chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had two hot bumps (bigger than a quarter size) on two sides of where the vaccine was administered in the upper left deltoid
Patient came in for pediatric Pfizer vaccine at 3PM on 11/8/21. Parent called on 11/9/21 at 2PM and informed me her child had coughing/tickling of throat around 9PM indicative of a local allergic reaction. The child had allergic reactions previously to flu shots and I advised them during the immunization to have benadryl as needed for the anticipated delayed reaction. Benadryl was administered and took care of the coughing/tickling of throat in roughly 30 minutes.
Dizziness; Vertigo; No longer maintain balance; disorientation; Vomited; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), VERTIGO (Vertigo), BALANCE DISORDER (No longer maintain balance), DISORIENTATION (disorientation) and VOMITING (Vomited) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery since an unknown date and Pacemaker insertion (cardiac) since an unknown date. Concurrent medical conditions included Blood pressure high and Subdural hematoma. Concomitant products included ATORVASTATIN and METOPROLOL SUCCINATE for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (Dizziness), VERTIGO (Vertigo), BALANCE DISORDER (No longer maintain balance), DISORIENTATION (disorientation) and VOMITING (Vomited). At the time of the report, DIZZINESS (Dizziness), VERTIGO (Vertigo), BALANCE DISORDER (No longer maintain balance), DISORIENTATION (disorientation) and VOMITING (Vomited) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Email ID  was Updated
One dose of the moderna on February 8 and did not receive my second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (One dose of the moderna on February 8 and did not receive my second shot) 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 08-Feb-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 PRODUCT DOSE OMISSION ISSUE (One dose of the moderna on February 8 and did not receive my second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (One dose of the moderna on February 8 and did not receive my second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.
This spontaneous report was received from a physician and refers to a 12-year-old male patient with allergies to penicillin and peanuts. On 14-AUG-2017, the patient was vaccinated with the first dose of GARDASIL 9 lot # N012093 with expiration date on 13-JAN-2020, intramuscular injection in the left deltoid. Concomitant therapies included ADDERALL XR 25 mg. On 15-AUG-2017, the patient experienced right sided jaw swelling and pain. The patient's mother was recommended to treat the events with warm compresses to the site. The mother took the patient to an urgent care who suggested that this might be a reaction to the vaccination with GARDASIL 9. The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested.
Pt reports 10/30/13 evening swelling, redness, "rash" pain at injection site. States fever, chills, sweating, nausea, general aches. Took NYQUIL with some relief. Reports symptoms improved/resolved by 11/1/13.
Extreme shortness of breath over several days about 3 weeks after vaccine.    Blood clots found  in rt calf, lungs and heart.  Anticoagulants administered and heart clots removed mechanically.  Outcome good.
Patient received vaccines (PREVNAR, HAVRIX, VARIVAX and MMR II) on 10-16-08. Follow up with FNP on 10-20-08 d/t a rash that started on 10-17-08. Mother stated that rash was from head to toe. Patient was treated for rash, ROM and URI. Patient recovered with no problems.
Scattered erythema papular vesicles lesion trunk (20) neck (5 or 6) edge of scalp (1) upper thighs and arms (3 or 4).
Since I received my first Pfizer COVID 19 vaccine, I started having tinnitus in my left ear associated with left sided headache. These symptoms started to increase in frequency and intensity with repeated Pfizer COVID vaccines. I received five doses so far, and for the last year my tinnitus and headaches have been increasing significantly. The tinnitus is every few minutes; sometime severe and wakes me up from sleep. The associated headaches is every few days; and at least once a week I would have severe headache in the left side for which I take NSAID or Excedrin.     I also received Pfizer Bivalent, that was the fifth vaccine.
Chilling 8NOV, vomiting 9NOV & became dehydrated;
Initial pain, swelling and redness starting soon after injection, but mainly appearing the day after injection. 10 days after injection the swelling has gone down, but the redness has spread and formed a bullseye around the injection site.
Morning: 2 super D vitamins, ningxia, 1 sulfurzyme  Shot at 10:15 10:30 done sitting Walk back, feeling hot, sweaty.  10:45 feeling a slight headache but ok 11:45 slight headache but still ok  Next morning 7am Arm is sore Body is sore Bent down around 2pm and felt really sore. Muscles and joints hurt. Couldn?t bend down without joints hurting.   Saturday evening/Sunday morning. Joints/muscles pretty sore. Not much sleep
This spontaneous report was received from a registered nurse referring to a patient of currently 5 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) with lot # L006390, expiry date 25-AUG-2016, albumin status HSA (dose, route of administration and anatomical location not reported). The doses of PROAQUD (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were not previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Approximately 4 hours after second dose, light nausea coupled with body aches and fatigue. Symptoms persisted for 6 hours, at that point nausea subsided. 22 hours after shot, fatigue and body aches persisted.
Under recommended age; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under recommended age) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (multiple autoimmune diseases), Rheumatoid arthritis, Cystic fibrosis and Wheelchair user.    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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under recommended age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under recommended age) had resolved.        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.   No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up received on 30-JUN-2021.Added patient race and vaccination address.
Left anterior/lateral aspect of front of thigh with erythema, edema, and warmth (11cm L x 16.4 cm W). No tenderness. No fever. Benadryl 7.5cc (12.5mg/5xx) QID. Cold compresses.
Pt here for covid vaccine. Received Pfizer at 800am. Was in observation area and RN noticed that pt was experiencing SOB at approx 811am . Upon questioning Pt stated this was his normal breathing and needed to use inhaler. Pt stated he has been experiencing this SOB for several weeks.  Used inhaler was stared was feeling better. RN went to get grandson from parking lot, he stated that pt was SOB this AM when he picked him up. Pt was being questioned by RN when he became diaphoretic and less responsive. 911 called at 819am. VS attempted difficult to get BP via dianamap. Pulse was present. 4L O2 placed on pt . Pox per dianamap was in the 60's. Paramedics arrived at approx 823 am and left at approx 826am . Pt opened eyes and responded to name on way out to ambulance.
Second dose has not been administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received 3 years before date of reporting).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 26-Jul-2022 Reporter's Comments: The second dose had not yet been administered. Additional AE information not available per health care professional (HCP).  AE contains all information provided by HCP.  HCP gives consent for safety team to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
right eye is swollen; breathes and lungs hurt; swollen lymph nodes under the left arm; Headache; fever 102/ 101.6; Chills; achiness; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (right eye is swollen), PULMONARY PAIN (breathes and lungs hurt), LYMPHADENOPATHY (swollen lymph nodes under the left arm), HEADACHE (Headache) and PYREXIA (fever 102/ 101.6) 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.     The patient's past medical history included COVID-19 in October 2020. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PULMONARY PAIN (breathes and lungs hurt), LYMPHADENOPATHY (swollen lymph nodes under the left arm), HEADACHE (Headache), PYREXIA (fever 102/ 101.6), CHILLS (Chills) and MYALGIA (achiness). On 16-Apr-2021, the patient experienced EYE SWELLING (right eye is swollen). The patient was treated with IBUPROFEN for Fever and Headache, at a dose of 1 dosage form. At the time of the report, EYE SWELLING (right eye is swollen), PULMONARY PAIN (breathes and lungs hurt), LYMPHADENOPATHY (swollen lymph nodes under the left arm), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (achiness) outcome was unknown and PYREXIA (fever 102/ 101.6) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.6-102 (High) Fever of 101.6 to 102. is high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-079413 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079413:daughter case
Herpes-type cold sores around mouth and anus and ulcer on tip of tongue.  Along with flu-like symptoms including fever, muscle aches, chills, headache, stomach pain, diarrhea, nausea
All my family got sick after the second shot. My brother and sister; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "All my family got sick after the second shot. My brother and sister". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts completed. No further information is expected.
my temperature was about 100.8, and at 2 pm it was 101.4; My arm was pretty sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (My arm was pretty sore) and PYREXIA (my temperature was about 100.8, and at 2 pm it was 101.4) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced INJECTION SITE PAIN (My arm was pretty sore). On 29-Jan-2021, the patient experienced PYREXIA (my temperature was about 100.8, and at 2 pm it was 101.4). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 30-Jan-2021, PYREXIA (my temperature was about 100.8, and at 2 pm it was 101.4) had resolved. At the time of the report, INJECTION SITE PAIN (My arm was pretty sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Body temperature: 101.4 f at 2pm and 100.8 f (High) at 11am in the morning.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Patient developed a widespread skin rash about 1 hour after receiving vaccine. Pt was brought back to the office and found to have hives. A dose of CLARITIN (25 mL) was given with instructions to continue CLARITIN for 10-14 days and give BENADRYL as needed. The following day, patient developed worsening hives which did not respond to ZYRTEC or BENADRYL. Pt eventually sent to ER where she was treated with oral prednisone, oral PEPCID, oral ibuprofen and sent home on oral prednisone and BENADRYL.
Diagnosed with COVID virus; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Diagnosed with COVID virus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Diagnosed with COVID virus). At the time of the report, COVID-19 (Diagnosed with COVID virus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Vaccine given 4-30-07. Redness, swelling, hot, tender (R) shoulder to elbow and across pectoral major.
Injection was administered Sub-q instead of IM. Age of patient at time of event: 18 years 5 months 28 days.
Pt exp swelling & pain over rt deltoid p/receiving Td; rxn progressed, w/redness over approx a wk; Pt exp pain on abduction of shoulder & some "tender glands in neck";  Seen in ER 1FEB91; Dx cervical lymphadenitis, MD felt not vax related;
Information has been received from a nurse concerning a 5 year old male who on 04-AUG-2003 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). On 20-AUG-2007, the patient received a second 0.5mL dose of varicella virus vaccine live (Oka/Merck) (Lot # 658054/10100). On 20-Aug-2007, the patient developed difficulty breathing and swallowing, and was itchy all over his body. The physician advised the nurse to take the patient to the local emergency room. The patient was advised to take Benadryl and was given an epinephrine pen. The physician suggested that the patient see an allergist. No laboratory or diagnostic tests were performed. No additional information was provided. No product quality complaint was involved. Additional information has been requested.
pt recv vax 1AUG97 & 2 days later pt exp rt axillary lymphadenopathy, tenderness & a dec ROM of the rt arm;discomfort was sufficient to keep the pt from sleeping on that side;
I am still in sirver pain; Can´'t sleep a night; I got the shingles april 30 2022. /suspected vaccination failure; I got the shingles april 30 2022.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 81-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On 30th April 2022, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain and sleeplessness. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain and sleeplessness were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and sleeplessness to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 23-SEP-2022 Reporter's comment: This case was reported via interactive digital media. The patient had got 1 shot and in a couple of days he/she got the 2nd one. The patient reported that he/she had got the shingles on 30th April 2022. He/she was still in severe pain. He/she could not sleep at night. Additional supportive information: This case was considered as suspected vaccination failure since details regarding time to onset and laboratory confirmation of shingles was reported at the time of reporting. Follow-up would not possible as no contact details were available.
0830- Patient reports that her face / upper back and chest are itching. Red spots are appearing on her chest. No redness on face or back. Also reports itching of palate - no SOB / wheezing.  VS - BP 147/81  HR 105 (pt reports that these are elevated from her normal) O2 sat 100%  RR20     History of multiple allergies and anaphylaxis (to Humerma). Currently taking prednisone. Has taken Benadryl in the past for allergic reactions.   0832 - Benadryl 25mg PO given   0835 - no increase in sx   0840 - decreasing redness of chest, continued itching of face near hair line   0849 - feeling well, minimal itching. Offered Urgent Care of ER visit... Patient declines both.  She is on her way to work and will continue to monitor for any increase in reactive sx.   0850 - left covid observation area by her own decision
taken to ER/amb, mom called 911 when unable to arouse p/nap;no visible trauma noted by ER MD:
felt a fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (felt a fever) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (felt a fever). At the time of the report, PYREXIA (felt a fever) had resolved.            No concomitant medication reported. The patient never tested positive for previous COVID-19 test. No treatment medication details reported.   This case was linked to MOD-2022-506338, MOD-2022-506344 (Patient Link).
He has a rash all over his arm and its puffy.; He has a rash all over his arm and its puffy.; Ringing of the ears, tinnitus; weight loss; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Manufacturer: Unspecified, Formulation: Solution for injection) via an unspecified route of administration to his left arm on 24May2021 (at age of vaccination) (Lot number: EW0191, NDC number/Expiry date: Unknown) as single dose for Covid-19 immunization. The patient was taking Covid 19 shot as he was forced to do it or he would lose his job, against medical advice. The patient's medical history was not reported. Concomitant medications were reported as none (other products: no). On an unspecified date in May2021, the patient experienced rash all over his arm and ringing of the ears, tinnitus. Caller stated he was a healthcare professional, he sold Medicare and other healthcare plans. He said he was calling about the shot. He did not get the information for reporting until he got the second shot today. Caller stated it said Pfizer EW0191 for the first shot and then PFIZER EW0196 for the second one. He was not sure if it was a zero or an O. He stated he was calling about the Covid 19. He wanted to report the first one and he had a sheet and he was reading all of things. He had a rash all over his arm and it was puffy. Not just a rash it exploded since then. They keep growing and then they dry off and come up again. Caller stated his first shot was done on 24May2021. He did not know he lost a lot a weight he was 175. Caller clarified the weight loss if from his treatments. He had a rash all over his arm. He could not tell if it was the first or second day. Either 24May2021 or 25May2021. He woke up with it. Then he did not realize until the next day until midday. It was probably sometime at night. It was ongoing and persisting. It was not getting worse, well actually now it on the right just a few. It said CDC Covid 19 vaccination on a 2x3 card. He got his first shot on his left and the second on his right. Ringing of the ears, tinnitus. That night he experienced it and it had not stopped. It was not loud or making him mad or crazy but he was hearing it. Attempted to clarify with caller the start date. Caller stated that night or the next. It was ongoing and persisting. It was a low tone, still there. He guesses it helps the more adverse events that are reported when people call in with adverse events. Now if he were to call now that he got the second shot to report more rashes, he already had a rash on each arm. Treatment was reported as none. Treatment included acne, benzoyl peroxide to dry it up. Communication: Provided caller with Report Reference 7OUJST6G. Outcome of the event weight loss was unknown, whereas other events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.