chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately after receiving first shot, I became light headed and developed a headache.   Within 2.5 hours, I began to develop itching and hives on my face and neck and within 24 hours they were also covering the trunk of my body.    Within three days they began to recede (treated with Zyrtec).  Roughly 13 days after the shot, I began to develop hives and itching again but this time over my entire body.    Began treating with Benadryl cream, Benadryl anti-itch spray, Zyrtec and by day 17 my hives had gone down by itching remained.     Going on day 21 and itching remains and gets worse depending on what I eat, what medications I take.   I now seem to be reacting as though I'm having an allergic reaction to (Gabapentin and Klonopin) and liquid and pill form Benadryl are making me itch.     All began immediately after shot - no issues before.
7/27/04 5 days post inoculation w/ 3 pokes of vaccinia c/o headache, body aches, fever, decreased appetite, rhinits, sore throat, and midsternal pressure. 8/8/04 17 days post inoculation c/o severe headache, chills, nausea, emesis. Lumbar puncture was done. Meningitis was ruled out, pt. was sent home with pain medication for atypical headache. 8/11/04 20 days post inoculation saw private health care provider for persistent nausea, given prescription for phenergan.
Information has been received from a nurse concerning a female (age not reported) with a history of stomach virus earlier in the week who on an unspecified date was vaccinated with the first dose of Gardasil. Immediately after receiving the first dose of vaccine, the patient became dizzy, light headed, and had nausea. The patient did not eat breakfast the morning prior to be vaccinated. Medical attention was sought. On an unspecified date, the patient recovered. No further information is available.
atrial fibrillation; itching on right scapula, intense incredible itching, whole body itching; face was flushed; led to intense red marks; Scratching would make blood vessels burst underneath; swollen armpits; Chills; big rash all over body; low grade fever of 99.1F; Itching on left scapula; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Drug allergy (Augmentin and Demerol). Concurrent medical conditions included Allergy (banana and plantain). Concomitant products included AMLODIPINE, EZETIMIBE (ZETIA), ATORVASTATIN CALCIUM (LIPITOR), NEBIVOLOL HYDROCHLORIDE (BISTOLIC), ACETYLSALICYLIC ACID (BABY ASPIRIN), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN 2000), CENTRUM SILVER +50 and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication.    On 22-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 PRURITUS (Itching on left scapula). On 31-Jan-2021, the patient experienced PRURITUS (itching on right scapula, intense incredible itching, whole body itching), FLUSHING (face was flushed), RASH ERYTHEMATOUS (led to intense red marks), SCRATCH (Scratching would make blood vessels burst underneath), SWELLING (swollen armpits), CHILLS (Chills), RASH (big rash all over body) and PYREXIA (low grade fever of 99.1F). On 13-Feb-2021, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria hospitalization, disability and life threatening). The patient was hospitalized on 13-Feb-2021 due to ATRIAL FIBRILLATION. At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation), PRURITUS (itching on right scapula, intense incredible itching, whole body itching), FLUSHING (face was flushed), RASH ERYTHEMATOUS (led to intense red marks), PRURITUS (Itching on left scapula), SCRATCH (Scratching would make blood vessels burst underneath), SWELLING (swollen armpits), CHILLS (Chills), RASH (big rash all over body) and PYREXIA (low grade fever of 99.1F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included Diphenhydramine, Cetirizine, OTC Cortisone cream, Methylprednisolone.  Company Comment - Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No specific follow-up information recorded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
approx 8 hrs following vax pt devel pain, massive swelling site of inj;fever x 1 day;pain & swelling worsened;tingling fingertips, burning up arm
Injection site redness; INjection site itchiness; Injection site warmth; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE PRURITUS (INjection site itchiness) and INJECTION SITE WARMTH (Injection site warmth) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 INFLUENZA LIKE ILLNESS (Flu like symptoms). On 15-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE PRURITUS (INjection site itchiness) and INJECTION SITE WARMTH (Injection site warmth). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE PRURITUS (INjection site itchiness) and INJECTION SITE WARMTH (Injection site warmth) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
12/13 Pt had large knot at injection site - then developed shingles on side of face days later. 12/10 - swelling, heated, knot at injection site.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose02/11/21 2nd dose03/04/21 Diagnosed covid positive:08/29/21 Symptom onset:08/28/21 Exposure:community Symptoms:fever, cough, loss of taste, diarrhea,HA
Narrative: Acute severe allergic reaction with angioedema of the tongue post moderna vaccine. " NO n/v/d/constipation/chest pain/dyspnea/wheezing/other swelling. no uri sxs/bleed. no dizziness/loc or other focal neuro sxs" Patient declined hospital admission. On 10/17/21 patient started" the angioedema has continued-however not worsening, but experiencing eye swelling. She admits to taking benadryl"
Superficial blood clot on left calf at the lower end of some varicose veins two days after injection; Superficial blood clot on left calf at the lower end of some varicose veins two days after injection; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6207), via an unspecified route of administration in right arm on 10Mar2021 14:30 (at the age of 62-years-old) as single dose for covid-19 immunisation. The vaccine facility type was a pharmacy or drug store. The patient had no other vaccine in four weeks. The patient did not have Covid prior vaccination and was not Covid tested post vaccination. Medical history included macular. Concomitant medication included amitriptyline. The patient previously took erythromycin and statins and experienced drug allergies from these. The reported adverse events were superficial blood clot on left calf at the lower end of some varicose veins two days after injection (on 12Mar2021 at 10:00). It may be unrelated, but the patient wanted to let know. The events resulted in emergency room/department or urgent care. AE treatment included hot compress, support stockings and ibuprofen (MOTRIN). The outcome of the events was recovering.; Sender's Comments: Varicose veins most probably was a preexisting condition, unrelated to BNT162B2 vaccine. The reported superficial blood clots are considered a complication of varicose vein and unlikely related to BNT162B2.
Pt exp an allergic rxn p/receiving flu vax; addtl info has been requested;
Received Tdap shot on 06/17 around 7pm. She felt tingling sensation on her left arm starting on following Sunday (06/19). She felt pressures on her left eye, had a difficulty blinking, along with facial swelling on  Wednesday (06/22)
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. Approximately in 2015 (reported as "in June into July"), unspecified number of patients received unspecified doses of VAQTA (dose, route of administration, lot # and expiry date were not provided) that were improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
09/21/22 presents to ED for "lethargy". PMHx of "HTN, HLD, PE on Eliquis, dementia"
Developed hives with raised bumps that itched. Used topical cream that helped some. The itching subsided overnight but sometimes returned the next evening.  Also, the hives presented themselves on different parts of body. Some days I had no hives but the they returned another day. Contacted doctors office. They prescribed over the counter Benadryl.
Information has been received from a physician concerning a 70 year old female with penicillin allergy and sulfonamide allergy, hypertension, hypothyroidism, osteoporosis and dyslipidaemia who on 29-JUL-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (Lot # 656394/0162U), SC, 0.5 mL, into the left deltoid. On 02-AUG-2008, the patient experienced herpes zoster. The patient was examined in the office and found to have vesicular rash in the right T1-T2 distribution, with 5 - 6 lesions extending from the right breast around to the right mid-back. The patient was prescribed topical ZOVIRAX cream. As of 06-AUG-2008 herpes zoster persisted. The physician has taken isolates from the lesions and is interested in the VZVID program. The patient was enrolled in the Varicella Zoster Virus Identification Program to Identify if VSV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the OKA/MERCK vaccine VZV strain. The sample of the lesion was collected on 06-AUG-2008. The sample was taken from a papulo vascular lesion in the T1-T2 dermatone. The PCR results for the specimen from a papulo vascular lesion in the T1-T2 dermatone, identified the presence of VZV WILD TYPE STRAIN. Telephone follow-up information was received which reported that the patient's lesions were healing and she was having a lot of pain. The patient was started on LYRICA for pain and ZOVIRAX cream. The physician waited for culture results prior to treating the patient and missed treated her with VALTREX. On 19-AUG-2008, another telephone follow-up was received which reported that the positive results for VZV WILD TYPE STRAIN made sense since the patient informed that she was exposed to shingles prior to vaccination and that was the reason she was vaccinated with ZOSTAVAX (Oka/Merck). The patient was doing better. No further information is available.
On Friday (10/1/21) Wife called the pharmacy regarding her husband's post vaccine status that he received on 4/30/21. Wife claimed that her husband has experienced pain and inflammation since receiving the vaccine, he has lost range of motion and has not been able to work since April. Wife claimed that the vaccine was administered higher than it was supposed to Wife wanted to know what can be done about the situation and inquired about the name of the vaccinator. I asked Wife if her husband sought medical advice regarding the reaction and what the outcome was Wife stated that her Dr. was not any help and advised to get the 2nd dose on the opposite arm. Wife requested to speak to the pharmacy manager and what can be done regarding the situation. I told Wife that I will speak to my advisors and that we will get back to her within a week. I will proceed to fill out an incident/VAERS report. If you have any questions please feel free to contact me.
No adverse effects reported; 6-month old patient inadvertently received one dose of VARIVAX subcutaneously in the right thigh; This spontaneous report was received from a nurse and refers to a 6-month-old patient of unknown gender. There was no information regarding patient's pertinent medical history, drug reactions, allergies and concomitant therapies provided. On 27-JUN-2019, the patient inadvertently received one dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously in the right tight, lot # R030606, expiration date 23-OCT-2020 (exact dose was not reported) for prophylaxis. No adverse event was reported.  The reporter informed that she submitted this information to the Vaccine Adverse Event Reporting System (VAERS).
Narrative:  Patient is a 73 year old male who received the Shingrix vaccine on  11/18/2020 and developed an itchy rash 2 days after that has not gone away. He  was prescribed a medrol dose pack, hydroxyzine prn and triamcinolone cream prn  and the rash cleared up. He was instructed to not receive the second dose of the  Shingrix vaccine.
I had both shingles shots & still got them. It was a very mild case/Suspected vaccination failure; Still got them. It was a very mild case / Dr. Said it was probably from stress; Felt like I had a sunburn on my back; Itched; This case was reported by a consumer via media and described the occurrence of suspected 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 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, sunburn-like rash and pruritus. On an unknown date, the outcome of the vaccination failure, shingles, sunburn-like rash and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, sunburn-like rash and pruritus to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had both the Shingles shots and still got the shingles, it was a very mild case. It felt like the patient had the sunburn on his/her back and itched. The physician said that it was probably from the stress and that was last year during Covid. This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Client received vaccine without incident (no crying or flinching).  Called at 1107 from parking lot for help to call 911 nurse x2 to client: 911 called.  Client had urinated & was a/o x3 very pale.  States felt dizzy.  Mom said she helped her down to ground (no hitting of head), eyes rolled back in head & had a seizure.  Mom states never had before.  Hand grasps weak but equal.  Moving toes equally, tongue out equally able to touch fingers to nose.  Fire arrive.  Information given.  Client transported by ambulance to hospital.  Mom asked by writer to call with outcome.  No slurred speech no diaphoresis.  No breakfast.  1200 8-7-08 P.C. clients HCP states surprised no postictal state.  Will send for neurology consult.
No adverse event; Bivalent was not properly administered and slipped down the patient's arm; Accidental underdose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Bivalent was not properly administered and slipped down the patient's arm), ACCIDENTAL UNDERDOSE (Accidental underdose) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Oct-2022, the patient experienced PRODUCT ADMINISTRATION ERROR (Bivalent was not properly administered and slipped down the patient's arm) and ACCIDENTAL UNDERDOSE (Accidental underdose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (Bivalent was not properly administered and slipped down the patient's arm), ACCIDENTAL UNDERDOSE (Accidental underdose) 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 NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT ADMINISTRATION ERROR (Bivalent was not properly administered and slipped down the patient's arm) and ACCIDENTAL UNDERDOSE (Accidental underdose).    No concomitant medication information was provided.  No treatment medication was provided.
administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 details were provided as follows: The age at vaccination was not reported. Office supervisor reporting had administered vaccine after temperature excursion outside of stability data, which led to incorrect storage of drug. Caller unable to provide any adverse event details, other than administration date. Health care professional stated that  she would have those available at a later date through their risk management process. The reporter consented to follow up.
pt recv vax 14JUN95 & devel swelling, redness & minor tenderness @ inj site;pt spent the day in sun @ beach on 16JUN95; swelling, redness & tenderness persisted;
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # reported as "L011846" exp. date "16-JUN-2017", (route and dose were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
9/6/12 - Phone reporting that inj. site had redness & swelling since inj. 9-7-12 - Phone call to patient - report golf ball size swelling that was now improving.
tongue numb/tingling, "medicine head", HA. Evaluated by EMS-Cleared
Information has been received from a certified medical assistant concerning an approximately 75 year old female consumer who on 06-JUL-2007 was vaccinated with 0.65mL of zoster vaccine live (Oka/Merck) (lot # 657765/0585U). Concomitant therapy included ALLEGRA, aspirin, FLONASE, and METROGEL. It was reported that in April 2008, the patient felt a shocking and burning pain under her left breast. The pain continued and developed into shingles lesions within two weeks. Unspecified medical attention was sought and it was unspecified if lab studies were performed. The patient was treated with NEURONTIN. At the time of the report the patient was recovering. There was no product quality complaint involved. Follow-up information has been received from the physician concerning this 75 year old female consumer with no known allergies and a history of chickenpox years ago who on 06-JUL-2007 was vaccinated in the left arm with 0.65 mL of zoster vaccine live (Oka/Merck) (lot # 657765/0585U). Concomitant therapy included ALLEGRA, aspirin, FLONASE, and minocycline. Subsequently, on 08-MAY-2008 the patient developed left sided chest pain and clusters of vesicles on the left side of her chest and back. The patient did not developed a rash at the site of injection or elsewhere within 42 days of vaccination. The patient's temperature was 98.3. It was noted that there was no recent exposure to chickenpox or herpes zoster. The physician also reported that the patient's treatment was changed from NEURONTIN to LYRICA. The patient recovered on an unspecified date. Additional information is not expected.
first dose was administered on 5-AUG-2022/ inadvertently received an early dose of Shingrix today 26-AUG-2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number P7k5p, expiry date 10th September 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 26th August 2022, the patient received the 2nd dose of Shingrix. On 26th August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 26-Aug-2022 Reporter's comment: The pharmacist stated that the patient inadvertently received an early dose of Shingrix today on 26th August 2022.  The first dose was administered on 05th August 2022.  The patient was not immunocompromised. The consent to follow up was granted. The Healthcare professional stated that follow-up via email was okay. Additional supportive information: The patient received the 2nd dose earlier than the recommended interval, which led to shortening of vaccination schedule.
PATIENT CAME INTO CLINIC WITH RASH COVERING SCALP, BACK OF EARS, NECK AND TRUNK AREA. RASH STARTED BEHIND EARS YESTERDAY AND HAS SINCE SPREAD. PT HAS HAD 102-103 FEVER. VERY FUSSY AND HAS BEEN SLEEPING ALOT. (ALSO WAS DIAGNOSED WITH LEFT ACUTE OTITIS MEDIA.)
After the first one I had slight thinning, I didn't think anything of it. After the second shot I was in the shower and clumps of my hair were falling out like crazy and from there I started seeing the doctor an dermatologist. My feet then started to go numb the feeling was completely gone. I have had problems walking ever since. The dermatologist had me try Rogaine for men, collagen, biotin, then they were gonna do injections but I refused It took about 7 months for my hair to grow back. My feet took about a year to get feeling back and they are still tingling until this day.