chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; headache; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 30Apr2021 (Lot number: EW0164) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Dry eyes" (unspecified if ongoing). Concomitant medication(s) included: PROLIA taken for osteoporosis (ongoing); XIIDRA taken for dry eye (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Her first COVID vaccine dose was given on 09Apr2021, with lot number ER8729., Anatomical location: left arm), administration date: 09Apr2021, when the patient was 63 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "fever"; HEADACHE (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "headache"; CHILLS (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "chills".  Additional information: Additional Vaccines Administered on Same Date of the Pfizer Suspect: no. Patient's Medical History (including any illness at time of vaccination): Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: no. Relevant Tests: List other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI): No. Prior vaccinations within 4 weeks was reported as no. After the second dose she had fever, chills, and headache for a day or so. She was fine after that. She wasn't nervous about that because she had read ahead and knew that those could be possible side effects. Adverse events did not result in Emergency or physician office visit. Investigation assessment was reported as no.  No follow-up attempts are possible. No further information is expected.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I received four of the six shots while in the guard. My shots were given between June 2003 and April 2004. My health prior to receiving the shots was perfect. After receiving the shots, I now suffer from fatigue, vertigo which can strike me suddenly, persistent headaches lasting months at a time, worsening joint aches and concentration difficulties. I have been seeing doctors since October 2003 when I could no longer pretend that nothing was the matter. Reliably, the symptoms got worse after each shot I received. I cam currently having my records evaluated by a hospital to see if any correlation can be made since there are no studies available. (OMIC)
Symptoms started around 9-10 of March still lose if vision in eye continuing to see eye dr
pt recv vax 5APR94 & 19NOV96 pt has been recently tested & was negative for rubella, positive for measles & borderline for mumps;
Her arm was swollen, red and puffy; Her arm was swollen, red and puffy; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (reported as "the patient had unknown pneumonia vaccine shot, unknown if it was Prevnar 13 or not, lot number was unknown), via an unspecified route of administration, was given in her arm on an unspecified date in 2020 at single dose for immunization. The patient medical history and concomitant medications were not reported. It was reported that the reporter had seen another individual in the last 6 months, did not remember what the date was, but patient was female and had an unknown pneumonia vaccine shot, unknown if it was Prevnar 13 or not; but where shot was given in her arm, her arm was swollen, red and puffy and it was around the muscle and it went down like the front inside of arm and back side of her arm on an unspecified date in 2020. That patient was on the way to a doctor's office about the events when caller saw her. The outcome of the events was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported a heavy feeling in the chest, with tightness and fullness as well as difficult breathing. Patient also reported numbness of the lips. Symptoms occurred within 5 minutes of vaccine administration. Epinephrine 0.3mg pen was administered at 11:05 per protocol. One diphenhydramine 50mg capsule was administered at 11:07 per protocol. Patient reported easier breathing and increased heart rate almost immediately. Her throat felt like she "swallowed an ice-cube sideways". Within 10 minutes, the patient reported that her lips and throat felt better, but still tingles. States that it was "like she had recently shaved". A wheelchair was provided by the long-term care facility staff, and the patient was wheeled to the ER within the facility. Patient arrived at ER at 11:18 and pass-off to the ER team was completed around 11:20.
Face looked extremely swollen; Thighs and arms were puffed up; Gained weight; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unknown date in Jan2021 as dose 2, single for COVID-19 immunisation; botulinum toxin type a (BOTOX), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Not Provided) to an unspecified date, at unspecified dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient face looked extremely swollen, thighs and arms were puffed up, gained weight on an unknown date in Jan2021. The patient underwent lab tests and procedures which included weight: gained weight on unknown date in 2021. Outcome of the events was not recovered.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
(R) arm pain, tingling, weakness x 10 weeks on NSAIDS. Pt and scheduled be seen by ortho. EMG pending.
He reported that the vial label is confusing; No adverse event; Received Monovalent booster instead of Bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster), PRODUCT LABEL CONFUSION (He reported that the vial label is confusing) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster). On an unknown date, the patient experienced PRODUCT LABEL CONFUSION (He reported that the vial label is confusing) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster), PRODUCT LABEL CONFUSION (He reported that the vial label is confusing) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster) and PRODUCT LABEL CONFUSION (He reported that the vial label is confusing).    No concomitant medication was reported.  Reporter had a Dark Blue Cap and a label with purple border. On the vial label it stated, Booster dose only. Reporter stated that the vial label was confusing, so 5 adult Patients received Monovalent booster instead of Bivalent booster of Moderna COVID-19 vaccine.  No treatment information was provided.
Booster shot on 11/10/2021. By about 6:30 pm next day, had a body rash from waist up to half way up my breasts. Also in groin area. Pink rash and itchy. Applied Benadryl lotion and took 1 Benadrill pilL Thought was clearing up next morning, but came back about same time in evening. Rash was more along edge of body up around arm pits. Also, in groin area again and bands around lower chests to back. Rash lasted a total of 4 days.
Headache (began roughly 12 hours after shot and lasted about 8 hours); Chills and flushing intermittently (began roughly 12 hours after shot and lasted approx 24 hours); Fatigue (noticed upon rising and lasted  about 24 hours)
Immed following vax, pt exp arm pain from shoulder to hand. Pain resolved within 30 min.This is 1of 3 employees to exp arm pain following vax with lot #4978143. Reporter notes: 25 gauge, 1 in. needle used to administer vax.
Pt w/ a hx of unknown Advil reaction.  Flushing/sweating, dizziness, vasovagal episode.  Pt had a vasovagal reaction from fear of needles/anxiety.  Placed patient in Trendelenburg position and felt normal/baseline.  OJ given.  BP 103/61, HR 102, RR 18 -- > 115/63, 89, 18.  Pt stable and released from vaccination site.
Headache, vomiting, weakness.  Admitted to the hospital 03/08/2010 and was diagnosed with the Miller-Fisher variant of Guillain-Barre Syndrome.
Around 7 days after booster I broke out in hives all over body. A week after hives I started experiencing numbness and tingling in the right side of face, hand and foot. It has been almost two months since vaccine and still experiencing all of these symptoms.
Information has been received from a registered nurse concerning a 13 month old white male with no known allergies and no pertinent medical history who on 02/26/2001 was vaccinated SC in the right lateral thigh with a first dose of MMR II. There was no illness at the time of vaccination. On 03/27/2001, the pt experienced fever, cough, poor appetite, swollen tonsils and a slight rash. It was noted that the pt presented to the office with a several day history of the fever, cough and decreased appetite. No treatment was given. Subsequently, the pt recovered. No further info is available.
Patient experienced fever, chills & body ache. She went to urgent care center 11/5/10 & they thought she had infection & gave her an antibiotic. She went to allergist on 11/8/10 & he said no infection but patient had arthus reaction. Patient received a 2 day course of steroids.
diarrhea; worsening to pain in entire arm with redness and inflammation; arm was warm; GI symptoms; Golfball sized bump on arm; worsening to pain in entire arm with redness and inflammation; worsening to pain in entire arm with redness and inflammation; .This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 62 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 02Dec2021 (Lot number: FJ8757) at the age of 62 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: DIARRHOEA (non-serious) with onset 03Dec2021, outcome "recovering", described as "diarrhea"; ERYTHEMA (non-serious), INFLAMMATION (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 03Dec2021, outcome "recovering" and all described as "worsening to pain in entire arm with redness and inflammation"; FEELING HOT (non-serious) with onset 03Dec2021, outcome "recovering", described as "arm was warm"; GASTROINTESTINAL DISORDER (non-serious) with onset 03Dec2021, outcome "recovering", described as "GI symptoms"; MASS (non-serious) with onset 03Dec2021, outcome "recovering", described as "Golfball sized bump on arm". The events "diarrhea", "worsening to pain in entire arm with redness and inflammation", "arm was warm", "gi symptoms", "golfball sized bump on arm", "worsening to pain in entire arm with redness and inflammation" and "worsening to pain in entire arm with redness and inflammation" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of diarrhoea, erythema, feeling hot, gastrointestinal disorder, mass, inflammation, pain in extremity.  Follow-Up (14Dec2021): Follow-up attempts are completed. No further information is expected
On June 8th, woke up with severe dizziness, needed assistance. Since then I have what would qualify as POTS.  The symptoms are improving slowly with time.  Symptoms- dizzy when standing, heart racing, fatigue.
extremely tired; This is a spontaneous report received from non-contactable reporter(s) (Pharmacist) from a sales representative. An 80-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "extremely tired". It was unknown if therapeutic measures were taken as a result of fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300370236 same reporter/vaccine/event, different patients;
Patient called our office to inform us that she had "pumps all over her body and they itch really bad." She states that she woke up with the pump and itching this morning. Her mom gave her a Benadryl pill.
horrible reaction; pains; spots on wrist|chest|bend of elbow; rash all over chest|arm|face/long lasting rash for at least a month; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (horrible reaction), PAIN (pains), RASH MACULAR (spots on wrist|chest|bend of elbow) and RASH (rash all over chest|arm|face/long lasting rash for at least a month) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to codeine), Drug allergy (Allergic to Phenergan), Contrast media allergy (Allergic to contrast dye) and Allergy to nuts (Allergic to Peanuts). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, CLOPIDOGREL, CARVEDILOL, ASPIRIN [ACETYLSALICYLIC ACID], TAMOXIFEN, TRAMADOL and PARACETAMOL (TYLENOL ARTHRITIS) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (horrible reaction), PAIN (pains), RASH MACULAR (spots on wrist|chest|bend of elbow) and RASH (rash all over chest|arm|face/long lasting rash for at least a month). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (horrible reaction), PAIN (pains), RASH MACULAR (spots on wrist|chest|bend of elbow) and RASH (rash all over chest|arm|face/long lasting rash for at least a month) had resolved.            After the second dose patient had a horrible reaction, rash, long lasting rash for at least a month, all over chest, arm, face, pains, all kinds of horrible things.Every once and a while out of the clear blue, patient got some spots on her wrist, chest and bend of elbow.  Patient did not experienced tightness or breathing problems.   Patient claimed she was doing fine and never got Covid19 even though her granddaughter got covid19 after having the Pfizer vaccine.  Patient taken aspirin for side effects at the time.   This case was linked to MOD-2022-500341 (Patient Link).
Sore left arm around vaccination site, high fever late at night, fatigue following day, headache and upset stomach in morning after booster COVID shot
12-19-07 child received Varicella vaccination in left arm SC.  Mom called 12-21-07 describing small red spot at injection site loking "like a bee sting".  States child complained of pain in arm at injection site.  No fever, drainage, or rash. Mom instructed to try tylenol or motrin for pain and swelling.  Also try warm or cold compresses to injection site 2-3 times a day as child permits.  Also instructed to call Primary Doctor if condition worsens.  Mom arrived at facility about 2:30 pm stating unable to accomplish above instructions as child too painful.  Child very tender to light touch.  Small hard red bump about the size of eraser head, pinpoint noted in center, no drainage. Instructed mom to notify PMD for appt. today.  We called Primary Doctor from our office and there were no appts. available for today. Primary Doctor instructed mom to take child to Promptcare for assessment of potential "sterile abcess". Mom states will followup with us as to outcome. Mom did not call back as of today (12-31-07) and we have made several attempts to contact mom via phone with no answer.  Message left for mom to call us.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of ROTATEQ (lot # M042821, expiration date 14-JUN-2018; lot # M042822 expiration date 19-JUN-2018; lot # M031805 expiration date 07-MAR-2018 and lot # M040269 expiration date 28-APR-2018) dose was not reported orally for prophylaxis. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA010673: US-009507513-1704USA010672.
I had never been that sick. I hadn't been sick at all for 3 years. I began feeling symptoms on 12/24/2022. I did test positive for COVID-19 on 12/25/2022. I had a sore throat, chest discomfort, fatigue, and shortness of breath when I would try to do things. I would start panting and my heartrate would go up. I also had a headache, a little dry cough like trying to clear your throat and sinus pressure. The tiredness lasted for two and a half weeks. I was prescribed PAXLOVID for the COVID-19 infection.
12 hours post 2nd moderna vaccine, 102 fever, bad joint,  muscle pain and bad neck and headache, extreme nausea,  fatigue, fast heart beat, had to stay in bed for 2 days. Three days post vaccine started the symptoms  of extreme fatigue,  nausea, dizziness  and some vomiting of crackers and water, some diarrhea which is still occurring presently.  Have some energy after 6pm, can eat rice but still extreme nausea,  fatigue, fast heartbeat.
Given PREVNAR 13 on 09-08-16 noted the next morning redness, edema and warm to touch. Instructed heat/ice/antihistamine call if worsening/no improvement in 5 days.
5 year old received a flu vaccine on 12/5/18 in Left Thigh. One hour after injection he began to have pain and swelling of left leg. Mother applied cold compress. The following day swelling progressed and he presented back to clinic on 12/6/18 with extensive leg swelling of his left leg, warmth, tenderness and inability to bear weight. No fevers.
The vial was initially stored in the refrigerator on 06-JUL-2022 and was administered from 19-Sep-2022 until 09-Nov-2022; No adverse event; Adult patient received expired Monovalent booster dose of Moderna COVID-19 vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Monovalent booster dose of Moderna COVID-19 vaccine.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-JUL-2022 and was administered from 19-Sep-2022 until 09-Nov-2022) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Monovalent booster dose of Moderna COVID-19 vaccine.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-JUL-2022 and was administered from 19-Sep-2022 until 09-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Monovalent booster dose of Moderna COVID-19 vaccine.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-JUL-2022 and was administered from 19-Sep-2022 until 09-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Monovalent booster dose of Moderna COVID-19 vaccine.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-JUL-2022 and was administered from 19-Sep-2022 until 09-Nov-2022).    No concomitant information was reported. It was reported that monovalent vials of Moderna COVID-19 vaccine in the freezer moved to the refrigerator on 06-JUL-2022 and beyond use date was 05-AUG-2022. The unknown vial did not underwent any temperature excursions.   No treatment medications were reported.     This case was linked to US-MODERNATX, INC.-MOD-2023-720531 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720531:
Patient returned to school after appointment and went to school health, did not feel well.  Nurse/caregiver at school called mother and reported that he seemed "loopy". Pt symptoms progressed to fever, headache, stomach ache and general malaise. Lasted for days and headaches for a week.  At the end of symptoms, patient developed hives the last few days, being sick over one week total.
soreness in the underarm area and felt it was lymph nodes; inflamed lymph nodes; This is a spontaneous report received from a contactable other health professional. A male patient of an unspecified age received BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date: unknown), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced soreness in the underarm and felt it was the lymph nodes. The reporter thought it was inflamed lymph nodes. The outcome of the events was unknown.  Information on the lot/batch number has been requested.