chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Dose have been administered to patient after this excursion occurred.; Moderna COVID-19 bivalent vaccine that were stored in the freezer that went out of range. The excursion occurred on 31JUL2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 bivalent vaccine that were stored in the freezer that went out of range. The excursion occurred on 31JUL2023.), POOR QUALITY PRODUCT ADMINISTERED (Dose have been administered to patient after this excursion occurred.) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Aug-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Jul-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 bivalent vaccine that were stored in the freezer that went out of range. The excursion occurred on 31JUL2023.). On 04-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose have been administered to patient after this excursion occurred.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 bivalent vaccine that were stored in the freezer that went out of range. The excursion occurred on 31JUL2023.), POOR QUALITY PRODUCT ADMINISTERED (Dose have been administered to patient after this excursion occurred.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 bivalent vaccine that were stored in the freezer that went out of range. The excursion occurred on 31JUL2023.) and POOR QUALITY PRODUCT ADMINISTERED (Dose have been administered to patient after this excursion occurred.).    No concomitant medication was reported.  This patient could have potentially received dose from a vial that was stored in the refrigerator and did not experience any excursions, however HCP was not sure about that. AE was being reported for awareness. No treatment information was reported.  This case contains information for patient3 out of 3.   This case was linked to US-MODERNATX, INC.-MOD-2023-736986, US-MODERNATX, INC.-MOD-2023-736987 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736986:Master case, Patient 1 US-MODERNATX, INC.-MOD-2023-736987:Patient 3
Parents complained of persistent lumps at the thighs, where the injections were given.  I explained to them that this is a common side effect and reassured them.  These bumps persist still to this day, right thigh more than left thigh.  The right thigh sometimes is red and itchy as well.  NO pain, limp or disability.
pt recv vax 13FEB96 & devel a fever of 100,vomiting,lethargy,& flu-like sx;the reporter notes that improper storage of vax might be r/t adverse rxn;dx rotavirus infect unrelated to vax
Pt reports insect bite like sensations on arms/legs/back & will have appointment w/ MD to examine per case in case he is developing shingles.
Information has been received from a physician concerning a 2 months old male patient who on 01-AUG-2010 ("5 days ago") was vaccinated orally with the first dose of ROTATEQ (lot# not reported). On 01-AUG-2010 the patient developed a discoloration at the corners of his mouth, and the discoloration had worsened since the ROTATEQ was administered. Unspecified medical attention was sought. The patient's a discoloration at the corners of his mouth persisted. Follow up information has been received from a physician concerning the male patient with a family history of eczema who on 28-JUL-2010 was vaccinated orally with the first dose of ROTATEQ (lot# 668123/0512Z). There was no illness at time of vaccination. On 29-JUL-2010, the patient developed discoloration (darkening) of his mouth. There were no laboratory diagnostics studies performed. At the time of this report, the patient's outcome was unknown. Follow up information has been received from a physician concerning the male patient who on 28-JUL-2010 was vaccinated orally with the first dose of ROTATEQ. On 29-JUL-2010, the patient developed discoloration of his lips. At the time of this report, the patient had recovered. Additional information is not expected.
The day after receiving the first vaccine, my fingers and toes on both sides became swollen and painful. Even now, four weeks after the first vaccine, my fingers are two ring sizes swollen, and my toes are swollen. There is constant pain in the joints in my fingers and toes. Also, I developed a sharp, intermittent shooting pain behind my right breast one day after receiving my second Pfizer vaccine on April 19.
Severe flu-like symptoms (body aches, fever and chills) that started a "few hours after" vaccination and lasted for 3 days. Treated with over-the-counter ibuprofen. Also reported injection site redness that lasted for about a day and diarrhea that started 3 days after vaccination and lasted a day.
Every time I go in sunlight or UV light I break out in hives all over my back, chest and stomach
Hives, itching, redness, swelling, and pain all over body. Started on 12/28/21 and is still persisting, even with taking Benadryl at night, Zyrtec during the day, and prednisone since 12/30/21.
?COVID arm?  The area around my injection site is red, hot, hard and itchy. My entire arm, all the way down to my hand, also feels sore and achy.
headaches in and out on day 6 and haven't stopped from any of the days before  headaches last for about 2 to 3 hours and stop but it has been throughout the entire course and I'm on day 6
Pt exp pain, swelling at inject site night of vax. No hives, resp problems. Site redness and 50 cent size duration. No streaking or fever. Shoulder ached.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. In August 2014, the patient was vaccinated with a first dose of GARDASIL (dose, route, lot# and expiration date were not provided. Then on 21-JUL-2015, the patient received a dose of GARDASIL 9, which was considered to be an inappropriate schedule of drug administration. No adverse effect reported. Additional information has been requested.
Patient expired 03/09/2022;  He was tranferred to facility 03-08-2022 with Covid Pneumonia per notes and resp failure
Shortly after vaccination, I began to have swelling in my right hand, started from thumb to elbow. Muscles hurt in upper arm. Received vaccination in left arm.  Aches up and down the arm, my right arm. I am holding the phone in my left hand. My hand still aches, if it's not swollen. My thumb is misshaped. I was told it's just coincidence. After the booster shot, my hand got much worst. In addition, it was elbow and my neck ached on the right side. I could turn my neck, but I have to force it. My right knee is swollen. The other stuff didnt go away, after the booster, it was just more.
blood clots; This spontaneous case was reported by a health care professional and describes the occurrence of THROMBOSIS (blood clots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criteria medically significant and life threatening). At the time of the report, THROMBOSIS (blood clots) 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.   patient who got their first dose back in April No concomitant medication was reported.  No treatment medication use was reported.  The patient did not experience any other known symptoms, and they are not sure about any treatments given. For their second dose of the vaccine now the provider gave this patient an anticoagulant to take 30 minutes prior to receiving the vaccine to try and prevent further clotting.  This case concerns a female patient (Unknown age) with no relevant medical history, who experienced the unexpected event of Thrombosis. The event occurred on an unspecified date after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. Limited information provided precludes a complete medical and causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a female patient (Unknown age) with no relevant medical history, who experienced the unexpected event of Thrombosis. The event occurred on an unspecified date after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. Limited information provided precludes a complete medical and causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Per employee health nurse note of 10/28/09. Received vaccine on 10/26/09 temp of 101-102 Sanofi Pasteur Lot # UP005AA Exp 3/15/11.
About March 30th I  had very large bruise on my left foot. Don't remember bumping it but it is possible I forgot. April1, 2021 I had another large hard red bruise on my left front forearm. Felt like a hematoma underneath bruise  Don't remember ever having such large bruises even when I did bruise. The one on my left foot on top front of foot was very large black and blue about 4 inches wide. The one on arm was red about 2 inches circle.
Approx 2 hours after vaccination, developed hives. Started on left arm (where got vaccinated) but also on right arm, then spread to legs, face, rest of body. Took Benadryl.
site of injection was warm to touch; site of injection was red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (site of injection was warm to touch) and INJECTION SITE ERYTHEMA (site of injection was red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced INJECTION SITE WARMTH (site of injection was warm to touch) and INJECTION SITE ERYTHEMA (site of injection was red). At the time of the report, INJECTION SITE WARMTH (site of injection was warm to touch) and INJECTION SITE ERYTHEMA (site of injection was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Patient was administered a second dose of Moderna Bivalent covid-19 vaccine. Standing orders from the state have not been issued hence the need for this to be reported as it was given out of the recommendations by the state.
Had same kind of headache with first vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Apr2021 10:30 (Lot number: EP8834) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Jan2021 (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 11Oct2021. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "Had same kind of headache with first vaccination".  Additional information: On 16Nov2021 at 18:00, the third dose resulted in right axillary lymph node swelling and pain, which continues 48 hours, still very sore/swollen. The patient experienced 30 hours headache (stingy like a migraine), fatigue, malaise. The patient had same kind of headache with the first vaccination. The patient experienced almost nothing with second dose. Armpit swelling and pain was unique to the third shot. On 16Nov2021 at 09:30, the patient received the third dose of BNT162B2 (Batch/Lot number: FH8030) at the age of 49 years, via unspecified route of administration in right arm. The patient was not pregnant at the time of third dose. On 28Apr2021 at 12:00, the patient received the second dose of BNT162B2 (Batch/Lot number: EW0172) at the age of 48 years, via unspecified route of administration in right arm. Facility where the most recent (third dose) of COVID-19 vaccine was administered reported as pharmacy or drug store. On 11Oct2021, the patient received FLU vaccines within 4 weeks prior to the COVID vaccine. Dose 3 adverse events was not resulted in emergency room or physician office visit. Dose 3 events outcome reported not recovered. The patient was not received treatment for dose 3 events. Prior to vaccination, the patient was diagnosed with COVID-19. Since the third dose of vaccination, the patient was not tested for COVID-19. The patient had no known allergy. Other medical history reported as no.  No follow-up attempts are possible. No further information is expected.
patient given diluent; patient given diluent; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient given diluent) and inappropriate dose of vaccine administered (Verbatim: patient given diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 17-OCT-2023 The reporter stated that there was mixing error and patient was given diluent of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not agreed to follow up.
I developed on my right neck halfway between jawline and shoulder a red raised hard lump. It didn't really bother me, a little itching, very mild pain when I touched it. Was just visually very unsightly.  But it continued for two weeks without getting better so I went to urgent care because I didn't know what it was.  I saw a Physician Assistant on 3/4/21 at 1500 at Urgent Care Clinic, who said it was an "abcess".
Rash over all body parts with intense itching and some bleeding. Application of Triamcinolone Acetonide Ointment, 0.1%. Some temporary relief of itching but no appreciable change to the rash. Any pause in ointment application produces intense itching. Rash remains. On going since May 2021 through the present
Pt states she had (L) arm pain following shot which went to back & then next day had pain with inspiration. This resolved w/ TYLENOL heat & another day.
Patient received Flu vaccine on 09/22/2022 and believed it was a COVID vaccine. He attended a Flu clinic and received a Fluava; Quad Lot # K7752 Exp. 06/30/2023 vaccine because he did not realize he had already had a 2022 Flu vaccine administered.
dizziness, vomiting, fever above 101, headache, feeling like hands are on fire, rash on body, flushed skin, weakness in limbs, fatigue, problems breathing, fast heart rate
REDNESS, ITCHING, SWELLING, PAIN AT INJECTION SITE, HEADACHE, MUSCLE PAIN, TIREDNESS, AND FEVER OF 102.
By the time I got home < felt worn-out and over tired, no energy.  By 6:15 resorted to sitting on the couch and noticed how hard my heart was pounding as if I'd just had too much sugar AND too much caffeine.  I hadn't.  By 7:15 noticed my heart flip-flopping (for lack of a better word)- that continued until 11pm.  I do not have a history of any heart problems or flip-flopping. My husband then called the dr.'s office to ask for advice.  She said this had nothing to do with the shot.  I slept for hrs this evening- which I understand is not a severe reaction.  My concern is the heart situation. I've had no problems with rapid heartrate today.
Headache, Arthralgia, Fatigue, chills, injection site pain Narrative:
Shingles in left neck, face, and ear. Prescription for antivirals, steroids and pain medication
Severe face rash bumps with peeling irritated skin all over face and neck. Triamcinolone Acetonide 0.1% cream twice per day for 2 weeks. Rash cleared up after 2 weeks of treatment.
My arm felt as if I could feel the vaccine moving down it, then began to tingle.  My vision went weird for a few minutes and I felt light headed and as if my whole body was vibrating/buzzing a bit.  It's hard to describe, but I knew something wasn't right.  I spoke with a nurse on site who suspected I had a vasovagal reaction to the vaccine.  I had to wait 40 minutes before I felt okay enough to leave the site.  I continued to feel off for the rest of the night, along with extreme fatigue and soreness in my arm, neck and back.  The day after the vaccine I still had extreme fatigue, muscle soreness, was nauseous, with hot flashes and chills throughout the day.  Currently on day 2 past the vaccine and still have fatigue and muscle soreness.  The other symptoms seem to have improved some.  I have not been able to sleep much that last 2 nights either.
Within days of receiving the first, second, and third dose of the vaccine my menstrual cycle started. The second dose was given on 2/1/21. The third dose was given on 10/15/2021. After each one, my cycle started and lasted anywhere from one to three weeks. Had to be placed on progesterone pills to decrease the flow. Before the shot, my cycle was very light.  After the shot, my cycle has been heavy and included cramping and clotting which is not the norm for me before the shot. I have never had cramps and my cycle was usually one to two days long. I had just had a cycle the week before my third shot and after I received that one my cycle came back on and has been on since 10/15 and today's date is 10/25.
finding out positive for covid right after booster receipt; finding out positive for covid right after booster receipt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFEC TIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "finding out positive for covid right after booster receipt". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: positive for covid. Therapeutic measures were taken as a result of vaccination failure, 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.
inflammation under her armpit; it hurts to touch between the side of her right breast and right under the armpit; she feels swelling when touching under her arm; feels unwell; weakness; body aches; She also had pain under her right arm; pain under her right arm; This is a spontaneous report received from a contactable consumer or other non-HCP (patient herself) via Medical Information Team. A 47-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 10Apr2021 as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 20Mar2021 as dose 1, single for COVID-19 immunization and experienced arm pain, on the third day she had almost no discomfort. The second dose was on Saturday 10Apr2021, she had no arm pain on that day, but quite some pain on Sunday (next day) on 11Apr2021 just like when she got the first dose, and at night she also had pain under her right arm on 11Apr2021. By Monday, she had inflammation under her armpit, it hurted to touch between the side of her right breast and right under the armpit on 12Apr2021. She was taking ibuprofen, she felt swelling when touching under her arm, and she also felt unwell, weakness and body aches since Sunday (11Apr2021). In the middle of the night she had to take 2 Ibuprofens to soothe the pain. Patient received treatment as ibuprofen for the adverse events reported. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing), notes: other medical history: GERD; "Paroxysmal A Fib" (unspecified if ongoing), notes: other medical history: Paroxysmal A Fib. Concomitant medication(s) included: PANTOPRAZOLE; METOPROLOL. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Yes the report is about covid treatment. Other medication was taken in 2 weeks. Paxlovid was taken as COVID 19 Treatment which start on 22Sep2022 and stopped on 26Sep2022. On 01Oct2022 rebound COVID 19 symptoms 5 days after completing paxlovid.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.