chrisvoncsefalvay/vaers-outcomes huggingface dataset:
skin rash / skin reaction / body rash that covered her stomach and chest. / looked like a bad case of measles; irritation / skin reaction; like a bad case of measles; uncomfortable; pain, swelling, and redness at the injection site; swelling, and redness at the injection site; redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of rash in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included stiff joint and drug allergy (prior history of allergic reaction to Clopidogrel). Previously administered products included Shingrix with an associated reaction of injection site pain (please refer the 1st dose case US2020AMR160862).   On 7th August 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 9th August 2020, 2 days after receiving Shingrix, the patient experienced rash, skin irritation, measles-like rash and discomfort. In August 2020, the patient experienced injection site pain, injection site swelling and injection site erythema. The patient was treated with benadryl (nos) (Benadryl). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the rash, skin irritation, measles-like rash and discomfort were recovering/resolving and the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the rash, skin irritation, injection site pain, injection site swelling, injection site erythema, measles-like rash and discomfort to be related to Shingrix.  Additional details were provided as follows: The patient had arthrosclerosis, prior history of allergic reaction to clopidogrel.  The patient stated she was on clopidogrel for a blood clot about 2 to 3 years ago and after about 6 months using it she developed a body rash. On 7th August 2020, the patient received the 2nd dose of Shingrix in the left arm. The patient experienced pain, swelling, and redness at the injection site. On 9th August 2020, the patient got a body rash that covered her stomach and chest. She said it looked like a bad case of measles.  The patient said she called the Medicine Doctor and they told her to take Benadryl. She says the rash was  uncomfortable because she lives in where there was a lot of heat. The rash was improving. She stated that rash was now only slightly visible and was not painful.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR160862:2nd dose
This was second dose. I experienced pain in arm, fatigue and muscle aches. The first dose from two to three months earlier was much worse. I experienced flu like symptoms (fatigue, fever, muscles aches and a a very sore arm). The symptoms for both doses lasted about 2-3 days.
This spontaneous report was received from a licensed practical nurse regarding a 1 year old male patient with no pertinent medical history reported. On 29-MAY-2013 the patient was vaccinate with PROQUAD (Merck) (lot number J000198, expiration date 08-JUL-2014) (0.5ml, subcutaneous). Other suspect therapies included the first scheduled dose of VARIVAX (Merck) (lot number and expiration date not reported) (dose and route not reported). No concomitant medications were reported. The licensed practical nurse reported that the patient received his first scheduled dose of VARIVAX (Merck) and then received a dose of PROQUAD (Merck) on the same day. No adverse effects were reported at this time. Additional information has been requested.
On 05/13/21 presents to the ER by EMS, reported bilateral flank pain since this morning with no other symptoms. The patient has a past history of mild dementia, hypertension, hyperlipidemia, known left bundle branch block; 5/17/21 D/C'd Home with Home Care services.
Rash at injection site; Redness at injection site; Pregnant; Soreness at injeciton site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness at injeciton site), INJECTION SITE RASH (Rash at injection site), INJECTION SITE ERYTHEMA (Redness at injection site) and EXPOSURE DURING PREGNANCY (Pregnant) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Sep-2020 and the estimated date of delivery was 12-Jun-2021. In October 2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 12-Feb-2021, the patient experienced INJECTION SITE PAIN (Soreness at injeciton site). On 19-Feb-2021, the patient experienced INJECTION SITE RASH (Rash at injection site) and INJECTION SITE ERYTHEMA (Redness at injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. In October 2020, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, INJECTION SITE PAIN (Soreness at injeciton site), INJECTION SITE RASH (Rash at injection site) and INJECTION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 04-AUG-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (dose and route were unknown, lot # L044694, expiration date 04-FEB-2018), which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Date given was 1st vaccination, second was 1/22/21. I have no indication that the event was vaccination related, but am reporting it to allow statistical analysis of possible adverse effects.   On 7/5 I experienced a seizure with LOC for an extended period of time (45 min?). Treated by EMS, ER, and CAT scan and MRI. No cause identified. No previous or subsequent similar events.
Approximately two weeks after vaccination rapid development of Dementia, literally from Saturday evening to Sunday morning.; This is a spontaneous report from a contactable consumer (patient herself). A 96-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in right arm on 14Feb2021 13:15 as dose 1, single (at the age of 96-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. Patient had been tested for COVID-19, since the vaccination using the nasal swab test with results as unknown on an unspecified date in 2021. Patient medical history included moderate dementia. Patient did had no known allergies. The concomitant medications were not reported. On 28Feb2021, approximately two weeks after vaccination patient developed rapidly Dementia, from Saturday (27Feb2021) evening to Sunday (28Feb2021) morning. The adverse events resulted in emergency room/department or urgent care, hospitalization (for a period of 2 days) and disability or permanent damage (as reported). The treatment received for the adverse events included supportive care. The outcome of the event was not recovered.   Information on Lot/Batch number has been requested.
Three days after the vaccination I started having severe nightmares and vivid violent dreams that prevent me from sleeping. They happen 5-6 times a night and each time my body experiences an Adrenaline rush. I jump from my sleep with high pulse and elevated blood pressure. It subsides quickly after I am awake. But then after I fall back to sleep and within one hour, the event repeats. I wake up again and again. The sleep has become very light and filled with violent dreams that I can remember vividly.
itchy; It is somewhat hard; eight days after the vaccine, I developed a red area around the point of the inoculation; rash-like texture; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE ERYTHEMA (eight days after the vaccine, I developed a red area around the point of the inoculation), VACCINATION SITE INDURATION (It is somewhat hard), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE RASH (rash-like texture) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (eight days after the vaccine, I developed a red area around the point of the inoculation), VACCINATION SITE INDURATION (It is somewhat hard), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE RASH (rash-like texture). At the time of the report, VACCINATION SITE ERYTHEMA (eight days after the vaccine, I developed a red area around the point of the inoculation), VACCINATION SITE INDURATION (It is somewhat hard), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE RASH (rash-like texture) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Since the vaccine I have found odd lumps on my scalp, jawline, wrist and mouth.  I went on April 5, 2021.  I spoke with the Dr. about the lumps and was told to watch them to see if anything changes.  The lumps on my scalp and jawline do not hurt but the lumps in my mouth and on my wrist do.
On 10/30/13 two days after administration patient presented with large, red, warm circle at site of injection. Advised ice, Ibuprofen and BENADRYL and follow up.
Narrative: Patient reports having a blood clot after his second moderna vaccine. Patient reports current stable condition and that he had an unknown history at the time of vaccination. His brother is deceased related to blood clot and he had DNA testing performed that revealed he has the associated risks. This event was not observed and only reported by writer via phone encounter. Vaccination was received at an outside facility.
8-10 minutes after I received the vaccine I felt a warm sensation on my throat and chest and after that my heart rate went up to 148-150. This heart rate lasted for about  7-10 m and then started to slow down . After 1 hr my heart rate was 110 and remained like that until next day . When I woke up next day it was back to normal.
Area where shot was given was warm, swollen, red and a little itchy. New rash appeared on her back.
Subjective history of arm swelling at injection site, erythema, malaise and headache started the afternoon he received the injection
ADVERSE EVENT REPORTED ON 4/29/14. PATIENT COMPLAINED OF PAIN/SORENESS AT INJECTION SITE EVER SINCE RECEIVING INJECTION 6 MONTHS PRIOR.
The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022; The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 037F, 029A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator on 11-Jan-2022. The vial did not undergo any temperature excursions. No patient has reported adverse reaction.  No treatment medications were reported.
Patient presented with abdominal pain and diagnosed with acute appendicitis, but CT scan showed incidental inferior vena caval thrombosis extending from iliac veins to IVC at level of liver.
Teary left eye, dripping left nostril, then drooling out of left side of mouth when eating, numbness entire left side of face down to chest including throat and neck. Eye does not close. Mouth when smiling droop on left side - can't smile, can't pronounce words with P or B- can't form whistle type mouth. Had flu injection Sat. afternoon and Mon afternoon developed symptoms. First thought could then when couldnt eat dinner without drooling and numbness, went to E.R. Had CT scan, various blood tests until l0:30 that night, and they thought it was Bells Palsy but could not be sure positively if it was a stroke.  I was referred me to my internist where I went Tues morning. He would like to do an MRI to completly rule out stroke but I said to wait. Meanwhile I am taking prednisone 20 mg. 4 for three days, 3 for three days, 2 for two days and l for one day along with Valtrex 1 gram 2 x a day for 7 days along with various eye ointments to keep my left eye lubricated (as it is blood red and hurts) along with wearing a patch.  Do not know at this time how much, if any, permanent damage this shall leave me with nor how long this shall continue with my entire left eye, head, face and neck and throat being numb.
Patient waited 15 minutes and then left the store. about 30 minutes later the patient called the pharmacy stating her tongue started to tingle and her face was starting to swell.
Headache, Myalgia, Fever, Asthma exacerbation Narrative:
About an hour after receiving the vaccine, my head and face felt tingly and my cheeks felt like they were on fire, I was having to concentrate on what I wanted to say. I felt really drunk. I went back up to the vaccine clinic and the Pharmacist and RN  took my vitals and sat me down. My blood pressure was high. After 15 minutes of sitting in a chair they took my vitals again and had me lay down in a bed with my feet up in hopes of making my blood pressure go down. After about 45 minutes my blood pressure started to go down. After about an hour and a half my head started to clear, but I had developed hives on my face and chest. The pharmacist gave me liquid Benadryl and then monitored me for another half hour. Once my hives started to look better they sent me home, where I slept for the rest of the day.  2/4/21 the next day I woke up with a headache but otherwise felt ok until about 3:00pm when I developed body aches, chills and a fever of 100.8. I took some tylonal and rested  until bed time. When I got up the next morning I felt alright. Just a mild headache.
Patient had a series of 4 smaller seizures, each lasting a few seconds over the course of several minutes. Ambulance was contacted and patient was taken to hospital within roughly 10 minutes of incident.
5 days after vaccine developed red raised area approximately 2" diameter. Reported itching, could feel a bump. Waited 2 days, wanted to be checked. States it is getting better, no longer itching, redness decreasing.
MS relapse; Based on the current case data, this case has been classified as invalid. This literature-study case was reported in a literature article and describes the occurrence of RELAPSING-REMITTING MULTIPLE SCLEROSIS (MS relapse) in subject of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: diagnosed with CIS or RRMS with initial clinical relapse less than 2 weeks after a COVID 19 mRNA vaccine. Mult Scler.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RELAPSING-REMITTING MULTIPLE SCLEROSIS (MS relapse) (seriousness criterion medically significant). At the time of the report, RELAPSING-REMITTING MULTIPLE SCLEROSIS (MS relapse) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered RELAPSING-REMITTING MULTIPLE SCLEROSIS (MS relapse) to be possibly related.    No concomitant information were reported.  Treatment information was not provided.  Company Comment: This case concerns a patient of unknown gender and age with no details on relevant medical history, who experienced the unexpected serious event/AESI of Relapsing-remitting multiple sclerosis after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). The event occurred less than two weeks after the first dose of mRNA- 1273 vaccine. Very limited information is available at this moment. The rechallenge is not applicable since only information about the first dose was disclosed.  The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report; Sender's Comments: This case concerns a patient of unknown gender and age with no details on relevant medical history, who experienced the unexpected serious event/AESI of Relapsing-remitting multiple sclerosis after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). The event occurred less than two weeks after the first dose of mRNA- 1273 vaccine. Very limited information is available at this moment. The rechallenge is not applicable since only information about the first dose was disclosed.  The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report
local DTP reaction red, swolled & tender to touch about 2" circumference systemic reaction fever x 2 days 11SEP92 & 12SEP92;
fever, chills , headache, t 101.7  , body aches recommended OTC ibuprofen or apap for symptoms
ZOSTAVAX given 6/21/11, pt returned 6/29/11 with pruritic rash on (R) side of neck consistent with shingles. Still had local reaction on (R) arm with redness slight pain, (-) swelling.
Chickenpox like spots "all over" about 1 week after Varicella vaccine with irritability and low grade fever.
Bell's Palsy dx 10/23/07 Tx aphtheus stomatitis 10/14/07.  10/29/2007 ER record received for DOS 10/23/07 for DX:  L Seventh Nerve Palsy.  Bells Palsy suspected.  Lyme Disease manifestation not excluded.  Pt presented with L sided facial droop, numbness and inability to close L eye. Recently seen for infection/apthous stomatitis.
Immunized 11 patients with expired flu vaccine/no AE; Initial information was received on 02-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/ non-health professional via email.  This case involves 11 patients (unknown age and gender) who were vaccinated with an expired dose of INFLUENZA VACCINE (batch number and expiry date not reported) via an unknown route at an unknown administration site on an unknown date for prophylactic vaccination (expired product administered).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of an actual medication error due to expired vaccine used (latency was on same day at the time of vaccination).  At the time of reporting, patients had not experienced adverse event.  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.  There will be no information available on batch number for this case.
Client presented to the vaccination site on 11/30/21. The client received 1st dose AstraZeneca COVID vaccine on 12/30/2021 and 2nd dose AztraZeneca COVID vaccine on 01/27/2021. Client reported no reaction to the vaccine and requested Janssen booster COVID vaccine for travel and work purposes. RN submitted a medical consult via text message to Vaccine Operations Lead requesting to proceed with the COVID vaccine Janssen booster. , RN elevated request to MD who gave approval for client to receive the Janssen booster COVID vaccine. Client received Janssen vaccine (lot# 1855191) on 11/30/2021 at approximately 1115 in the L deltoid. No reaction was observed while client was in observation
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 30.7F for 3 hours and 30 minutes and in 57.9F for 11 hours and 45 minutes) doses of PNEUMOVAX23 (lot # L018503, expiration date 16-MAR-2017; dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. The call was made because of the data logger. This is one of two reports received from the same reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA009265: MERCK 1610USA010825: Mfr number.
around 45 minutes after vaccine was administered, my tongue got swollen and felt fat and fuzzy. Headache and chills immediately followed (all within 1 hour of injection). I took a lot of Benadryl , and Tylenol, Swelling went down and still felt fatigued for 3-4 days following.
Joints do not bend well (joint disorder nos). Muscle soreness. Sixteen days post vax, pt experienced muscle soreness in legs. Additionally he found it difficult to bend his ankles, shoulders, and finger joints. He was treated with aspirin. He reported that symptoms were gone within the next week and he was back to normal again. Most recent information received on 11/30/99 reports the condition is resolved.