chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediate arm soreness after injection but otherwise felt fine until about 2130 when over about a 30 minute period onset of fever, myalgias, chills, and nausea. Called off work from my job as a flight nurse at midnight. Tried to sleep it off until about 0430 when the body aches became unbearable. Ate a few bites of yogurt and took 400mg of ibuprofen. No change in symptoms until 0530 when I took a hot shower which helped relieve some muscle pain. Took 400mg ibuprofen again at 1030 with a small snack with no change in pain or fevers. Took hot shower again which helped briefly. Nausea subsided around 1630, enough that I had a small meal of bland food and another 400mg of ibuprofen. By 1700 more tolerable myalgias and fever came down some. 2230 another 400mg dose of ibuprofen, fitful night of sleep waking again at 4am with shooting lower back pain and fever. Took another dose of 400mg ibuprofen and a hot shower. Woke up at 1000am sweaty with mild myalgias and low grade fever. Took another dose of ibuprofen 400mg, 30 minutes later profusely sweaty but afebrile. Fatigued all day and poor appetite until late evening. Woke up next day after better night of sleep at 0730. Mild fatigue and bad heartburn all day and night. Left arm still sore to touch. This morning (1/11) feeling mild heartburn but better.
Patient had loss of taste, loss of sense of smell after getting the vaccine.  She also started having headaches from 9/30/2021?10/11/2021.   Patient had difficulty sleeping and felt really ill despite intake of Motrin, Advil, Excedrin.  She noted blood pressure to be high at 141/91.  She was tested for COVID-19 10/1/2021 and resulted negative.  Reaction was severe enough that patient could not go to work for that entire time.  She was able to go back to work 10/12/2021.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: 24Apr2014; FISH OIL, start date: 01Dec2019; MULTIVITAMIN [VITAMINS NOS], start date: 03Feb2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Mar2023) Positive, notes: 07Mar2023 and tested positive; (Mar2023) Negative, notes: Tested negative for Covid on Sunday Mar2023. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300100617 same patient, different drug/event;
Debilitating tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Debilitating tinnitus) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 003B21A) for COVID-19 vaccination.     No Medical History was provided.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (Debilitating tinnitus). At the time of the report, TINNITUS (Debilitating tinnitus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Virus not detected.         No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Follow-up received and contains no new information.
Bilateral Tinnitus Eustachian Tube Dysfunction  Gradually onset.  Noticed around 48 hours after 1st Moderna dose.  I've been to urgent care and an ENT specialist.  Hearing hasn't been lost, but it has changed.  Harsher sounding and with Tinnitus.  Only slight recovery after taking nasal and pill pack steroids, prescribed by the Urgent Care Dr.
Pinkeye. Swollen right and left eye. Both red and burning, draining. Right eye stuck shut and crusty upon awakening the next morning. Continued to be swollen and red.
A physician reports a pt received vaccine on 7/6/00, she awoke on 7/14/00 with an injection site reaction characterized by a 5cm area of induration, swelling and tenderness that made it difficult to raise her arm. She was treated and recovered.
Pain - felt like my lungs were going to explode. Rx RX ZITHROMAX 250mg, 250 mg - VENTOLIN HFA. Outcome 3 mos later 12-12-2017 panlobar Panlobular emphysema. Now have daily near syncope making it difficult to perform daily ADL's. ADLs. I have scheduled appn't with a cardiologist.
Nausea, vomiting, dry heaves, tachycardia until 5am 10/17/02. Pt noted similar reaction from previous hep B vaccination. (Possible reaction preservative component?)
Patient fully vaccinated and was diagnosed and hospitalized with COVID on 8/15/21. Patient recovered and was discharged on 8/18/21
Numbness, legs and arms feeling heavy, trouble seaking, jittery, mobility issues.
Pt has a PMH of COPD and is on 5 to 6 L of oxygen. She presented to the ED with worsening shortness of breath. She was found to be COVID positive and had pneumonia.
This patient was immunized for chicken pox. Around 11/21/02 he developed chicken pox illness. On 11/27/02 he developed meningitis (aseptic) requiring hospitalization. He has completely recovered.
pt woke with large (approximately 3in diameter) red, swollen, hot and hard spot on her arm. it appeared to have about a thumb size area in the center that looked like little blister. pt reported fever, dizzy, lightheaded and nauseous. pt counseled to apply ice 15min q3 to4 hours and take ibuprofen. pt visited dr office but only seen by nurse who seemed unconerned. pt call back 5/12 to say red area was now larger and there were more blisters.
( L ) arm 6x9 cm erythema, indurated on upper arm middle is at site of DTaP imm. Varicella site is at border of area. Has FRO arm, tender to palp, uses without apparent pn.
Developed swelling of upper lip within 6 hours of vaccine administration.  Took diphenhydramine 50 mg and went to ED.  Swelling had reduced before could be seen by MD.  Recurred next day and again responded to diphenhydramine.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On unknown dates the patients were vaccinated with doses of ZOSTAVAX (dose and route not reported, lot number reported as L039094 with expiration date 08-JAN-2017) that were improperly stored (temperature: -1C and time frame: 4 hours). It was reported that there was a previous temperature excursion (-6.7C or 2.5 hours). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for follow up.
Child's R arm is red, swollen and hot to touch from below deltoid to elbow. C/O itching. No temp.
Body Aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body Aches) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included HYDROCHLOROTHIAZIDE, METOPROLOL, SIMVASTATIN, PHYTOMENADIONE (VIT K1), PYRIDOXINE HYDROCHLORIDE (B6) and ZN [ZINC] for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (Body Aches) and CHILLS (Chills). At the time of the report, PAIN (Body Aches) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medicines were not reported.
On 12 April 2021, 80 vials of Moderna vaccine (Lot# 046A21A) were discovered to have been improperly handled and stored at the facility.  These vials were determined to have been at room temperature from 22 March to 6 April.  Before this temperature excursion discovery on the afternoon of the 12th, those doses were regrettably administered to 806 patients on 7 and 12 April at the vaccination site at the training center.  After conferring with immunization experts and the manufacturer, it was confirmed that the efficacy of the doses in question could not be guaranteed.  This facility has assembled a clinical team to contact each of these patients, disclose the information, and offer them re-vaccination.  Re-vaccination efforts are beginning on 20 Apr 2021.  Initial guidance was that a VAERS needed to be completed for each patient impacted and that effort was started.  However, subsequent opinion from an employee at the CDC was that one VAERS report to describe the incident was sufficient.  This VAERS is to cover the incident.  If there are any follow-on questions/concerns, please contact me.
Outside of upper arm red and slightly puffy from elbow to about a couple inches below injection site. Patient states that this started on Saturday, the day after vaccination. Itchy sometimes, but otherwise not bothersome according to patient.
Flu like symptoms which went away with in a few days. Along with heaviness of chest, labored breathing, chest pains,  rushing heart (comes and goes even when resting), and fatigue. All of which remain.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: during post vaccination observation period, patient fell to floor, never lost consciousness, immunizing tech alerted pharmacist on duty, patient was alert but lightheaded while laying on back, we elevated feet using her chair, provided ice pack for head and water bottle for hydration.  Patient remained lying down with feet elevated for about 15 minutes then returned to seated position with ice pack on top of head.  Patient was observed by staff and parent/friend 30 minutes before leaving.
I felt like a very short taste of COVID-19 all over again for 1 day. Very tired and arm pain in the muscle. I had a low-grade fever like 99.8 or something, my normal temp is 97.8. Mild headache and just wanted to lay in bed and rest and sleep. The next day I woke up and felt better and it was gone. Within 24hours my symptoms were gone. Then I started having headaches every day, mild ones but they were a flag to me because I was never a person to have headaches. Even when I had COVID-19 they were fairly mild. They lasted 2-3 weeks or a month and then finally went away. Then I started losing my upper body muscle tension like I was climbing a chair one day and dropped the phone because my arm muscles went into a total state of relaxation without any muscle tension to hold anything- and it was up to my shoulder as well and had a hard time holding my head up and it fell to the side because the muscle tension in my neck was extremely relaxed. Then I got brain fog with slight dizziness and my head gets weak. Now it happens every day in my life, and it happens mostly in the morning 3-4 times in a day. Some last 10 min and some last 2-3 minutes were my body goes into a relaxed state. I don't notice it in my legs as much. I've never had this kind of thing before, I'm very active and used to play gold 3 days a week. Right before I had COVID-19 I had neck surgery and think that the COVID-19virus did something to my neck because bone marrow and chips were implanted into my neck during the surgery. Per my Neurosurgeon the chips have not infused into my neck which should have taken 6-9 months to a year, but it's been 2 years and it hasn't completely fused yet. And the symptoms I'm experiencing is
T+6hrs, aches and joints hurt. Fever started T+8hrs, continued to T+36. Severe headache T+8 to T+20, then tapered off. Mild aches continued to 3rd day following shot. Back to preshot normal by 4th day. The night and day following shot were worse than my covid symptoms in January.
Client called 3/28/05 states had reaction to meningitis vaccine given 3/23/05 states 2 hrs after receiving vaccine had fever, nausea, and headache. Did not seek medical treatment. States did not feel good for 3 days.
Severe cough, shortness of breath, chest pains and body aches. Patient saw Doctor on 12/22 and was given Avelox and Cyproheptadine.
Now tastes like metallic; Felt like hit by a truck; Splitting headache; Tongue started to itch; Crazy dreams; Pains; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE PRURITUS (Tongue started to itch), ABNORMAL DREAMS (Crazy dreams), DYSGEUSIA (Now tastes like metallic), FEELING ABNORMAL (Felt like hit by a truck) and PAIN (Pains) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN for Hypertension, GLUCOSAMINE HCL for Joint pain, LORATADINE for Seasonal allergy, ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced TONGUE PRURITUS (Tongue started to itch), ABNORMAL DREAMS (Crazy dreams), PAIN (Pains) and FATIGUE (Fatigue). On 22-Apr-2021, the patient experienced FEELING ABNORMAL (Felt like hit by a truck) and HEADACHE (Splitting headache). On 23-Apr-2021, the patient experienced DYSGEUSIA (Now tastes like metallic). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Apr-2021, TONGUE PRURITUS (Tongue started to itch) had resolved. On 25-Apr-2021, ABNORMAL DREAMS (Crazy dreams), DYSGEUSIA (Now tastes like metallic), FEELING ABNORMAL (Felt like hit by a truck), PAIN (Pains), FATIGUE (Fatigue) and HEADACHE (Splitting headache) had resolved.            The patient drank Gatorade and water more than normal.   This case was linked to MOD-2021-090755 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Updated concomitant product use.
Throat and lymph node swelling that is not going away. All other normal symptoms came and went. Throat continues to swell, hard to swallow. I think this is an allergic reaction. I will take a benadryl today and call doctor tomorrow if this doesn?t go away.
Symtpoms: dizzy, clammy, vomit, pale, ringing in ears, headache after symptoms got better Patient was given water, juice, and assisted to laying down. patient reported feeling better after but with a headache.  This happened within 20-25 minutes after vaccine.
After my second Moderna shot I experienced: headache, aching muscles, fatigue, muscle and joint pain, chills and fever, nausea. These symptoms lasted for about 36 hours. However, three days later, my stomach is still somewhat upset. I would characterize my discomfort as severe. After my first shot, I experienced the same side effects, although they were not nearly as bad. (While annoying, I would categorize them as mild.) They also dissipated in about 36 hours.
Patient had allergic reaction in office after waiting his 15 mins. Patient was checking out and informed he was noticing a rash and red blotches on his arms. Patient was brought back to the clinic and he explined the rash on his arms was itchy and he was feeling itchy and tingling in his face. Patient denied shortness of breath, difficulty swallowing, and facial swelling.  Patient was given 50ml of benadryl IM and waited an additional 20 minutes. After 20 minutes patient was notably improved and still had no complaints of difficulty breathing and swallowing.
I developed chronic pericarditis over the past few weeks leading to incidental Dxof pericardial effusion and cardiac tamponade on 6/16 after presentation of acute gallbladder- my gallbladder was removed, then pericardiocentisis was performed.  I am still experiencing inflammation and thick pericardium.
Pt had adverse reaction on the right arm, Deltoid IM Warm, swelling, blistering on day 2 seen by doctor on 7/19/04.
Narrative: Pt reported to his PCP at clinic he was experiencing muscle aches and fever on 8/2/2021 after receiving the J&J covid vaccine on 8/2/21. Pt self treated with acetaminophen & symptoms resolved. Pharmacy was notified and ADR to covid vaccine was entered in CPRS and in VAADERS.
A "few" hours after the IMZ the patient said her arm got swollen, red, sore, and itchy.  On 11/30/2016 she went to her PCP and he said he'd seen this rxn before-and she appeared to be allergic to the Pneumovax-23.  Dr put her on a course of prednisone and Benadryl.
pt inadvertently recv double dose of flu vax on 13OCT or 14OCT97;16OCT97 pt devel fever 104 which rose to 107;hosp;this is 1 of 80 pt from this facility to recv double dose of flu vax;17OCT97 the other 79 had no adverse exp;
Red blotch on my skin that was hot, a rash and it was achy; It was a little painful where the shot was injected; I have a hot red flash; Red blotch on my skin that was hot, a rash and it was achy; This is a spontaneous report from a contactable consumer or other non hcp.     An 80-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 05Feb2021 as single dose for covid 19 immunization. The patient medical history and concomitant was not reported. The patient experienced red blotch on my skin that was hot, a rash and it was achy, it was a little painful where the shot was injected, i have a hot red flash, red blotch on my skin that was hot, a rash and it was achy on 08Feb2021 with outcome of unknown. No treatment was received for the event.  Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Red hot itchy raised circle above vaccination area; Red hot itchy raised circle above vaccination area; quarter sized.; Headache; Fever of 101; Nausea; Chills; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 09Apr2021 at 12:00(at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy and penicillin allergy. Concomitant medications included Botox, ibuprofen (MANUFACTURER UNKNOWN) and loratadine (CLARITIN) for unknown indication and from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021(at the age of 50 years old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021, the patient experienced a red hot itchy raised circle above the vaccination area; quarter-sized. The patient did experience side effects like headache, fever of 101, nausea, and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events red hot itchy raised circle above the vaccination area, headache, fever of 101, nausea, and chills were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Antibodies less 0.02% after two shots; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST ABNORMAL (Antibodies less 0.02% after two shots) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-A) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ACETYLSALICYLIC ACID (ECOTRIN), DUTASTERIDE (AVODART), MAGNESIUM, MECLOZINE HYDROCHLORIDE (ANTIVERT [MECLOZINE HYDROCHLORIDE]), NYSTATIN (MICOSTATIN), ROSUVASTATIN CALCIUM (CRESTOR), HYDROCHLOROTHIAZIDE, VALSARTAN (DIOVAN HCT), RIVAROXABAN (XARELTO), AMLODIPINE and METOPROLOL SUCCINATE (TOPROL) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANTIBODY TEST ABNORMAL (Antibodies less 0.02% after two shots). At the time of the report, ANTIBODY TEST ABNORMAL (Antibodies less 0.02% after two shots) outcome was unknown.            No treatment medications were provided.
Discharge Provider: MD Primary Care Provider: DO Admission Date: 9/3/2022 Discharge Date: 9/5/2022   Clinical Narrative: Patient was admitted for covid 19 pneumonia,started oniv remdesivir and completed 3 days. Was also started on decadron, breathing treatment with zinc,thiamine and ascorbic acid. Her symptoms resolved, oxygen has been weaned of she has been on room air saturating at 94%.  She was evaluated by PT/OT for weakness/debility with recommendation for home with home care Patient was treated for bacterial pneumonia in the previous admission and completed antibiotics, chest x-ray done on admission on 09/03/2022 showed improvement of the infiltrate
This spontaneous report as received from a physician refers to a 22 year old female patient. The patient was no pregnant. The patient developed cervical cancer after the patient mentioned she previously received 3 doses of GARDASIL (injection, 120Y). The physician said he only saw this patient in his office on 2 occasions and the patient told him that she received 3 doses of GARDASIL on unspecified dates when she was 16 years of age, prior to sexual activity. The physician stated the patient tested positive for "a high grade lesion type 16, and the patient has cervical cancer". The physician said the patient had her entire cervix removed and the cancer has progressed into the patient's lymph nodes. Lab diagnostics included type testing on lesions. Colposcopy, loop electrosurgical excision procedure (LEEP) procedure. The patient sought medical attention through office visit. The patient was not recovered from the AE. Upon internal review, cervical cancer and the cancer has progressed into the patient's lymph nodes were considered to be an other medically significant event. Additional information has been requested.