chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt immediate tiredness after injection; Debilitating symptoms; Developed body pain; Swelling in joints; Inflammation; This is a spontaneous report from a contactable consumer (patient). This 73-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 07Apr2021 at 14:15, at patient age of 73-year-old, as single dose (Lot number ER8737) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included asthma, pituitary surgery, spinal surgery, knee replacement. The patient's concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), lorazepam, salbutamol (ALBUTEROL), ibuprofen (ADVIL). The patient's relevant past drug history included penicillin and sulfa drugs. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 17Mar2021 at 14:00, at patient age of 73-year-old, as single dose (Lot number EN6208) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the second dose of bnt162b2 on 07Apr2021. On 07Apr2021, the patient felt immediate tiredness after injection with debilitating symptoms continuing for 7 weeks, under the care. Finally, she developed body pain and swelling in joints. The patient was examined by doctor and gave blood sample on 24May2021. Blood work showed inflammation, causing pain and swelling. Initially prescribed hydroxychloroquine and gabapentin; added prednisone which started on 10Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not resolved.
2 days p/recv vax pt exp nausea, fever (100-102f), palpitations, back pain, lightheadedness, and petechiae from her ankles to 2'' above knees; p/tests pt dx w/vasculitis
Pt recv vax on 4/13/99; 15 min post vax pt exp urticarial rash
pt recvd vax 3AUG92 & 2 days p/vax devel a fever of 100 & pain in rt hip, shoulder, sterum & rt knee; also had upper body aches & elevated eSR 7 C3;
Pt received vaccination 8/9, then developed fever of 102 evening of 8/10.  General feeling of unwell 8/11, Tmax that day 101 reported by pt.  Admitted to our hospital 8/12 Tmax 102.6, WBC 1.9 and ANC 0.91, PLT 126.  8/13: ANC 1.05 Tmax 101.4, 8/14: ANC 0.66 Tmax 100.1, 8/15: ANC 0.65 Tmax 99.6, 8/16: ANC 0.39 Tmax 98.1.  Pt was started on vancomycin (8/13-8/16) and cefepime (8/12-8/16) which were discontinued by the consulting infectious disease physician 8/16.  Patient feels improved, near baseline energy level as of 8/16.
patient was scheduled for both the seasonal influenza vaccine and the shingrix vaccine.  The patient received the covid moderna bivalent booster and the seasonal flu immunization. patient was contacted and informed of the error. the immunization registry was checked and it was determined the patient was eligible for the booster.
Pregnant lady I know has told story about passing out during epidural (had seen on social media); not sure which individual has covid on the podcast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Pregnant lady I know has told story about passing out during epidural (had seen on social media)"; SUSPECTED COVID-19 (non-serious), outcome "unknown", described as "not sure which individual has covid on the podcast". The lot number for bnt162b2 was not provided and will be requested during follow up.
LOCALIZED SWELLING IN SHOULDER AREA TO A BIT LARGER THAN QUARTER (PER PT, QUARTER SIZED)
5: mom states right leg is swollen, hot and redness after vaccines. Pt complained of pain x 3 days. Erythema 3x3 around injection site right lateral thigh. 12.5/55g 7.5 ml q8x3days. Keflex 250/ 5 po 7.5 q 8 hours x 10 days. (seen by doctor)
Patient recieved both Typhoid Vi and Anthrax #6 shots in left arm. Now presents with large local reaction (about 18cm x 18 cm)from Deltoid to elbow. Tense, hot, itchy arm. Topical Steriods applied, patient given Motrin, and encouraged to use ice on site and RTC for no improvement or worsening of reaction. Patient does not report any concurrent illness. Also states no directions were given to her about follow-up for possible reactions. She reports large local reactions to most of the previous doses Also no lot number is present on the immunization form.
Moderna COVID-19 Vaccine EUA  Diarrhea started approx 8-9 pm Went to bed around 1030 pm - woke up with muscle and joint aches
2 weeks post vaccination patient developed 10 cm red circle at site of injection that was raised and itchy.  symptom lasted 4 days
Normal injection, no immediate side effects except for a sore arm that went away after two days. However, 7 days post-vaccine the injection site became itchy and painful to touch. The pain went away within a day, but the site remains itchy (10 days post-vaccine). The injection site now also has a light yellow bruise on it.
Muscle spasms, a sudden, brief, unintended (involuntary), and usually painful contraction of a muscle or group of muscles, specificaly in left and right legs and feet.  In addition to torso or core area.       Spasm occurred every few minutes, lastinng 30 seconds to 90 seconds for 15-18 hours.     Caused extreme pain and inability to do any daily activities and inability to sleep.       After approximately 15 hours, Interval of spasms increased gradually until reaching baseline in approximately 36-42 hours.     Currently taking muscles relaxant (Baclofen and Tizanidine) for intermittent spasms related to Multiple Sclerosis.
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 7-month-old male patient who experienced fever. The patient received the first dose on 07-May-2010 along with a second dose of PENTACEL (Aventis-Pasteur) and ENGERIX B (Smith Kline & French Laboratories). On 08-May-2010, the patient experienced fever and was hospitalized. Treatment was not reported. On an unspecified date, the patient was discharged from the hospital. The outcome of the event was unknown. no additional information was available at the time of this report.
expired vaccines inadvertently administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number T93SR, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra 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: 27-SEP-2022 Reporter's Comments: The medical assistant reported there were 2 boxes of Fluarix that left over from last year which was expired on June 2022. The three vaccines from it was inadvertently administered to 3 patients. The vaccine administration facility was the same as Primary Reporter No other details were available.  The reporter did not consent to follow up. The case was linked with US2022138666 and US2022AMR139388 reported same reporter. Additional Supportive Information: The patient received an expired dose of Fluarix, which led to expired vaccine used.; Sender's Comments:  US-GSK-US2022138666:Same reporter US-GSK-US2022AMR139388:Same reporter
Patient's mother put age on Covid Vaccine Documentation form at 2009. When entering information Patient Birthdate is 2010 per Records.
pt recv vax 25OCT97 & w/in 1hr pt had diff breathing & hives down both arms;treated w/atarax, DPH & parenteral pred in ER & hives resolved;26OCT pt exp weakness & generalized muscle spasms;
After the initial flu-like symptoms and migraine, patient became itchy and hives arrived on left and right arms, as well as left and right legs. From Saturday to the following Saturday, hives extended from legs and arms to lower back and lower belly. Hives were treated with Cortizone and Benadryl. Mental fog, fatigue, nausea, and a second migraine attack also occurred. Now, a week later, hives are almost gone. Patient is still fatigued and experiencing light itchy patches and muscle soreness,
Fatigue, nausea,  vivid dreams, mild chills that lasted 48 hours
severe abdominal pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: 301358A) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN (non-serious), outcome "unknown", described as "severe abdominal pain".  Addition information: The report was not related to a study or programme. Expiry Date of COVID-19 Vaccine was unknown.  No follow-up attempts are possible. No further information is expected.
Arm pain, from below shoulder down toward elbow.  The pain has occurred intermittently to this time.
After the second  Moderna dose, a day later I exhibited severe neck pain - this lasted for 2  one-half weeks before it subsided. I did not go to the doctor but was very worried about it. I am 5'2" tall, weigh 100 lbs. and in excellent health. I am very active, ride my bike, go to water aerobics, and walk - this reaction was very debilitating; I am concerned about taking a booster shot and feel that the dosage should be adjusted based on weight as I had the same dosage a much heavier person would receive. Please consider this issue in the  future if a booster is needed. Thank you.
Took Vivotif for 4 days in a row; Spontaneous report received on 24FEB2020.  Based on the information obtained from a consumer, two individual case safety reports PVX2020-401 (20000166SP; wife) and PVX2020-403 (20000167SP; husband) were created and cross-linked in the database.  This case described a male consumer who "took Vivotif 4 days in a row" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif capsule for prevention of typhoid. The consumer took four doses of Vivotif every day from 19FEB2020 to 22FEB2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the event was unknown.  Company Comment: A consumer took Vivotif 4 days in a row (Inappropriate schedule of product administration) instead of taking every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took Vivotif 4 days in a row (Inappropriate schedule of product administration) instead of taking every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
No reactions on the 1st dose. On the 2nd dose experienced a strong headache the next morning, followed by hives below the injection point which lasted three days. From 10/17/18 through 10/19/18 experienced hives on upper chest area. From 10/19 through 10/21 experienced hives in genital area. On the 29th the hives returned to arm area.
Contracted COVID 6 days after receiving first Dose.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 7 year-old male patient received bnt162b2 (BNT162B2), administration date 09Nov2021 18:00 (Batch/Lot number: unknown) at the age of 7 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 15Nov2021, outcome "recovering", described as "Contracted COVID 6 days after receiving first Dose.". The event "contracted covid 6 days after receiving first dose." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Nov2021) positive. There is no information that patient receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Fever, arm swollen, red, hot.  Seen this am - given AB's x 5 days
Localized urticaria and hives at injection site.  Doubt relationship to immunization.
Started as a tingling sensation on the left side of my face about 15 minutes after shot and 3 hours later it is more of a numbness/tingling feeling.
Rash around the injection site measuring about 3.5 x 5 cm, irregularly shaped.; Area of the injection hurt; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Area of the injection hurt) and VACCINATION SITE RASH (Rash around the injection site measuring about 3.5 x 5 cm, irregularly shaped.) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M28A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Area of the injection hurt). On 08-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash around the injection site measuring about 3.5 x 5 cm, irregularly shaped.). At the time of the report, VACCINATION SITE PAIN (Area of the injection hurt) and VACCINATION SITE RASH (Rash around the injection site measuring about 3.5 x 5 cm, irregularly shaped.) 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 relevant concomitant medications were reported. No treatment information was reported.
This spontaneous report was received from a medical assistant and refers to a 13 months old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 19-FEB-2019, PROQUAD 1 dosage form, lot# R017626, expiration date 18-DEC-2019 (dose number, exact dose and route of administration were not provided), reconstituted with MERCK STERILE DILUENT, were inadvertently administered with VARIVAX, 1 dosage form, lot# R018933, expiration date 02-JUL-2020 (dose number, exact dose and route of administration were not provided) for prophylaxis. No adverse effect was reported.
This spontaneous report was received from a licensed practical nurse and refers to ten patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL injection, lot # K011562, expiry date 08-APR-2017 (dose, route of administration and anatomical location were not specified). On an unknown date, the administered doses of GARDASIL underwent temperature excursion at 1.2 Celsius degrees for 54 minutes. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
mild pain; Shingles-Severe; Itchy spots around back of L arm and onto chest area/Extended onto back of Left chest to centerline of back/Also extended to cover my Left breast; Spots became red in 1 to 2 days/Color became very red; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (mild pain), HERPES ZOSTER (Shingles-Severe), RASH PRURITIC (Itchy spots around back of L arm and onto chest area/Extended onto back of Left chest to centerline of back/Also extended to cover my Left breast) and ERYTHEMA (Spots became red in 1 to 2 days/Color became very red) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient had no known allergies.  The patient's past medical history included Sjogren's disease in 2005. Concurrent medical conditions included Rheumatoid arthritis since 1994 and Tachycardia (Fast Heart Rate.). Concomitant products included TOCILIZUMAB (ACTEMRA) from 2019 to June 2021, METHOTREXATE from 1998 to 15-Sep-2021 and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) from 1994 to an unknown date for Rheumatoid arthritis, CICLOSPORIN (RESTASIS) from 2001 to an unknown date for Sjogren's disease, ATENOLOL from 2015 to an unknown date for Tachycardia.    On 28-Jan-2021 at 4:52 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021 at 8:00 AM, the patient experienced HERPES ZOSTER (Shingles-Severe). On an unknown date, the patient experienced PAIN (mild pain), RASH PRURITIC (Itchy spots around back of L arm and onto chest area/Extended onto back of Left chest to centerline of back/Also extended to cover my Left breast) and ERYTHEMA (Spots became red in 1 to 2 days/Color became very red). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALCIVIR) for Adverse event, at an unspecified dose and frequency. On 22-Mar-2021, HERPES ZOSTER (Shingles-Severe) had resolved with sequelae. At the time of the report, PAIN (mild pain) outcome was unknown and RASH PRURITIC (Itchy spots around back of L arm and onto chest area/Extended onto back of Left chest to centerline of back/Also extended to cover my Left breast) and ERYTHEMA (Spots became red in 1 to 2 days/Color became very red) had resolved with sequelae.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HERPES ZOSTER (Shingles-Severe) to have an unknown relationship. No further causality assessments were provided for PAIN (mild pain), RASH PRURITIC (Itchy spots around back of L arm and onto chest area/Extended onto back of Left chest to centerline of back/Also extended to cover my Left breast) and ERYTHEMA (Spots became red in 1 to 2 days/Color became very red).    The patient also used an unknown lotion with specific medications that was made at. It took about 8 weeks to be mostly gone. The patient still had itches at the area it started, with occasional mild pain.   This case was linked to MOD-2021-319198 (Patient Link).
ive had a sore throat and very hoarse, been checked for strep and it came back negative. its been a  week and still not improving.
I received my first dose on March 23rd and never heard back from the provider  now nearly 2 months have passed; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I received my first dose on March 23rd and never heard back from the provider  now nearly 2 months have passed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I received my first dose on March 23rd and never heard back from the provider  now nearly 2 months have passed). On 23-Mar-2021, PRODUCT DOSE OMISSION ISSUE (I received my first dose on March 23rd and never heard back from the provider  now nearly 2 months have passed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
no AE; ROTATEQ administered during temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 22-SEP-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # 1684163, expiration date was reported as 20-JUN-2021 but upon internal verification it was established as 26-JUN-2021 (exact dose was not provided) for prophylaxis.   On an unknown date, the administered dose had experienced a temperature excursion. No adverse events (AE) were reported.
Pt had fever for 2 days after vaccination (about 100 degrees). Then on 8/23/03 developed papule at Varivax vaccine site, itchy. Gradually increased in size. Now 1.3cm redness with central raised non-vesicular papule. Non-fluctuant.
Arm pain 6-36 hours following vaccination; This is a spontaneous report from a non-contactable consumer. A 24-year-old non-pregnant female consumer reported herself who received first dose of COMIRNATY (BNT162B2, solution for injection) (Batch/Lot Number: EL3247, Expiration date: unknown) via intramuscular route of administration on 26Jan2021 at 03:45 PM in left arm as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination. On an unknown date in Jan2021, the patient experienced arm pain 6-36 hours following vaccination for which she did not receive any treatment. The outcome of the event was recovered in Jan2021.  No follow up attempts are possible. No further information is expected.
Recurring pericarditis. Flu like symptoms. Chest pain, fever, chills, sweats, exhaustion, loss of appetite. 8 times since vaccine. Hospitalized twice for total of 8 days for pericarditis since vaccine. Treated with antibiotics, anti-inflammatory meds, auto immune meds. Still not resolved.
Heart feels like it is fluttering or skipping beats. At the same time, shortness of breath occurs with feeling of passing out. This happens every day at random times .
Got diagnosed with Carcinosarcoma of uterus stage 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UTERINE CANCER (medically significant) with onset Nov2021, outcome "unknown", described as "Got diagnosed with Carcinosarcoma of uterus stage 4". Event Awareness Date: 25Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.