chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm got extremely swollen; also felt really sick; (arm) red; (arm) hot; (arm) painful; headache; fatigued; (arm) itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm got extremely swollen), MALAISE (also felt really sick), ERYTHEMA ((arm) red), SKIN BURNING SENSATION ((arm) hot) and VACCINATION SITE PAIN ((arm) painful) in a 60-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.     The patient's past medical history included COVID-19 in March 2020.    On 20-Jan-2021, 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 (arm got extremely swollen), MALAISE (also felt really sick), ERYTHEMA ((arm) red), SKIN BURNING SENSATION ((arm) hot), VACCINATION SITE PAIN ((arm) painful), HEADACHE (headache), FATIGUE (fatigued) and INJECTION SITE PRURITUS ((arm) itchy). At the time of the report, PERIPHERAL SWELLING (arm got extremely swollen), MALAISE (also felt really sick), ERYTHEMA ((arm) red), SKIN BURNING SENSATION ((arm) hot), VACCINATION SITE PAIN ((arm) painful), HEADACHE (headache), FATIGUE (fatigued) and INJECTION SITE PRURITUS ((arm) itchy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: ??-mar-2021 Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
After receiving vaccines the day before the patient started breaking out in a pin point rash on her arms and hands and it was beginning to be on her neck and face.  It did itch and the patient did not have any shortness of breath, mother will call back if she had to take child to the doctor.
Generalized body aches, malaise, tachycardia, nausea, headache, sweats. Intermittently for 48 hours, worse at night.
Systemic: Rash (other than injection site)-Mild; symptoms lasted 2 days
02/26/2021 vaccination. About 42 minutes later, I started to experience a HA. This HA became debilitating, lasting about 10 full days. The side affects from the HA lasted about 5 days thereafter. Hard to maintain normal daily activities, could hardly get out of bed. I did see a doctor after 10 days; prescribed HA medicine (I can't remember the name of the medicine). I started to experience syncope about the 6th day after vaccination, lasting about 20 days. Dr. kept stating to call the CDC as it was due to the vaccine.
GENERALIZED RASH  APPEARING 20 MINUTES AFTER RECEIVING VACCINE, GIVEN IV BENADRYL, FAMOTIDINE, AND SOLUMEDROL IN EMERGENCY DEPARTMENT. PER EMERGENCY DEPARTMENT NOTE, PT REPORTED INCREASED ITCHING AND RED BLOTCHES AND THEREFORE WAS ADMINISTERED IM EPI
Information has been received from a physician concerning a 9 year old male who on 15-FEB-2007 was vaccinated with a single dose series of varicella virus vaccine live (Oka/Merck). On 10-OCT-2007, the patient came into the office and had a rash and experienced pain on his right leg. The physician reported that the patient was diagnosed with shingles. At the time of report the patient had recovered. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Sore injection site/arm - starting in 02/13/21  Sore throat - starting in 02/14/22 Muscle aches - starting in 02/13/21 Fever - starting on 02/14/21 (101 degrees F) Dull headache - starting in 02/14/21  Symptoms have not subsided yet but is currently less than 24 hours post vaccine.
Patient presented with complaint of ankle pain, swelling, tenderness, redness for past 2 days (unable to put boots on). Received 8 vaccines on 8/24/05. Admitted to hospital on 8/25/05. Diagnosis: serum sickness/vasculitis base don high CRP lab test.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter stated that the vaccine was stored in freezer, and they take out one to two vials and place in fridge each day as needed.  No treatment medications were reported.
6-7 days after she received injection to right arm she noticed a rash, slighly itchy that increased in size. came to office and redness, swelling noted 12 cmx12 cm. pt otherwise feels well. no fever, chills, aches. appears to be a delayed localized immune response at injection site. pt concerned that she had "covid arm" so wants it documented.
Pt reports frequent falling at home. Having cough and sore throat. No fever. Pt believes he got his 2nd COVID shot earlier this month
Info has been received from a health professional concerning a 4 year old white female, with no known drug allergies, who, on 9/13/02, was vaccinated with a 1st dose, in the left leg of varicella virus vaccine live (lot 643117/0502M). Concomitant vaccine administered on the same day included a 3rd dose in the right leg of Hep-B vaccine recombinant (Recombivax HB) (lot 643387/0533M). It was noted that there were no other concomitant medications. There was no illness at the time of vaccination. Subsequently, the pt developed full blown chickenpox. It was noted that the pt was not hospitalized and was not seen by the doctor. A nurse saw the pt. There were no lab or diagnostic tests performed. Follow-up info has been receive from a physician that indicated that on 12/9/05, the pt experienced a chickenpox rash, with several pox all over her body. Additional info has been requested.
After receiving TDaP vaccine, patient was waiting in clinic room with mom for the recommended wait time after receiving injection. Around 10:18AM, mom came to the clinic door and notified medical staff she needed help. Medical staff arrived to clinic room including myself to find patient sitting in chair with her head leaned over onto table stating "I'm going to be sick." repeatedly. Patient diaphoretic and loss of color noted in face. Initial vital signs: 10:19AM BP: 69/45 Pulse Ox: 96% room air HR: 49 Respirations: 18/min. After  a few minutes passed, patient reported to not feeling sick anymore. 10:23AM patient given apple juice and gummy snacks. Repeat Vitals at 10:32: BP 87/66 HR: 74 Pulse Ox: 100% room air Respirations: 18/min. Patient laid down on exam table for about 10 minutes. Final repeat of BP at 10:42AM 101/66 HR 83. Patient stated she feels much better. Mom and patient escorted about at 10:51AM.
Arm for about a week, remained warm in that spot, as if I had a fever in that spot; Had a red patch, 3inches by 1inch, lasted whole time arm was warm; Muscle I had shot in was sore for a couple of day; A spontaneous report was received from a healthcare professional concerning a 70-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site erythema ( had a red patch, 3inches by 1inch), injection site pain ( muscle i had shot in was sore for a couple of day) and injection site warmth (remained warm in that spot, as if i had a fever in that spot).  The patient's medical history was not provided. Concomitant medications reported were Avapro,  Claritin, Crestor, Flonase,  Singulair, Synthroid, Zetia,  for drug use for unknown indication.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, on that evening the patient stated that her arm was warm and muscle was sore for 3 days at the injection site. she had redness that had not spreaded and had stayed localized. she also added that she felt like she had fever in that particular spot in arm. she reported that all this lasted for about 7-10 days and now they are completely gone an she is feeling fine.  Treatment details was not included.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was reported to be recovered/ resolved.
Same day:  headache and dry mouth, sore injection site 2nd day:  headache worsened, dry mouth worsened, site was hot to touch, red and swollen; could not sleep that night due to headache, pressure on chest and sore arm; fever began 3rd day:  Fever measured at 102 in morning, skin all over very painful to touch, chest pain faded while other symptoms began - fatigue, nausea, continued headache and extremely faint (light-headed every time I attempted to stand or walk), arm redness and swelling still 4th day:  Fever measured 101.4 in morning, continued symptoms as day 3, but nausea improved, new added musle (thigh aches) and joints in fingers.  Inje 5th day:  Fever measured 100.5 in morning, nausea gone, skin pain gone
Large red rash, hot to touch, itchy, sore, spread from size of orange first day, down to elbow and 4+ inches wide today, one week later.
Nausea  Diarrhea, chills, intense migraine, body aches.    No Rx
Left ear ringing non-stop.  Have not seen a doctor about this.  Daughter recently had brain surgery so there been no time to see my physician who works very limited hours.  Regarding Q21 since I can't go on with this report with our answering something, I will call and let them know that I have this symptom today.
Spoke with mother 04/01/2019 called clinic stated patient had a cardiac arrest on 09/28/2018 and would like a Vaers completed.
I received my vaccine in the morning and was fine with slight discomfort in that arm. Between 6:30 -7pm I started to get chills which turned into minor body aches that come and go and don't last very long. The chill sometimes starts between my shoulder blades where my back and neck meet then expand. I also feel tired.
Hearing loss, ringing. Prednisone, 4per day for 3 days, 3 per day for 3 days, 2 per day for 3 days, 1 per day for   3 days. Have had some improvement.
Case number PHEH2015US021637, is an initial spontaneous report received from a pharmacist on 22 Oct 2015. This report refers to a patient of unknown demographics. Medical history and concomitant medication were not reported. On an unknown date, the patient was intramuscularly vaccinated with FLUVIRIN (batch number: not reported) which was out of temperature range for 24 hours. No adverse event was reported following this medication error.
pt recv vax; c/o unsteady gait, HA, dizziness for 3 days; flu sx?
Administered adult Hepatitis A vaccine to an 18 year old instead of a Pediatric Hepatitis A vaccine.
pt recv vax 30OCT96 & 23NOV96 pt devel pain that originated @ the inj site & radiates into the back of neck;also reports pain into he arms & legs;MD described sx as migratory synovitis, myalgias & arthralgia;mild inc ESR;
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD injection, lot # M003436, expiration date 19-JUL-2017 (dose, albumin status, anatomical location and route of administration were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
2 hours after injection she had severe dizziness. She had BP checked and it was 214/112. Over the next 3-4 days she had persistent dizziness and elevated BP (slowly improved).
received the first dose / on 25Sept2018 / has not received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 25th September 2018 with batch number C7B9P and expiry date 27th February 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix at primary reporter's facility. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 71-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported   Patient does state that no adverse reactions were reported by any patients.   No Treatment medication reported
Patient had reaction to chicken pox vaccine. It was red and itchy about a 4" circle.
Adolescent Received Moderna COVID-19 Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adolescent Received Moderna COVID-19 Vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. In March 2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adolescent Received Moderna COVID-19 Vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adolescent Received Moderna COVID-19 Vaccine) outcome was unknown. Not Provided      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.
immediately started feeling tingling sensations and burning in both arms, Chest felt cold and tight making it difficult to talk, throat felt like it was swelling and I couldn't swallow, Lost consciousness within minutes of getting the shot.
RECEIVED HALF DOSE FOR THEIR BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 60-year-old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 01 total, administered on unspecified date for prophylactic vaccination (dose number in series 1). No adverse events were reported following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number was either 1822809 or 211A21A expiry: unknown) dose was not reported, 01 total, administered on 27-NOV-2021 for prophylactic vaccination (dose number in series 2). No concomitant medications were reported.  On 27-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient received half dose for her booster dose (vaccine under dose and off label use).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for their booster dose and off label use was unknown. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211202193, 20211201228, 20211201168, 20211200752, 20211201351, 20211200994, 20211201450, 20211202199, 20211202469, 20211204104, 20211202379, 20211201179, 20211201443, 20211220152, 20211220146, 20211220262, 20211220250, 20211220145, 20211219871, 20211219926, 20211220155, 20211201963, 20211220129, 20211220619, 20211202371, 20211202246, 20211202207, 20211201362, 20211201304, 20211200769, 20211200717 and 20211200723.
Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 10:13 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 10:24 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-Mar-2021 at 10:13 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  Regarding vial with batch number: 014M20A Date vaccine moved from freezer to refrigerator: 24-Feb-2021. Vaccine moved to clinic on 03-Mar-2021. Vaccine Use by Date was 26-Mar-2021.  Regarding vial with batch number: 030B21A Date vaccine moved from freezer to refrigerator: 30-Mar-2021. Vaccine moved to clinic on 31-Mar-2021. Vaccine Use by Date was 29-Apr-2021. On 31-Mar-2021 at 10:24 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion).   Vaccines were not frozen at time of administration. Vials only punctured right before administration - during COVID-19 vaccine clinic all doses were drawn from vial due to high-pace clinic. traceable temperature monitor was used to record hourly temperatures. It was reported that patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Treatment medications were not reported.
Right after administration, patients arm started bleeding a lot so we cleaned up the blood and were going to switch out the bandaid and noticed her arm was already really swollen and hard (like a big marble under the skin). She then said that she was feeling really dizzy and thought she was going to pass out. She turned white and said she felt very sick. She leaned back in her chair and a cold ice pack was applied to her forehead and the injection site. This continued for about 30 minutes and then colored returned to her face and lips and she said she was feeling much better.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 28-JUL-2014 the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) lot # J015378 dose 1 for prophylaxis.  Other suspect therapies included hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On SEP-2014 the patient experienced inappropriate schedule of drug administration. On 25-SEP-2015 the patient experienced interchange of vaccine products. On an unknown date the patient experienced no adverse event. The outcome of inappropriate schedule of drug administration, no adverse event and interchange of vaccine products is unknown. The reporter considered inappropriate schedule of drug administration to be not related to GARDASIL 9 and GARDASIL. The reporter considered no adverse event and interchange of vaccine products to be not related to GARDASIL and GARDASIL 9.
No additional AE was reported; her son received an expired MMR 2 vaccine; This spontaneous report was received from the patient's grandmother concerning a 12-month-old male patient. The patient's medical history, concurrent conditions, and concomitant medications were not reported.   On an unspecified date in 2022 (reported as "a couple of weeks ago"), the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) as prophylaxis (Expired product administered) (dose, route of administration, injection anatomical location, lot # and expiration date were not reported). No additional adverse events were reported (No adverse event).
Information has been received from a physician concerning a 33 year old male, affiliated with another unspecified practice, who on 29-JUL-2008 was vaccinated IM in the upper arm with the second dose (lot# not reported). Per the physician, the patient was inadvertently administered a dose of MMR II diluted with MENACTRA. The patient now notices soreness at the injection site. No further information was available. Patient outcome was not reported. Additional information is not expected.