chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site nodule, first noted approx 1 week after immunization. Associated with left axillary adenopathy and erythema. Given course of cephalexin with resolution of axillary LAD and erythema, no improvement in injection-site nodule. Soft tissue ultrasound obtained approx 18 days after immunization notable for: Ill-defined area in the subcutaneous fat overlying the left deltoid, possibly reflecting an injection granuloma or focal inflammation. No discrete fluid collection or abscess visualized. Measured size: 1.7x0.6x3.0 cm
EW0198 7/21/2021 FC3180 8/11/2021 7/12/2023 - present (16 days) presents to the emergency department complaining of worsening shortness of breath x1 day
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 13-May-2021. On 24-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 24-Dec-2020, EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) 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.   On 24dec2021, post vaccination, the patient reported that she experienced symptoms of exposure during pregnancy   Concomitant medications were not provided No treatment information was provided.
Information has been received from a physician, via a company representative, concerning a "teenaged" female patient, who on an unspecified date was vaccinated with the first dose of Gardasil (Lot # not provided). Concomitant therapy included MENACTRA. Subsequently, after receiving the first dose of Gardasil, the patient developed hives, that "were most severe on the injection site arm." The physician confirmed that the patient had recovered from the hives (duration and date not provided). The patient sought unspecified medical attention. The physician reported that three additional teenaged female patients also developed hives after vaccination with the first dose of Gardasil (lot # not provided) (WAES: 0707USA00837, 0707USA01121, and 0707USA01122). Additional information has been requested.
poor sleep; fatigue; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site), FATIGUE (fatigue) and POOR QUALITY SLEEP (poor sleep) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M201A) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). On 03-Feb-2021, the patient experienced FATIGUE (fatigue).   On 04-Feb-2021, the patient experienced POOR QUALITY SLEEP (poor sleep). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of UNK UNK, bid. On 03-Feb-2021, FATIGUE (fatigue) had resolved.   At the time of the report, VACCINATION SITE PAIN (pain at injection site) and POOR QUALITY SLEEP (poor sleep) had not resolved. 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.
A report has been received from a Physician concerning a 43 year old female. No medical history and concomitant medications provided. The patient had been receiving FLUMIST QUADRIVALENT 2 ml started on 17 OCT 2014 with Lot number CJ2129 and expiration date was 05-JAN-2015. The patient received FLUMIST QUADRIVALENT and a few days later reported flu like symptoms/flu like symptoms which started on 21-OCT-2014 and nasal congestion, cough, sore throat, aching and fever. The patient had sought increase platelet count which started during 21-OCT-2014. The patient recovered from the event of patient received FLUMIST QUADRIVALENT and a few days later reported flu like symptoms/flu like symptoms on an unspecified date and the outcome of the event of nasal congestion, cough, sore throat, aching, slight increase platelet count and fever was unknown. The reporter considered the events of patient received FLUMIST QUADRIVALENT and a few days later reported flu like symptoms, nasal congestion, cough, sore throat, aching to be non-serious. The event of fever and slight increase platelet  count had been identified by the company physician from the source documents  and added as adverse event and considered it non-serious.
Pt reports painful pruritic, diffuse hives and low grade fever about 2 days after administration of Moderna vaccine
1 of 2 pts vaxed w/pneumovax & approx 1 mon later-JAN95 was re-immunized w/pnu immune;pt exp red,sore arm- warm to touch,& also devel a fever;
Right thigh swollen and sore, required ER visit, for sterile abscess, received antibiotics.
localized redness and warmth at site , axillary lymph node tenderness and swelling the size of a cherry
Narrative:  COVID infection following COVID vaccine series 01/16, Pfizer, dose #1 02/06, Pfizer, dose #2 07/28 pt cc: cough, myalgias, fatigue; exposure: unknown 08/03 COVID swab, result: detected 08/06 clinically resolved 08/11 pt c/o body aches, loss of taste and smell but able to eat, feels he is improving 08/16 minimal cough, taste returned 08/25 pt reports close exposure to COVID positive person; COVID swab, result: not detected
0.5 mL dose drawn into syringe for administration. Nurse and patient report that on slow IM injection, some of the vaccine 'spurted' out, felt by both administering nurse and patient. Just a few small dots (nurses writs, patient's arm and forehead). Administering nurse subsequently inspected syringe and saw that it had a crack in it, allowing some of the vaccine to expel.  Estimate that patient received 0.4 ml.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received bnt162b2 (BNT162B2), on 21Apr2022 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 22Aug2023 to 24Aug2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300296516 Same patient, different drug/AE;
After vaccination, a reconstitution error was discovered, the vaccination received was slightly more concentrated. The employee was attempted to be  contacted, made aware of the incident, educated on reporting signs and symptoms.
After my second dose of Moderna, at about 7:00 pm I noticed that my glands in my neck were hurting, almost like a sore throat. At 9:00 I went to bed because I was extremely tired and I just shook. At first I was not cold, however after about an hour of shaking I became cold along with the shaking and just could not warm up. My head hurt and it felt like someone took a zip tie and put it around my chest.  My breathing was not normal, but rather shallow. I took my temperature around midnight and it was 101.5 degrees. I took Tylenol and tried to sleep. About 4 am I started sweating and then getting cold. This went back and forth for hours. Every 4 hours I got up and took more Tylenol. My chest and head continued to hurt and I stayed in bed until Sunday evening, around 8:30. I finally ate something and went back to bed as soon as I could take more medicine. I woke up around 3 and my fever finally went down to about 99 degrees. I went to work on Monday with a headache but no high fever. As the day continued, my head started feeling better and my breathing improved. I went to bed about 8:00 on Monday evening. It was wonderful Tuesday when I woke up and could take a deep breath! My headache was almost gone. It took me until Friday before I had my energy back.  I had no reaction except a sore arm after my first Moderna shot.  This second shot took me out. If this shot is required yearly, I will opt out! I care not to do this every year!
pt recvd vax;fever of 103-104 for 2-3 days approx 7 days p/ vax; tx w/ apap & advil drops;
Fever (low grade) Chills/flush  Tired Headache  Soreness -neck tight & sore
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient reported redness and swelling that is "warm to touch" at injection site on weekend after injection, not immediate reaction. Asked us to report.
Dizzy, nausea, Hyperventilating Code called over head, Zofran given, vital signs (WNL), transferred to emergency department for further treatment
Patient states 5 days after 1st Pfizer COVID vaccine she developed freckles or dark spot on her right hand that then later spread to right hand. On 7/9/21 she came back for her 2nd dose and is worried dark spots will reoccur or get worse and showed her current freckles on both arms.
Extremely swollen at the site of injection. She knew something wasn't right immediately after injection. A little white dot appeared where needle was inserted. Arm swelled. Initially thought it was common. But was not getting better and was painful and made her not feel well. She went to the doctors thankfully a few days after and was advised that it was infected. Could have been dangerous for her if infection continued to move through her body.   She is now on antibiotics. This is strange to have an infection which makes us feel the needle was not properly sterilized? Something foreign entered at the time of that shot and we would like to have answers. The doctors could not even identify why this happened.  Company Pfizer..
Patient developed shortness of breath and chest tightness later in the day after receiving her first and her second  COVID Vaccine.  She also vomited about 10 hours after receiving her first COVID Vaccine.  The following 3 days after receiving both her first and second dose of the COVID Vaccine, she experienced shortness of breath and chest tightness.
pt states his right arm became red at site the day after injection and has increased in swelling over past 4 days with heat and redness increasing . no other symtpoms reported
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 1 day after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site ecchymosis. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site ecchymosis were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site ecchymosis to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. Redness, swelling and ecchymosis at the site were resolved after 10 days. The patient reported the events to her pharmacist. For tolerability of 2nd dose of SHINGRIX, refer case US2018GSK129632.
his anal seepage is running rampant; Initial information received on 22-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non health care professional via social media under reference number: US-SA-SAC20211027001637.  This case involves an unknown age male patient was experienced his anal seepage is running rampant (anal incontinence) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event his anal seepage is running rampant (anal incontinence) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported" Author/Reporter Comment: A guy at work got his shot and now his anal seepage is running rampant, can't come to work now."  It was unknown if the patient experienced any additional symptoms/ event.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was reported as unknown.
Rash on chest and stomach.  Spots subsided but still visible 1.5 months after vaccine.  They are red and scaly.
TRANSIENT CEREBRAL ISCHEMIA ACUTE ST ELEVATION MI, ANTERIOR WALL ACUTE ST ELEVATION MI, UNSPECIFIED ACUTE NON ST ELEVATION MI HYPOTENSION 10/17/2022,  11/2/2022,  2/17/2023,  1/28/2023  --  RECURRENCE OF SAME SYMPTOMS
I got the shot and a week later I got them; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-June-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient stated that he/she got the Shingles shot and a week later he/she got the shingles. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Client received 0.5 ml dose as booster dose instead of 0.25 ml dose of Moderna on Friday 11/19. She reports body aches, fatigue, fever, injection site swelling, redness, and tenderness develop within 24 hours. Symptoms persisted for about 24-48 hours with complete resolution at this time.
The day before she got her vaccine she had started her menstruation cycle.  She is not on any medications, everything was normal, went to work and went to get her vaccine.  She got her vaccine and around 4:15 she started gushing, which is abnormal for her and having clots the size of a half dollar and covered in blood.  This is not normal for her periods, and she is now in the bathroom every hour and a half and looks like a murder scene.  Her normal menstrual cycle is heavy for one day and then gradually lessens and only lasts a few days.   She does occasionally have small clots with hers, but this are large and bleeding profusely.  The only side effect she has is that she is extremely tired.  She slept from 4:30 yesterday to 2:00 AM and feels like she could sleep the rest of the day.   Her arm is a little bit sore, but otherwise fine from the injection site.  Is concerned due to the heavy volume of bleeding, which is extremely abnormal for her.   She has taken Tylenol and drinking a lot of fluids.
The vial was initially stored in the refrigerator on 6-Oct-2022 and was administered on 7-Nov-2022; No adverse event; Administered expired dose to patient/expired dose was given after the 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired dose to patient/expired dose was given after the 30 days), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 6-Oct-2022 and was administered on 7-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 3V (FLUZONE HIGH DOSE) for an unknown indication.    No Medical History information was reported.   On 07-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE INACT SPLIT 3V (FLUZONE HIGH DOSE) (Intramuscular) 1 dosage form. On 07-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired dose to patient/expired dose was given after the 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 6-Oct-2022 and was administered on 7-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired dose to patient/expired dose was given after the 30 days), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 6-Oct-2022 and was administered on 7-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Administered expired dose to patient/expired dose was given after the 30 days) and NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 6-Oct-2022 and was administered on 7-Nov-2022).    No concomitant medications were provided. The reporter states that vaccine had been punctured and used. It was in their fridge for 32 days.  The vial size was 2.5 mL. The vial was initially stored in the refrigerator on 6-Oct-2022 The vial did not undergo any temperature excursion. It was reported that expired dose was given after the 30 days.  On 12-feb-2021, patient received 0.5 ml dose 1. On 12-mar-2021, patient received 0.5 ml dose 2 with batch number 032M020A. On 28-oct-2021, patient received 0.25 ml dose 3 with batch number 076C21A in left arm. On 31-mar-2022, patient had dose 4 with batch number 045J21A in left arm. No treatment medication was provided.
Pt received both immunizations in left arm (about 4 inches apart). Reports pain and discomfort x 2 days. Came into clinic and reports being transferred to MC. In hospital for weekend where she was treated. Discharged home w/ discomfort after the weekend. Pt report being treated w/ Atbx and pain medications.
The next day laid in bed until 2pm, was exhausted; sore arm; itchy arm, it was a big circle around injection site; got up from the couch and thought that was going to pass out; so weak; did not sleep that night; went to bed with a terrible headache; chills; A spontaneous report was received from a 67 year old female consumer, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced got up from the couch and thought that was going to pass out, so weak, went to bed with a terrible headache, chills, did not sleep that night, The next day laid in bed until 2pm was exhausted, sore arm, itchy arm and it was a big circle around injection site.  The consumer's medical history included Covid infection in Nov 2020. Relevant concomitant medications included atorvastatin, bupropion, donepezil, vitamins and prilosec (stomach).  The consumer received the first of the two planned doses of mRNA-1273 on 13-FEB-2021 intramuscularly for prophylaxis of COVID-19 infection. On the same night, she thought she was going to pass out as she got up from the couch; felt weak. She went to bed with a terrible headache and chills; did not sleep that night.  On 14-FEB-2021, she laid in bed until 2pm, exhausted chilling and with a headache. However, she felt better by the same evening. She also experienced an itchy arm which resolved in a week. There was a big circle around injection site and still has a bit of a sore arm.  Tylenol was given as a treatment.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events got up from the couch and thought that was going to pass out, so weak, went to bed with a terrible headache, chills, did not sleep that night, the next day laid in bed until 2pm, was exhausted sore arm was unknown and for, itchy arm and it was a big circle around injection site was resolved.  The consumer did not provide an assessment for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Thrombocytopenia noted; Elevated temps to 104; Associated chills; headaches; This is a spontaneous report from a contactable healthcare professional. A 16-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 intramuscular on 25Apr2021 (Lot Number: EWO171) as 1st dose, single for covid-19 immunization. Medical history included eczema, Pyle disease, food allergies, short stature, seasonal allergies, peanuts allergies and nuts allergies. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient did not have other vaccine in four weeks. On 26Apr2021, the patient had elevated temperatures to 104 [unspecified unit], 4-5 days post vaccination (pending clarification) with associated chills and headaches. Thrombocytopenia noted. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was provided for the adverse events. The patient was tested post vaccination with a nasal swab test on 28Apr2021 and the result of negative. The reporter did not consider the events was serious. The outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: The reported event thrombocytopenia was observed only 1 day after vaccination.  It is unlikely that thrombocytopenia is related to BNT162B2.  It's more likely intercurrent medical condition. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Flare up of autoimmune disease overheated flu like symptom, back pain, intense itch
Evening after 1z given, pt developed warmth and swelling at injection site. 1 1/2 days after 1Z given pt developed 4-6 vesicles at injection site, +swelling, + warmth, no fever.
Burning in neck, hives, shortness of breath, chest spasms and pain, and projectile vomiting while urinating on myself. Chest x-ray, cardiac work up, labs, Solumedrol, Benadryl, Prednisone, Epipen given in case needed in future event.