chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm hurt so bad; arm swollen; arm real red; feverish; Injection site swelling; injection site redness; injection site pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm hurt so bad), PERIPHERAL SWELLING (arm swollen), ERYTHEMA (arm real red), PYREXIA (feverish) and VACCINATION SITE SWELLING (Injection site swelling) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. O29L2OA and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm hurt so bad), PERIPHERAL SWELLING (arm swollen), ERYTHEMA (arm real red), PYREXIA (feverish), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE PAIN (injection site pain). At the time of the report, PAIN IN EXTREMITY (arm hurt so bad), PERIPHERAL SWELLING (arm swollen) and ERYTHEMA (arm real red) had not resolved and PYREXIA (feverish), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE PAIN (injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consumer states she got her first dose on 18FEB2021 (lot: 029L20A) on her left arm, her arm hurt so bad, it was swollen, and real red. HCP advised she put ice packs on it.Patient was treated with ice packs and steroid shot. No relevant concomitant medications were reported.   This case was linked to MOD-2021-099346 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Updated :new events added, 2nd dose details added.
Itching on left arm of vaccine; Swelling on arm of vaccine; Sore arm on left side; Redness on arm on arm of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching on left arm of vaccine), VACCINATION SITE SWELLING (Swelling on arm of vaccine), VACCINATION SITE PAIN (Sore arm on left side) and VACCINATION SITE ERYTHEMA (Redness on arm on arm of vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Itchy skin.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching on left arm of vaccine), VACCINATION SITE SWELLING (Swelling on arm of vaccine), VACCINATION SITE PAIN (Sore arm on left side) and VACCINATION SITE ERYTHEMA (Redness on arm on arm of vaccine). At the time of the report, VACCINATION SITE PRURITUS (Itching on left arm of vaccine) and VACCINATION SITE SWELLING (Swelling on arm of vaccine) had not resolved and VACCINATION SITE PAIN (Sore arm on left side) and VACCINATION SITE ERYTHEMA (Redness on arm on arm of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included cream for itchy skin.  No treatment medication was reported.
Received COVID vaccine on 06/24/2021. On 07/10/2021 I started to feel abdominal pain. On 07/11/2021 I went to the ER and was diagnosed with an acute appendicitis, which required surgery to remove that same day. I was in the hospital one night. Heal time was 2 weeks after the surgery. Activity is back to normal. Have read articles since then which indicate appendicitis is a side effect of the vaccine, which is why I am submitting this form in case it is related.
Aches and pain in muscle; Aches and pain in Joint; Received the 1st booster less than 5 months after receiving the 3rd primary dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches and pain in muscle), ARTHRALGIA (Aches and pain in Joint) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 1st booster less than 5 months after receiving the 3rd primary dose) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 004M21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Arthritis. Concomitant products included CELECOXIB (CELEBREX) for Arthritis.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 1st booster less than 5 months after receiving the 3rd primary dose). On 26-May-2022, the patient experienced MYALGIA (Aches and pain in muscle) and ARTHRALGIA (Aches and pain in Joint). The patient was treated with TRAMADOL at an unspecified dose and frequency. At the time of the report, MYALGIA (Aches and pain in muscle) and ARTHRALGIA (Aches and pain in Joint) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 1st booster less than 5 months after receiving the 3rd primary dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) tested positive for Covid 19.         On 25-May-2022, patient received first booster of Moderna COVID-19 Vaccine.   This case was linked to MOD-2022-580242 (Patient Link).
Local reaction with redness, warmth to left deltoid. No fever, chills. Dr./nurse instructed pt use cool compress, BENADRYL. Pt. verbal understanding if symptoms worse notify physician or go to E.R. pt agreed.
Swelling and redness at the site of the Vaccination treatment with Tylenol and cool compresses
weakness; dizziness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (dizziness) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced ASTHENIA (weakness), DIZZINESS (dizziness) and NAUSEA (nausea). At the time of the report, ASTHENIA (weakness), DIZZINESS (dizziness) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient asked "did have something to recommend that he could take for the side effects of the booster dose he took yesterday.  No treatment information was reported.
arm itching, inj site black & blue raised area size of silver dollar-red-tingling in both arms & legs;felt warm still sensitive p/1wk;
inadvertently administered expired ACTHIB to a patient because the diluent was still in date but the powered portion was expired; with no reported AE; Initial information was received on 23-Feb-2021 regarding an unsolicited valid non-serious case from a other healthcare professional in the United States.  This case involves child patient (age and gender unknown) who inadvertently administered an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (lyophilized powder: lot number: UJ184AA, expiration date: 15-Feb-2021) via an unknown route at an unknown administration site on 23-Feb-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was reported that this occurred because diluent was still in date but the powered portion was expired [diluent: lot number: U6723AA, expiration date: 17-Sep-2021]. The agent asked caller if she can answer additional questions for a safety report. Caller stated that she cannot but if safety wants to send her the questions via email she can follow up that way.  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of report, no adverse event was reported.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
No other adverse event; Vaccines were administered following a temperature excursion.; This spontaneous report was received from a state vaccine coordinator regarding a 4-month-old patient of an unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 27-SEP-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #W004501, expiration date: 20-APR-2023, taken orally (strength was not provided) as prophylaxis (Product storage error).  The improperly stored vaccine underwent a temperature excursion of 8.6 degrees Celsius (C) for 18 minutes with previous excursions of 11.5C for 1 hour and 6 minutes; 8.8C for 21 minutes; and 9.6C for 6 hours and 41 minutes. No adverse events were reported.  This is one of nine cases received from the same reporter.; Sender's Comments:  US-009507513-2209USA010833: US-009507513-2209USA010884: US-009507513-2209USA010940: US-009507513-2209USA010983: US-009507513-2209USA010910: US-009507513-2209USA010935: US-009507513-2209USA010872:
Information has been received from a health care professional concerning a 23 year old female patient who on 06/02/00 was vaccinated with one dose of Hepatitis B vaccine recombinant. Subsequently, the patient experienced a rash described as "flesh-colored bumps" on her face, sides and legs. Unspecified medical attention was sought. Additional information has been requested.
This spontaneous report was received from a physician refers to a 25 years old female patient who "a couple of years ago" was vaccinated with the first two doses of GARDASIL and who was in the physician's practice on 26-JUL-2012, requesting to receive her third dose of GARDASIL (dose, routes and lot numbers not reported). No adverse effect had been observed or reported. Additional information has been requested.
TOOK ALL FOUR DOSES OF VIVOTIF BUT DID NOT REFRIGERATE IT; A spontaneous case report was received from a caregiver on 20-May-2019 for two consumers.  Based on the information obtained from the caregiver, two individual case safety reports PVX201905-000394 (PVX2019-1250; younger daughter) and PVX201905-000395 (PVX2019-1251, elder daughter) were created and cross-linked in the database.  This case describes a 14-year-old adolescent female consumer who "took all four doses of Vivotif but did not refrigerate it". The consumer was receiving oral Vivotif (one capsules every other day; lot no: 3003253) for typhoid prophylaxis.  Case report: The consumer took all the four doses of Vivotif but forgot to refrigerate it. The doses were taken on 12-May-2019, 14-May-2019, 16-May-2019, and 18-May-2019 respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took all four doses of Vivotif but did not refrigerate it" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took all four doses of Vivotif but did not refrigerate it" was considered as not applicable. US-PaxVax Berna GmbH-PVX201905-000395:
EMPLOYEE STATES ON 08/05/2018 STARTED FEELING SYMPTOMS OF PAIN, ITCHING, SWELLING, WARMTH TO INJECTION SITE- LEFT DELTOID. OTHER SYMPTOMS INCLUDE TIREDNESS, AND RUNNY NOSE. SYMPTOMS REPORTED ON 08/07/2018, WITH VITAL SIGNS OF 144/90 BP, 98.0 TEMP, 47 PULSE AT TIME OF REPORTING.
Erythema, swelling and pain in joints of hands, elbows and knees. Rash on legs; erythematous urticaria. ER dx: serum sickness with adverse reaction to the vaccine. Good relief with Solu-Medrol IV followed by prednisone taper and Atarax.
Mother called states child's left arm has a rash. Also informed water that "both legs swollen and red." Advised mother to bring child and clinic now, but left almost immediately. Follow up phone call - mother states - "rash is gone."
Fever of 106.1 and sick for almost 1 month. Change in mood and personality.
Narrative:  62 yo F with HF. Received J&J vaccine booster (dose#2) on  4/20/22 at 14:00. Later that evening, patient had angioedema. Note, the patient had reported mild angioedema of the lip and itching the evening of 4/20/22 after  vaccine given. Benadryl 25mg x1 was given and helped. Only new med was clotrimazole (without dyes per MD note). Drank a few Boosts that pt later realized contains soy of which she is allergic. Later on 4/21/22 in the evening, sx of angioedema were improved. Previously received J&J vaccine (dose#1) on 11/30/21 without reported complication. Had previous reaction of angioedema  to 1 dose of Moderna vaccine (given 1/29/21). Angioedema following Moderna vaccine was tongue/lip/facial swelling. This occurred 3-4 hours after the the dose was given. Sx improved following dose of Benadryl 25mg po. Also c/o R arm injection site swelling, extreme fatigue. Allergist evaluated the patient and said OK to get 2nd dose of Moderna vaccine but patient declined.
The patient left the vaccine clinic after the 15 minute observation period.  While driving home, about 25 minutes post vaccination, the patient developed what she described as "tongue and throat felt funny and stuffy.'  She drove to her PCP clinic and was evaluated by a physician.  Vitals were normal/baseline (BP=96/68, HR=79, SpO2=100%, RR=14).  She was treated with diphenhydramine 25mg by mouth, and Solu-Medrol 40mg intramuscular.  Symptoms resolved following treatment and observation.  The provider recommended that patient could proceed with 2nd dose.
This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a female patient who received Men ACWY-CRM NVS (Meningitis ACWY vaccine (potential Menveo)) for prophylaxis. On an unknown date, the patient received Meningitis ACWY vaccine (potential MENVEO) at an unknown dose. On an unknown date, unknown after receiving Meningitis ACWY vaccine (potential MENVEO), the patient experienced unwell. On an unknown date, the outcome of the unwell was unknown. It was unknown if the reporter considered the unwell to be related to Meningitis ACWY vaccine (potential MENVEO). Additional details were provided as follows: The age at vaccination was not reported. The parent of the patient posted on the social media that they knew how ill the vaccine would make there daughter (patient). The patient could not get out of bed for a week. The parent said that if they know how Meningitis would be much worse, then would be more prepared.
horrendous headaches; constipation; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (horrendous headaches) and CONSTIPATION (constipation) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included WARFARIN, CARVEDILOL, LOSARTAN, FUROSEMIDE, GABAPENTIN, LEVOTHYROXINE, POTASSIUM and LORATADINE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced HEADACHE (horrendous headaches) and CONSTIPATION (constipation). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 01-Mar-2021, HEADACHE (horrendous headaches) had resolved. At the time of the report, CONSTIPATION (constipation) 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.
A rash ring around my neck broke out about a week after the first vaccine and exploded all over my upper back after the second. It?s not been resolved since, 5 months later. It?s traveled around my body but primarily on my trunk. I?ve tried everything including prescription steroids.
I received my first Pfizer booster for COVID-19 on 7/1/2022. On the morning of 7/27/2022, I woke up with a sore throat. I have allergies, so I didn't think much of it. I just drank some lemon tea and went about my day. I had a slight headache later that day, which I didn't really give much thought to.  I didn't have any other symptoms, but I was babysitting my granddaughter at the time, and she vomited at one point and felt lethargic. When my daughter returned home from a conference, I told her about it, and she suggested that we all get tested for COVID-19.  On 7/28/2022, we underwent a PCR test. When I got my results back a few days later, they were positive. On 7/29/2022, I called my doctor's office and got a prescription for Paxlovid. Aside from the abovementioned symptoms, the only real issue I had with the COVID-19 was a slight cough, which lasted for maybe just a day. I took a home COVID-19 test on or about 8/2/2022, and the result was still positive. I didn't take any more tests after that. I just isolated for about 5 days, as I was directed by my doctor, and then came out of isolation and resumed my normal activities afterwards.
dry cough; congestion; bone and joint icky; Red rash and a bruise on the injection site; Fever; strong headache; Lot of fatigue; Arm swelling and pain; Arm swelling and pain; Red rash and a bruise on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry cough), NASAL CONGESTION (congestion), MUSCULOSKELETAL DISCOMFORT (bone and joint icky), VACCINATION SITE BRUISING (Red rash and a bruise on the injection site) and PYREXIA (Fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy.    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced COUGH (dry cough), NASAL CONGESTION (congestion), MUSCULOSKELETAL DISCOMFORT (bone and joint icky), VACCINATION SITE BRUISING (Red rash and a bruise on the injection site), PYREXIA (Fever), HEADACHE (strong headache), FATIGUE (Lot of fatigue), VACCINATION SITE PAIN (Arm swelling and pain), VACCINATION SITE SWELLING (Arm swelling and pain) and VACCINATION SITE RASH (Red rash and a bruise on the injection site). At the time of the report, COUGH (dry cough) and NASAL CONGESTION (congestion) had not resolved and MUSCULOSKELETAL DISCOMFORT (bone and joint icky), VACCINATION SITE BRUISING (Red rash and a bruise on the injection site), PYREXIA (Fever), HEADACHE (strong headache), FATIGUE (Lot of fatigue), VACCINATION SITE PAIN (Arm swelling and pain), VACCINATION SITE SWELLING (Arm swelling and pain) and VACCINATION SITE RASH (Red rash and a bruise on the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: 101.6 (High) 101.6.         No concomitant medications were provided. Patient stated that having a rare disease and after finish radiation hcp recommended get a 3rd dose.   This case was linked to MOD-2021-354688, MOD-2021-354613 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 02Jun2022 at 12:00 as dose 4 (booster), single (Lot number: rn2908) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "covid infection", start date: 15Jan2019 (unspecified if ongoing), notes: Other medical History: Possible previous covid infection on 15Jan2019. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jun2022) Negative; (15Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment was Verapamil start date 30Apr2022. the patient was previously received a COVID-19 Vaccine. Reported Event 6 days after taking a full course of Paxlovid and testing negative with a home antigen test mild symptoms returned and patient tested positive with another antigen test. Adverse event start date 15Jun2022. Anti viral details product COVID 19 Treatment, brand Paxlovid, Treatment start date 05Jun2022, Treatment stop date 09Jun2022, Indication for treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Left deltoid area local reaction redness, swelling denies pain or fever. Apply cool compresses, OTC tylenol PRN return if not better.
340P pt had vasovagal syncope, fell and hit head after injection with prompt recovery. 6p-pt returned to have arm checked for fx and became weak and passed out while sitting, pt sent to ER.
Patient did not request a Shingles Vaccine. She requested Flu shot and COVID booster. Technician accidentally gave Shingrix instead of COVID. She realized it immediately after giving the shot. Patient has never had a shingles vaccine before.  She is 83 years old. She did not want to receive the Shingles vaccine. No physical adverse effects have occurred.
With in 5 mins of getting my shot I started to get sweaty and my heart starting getting bad palpitations.  I could feel myself get super flush, I could feel my whole body warming.   I had a hard time swallowing and my tongue burned and felt swollen.  My throat would just get super tight. Each episode lasted under a minute This happened on and off it for about 30 minutes.  Each time it happened it was not as bad as the time prior.  I was dizzy when I tried to stand up and I sat and was monitored for an hour.  They administered  Benadryl.   I have some edema on my upper chest when I got home.  I was super tired too. The next day still the edema and I have a sore throat .   I explained the best I could to the pharmacist when it was happening .  I refused to get EMT because it was not constant and it was getting less intense each time.
Severe headache which was not helped by TYLENOL. Ice pack gave some relieve. Continued until about 6 am Wednesday, Aug 15.