chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness, swelling, itching; large area approximately 6" X 6" to left deltoid. Pt was given Sterapred, Cipro and Atarax.
The initial case was missing the following minimum criteria: Unidentifiable patient. Upon receipt of follow-up information on 15JUL2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician. A 18 year old female patient received TRUMENBA (lot J28923, expiry date JUN2016) first single dose on 11MAR2015 and second single dose on 19MAY2015, both intramuscular in left arm. Medical history and concomitant medications were not provided. On unspecified dates in 2015, the patient experienced pain after administration of vaccine at the vaccine site after both firsts and second dose. The event did not require an emergency room or physician visit. Event outcome was unknown. The physician considered there was a reasonable possibility that the event was related to suspect product.
Onset several hrs after H1N1 vaccination of chills, fever, redness, muscle aches, headache. Unsure if patient has a viral illness versus side effects H1N1.
Information has been received from a health professional concerning a patient who on 18-FEB-2009 was vaccinated with the first dose of GARDASIL. In February 2009, the patient experienced fever, nausea, vomiting, itching and rash. It was reported that the patient would not continue series. Additional information has been requested.
Several hours after injection arm/deltoid became progressively sore. The pain wakes her at night. She rates pain a "6" at it's worst. ADVIL/ASA takes the edge off and pain is tolerable. Has a small hardened area at injection site. The area is not red, swollen or warm to the touch. She has had no fever. Pain radiates down to her hand at times. Recommended to see a physician. PHN not sure if MD was seen. Client lost to f/u.
Started experiencing severe pain, flu-like symptoms later that evening and into the next day, relieved only with TYLENOL. Also experienced bruising/redness and burning that are still persisting 4 days post-injection.
2 days /p vax had T of 103-chilling,nausea-vomiting&raised pink patch on lt leg,sore to touch,given Fenergan/Tylenol,in night inc T 104-gave tepid bath/Tylenol/Fenergan,had purpura in lt groin-went to ER/admit,purpura on legs/hands/shoulder
Pt received DTaP and IPV in the left deltoid. Pt also received MMR in the right deltoid on 05/20/2002. Pt was seen that evening because of swelling and warmth. It was felt that he had a cellulitis and the pt was started on Augmentin. He was seen the following day in the ER and started on zyrtec for presumed allergic reaction. I saw pt on 5/23/2002. He had significant warmth and redness on the left deltoid. It was previously measured 13cm x 10cm. It had decreased to 9 x 9cm when I saw him. My impression was local reaction and the Augmentin was stopped.
Dyspnea and fatigue and low back pain starting 4/26. Seen at Urgent Care 5/1 and recommended to go to ED for ACS rule out.  Declined. Followed up on 5/3 with persistent dyspnea, no hypoxia or tachypnea but visible increased work of breathing in office.
The patient came in today for her medication and she was due to her second shingles vaccine.  She stated she had a rash after the first vaccine that only appeared on her back.  She could not identify the exact date it started; however, she did state that it appeared after vaccination and progressively worsened.  She finally went to see the doctor on 10/7/19 after the rash kept getting worse.  She stated the rash was incredibly itchy and uncomfortable.  She stated the doctor didn't think it was shingles; however, the patient took at 7 day course of Valtrex 1000mg TID for 7 days and it made the rash less itchy and more manageable.
Chief complaint: Chest Pain RN note- Pt reports sudden onset of left sided CP radiating into left arm that started 2 hours PTA while unloading boxes at work. Went to UC. UC gave 4 baby ASA. Denies medical hx. Pt is deaf. Interpreter in use.  Dr. note- CC: CP HPI: 57 y.o. mail who presents to the emergency department complaining of left sided CP radiating to his left arm. Per sign language interpreter patient was lifting boxes at facility where he works two hours prior to arrival when he started to experience left sided CP. Patient states he was not exerting himself any more than usual but when he started to feel pain sat down in the office for awhile and was told by his employer to go to this hospital. He describes pain as a "tightness, tension, or discomfort" that is worse with standing. It radiates down the left arm. Patient states that his twin brother had heart issues and had a myocardial infarction five years ago. Patient denies shortness of breath, abdominal pain, nausea, vomiting, recent illness, or any other symptoms.  Dr. H&P- CC: CP Assessment: CP acute. Appears noncardiac thus far. Albeit given family hx of early CAD in twin brother, will trend troponin. If neg, will get stress test in AM. Will start on ACS protocol. Prophylaxis: Lovenox
Approx 5 mins. after vaccine client c/o of "feeling itchy." Redness observed just above the injection site and around client's neck. Client denied SOB or other respiratory concerns. Lead nurse offered Benadryl (liquid solution 25mg x2) and was accepted by client. All vitals WNL. After 30mins client left site with steady gait and accompanied. Was advised to notify PCP if symptoms became worse. Client experienced same symptoms with first dose
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 9:34 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 9:34 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 42.24 for dose administered on 03-Apr-2021.  No concomitant medications were reported.  Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
No adverse effect; 7 year old patent was given an adult dose of VAQTA; This spontaneous report as received from an office manager refers to a 7 year old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 24-APR-2019 the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated(VAQTA) 50/1.0 U/milliliter injection (lot # S001832, expiry date: 12-MAY-2020) intramuscularly for prophylaxis (product administered to patient of inappropriate age). No adverse effect was reported. No product quality complaint was involved.
RN Emergency Treatment  Chief Complaint Patient presents with ? COVID-19 VACCINE   BP 130/82 (BP Location: RA-RIGHT ARM, BP Patient Position: LYING, Cuff Size: Standard Adult)  | Pulse 89  | Resp 20  | SpO2 100%    Location of event Vaccine Center TRM  Description of Event Patient came in today to receive second dose of Moderna. Patient did state she had fainted when she received her first dose at the pharmacy. As well as SOB that lasted shortly after receiving the vaccine. Patient does have allergies to amoxicillin, sulfa drugs, pineapple and kiwi. Patient does carry epi-pen for pineapple and albuterol for asthma. At 1515 patient's dad alerted RN that patient was not feeling well. RN assessed patient, placed 6L of O2 nasal cannula. Patient stated she was having a hard time breathing, and was experiencing chest pain. RN assessed vital signs, administered epinephrine to the right vastus lateralis at 1515. Patient stated very little improvement. Patient had albuterol inhaler, and patient had 2 puffs. Patient was moved to front of hospital, with little improvement in symptoms. EMS came and assessed patient and left at around 1538. Dr.  was called and updated on patient.   Interventions:Patient was assessed, monitored,   Medications administered:  Epinephrine 0.3mg auto injector; Lot:200909X Exp. 2/2022  Response to interventions and/or medications given:Little improvement  Disposition:911 and Emergency Dept
Angioedema, HYPERtension, Narrative:  Lips swollen and hypertension. Lips less after 20 mins
Sudden Loss of hearing in Left ear. Unable to hear when talking  on phone with left ear. Can hear perfectly fine with right ear. Thought it may be allergies but had been taking allergy meds, started flonase for allergies without relief.  Started on antibiotic in April for 10 days no relief. Referred to ENT. Appointment on May 21. Confirmed hearing loss in Left ear.
Swollen leg; Pain; Very sick; sore under arm; sore rib cage, cannot rock side to side; Pain in the same arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen leg), PAIN (Pain), ILLNESS (Very sick), AXILLARY PAIN (sore under arm) and MUSCULOSKELETAL CHEST PAIN (sore rib cage, cannot rock side to side) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 PERIPHERAL SWELLING (Swollen leg), PAIN (Pain), ILLNESS (Very sick), AXILLARY PAIN (sore under arm), MUSCULOSKELETAL CHEST PAIN (sore rib cage, cannot rock side to side) and VACCINATION SITE PAIN (Pain in the same arm of injection). At the time of the report, PERIPHERAL SWELLING (Swollen leg), PAIN (Pain), ILLNESS (Very sick), AXILLARY PAIN (sore under arm), MUSCULOSKELETAL CHEST PAIN (sore rib cage, cannot rock side to side) and VACCINATION SITE PAIN (Pain in the same arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Initial information received on 18-May-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 years old male patient who experienced lower body weakness and fever, while he received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included TRUMENBA for Product used for unknown indication; and VARICELLA VACCINE for Product used for unknown indication. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported. The patient developed a non-serious lower body weakness <<Unknown latency>> following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The patient developed a non-serious fever <<Unknown latency>> following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Final diagnosis was fever and lower body weakness. An unknown corrective treatment was received. The patient outcome is reported as Recovered/Resolved on an unknown date for lower body weakness and as Recovered/Resolved on an unknown date for fever.
Complained of sore right arm, chest pain, rib pain, pain on inspiration.  On right side of body ache all over legs arched.  10/24: Headache general achy pain.  Moved to left and right side of chest and back.  Sunday headache severe.  Had temp to 103 saw MD.  11/02/2003: feeling better had "flu" per patient.
Patient was given MMRV and Varicella on the same day meaning she got 2 doses of Varicella vaccine on the same day. No reaction that I know of.
Mother called and stated child had been immunized earlier that day and now leg, arms, neck, and face beginning to swell.  Area around injection site red and swollen.
few people on the same pharmacy had the ear infections too; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (few people on the same pharmacy had the ear infections too) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced EAR INFECTION (few people on the same pharmacy had the ear infections too). At the time of the report, EAR INFECTION (few people on the same pharmacy had the ear infections too) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter.
The patient reported feeling light headed/dizziness 5-10 minutes after the immunization. I then checked the patients blood pressure and it was 155/88. I continually monitored the patient. When I asked the patient if they were any problems breathing or swelling in the throat o face, the patient reported their throat felt dry. I monitored the patient several more times, and the patients blood pressure normalized to 138/74. I asked the patient how they where feeling over the course of several minutes and she reported she felt better/fine. I next gave the patient a bottle of water. She left the pharmacy and store soon after since she said she felt fine. I called and check on the patient at 3:15 pm the same day, and the patient reported feeling fine - no other issues to report.
All reactions were on the left side of the body: Rash on neck, cracked toes and skin coming off the entire foot, vagina area affected, red and dry labia, diaper rash on the buttocks more to the left, mouth was sore, felt raw and cut, red spots on the entire face. Overall severe dry skin
Pt received flu vaccine, following day reported HA, weakness, "falling down" x 4 but no syncope or seizure.
pt recvd vax; 24 hrs later, exp rash & urticaria on the trunk & scalp;
18 yo male received 1st dose of BEXSERO on 4-19-17. Noted pain in arm the evening of 4/19 and then redness and swelling on 4/20/17. This has worsened since then. Seen today in office - has raised swollen area on right arm 5.5 in x 4.75 in. Area is hot to touch. Pain in right arm, axilla, and down into arm. Placed on antibiotic.
25JAN93 pt exp coughing; 26JAN93 pt started w/diarrhea & coughing; denied any fever; pt taken to ER on 27JAN93; was dx w/URI; Amoxil given & inst upon APAP for fever; mom states t100 while @ ER;
This spontaneous report as received from a registered nurse refers to a 32 year old female patient. On 10-FEB-2014 the patient was vaccinated with a first dose of PNEUMOVAX 23 (25/0.5 Y) lot # J004747 (expiry date July 2014), intramuscular in the arm. The nurse stated that the patient experienced pain in her arm after receiving the first dose on 10-FEB-2014. The pain was in the outer aspect of the patient's arm and the patient could not pick up her child or lift her arm. The outcome of pain in her arm was reported as recovered/resolved on 13-FEB-2014. Causality assessment was not provided. Additional information has been requested.
redness, itching, swelling @ site of inj started 9OCT96;better today;
Mid-grade fever for 18 hours, 2x325 mg acetaminophen about every 4 hours. Fever did not reduce after 4th dosage at 4pm 05/01/2021. General weakness, chills.
Unapproved Age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 30-year-old female patient who received Men B NVS (Bexsero) (batch number 5YP3L, expiry date 18-OCT-2023) for prophylaxis.   On 18-JUL-2023, the patient received Bexsero. On 18-JUL-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Unapproved Age). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JUL-2023 The reporter stated that local state requirements indicate that adults aged 30 and under should receive meningococcal B vaccination for entering higher education facilities. The reporter reported that clinic administered a dose of Bexsero to the reporting day, to a 30-year-old patient. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. The reporter reported that the 30 years old patient administered Bexsero vaccine, which led to inappropriate age at vaccine administration.
patient came in approximate 5 days after vaccine with vaccine site on left upper arm swollen, hard, and, red and purple. Vaccine site bruised (aproximately 1 cm round) with skin removed.
Information has been received from a health professional concerning 3 patients who on an unspecified date, were vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 659727/1771U). It was indicated that they all presented with a similar presentation of after 5 to 10 seconds of receiving the vaccine, they developed a local reaction of a hive at the injection site. Specific treatment for those patients was not reported. Current patient status was not reported. A product quality complaint was not reported. The healthcare worker requested a lot check. This is one of 3 reports from the same source. Attempts are being made to obtain additional identifying information is distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is in follow-up to report (s) previously submitted 5/16/2008. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements for the Center for Biologics Evaluation and Research and was released.
Woke up last night sheets wet (sweats)/awakening both symptoms very pronounced; Hoarse voice/awakening both symptoms verypronounced; Hoarse voice (throat irritatation); This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 29Apr2021 at 09:45 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included mild hypertension at times. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sildenafil citrate (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 08Apr2021 at 09:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. On 03May2021 at 02:00, the patient woke up with night sheets wet (sweats) and hoarse voice (throat irritation) and that morning upon awakening both symptoms were very pronounced. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, woke up with night sheets wet (sweats) and hoarse voice (throat irritation) that morning upon awakening both symptoms very pronounced was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Head Hurts; Body is Hot; Arm is Red; Arm is Swollen; Feels Horrible; trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (trouble breathing), HEAD DISCOMFORT (Head Hurts), DRY SKIN (Body is Hot), ERYTHEMA (Arm is Red) and PERIPHERAL SWELLING (Arm is Swollen) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced DYSPNOEA (trouble breathing). On 23-Feb-2021, the patient experienced HEAD DISCOMFORT (Head Hurts), DRY SKIN (Body is Hot), ERYTHEMA (Arm is Red), PERIPHERAL SWELLING (Arm is Swollen) and FEELING ABNORMAL (Feels Horrible). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN ASPIRIN FREE) at an unspecified dose and frequency. On 23-Feb-2021, DYSPNOEA (trouble breathing) had resolved. At the time of the report, HEAD DISCOMFORT (Head Hurts), DRY SKIN (Body is Hot), ERYTHEMA (Arm is Red), PERIPHERAL SWELLING (Arm is Swollen) and FEELING ABNORMAL (Feels Horrible) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  No relevant concomitant medications were reported.