chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hip started hurting; shingles; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 08Feb2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program A 72-year-old female patient received bnt162b2 (BNT162B2), first dose via an unspecified route of administration on 28Jan2021 (Batch/Lot Number: EL9269) as single dose (at the age of 72-years-old) for COVID-19 immunisation; and ibuprofen (MOTRIN [IBUPROFEN]), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 1800 mg, daily as anti-inflammatory. Medical history included hypertension. Concomitant medication included amlodipine taken for hypertension, start and stop date were not reported.  The patient had her first Pfizer vaccination on 28Jan2021 and was scheduled for her next one in 18Feb2021. Days later she started noticing that she had no other symptom, she stated that "nothing happened to me, I didn't feel bad, my arm didn't hurt, I had no problems with the vaccine." A couple of days later, her hip started hurting and then just Wednesday (Feb2021) she went to her doctor and he said it was shingles and was given valacyclovir. No investigation assessment was done. The outcome of the events was unknown.
Patient up to date on COVID vaccines who admitted with an incidental COVID test.  Asymtpomatic for COVID.  Provider d/c note:  "90 year old male with a history of CKD stage III, anemia, BPH, hypertension, and osteoarthritis admitted with COVID and black stools. CT two weeks ago revealed proximal duodenal wall thickening, surrounding fat stranding, and a couple areas of suspected ulcer is in the duodenal bulb suspicious for peptic ulcer disease with neoplastic or other duodenitis. He was incidentally found to have COVID.    Hospital Course:  Pt was seen by GI who offered endoscopy. The pt declined endoscopy in favor of medical treatment. A full and detailed discussion of the risks and benefits of this course of action was held. Spouse and other family member (daughter or grandaughter) made aware of this decision as well and they agree. They understand it could be from cancer.  His hemoglobin has stabilized with PPI therapy, which will continue.    He remained asymptomatic in regards to COVID, in fact today he states, ""I feel great."" He has been instructed on quarantine measures. "
At first there was an strong onset of fatigue. Within an hour I had fever, headache, and the chills. Slept through the night waking every 2-3 hours.
Waited 20 minutes after shot in facility. Walked to my car and felt very thirsty and that swallowing was not normal. Thought I was panicking and sat in my car for a little bit. My throat, tongue and mouth felt weird like they were swelling. Kept looking at my tongue and it appeared normal. Sat for about 15 minutes and decided it was nothing. Started to drive away and then my mouth became so dry like nothing I have ever experienced before. I had trouble talking. Turned around and went back into the clinic. Paramedics took my oxygen level and my heart rate which was elevated. My throat, mouth and tongue felt like I had been given Novicane  at the dentist. I had no rash. I sat with the paramedics for about thirty minutes and they thought I was fine and that I should go home and be prepared that the next dose would be worse. My mouth did not feel normal again until the next day.
4 days after receiving the vaccine it started with chest pain and tightness of the chest about 3 days after that my heart began to flutter and skip beats.  I had to go to the emergency room where they admitted me into the hospital for two days.  I am now seeing a cardiologist but have not been able to get back to normal at this time.  Also, having shortness of breath which is causing chest pains to become worse.
vaccination failure; covid-19; This is a literature report for the following literature source(s):.  A 69-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "obesity" (ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19  and the suspect drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-202200910724 Same patient;
Suddenly felt heavy, her arms and legs also felt so heavy; I felt my head, arms, and legs heavy; She thought she was going to pass out; She felt as if all of her blood went straight to her head but the episode only lasted a few seconds.; I felt very sick; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Suddenly felt heavy, her arms and legs also felt so heavy), HEAD DISCOMFORT (I felt my head, arms, and legs heavy), PRESYNCOPE (She thought she was going to pass out), FEELING ABNORMAL (She felt as if all of her blood went straight to her head but the episode only lasted a few seconds.) and MALAISE (I felt very sick) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and High cholesterol.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced LIMB DISCOMFORT (Suddenly felt heavy, her arms and legs also felt so heavy), HEAD DISCOMFORT (I felt my head, arms, and legs heavy), PRESYNCOPE (She thought she was going to pass out) and FEELING ABNORMAL (She felt as if all of her blood went straight to her head but the episode only lasted a few seconds.). In 2021, the patient experienced MALAISE (I felt very sick). In April 2021, LIMB DISCOMFORT (Suddenly felt heavy, her arms and legs also felt so heavy), HEAD DISCOMFORT (I felt my head, arms, and legs heavy), PRESYNCOPE (She thought she was going to pass out) and FEELING ABNORMAL (She felt as if all of her blood went straight to her head but the episode only lasted a few seconds.) had resolved. At the time of the report, MALAISE (I felt very sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative (Negative) Negative.         Concomitant medications include medications for high blood pressure and high cholesterol level.   Reporter stated that about 10 months ago she felt sick and thought it was COVID but the blood test came out negative.  Patient had experienced the events 15 days after the second dose and the whole episode lasted a few seconds.  No treatment information was provided.   Reporter did not allow further contact
Blood clot diagnosed in left leg on 2.2.22, blood clot diagnosed in left leg 4.16.22
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 23-MAY-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ, vial, lot # N011647, expiry date: 17-NOV-2018, orally, for prophylaxis (strength, dose and dosage schedule were not provided) (product storage error). No adverse effects were reported. The temperature excursion and time frame for ROTATEQ was between 47°F to 77°F for a time frame of 36 hours. No previous temperature excursion was reported. No data logger was reported.
After receiving the #2 HPV vaccine on Jan 4 ,2008 I started getting strange symptoms of headaches, nausea , stomach ache flu like symptoms , aversion to light among other odd symptoms over time.  Gradually things got worse as I became older and had much difficulty with school work and attending school and physical activities. The headaches became worse along with nausea, vomiting , body pain, joint pain , shooting pain, fainting , dehydration and many other problems.
pt recvd vax 20OCT93 & devel intense upper lt body quad pain; pt took relafen w/some relief; work-up including x-rays has been unrevealing & neuro had r/o a pinched or trapped nerve;
Numbness in right hand, right foot and right side of the face. Blurred vision, dizziness, disorientation, fatigue and tremors in the right hand.
My husband had a stroke on 01/25/2021, with one large blood clot and many small blood clots.  He was put on a ventilator until 02/06/2021 when I asked to have it removed.  I died within 5 minutes after it being removed.
11:15am- vaccine given 12:15pm- patient reported syncope & collapse at work- +loss of consciousness for a few seconds- felt better after lying down  Reports significant L arm soreness day 24 hours after- improved by motrin. ROM improved with ibuprofen but still limited abduction. Denies R arm soreness.
EXTREME LEFT SHOULDER PAIN PERSISTING 60 DAYS.   TWO TRIPS TO URGENT CARE AND PHYSICAL THERAPY.
Patient received his vaccine at 3:00PM. At 3:24PM he reported a metallic taste and dry mouth. I then gave the patient 50mg of oral diphenhydramine and he took that along with 16 oz of water. He also stated that he "felt like" his blood pressure was elevated, but that he was anxious about getting a shot so it was probably that. 25 minutes after the diphenhydramine was administered the patient stated that the metallic taste was gone, his mouth wasn't dry, and his BP was normal. I observed the patient for a total of 60 minutes and he felt normal and wanted to go home.
Redness, warmth, edema size of a tennis ball beginning 40 minutes after administration.
No adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor.     In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 (HCP states that they administered 16 shots to patients after their expiration date).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported.  This case was reported for patient 13th out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master Case
Right arm is slightly swollen and has red band maybe 3 inches wide circling the arm above the elbow...this is approximately 2-3 inches below the injection site, which is bruised. Patient says arm was painful yesterday, but not too bad today.
This spontaneous report as received from a nurse referring to a 64-year old female patient. Patient's concurrent condition included erythromycin allergy. Historical drug included erythromycin. Patient's medical history was not reported. On 18-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # R011632, expiry date: 02-FEB-2020), 1 dosage form intramuscularly in the arm for prophylaxis. Concomitant therapies included as vitamin d (unspecified) and fluticasone (FLONASE). On 19-DEC-2018, the patient developed a temperature of 101 F (temperature increased), bruised, mottled appearance at the injection site and chills. The nurse reported that the patient had a scheduled appointment with an unspecified pulmonologist who made unspecified changes in her unspecified medications due to respiratory distress. The patient returned to the office on 20-DEC-2018 and was wheezing and having shortness of breath and that the injection site appearance looked like hives. The patient received an unspecified dose of oral prednisone, Ipratropium bromide/salbutamol (DUONEB) and albuterol sulfate (ALBUTEROL) nebulizer treatment (also reported as concomitant medication), unspecified dose of ibuprofen, paracetamol (TYLENOL) and an unspecified dose of diphenhydramine (BENADRYL). The patient called to the office on 27-DEC-2018 and reported she still had extreme injection site pain and difficulty moving her arm to dress (dyskinesia). The patient would return to the office on 28-DEC-2018 to office for further examination. The outcome of events was reported as not recovered/not resolved. The reporter did not provide any causality assessment for events. Upon internal review, the events the event dyskinesia was considered to be serious due to disability and the event respiratory distress was found to be medically significant.
Trigeminal neuropathy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of TRIGEMINAL NERVE DISORDER (Trigeminal neuropathy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TRIGEMINAL NERVE DISORDER (Trigeminal neuropathy). At the time of the report, TRIGEMINAL NERVE DISORDER (Trigeminal neuropathy) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter.  The treatment information was unknown.  The action taken with the drug was Not applicable.
She came in with infected hardware orthopedics took her to the OR.  With irrigation debridement the left tibial plateau with removal of hardware.  Hospital admission within 6 weeks of receiving the COVID vaccine.
patient complained arm soreness that lasted for 3 weeks post the initial injection. soreness to a point of not being able to raise the arm.
Patient came in 7/24/18 for evaluation of a skin rash. Yesterday, 5 days from BEXSERO #2 on R arm she took off her sweater and noted a red irregular rash on her R arm. She has been well. Recently traveled. No known Lyme exposure. The rash is not raised and does not hurt or itch. Today she noted that the rash seemed bigger and seemed to spread up the lateral part of her arm. I consider the possibility of an atypical presentation of Lyme disease or possibly a mild local reaction to the BEXSERO vaccine. Called at 7:30AM to follow up. She tells me that it has faded considerably since yesterday and is almost gone.
I was hospitalized on 04/30/2021. I developed Superficial Thrombophlebitis in my right leg. My leg was tender and the veins were very hard and painful. I was treating it with ice Then I had some Dyspnea and I had some Pleuritic chest pain. I went to the hospital and it was confirmed that I had multiple small Emboli in my lungs. They were in both lungs. I was given IV Heparin and the right ventricular pressure was normal the next day. I am currently taking Eliquis.
Patient reports soreness the next day, 2 days out noticed  baseball size lump, large red ring around site, still present on day 3
pt states that about 10 days after taking the covid vax he woke up very cold, very tired with a headache.  He felt bad all over.  He had a 99. 9 temperature so he took Tylenol and ibuprofen which helped bring temp down but he continued to have the headache.  Next day all of these symptoms were gone except the headache.  Pt went to be tested for covid which was negative.  He took Nurtec for his headache and today he feel fine.
Two days post vaccination, I developed palpitations, SOB and a headache. By Friday, the duration and intensity of the palpitations increased. By Saturday, my heart rate and blood pressure were elevated. I was in Bigeminy and developed nausea, dizziness and thightness in my throat. I then spiked a fever of 104I was seen by Cardiology where they performed a battery of tests.
12 hours after shot, woke up in the middle of the night with chills, body aches, very sore/swollen arm, headache, slight fever (100.4 degrees), fatigue. 12 hours after the symptoms first started, the headache, body aches, fever, chills ceased but intense fatigue, sore/swollen arm, and body changing from hot to cold to hot persisted.  I also noticed at about 30 hours when I was showering that I had swollen lymph nodes the size of golf balls in my left armpit when I raised my arm above my head. Now, 45 hours later I feel more like myself but the sore arm and swollen lymph nodes still persist.
Pt. received ZOSTAVAX 10/13/16. Reports to pharmacy on 10/24/16 that on 10/22 he "broke out in an active shingles rash from underarm to nipple".
The pt experiences left arm redness and swelling. Seen in the ER on 4/15/01. The left upper arm had a circular, reddened area surrounding vax site. Minimally tender to the touch, slightly warm, slightly indurated suggesting a local reaction to vax. The pt was released home in good condition. No meds given until 4/16/01. Augmentin was given per moms request. Arm was discolored for 2 weeks.
arm muscle aches, backache, low grade temp Narrative: On day 1 and 2 patient experienced arm muscle aches, back ache and low grade temp of 99.7. Took OTC Motrin.
The pt experienced joint pain, shoulder, neck, lower back, waist, knees, ankles, hand and hips at all times. Per doc 215546, patient still have stiffness of all joints, including lower back pain and neck pain. Also, at times there is extreme pain in both wrists.
Low grade fever (~100F); Fatigue; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0716) via an unspecified route of administration in the left arm on 30Apr2021 at 17:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included Crohn's disease. The patient had known allergies to CT contrast media. Concomitant medications included vitamin d (vitamin d nos) (MANUFACTURER UNKNOWN), adalimumab (HUMIRA), escitalopram oxalate (LEXAPRO) and loratadine (CLARITIN) for unknown indications, from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 09Apr2021 at 17:30 as a single dose for COVID-19 immunisation. On 01May2021, the patient experienced low grade fever (~100F), fatigue and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures, which included body temperature on 01May2021 and the result was body temperature 100 Fahrenheit (low-grade fever (~100F)). The clinical outcome of the events low-grade fever (~100F), fatigue and body aches were resolving at the time of report.  No follow-up attempts are possible. No further information is expected.
PATIENT BEGAN TO FEEL TIRED ABOUT AN HOUR LATER, BY 5:00 PM WAS IN BED COUGHING, IT WAS HARD FOR HER TO SWALLOW, HEADACHE, EYES WERE SWOLLEN, RED AND HAD A WHITISH DISCHARGE, NASAL CONGESTION.
she had just a slight smell but it was so horrible; This is a spontaneous report from a contactable nurse (patient). A 80-year-old female patient received bnt162b2, via an unspecified route of administration, administered in Right Deltoid on 22Jan2021 (Lot Number: EK9231) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had the first one 22Jan2021 and after that (22Jan2021) she had just a slight smell but it was so horrible. She thought that it was the blanket on the bed and she had passed it off a little bit. When she had her first shot she had mild side effects and then the next morning she could eat a little bit. After her first COVID vaccine she only had the horrible smell. That episode was short and by the next morning she didn't have the smell anymore. The event was reported as medically significant. The outcome of the event was recovered on 23Jan2021. The reporter considered the causality was related.; Sender's Comments: As there is limited information in the case provided, the causal association between the event parosmia and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Constant tinnitus (high pitched ringing in both ears), not responding to any OTC antihistamine or anti-inflammatory treatments
After vaccine, within an hour, I started having a headache and hazy feeling. I took Tylenol or Ibuprofen over the course of the 10th and 11th to help with the headache/migraine and low-grade fever. Each time I took the medicine, it made me feel hazy and didn't help my headache much. I still had a migraine on the 12th. Today, the 13th I feel much better.
vision changes,  acute onset migrane for 3 hours then headache for 3 hours