chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reported reaction with #1 dose of mild SOB and itchy throat. Given PO Benadryl and brought to ED for his SOB, though no additional treatments administered. Both ED Physician and PCP advised pt should still receive #2 dose. Pt presented prior to dose with normal mentation, and no difficulty ambulating or verbalizing beyond baseline. Pt had no issues when receiving vaccine then called over staff 2-3 minutes after vaccination to report SOB. EMS notified and staff. EMT and staff. EMR came to assist patient. Clinical Lead notified of 1st dose reaction and current reaction after SOB onset began and EMS brought over. Pt provided PO Benadryl 5 minutes after vaccine administered and able to swallow with no issue. I, Clinical Lead, remained at patient side where patient was able to describe his pain but had dyspnea and only able to get out 2-3 words at a time. After a few minutes, pt SOB worsened to the point he was unable to speak but no color changes noted. Mentation declined with pt somnolence present. At this point, Clinical Lead called 911 for backup as Benadryl had no relief of symptoms and SOB worsened along with mentation. Also noted that EMS pulse ox was not working so unable to provide accurate O2 saturation to delineate whether reaction was anxiety or allergic. Pt also noted history of seizure disorder though declined feeling was a current seizure and denied history of respiratory or cardiac conditions. Paramedics felt pt needed transport to the hospital and report provided by Clinical lead.
Left side of face felt tingly and swelled slightly.  One day later I began having a severe pain in my left jaw area making it extremely difficult to open my mouth.  Chewing was difficult as well.  It lasted for about a week.
Started with horrible skull pain behind my left ear(Like a bad headache) .  Swollen Lymph Nodes so swollen it caused pressure on my ear and pain in outer ear.  My NP could not confirm it was from the vaccine.  They put me on an antibiotic and steroids and no relief .. then ear drops... I still cannot hear out of my ear completely and the Lymph nodes in neck, collar bone and armpits are still there and it's been 16 days since I had the shot.... I am refusing the second injection because of this.  Nothing on right side of body only on left which is the injection side.
Hurt as much as the flu shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Previously administered products included Flu shot with an associated reaction of pain.   On 30-AUG-2023, the patient received RSV vaccine. In AUG-2023, an unknown time after receiving RSV vaccine, the patient experienced pain (Verbatim: Hurt as much as the flu shot).The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to RSV vaccine.   It was unknown if the company considered the pain to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 31-AUG-2023 This case was reported by a patient via interactive digital media. The patient just received his/her RSV shot the day before reporting and told that it hurt as much as the flu shot, might be more.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received concerning the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 19-MAR-2010 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-MAR-2013, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed acyclovir for treatment of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Son thought he had dry skin and asked me for moisturizer around 10:30PM (itching started a few hours prior).  Around 1am he woke me up to ask if he had to be concerned about a 'rash'.  He was red/itchy around his hips on both sides, he had raised bumps and was red, on the side of his trunk I saw elongated hive welt.  The back of his neck itched had some red (this was the first part that he noticed itching earlier).  He also was itching in his armpits.  I google and saw with hives to go to the ER so that is what we did. They gave him 2 Benadryl, Pepcid, and prednisone (not sure of dosage). Symptoms resolved so we were discharged around 4am. They gave him a prescription for 20mg prednisone for 3 days, and said to take Benadryl in the am.
Fever/ chills and crashing headache that could not be alleviated by NSAIDs. Dry heaves for 14 hrs. occasional floating feeling. Soreness in arm that migrated to shoulder muscles and back severe enough to be felt when breathing. Fatigue.
"Moderna Covid- 19" had uncontrallable shaking of whole body, not chills especially just convulsive type shaking, had trouble walking, swelling and rash at the injection sight, labored breathing
(L)-sided numbness/weakness/burning pain in back/legs/feet. Muscle spasm. Hypersensitivity to light touch.
Rash started on legs late Saturday afternoon (02/13).  Over the next week, rash gradually spread to arms, back of hands, back, and scalp.  Saturday (02/21) I had a severe sore throat.  I didn't contact my physician right away as I kept thinking rash would go away.  My daily Loratadine for allergies didn't seem to be working, so I took a few doses of Benadryl over the weekend.  It seemed to help.  I called my physician on Mon. (2/23) to inform.   He told me  it was likely a reaction from the vaccine and to continue with  the Benadryl.
Swelling in right leg started on 9-10-2022. Shortness of breath episodes and heart palpitations randomly. Ended up with DVT in right leg and bilateral PE - May 2022
Fever, leg, arm muscle pain, nausea, baseball size welt - very hot to touch.
MMR vaccine given (patient had already received 2 doses required) instead of Varicella vaccine (2nd dose due) at time of visit. No symptoms during visit. Patient monitored 30 minutes after vaccination. Varicella vaccine not given during visit.
tiredness; headache; chills; nausea; musclepain; jointpain; feeling unwell; This is a spontaneous report from a Pfizer-sponsored program A contactable consumer (patient) reported that a male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on 10Apr2021 (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient said after he got the 1st dose and until today, 12April2021, he's still experiencing side effects like tiredness, headache, chills, nausea, muscle pain, joint pain and feeling unwell. He's calling to report it and to know what he needs to do about it. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
chills @ 24 hrs to 36 hrs; muscle pain @ 36 hrs to 72 hrs; redness of skin over muscle area @ 72 to present
Sore throat; Ringing in the ears; Diarrhea; Fast heart rate; Rash for 7 days; Tiredness; Headache; Muscle pain; Chills; Fever over a hundred; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea), HEART RATE INCREASED (Fast heart rate) and RASH (Rash for 7 days) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (symptoms were headache, ringing in the ears and diarrhea one time).    On 06-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea), HEART RATE INCREASED (Fast heart rate), RASH (Rash for 7 days), FATIGUE (Tiredness), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever over a hundred) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), TINNITUS (Ringing in the ears), DIARRHOEA (Diarrhea), RASH (Rash for 7 days), FATIGUE (Tiredness), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever over a hundred) and NAUSEA (Nausea) had resolved and HEART RATE INCREASED (Fast heart rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: over a hundred (High) over a hundred.         No concomitants drugs were provided. Future date (23-DEC-2021) was captured for the Historical Condition Covid -19 in the source document. Patient mentioned that EVENT Fast heart rate comes and goes.   This case was linked to MOD-2021-348365 (Patient Link).
3 DOTS UNDER FOREARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206821A expiry: UNIKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced 3 dots under forearm. The action taken with covid-19 vaccine was not applicable. The outcome of 3 dots under forearm was not reported. This report was non-serious.
This spontaneous report as received from a nurse refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 02-AUG-2017 inadvertently the patient was vaccinated with expired dose of PROQUAD (lot # M006103, expiry date 01-AUG-2017) 1 DF, subcutaneously for prophylaxis. No adverse effects were reported.
My arm was initially sore; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (My arm was initially sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (My arm was initially sore). At the time of the report, PAIN IN EXTREMITY (My arm was initially sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-054919 (Patient Link).   Reporter did not allow further contact
I had coughing, running nose, and brain fog. I tested positive at home for COVID-19. I talked to my doctor and she prescribed me antibodies. I still have a cough and brain fog.
Fever x 36 hrs over W/E. Increased 101.5 degrees on 10/31, (+) myalgia, chills, sweats. Cough onset 11/2. Sore throat.
Diarrhea about once a day for the last 6 days, tired, sore muscles; especially hips, buttocks, thighs, calves, now lower back, headache on and off, stiff neck on and off, and nausea on and off daily, for the last 7 days,
Pt was administered flu vaccine and approx 3 mins later, felt heart racing, and throat closing/tightening. Went to ER for eval.
Patient developed rash over 75% of his body and stayed in bed for approximately 2 weeks.
Narrative:  Pt was admitted on 8-13-21 for cellulitis on LLE post knee replacement. Pt was tested for COVID as part of routine screening for hospitalization and tested positive upon admission despite being vaccinated in timely manner. Pt had no symptoms related to COVID and received no treatments related to COVID--remained on room air with no respiratory issues during hospitalization.
Headache, Myalgia, photo sensitivity, arm tenderness at injection site Narrative:  N/A
There was a nickel-sized red bump on arm next day that grew and grew; it was warm to touch yesterday; There was a nickel-sized red bump on arm next day that grew and grew; I had an elevated temp; injection site was itchy and red; it started to hurt at night when I'd roll over; injection site was itchy and red; headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (There was a nickel-sized red bump on arm next day that grew and grew), VACCINATION SITE WARMTH (it was warm to touch yesterday), VACCINATION SITE PRURITUS (injection site was itchy and red), VACCINATION SITE SWELLING (There was a nickel-sized red bump on arm next day that grew and grew) and HEADACHE (headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced HEADACHE (headache). On 16-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site was itchy and red), VACCINATION SITE ERYTHEMA (injection site was itchy and red) and VACCINATION SITE PAIN (it started to hurt at night when I'd roll over). On 17-Jan-2021, the patient experienced VACCINATION SITE MASS (There was a nickel-sized red bump on arm next day that grew and grew), VACCINATION SITE WARMTH (it was warm to touch yesterday), VACCINATION SITE SWELLING (There was a nickel-sized red bump on arm next day that grew and grew) and PYREXIA (I had an elevated temp). On 11-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE MASS (There was a nickel-sized red bump on arm next day that grew and grew), VACCINATION SITE WARMTH (it was warm to touch yesterday), VACCINATION SITE PRURITUS (injection site was itchy and red), VACCINATION SITE SWELLING (There was a nickel-sized red bump on arm next day that grew and grew), VACCINATION SITE ERYTHEMA (injection site was itchy and red), VACCINATION SITE PAIN (it started to hurt at night when I'd roll over) and PYREXIA (I had an elevated temp) outcome was unknown.        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.   No relevant concomitant medications were reported.  Patient took ibuprofen to help with symptoms starting 17Jan2021
I got sick last week; pain on the insides felt like insides were tearing and felt like back or kidney pain; pain on the insides felt like insides were tearing and felt like back or kidney pain; I had a temperature; fatigue,exhaustion; got sick with my stomach on 5/16; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I got sick last week), BACK PAIN (pain on the insides felt like insides were tearing and felt like back or kidney pain), RENAL PAIN (pain on the insides felt like insides were tearing and felt like back or kidney pain), ABDOMINAL DISCOMFORT (got sick with my stomach on 5/16) and PYREXIA (I had a temperature) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included RIVAROXABAN (XARELTO) and FAMOTIDINE (PEPCID AC) for an unknown indication.   On 12-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, the patient experienced ABDOMINAL DISCOMFORT (got sick with my stomach on 5/16). On an unknown date, the patient experienced ILLNESS (I got sick last week), BACK PAIN (pain on the insides felt like insides were tearing and felt like back or kidney pain), RENAL PAIN (pain on the insides felt like insides were tearing and felt like back or kidney pain), PYREXIA (I had a temperature) and FATIGUE (fatigue,exhaustion). At the time of the report, ILLNESS (I got sick last week), BACK PAIN (pain on the insides felt like insides were tearing and felt like back or kidney pain), RENAL PAIN (pain on the insides felt like insides were tearing and felt like back or kidney pain), PYREXIA (I had a temperature) and FATIGUE (fatigue,exhaustion) had resolved and ABDOMINAL DISCOMFORT (got sick with my stomach on 5/16) outcome was unknown.
painful lymph nodes came back on right side even though shot was on left. Lymph nodes in back were painful too.; ringing in ears very noticeable and constant; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot number: Unknown, DOSE 1, SINGLE, vaccine location: Right arm), for COVID-19 Immunization, reaction(s): "Very unusually heavy period", "painful lymph nodes in armpit and under arm of right side", "painful lymph nodes in armpit and under arm of right side where shot was administered". The following information was reported: LYMPH NODE PAIN (non-serious) with onset 15Apr2021, outcome "not recovered", described as "painful lymph nodes came back on right side even though shot was on left. Lymph nodes in back were painful too."; TINNITUS (non-serious) with onset 15Apr2021, outcome "not recovered", described as "ringing in ears very noticeable and constant". The events "painful lymph nodes came back on right side even though shot was on left. lymph nodes in back were painful too." and "ringing in ears very noticeable and constant" were evaluated at the physician office visit. Therapeutic measures were taken as a result of lymph node pain, tinnitus.  Additional information: No other vaccine in four weeks. No other medications in two weeks. Treatment for Ae - Advil, counseling. No COVID prior vaccination nor tested post vaccination. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Increased redness and itchiness at injection site one week AFTER 2nd dose. Has been 7 days and redness keeps spreading.
Patient received booster dose of Pfizer after initial 1st and 2nd doses were Moderna.  Patient arrived confused and acted as if he was here for an inital 1st covid dose.  We preceeded with Pfizer dose and were unaware of incident until patient returned  for 2nd dose and a 2nd flu shot.  At this time system was checked and we then realized the Moderna/Pfizer mistake.  Patient has had no ill effects or issues following vaccination.
Information has been received from a Registered Nurse referring to a 4 month old female patient. On 22-MAR-2016 at 14:23, the patient was orally vaccinated with improperly stored (temperature: 32F - Time frame: 5 minutes) dose of ROTATEQ (second dose, lot # L013202, dose was unknown). NO adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
I was diagnosed with pericarditis in February. I have been on colchicine for eight months. If I don?t take it for two days I will have chest pain nine out of 10. I have an appointment to see a cardiologist soon.. I was a travel nurse in two areas. I originally saw ER for my chest pain and followed up at another location with cardiology. I am now living in another state.
I had pinprick feeling on my torso, hands, eyes, feet, arms, face. It was constant, and it eventually it became milder until it was tingling and in less parts of my body. It lasted for 2 months. I contacted my doctor and he believed it would eventually reside and as long as the tongue didn't swell and I did not have trouble breathing, that it was just a neurological response from the vaccine and that it would subside.
This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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 admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced hot flashes. On APR-2021, the subject experienced back hurts. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, hot flashes, and back hurts. This report was non-serious.
HIVES EVERY WHERE: ITCHING, RED AND PAINFUL AND ITCHING AT INJECTION SITE.
Around the end of Feb 2021, I started experiencing frequent headaches and when I checked my BP it was much higher than normal. I visit my doctor in mid-March. I was RX'd Metoprolol at the end of Feb 2022.
Next day post vax, the pt developed a rash which started on abdomen and then spread to back; described by physician as fine papular, blanching rash. Mother also complained of irritability and restless sleep after vax.
dose administered past the 30-day use; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP didn't provide information for if the dose administered past the 30-day use by date was the first or second shot Event verbatim stated that updated patient info.  No concomitant medications information was reported. No treatment medications were provided.