chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shooting pains in left side neck; Rash on left Shoulder; Pain in shoulder felt like bees stinging; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Shooting pains in left side neck), RASH (Rash on left Shoulder) and ARTHRALGIA (Pain in shoulder felt like bees stinging) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy (Gastro Sensitivity.). Concomitant products included LISINOPRIL for Blood pressure, SIMVASTATIN for Cholesterol, FAMOTIDINE for Reflux oesophagitis, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and FISH OIL for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced PAIN (Shooting pains in left side neck), RASH (Rash on left Shoulder) and ARTHRALGIA (Pain in shoulder felt like bees stinging). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) on 31-Dec-2020 for Adverse reaction, at a dose of 50 milligram. At the time of the report, PAIN (Shooting pains in left side neck), RASH (Rash on left Shoulder) and ARTHRALGIA (Pain in shoulder felt like bees stinging) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was taken to urgent care and watched for couple of hours.   This case was linked to MOD-2021-037399 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Added demographics, concomitant drugs and event outcome updated.
Patient describes not being able to breathe, "stopped breathing." Denies any facial swelling or edema.
The day after my vaccine the injection site got very red and swollen. That went away after 3 days. But 8  days after the vaccine a red itchy rash appeared at the injection site.
Vaccinee experienced nausea & vomiting on the evening of the inject IM deltoid (27SEP90). 24 hrs post inject experienced chest pains (& pressure), intermittently w/sob; Tx vistaril for sedation.
Within fifteen min. pt c/o rash on chest & localized rash around injection site. Pt sent home with Rx (antihistamine).
This spontaneous report as received from a nurse refers to an unspecified number of patients. Demographic information was not provided. On 23-DEC-2013 the patients were vaccinated with a dose of GARDASIL which had been exposed to -5 degrees Celsius for 20 minutes which was not supported. Route, strength, dose and lot number were not reported. No adverse effects were reported. This is 1 of 3 reports received from the same source (other case IDs 1312USA010886 and 1312USA012121). Additional information has been requested.
Patient received her first vaccine on 2/9/21. On 3/5, patient woke up with extremely swollen lymph nodes on bilateral sides of lower neck. Lymph nodes visible without touching them.
Elevated temperature (in late afternoon was 97.6, now, several hours later, is 99.2),  feeling chilled, headache, malaise.
TONGUE FELT STRANGE TONGUE MOVEMENT WAS WEIRD, VOICE SLURRED. GIVEN 0.3 MG OF 1:1000 EPI R ARM IM
Pt recvd vax & 24 hrs p/vax exp nausea, sweats, & difficulty catching breath; prev dose administration dates dose 1 26JAN93; dose 2, 22JUL93;
Patient was given at 10:05 vaccine, sat in car for 15 minutes left and came back at 10:55 stating, "I do not feel right.  I feel itchy and like I have drank a lot of caffeine.  10:55 gave 50 mg of benadryl (refused epi pen).  EMS was called at that time.  143/99, 99 Pulse.  EMS arrived and evaluated patient and discharged at 11:10 AM>
Information has been received from a registered nurse concerning a 9 year old female with no pertinent medical history or drug allergies who on 13-SEP-2007 was vaccinated with her second 0.5ml SC dose of varicella virus vaccine live (Oka/Merck) (lot# 658373/1116U). There was no concomitant medication. On 14-SEP-2007 the patient developed a red, warm, raised and swollen area at the injection site. Medical attention was sought through contacting the physician's office. No lab diagnostic studies were performed. The patient was noted to be recovering. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Patient Stated they had elevated blood pressure and heart rate post vaccination. Was very concerned and went to ER.
Optic neuritis 6 wks after vaccine.  Rx high dose solumedrol followed by prednisone. 3/31/08-treatment records received from facility for DX optic neuritis. IV steroid therapy. 5/6/08-records received for DOS 2/15/08-presented with left eye visual symptoms, began somewhat abruptly 10 days prior with visual blurring and left periorbital pain. Moving his eyes caused some discomfort. Optic nerve head pallor and some peripapillary hemorrhages. Treated with Solu-Medrol.
Three or four days later, patient got the COVID and received plasma at the hospital.; This is a spontaneous report from a Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A contactable pharmacist reported for a 69-year-old female patient received 1st dose of BNT162B2 (PFIZER BIONTECH COVID 19 VACCINE) in Feb2021 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Pharmacist stated that one of her patients received the first dose of the Pfizer BioNTech COVID-19 vaccine in Feb2021. Three or four days later, patient (female) got the COVID and received plasma at the hospital. Patient received her second dose of the Pfizer BioNtech COVID-19 vaccine yesterday 20May2021 (refer to AER# 2021586368). Pharmacist wants to know if she should restart the vaccination. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, the event COVID-19 most likely represents an intercurrent infection as it is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset. 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.
This spontaneous report received from a registered nurse referred to a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-MAR-2017, the patient was vaccinated with VARIVAX (dose, frequency not reported, lot:M028546, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Pregnant patient received 1st dose of the vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received 1st dose of the vaccine) in a 38-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m20a) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to animal (Allergy to bees reported.). Concomitant products included MULTIVITAMIN [VITAMINS NOS] and ASA for an unknown indication.    On 20-Feb-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 02-Jul-2020 and the estimated date of delivery was 08-Apr-2021. On 20-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received 1st dose of the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy.  On 20-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received 1st dose of the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2020, Pregnancy test positive: positive (Positive) 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 information not reported. Estimated date of conception 14 Jul 2021.
Pt reports swelling and pain in right arm the night of the injection. Slight improvements day after 9/22/17. On 9/23/17, patient reports worsening of swelling, pain, and new onset tachycardia (120 BPM) and difficulty walking. Patient checked into ER 9/23/17 and was administered IV diphenhydramine. Symptoms improved and was discharged. Now continuing on oral diphenhydramine. Swelling was localized to the right arm. No epinephrine was necessary.
no adverse event; the patient received one dose of Gardasil 9 on 13-JUN-2019 and a second dose on 14-JUN-2019; This spontaneous report was received from a nurse and refers to a 17-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.    On 13-JUN-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R021636, expiration date 12-MAY-2021, intramuscularly for human papillomavirus (HPV) prevention. On 14-JUN-2019, the patient received a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No adverse events were reported.     The outcome of an inappropriate schedule of product administration was unknown.
sick; on the 27Aug she got a cold; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 48 year-old female patient received bnt162b2 (BNT162B2), administration date 24Aug2021 (Batch/Lot number: unknown) at the age of 48 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ. The following information was reported: ILLNESS (non-serious) with onset 27Aug2021, outcome "unknown", described as "sick"; NASOPHARYNGITIS (non-serious) with onset 27Aug2021, outcome "unknown", described as "on the 27Aug she got a cold".  Additional information: Reporter missed 5 doses due to taking Covid vaccine. Reporter had used Methotrexate Claritin Tylenol extra strength folic acid extra sulfomethazole/trimetho. reporter stated that she wanted to take the Covid shot. Prescriber was advised to be off Xeljanz a week before she gets her shot. She did and she had been without medication still. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I developed a tennis ball sized red circle around the injection site.  It was very itchy and developed a bumpy texture.  It is still slightly itchy but the redness has gone away.  The itch is still slightly present.  After research, it appears to be what has become known as "covid arm"  I took advil to dull the itch but no other treatment.
Right arm very hot to touch red area all around where shots were given. Parents state it grew about 1/2 more in diameter today. It is about the size of a baseball and very hot, has hard spot in middle of it. Patient states that it is not painful and has not hurt at all. Has been cold gel pack on it and warm compresses. It measures 100mm x 80mm. Was given MCV4 and HPV in right arm. Per parents it is not as red today.
Patient came to pharmacy in October of 2023 and said her arm had not stopped hurting since receiving COVID vaccination in October of 2022. She said her doctor suggested the pharmacy fill out a VAERs report.
I only experienced fatigue the evening I received these vaccines. On May 2nd, I began to notice lesions on my chest. I do get chest acne so I chalked it up to that at first, even though the lesions looked distinct from acne. On May 3rd and 4th, I woke up with several new lesions throughout my chest that persisted for months. The lesions were most concentrated on my left side. I also had one lesion near my left eyebrow; the rest were on my chest.
Very high heart rate over 120 for 8 hours; Fever.; Chills; Sore muscles; Headache; Dizzy; Very high heart rate over 120 for 8 hours.  Fever, chills, sore muscles, headache, dizzy, and tired.; This is a spontaneous report from a contactable consumer (patient). A 16-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left (at the age of 16 years old) on 12May2021 at 18:30 (Batch/Lot Number: EW0186) as DOSE 2, SINGLE for covid-19 immunization. Also reported 'Device Date:19May2021' no additional details provided. Facility where the most recent COVID-19 vaccine was administered was health facility. No other vaccines were given within 4 weeks. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Medical history included attention deficit hyperactivity disorder. Concomitant medication(s) included methylphenidate hydrochloride (CONCERTA) 54mg. Historical Vaccine includes BNT162B2 Dose 1 (at the age of 16 years old) on  21Apr2021 at 18:30 Batch/lot number ER8736, Left arm Covid-19 immunization and not events were reported. The patient previously took amoxicillin and experienced drug hypersensitivity. On 13May2021 at 02:00 The patient experienced Very high heart rate over 120 for 8 hours, Fever, chills, sore muscles, headache, dizzy, and tired. The event Very high heart rate over 120 for 8 hours was considered medically significant. The patient underwent lab tests and procedures which included heart rate: high on 13May2021 (Very high heart rate over 120 for 8 hours). No Treatment was given and No hospitalization was involved. The clinical outcome of the events was recovered May2021.   Follow-up attempts completed. No further information expected.
Information has been received from a healthcare worker (immunization official) referring to a 4 year old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 27-JUL-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # K010440 (expiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
I reported in V-Safe that I had pain for the first 3 days. What I failed to report, and now realize, is that I had a fever in the first 24 hours and a hive/red welt still exists at the injection site. The red welt is slightly swollen and very warm to the touch. It is approximately 3" x 5" oval shape around the injection site. It has persisted for 8 days since the vaccination.
Patient came in for 2nd dose of Moderna vaccine. Due to malfunction of syringe (not completely screwed on), vaccine was seen leaking out when injected and it is unknown how much vaccine patient received. Consulted lead at vaccine clinic and situation explained to patient. Another dose will not be administered at this time. Patient is ok with this and sent to observation.
6/26/2019   Dear Dr.,   I hope all is well with you. As suggested in the literature accompanying the vaccine, this is to report on my allergic reactions to my prescribed shingles vaccine (Shingrix) which I received this past Monday, 6/24/2019 around 3pm. The site was increasingly painful and I grew tired.  By late night through early morning, I had high fever and shivers, and such dehydration that I had to continually drink water. The fever abated toward the morning (6/25 )and I slept until 10am, unusually late for me.  I functioned at a slow pace, with a needed nap around 5pm, again unusual for me. I am almost back to normal today(6/26/2019.)  I have never had such a reaction to any other vaccine. Please file this report to the Vaccine Adverse Event Reporting System (www.vaers.hhs.gov.) as suggested.  Thank you for your attention and care.  Respectfully,
Pt was asked to wait 15 min. after H1N1 vaccine given. Within 15-20 minutes, patient c/o dizziness, nausea, throat sore and hoarseness. EMT called one dose of Epinephrine 1:1000 given sc (0.3cc) vitals prior to epinephrine BP185/95, 72,20 96.6 F
Atrial fibrillation; Woke up dizzy; Sweating; He felt very weak, he sat on the sofa for the rest of the day; Redness; Big lump; It was very hard; It itched a little bit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 01-Apr-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced ERYTHEMA (Redness), MASS (Big lump), INDURATION (It was very hard) and PRURITUS (It itched a little bit). On 30-Apr-2021, the patient experienced DIZZINESS (Woke up dizzy), HYPERHIDROSIS (Sweating) and ASTHENIA (He felt very weak, he sat on the sofa for the rest of the day). On 17-May-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant). The patient was treated with DILTIAZEM ongoing since an unknown date at an unspecified dose and frequency; FUROSEMIDE ongoing since an unknown date at an unspecified dose and frequency; AMIODARONE HYDROCHLORIDE (PACERONE) ongoing since an unknown date for Blood pressure, at a dose of 200 mg once a day and AMIODARONE HYDROCHLORIDE (PACERONE) in April 2021 for Blood pressure, at a dose of 200 mg three times a day. On 30-Apr-2021, ERYTHEMA (Redness), MASS (Big lump), INDURATION (It was very hard), PRURITUS (It itched a little bit), DIZZINESS (Woke up dizzy), HYPERHIDROSIS (Sweating) and ASTHENIA (He felt very weak, he sat on the sofa for the rest of the day) had resolved. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Cardiac stress test: normal (normal) Normal. On 17-May-2021, Electrocardiogram: normal (normal) Normal. On an unknown date, Blood pressure measurement: unknown (Inconclusive) Unknown.         Treatment for the events included Letopherol and cardio inversion. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-220992 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Pt attributes 10 month hx of R flank pain to Anthrax series. UA negative, appears musculoskeletal in nature.
Patient woke up with skin irritation left arm pit, left chest, and both sides of neck. He states he took Benadryl and used cold compresses.
Patient came to the store to receive his second dose on 5/27/21 at 1:40pm. He referred after getting 1st dose on 4/28/21 he had SOB and pain in the injection site, the event appeared 4 hours after the injection, he went to the ER and was advised it might be due to the vaccine, no information received about the facility he went to or other therapies received, patient was not hospitalized and recovered. Limited information provided by patient. ***This Event may have been reported by the ER department patient was seen at at that time, doing this report considering we do not have confirmation of whether that entity have reported the event already***
pt recv vax; devel diff in achieving max exercise output;following 3rd dose of vax, began to notice SOB even when not exercising;felt that he had "a heart electrical blockage";
No adverse reaction.  Vaccine temperature excursion.  Vaccine was kept at a frozen temperature, not refrigerated temperature upon receipt of shipment.
Asymptomatic 14 days post vaccine break through Narrative: Asymptomatic 14 days post vaccine break through
FLU-LIKE SYMPTOMS, WEAKNESS, BODY ACHES, BACK PAIN.
Pt has small bumps (red) that itch on shoulder, both arms, both legs, and back.
Swollen Lymph nodes on her left arm; Left breast pain; Lung pain; Lightheaded; Muscle aches; Tiredness; Weakness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 16:00 (Batch/Lot number: unknown) at the age of 37 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "sulfa allergy" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Penicillin, reaction(s): "Penicillin allergy"; Cipro, reaction(s): "Cipro allergy". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Swollen Lymph nodes on her left arm"; BREAST PAIN (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Left breast pain"; PULMONARY PAIN (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Lung pain"; DIZZINESS (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Lightheaded"; MYALGIA (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Muscle aches"; FATIGUE (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Tiredness"; ASTHENIA (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Weakness". It was unknown if therapeutic measures were taken as a result of lymphadenopathy, breast pain, pulmonary pain, dizziness, myalgia, fatigue, asthenia.  Additional information: No other vaccine in four weeks. No other medications in two weeks. Covid prior vaccination was yes. Covid tested post vaccination was no.  Follow-up attempts completed. No further information is expected.