chrisvoncsefalvay/vaers-outcomes huggingface dataset:
booster; sick; chills; Under my armpit my lymph nodes are swollen as the size of tennis ball; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Dec2021 17:30 (Lot number: 33030BD) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 01), for Covid-19 Immunization; Bnt162b2 (Dose Number: 02), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 17:30, outcome "unknown", described as "booster"; ILLNESS (non-serious) with onset Dec2021, outcome "unknown", described as "sick"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "chills"; LYMPHADENOPATHY (non-serious) with onset Dec2021, outcome "unknown", described as "Under my armpit my lymph nodes are swollen as the size of tennis ball". Therapeutic measures were taken as a result of illness, chills.  Additional information: clinical course: Patient reporting an adverse effect to the vaccine, for the Pfizer booster shot. So, this part is normal the whole getting sick, having chills and all of that, that is not his biggest concern. (Further clarification unknown. Hence, captured as event conservatively). The biggest concern is that effect that he was really concerned about was under his armpit his lymph nodes were swollen as the size of tennis ball. Patient asking that have you heard this happening because 1st two shots he did not feel anything he was totally fine. Have you heard of this happening with swollen lymph node before from the booster shot? He never had a reaction; this was the first time it happened to him 2 days after the vaccine.  Follow-up attempts are completed. No further information is expected.
Information has been received from a consumer concerning her daughter's friend (age and gender not reported) who was vaccinated (date, route, and site not reported) Gardasil (lot# not reported) and complained of pain on the injection arm. The friend still has pain when she gets tapped around the injection area. The friend was vaccinated in June 2007 (exact date not reported). It was not reported if the friend sought medical attention or if diagnostic lab test were performed. No additional information is expected.
3rd dose/Primary Immunization series complete but unknown manufacturer; 3rd dose really knocked her down; This is a spontaneous report from a contactable consumer. An adult female patient of unknown age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 28Sep2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown whether the patient was pregnant at the time of this report. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient previously received the first and second dose of covid-19 vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration on unknown date as a single dose for COVID-19 immunisation. On 28Sep2021, the patient said that 3rd dose really "knocked her down." No other details were provided. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event 3rd dose really knocked her down was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness, vertigo, chills, headache, fatigue, soreness. Onset the following evening after administration 10-1-15 lasting continuously through 10-5-15.
Patient wrote a letter to pharmacy stating shoulder joint injury. Patient description states "hurt to move arm," "pain was about 6-7". Patient went to see PCP.
DIZZINESS AND LIGHT HEADEDNESS; PAIN BEHIND THE EARS; LEFT ARM SWOLLEN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced dizziness and light headedness. On 17-MAR-2021, the subject experienced pain behind the ears. On 17-MAR-2021, the subject experienced left arm swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain behind the ears, and left arm swollen on 17-MAR-2021, and had not recovered from dizziness and light headedness. This report was non-serious.
Patient received a pneumonia vaccine and a flu vaccine and 10 minutes later, was asked to go to a different seating area since another pt was getting vaccine. Patient got up and a few steps later fell on the floor. Pharmacy staff called 911 and got nurse practitioner working in the store to check patient.
Nausea with vomiting beginning 24 hours after injection, lasting 48 hours after injection. Residual nausea 72 hours after injection. Menstrual cycle began 12 days after last menstrual cycle, not due to start until on or about 05/30/2021.
A report has been received from a Physician concerning a female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. It was reported that the patient received 2 doses of FLUMIST Quadrivalent one at school on 08-OCT-2014 and 10-NOV-2014. The outcome of the event of received two doses of FLUMIST Quadrivalent is unknown. The report was considered to be non-serious.
he has COVID-19 after the COVID-19 Vaccines; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (he has COVID-19 after the COVID-19 Vaccines) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (First dose: 12Jan2021) on 12-Jan-2021, MODERNA COVID-19 VACCINE (Dose 2: 09-Feb-2021) on 09-Feb-2021, MODERNA COVID-19 VACCINE (3rd dose: 15Sep2021) on 15-Sep-2021 and MODERNA COVID-19 VACCINE (4th dose: 06Apr2022) on 06-Apr-2022. Past adverse reactions to the above products included No adverse drug reaction with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE and MODERNA COVID-19 VACCINE. Concurrent medical conditions included Hypertension (Diagnosed 5-6 years ago), Cholesterol high and HDL (Diagnosed 8-9 years ago.). Concomitant products included ROSUVASTATIN for Cholesterol high, LISINOPRIL for Hypertension.    On 26-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (he has COVID-19 after the COVID-19 Vaccines). At the time of the report, COVID-19 (he has COVID-19 after the COVID-19 Vaccines) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was also reported that vaccine didn't seem to protect the patient. Patient took vitamins and normal stuff for health.  No treatment medication was provided by the reporter.
Information has been received from a physician's office concerning a female patient was was vaccinated IM with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The reporter indicated that using the prefilled syringe was "painful and startling" to the patient. Her outcome was not reported. A product quality complaint was not involved. Additional information has been requested.
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 24Mar2021 (Batch/Lot number: unknown) at the age of 61 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Asthma" (ongoing). Concomitant medications included: TESTOSTERONE. Past drug history included: Testosterone.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  Additional information: The patient reported that he had his first dose yesterday (at the time of reporting). The patient only had a sore arm. The patient was a 61-year-old asthmatic that receives testosterone once a week. The patient had a question about the testosterone and COVID vaccine if the medications together could possibly minimize his immune system.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I got hives and rash on neck to mid thigh. I thought I possibly ate something that could of caused it. By Wed it seemed to be gone and on Fri came back. I started back taking Benadryl cleared it up and on 3/24 appeared again on my arm (both).
Nausea and Lightheaded Patient states she may be dehydrated; had not had water since last night.  Gave bottle of water and symptoms left.
High fever, chills, cold sweat, light headedness, loss of sleep during the night; daytime, nausea, body aches, mild fever. 1/20/2017 night sweats, body aches; loss of sleep. 1/21/2017 Nausea, body aches, ongoing today. Treating with Excedrin, extra fluid intake.
Chills, body ache at 6:00 pm and took 600 mg of Motrin,. fever set in (101.0) and massive headache 12 hours after side effects started, took 400 mg of Tylenol and back to sleep.  By afternoon effects eased and 26 hours later at approximately 8:00 pm on 14th they went away. Woke up on 15th 100%
Administered expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) in a 73-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that 173 doses were administered with Lot number 070H21A. The vial did not undergo any temperature excursions. Date the vial initially stored in the refrigerator was unknown.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information.
Sore arm; fatigue; This is a spontaneous report from a contactable consumer (patient). This 53-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL3247) via an unspecified route of administration on 18Feb2021 at 11:25 (at the age of 53-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included Type 2 diabetes since Sep2017. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient previously received dose 1 of BNT162B2 (lot number EL3247; expiration date May2021) intramuscularly on 27Jan2021 as a single dose in the left arm for COVID-19 immunization. Concomitant medications included metformin from 3 or 4 years ago as of 2021 for an unspecified indication, colecalciferol from over 10 years ago as of 2021 for an unspecified indication, omega-3 fatty acids from at least 4 years ago as of 2021 for an unspecified indication. The patient previously received azithromycin on an unspecified date for an unspecified indication and experienced full body itchy hives/rash. On 18Feb2021, about six hours after the second dose of BNT162B2 the patient experienced sore arm. The following day (also reported as 48 hours later) the patient experienced fatigue. The patient was not hospitalized for the events and did not visit a physician's office or emergency room for the events. The patient did not receive any treatment for the events. The outcomes of sore arm and fatigue were recovered.  No follow-up attempts are needed. No further information is expected.
approx 45 min /p dose, mom called-eyes swollen, B/P 90/70, HR unk(ambulance arrived), scared, said he had trouble breathing-no use of accessory muscles/retractions/nasal flaring
Within a few hours of receiving vaccine, child had a small area of localized redness & swelling. Over the next 2 days, he had increasing redness & swelling. 10/31 he had marked increase in redness & swelling - annular 10cm & was seen at a minor Er. Child had been on amoxicillin for an URI with cough. ER left him on amoxicillin. I saw patient the next day and opted to cover possible cellulitis with cephalexin. Area was quite red but was not particularly tender to touch & child was not limping. He did have some fever & flu like symptoms but I did not test him for flu. Child improved over the next days & a phone call to mom on 11/4/19 reported almost complete resolution of erythema. Mom denied that child ever had a noteable scratch in the area of the injection. She did not feel child fought the injection or had significant bruising at the time of the injection. Child has had 3 previous flu shots on 10/17, 1/18,10/18 without any significant reaction. Those vaccines were all fluzone quadirvalent but were the 0.25 dose. (This was the 0.5ml dose). I am not sure whether this was cellulitis or a severe local reaction but thought it should be reported since this was the first year to give children under 3 the higher dose.
the dose administer expired on 18Oct2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 39-year-old female patient who received HAB (Twinrix) (batch number H4A37, expiry date 18th October 2021) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th November 2021, the patient received the 3rd dose of Twinrix (intramuscular) and Twinrix Pre-Filled Syringe Device. On 16th November 2021, unknown after receiving Twinrix and Twinrix 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 details provided were as follows: The patient received 3rd dose of expired Twinrix vaccine in left deltoid which led to expired vaccine used. The vaccine got expired on 18th October 2021. The reporter consented to follow-up.
lower back pain; Joint pain; Dull headache; Intense chills exactly 12 hours after the dose; No energy; Shaking; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy), TREMOR (Shaking), BACK PAIN (lower back pain), CHILLS (Intense chills exactly 12 hours after the dose) and ARTHRALGIA (Joint pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced ASTHENIA (No energy), TREMOR (Shaking) and CHILLS (Intense chills exactly 12 hours after the dose). On 06-May-2021, the patient experienced BACK PAIN (lower back pain), ARTHRALGIA (Joint pain) and HEADACHE (Dull headache). At the time of the report, ASTHENIA (No energy), TREMOR (Shaking), BACK PAIN (lower back pain), ARTHRALGIA (Joint pain) and HEADACHE (Dull headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-114430 (Patient Link).
Immediately after vaccination, "shrill, fierce cry" and 20 minutes later had hives over both legs and on face and right arm and right leg contracted. Sent to ER (minutes away) and was given Benadryl, Tylenol, Codeine and contraction resolved. Hives became "pinhead dots". After ER visit child slept and woke up fine. On 7/22/02, he has "knot" where DTAP was given and cried longer than usual last night. Relieved by Tylenol. ER doctor noted "allergic reaction".
Pt developed irritability > 4 hrs post vax. Pt developed petechiae to bilateral lower legs.
Developed itchy rash on upper arm just below vaccination site. Treated with cortisone cream.  I have photo
3RD DOSE OF PFIZER COVID VACCINE GIVEN 3/29/22, LOT #FJ762; 7/20/22  pt brought from hospital to our hospital; found to be positive for COVID; also having acute upper abdominal pain; RUQ Ultrasound showed hepatomegaly, splenomegaly, left intrahepatic ductal dilation; oncology and hepatology recommended palliative care; 7/27/22 family decided to take home with hospice care; hospice name not mentioned in medical records; pt passed away at home;
Severe nausea, cold sweats, dizziness and extreme localized swelling to vaccine spot on arm.  Seemed almost to have a pocket of vaccine 2 inches in diameter in my arm that needed to absorb. tingling in my arm for 72 hours
Pt returned to the store after about 55 minutes stating that she was having trouble breathing, her neck felt swollen, and her chest felt heavy.  She also reported feeling shaky.  We called 911 and gave 50 mg of benadryl liquid.  We also checked her blood sugar and found it to be slightly elevated, but not concerning.  By the time the EMTs arrived (5 min or less) she reported already being able to breathe much easier.
Tingling in different areas of head , pain at base of skull followed by heavy nosebleeds. Happening 1-3 times a day .....duration at least one month
Red spots started to appear on ankles the day after the vaccine, then spread throughout legs and on stomach and a few on back as days passed. Spots tend to change to purple-ish color after some time. It has been over a month and she still has the spots. They look like mini bruises (red and purple).
Presents to clinic with right arm edema, erythema noted. Area red, and hot to touch. Received DTap injection on 05/02/05 DX: Immunization reaction. TX: ice TID, Tylenol, Ibuprofen and monitor.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Patient developed cellulitis. She did not disclose to pharmacist what treatment was given. Cellulitis cleared up after time.
Swollen Lymph nodes in armpits ,arms, groin, legs, neck. Fatigue,  aches and pains no fever. Lasted 5 days then today 10/6/21 muscle cramping.
This spontaneous report was received from a Licensed Practical Nurse referring to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 20-NOV-2017, the patient was inadvertently administered a dose of VARIVAX (0.5 ml) subcutaneous (dose, frequency and anatomical location  were unknown) with lot # M047662 and expiration date 02-DEC-2018, and a dose of PROQUAD (dose, frequency and anatomical location date were unknown) with lot # N009774 and expiration date 20-SEP-2018 reconstituted with sterile diluent (MERCK STERILE DILUENT) for prophylaxis. No adverse effects reported.
Ongoing hospitalization with pneumonia, hypotensive, hyperkalemic with acute kidney injury. Treated with IV fluids
Hospitalized 6/14/22-6/20/22 hypotensive, weakness, congestion, cough, dizziness, headache, nausea, decreased appetite, AKI, PNA, UTI, dyspnea,
information has been received from a medical assistant concerning a 69 year old female with no allergies or medical history, who on 06-SEP-2006 was vaccinated IM into the left deltoid with 0.5 ml dose of Pneumovax 23 (lot# 651374/0485F). Concomitant therapy included simvastatin (manufacturer unknown), TOPROL XL TABLETS and lisinopril (manufacturer unknown). On 07-SEP-2006, the patient called the office to report her symptoms which included a sore left arm that was swollen and painful around the whole injection site. The physician's notes mentioned that cellulitis should be considered. The patient was treated with BENADRYL and AUGMENTIN as needed. No diagnostic laboratory studies were performed. At the time of this report, the patient's outcome was unknown. A lot check was requested by the reporter. No product quality complaint was involved. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of Standards of the Center for Evaluation and Research and was released. Sore, painful left arm and swollen around the whole injection site were considered to be other important medical events. Additional information has been requested.
approx. 24 hrs after injection, I experienced popping type surges in my head on and off for about 2 hours.  this worried me because I had been diagnosed with 2 possible TIA"s several years ago.  I associated this with previous symptoms.
Second Vaccine Issue 1/19/2021    Vaccine admin 1015am  Left Gluteal. 1/20/2021   AM fatigue and low back ache.  Some swelling and discomfort at injection site.  No Redness. 1200 Increased fatigue and general malaise  1430 Onset of nausea and headache  1445 Vasospasm of hands due to Raynaud's and Sjogrens.  Chills and shivering  1515 Fever 99.8. Vasospasm continued.  Joint aching and generalized pain  1545 Vasospasm resolved.  Ibuprofen 600mg.  Vasospasm lasted 1 hour 15 min.    1745 Fever 100.1. Tylenol 1000mg.   Joint pain and back pain increased.    1845 Fever 102.7  2100 Temp 100.0  2200 Temp 99.0.  Joint pain and back pain decreased.