; The first night arm was quite sore; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 64 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 11:30 (Batch/Lot Number: EL9261) as DOSE 2, SINGLE for covid-19 immunisation, received historical vaccine bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 10:30 (Batch/Lot Number: EL9261) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced a little achy on 19Feb2021 19:00 with outcome of recovering, tiredness causing fatigue on 19Feb2021 19:00 with outcome of recovering, chills on 19Feb2021 19:00 with outcome of recovering, the first night arm was quite sore causing pain in extremity on 19Feb2021 19:00 with outcome of recovering, her armpit started hurting causing axillary pain on 20Feb2021 19:00 with outcome of recovering, she had a lump about the size of a ping pong ball in her armpit causing axillary mass on 20Feb2021 19:00 with outcome of recovering.    Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.
Cervical, left axillary, left supraclavicular lymph adenitis. Tenderness left arm, left, chest and left upper back.
Less than one minute after vaccine was given, patient fainted, LOC for 20 seconds. Arms and legs began to stiffen and shake. She then returned to her baseline. (+) nausea, no vomiting. BP 109/69. HR 96.
Pt received an extra dose of Hib due to a discrepancy with the department of health reporting system. Pt was given a Pentacel but in fact only needed a Kinrix.
Initial and follow up information has been received from a nurse practitioner, concerning a 24 year old female registered nurse who on 07-JAN-2008 was splashed in her eye when she was administering a dose of COMVAX (lot # not reported). The NP flushed the nurse's eye (details not reported). The RN developed redness and induration under her eyes, which lasted for 2 days and then resolved. Additional information is not expected.
w/in 30min of vax pt devel a 40mm by 30mm area of induration @ inj site;pt had recovered @ the date of this report;this is 1 of 4 pt from this site to devel an inj site rxn p/flu vax;
09/2021 when I had yearly lab work, it showed stage 3 kidney chronic disease. I had to get an ultrasound of my kidney which was normal, but during the ultrasound, they found tumors on my liver which they thought was metastatic cancer. They did a liver biopsy and they found out it was granulomas, not cancer. Then I saw a kidney specialist and they did more labs, it was with more labs, extensive testing, that I was diagnosed with sarcoidosis, is an inflammatory condition, which is rare. I also now have a liver specialist. The kidney specialist recommended a chest x-ray on my lungs. And the sarcoidosis is in my lungs, my kidneys and my liver. The kidney specialist referred me to a pulmonologist because I have the sarcoidosis in my lungs. And to  an eye doctor. I am now on 60 mg of prednisone daily trying to improve the kidney problem, their functioning, to see if they are going to get better. It concerns me that it is an inflammatory condition, it is attacking my organs. And doesn't the vaccine cause an inflammatory response to my body? Do I get the booster because is it going to have an inflammatory response to my body? Or if I don't, will I get COVID-19 because I am immune compromised? I was healthy before the vaccine. Now I am immune compromised. Now I have 3 new doctors, nephrologist, and pulmonologist and liver specialist.
Vaccines are kept frozen until they are ready for administration; Moderna vaccines administered beyond the use date and/or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccines administered beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines are kept frozen until they are ready for administration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccines administered beyond the use date and/or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines are kept frozen until they are ready for administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccines administered beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines are kept frozen until they are ready for administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Moderna vaccines are kept frozen until they are ready for administration which means they would have been in the fridge about 1-3 days. They tend to store 1 to 3 bottles in the fridge to thaw out and be ready for the patients when needed. No treatment medication reported.
13 yr. old male developed headache, weakness of legs. (Pulse & BP remained normal).
The patient presents with Chest Pain  The patient is a 69 year old female, known to medical facility, with a past medical history as detailed below including No Known ASHD, Preserved LVEF, HTN, NIDDM, Hypothyroidism, and Family Hx CAD. She was seen in consultation per Dr. 12/10/15 due to a family history of CAD. Given she underwent Stress TTE 11/10/15, which was negative and her symptoms improved with protonix, it was felt to be related to GERD. She has since been lost to follow up.  She presented to  ED 1/23/22 secondary to chest pain and recent syncopal episode. Upon arrival, she was found to be afebrile with blood pressure 107/73, pulse 124, and SpO2 98%. Significant initial laboratory demonstrated COVID19+, troponin 14.6-- >14.5-- >14.5 and negative d-dimer. EKG demonstrated sinus tachycardia with no acute ST/T wave abnormalities and right axis deviation. CXR was negative for acute process. CT Head was negative for acute process. She was given full dose ASA and NTG and admitted for further workup. Cardiology was consulted on 1/24/22 to address her chest pain and syncope.  The patient reports a 2 month history of initially intermittent chest pain at both rest and with exertion which has become more constant over the last week.  She was recently hospitalized at Hospital 2 weeks ago at which time she underwent MPS which was reportedly negative.  Over the last week, she reports her chest pain has become more constant.  She describes central chest pressure and also a knife like twisting at times.  She reports it occasionally radiates to her left jaw.  The chest pain is worse with exertion and deep breathing at times. She has tried baking soda at home with some improvement.  Yesterday around 4:00 PM after getting up to walk to the bathroom, she became lightheaded with a tingling sensation in her head and subsequently slid down the wall.  She denies associated head injury, chest pain, or palpitations.  She feels that she did pass out for a few seconds. As such, she notified her son and the decision was made to proceed to the ER.  She describes a similar syncopal episode last week after getting up to walk into the kitchen.    She denies known cardiac history and has never undergone cardiac catheterization.  She reports a history of HTN and DM.  She is a nonsmoker.  She reports a strong family history of CAD in both parents and multiple siblings who reportedly had issues with a blockage "on the backside of their heart. "  She denies otherwise denies recent fever, chills, or known COVID exposure.  She does describe shortness of breath at both rest and with exertion over the last 2 days.  She denies cough, sore throat, or loss of taste/smell, She got her 2nd COVID vaccine 12/2021.  Presently, she is resting comfortably in bed and and reports resolution of her chest pain with NTG paste.  She denies chest pain or shortness of breath.  Telemetry is demonstrating NSR rate of 95 with blood pressure 164/95, and SpO2 100%/RA.  She is a widow and has 3 children.  PT IS INPATIENT AT THIS TIME.
Patient came to ED with increasing shortness of breath and cough.  Patient was admitted to hospital for Covid.
Right arm pain with movement starting next day after injection 12/24/2020 and then about one week later  the injection site is painful to touch, redness present, swelling, and itching.
tested positive for COVID; This spontaneous case was reported by a patient and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant was provided. Patient treatment information was not provided.
Case number PHEH2012US014371 is an initial spontaneous report received from a medical assistant on 19 Jul 2012. This report refers to a patient whose age, gender, medical history, past drugs and current conditions were not reported. It was reported that the patient inadvertently received a 0.5 ml intramuscular dose of MenCWY liquid conjugate component of MENVEO (batch number: not reported) without being reconstituted with Men A on an unspecified date. No adverse event was reported following the medication error.
Body rash spotty on both arms, but more extensive on midriff and groin; This is a spontaneous report from a contactable consumer. A 81-years-old male patient received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection) via an unspecified route of administration in Arm Left on 17Feb2021 at 14:00 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received other vaccine (first dose) in four weeks on 27Jan2021. On an unspecified date, the patient had experienced Body rash spotty on both arms, but more extensive on midriff and groin. Patient did not received any treatment. Patient did not tested covid post vaccination. The outcome of the event was not resolved.  Information of lot and batch number has been provided.
Reports about 3 days after the shot she developed a headache, was cold, felt like a "dishrag", tired. She went to her family physician. He sent her to the hospital as she said he told her that her heart was hardly beating. At the hospital she had to have a pacemaker placed. She had no history of any heart issues. She reports being healthy before the vaccine.
Nerve pain in teeth and gums.  Lasted several hours. Muscle spasms in small muscles:,ex. Top of feet, fingers
Pt's head went down. He picked it back up. He had a blank stare on his face and started shaking (like a convulsion). Called 911. Pt came out of it. Asked what had happened, said he felt a little dizzy. Pt left with his mother from the store after paramedics arrived to check on him.
First day at first was just feeling fatigue and a sore arm for a day.   3 weeks after shot: feeling very tired, headache, body pain, numbing areas on body. Overall feeling sick.
Rash, swelling, sore/pain, nausea, light headedness. Rash had spread from shoulder to elbow. Patient said Dr at Urgent Care told him to take BENADRYL and MOTRIN.
Pain in lower right arm and shoulder blade followed by itching all over lasting > 12 hours. Treated with Medrol Dose Pak and self admin Benadryl.
Fever up to 100.8 off and on, the day following the injection, chills, slight nausea, pain injection site, body aches
Headache, rundown, tired, injection site pain, joint pain, fever, dizziness.
had no detectable immunity; This is a spontaneous report from a contactable nurse (patient's wife) via the medical information team. A male patient of an unspecified age received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), both via unspecified routes of administration from unspecified dates at single dose for COVID-19 immunisation. Medical history included Non hodgkins lymphoma and chemotherapy (recently finished with his second round). Concomitant medications included unspecified antiviral and antibacterial medications (still taking) while the effects of the chemo was still in his system (until mid April). The nurse reported that her husband had both Pfizer vaccines and after he had an antigen blood test he found out he had no detectable immunity. The nurse asked if the chemo or the antiviral or antibacterial meds would cause the vaccine not to work at this time in his system and should get revacinated later. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Fever: 102 degrees F for 2 days, 100 degrees F next 2 days coughing up phlegm from chest & nose - bed rest slept for 3 days, no appetite except chicken broth. After 12 days still coughing but feel better no more fever.
HEARING LOSS IN LEFT EAR, COMPLETE LOSS PRESSURE IN LEFT EAR I recieved the vaccine on 1/23/2023 at 1130am.  On 1/25/2023 woke up with complete hearing loss in left ear.   I was very dizzy all day and had to lay down .  I went to medical doctor on 1/25/2023 at 240pm  and saw a primary care provider who said it could be from covid vaccine.  I had a hearing test that I failed.  She examined my ears and it looked completely normal.  She perscribed prednizone 20mg for 5 days and said to follow up with ENT.  I have a ENT appt for tomorrow 1/27/2023 at 730am for a hearing test and to see a medical provider.   I woke up today on 1/26/2023 my hearing is still gone with still pressure in ear.
Ankle is still discolored, happened after the first shot, it went down a week later and then it came back; pain in the left ankle; started lambing; swelling in the left ankle; Blood pressure was elevated; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure was elevated), GAIT DISTURBANCE (started lambing), JOINT SWELLING (swelling in the left ankle), SKIN DISCOLOURATION (Ankle is still discolored, happened after the first shot, it went down a week later and then it came back) and ARTHRALGIA (pain in the left ankle) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced HYPERTENSION (Blood pressure was elevated). On 26-Mar-2021, the patient experienced GAIT DISTURBANCE (started lambing), JOINT SWELLING (swelling in the left ankle) and ARTHRALGIA (pain in the left ankle). On an unknown date, the patient experienced SKIN DISCOLOURATION (Ankle is still discolored, happened after the first shot, it went down a week later and then it came back). At the time of the report, HYPERTENSION (Blood pressure was elevated), GAIT DISTURBANCE (started lambing), JOINT SWELLING (swelling in the left ankle) and ARTHRALGIA (pain in the left ankle) outcome was unknown and SKIN DISCOLOURATION (Ankle is still discolored, happened after the first shot, it went down a week later and then it came back) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment information were provided by the reporter.   This case was linked to MOD-2021-223928 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Significant follow up report received included new event of skin discoloration and reporter's email address was added.
Narrative: Per nursing report: Fever 99.9. sore arm Soreness at injection site  Fever
A couple days after receiving my booster shot, I began having mild chest pains.  These chest pains were similar to those I had after having COVID-19 and then receiving my first and second COVID-19 vaccinations using Moderna.  The chest pains do not increase with exercise and are located specifically near the upper-left side of my chest.  Certain arm movements can cause a twinge or increase in pain that then quickly clear with a little rest.  I had a full cardiological examination after my initial bout with chest pain and was cleared of any heart related issues.  The chest pain eventually completely cleared after approximately 4 months.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 15-APR-2015, the patient was vaccinated with a dose of MMR II, expiration date: 12-APR-2015, subcutaneous (lot number was not provided). No concomitant therapies were reported. Additional information has been requested.
Twinrix expired administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 9th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 10-Aug-2022 Reporter's Comments: The nurse reported that patient was administered Twinrix on 9th Aug 2022, that was expired on 07th AUG 2022.  The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of Twinrix vaccine, which led to expired vaccine used.
Per mother, at 2 months, baby received shots (Pediarix, Prevnar, HIB) and cried. Mother states baby passed out and pale for about 30 minutes; not arousable. No distress, no rash, no shaking, breathing regularly. Went to ER waiting area until baby woke up and went home.
arthritis in spine/worsening of arthritis in spine; worsening of arthritis in spine; could not sit up; This case was reported by a consumer via call center representative and described the occurrence of spondylarthritis in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included spondylarthritis (had severe arthritis in spine prior to dose).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced spondylarthritis, condition aggravated and mobility decreased. The patient was treated with steroids nos (Steroid Shot (Nos)) and prednisone. On an unknown date, the outcome of the spondylarthritis was not recovered/not resolved and the outcome of the condition aggravated and mobility decreased were unknown.   It was unknown if the reporter considered the spondylarthritis, condition aggravated and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received Shingrix a few months ago from reporting date.  The patient reported that received her dose on a Thursday and on Friday, she could not sit up due to the worsening of her arthritis in her spine.  The patient went to see her physician the following Monday where she received a steroid shot and prednisone dose pack and she continued to experience arthritis of her back. The reporter consented to follow up.
Fatigue; multiple fevers (102.7F); malaise; headache; loss of appetite; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 15:30 (Lot number: FJ8757) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: tree nuts" (unspecified if ongoing); "known allergies: stinging insects" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]. Vaccination history included: Bnt162b2 (Dose 2, Lot number: EP7533, Previous dose administration date: 09Apr2021, Previous dose vaccine location: Left arm), administration date: 09Apr2021, when the patient was 53 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Lot number: ER8727, Previous dose administration date: 19Mar2021, Previous dose vaccine location: Left arm), administration date: 19Mar2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 15:30, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 01Dec2021 19:00, outcome "recovered" (Dec2021), described as "Fatigue"; PYREXIA (non-serious) with onset 01Dec2021 19:00, outcome "recovered" (Dec2021), described as "multiple fevers (102.7F)"; MALAISE (non-serious) with onset 01Dec2021 19:00, outcome "recovered" (Dec2021), described as "malaise"; HEADACHE (non-serious) with onset 01Dec2021 19:00, outcome "recovered" (Dec2021), described as "headache"; DECREASED APPETITE (non-serious) with onset 01Dec2021 19:00, outcome "recovered" (Dec2021), described as "loss of appetite". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, pyrexia, malaise, headache, decreased appetite.  Additional information: The patient had fatigue, multiple fevers (102.7F), malaise, headache, loss of appetite for duration of 72 hours. The vaccine was administered at public health clinic/veterans administration facility. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.   No follow-up attempts are possible. No further information is expected.