chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lethargy, fever, chills, nausea, from 12 hours after to 48 hours after
I saw the possibility of it impacting blood sugars. For 7 days, my blood sugars were all over the place, despite no changes to my exercise regimen or diet. I have been under 100 glucose for weeks, then had readings between 24 and 58 points above. I felt a head fog and most importantly stress. I had disappointment with these readings as it felt like the diet and exercise were not helping.
Patient described having panic attack like symptoms an hour or so after the vaccination.  Patient said she noticed increased heart rate, feeling dizzy, difficultly breathing and feeling clammy.  These symptoms lasted for about 5 minute and then return about 45 minutes later for another 5 minutes.
Kinrix administered to a 2-year and 8-months-old; Kinrix as third dose of DTap and Polio; 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 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5AY2J, expiry date 10th June 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd February 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd February 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were 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: 15-FEB-2023 Reporter's Comments: The reporter called and informed that a dose of Kinrix was administered to a 2 year and 8 months old patient. The HCP(health care professional) told that was supposed to be the third dose of DTap and third dose of polio. The reporter did not consent to follow up. Additional Supportive Information: The 2 year and 8 months old patient received a dose of kinrix, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
21 weeks pregnant with singleton 3rd pregnancy Estimated delivery date 7/18/21  9 days after injection, injection site began to itch, slightly swell, and redden, similar to a bug bite.  The affected area is about the size of a nickel.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old male patient who received SHINGRIX for prophylaxis. In November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In November 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in the right arm. On the next day after receiving the SHINGRIX, the patient's injection site was very sore to the touch and sore when he moved his arm which lasted for over a week but resolved. For tolerance to next dose refer case US2019027595.
Four days after receiving the shingles vaccine, pt. reported flu-like symptoms, headache, body aches, and fatigue lasting 3 days. 2 days later, skin soreness began and increased. 72 hours later, rash appeared on left side waist area. Rash sores persisted on abdomen and back. MD visit on 10/27/15 and MD diagnosed patient being confirmed to having "shingles".
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX 23 on 31-AUG-2012. Lot# was reported as 0493AE, expiration date: 08-DEC-2013. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 80 minutes. High temp excursion exposed to 11.1C for total of 322 minutes (5.4 hrs). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, -0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes. From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reports received from same source. 1209USA007525, 1209USA008597, 1209USA008598, 1209USA008599, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008605, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613, 1209USA008614. Additional information has been requested.
Neck/shoulder stiffness; all over body aches; severe fatigue; nausea; chills; high temperature; migraine, and loss of appetite.
Roughly 6 hours after administration of this second dose, I contracted a slight fever of 99 along with a minor headache. At some point after midnight (approx 13 hours after admin), fever worsened, had chills and headache was more severe. I took 2 tylenols and drank a glass of water. Upon waking in the morning, the fever had broken, but headache was quite severe. Again I took 2 tylenols, drank water and rested until about 1p on 4/20 at which point I felt better. Another potential side effect was inflammation of gums and soft pallet.  This is a condition I am predisposed to where gums become sensitive and inflamed when I am experiencing stress or sometimes when I am getting sick. This was the first symptom I experienced on 4/19 in the afternoon (maybe around 4p). This dissipated, but returned the evening of 4/22 and continued on 4/23.
Day #13  following the 2nd shot, patient experienced severe pain in his left knee and began running fevers.  Past medical history includes a surgical infection in 1979 leading to 3 knee replacements in this knee.  His hardware extends from mid- thigh to his ankle.  On 4/21/21 he required a revision of the total knee (the plastic was replaced)  after flushing out the wound with antibiotic solution.  He is now on oral and IV antibiotics (Rifampin & Vancomycin, respectively).   He is being followed mainly by infectious diseases and ortho, but to my knowledge, this has not been reported by them or his PCP.
By the first evening (Thursday), I had developed a low fever. Overnight, it rose to over 102, with shakes and body aches.  When I got up during the night to use the bathroom, I passed out twice (I have only fainted twice before in my life). The following day (Friday), I took Tylenol about 7:30 am, and my fever remained over 101 (101.4, 101.2, 101.1) all day. That evening it dropped to 100.4, and remained there overnight. Over the course of the next day (Saturday), it remained over 100 (100.4, 100.2, 100.1) until about 5:00 pm, when it dropped to 99, and then went away overnight.  On Sunday, I was exhausted, but felt okay by evening. I am still thrilled I got the vaccine.
Moderna COVID-19 Vaccine EUA: Fever, large swelling at injection site, dizziness and weakness, shortness of breath, headache, body ache (joint and muscle pain), chills
SWELLING AND PAIN IN LEFT ARM. BEGINNING AT SITE OF SHOT AND SPREADING DOWN ARM OVER THE COURSE OF 48 HOURS. PT REPORTS SIGNIFICANT SWELLING
Employee Received Flu vaccine 10/23/2001 At 2pm, 0.5 mL IM left deltoid. Reported on 10/25/2001 that half hour after injection experienced upper lip and nose area tingling, slight numbness. Persisted for one hour. No treatment resolved.
could hardly move; body aches; rash on the lower part of her right arm; chills; arm was sore at the injection site; A spontaneous report was received from a consumer concerning a 60-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rash on the lower part of her right arm (rash), arm was sore at the injection site (vaccination site pain), body aches (Myalgia), chills, could hardly move (hypokinesia).  The patient's medical history was not provided. Concomitant product use was not reported.  On 12 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly in right arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, on the same day of receiving vaccine, the patient experienced rash on the lower part of her right arm, arm was sore at the injection site. She had body aches, chills and could hardly move on the morning of 13 Feb 2021. Treatment included acetaminophen and an anti-itch cream.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the events, rash on the lower part of right arm, arm was sore at the injection site, body aches, chills, and could hardly move, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
after getting out of shower, I noticed redness on my right thigh.  I have noticed redness on my arms and it is very itchy.  I have used hydrocortisone cream to help with itching and took allergy medication as well.
Pain at injection site.  Unable to lift arm.  Achy.  Chills.
migraine; weakness; itchiness, redness and swelling around the injection site; itchiness, redness and swelling around the injection site; itchiness, redness and swelling around the injection site; This is a spontaneous report from a contactable nurse. A 32-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on 30Dec2020 at SINGLE DOSE at left arm for covid-19 immunization. Medical history was reported as none. There were no concomitant medications. On 30Dec2020, the patient reported migraine and became more severe on 31Dec2020, weakness, itchiness, redness and swelling around the injection site post vaccination. Caller wants to know if she can receive the second dose of the vaccine despite the redness and swelling around the injection site. The outcome of the event Itchiness, red and swollen injection site was recovered on 31Dec2020, the event migraine, weakness was recovered on 01Jan2021  Information about Lot/Batch number has been requested.
minor soreness; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received BNT162B2 (lot number was not reported) solution for injection, via an unspecified route of administration on an unspecified date at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced minor soreness after his injection on an unspecified date. Outcome of the event was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
I had just gotten over a period a week before my vaccine. Within 2 hours of my vaccines, I started another period which was the worst ever experienced in my life!!!!! Ever since, my PMDD has been out of control, with suicidal thoughts prevelent every single week to two weeks before my period, and every period now is EXTREME. To the point that I may have a full hysterectomy at just 30 years old, because I CANNOT live this way anymore!!! Please help.
Left underarm lymph node is swollen and painful; Fatigue; Underarm lymph node is swollen and painful; Feverish; Pounding headache; Mild stomach discomfort; Chills; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 08May2021 at 10:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient was allergic to shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included vitamin d (MANUFACTURER UNKNOWN), multivitamins (MANUFACTURER UNKNOWN) and calcium chews (MANUFACTURER UNKNOWN); all medications for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 17Apr2021 at 10:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 08May2021 at 22:15, 12 hours after second vaccine, the patient experienced chills and body aches. On 09May2021, at 01:15, the patient experienced feverish, pounding headache and mild stomach discomfort. On 09May2021, at 16:00, the patient experienced left underarm lymph node is swollen, painful and fatigue. The events did not result in doctor or other healthcare professional office, clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events chills, body aches, feverish, pounding headache, mild stomach discomfort, left underarm lymph node is swollen and painful and fatigue. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event feverish was resolved on 09May2021 while that of the events chills, body aches, pounding headache, mild stomach discomfort, left underarm lymph node is swollen and painful and fatigue were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
This case was reported by a nurse via call center representative and described the occurrence of ovarian cyst in a 16-year-old female patient who received BEXSERO (batch number 154101A, expiry date 31st May 2017). Co-suspect products included MENVEO (batch number X15144, expiry date 31st July 2017). On an unknown date, the patient received the 1st dose of BEXSERO .5 ml and the 2nd dose of MENVEO .5 ml. On an unknown date, 1 day after receiving BEXSERO and MENVEO, the patient experienced ovarian cyst (serious criteria other: as per reporter), abdominal pain (serious criteria other: as per reporter), nausea (serious criteria other: as per reporter), low back pain (serious criteria other: as per reporter) and urination difficulty (serious criteria other: as per reporter). On an unknown date, the outcome of the ovarian cyst was unknown and the outcome of the abdominal pain, nausea, low back pain and urination difficulty were recovering/resolving. It was unknown if the reporter considered the ovarian cyst, abdominal pain, nausea, low back pain and urination difficulty to be related to BEXSERO and MENVEO. Additional details were reported as follows: The patient received BEXSERO and MENVEO on the same day. The patient was brought into the office for assessment and CT-Scan was performed at which point a large ovarian cyst was found. The patient was then referred to a gynaecologist for further treatment. The patient's symptoms was resolving however nausea and abdominal pain remained. No further information was reported regarding the event. The health care professional was agreed to further contact for follow-up as needed.
4 hrs after chills and shaking (2 hrs), headache, body aches, and fever of 103.2. Headache too severe to read missed work Thurs and Fri (would have missed more if not a weekend). Lasted four days/exhaustion.
This case was reported by a healthcare professional via a distributor and described the occurrence of red, swollen arm in a female subject aged between 40 and 49 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (0.5 ml, unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced red and swollen arm. There were no other side effects. Medical attention was not required. At the time of reporting the outcome of the event was unspecified. At the time of reporting, the healthcare professional reported five other adult female subjects who experienced side effects from FLULAVAL injections at her practice (see case id's A0887614A, A0887617A, A0887618A, A0887619A, and A0887620A for specific details on these other subjects). It was unknown if all six subject's FLULAVAL was administered from the same vial. Follow-up information was received on 29 October 2010. It was reported that the subject was 41 years old and received a flu shot, FLULAVAL, on 05 October 2010. One day later, on 06 October 2010, the subject developed a red, swollen arm. The event resolved.
Nausea and serious hoarseness on 01/16, 17, and 18. Dizziness and weakness appeared on 01/19/21, seemed to peak on 01/20/21 and diminished throughout 01/21/21. Ongoing recovery  after right after. I did not see a health professional for side effects.
Light headedness, sweating, Anxious. BP 84/64, 82/46, 100/60, HR 82, O2Sat 98% 1:15 BP 118/70, talking with friend on phone, stated feel better.
Heart pain; pneumonia-like symptoms; Flue symptoms; Aching; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Heart pain) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Kidney disorder.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced ANGINA PECTORIS (Heart pain) (seriousness criterion medically significant), RESPIRATORY SYMPTOM (pneumonia-like symptoms), INFLUENZA LIKE ILLNESS (Flue symptoms), MYALGIA (Aching) and FATIGUE (Extreme fatigue). At the time of the report, ANGINA PECTORIS (Heart pain), RESPIRATORY SYMPTOM (pneumonia-like symptoms), INFLUENZA LIKE ILLNESS (Flue symptoms), MYALGIA (Aching) and FATIGUE (Extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Echocardiogram: normal (normal) normal.         The patient went to emergency department and everything was normal. The reporter stated that the patient was better with nitroglycerine.  No concomitant medications were reported.  Treatment for the events included nitroglycerine.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 12-year-old male patient. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications. On an unknown date, at age of 14 months, the patient was vaccinated with his first dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (exact dose, route, anatomical location, lot# and expiration date were not reported). On an unknown date at age of 30 months, he received second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose, route, anatomical location, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the previously healthy patient, presented to the emergency department with a 1-day history of fever, headache, phonophobia and photophobia. Because he had neck stiffness, a lumbar puncture was performed. Laboratory analysis of cerebrospinal fluid (CSF) revealed 83 white cells/mm3 (88% lymphocytes). The CSF was tested by the meningitis panel and found to be positive for varicella zoster virus (VZV) and negative for enterovirus, herpes simplex virus, and HHV6, as well as bacteria. The patient was hospitalized, and acyclovir intravenous (IV) (30 mg/kg/day) was initiated. No radiologic studies were ordered. On day 5, he was discharged home; his acyclovir was switched to oral administration for a total treatment course of 14 days. The virus in the CSF was confirmed to be the VZV vaccine strain by Sanger sequencing. Polymerase chain reaction (PCR) analysis for HHV-7 DNA on the CSF was performed; that test was negative. The patient had an extensive immunology evaluation, which showed normal serum immunoglobulin (IG) IgG, IgA, and IgM levels and normal serum levels of vaccine antibodies for all tested antigens (measles, varicella, tetanus, and diphtheria). An extended immunophenotyping showed normal subpopulations of B, T, and NK cells. Finally, genetic analysis was performed by immunology exome sequencing, which included a panel of 356 genes of primary immunodeficiency. However, no errors in innate immune genes or other rare primary immunodeficiencies were discovered; specifically, there were no errors in RNA polymerase III genes. The child had undergone a complete recovery when seen at 1 and 12 months after his hospitalization. A copy of the published article is attached as further documentation of the patient's experience. This is one of three cases derived from the same literature article (cross referenced with MARRS# 2112USA003020 and 2007USA012025).; Sender's Comments:  US-009507513-2112USA003020: S-009507513-2007USA012025.
constant headache; Very tired; achy; low fever; injection site soreness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-years-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, SINGLE dose, Lot number EN6199, Expiration date: unknown), via an unspecified route of administration, administered in Arm Right on 10Mar2021 12:00 (at the age of 42-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The medical history included hypertension, blood cholesterol increased, and anxiety. Concomitant medication included (other medications in two weeks) HYRDOCHLOROTHIAZIDE, LISINOPRIL, AMLODIPINE, AND LISINOPRIL. The patient previously took CELEBREX. The Patient's allergies to Celebrex, erythromycin, and NSAIDs. The patient not covid vaccination prior. The patient not covid tested post vaccination. The patient experienced Headache started 13 hours after shot. Tylenol didn't help. Had constant headache for 20 hours, Very tired, achy, low fever, and injection site soreness on 11Mar2021, 01:00 AM. The patient did not receive treatment for events except headache. The outcome of the events were recovered on an unspecified date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Pt recvd vax & lab eval revealed that pt was core antibody pos; No further details were provided;