chrisvoncsefalvay/vaers-outcomes huggingface dataset:
right swollen lip; tingling sensation in lip; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling sensation in lip) and LIP SWELLING (right swollen lip) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced PARAESTHESIA ORAL (tingling sensation in lip). On 22-Mar-2021, the patient experienced LIP SWELLING (right swollen lip). At the time of the report, PARAESTHESIA ORAL (tingling sensation in lip) and LIP SWELLING (right swollen lip) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
pt got fever same night, diagnosed with meningitis 2 days later.  Strongly felt to be HSV meningitis; unlikely that this is due to IZ but very significant illness therefore I am reporting.  Plan for 21d IV abx in hospital.  12/01/2008 MR received for DOS 9/5-26/2008 with D/C Dx: Meningitis, possible HSV meningitis. Pt presented with 2 day hx of fever and episodes of twitching, eye deviation and unresponsiveness as well as decreased po intake and fussiness. During PE episode of eye deviation with nystagmus which self resolved-focal seizures. Admitted for w/u. Continued having focal seizures and started on phenobarb with reduction in seizures. Tx with IV Acyclovir for presumed HSV meningitis despite  (-) PCR. D/C for 6 months Acyclovir po. F/U visit 11/12/08 with pt reportely seizure free. Will wean from phenobarb.
Symptoms after my second dose of Pfizer is a missed period, armpit pain (like a popping sensation), neck stiffness, muscle aches, headache, vaccination site soreness, and gastrointestinal changes. 2nd shot took place on July 5, 2021 at 3-3:15pm.
received and expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 66-year-old male patient who received HAV (Havrix 1440 adult) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th June 2022, the patient received Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 30th June 2022, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-JUN-2022 Reporter's comment: The medical assistant reported that the patient received an expired Havrix dose. The reporter confirmed vaccine formulation by looking up batch number in database. The reporter consented to follow-up. Additional Supportive Information: The patient received a dose of Havrix vaccine which was already expired, which led to expired vaccine used.
Swelling over (R) upper arm with redness, warmth, tenderness. Site: 7x13 cm of erythema.
Some of the same symptoms as when I believe I contacted Covid 19 in another country; headache, fever, general flu-like discomfort (muscle pain, skin burning, extreme tiredness, general malaise) spot where inoculated was painful for 5 days, then itched for 3 days. Fear and stress of getting sick again for prolonged period.  No adverse effects after 48 hours except for injection site pain
Diarhea for three months,loss of appetite and weight (15 pounds in one year), went to several physicians and later to Clinic.
chills, shivering, mild but constant nausea, body ache, muscle and bone pain, headache lasted for 24hrs
very very lil sore on her right arm; neighbors got sick; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very very lil sore on her right arm) and SICK RELATIVE (neighbors got sick) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2010, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-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 PAIN IN EXTREMITY (very very lil sore on her right arm) and SICK RELATIVE (neighbors got sick). At the time of the report, PAIN IN EXTREMITY (very very lil sore on her right arm) and SICK RELATIVE (neighbors got sick) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Chills; Stomach upset; Sore arm; This case was reported by a consumer and described the occurrence of chills in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced chills, upset stomach and pain in arm. On an unknown date, the outcome of the chills, upset stomach and pain in arm were unknown.   It was unknown if the reporter considered the chills, upset stomach and pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter was the father in law of the patient. The patient was either 57 or 58 years old. The age at vaccination was not reported, however it could be 57 or 58 years. The reporter had very limited information. The patient received the 1st dose a week or so ago from the time of reporting and experienced chills, stomach upset and a sore arm.  The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020246458:Same reporter.
I got nauseated and was not feeling good; little bit fever/fever 102.6; was not feeling good; I feel like I got COVID again; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EN6202, expiration date unknown)  via an unspecified route of administration administered on an unspecified date as 1st dose, single for covid-19 immunization. Medical history included covid-19. The concomitant medications were not reported. On an unknown date, patient stated that,  I had my second vaccine yesterday the Pfizer and on the first one I got nauseated and was not feeling good and little bit of fever and I told them about it. I just need to know what to do. I have fever 102.6 and I feel nauseated. I felt like I got COVID again and I know I don't but it gave me that feeling. On an unknown date, the patient underwent lab tests and procedures which included body temperature which result showed fever 102.6 (unit not provided). The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Having had a stroke around 2019 and after the initial vaccine I suffer a bad reaction to my eyesight which was already affecting my vision, the eyes were progressively more unstable and crossing giving me double vision with the legs needing some walking lessons as my legs were not quite affected severely but my efforts to learn to correct my walking and the double crossing of my eyes are becoming an issue with my falling down.
Wrong brand and age range given to patient. Given pfizer 5-11 when should have given moderna under 5
Pt devel urticaria & andioedema following immun @ 9-10 months of age;
Pfizer-BioNTech COVID-19 Vaccine EUA  Patient reported symptoms beginning on 1/28/2021 after receiving COVID vaccine on 1/27/2021. States that she had had increasing pain in her LUE, where she received the vaccine. States that there is discoloration and redness, warmth, and mild swelling around the injection site. Additionally reports tingling radiating from the injection site to her finger tips.  Pt referred to emergency department and was treated for L shoulder pain consistent with localized inflammation secondary to recent vaccination
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Since 01-JAN-2015, improperly stored PROQUAD (Merck) (lot#, expiration date, dose, frequency and route were unknown) were administered to multiple unspecified patients. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Pt. started scratching/itching, eyes puffy and red, c/o scratchy throat. Pt. given 0.15 EPIPEN JR. and 12.5 mg BENADRYL po. BENADRYL repeated 20 min later. Due to epi admitted for observation.
On 3/20/23, symptom onset began with low back pain, that progressed to pain and paresthesias in bilateral upper and lower extremities, as well as paresthesias of the tongue. Pain progressed despite being given muscle relaxant and gabapentin, and thus pt was advised to go to the ER. She was admitted 3/27/23 and diagnosed and treated for Guillain Barre Syndrome. Discharged 4/4/2023.
Chest pain along with fluttering heart. Shortness or breath. Fever headache the second day.
immediate medication taste in mouth  about 5:35pm ,bilateral ears itching , burning, painful, skin sloughing 6:00PM,  9:00pm bilateral drainage noted to ears. 1/18/22 grapefruit size mass under left arm with pain and tenderness, chest rash and palms red and itch spastically
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to clinic reporting redness at injection site that developed within 12 hours of vaccination, lasted a few days, resolved, but over the past few days there is pain and the area is red again. Clinic documented a rash. Patient denies fever/chills and all vital signs within normal ranges. No streaking or swelling noted. Advised to take over the counter analgesics and antihistamines.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored GARDASIL lot # K009482, 06-MAR-2017. No adverse event was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse, concerning a 26 year old female patient with a low grade squamous intraepithelial lesion, cervical dysplasia and cervical intraepithelial neoplasia-1 (18-AUG-2006), who on 16-OCT-2006 was vaccinated with the first dose, 0.5ml, IM in the left arm, of Gardasil (Lot #654540/0800F). There was no concomitant medication. On 15-DEC-2006, at an office visit scheduled to determine if she was pregnant, the patient reported that she felt a small lump in her left breast that had been there since approximately 15-NOV-2006 ("approximately one month'). The nurse added that the patient was sent to the hospital for a pregnancy test, which was negative. On 09-JAN-2007, the patient had a mammogram of the left breast which recommended that she undergo a biopsy, and on 17-Jan-2007, an ultrasound guided core biopsy of the left breast was performed; on 19-Jan-2007, the biopsy result showed "invasive and intraductal breast carcinoma." On 20-Jan-2007 the patient was vaccinated with the second dose, 0.5 ml, IM in the left arm, of Gardasil (Lot #654540/0800F). On 21-MAR-2007, a repeat Pap smear result was positive for human papilloma virus, and the nurse added that the usual treatment to remove the abnormal cells with the loop electrosurgical excision procedure (LEEP), was not performed due to the patient's breast cancer diagnosis. The nurse stated that the patient was scheduled to be seen by 2 surgeons for consideration and opinions of a bilateral mastectomy, and indicated that the patient would undergo chemotherapy following the surgery. The reporter considered the patient's invasive and intraductal breast carcinoma and/or positive human papilloma virus results to be immediately life-threatening and an other significant medical event. Additional information has been requested.
One week after the shot, a rash appeared at the injection site. It is red and warm to the touch.
rash on both arms and the back of both of her legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on both arms and the back of both of her legs) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced RASH (rash on both arms and the back of both of her legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at an unspecified dose and frequency. At the time of the report, RASH (rash on both arms and the back of both of her legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication Benadryl
I had a big red raised circle (size of my palm) at the injection site for about 5 days. One week after the shot, I broke out in red itchy hives all over my body. Today is day six of hives. I have been using Benadryl every 6 hours to relieve the symptoms.
Pleuritic chest pain; pneumonia; Information has been received regarding a case in litigation, concerning a female (also reported as "his" (discrepant information)) patient of an unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. In or around 25-OCT-2017, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot #, expiration date, strength, dose, route of administration or anatomical location were not provided), as part of the routine health maintenance for prevention of shingles (herpes zoster). On an unspecified date, shortly after vaccination, she was hospitalized and diagnosed with pneumonia and pleuritic chest pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), she sustained severe and permanent personal injuries. Further as a tragic consequence she also suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the time of this report, the patient had not recovered from pneumonia or pleuritic chest pain. The events were related to zoster vaccine live (ZOSTAVAX). Upon internal review, the pneumonia was considered to be a medically significant event.
shot #1 on 2018, yet to receive #2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included vaccination with live shingles vaccine (Zostavax) in 2014 (received zostavax in 2014) and Shingrix (received 1st dose on 18th November 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 14th Apr 2022 Reporter's Comments: The case was reported by patient's husband. The patient received Shingrix shot 1 but had yet to receive Shingrix shot 2. The reporter did not have the lot number of the shot which was administered. The reporter provided limited information. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination. This case has been linked with case US2022065242 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022065242:Same reporter
Numbness sensation in left side neck and arm in nerve that runs across top of shoulder and down backside of left arm. Tingling sensation, numbness, and weakness had begun about a week after shot and has persisted still to this day 4 months later. It?s not getting worse nor is it getting better. Never experienced anything like this in 56 years of life
The day after the shot my neck and right shoulder were sore.  Three days later I was very tired.  Nine days later the shot site on my right arm swelled and was red and very itchy (I took pics).  I also had an itchy rash on the right side of my face and neck.
Warm, redness, swollen, itchy, near injection site, size of 2 quarters.
Patient has noticed soreness in the upper arm in which he received the vaccine. Soreness lasted longer than the expected time.
administered a 0.7 ml  Fluzone High Dose to 8 years old patient, no AE; administered a 0.7 ml  Fluzone High Dose to 8 years old patient, no AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from the nurse via phone.  This case is linked to case 2020SA242573 (same reporter).  This case involves an eight-years-old female patient who was vaccinated with a 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (prefilled syringe, lot UJ450AB and expiration date 30-Jun-2021) via an intramuscular route in the left deltoid on 01-Sep-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient did not received any other vaccine concomitantly.    It was an actual medication error case due to inappropriate age at vaccine administration and overdose (latency was same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
herpes outbreak; This case was reported by a consumer via call center representative and described the occurrence of herpes zoster in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced herpes zoster. On an unknown date, the outcome of the herpes zoster was unknown.   It was unknown if the reporter considered the herpes zoster to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient experienced herpes zoster after receiving 1st dose of Shingrix.
It began with a mild rash on the belly and neck and a low grade fever (100 F). I treated the fever with Tylenol, but it did not go away. I put the patient down for a nap and he woke up about 2 hours later. His fever was up to 102 F and I gave ibuprofen. I alternated the Tylenol and ibuprofen every 3 hours. The fever kept rising and leveled off at 102.8F. I put the patient to bed at 7:45 PM. He woke up screaming at 2AM and was burning up to the touch. I treated with Tylenol and then checked the temp at 2:15 AM. The thermometer read "High" and he began jerking and having a febrile seizure. I took him to the ER at this point. He had another small seizure. The fever eventually broke with the Tylenol at 5:00 AM. He stopped having fevers on 04/10/2010 at 4:30 PM. The rash went away early morning on 04/12/2010.
Swollen arm, shoulder, collar bone area with decreased range of motion. Hardened skin, warm-to-touch. Patient reports a "hard pad" 3-4 inches deep in skin that can be manipulated/moved. Antibiotics used for presumed skin infection.
45 y/o FEMALE WHO REFERED NAUSEAS AFTER COVID VACCINATION 30 MINUTES BEFORE. B/P 144/87, SAT 100%, RESP FRE. 16 PER MINUTE. PATIENT WAS DICHARGE HOME AT 2:40 PM SAME DAY. FOLLOW UP WITH PRIMARY CARE MD PATIENT STATED SHE WAS FEELING WELL N O NAUSEAS AT TIME OF DISCHARGE.
Patient received the second dose on day 23; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose on day 23) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1412B) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose on day 23) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose on day 23) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose on day 23).    Concomitant drugs were not reported. It was reported that first and second dose had the same Lot numbers. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-643385 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-643385:(Case For WB Patient)
Wound Infection     cellulitus on the leg, failed outpatient treatment both         HPI:   This is a 69y.o. female with a past medical hx of cellulitis, HTN, DM, CAD who presented to the ED with complaints of pain and wound infection. Per chart review patient was undergoing treatment with clindamycin and doxycycline. Patient also complained of bilateral lower extremity swelling. Bilateral lower extremity doppler revealed a DVT f right femoral vein. No evidence of DVT in Left lower extremity. Patient was placed on a heparin infusion and placed on vancomycin for lower extremity cellulitis. Patient seen and examined, eating breakfast, states she is doing fine. No CP, N/V/D.