chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INJECTION SITE PAPULE; SHOULDER PAIN; VACCINATION SITE ERYTHEMA; PAINFUL JOINTS; This spontaneous report received from a patient concerned a 37 year old female. The patient's past medical history included rheumatoid arthritis flare up, Crohn's aggravated, and allergic cough, and concurrent conditions included social smoker, non alcoholic, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported. The unspecified Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1132647 expiry: UNKNOWN) dose was not reported, 1 time every 2 weeks, from SEP-2019 for Crohn's disease, and rheumatoid arthritis. No concomitant medications were reported. On MAR-2021, the subject experienced painful joints. On 30-MAR-2021, the subject experienced injection site papule. On 30-MAR-2021, the subject experienced shoulder pain. On 30-MAR-2021, the subject experienced vaccination site erythema. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient recovered from injection site papule, and vaccination site erythema on 01-APR-2021, and shoulder pain on APR-2021, and had not recovered from painful joints. This report was non-serious.
Developed localized cellulitis at injection site, Tx'd with Azithromycin, prompt resolution, no sequelae or serious injury
Presented to ED with shortness of breath and edema. Echocardiogram showed increased thickness of his pericardium which was considered to represent myocarditis or pericarditis. Patient had no prior history of cardiac events.
patient was given the wrong vaccine (Moderna 6year-11year) for his age group.
Pt had already received his influenza vaccination on 9/30/21, received a 2nd one on 1/13/22
sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03T20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-360193 (Patient Link).   Reporter did not allow further contact
"COVID vaccine arm- LT arm near bicep. Swelling, non pitting, warm to touch, minimal redness. Iced arm and took and NSAID which helped a little.
Information has been received from a physician concerning a 14 year old female who on an unspecified date was vaccinated with Gardasil (lot # unknown) and developed a rash. At the time of reporting it is unknown if the patient has recovered. This is one of two reports received from the same source. Additional information has been requested.
lymph node is big enough ( noticeable; clavicle gland is big; Vaccination site pain; flushing red face; 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 VACCINATION SITE PAIN (Vaccination site pain), FLUSHING (flushing red face), LYMPHADENOPATHY (lymph node is big enough ( noticeable) and LYMPHADENOPATHY (clavicle gland is big) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and FLUSHING (flushing red face). On an unknown date, the patient experienced LYMPHADENOPATHY (lymph node is big enough ( noticeable) and LYMPHADENOPATHY (clavicle gland is big). On 03-Apr-2021, FLUSHING (flushing red face) had resolved. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) had resolved and LYMPHADENOPATHY (lymph node is big enough ( noticeable) and LYMPHADENOPATHY (clavicle gland is big) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided    Reporter did not allow further contact
Information has been received from a certified medical assistant concerning two patient's who were vaccinated with pneumococcal 23v polysaccharide vaccine. Subsequently, the patients experienced cellulitis-like reactions. The patients were treated with an antibiotic. At the time of the report it was unknown if the patients recovered. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. In follow-up it was reported by the physician that a patient with no pre-existing allergies, birth defects, or medical conditions was vaccinated intramuscularly in the a.m., on approximately 31-JAN-2007, with pneumococcal 23v polysaccharide vaccine, (Lot # 651046/0620F). It was reported that the patient had a localized cellulitic-like reaction. The patient had a clinical exam only. It was reported that the patient recovered. The reporter stated that there were three other patients that had localised cellulitic-like reactions after receiving the pneumococcal 23v polysaccharide vaccine, (WAES # 0702USA03808, #0711USA03297, 0711USA03298). Additional information has been requested.
The patient is in her first trimester of prenancy. On 01/01/2001 the patient developed a rash after her child was vaccinated with varicella virus vaccine live. The rash was described as vesicles with 150 to 200 lesions total which started on the chest and spread throughout the trunk, the patient had lesions from head to ankles. The patient had a fever of 103F, chills and felt tired. Subsequently the patient recovered. It was noted that the patient's child experienced an adverse event after the vaccination. No additional information is available.
Immediate muscular pain and soreness at injection site Delayed muscle soreness in back, legs, and arms. Chills Headache/Sinus Pressure Nausea/dizziness
Reported of severe aching and pain in legs-hurt to walk.  No numbness or tingling or loss of function.
the caller's arm was itching and was sore with a little red circle around it; the caller's arm was itching and was sore with a little red circle around it; she had a lump on her skin that is pink and red; redness; This is a spontaneous report from a contactable consumer reported for herself. An 80-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 04Mar2021 as DOSE 2, SINGLE for COVID-19 immunization. Reason for no lot number: of COVID shot: Patient unwilling to complete the report. The patient medical and concomitant medication history were reported. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) as dose 1, single on 04Mar2021 for COVID-19 immunization. Patient never had a problem with the first one. Other products, patient history and investigation assessment were not provided. It was mentioned that patient never had a reaction to shots, but arm was tender but arm seems like its getting better, patient never had a problem with flu shots, other people have had worse problems. On Mar2021, after the second dose of the vaccine, patient sat there for 15 minutes and everything was fine. The patient went home and put alcohol on arm. The next day (on 05Mar2021), the arm was itching and was sore with a little pink and red circle around it where patient got the vaccine. Patient wonders if that shot was stronger than the other one? Patient did not have fever or sickness. There was a little lump on arm which was pink and had some redness. Was it normal for it to did this? Patient mentions that the redness was gone but there was still a lump and itching, patient was keeping alcohol on it. The outcome of the events were unknown.  No follow-up attempts are possible. No further information are expected.
he has strange phenomenon in which he shakes his head from side to side every 10 seconds, raise his eyes, and move his mouth very unnaturally.He didn't mean these at all; And he has a nosebleed every other day, and once he has a nosebleed, he can't stop bleeding for 30 minutes.; And he has a nosebleed every other day, and once he has a nosebleed, he can't stop bleeding for 30 minutes.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), on 13Jul2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSKINESIA (non-serious), outcome "unknown", described as "he has strange phenomenon in which he shakes his head from side to side every 10 seconds, raise his eyes, and move his mouth very unnaturally.He didn't mean these at all"; EPISTAXIS (non-serious), BLEEDING TIME PROLONGED (non-serious), outcome "unknown" and all described as "And he has a nosebleed every other day, and once he has a nosebleed, he can't stop bleeding for 30 minutes.". Additional information included: But after vaccination, the patient had strange phenomenon in which he shakes his head from side to side every 10 seconds, raise his eyes, and move his mouth very unnaturally. He didn't mean these at all. It's no use going to the hospital or taking medicine. And he has a nosebleed every other day, and once he has a nosebleed, he can't stop bleeding for 30 minutes. I'm afraid his symptoms will get much worse if he get the second vaccination. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A severe headache and neck pain started on 1/14/22 that would not go away. It lasted continuously for two weeks and finally on 1/28/22 I went to the ER with only partial relief from IV infusion of three different meds.  Headache later subsided.  Then on 4/8/22 I started with itching and I noticed that I had whole-body rash (patchy red). It was  unbearable and I went to the ER on 4/14/22. They gave me IV benedryl and steroid cream and prednisone. This only partially helped with the itching. Then, my upper legs started turning into a purple rash.  On 4/24/22 I went to the ER again because I woke up with a swollen tongue and lip and the rash started blistering on my hands and feet and genitalia and was EXTREMELY itchy. I was admitted into the Hospital at that time (4/24/22) due to swelling of my lips and tongue and was also experiencing numbness/tinglling in my hands and feet. As an inpatient I received more IV medications for the above and also the itching and the rash and blistering. The swelling was reduced however,  I experienced little relief of the ithcing/blistering and  was discharged a day and a half later to continue meds at home (Steroids, benedry, claritin, gabapentin). They also gave me a prescription or an EPI pen.  The redness subsided days later, however the blistering still continued and actually turned into weeping blisters on my hands and feet.  I was then seen by a dermatologist who diagnosed me with SJS (Steven-Johnson-Syndrome) and "Covid toe".  She advised my to NOT GET ANY MORE VACCINES.  I was to continue my medication regime and "let it run its course".    My hands became much worse with blisters and became a concern in doing my job at work, so I then made an appointment with a Wound/burn physician.  She basically told me the same thing - it has to run its course. Another follow-up appointment is on the horizon.   To this day, my hands and feet have now blistered and are dry and peeling. (I can't even clock into work with my finger pads because the biometrics can read my fingers!)  The numbness continues in my hands and feet, which I was advised to follow up with a Neuologist and will.
Called about 5 minutes after vaccination with MMR, Comvax and Varivax with bilateral thigh urticarial reaction with erythema initially 3cm and increased to 5-6cm diameter. No cardiorespiratory compromise; BP-84/43; HR-130's with good pulses. Benadryl 12.5mg po X 1 with improved symptoms.
Member received her 1st 2 doses of Covid 19 vaccine as Moderna Monovalent. Pfizer was administered and is not part of the approved formulary.
Warm to touch; Angry red ring (3 by 2.5 inches); This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Angry red ring (3 by 2.5 inches)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Angry red ring (3 by 2.5 inches)). At the time of the report, VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Angry red ring (3 by 2.5 inches)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included ice and antihistamine.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up information  received  on 01-JUL-2021 and it  contains no new information.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded. Vaccination site erythema is consistent with the product safety profile.
Narrative:  84 year old male with PMH: HTN, DM2 (last A1C of 7.4% December 2020), and hyperlipidemia presented to same day access at the local agency on 4/9/2021 stating that after he received his second Moderna on 3/24/2021, he has been very sick. Pt said he had no appetite, no energy, and no taste or smell the last 2 weeks. Patient was tested for covid19 but result was negative. Pt denied fever or chills. Per progress notes, patient was pale on appearance, oral mucosa was moist, neck was supple. Lungs were clear to auscultation and respirations were comfortable. Extremities show bilateral edema from the knees down which patient said was chronic for him. CBC and BMP were done, which showed a hemoglobin of 5.3, potassium of 6.7, Scr of 6.5 (baseline respectively, 13.7, 4.1, 0.8, November 2020). Patient was then referred to the local ED where he was admitted. Hospital records have not been scanned.
sores on her face; sores on her mouth; open ulcer/lesions in the vagina; severe burning; Sores on her gums; Very painful; affects nervous system; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (sores on her face), STOMATITIS (sores on her mouth), VAGINAL LESION (open ulcer/lesions in the vagina), BURNING SENSATION (severe burning) and NONINFECTIVE GINGIVITIS (Sores on her gums) in an adult female patient 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 FACIAL PAIN (sores on her face), STOMATITIS (sores on her mouth), VAGINAL LESION (open ulcer/lesions in the vagina), BURNING SENSATION (severe burning), NONINFECTIVE GINGIVITIS (Sores on her gums), PAIN (Very painful) and NERVOUS SYSTEM DISORDER (affects nervous system).   At the time of the report, FACIAL PAIN (sores on her face), STOMATITIS (sores on her mouth), VAGINAL LESION (open ulcer/lesions in the vagina), BURNING SENSATION (severe burning), NONINFECTIVE GINGIVITIS (Sores on her gums), PAIN (Very painful) and NERVOUS SYSTEM DISORDER (affects nervous system) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Received Vaccines on 2/3/2009, and rash started 2/6/2009 from neck down. Advised mom to give patient Benadryl every 6 hours.
He had the first shot......then got the shingles; He'll be able to get the second one in March / Has to be a year from when you had the shingles; This case was reported by a consumer and described the occurrence of shingles in a adult male 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 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose. The age at vaccination was not applicable for this report for 2nd dose. The patient received Shingrix and had shingles. The patient would able to get the second one in March but till the time of reporting did not receive, which led to incomplete course of vaccinations. The reporter stated it had to be a year from when had the shingles.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions concomitant therapies or medical histories provided. On unknown dates since 08-JAN-2016, the patients were vaccinated with improperly stored doses of VAQTA intramuscularly (dose, lot # and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of -1 degrees Celsius for 220 hours. Time frame/date of excursion: from 08-JAN-2016 to 24-MAY-2016. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a licensed vocational nurse and refers to a patient of unkonwn age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (Lot # L006386 with expiration date 25-FEB-2017; dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
swollen lymph node; Painful lump in left armpit; Painful lump in left armpit; This is a spontaneous report from a contactable consumer (Patient). A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Oct2021 at 12:00 (Lot number: 32030801) at the age of 48 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "depression" (unspecified if ongoing); "acne" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII, administration date 13Sep2021; ESCITALOPRAM taken for depression (ongoing); WIXELA INHUB taken for asthma (ongoing); PROAIR DIGIHALER taken for asthma (ongoing); SPIRONOLACTONE taken for acne (ongoing). Vaccination history included: Bnt162b2 (Dose, 1st dose, Date:04Mar2021, Anatomical site of injection: left arm, Route of Administration: Intramuscular, Batch/Lot number: EJ1685), administration date: 04Mar2021, when the patient was 48 years old, for Covid-19 immunization; Bnt162b2 (Dose, 2nd dose, Date:25Apr2021, Anatomical site of injection: left arm, Route of Administration: Intramuscular, Batch/Lot number: EK5730), administration date: 25Apr2021, when the patient was 48 years old, for Covid-19 immunization; Flu (Vaccine Name: Flu, Manufacturer: Unknown, Batch/Lot#: Unknown, Route: IM, Anatomical site of injection: left arm, No of previous doses: Unknown, Date:23Sep2021), administration date: 23Sep2021.The following information was reported: PAIN (non-serious), AXILLARY MASS (non-serious) all with onset 25Oct2021 08:00, outcome "not recovered" and all described as "Painful lump in left armpit"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph node". Therapeutic measures were not taken as a result of pain, axillary mass.  Additional information: facility type vaccine: Pharmacy or Drug Store. if other vaccine in four weeks: Yes. other vaccine 4weeks details: other vaccine 4weeks product=Flu vaccine. adverse event: Painful lump in left armpit. adverse event: start date 25Oct2021. adverse events start time: 08:00 AM. adverse event country: US. ae resulted in: [None of the above]. if patient recovered: Not recovered. if treatment ae: No. if COVID prior vaccination: No. if COVID tested post vaccination: No. known allergies: No. other medical history: Asthma. I experienced a painful lump in my left armpit (presumably swollen lymph node) for two days after vaccination.  No follow-up attempts are possible. No further information is expected.
Patient came in for flu shot for the first time. After I administered it, I told her to stay around the area for 10 min, she came back telling me she was feeling hot and had difficulty breathing but not to the point where she was in anaphylaxis. 20 minutes of monitoring she felt as if we should call 911, so they came and said she was fine.
Headache from temples to ears for 3 days starting 2 days after vaccine; pt normally has no h/a.
Morning after injection, injection site was raised, warm, and red with about 4 inch diameter of reaction. Reaction still visible on 10/22/12, but has decreased in size.
I had a covid tounge reaction to the first Moderna Vaccine; 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 VACCINATION COMPLICATION (I had a covid tounge reaction to the first Moderna Vaccine) 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 VACCINATION COMPLICATION (I had a covid tounge reaction to the first Moderna Vaccine). At the time of the report, VACCINATION COMPLICATION (I had a covid tounge reaction to the first Moderna Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient enquired about need my second dose, after getting reaction after first dose  Concomitant medication not reported and Treatment medication was not provided   Reporter did not allow further contact