chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sweaty around the neck; Feels like hot flashes; Feels like being clammy; Itchy on left upper arm; Red on left upper arm; Fever 101F; Flu like symptoms; Chills; Achy; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), PAIN (Achy), PYREXIA (Fever 101F) and HYPERHIDROSIS (Sweaty around the neck) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039BZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Positive Covid-19 antibodies) in October 2020. Concomitant products included VALSARTAN for Blood pressure, VITAMIN D3 for Vitamin D supplementation, VITAMIN B COMPLEX, ZINC and ASCORBIC ACID, BIOFLAVONOIDS NOS (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS]) for Vitamin supplementation, UBIDECARENONE (CO-ENZYME Q10) for an unknown indication.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and PAIN (Achy). On 20-Apr-2021, the patient experienced PYREXIA (Fever 101F). On 23-Apr-2021, the patient experienced HYPERHIDROSIS (Sweaty around the neck), HOT FLUSH (Feels like hot flashes), COLD SWEAT (Feels like being clammy), INJECTION SITE PRURITUS (Itchy on left upper arm) and INJECTION SITE ERYTHEMA (Red on left upper arm). On 20-Apr-2021, PYREXIA (Fever 101F) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), PAIN (Achy), HYPERHIDROSIS (Sweaty around the neck), HOT FLUSH (Feels like hot flashes), COLD SWEAT (Feels like being clammy), INJECTION SITE PRURITUS (Itchy on left upper arm) and INJECTION SITE ERYTHEMA (Red on left upper arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 19-April-2021 patient used Acetaminophen 2 tablets for fever.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: No specific follow-up information recorded.
shortness of breath, wheezing, phlegm, nasal congestion  Rash (vesicular) right groin
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant use were reported No Treatment were reported
Abnormal, severe facial acne, bodyaches,  chills, local and general muscle soreness, fatigue, swallowing difficulty, >100F fever;
Day 1 - significant arm soreness, dizzy, chills, body aches. Day 2 - same and chest pain
Severe abdominal pain .. emergency room...morphine..CT scan...diagnosis Diverticulitis..admitted to hospital given Flagyl (adverse reaction)...second vaccine same situation severe abdominal pain...diverticulitis again..CT scan entered hospital... four days..augmenton given... taken two months to get to feeling better...because IBS...also a problem.
No additional adverse effect.; the patient ws inadvertently administered a dose of VARIVAX on 12/4/2019, that had been improperly stored.; This spontaneous report was received from an immunization coordinator referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent.  Information about pertinent medical history, drug reactions or allergies was not provided.     On 04-DEC-2019, the patient was inadvertently vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S020464, expiration date 02-JUL-2021, dosage detail, route and strength was not provided) for prophylaxis.  The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent.  Administered doses of vaccine experienced temperature excursion of -2.1 degrees Celsius (C) for 4 hours 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Information has been received from a health professional concerning a 19 month old female with no known medical history or allergies who on 3/1/04 was vaccinated with a dose of varicella virus vaccine live (lot # 644796/0336N). Concomitant therapy included MMR. Subsequently on 10/15/04 the patient developed chicken pox which included 72 lesions. It was reported that she was afebrile, irritable and had a runny nose. Unspecified medical attention was sought. Calamine lotion and ibuprofen were prescribed. There was no product quality complaint involved. Additional information has been requested.
1st dose on May-2019, 2nd dose not administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in May 2019 with expiration date 31st May 2020).   On an unknown date, the patient did not receive 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: 07-SEP-2022 Reporter's comment: The reporter asked if patient could receive second dose or needs to start over vaccination. Pharmacist did not provide lot number of vaccine as well as exact date of administration of the first dose of Shingrix. Details were reported for 1st dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine was given "Beyond Use Date" of 6/19/23.  Not expired.  Healthcare provider informed. Moderna contacted and assessed vaccine to be viable.  No known health complications.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 05-NOV-2015. the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K024036 exp date 26-NOV-2016)(dose and route not reported). The temperature excursion was 53.8 F for 10/75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Itchy and red approximately 2-3 inch spot on injection site noted on 2/28/2021 around 4a.m.  Applied hydrocortisone cream and ice intermittently during the day.  No itching morning of 3/1/2021; redness same as previous day.
3 minutes after receiving vaccine patient had seizures lasted 4-5 seconds. Paramedics called checked patient but patient refused transfer to ER. Said that will be taken later by family member.
About 28 hours after the second shot I experienced fatigue and rapidly changing heart rate. My blood pressure also increases. About 36 hours after the shot I went to the hospital emergency room with a blood pressure reading of 191/90.  Today, March 9th, I am still experiencing  swings in heart rate.
Randomly rapid heart rate for which she hasn't been able to assign a pattern; Constant chest pressure; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Randomly rapid heart rate for which she hasn't been able to assign a pattern) and CHEST DISCOMFORT (Constant chest pressure) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced TACHYCARDIA (Randomly rapid heart rate for which she hasn't been able to assign a pattern) and CHEST DISCOMFORT (Constant chest pressure). At the time of the report, TACHYCARDIA (Randomly rapid heart rate for which she hasn't been able to assign a pattern) and CHEST DISCOMFORT (Constant chest pressure) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were reported.  The patient had ECG that came back normal and did not determine a cause.   Cardiac related signs and symptoms: randomly rapid heart rate for which she hasn't been able to assign a pattern and constant chest pressure
Fever, joint and muscle pain, swelling and redness at injection site began 24 hours after injection.  Arm increasingly red, inflamed and hot to touch at 72 hours post injection.
Vaso vagal syncopy symptoms developed while sleeping. Brief shallow breathing, not responsive to verbal questions for 2-3 minutes. History of Vaso vagal responses to shots as child, but not for past 20 years. Symptoms this evening were consistent with experience as a child .
1/31/2023 tested in the morning on an at home COVID-19 test, positive. Very mild cold symptoms. Televisit with doctor, who proscribed PAXLOVID. Symptoms lasted maybe 3 days with very mild cold symptoms.
Covid-19; Covid-19; 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), in May2021 as dose 1, single (Lot number: ew0183) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Nov2021 as dose 2, single (Lot number: 027h21b). The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "interchange of vaccine administered" (unspecified if ongoing), notes: Dose 1: BNT162B2, Dose 2: Moderna. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient did not received Other medication in 2weeks. Anti-viral COVID 19 Treatment included paxlovid from (23Apr2022 to 28Apr2022). Patient did not have known allergies.  No follow-up attempts are possible. No further information is expected.
Next day after shot, 3/6/21, I woke up with a severe back pain. When I walked to bathroom I was not able to sit on Toilet to urinate and not able to hold the urine back causing me to urinate all over my clothes.
None reported. Administered out of date vaccine - spoke with pt mom, no report of any SE or problems.
Patient noticed redness and lump under arm after getting vaccine. Iced and watched and 4 days later bruise appeared.
This case was reported by a consumer and described the occurrence of fever in a 72-year-old female patient who received 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 fever, pain and feeling miserable. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the pain and feeling miserable were unknown. It was unknown if the reporter considered the fever, pain and feeling miserable to be related to SHINGRIX. Additional details were received as follows; The age at vaccination was not reported. After receiving SHINGRIX vaccine the patient had a fever for two days, ached, and was miserable. For tolerance refer US2018GSK215265 for 2nd dose of SHINGRIX.
Chills, headache, aches, fatigue...ongoing slight headache 5 days later
7 mins. after 3rd GARDASIL given patient's mother stated patient red blotches on chest, bra line. No other symptoms noted at this time per patient. 7 more mins. patient reporting that her skin feeling more itchy, throat feeling funny and lips feeling funny - BENADRYL 12.5 per 5 mls-10 ml given orally by mouth - oxygen at 2L per NC applied - transferred to E.R. with wheelchair.
Neck Stiffness; Body sore; Sore at Injection Site; tenperature at 100.4 F; Mild cough; Back ache; Headache; A report was received from a 57-year-old, female patient, participating in the mRNA-1273 Emergency Use Program who experienced a mild cough, back aches, a headache, neck stiffness, her body was sore, soreness at the injection site and a temperature of 100.4 degrees Fahrenheit.    The patient's medical history included tow prior episodes of COVID-19 on  26 Nov2020 and 16Dec2020.  No relevant concomitant medications were reported.   On 28 Dec 2020 at 1:30pm, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 28 Dec 2020, the patient had a mild cough during work, but felt otherwise asymptomatic until returning home from work, when she experienced a back ache. The patient stated that the back aches are common for her.  At 10pm that night, she noticed a headache. On the morning of 29 Dec 2020, she experienced neck stiffness, her body was sore, soreness at the injection site and took her temperature at 100.4 degrees Fahrenheit. Treatment was unknown.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, mild cough, back aches, a headache, neck stiffness, her body was sore, soreness at the injection site and a temperature of 100.4 degrees Fahrenheit were not resolved.     The reporter did not provide an assessment for the events.; Reporter's Comments: Company comment: This case concerns a 57 year old female, with relevant medical history of 2 prior episodes of COVID-19 on 25Nov2020 and 15Dec2020, who experienced nonserious events of cough, back aches, a headache, neck stiffness, her body was sore, soreness at the injection site pain and fever the same day she received her first dose of mRNA-1273.  Details of prior events of COVID-19 (25Nov2020 and 16Dec2020) were not reported.  Treatment of the events and event outcomes were not reported. Based on the current available information and temporal association between the use of the product and the start date of the event(s), a causal relationship cannot be excluded.
The patient experienced redness at each injection site two days after the injection. The patient expereinced a fever 1 hour after the injection. The patient devleoped an irregular heartbeat, light headedness and shortness of breath.
Kinrix / to a 8 year old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa-IPV (Kinrix) (batch number Z9MZ2, expiry date 3rd December 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th May 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 5th May 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 Kinrix was adminsitered to 8 year old patient, which led to inappropriate age at vaccine administration. The reporter preferred follow-up by email and did not provide address. This is 1 of 3 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR097825:Same reporter US-GLAXOSMITHKLINE-US2021097952:same reporter
This is a spontaneous report from a contactable physician via a Pfizer Sales Representative. A 17-year-old female patient received on 01May2018 second dose of TRUMENBA (batch number S26985) at single dose for immunization. First dose was administered for immunization on an unspecified date. Medical history and concomitant medications were not reported. She came back to the office on 02May2018 with fever, chills, headaches, feeling faint and was checked for flu which was negative. Outcome was not reported.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUL-2017, the patient was vaccinated with an improperly stored dose of PROQUAD at a dose of 0.5 (units not specified), lot # N013865 with expiry date 31-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
I thought I was having a stroke, lips and tongue were numb, had trouble walking and vision went on for ten minutes was taking to local hospital, performed a stroke test, Ct scanned performed left carotid 95-99% blocked. Endarterectomy was needed to be performed, transported to another hospital to perform 02/15/2023. Discharged 02/16/2023. Have had a pervious endarterectomy in 2017.
Nausea, swollen, warm to the touch, bright red, diarrhea.
pt recv vax 16SEP96 & 3OCT96 & pt devel a generalized papular rash around ear & face;rash became vesicular 7OCT96;
At work 24 hours after vaccine administration - Lip swelling, jaw swelling  increased BP - patient has anxiety Benadryl and prednisone provided, staff member was sent home from work, PCP called patient advised to rest and monitor swelling - if swelling continued notify physician.
left calf pain/ significant DVT in left quad; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9264, unknown expiration), via an unspecified route of administration in left arm on 18Feb2021 as single dose for COVID-19 immunisation.  Medical history included rheumatoid arthritis and Leiden factor 5. Concomitant medications included etanercept (ENBREL); gabapentin; meloxicam; and vitamin D3.  The patient previously took Keflex and experienced allergies. The patient also received first dose of BNT162B2 (Lot number: GL9261, unknown expiration) in left arm on 28Jan2021 at 01:00PM for COVID-19 immunization. On the night of second dose on 18Feb2021 at 08:00 PM (20:00), the patient experienced left calf pain. Then quad pain started 2 weeks later along with the return of calf pain. The patient was diagnosed on 15Mar2021 with a significant DVT in left quad. The patient did not receive other vaccine in four weeks.  The patient had no COVID prior to vaccination and not tested for COVID post vaccination. The event significant DVT in left quad resulted in doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient is currently on blood thinners as treatment.  The patient is recovering from the event.   No follow-up attempts are possible. No further information is expected.
Nausea  abdominal pain Difficulties swallowing  Headache  Diarrhea  Swollen lymph node
chills; nausea; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age (reported as Age: 69; Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on 08Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient had received first dose on 08Mar2021 and he was scheduled for second dose on 31Mar2021. Caller wanted to know what to expect for his second dose of the vaccine, regarding the chills and nausea that he had experienced from the first dose injection of Pfizer-BioNTech COVID-19 Vaccine. The outcome of events was unknown.  No follow-up attempts are possible; information on lot/batch number cannot been obtained.
Information has been received from a nurse referring to a patient of unknown age and gender. On 27-MAY-2015, the patient was administered with improperly stored dose of M-M-R II (lot # K016153, expiration date 24-SEP-2015, dose was unknown) subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Injection site started to itch two days after injection. Developed small hives under injection site. Went away for a day or two. Came back on 8th day after injection  itched  a little more and there were more hives.
History of 15 minutes of seizure like activity. Received immunizations 12 hours before mother noted behavior changes (leg twitching, upper/lower extremity convulsions) and fever (38.2C). Also, slightly fussy over 12 hour period. Convulsions described as tonic-clonic with stiffening in all 4 extremities, eyes deviated down and to right. Admitted as inpatient with provisional diagnosis of new onset seizure. 07/10/06-diagnostic reports received from facility, WBC 15.49, segs 60, neutrophils063.3, lymph 26.1.  UA normal.,  CSF Band 1, lymph 35, macrophage 21.  HSV DNA negative. CXR PA/LAT mild prominence of central lung markings. Progress notes requested as a DC summary is not available. krk 07/26/06-progress notes received from DeVos Hospital. Assessment: At risk for possible seizure with  abnormality. At risk for seizure and developmental delay. Doubt contraindication for further vaccinations.
patient reports 90 minutes after injection she experienced tongue swelling, took benadryl and symptoms resolved
This spontaneous report was received from a female pharmacist of unknown age reporting on herself. The patient reported that on 21-SEP-2015, as she was administering a dose of ZOSTAVAX injection to unknown patient. The patient pulled away from the syringe. The pharmacist reported, that this may have caused some of the ZOSTAVAX to squirt into her eye. She stated, that she removed her contact lenses and washed her eyes and after that she did not use her contact lenses. The patient stated, that since this her eyes had been very dry and her sinuses were also dry. The outcome of the events was unknown. Relatedness between the events and ZOSTAVAX was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Extreme pain in shoulder Injection site is high on  deltoid possible in bursa Limited mobility in arm  Painful with light touch  on entire deltoid Pain worsening each day
pt suffered a high fever, serum sickness & arthritis 6hr p/vax;this event lasted for 7 to 10 days;