chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of hyperhidrosis (sweated), headache, myalgia (body aches) and chills in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 015M20A) for COVID-19 immunization. No medical history reported. On Feb 25, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Feb 25, 2021, patient experienced hyperhidrosis (sweated). On Feb 25, 2021, at 5:30 pm, patient experienced chills. On Feb 26, 2021, patient experienced headache and myalgia (body aches). At the time of the report, hyperhidrosis (sweated), headache, myalgia (body aches) outcome: unknown; and chills: resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
R trapezius pain that radiates to R elbow x 12/29. Onset after covid vaccine 1100 12/29. Bilat shoulder pain/achy that evening, when awoke felt "like I had been shot". States would rather give birth to a child than have this pain. Ibuprofen 600mg "around the clock", 5 year old oxycodone, heat, massage, tiger-balm, voltaren gel, 1.5 bottles of wine - nothing has touched it. Considered dry needling with PT, but declined. No injection site rash or soreness. Has not contacted RSF regarding concern for vaccine side effect.
12 hours after receiving the second Pfizer Covid 19 vaccination dose, I started getting chills and body shakes for about 24 hours.  I had significant night sweats waking up completely soaked.  I measured a fever at 101.7 in the morning of the next day after the dosing of 2 advils clearly had worn off.  I continued to take 1 advil every 4 -6 hours when i noticed getting chills again until the afternoon on 4-25-2021 when I started to feel better. i had no other sideeffects with the exception of body aches which I contribute mostly to staying in bed for over 24 hours.
pt recv vax 15JUL96 & on 18JUL96 pt exp parotitis of lt cheek where the swelling occurred rapidly p/the onset of sx, & on 19JUL96 pt was hosp;lab eval revealed mumps IgG 10 & IgM less than 10;20JUL96 pt recovered from exp;
BODY ACHES; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch no was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced fever, and body aches. Laboratory data (dates unspecified) included: Body temperature increased (NR: not provided) 102 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and body aches was not reported. This report was non-serious.
9/11/09 broke out all over red, raised areas, no blisters, itches.
Erythema over left forearm 14cm x 8 cm with elevation in temperature. Gave Prednisone.
Since 3/3/21, patient has been seen by numerous providers and ophthalmologists for shingles. She has had a CT (3/6/21), MRI (3/25/21), and lab work (3/22/21). Patient was started on Gabapentin, Oxycodone, valacyclovir, prednisone, Latanoprost drops, Systane drops, and prednisolone drops since that time.  Patient is seeing a specialist  and will remain under his care due to the potential for long term loss of vision due to nerve damage.
patient had red rash going down arm that she said showed up the day she got her flu vaccine. it did not hurt but it was warm to the touch still even 2 days later. she did mention that she also had an allergic reaction to her covid shot she got this year as well but has never had that reaction to a flu shot in the past. her doctor would not give her her allergy shot today because of the rash
The pt was vaccinated on 12/26/2001. At the DTaP injection site within 6 hours, the pt developed marked redness and swelling; not painful. Seen 24 hrs after injection area with approximately 12 cm diameter. No drainage. On 12/28/2001, the pt reported slight itching.
Patient received a vaccine that was expired. Product was placed in fridge 1/3/23 and should have been discarded 3/14/23.
This spontaneous report was received from a nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On 03-AUG-2016 the patients were vaccinated with improperly stored GARDASIL 9 lot # L038503/expiration date- 18-DEC-2017, lot # L026602/expiration date- 19-OCT-2017. No adverse event was reported. No concomitant medication was reported. The call was because of digital data logger. Temperature/Time frame: 8.9C for 1 hour and 1 minute and previous excursion was 10.4C for 6 hours 18 minutes. The outcome of event was unknown. No PQC (product quality complaint was involved). This is one of several reports received from the same reporter. Additional information has been requested.
SARS-Cov-2 Antigen Positive 11/24/2021  and developed pneumonia.
Admit for COVID 19 Pneumonia with acute hypoxic respiratory failure--with cough as presenting symptom.On IV solumedrol, zinc, singulair, pepcid, Remdesivir 8/18-8/27. Toci given 8/19/21. Rocephin/doxy d/c'd. His O2 requirements worsened with worsening agitation. Family elected to pursue hospice care. DC to HCF. Disposition:He will be dischargedtodayto inpatient hospiceHCF
Patient with onset of facial tingling and sensation of facial swelling and tongue swelling approximately 10 min after receiving the second dose of her COVID-19 vaccine. This persisted throughout evaluation. She received the first dose of her COVID-19 vaccine 3 weeks prior, without adverse effects. She had progression of symptoms during her evaluation, with some chest pressure, described as a sensation of a brick sitting on her chest, duration approximately 10 min at the time of evaluation, continual, approximately 3/10 on pain scale, persisting chest pressure worse with deep breathing. Oxygen saturations were stable at 95%, anterior breath sounds clear with good air exchange, distant heart sounds. Good peripheral pulses, perfusion difficult to assess since fingertips were cold due to cold external air temperatures. She was transferred from private vehicle to ambulance and oxygen was placed and EKG obtained as below. She was then transferred to hospital for further evaluation. Of note, the patient reported that during the day prior to receiving the second dose of her vaccine, she had worsening shortness of breath with need for supplemental oxygen, 2L by nasal cannula, with activity and at rest.  Onset prior to her evaluation after her vaccination. This is above her baseline of nocturnal oxygen use. She was feeling poorly prior to presenting for the vaccine. She had been hospitalized with intubation for CHF exacerbation in the week prior to 2nd dose COVID-19 vaccine administration.
No Adverse Event; Moderna covid-19 monovalent red cap with expiration date 11 mar 2023 was administered to 1 patient of Lot 074B22A; first Moderna dose on 03 Feb 2023 and Date of administration of 2nd vaccine 13 Mar 2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna covid-19 monovalent red cap with expiration date 11 mar 2023 was administered to 1 patient of Lot 074B22A), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna dose on 03 Feb 2023 and Date of administration of 2nd vaccine 13 Mar 2023) and NO ADVERSE EVENT (No Adverse Event) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 074B22A and 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Mar-2023, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna covid-19 monovalent red cap with expiration date 11 mar 2023 was administered to 1 patient of Lot 074B22A). 13-Mar-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna dose on 03 Feb 2023 and Date of administration of 2nd vaccine 13 Mar 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna covid-19 monovalent red cap with expiration date 11 mar 2023 was administered to 1 patient of Lot 074B22A), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna dose on 03 Feb 2023 and Date of administration of 2nd vaccine 13 Mar 2023) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna covid-19 monovalent red cap with expiration date 11 mar 2023 was administered to 1 patient of Lot 074B22A) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna dose on 03 Feb 2023 and Date of administration of 2nd vaccine 13 Mar 2023).    No concomitant product reported by the reporter.  Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vial size was reported as 5.5 ml. Vial was initially stored in the refrigerator on 10-Mar-2023. Vial did not undergone any temperature excursion issue.  No treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Mar-2023: Live significant follow up received. Dosage Information updated. Product coding changed from Moderna COVID-19 Vaccine to Spikevax. Event added. Narrative Updated.
This spontaneous report was received from a registered nurse and refers to a 15 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-AUG-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N000683 with expiry date: 06-JAN-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Vasovagal response. Approximately 4-5 minutes after all vaccines administered. Extreme pallor, lowered head, moaning. Client able to verbally respond. Complained of dizziness and lightheadedness. Assisted to a supine position, cold cloth placed on forehead, water, candy, juice given. BP 110/70.  Color returned within 5 - 7 minutes. Monitored client for further reaction for approximately 30 minutes. After 30 minutes client reported no further symptoms. Able to stand and walk without issue. Follow up phone call at 1 hour post leaving clinic, client stated she felt good and made it home safely, denied further symptoms.
Patient was given Moderna COVID 19 vaccine at 7:00 am April 27,2021 and says she felt fine while sitting in the store for the 15 minute observation period, but then felt short of breath after getting in her vehicle to drive home.  Patient did not go to the emergency room or call 911, but went to a park to sit and get some fresh air.  Patient called the pharmacy just before closing around 6:30pm to inform us of her reaction and that her breathing was still not 100%.  I suggested she go the the emergency room, but the patient seemed to feel comfortable enough to not need to do so.  I encouraged her to call 911 if necessary and to contact her doctor to inform him of her symptoms.
Normal upper arm soreness after a flu vaccine for 2 days. The soreness then moved to muscle area in upper left arm. My arm hurts to move it upwards, outward from my body, and inward toward my body. This pain has been ongoing since October 21st, 2017. I went to the doctor and explained the pain and how I believe it's a result of the flu vaccine. Xrays were taken and they showed no problem. I was given a steroid shot which helped minimize the pain, but only temporarily.
Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium
Child presented @ office with history of clustered vesicles 5x10cm on right medial thigh 2" below inguinal skin fold. Erythematous base. No pain or itching initially but next day as culture obtained, experienced pain, second degree cellulitis. Treated with Acyclovir 200/5 cc 300 mg po q 5hrs x 3-5 day, Duricef 250 mg BIDx7-10 days
Bad vision in the left eye; Rush of pressure in the brain and head; Heart pounding; Palms of arms and hands sweating; Legs begin to quiver shake; Bowel movement; Dizziness; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Bad vision in the left eye), HEAD DISCOMFORT (Rush of pressure in the brain and head), PALPITATIONS (Heart pounding), HYPERHIDROSIS (Palms of arms and hands sweating) and TREMOR (Legs begin to quiver shake) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardiac ablation. Concomitant products included ATORVASTATIN for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced VISUAL IMPAIRMENT (Bad vision in the left eye), HEAD DISCOMFORT (Rush of pressure in the brain and head), PALPITATIONS (Heart pounding), HYPERHIDROSIS (Palms of arms and hands sweating), TREMOR (Legs begin to quiver shake), BOWEL MOVEMENT IRREGULARITY (Bowel movement), DIZZINESS (Dizziness) and PAIN IN EXTREMITY (Sore arm). At the time of the report, VISUAL IMPAIRMENT (Bad vision in the left eye) and HEAD DISCOMFORT (Rush of pressure in the brain and head) had not resolved and PALPITATIONS (Heart pounding), HYPERHIDROSIS (Palms of arms and hands sweating), TREMOR (Legs begin to quiver shake), BOWEL MOVEMENT IRREGULARITY (Bowel movement), DIZZINESS (Dizziness) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had a history of rare blood IgA factor. No treatment information was provided.
Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from an-other health professional. This case is linked to case 2018SA226817 (same reporter). This case involves adult female patient (age not reported) who was vaccinated with a 0.5 ml dose of QUADRACEL (Batch number: C5248AA and expiry date: 21-Aug-2019) via intramuscular route on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because stability on QUADRACEL, the excursion was actually for 9 days, starting in May, and ranged from 48-49 F. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: None.
Swollen tonsils; Clogged ears (both left and right); This spontaneous case was reported by a consumer and describes the occurrence of TONSILLAR HYPERTROPHY (Swollen tonsils) and EAR DISCOMFORT (Clogged ears (both left and right)) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfa containing drugs), Allergic to cats, Pollen allergy and Allergic to dogs.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced TONSILLAR HYPERTROPHY (Swollen tonsils) and EAR DISCOMFORT (Clogged ears (both left and right)). At the time of the report, TONSILLAR HYPERTROPHY (Swollen tonsils) and EAR DISCOMFORT (Clogged ears (both left and right)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Outcome of the events updated from unknown to not recovered.
Extra Bowel Movement then before; Swelling only present during the 15 minutes after vaccination.; Tenderness only present during the 15 minutes after vaccination.; I experienced tingling in my arm during that 15 minutes; But my arm,where I was injected, I was feeling it and it is feeling a little numb; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PARAESTHESIA (I experienced tingling in my arm during that 15 minutes), INJECTION SITE HYPOAESTHESIA (But my arm,where I was injected, I was feeling it and it is feeling a little numb), FREQUENT BOWEL MOVEMENTS (Extra Bowel Movement then before), VACCINATION SITE SWELLING (Swelling only present during the 15 minutes after vaccination.) and VACCINATION SITE PAIN (Tenderness only present during the 15 minutes after vaccination.) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026021A) for COVID-19 vaccination.     Concurrent medical conditions included Immune system disorder (NOS) (Overactive immune system) and Headache.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced INJECTION SITE PARAESTHESIA (I experienced tingling in my arm during that 15 minutes), INJECTION SITE HYPOAESTHESIA (But my arm,where I was injected, I was feeling it and it is feeling a little numb), VACCINATION SITE SWELLING (Swelling only present during the 15 minutes after vaccination.) and VACCINATION SITE PAIN (Tenderness only present during the 15 minutes after vaccination.). On an unknown date, the patient experienced FREQUENT BOWEL MOVEMENTS (Extra Bowel Movement then before). On 18-Oct-2021, INJECTION SITE PARAESTHESIA (I experienced tingling in my arm during that 15 minutes), INJECTION SITE HYPOAESTHESIA (But my arm,where I was injected, I was feeling it and it is feeling a little numb), VACCINATION SITE SWELLING (Swelling only present during the 15 minutes after vaccination.) and VACCINATION SITE PAIN (Tenderness only present during the 15 minutes after vaccination.) had resolved. At the time of the report, FREQUENT BOWEL MOVEMENTS (Extra Bowel Movement then before) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up added contact information and new event.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: pt fainted while sitting down 10 mintues after vaccine and hit his head. RN assessed- weak pulse, blurred vision. BP was stabalized at 110/797, hr 72, o2 sat 98%. 911 was notified because he hit his head. Pt was suggested for CT for head injury but signed himself AMA from the paramedics. Pt's said friend would take him to ER. Followed up next day- CT scan clear. Pt is fine.
Fever of up to 101.4, chills, body aches, nausea, runny nose
FEELS SKIN FLUSHING (IN BACK OF LEGS, ARMS, NECK AND CHEEKS AND GOES AWAY AND THEN COMES BACK BUT NOT GOT WORSE SINCE THEN); FEELS TINGLING (IN BACK OF LEGS, ARMS, NECK AND CHEEKS AND GOES AWAY AND THEN COMES BACK BUT NOT GOT WORSE SINCE THEN); NAUSEA; This spontaneous report received from a patient via a company representative concerned a 53 year old male. The patient's weight was 215 pounds, and height was 69 centimeters. The patient's past medical history included: covid-19, and other pre-existing medical conditions included: The patient had not experienced any weakness and did not get sick or anything like that. The patient was taking allergy nose spray. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: UNKNOWN) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. Concomitant medications included quetiapine fumarate for drug used for unknown indication. On NOV-2021, the patient experienced nausea. On 09-NOV-2021, the patient experienced feels skin flushing (in back of legs, arms, neck and cheeks and goes away and then comes back but not got worse since then). On 09-NOV-2021, the patient experienced feels tingling (in back of legs, arms, neck and cheeks and goes away and then comes back but not got worse since then). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feels skin flushing (in back of legs, arms, neck and cheeks and goes away and then comes back but not got worse since then), and feels tingling (in back of legs, arms, neck and cheeks and goes away and then comes back but not got worse since then), and the outcome of nausea was not reported. This report was non-serious. This case, from the same reporter is linked to 20211124555.
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (after the expiration date) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 030B21A and 016B21A) for COVID-19 immunization. No medical history reported. On Aug 26, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 22, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 22, 2021, patient administered expired product (after the expiration date). On Sep 22, 2021, administered expired product (after the expiration date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Sudden-onset sensorineural hearing loss (SSNHL) with loud tinnitus in the right ear occurring 3.5 days after administration of approved booster (3rd dose in series) COMIRNATY. Initial reaction to vaccine was similar to first two doses - sore arm, mild myalgias, resolving within 48 hours. Other potential causes for SSNHL included air travel (12-18 hours prior to symptom onset), change in temperature. At time of reporting the symptoms have continued unabated for 5 days, been objectively confirmed by audiogram, and have been refractory to high dose steroid therapy. It is unclear whether the hearing loss and accompanying tinnitus will be reversible - idiopathic cases have reported recovery rates up to 75% but there is understandably sparse data on potentially vaccine-associated cases.