chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two day after the above vaccines, the baby is reported to have suffered a pause in breathing along with her face turning red and somewhat unresponsive. The event happened again today 5 days after the vaccine date of 03/07/2018. Brief resolved unexplained event (BRUE) in infant. She was evaluated at the hospital where infection/seizures were ruled out.
This spontaneous report as received from a pharmacist refers to a 26 year old female patient with no drug reactions or allergies and no pertinent medical history who on 18-OCT-2013 was vaccinated with GARDASIL, lot# J006587 exp. 06-AUG-2015, first dose, 0.5 ml, intramuscular. There was no concomitant medication. On 18-OCT-2013, immediately after administration of the first dose of GARDASIL the patient experienced pain at the injection site and dull, steady pain in her upper body. The patient call the pharmacy (sought for medical attention) and the pharmacist suggested she take ADVIL as needed (treatment given for the events). No lab diagnostics was performed. The outcome of the events was reported as not recovered. Additional information has been requested.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Systemic: Hyperventilation-Medium, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
The patient stated that he felt dizzy after receiving the vaccine and did not feel good. Patient was pale but breathing normally but for less than 30 seconds the patient's eyes became unfocused and his body seemed to tremble and he was unresponsive to questions but never lost consciousness. After this, the patient recovered quickly. First responders evaluated the patient and the patient refused  any medical treatment and stated that he felt better and  left 30 mins after receiving the vaccination
Numbness in hands and arms almost immediately after vaccine.  Pains in joints and headache with nausea began within 8-12 hours after vaccine.  Severe headache, back pain, photophobia, hand and arm numness continued into next day, 2/9/2010, culminating in ER visit evening of 2/9/2010.
This spontaneous report as received from a healthcare worker refers to a 16 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 27-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (Lot# L000610, expiration date 31-JAN-2017) (Strength, dose and route were not provided). Concomitant medication was not reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
vomiting sporadically for a full day with queasiness; vomiting sporadically for a full day with queasiness; lightheadedness; Fever; hives; Migraine accompanied by limited appetite; Migraine accompanied by limited appetite; Migraine accompanied by limited appetite;  This is a spontaneous report from a contactable consumer or other non-health care professional (patient).   A 26-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 29Apr2021 17:30 (at the age of 26-year-old) as dose 2, single for covid-19 immunization. Patient's relevant medical history included ongoing hormonal migraines, depression and anxiety from an unknown date and unknown if ongoing. The patient had no known allergies. Prior to vaccination, patient was not diagnosed with covid-19 and post vaccination, patient was not tested for covid-19. Concomitant medications included paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included, patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 08Apr2021 18:15 (at the age of 26-year-old) as dose 1, single for covid-19 immunization and experienced after the first shot, had migraine for 2 days. The patient did not receive any other vaccine in four weeks. On 30Apr2021 07:00 after second shot, patient experienced vomiting sporadically for a full day with queasiness, lightheadedness, fever, small of hives, migraine accompanied by limited appetite for at least 4 days. The patient did not receive any treatment for adverse events. Outcome of the events was recovering.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Searing pain in my right shoulder and arm.  Could not lift my arm at all for two days.  My left arm had to lift right arm.  After that I could only use my arm from elbow down.    As my fibula is fractured, I used my arms to get up and down my stairs   My right arm was in pain and useless.   I could not turn on shower, wash my hair.  Had excruciating pain shifting gears and turning on heat and radio in car.   5 days later it felt like I was getting constant injections in my arm.   It took 11 days before I could lift my arm half way with pain.  Probably another week after that until I could lift my arm over my head.  Pain still lingers to some extent a month later.    I felt shot was administered too far up on my arm (on my shoulder).   How can I prevent this from happening again.
Client given PPSV23 in L deltoid, within minutes face became pale, swelling under both eyes, lips became pale, both arms reddened and rash present.
Came down with a cold; On-going cough; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Came down with a cold) and COUGH (On-going cough) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced NASOPHARYNGITIS (Came down with a cold) and COUGH (On-going cough). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Came down with a cold) and COUGH (On-going cough) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were blood pressure medicine.    Reporter did not allow further contact
Dizziness, Headache, Myalgia, NauseaVomiting, Back pain Narrative:
Extreme pain in shoulder. Unable to move shoulder or lift arm. 10 days later pain still present. Will see doctor today.
Other then a sore arm at the site of injection it may have caused the glands in my eyelids to become clogged and putting out chunks which feel like dust when I put on my contact lenses.
mild hives on the arms and trunk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Soma, reaction(s): "Known allergies: soma". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: URTICARIA (non-serious), outcome "recovered", described as "mild hives on the arms and trunk". Therapeutic measures were taken as a result of urticaria.  Additional information: Within 10 days of the first booster, the patient developed mild hives on the arms and trunk which resolved after a month. The patient was treated with steroid cream and antihistamines. The patient did not received any other vaccine in four weeks. The patient did not had COVID-19 prior vaccination and not tested for COVID -19 post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient developed shingles rash 2.5 weeks after receiving dose #1 of COVID vaccine.
Pt devel soreness @ inject site p/Td vax; sx resolved w/in a wk;
crying continuously more than 4hr p/vax;(w/in 48hr p/vax);
Shortness of breath:  First noted about 18 hours after the dose, along with body aches, headaches and fatigue.  The latter symptoms resolved after 48 hours, however, the shortness of breath has not resolved as of today (77 hours after the dose).  No crackles or wheezes but inhalation and exhalation feels restricted.  I had Covid-19 with symptoms beginning on 11/16/2020 and had shortness of breath along with crackles and chest tightness  during the second week of illness.  The oxygen level declined to 92-93%.  I was treated with steroids and azithromycin at that time and the tightness of the chest resolved by about day 17 of illness.    I am reporting this adverse effect (chest tightness and shortness of breath) because it may be an autoimmune reaction triggered by the response to the vaccine.
Illness began 20 days after vaccine administration with headache, visual changes, with progressive weakness, fatigue, and bilateral upper and lower extremity pain.  The patient required hospitalization.  Multiple labs including CSF studies were obtained as well as a brain and full spinal MRI.  The patient was diagnosed with Guillain Barre Syndrome for which he received IVIG.  He has required pain control, NG feedings, and physical rehabilitation.  He is currently still admitted at Hospital for rehab.
Patient presented to vaccine clinic with mother. Patient was screened for contraindication and answered all no. Patient was administered Moderna vaccine despite having less than 18 years old. This error was noted after patinet had left with no adverse/side effects.
Strange taste in mouth; Slight fever; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Strange taste in mouth), PYREXIA (Slight fever) and VACCINATION SITE PAIN (Injection site pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced TASTE DISORDER (Strange taste in mouth). 10-Feb-2021, the patient experienced PYREXIA (Slight fever) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, TASTE DISORDER (Strange taste in mouth) had resolved and PYREXIA (Slight fever) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown. Not Provided          No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow-up information received on 28-APR-2021 contains non-significant information: Contact details updated
A few minutes after getting IM vaccine, patient developed itchyness and redness on neck.  She was given IM Benadryl and sent home with PO antihistamines.
It was her fourth vaccine and the first three were moderna; feeling like she had covid over a month with the Pfizer vaccine; feeling like she had covid over a month with the Pfizer vaccine; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5, on 23Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "It was her fourth vaccine and the first three were moderna"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "feeling like she had covid over a month with the Pfizer vaccine". The event "feeling like she had covid over a month with the pfizer vaccine" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: nothing. Clinical course: Reporter's mom (patient) had been feeling like she had covid over a month with the Pfizer vaccine. It was her fourth vaccine and the first three were Moderna. She didn't feel like this with the first three however, the last vaccine she put was on 23Sep2022. She had long term symptoms such as fatigue, feeling of fever, harsh headaches, body aches and pain in muscles. Reporter asked how this could be treated and how they could reverse the long term symptoms of it. They had gone with several specialist with blood test and nothing.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
exposed on vacation for a week ending 30May2022, then sx ST congestion HA fatigue and positive test 02Jun2022 Ag; exposed on vacation for a week ending 30May2022, then sx ST congestion HA fatigue and positive test 02Jun2022 Ag; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the parent.  A 24-year-old patient received BNT162b2 (BNT162B2), on 24Dec2021 as dose 1, single (Lot number: FF2589) at the age of 23 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jun2022, outcome "unknown" and all described as "exposed on vacation for a week ending 30May2022, then sx ST congestion HA fatigue and positive test 02Jun2022 Ag". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jun2022) Positive, notes: Nasal Swab; (01Jun2022) Pending, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Patient exposed on vacation for a week ending 30May2022, then sx ST congestion HA fatigue and positive test 02Jun2022 Ag.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event covid 19 and Drug ineffective and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Pain in arm. Pain when moving arm. It has been 7 days and arm still hurts.  No swelling or redness is reported.
Painful arm, body aches, chills, muscle aches, headache, fatigue, within 15 hours of receiving vaccine. Arm swollen, red, and hot a few inches below injection site 48 hours later.
Expired vaccine used; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 12-Jan-2021. Concomitant products included METFORMIN, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), ATORVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID] and GLIMEPIRIDE for an unknown indication.    On 03-Sep-2021 at 11:33 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021 at 11:33 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 03-Sep-2021 at 11:33 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Polymerase chain reaction: positive (Positive) positive for COVID-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. It was reported that, the patient had no known drug allergy.The patient had no chronic conditions like Diabetes type 2, obesity, PAD and HTN. The patient had no adverse events.  The patient height was 67.5 inches and weight was 316 pounds   This case was linked to MOD-2021-328706 (Patient Link).
9/3/21 hx of HTN, DM-II, HLD, obesity, asthma, OSA, R knee OA s/p R-TKA 8/24/21 who presented to the ED for evaluation of increasing shortness of breath, persistent cough, body aches, nausea, vomiting and diarrhea
2 days after receiving bivalent booster, which was patient's third documented covid shot, patient woke up complaining to mother of severe headache.
burning,itching,& rash on the left arm. Benadryl. Pt declined Steroid treatment for now
Flu like symptoms, aching joints, slight cough, nasal drip and congestion, headache, sore at injection site.
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On 29-OCT-2014, the patient was vaccinated with M-M-R II (route, dose, frequency and lot # were not reported) which underwent a temperature excursion (on an unspecified date). This is one several reports received from the same reporter. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of eye red in a adult male patient who received TWINRIX adult. On an unknown date, the patient received the 2nd dose of TWINRIX adult. On an unknown date, 1 hr after receiving TWINRIX adult, the patient experienced eye red. On an unknown date, the outcome of the eye red was unknown. It was unknown if the reporter considered the eye red to be related to TWINRIX adult. Additional details provided as follows: A later after vaccination, the patient's eye became red. The patient declined to proceed with Safety report. No further details were known. Age at vaccination was not provided.
extremely sore arm; received an incorrectly diluted Covid-19 vaccine on 7/19/22. The nurse feels he got over twice the dose strength for his age; received an incorrectly diluted Covid-19 vaccine on 7/19/22. The nurse feels he got over twice the dose strength for his age; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5-year-old male patient received BNT162b2 (BNT162B2), on 19Jul2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PREPARATION ISSUE (non-serious), ACCIDENTAL OVERDOSE (non-serious) all with onset 19Jul2022, outcome "unknown" and all described as "received an incorrectly diluted Covid-19 vaccine on 7/19/22. The nurse feels he got over twice the dose strength for his age"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "extremely sore arm".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Had all of the vaccinations. Got a mild case/Suspected vaccination failure; Mild case; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with acyclovir. 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 Shingrix.     Additional Information: GSK receipt date : 28-Aug-2022 Reporters comment: This case was reported by a consumer via interactive digital media  The patient had mild case of shingles after received shingrix  vaccine. The patient also stated that he/she had all of the vaccinations. The patient took the Acyclovir in high dosage for three days. Additional Supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Nausea, shortness of Breath and fast heart rate. 09009-2001 had red rash and dizziness
No additional AE reported; dose of MMR II was inadvertently administered after the labeled expiration date.; This spontaneous report was received from an other health professional and refers to a patient of unknown age and gender. No information on patient medical history, current conditions and concomitant medications was provided.   On 21-APR-2023 the patient was vaccinated with 0.5 milliliters of expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # U011993 and expiration date 15-APR-2023 for prophylaxis (route of administration was not provided) (expired product administered and no adverse event).
16 year old receive their first Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old receive their first Moderna vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old receive their first Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old receive their first Moderna vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Pharmacist asked should the 16 year old receive their second Moderna vaccine.  No treatment information was provided.
Bad pain and swelling under left armpit still there today. Cannot touch. Headache and body ache in bones and muscles.
Pt developed swelling at injection site and fever to 104 which resolved on its own. Symptoms started 48 hours after injection.