chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm from elbow to shoulder; red arm from elbow to shoulder; hard, swollen, sore arm; hard, swollen, sore arm; red, itchy rash; raised white pimple-like; red, itchy rash; giant rash on arm; rash under bandage; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm from elbow to shoulder), ERYTHEMA (red arm from elbow to shoulder), PERIPHERAL SWELLING (hard, swollen, sore arm), INDURATION (hard, swollen, sore arm) and ERYTHEMA (red, itchy rash) in a 49-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.     The patient's past medical history included Asthma since an unknown date and Allergy since an unknown date.    On 05-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 PAIN IN EXTREMITY (sore arm from elbow to shoulder), ERYTHEMA (red arm from elbow to shoulder), PERIPHERAL SWELLING (hard, swollen, sore arm), INDURATION (hard, swollen, sore arm), ERYTHEMA (red, itchy rash), RASH PAPULAR (raised white pimple-like), RASH PRURITIC (red, itchy rash), INJECTION SITE RASH (giant rash on arm) and RASH (rash under bandage). The patient was treated with BETAMETHASONE (topical) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm from elbow to shoulder), ERYTHEMA (red arm from elbow to shoulder), PERIPHERAL SWELLING (hard, swollen, sore arm), INDURATION (hard, swollen, sore arm), ERYTHEMA (red, itchy rash), RASH PAPULAR (raised white pimple-like), RASH PRURITIC (red, itchy rash), INJECTION SITE RASH (giant rash on arm) and RASH (rash under bandage) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include asthma medications, allergy medications and immunosupressants. Additional treatment medications include steroid cream and cold pack.
High fever, severe irritability, crying for more than 2 hours and questionable meningeal signs.  Full sepsis work up was done with negative results.  Patient received Rocephin insection at ER.  This patient developed the symptoms previously mentioned the same day of vaccines 10-12 hours later.  The mother took him to the local ER and from there was transferred to another hospital where complete sepsis work up was done, including spinal tab.  All the laboratory work up was negative, and patient was sent home with no medicines and no obvious sequelae or permanent disability.  I saw the patient back on 10/10/2003 and he was doing fine. Copy of laboratory results not available. The discharge summary received on 2/17/04 states vomiting.
On sat, 2/27, of subjective fever rhinorrhea, sore throat and dyspnea with talking, seen 3/2/10. Still c/o dyspnea - O2 sat 100% rest and with reading, lungs clear. Tele. f/u 3/4 - fine.
Severe headache, fever (101° F), chills, body aches, neck pain, joint pain. Treated with OTC NSAID medication. Symptoms subsided about 24 hours after vaccine administration.
SCABED/NON-SCABBED RED BASED VESICLES PAPULES IN VARIOUS STAGES OF ERUPTION, ON TORSO/EXTERMITY x4. AVOID ASA/NSAID
Got vaccine on 2/4 symptoms started on 2/5 with headache and body aches and sinus issue. Feels fine today 2/7/2021
Patient with 2 Moderna vaccinations, last dose 03/27/22, who admitted through ED for complications of COVID.  H+P note below:  "Patient is brought to ED from home with 5 days of increasing weakness, cough, and some confusion. He has HX parkinsons and his wife is caretaker. Usually ambulates with cane, and wife reports he has become weaker since he tested positive for COVID and has been coughing more. No fever or chills. No CP. No V,N. Had constipation and was relieved with miralax. Had his foley changed on the 28th by urology. He is vaccinated and boosted. Wife does report occasional difficulty with swallow.  His COVID here was positive. WCC is 12.6. CTA shows RUL consolidatoin. Procal was high. He has been started on zosyn, doxy. No PE on CTA. No hypoxia noted here. "
Patient received Janssen covid 19 vaccine.  She did not disclose that she had already received one dose of Moderna.  She also did not present her vaccine card.  When we were discussing her immunization form, she did not mention that she had previously taken the Moderna vaccine.
Information has been received from a female who "last week" (on approximately 15-AUG-2008) was vaccinated with one dose of VARIVAX (Merck) 0.5ml SQ.  Subsequently the patient experienced an itching bump at the injection site and itchiness on her palms.  It was unspecified if the patient sought medical attention.  No further information is available.
This spontaneous report was received from a physician and a nurse via the company representative refers to an 18 month old patient of unknown gender. No relevant medical history of the patient was reported. On 14-JUL-2014, the patient was administered with MMR II dose 1 (strength, route and lot number were not reported). On 06-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX dose 1 (strength, route and lot number were not reported). No concomitant medications were reported. It was reported that the doses were given too close together. There were no adverse effects reported. There was no product quality complaint involved. The outcome was unknown. Additional information is not expected.
administered in the hip; This case was reported by a consumer via call center representative and described the occurrence of vaccine administered at inappropriate site in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Fluad with an associated reaction of tendon injury (received on 10th September 2019 (National Drug Code: 70461-0019-03)). Concomitant products included VIRAL VACCINES (COVID VACCINE (NOS)).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown.  Additional details were provided as follows: The patient reported the case for herself (reporter was a massage therapist). The patient received the Fluad 2019-2020 syringe flu shot was given at a pharmacy by a pharmacist and the patient believed that the pharmacist injected her too high on the upper arm/deltoid. This resulted in a visit to the emergency room and 7 months of severe pain and the use of prescription pain medications due to tendon damage. Since then patient had requested that all of her immunizations to be done in non-deltoid shots such as thigh or hip. The patient got a subsequent unspecified flu shot in the hip rather than the deltoid to avoid the risk of having the same shoulder tendon problem occur again, which led to vaccine administered at inappropriate site and her Covid shot(s) in the thigh. The reporter provided limited information
On April 1, 2 weeks after Dose 1, began experiencing upper R arm aching radiating from shoulder to elbow, similar to strain. However, no injury or muscle strain occurred.  In addition, began feeling tired in the afternoons, yawning continuously for a few hours.  Pain relieved with Aleve. Reoccurs daily.   Symptoms have continued.  Knowing my daily activity, these are not usual symptoms for me.  Of course there is nothing to link this to the vaccine, however, I feel it prudent to report.  When I initially received the shot, I had some aching at the shot site, but that went away after a few days.
No additional AE's; The nurse stated that an expired dose of PNEUMOVAX 23 vaccine was administered to a patient.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-SEP-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #T039322, expiration date: 09-SEP-2022, administered for prophylaxis (strength, dose, dose number and route of administration were not provided) (expired product administered).  No additional adverse event was reported.
Throat closing, SOB, tongue/lips swollen. Evaluated by EMS-Transported to Emergency room/department or urgent care.
06/02/2003: Patient is here today for her 23 month old well check.  Mom reports after her last injection of DTAP she had vomiting and diarrhea for approximately 3 days to the point she was not able to keep anything down and mom was very concerned about her.  Mom is concerned that this is related to the immunization and is refusing any further DTAP.  Discussed that this could be viral illness.
Dose 1:   45 minutes after shot: slight swelling of airways; breathing difficulty. Congestion lasted roughly an hour.   10 hours: slight nausea, dizziness and possible fever. Slept it off and woke up fine.   Dose 2:   About 3 hours after injection the worst swelling of airways I've experienced. Slight panic arose from being unable to breathe freely. Was making plans to go to the ER when breathing became easier. It was all in all a very strange experience. Airways remained somewhat contracted for about an hour but faded without anything noteworthy.   6 hours after injection severe arm pain.   About 10 hours after the shot i experienced the worst feeling fever i have had. Did not take temp. Serious chills. I was under piles of blankets. Quite disoriented. Felt the need to move but was completely wracked with pain in all my joints.  Despite that I couldn't sit still. I am a complete stranger to insomnia. No medication has ever induced it.  However, this night I simply couldnt sleep more than 10 minutes at a time.  Finally took extra ibuprofen and my body seemed to respond well and the pain and chill subsided. I was achey and exhausted but couldn't sleep. I was also quite nauseous. About 36 hours after first dose i mostly seemed back to normal.    I think it was 6 days later i got hit with the same vertigo and dizziness that preceded my fevers. It's so bizarre. It happens mildly throughout the day but around 10pm or later it hits me hard and is debilitating. I have to stop whatever I'm doing just to lay down. There's no chance of walking without falling unless I have a wall to guide me. The worst of it passes in about 10-15 minutes but lasts about a full hour. Then I'm just nauseous but otherwise fine.
High fever ranging from 101.5-104 degrees fahrenheit, mild rash across back and neck and at point of injection sight, decreased appetite, severe drowsiness, diahrrea. All symptoms lasted 5 days and began in the evening of day 7 after the vaccine was administered. Took son to the E.R. on day 3 after temp reached 104. The nurse practitioner diagnosed him with adverse reaction to MMR vaccine and diahrrea. I am not sure how accurate that is considering he recieved 3 vaccines at once and all the information said rash and fever are possible. Fever broke on day 5. Gave children's motrin for fever and Pedialyte for diarrhea.
Swollen lymph node under Left arm. Other sxs included fever, chills, malaise, nausea x 48 hours.
patient came in clinic for vaccintion and stated she didn't like needle at all.After recieving MMR and Varicella vaccination she complained of dizziness. At 3:23 patientfloor and legs up position. patient was alert and oriented BP100/80Respiration rate:18.ammonia administered as precaution.patient left clinic at 3:38pm on own ability ambulating and stating she is fine.
Patient was seen on 12/11, zoster vaccine was administered. Patient reports the last time she had a zoster vaccine, she had redness and pain. However, it went away after a couple days. Reports these symptoms are persisting and worsening. Redness and warmth to the site measures roughly 7 cm in diameter. Induration noted as well. Patient reports the pain has been worsening in the last couple days. Reports using warm and cool packs. Denied using allergy medication, since she has been concerned regarding being sleepy. Consulted with Doctor. Bedside u/s performed. Advised to have patient continue with warm compresses and start keflex rx. Advised to have patient come in to be seen on Thursday or Friday by nursing.Patient scheduled. Gave red flags. Denied needing anything further at this time. Patient was seen on 12/22 as well. Site was almost completely better.
A spontaneous report was received on 19-JUL-2016 from a healthcare worker/certified medical assistant (CMA). The CMA reported that multiple unspecified patients received PROQUAD (Lot No L046508, expiration date 17-MAY-2017), and VARIVAX (Lot No. L041205, expiration date 20-OCT-2017) that were improperly stored on multiple unspecified dates. Temperature: Min 2.3F and Max 6.6F. Time frame: 40 hours. No adverse effects were reported. No further information provided. Additional information is not expected.
Right deltoid, red, swollen, warm to touch (5" x 5") ice pack for 15 minutes every 2 hours.
tested positive for covid; 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 COVID-19 (tested positive for covid) 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) (Intramuscular) 1 mg. On an unknown date, the patient experienced COVID-19 (tested positive for covid). At the time of the report, COVID-19 (tested positive for covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.   Reporter did not allow further contact
swelling left elbow and knee; pain on the entire left half of body especially her hip, elbow and knee; Fever; Headache; Dizziness; Rapid Heart rate; A spontaneous report was received from a consumer  concerning  herself, a female patient who experienced Dizziness/Dizziness, Rapid heart rate/Tachycardia, Fever/Pyrexia, Headache/Headache, Pain on the entire left half of her body especially her hip, elbow and knee/Arthralgia,  Swelling left elbow and knee/ Joint swelling.   The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, was not provided by the reporter.   On 29-JAN-2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly at an unspecified site  for prophylaxis of COVID-19 infection.    After few hours the vaccination on 29-JAN-2021, she had dizziness with rapid heart rate, fever, headache and on 31-JAN-2021 she had  pain on the entire left half of her body especially her hip, elbow and knee with swelling left elbow and knee. Laboratory information at the time of events was not provided. She reported that she was in lot of pain when she called.  Treatment information included Tylenol and Ibuprofen, but the events didn't respond to the medicines.    Action taken with mRNA-1273 in response to the events were unknown.  The events, dizziness with rapid heart rate, fever, headache and pain on the entire left half of her body especially her hip, elbow and knee with swelling left elbow and knee were considered  as unknown.
ULCERATIVE COLITIS FLARE/WORSE; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE/WORSE) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. In July 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to citrate free. In 2021, the patient experienced FATIGUE (Tiredness) and HEADACHE (Headache). In September 2021, the patient experienced COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE/WORSE) (seriousness criterion medically significant). In 2021, COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE/WORSE), FATIGUE (Tiredness) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Concomitant medications were not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment medications were not reported.  The reporter's causality for the event(s) of tired and headache with Humira(adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of ulcerative colitis flare/worse with Humira(adalimumab) was a reasonable possibility.  Company comment: This is a spontaneous case concerning a 27-year-old female patient with Ulcerative colitis on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event Colitis ulcerative flare, on an unknown date after an unspecified dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 27-year-old female patient with Ulcerative colitis on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event Colitis ulcerative flare, on an unknown date after an unspecified dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.
She declined to receive second dose during recommended interval; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INTENTIONAL DOSE OMISSION (She declined to receive second dose during recommended interval) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (She declined to receive second dose during recommended interval). At the time of the report, INTENTIONAL DOSE OMISSION (She declined to receive second dose during recommended interval) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Concomitant medications were not provided.  Treatment information was not provided
Xeljanz (tofacitinib citrate) was given for Alopecia; First Dose: felt a little sluggish and lethargic; First Dose: felt a little sluggish and lethargic; This is a spontaneous report from a contactable consumer (patient's father) via a Pfizer sponsored program. A 16-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 01Jun2021 (at the age of 16-years-old) as SINGLE DOSE for covid-19 immunisation; tofacitinib citrate (XELJANZ), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for alopecia. The patient medical history was not reported. The patient concomitant medications were none. It was reported that tofacitinib citrate was given for alopecia. She had no reaction except she felt 'sluggish' and lethargic. Caller did not want to file a report. She was currently on tofacitinib citrate and she was scheduled to receive her second dose of the Pfizer BioNTech COVID-19 vaccine in 1 to 2 weeks. Since tofacitinib citrate was an immunosuppressant and people who are taking immunosuppressants may have a lower response to the vaccine and therefore not produce enough antibodies, should her daughter get an antibody test done and how long after the second dose should she get it done. The caller's daughter was taking tofacitinib citrate for Alopecia and he wanted to know the reaction between tofacitinib citrate and the Pfizer COVID Vaccine. Caller stated his daughter has been taking tofacitinib citrate for a couple of years now and he was reading how the medication would interact with the COVID vaccine. Caller stated some reports stated that after the second vaccine, it might be wise to get an antibody test to make sure the body was producing antibodies. Caller stated the patient took the first dose, but she hasn't taken the second one. Caller stated there were no adverse events, other than she felt a little sluggish and lethargic for a day or two. The outcome of all event were unknown.  Information on Lot/Batch number has been requested.
Pain at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-MAY-2023, the patient received the 2nd dose of Shingrix. On 18-MAY-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain at injection site). The outcome of the injection site pain was not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK receipt date: 18-MAY-2023 The patient experienced pain at injection site after receiving dose of Shingrix. The reporter did not consent to follow up.