chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain all over the body; fever; headache; tiredness; pain all over the body; tiredness; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PAIN (pain all over the body), the second episode of PAIN (pain all over the body), the first episode of PYREXIA (fever), the second episode of PYREXIA (fever) and the first episode of HEADACHE (headache) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient medical history was not reported.  Concomitant products included VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced the first episode of PAIN (pain all over the body), the first episode of PYREXIA (fever), the first episode of HEADACHE (headache) and the first episode of FATIGUE (tiredness). On 28-May-2021, the patient experienced the second episode of PAIN (pain all over the body), the second episode of PYREXIA (fever) and the second episode of HEADACHE (headache). 28-May-2021, the patient experienced the second episode of FATIGUE (tiredness). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, last episode of PAIN (pain all over the body), the last episode of PYREXIA (fever), the last episode of HEADACHE (headache) and the last episode of FATIGUE (tiredness) outcome was unknown.
Heat & redness down to elbow, family reports swelling on 10/26 but none is noted today 10/27. Pt was given a DEPO MEDROL 80mg inj IM on 10/27/ for treatment.
still has a very bad headache; extremely sore arm; nauseous; felt like her head split open; vomited twice (liquid brown); This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (extremely sore arm), NAUSEA (nauseous), HEADACHE (felt like her head split open), VOMITING (vomited twice (liquid brown)) and HEADACHE (still has a very bad headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023U20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced LIMB DISCOMFORT (extremely sore arm), NAUSEA (nauseous), HEADACHE (felt like her head split open) and VOMITING (vomited twice (liquid brown)). On 21-Feb-2021, the patient experienced HEADACHE (still has a very bad headache). On 21-Feb-2021, LIMB DISCOMFORT (extremely sore arm) had resolved. At the time of the report, NAUSEA (nauseous), HEADACHE (felt like her head split open), VOMITING (vomited twice (liquid brown)) and HEADACHE (still has a very bad headache) outcome was unknown.
1/9/22 Started 1 day(s) ago with URI SX     She has tried Tylenol, which  has helped.    In general, the problem is better compared to when it started.    COVID-19 contacts? No    Loss of taste/smell? No    COVID Vaccinated? Yes     ROS:  Const: Fever: No, Chills: Yes, Body Aches:  Yes ENT: Ear Pain :No, Sore Throat: Yes, Nasal Cong: No Resp: Cough: No GI: Nausea:No, Vomit: No, Diarrhea:No     Neuro: Headache:   YesPhysical Exam Constitutional:      General: She is not in acute distress.    Appearance: She is well-developed.  HENT:     Mouth/Throat:     Pharynx: No oropharyngeal exudate or posterior oropharyngeal erythema.  Eyes:     Conjunctiva/sclera: Conjunctivae normal.  1/9/22   Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Heart sounds: Normal heart sounds. No murmur heard. Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing or rales.  Chest:     Chest wall: No tenderness.  Musculoskeletal:     Cervical back: Normal range of motion and neck supple.  Lymphadenopathy:     Cervical: No cervical adenopathy.  Skin:    General: Skin is warm.     Findings: No rash.
Pt received FLUMIST and MENACTRA on 10/12/15 and started with headache that night, followed by runny nose, sore throat, cough and fever up to 102 in the next day, with symptoms persisting for 5 days, slow but complete resolution of symptoms.
The fire department came to his house as he is a paraplegic to give him the vaccine, and  he can't move, is fatigued, has tightness in his joints, and has stomach issues, and takes Oxybutynin to control his urine and doesn't know what he's supposed to do.  Off and on he has had a headache.   Doesn't understand why they would give him a shot if it gives people a blood clot and he's a paraplegic.   He already has an IVC filter in his veins to prevent him from getting blood clots.
Pt c/o red face, also stated she had been in the sun yesterday. After 10 minutes symptom resolved and patient left the site -RN
About 2 to 3 hours after being inoculated both hands became tingly and eventually went numb, my left was worse than my right, I also felt very light headed and could not stand and my heart rate was extremely rapid. This continued but then completely stopped 2 hours later, weirdly it returned exactly 24 hours later only not as extreme. I feel fine now but I also felt the need to call 911 during this episode.
Suspected vaccination failure; Got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The reporter's friends husband had a vaccination and still got shingles. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed chickenpox that consisted of approximately 50 lesions and no fever.
blood count was low; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 77-year-old female patient received COVID-19 vaccine (UNSPECIFIED TRADE NAME) 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. Patient stated that she received a covid 19 vaccine shot, and her blood count was low. The outcome of the event was unknown.    Information about lot/batch number was requested.
The patient stated he started having tinnitus in one ear the morning after the 2nd Pfizer covid vaccine and has had it since.
reduce ability of the eye lense to accommodate for far and near vision.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Feb2021 11:00 (Lot number: en6202) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset May2021, outcome "not recovered", described as "reduce ability of the eye lense to accommodate for far and near vision.". The event "reduce ability of the eye lense to accommodate for far and near vision." was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of visual impairment.  Additional information: The patient received no other vaccine in 4 weeks. The patient had covid prior vaccination. The patient had not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
next day (3/31) headache and fatigue started around noon, aches around 4pm along with chills- similar to COVID symptoms from 11/20/20
a little over 30 days post vaccine - patient experienced "stroke like event" that took her to overnight stay in hospital - this patient had no history of elderly illness except for well managed diabetes - from first Covid shot April 19 to current, patient has had a seizure, an extreme reaction to codeine, and a stroke like event - patient now exhibits mild to moderate short term memory loss - patient has had 4 CT scans and 1 MRI
9 months old received adult dose; 9 months old received adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 9-month-old female patient who received HBV (Engerix B adult) (batch number T2S4Z, expiry date 20th November 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st December 2021, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 21st December 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child 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 details were provided as follows: A nurse reported that a pediatric patient, received an adult engerix-B dose, which led to overdose and adult product administered to child. The reporter consented to follow up.
4 doses of expired Bexsero were inadvertently administered; This case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA14BA, expiry date March 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th April 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 26th April 2021, unknown after receiving Bexsero and Bexsero 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 without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: During a school vaccination clinic, a dose of expired Bexsero was inadvertently administered to the patient which led to expired vaccine used. This was one of 4 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR094018:same reporter US-GLAXOSMITHKLINE-US2021AMR094019:same reporter US-GLAXOSMITHKLINE-US2021AMR094010:same reporter
"Allergy" written on form. "No" checked to egg allergy screening question. FLUMIST given. No reaction within 90 minutes. BENADRYL 25mg PO given per mother's request.
Within 3hrs of receiving vaccine noted - "itching, heaviness inside chest. Took ZYRTEC, went to bed tired had feelings of hot , cold & shivering, followed by muscle twitching in extremities throughout the night. Unable to make conscious decisions. On 11-5-10 - face swollen, hands numb, headache eyes-gooey 1" diam. bruise - injection site. Attended Yoga class 11/6/10. S/s resolved - 11/6/10.
PT INITIALLY STARTED WITH SORE ARM WITHIN A COUPLE HRS. THE ARM BECAME RED WITH HEAT AND SWOLLEN AND COULD NOT SLEEP THE NEXT DAY. THE REDNESS SPREAD TO HALF OF INNER BICEPS, THEN SHE WENT TO SEE A DR AT ER. THE PATIENT WAS GIVEN PREDNISONE AND CEPHALEXIN UNKNOWN DOSE AT THE OFFICE. THE PATIENT'S REDNESS SUBSIDED THEN SHE WAS DISCHARGED THE SAME NIGHT WITH CEPHALEXIN 1000MG BID X7D AND PREDNISONE 60MG QD FOR 4 DAYS. THE PHYSICIAN DIAGNOSED AS ALLERGIC REACTION WITH NO SIGNS OF INFECTION.
4 year old female patient received expired vaccine, no AE; Initial information received on 12-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 4 years old female patient who received a 0.5 mL expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] for prophylactic vaccination (lot C5366AA and expiry date: 07-Feb-2020) via an unknown route in the right deltoid, on 12-Feb-2020.  Medical history, medical treatment, vaccination and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pain in the back of the neck; Scratchy throat; Aches; Fever of about 101.5 that lasted for a few hours; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain in the back of the neck), THROAT IRRITATION (Scratchy throat), MYALGIA (Aches) and PYREXIA (Fever of about 101.5 that lasted for a few hours) 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 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced NECK PAIN (Pain in the back of the neck), THROAT IRRITATION (Scratchy throat), MYALGIA (Aches) and PYREXIA (Fever of about 101.5 that lasted for a few hours). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia, Neck pain, Throat irritation and Pyrexia, at an unspecified dose and frequency. On 02-Sep-2021, PYREXIA (Fever of about 101.5 that lasted for a few hours) had resolved. At the time of the report, NECK PAIN (Pain in the back of the neck), THROAT IRRITATION (Scratchy throat) and MYALGIA (Aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Sep-2021, Body temperature: 101.5 (High) Fever of about 101.5 that lasted for a few hours.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications includes an antidepressant.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case was created for 119th of the 190 patients involved. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. Treatment information was not reported   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER CASE
Vigorous smallpox reaction at deltoid (local), rubor, pruritus, lymphadenopathy (streaking).
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 82-year-old male patient who received SHINGRIX (batch number KB99G, expiry date 22nd February 2021) for prophylaxis. On 28th September 2018, the patient received the 1st dose of SHINGRIX. On 15th October 2018, 17 days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. The patient experienced constant pain in his right arm, which was described as a dull aching pain. The patient stated, when the arm was not in use the pain was 1 to 2, but in use it was 5 to 6. The patient related his pain to the vaccine. Till the time of reporting, the patient had not informed or spoken with his physician about the pain.
pt recv vax 14AUG95 & same day pt devel mild flu-like sx & some sl edema & discomfort of the lt parotid;18AUG95 pt was seen by MD & c/o lt parotid edema & discomfort;exam revealed an enlarged & very tender parotid gland;t98.3;dx parotitis
patient had a syncope; patient had anxiety before getting vaccine; patient had  similar issue when go  to dr office to draw blood but doesn't lately happened with flu shot.
School Nurse Volunteer for Public Health School-Based COVID-19 Clinic administered Pfizer Gray top to this 11y 7m female patient.  No adverse reactions were noted in past 3 wks since administration.  Patient's mother and PCP, (Privacy), MD were notified of the error and no further action has been taken.  The patient was referred to (Privacy) for follow-up & 2nd dose of Pfizer COVID_19 Orange Cap Vaccine.
tired for 3 days after booster shot; creatine was up about 22% again; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 02Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administration date 02Oct2021 (Batch/Lot number: unknown) for immunisation. Relevant medical history included: "Chronic Kidney Disease" (unspecified if ongoing), notes: numbers show in the middle of phase 2 to 3; "Diabetes" (unspecified if ongoing); "Immune compromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, felt tired little bit of swollen arm went away after 2 days), for COVID-19 Immunization, reaction(s): "Swollen arm"; Bnt162b2 (DOSE 2, SINGLE, his creatine level went up 20 to 25%), for COVID-19 Immunization, reaction(s): "Creatinine level"; Bnt162b2 (DOSE 2, SINGLE, he felt tired), for COVID-19 Immunization, reaction(s): "he felt tired". The following information was reported: FATIGUE (non-serious) with onset Oct2021, outcome "recovered", described as "tired for 3 days after booster shot"; BLOOD CREATINE INCREASED (non-serious) with onset Oct2021, outcome "unknown", described as "creatine was up about 22% again". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient history of chronic kidney disease (numbers show in the middle of phase 2 to 3), diabetes and immune compromised. Patient was fine after the first Pfizer BioNtech covid 19 vaccine. After his second dose he felt tired little bit of swollen arm went away after 2 days. Also reports that he was tired for 3 days after booster shot, also took flu shot at the same time but then felt ok and his creatine level went up 20 to 25%, made some medication changes after 2 months kidney levels got better, came back to the number we had before. He took booster shot 2 weeks ago on 02Oct2021 and his blood test from this Friday showed that his creatine is up about 22% again. He was not feeling tired as he normally is with kidney issues. Patient seeking information regarding the covid information guide in the document it says, increased endocrine level of 20% from the baseline without any other possible explanation, timeframe of 2 weeks after, back to normal a few months after, do you have any information about this?  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-202101392702 same patient, different vaccine dose/AE
Pt comes in today to report reaction on her vaccination The symptoms appeared 1 day after her vaccination. Symptoms includes. rashes over her body, mild fever. She went to her doctor today and everything appeared to be normal other than rashes on her body. No other complications were detected.
she was tired after her first booster to Pfizer.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 23Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 19Jan2021, when the patient was 79-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 09Feb2021, when the patient was 79-year-old, for Covid-19 Immunization, reaction(s): "Tired", "Chills", "Cold", "Felt drugged". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "she was tired after her first booster to Pfizer.".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash with papules on erythematous base and surrounding pallor on arms, shoulder and neck pain on side of injection, arm "tingling" on side of injection.
Substantial increase in tinnitus in left ear (deaf in left ear since age 7).  First noticed sometime after second dose given on 4/15/2021, but not correlated to vaccine at the time. Two days after third dose, ringing was substantially louder upon waking. Ringing level has since reduced a little, but it is still much louder than before receiving COVID vaccine. Hearing tested (notes below), with no major loss in sensitivity detected. However, the ringing is fatiguing, particularly in quiet settings, and it impacts sleep.