chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cellulitis; A spontaneous report (United States) was received from a consumer regarding a 31 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced cellulitis.   The patient's medical history was not provided. Concomitant medication use was not provided.  On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273  intramuscularly for prophylaxis of COVID-19 infection.  On 19 Jan 2021 the patient experienced cellulitis.   Treatment for the event included intravenous antibiotics.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome for the event , cellulitis,  was considered unknown.; Reporter's Comments: Very limited information regarding the event has been provided at this time.  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.
LEFT ARM HAS BECOME WEAK AND PAINFUL.  HAVING DIFFICULTY LIFTING OR EXTENDING MY LEFT ARM.
This child had swelling and redness to the right deltoid area, warm to touch, febrile.
had both shingle shot, into outbreak/suspected vaccination failure; large outbreak around waist into back; Worst pain ever; couldn´t eat; weak; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had both shingle shot, into outbreak/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: large outbreak around waist into back), pain (Verbatim: Worst pain ever), eating disorder (Verbatim: couldn´t eat) and weakness (Verbatim: weak). The patient was treated with non-drug therapy (Physical Therapy). The outcome of the vaccination failure was unknown and the outcome of the shingles, eating disorder and weakness were not reported and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, eating disorder and weakness to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain, eating disorder and weakness to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 20-Mar-2023 The case was received from the patient via interactive digital media. The patient had both shingles shots 3 years ago and month into large outbreak around waist all the way into back.  The patient stated still had worst pain he or she ever.  The patient could not eat and got so weak.  Now had nurses, physical therapy, occupational therapy coming weekly to get the patient's strength back.  This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient states that 2 days after receiving flu shot in his left arm that he cannot lift his left arm above shoulder level without pain. Did not report this until 1/27/14.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline).  In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint.  The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified.  For the other 79 linked subjects please see cases : A0756483A - A0756509A, A0756511A - A0756562A.  The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A.  With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) : AFLUCA320, AFLUA320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA.  On 26 March 2009, QA results were received from batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA3508.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
reddened sl raised area approx 5"x5" @ inj site lt deltoid;
Complain of feeling hot, flashed, scratchiness in the back of throat. No swelling, hives, itching, SOB. Patient had tingling in hands and face that patient stated is normal with her MS. T98.1, P80, R18, BP139/89, O2 sat 94%. Pt advised to take Benadryl when she gets home because it makes her very drowsy
Pt had myalgias, skin sensitivity, blister formation on her lip, cold sore and swelling of lips
Full body itching including eyes and throat, blurry vision, headache, fatigue, dizziness, 1-101 fever
Sick as a dog/ I am really sick; Fever; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient stated that, consumer stated, "I have my second dose on Tuesday and I have been sick as a dog ever since and I can't 'write' my fever now. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 11-SEP-2016, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 injection, lot # K012424, expiration date: 05-JUN-2016, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. On the same date, the patient also experienced "soreness" at the injection site. The outcome of injection site pain was unknown at the time of the report. The relatedness between the event and PNEUMOVAX 23 was not provided. Additional information has been requested.
itchiness at injection site; big red area in a weird shape at injection site; warm to touch at injection site; bad headache; very tired; nausea; not feeling like myself; possible low-grade fever; worsening soreness and pain at injection site; arm felt a little sore, as the night went on my harm was becoming more and more painful; didn't sleep well; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm felt a little sore, as the night went on my harm was becoming more and more painful), SLEEP DISORDER (didn't sleep well), HEADACHE (bad headache), FATIGUE (very tired) and NAUSEA (nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm felt a little sore, as the night went on my harm was becoming more and more painful), SLEEP DISORDER (didn't sleep well) and VACCINATION SITE DISCOMFORT (worsening soreness and pain at injection site). On 12-Jan-2021, the patient experienced HEADACHE (bad headache), FATIGUE (very tired), NAUSEA (nausea), FEELING ABNORMAL (not feeling like myself) and PYREXIA (possible low-grade fever). On 19-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at injection site), VACCINATION SITE ERYTHEMA (big red area in a weird shape at injection site) and VACCINATION SITE WARMTH (warm to touch at injection site). On 12-Jan-2021, PYREXIA (possible low-grade fever) had resolved. On 13-Jan-2021, FATIGUE (very tired), NAUSEA (nausea) and FEELING ABNORMAL (not feeling like myself) had resolved. At the time of the report, PAIN IN EXTREMITY (arm felt a little sore, as the night went on my harm was becoming more and more painful), SLEEP DISORDER (didn't sleep well), HEADACHE (bad headache), VACCINATION SITE PRURITUS (itchiness at injection site), VACCINATION SITE ERYTHEMA (big red area in a weird shape at injection site), VACCINATION SITE WARMTH (warm to touch at injection site) and VACCINATION SITE DISCOMFORT (worsening soreness and pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Mom called after hours at 8:00pm to report left are soreness, red, swollen at injection site, fever 103F and vomited once.  On 9/9/2020 at 7:45 am pt passed out at home,  Was taken to hospital ER at 10 am.
Information has been received from a consumer concerning her 5 year old son who was vaccinated with a dose of MMR. Concomitant therapy given around the time of vaccination included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine. Subsequently he developed autism. Unspecified medical attention was sought and no further information was given. There was no product quality complaint involved. Follow up information from a nurse indicated that the patient was first seen in that physician's office on 4/27/01 with complaints of not speaking well, becoming demanding and needy, and liked to be alone. A well visit on 7/5/01 indicated that the patient was uncooperative for the exam, the physical exam was normal and the patient displayed normal warm behavior toward parent and other children. The patient's mother reported that the patient was using made up words, which was difficult to assess, as the patient spoke Indian. No developmental issues were reported at that time. In February 2002, the patient was unable to use two word phrases and could no longer point to objects upon request. The patient was referred for further evaluation and testing. In March 2002, it was reported that the patient was diagnosed with autistic disorder. In May 2004, the patient was referred to occupational therapy, a developmental preschool, and was enrolled in an educational program. Upon internal review, autism was determined to be an other important medical event (OMIC). Additional information has been requested. Follow up 03/03/05: Patient has not recovered from the adverse event(s).
Pt stated after 48 hours of recieving the 2 vaccines, she started to have chills, cold sweats, a rash on neck and chest area, and body aches.
Itchy rash on throat.  Rash still there at time of this report - almost 24 hours later.  Cold Ice, hydrocortozone, allegra used for treatment.  Will take benedryl tonight if still persists.
10-24-08 - PM been feeling sick (L) arm ache. 10-25-08 - Sick, feeling of passing out, Temp hi. 103.9 - Ibu/Tyl to decrease Temp. - 101.9. 10-26-08 - (L) D area red/swollen - painful, warm to touch 10-27-08.
Nausea the day following the vaccine administration. Pt reported vomiting as well. As of today, 10/31/2011, pt reports resolution of nausea and vomiting and that she is feeling better.
OBSTRUCTIVE SLEEP APNEA ACUTE HYPOXEMIC RESPIRATORY FAILURE  10/13/2022 - RECURRENCE OF SAME SYMPTOMS
I had sore arm; I had swollen lymph node on my neck; painful swollen on lymph nodes; perturb menstrual cycle/ perturb dysfunctional not regular not ok; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 50 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EW0191) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot: EW0186), when the patient was 50 years old, for Covid-19 Immunization, reaction(s): "Lymphadenopathy", "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I had sore arm"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "I had swollen lymph node on my neck; painful swollen on lymph nodes"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "perturb menstrual cycle/ perturb dysfunctional not regular not ok". Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy, menstrual disorder.  Additional information: Consumer stated, "So I had three adverse event. So I had sore arm, I had swollen lymph node on my neck, painful swollen on lymph nodes this is after my second shot. Let me explain the first dose swollen was just a sore arm but the second one sore arm, lymph nodes that was swollen and really painful and the third one is that I experience a perturb menstrual cycle, perturb dysfunctional not regular not ok. I am going through very menopause and I the cycle I had was very unusual and so." (Incomplete sentence). The patient did not receive any vaccination, prior vaccine within Four weeks. Consumer further stated, did you capture those three adverse events, yes what is important is painful swollen lymph node. The seriousness for all the events was not reported.  Follow-up attempts are completed. No further information is expected.
symptoms / w/ symptoms; This spontaneous case was reported by a consumer and describes the occurrence of GENERAL SYMPTOM (symptoms / w/ symptoms) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GENERAL SYMPTOM (symptoms / w/ symptoms). At the time of the report, GENERAL SYMPTOM (symptoms / w/ symptoms) outcome was unknown.            No concomitant medication were reported. No treatment information was reported.
Baby screamed with a very high pitched sound. After she calmed down (about 15 minutes after receiving the vaccine) she was acting like she was completely disconnected from the world. She had a blank look on ther eyes and did not follow objects or recognized my voice. She did not eat and she slept all day and all night.
Mother described fever and hives all over. Denied any respiratory distress. Phone call placed to private physician and rx'd Benadryl PO and symptoms subsided. PHD alerted by grandmother of event on 4/6/05.
Chest pain x2 hours post injection, subsided, pt didn't seek medical attention, pt with h/o MVP, heart rate never above 60 bpm - on beta blockers. Pt reported when calling office on another unrelated call.
Initial and follow-up information has been received from a nurse concerning an 11-12 year old female who was vaccinated with VARIVAX (Merck) (lot no., route and site of administration were not reported) 6-8 months ago. At the same time the patient was vaccinated with HPV (lot no., route and site of administration were not reported). The vaccinations were given in the same arm. The day after the patient received the vaccinations, the patient developed redness and swelling at the injection site. It was reported that these events had an onset date of 6-8 months ago (approximately October 2007). All symptoms resolved in a few days. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information is not expected.
Vaccine error - Child came in for #5 DTaP and #4 IPV - was given Pediarix and #4 IPV
Pt had a rash all over left side of body. She also had bumps and they were itchy.
2 doses of Covid Vaccine but as a mistake he was given the Sputnik and 3 months later the second dose of the Moderna; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 doses of Covid Vaccine but as a mistake he was given the Sputnik and 3 months later the second dose of the Moderna) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 doses of Covid Vaccine but as a mistake he was given the Sputnik and 3 months later the second dose of the Moderna). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 doses of Covid Vaccine but as a mistake he was given the Sputnik and 3 months later the second dose of the Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.
She has noted that the muscle under the skin of the injection site started to go away; She has noted that the muscle under the skin of the injection site started to go away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 20Mar2022 at 16:00 as dose 1, single (Lot number: FK9729) at the age of 47 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious), MUSCLE DISORDER (non-serious) all with onset Apr2022, outcome "not recovered" and all described as "She has noted that the muscle under the skin of the injection site started to go away". Therapeutic measures were not taken as a result of vaccination site discomfort, muscle disorder.  Additional information: Patient does not have history of all previous immunization with the Pfizer vaccine considered as suspect Patient does not had any additional Vaccines Administered on Same Date of the Pfizer Suspect. Adverse events does not require a visit to: Emergency Room or Physician Office.  There were no prior Vaccinations(within 4 weeks) within four weeks prior to the first administration date of the suspect vaccine(s). Family Medical History Relevant to AE(s) was provided as none
24 hours of chills, malaise and fever to 102. 48 hours of fatigue and arm soreness. Tylenol taken.
He wants to know if it's okay to take stool softener (colace); This is a spontaneous report from a contactable consumer (patient reported himself) via Pfizer-sponsored program. A male patient received first dose of BNT162B2 (COVID 19 VACCINE, Solution for injection) via an unspecified route of administration on 28Jan2021 as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, "caller just took his first dose of Covid 19 vaccine just today and wanted to know if it was okay to take stool softener (COLACE). Precautionary-AE. Outcome of the event was unknown.  Follow-up attempts are completed. Information about Batch/Lot number has been requested. No further information is expected.
Patient had gas starting the day after shot. It then progressed to stomach pain intermittent and then diarrhea with bloody stools. It progressively got worse and has been suffering with it for 3 weeks now.
sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (148871). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Malig neoplm of upper-outerquadrant of right female breast" (unspecified if ongoing). Concomitant medication(s) included: IBRANCE taken for breast cancer female, start date: 19Aug2020. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information: Patient reported missed doses due to receiving covid booster shot and was sick after and IBRANCE 75 MG TAB / Malig neoplasm of upper-outer quadrant of right female breast.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt presented to Emergency dept by ambulance w/ shortness of breath, and syncopal episode. Pt was vaccinated by x2 with Pfizer vaccines in March/April and tested positive for COVID on 6/17/21. Pt here at MC tested positive again for COVID pt was found to have a LARGE saddle embolism extending to bilateral pulmonary arteries. Pt also presented w/ elevated troponin and D Dimer and will be admitted to ICU 8/6/21
Gave Pneumonia shot to pt. Within minutes, pt felt dizzy and had trouble breathing. She said throat was closing and hands were shaking. I administered one shot of Epi Pen in same arm vaccine was given. Pt had almost instant relief. Medic came and check pt. After 20 minutes they let her go home. Called back at 7pm. She broke out in hives after taking a Beta. She was going to take Benadryl. If no relief, she was going to ER.
Splotchy red rash appeared around injection side ~10 days after injection. Not painful or itchy
Approx 12 hours after receiving flu shot developed vomiting, hoarse voice, chills.  Lasted approximately 12-14 hours.  No specific treatment required.
Bloating - full stomach - Declined but still present for 48 hrs. Constipation - for two days. Panting rapid breathing - symptom declined overnight.
red blotch itching arm; red blotch itching arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotch itching arm) and VACCINATION SITE PRURITUS (red blotch itching arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) 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 RASH MACULAR (red blotch itching arm) and VACCINATION SITE PRURITUS (red blotch itching arm). At the time of the report, RASH MACULAR (red blotch itching arm) and VACCINATION SITE PRURITUS (red blotch itching arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment details were reported.