chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered 1st dose of vaccine to a 17 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of vaccine to a 17 year old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of vaccine to a 17 year old). On 20-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of vaccine to a 17 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.
Pneumovax 23 administered on 10/14/15. On approx. 6:00 AM on 10/15/15, rashed were noted on bilateral upper and lower extremities and lower abdomen area. No other complaints. Benadryl and Prednisone were prescribed by MD. Rash has resolved.
Patient received a vaccine under the age of 18. He was 17 and 1/2 when he received the vaccine. Apparently the patient and his mother were both aware he was too young, but were able to push through our system.
Slightly sore arm; Mild headache; Slight dizziness; This case was reported by a consumer and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On 29th October 2019, unknown after receiving Shingrix, the patient experienced pain in arm, headache and dizziness. On an unknown date, the outcome of the pain in arm, headache and dizziness were unknown.   It was unknown if the reporter considered the pain in arm, headache and dizziness to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported. The patient experienced sore arm, mild headache and slight dizziness on the day of reporting.
Headache chills Narrative:  Pt reported headache & chills on same day after receiving covid vaccine dose #2. Pt treated with Tylenol & ibuprofen.  Other Relevant History:
Large, circular, red, swollen, warm to touch. Started 24 hours after vaccine and lasted 5 days.
This spontaneous report as received from a physician via company representative refers to a patient of unknown age. The patient's pertinent medical history was not reported. Approximately in 2012 (reported as 2 years ago), the patient was vaccinated with ZOSTAVAX (dose, frequency and lot # were not reported). Concomitant medications were not reported. On 17-OCT-2014 the patient was diagnosed with herpes zoster after 2 years of vaccination. The outcome of  herpes zoster was unknown. The causality of herpes zoster was not reported. No product complaint was reported for ZOSTAVAX. Additional information has been requested.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent condition and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX lot # N012618 with expiration date 21-APR-2019 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). Temperature excursion ranged from 15 to 46 degrees Fahrenheit (also reported as 25 degrees Fahrenheit) for the time frame of 1 hour and 15 minutes. No previous temperature excursion was involved. Digital data logger was used. No adverse events were reported. Product quality complaint was not involved. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000884:
This spontaneous case reported by a consumer, describes the occurrence of depression, asthenia (weakness), myalgia (soreness) and arthralgia (joint pain) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced depression, asthenia (weakness), myalgia (soreness) and arthralgia (joint pain). At the time of the report, depression, asthenia (weakness), myalgia (soreness) and arthralgia (joint pain) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 79-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 04Feb2021 as dose 2, single (Lot number: EL9269), in left arm, on 13Oct2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SIMVASTATIN, start date: Jan2012, stop date: 28Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Aug2022, outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Aug2022) Negative; (unspecified date) Positive; (09Aug2022) Positive, notes: Tested again 09Aug, strongly Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Myalgias, severe fatigue, loss of appetite with weight loss, orthostatic hypotension
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN6203), in right arm, on 21Mar2021 as dose 2, single (Lot number: EP7534), in right arm, on 11Oct2021 as dose 3 (booster), single (Lot number: FF8839), in right arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FR9896) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: well managed with medication; "high cholesterol" (unspecified if ongoing), notes: well managed with medication; "Known allergies: mussels" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Jan2015; XYZAL, start date: Jan2018. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05May2022 at 12:00, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05May2022) Positive, notes: 12:00 AM, COVID 19 Treatment; (unspecified date) Negative, notes: Tested negative. Clinical course: : A resurgence of Covid symptoms 3 days after completion of Paxlovid 5 day regimen. Tested negative and felt well, Then symptoms returned, including headache, body aches, mild fever, sore throat, cough, runny nose and extreme fatigue. Paxlovid, Treatment start date=26Apr2022, Treatment stop date=01May2022.  No follow-up attempts are possible. No further information is expected.
Patient was vaccinated on 03/30/2021 @ 1340.  At 1159 the same day, patient started with hives all over her body, tightening in her chest, HTN (186/119), fever and body aches.  Patient went to the Emergency Room and was treated for an allergic reaction and released.  She called our onsite RN on 31MAR21 to report.
I woke up with an extreme sore throat and a cough.  My throat hurt when I coughed.  This pain when coughing lasted 2 days. I tested positive on an At Home COVID-19 test, 1/25/2023.   I contacted the Doctor who proscribed Paxlovid.  I continued to have runny nose and fatigue in addition to the cough and sore throat.   Symptoms lasted about a week and I continued to test positive until 2/13.
L deltoid with redness, warm to touch. Pain radiating from shoulder to elbow increased pain in am . Aches all day long. Getting worse and more painful since vax, it has been 10 days since vax.
Pt states that one day after COVID vaccine dose 2 - had HA, became dizzy, diaphoretic, and had syncopal episode. Pt states she was only unconscious for a second. Pt states that her appetite was poor that day and she did not eat leading up to this syncopal episode. Denies hitting head. Pt states she ate a large meal and felt better. Denies any subsequent dizziness, CP, or SOB.
a 16 year old patient got her both doses; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 16 year old patient got her both doses) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 16 year old patient got her both doses). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 16 year old patient got her both doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-328274 (Patient Link).
blurry vision; Could not stand or walk for more than 1-2 mins without discomfort; Could not stand or walk for more than 1-2 mins without discomfort; Tingling sensation from the back ofboth knees, down to the feet & toes; numbing; Feels likes pins & needles; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 29Mar2021 at 09:00 as a single dose (at the age of 53-year-old) for COVID-19 immunisation. The medical history of the patient included type II diabetes mellitus. The patient reported no allergies to medications, food, or other products. Concomitant medications included metformin hydrochloride (METFORMIN), rosuvastatin calcium (CRESTOR), ascorbic acid (ESTER-C), colecalciferol (VITAMIN D3). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 at 14:00, the patient experienced tingling sensation from the back of both knees, down to the feet & toes, felt likes pins and needles and numbing and was not able to stand or walk for more than 1-2 mins without discomfort, even when sitting down, having both feet down on the ground. Had to be in a lying position or raised leg/feet position to feel relief. Also noticed blurry vision on 30Mar2021, the following day of administering the vaccine, even with his reading glasses on. No other unusual discomfort or adverse effect was noted that time. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events of tingling sensation, pins and needles, numbing, blurry vision. The clinical outcome of tingling sensation, pins and needles, numbing, blurry vision walking difficulty and difficulty in standing was not recovered.   No follow-up attempts are needed. No further information is expected.
Patient received vaccine 4 days past beyond use date 9/4/21  No adverse outcomes or symptoms reported by patient
right thigh area in the muscle feels throbbing and pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "recovered" (2021), described as "right thigh area in the muscle feels throbbing and pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 6 to 7 hours post-vaccine, I developed large baseball-sized swelling, either lymph node or mammary gland in the LEFT AXILLA (left armpit), painful and tender to touch. At first, I felt I had a mild reaction to the vaccine, but symptoms did not dissipate; instead, swelling increased.  I am currently applying COLD COMPRESS to site with no relief.  I will see my Doctor on 8/16/2021 for further evaluation - I am scared and regret taking the Pfizer vaccine. Looking forward to hearing from theCDC
Within one week of receiving the first Pfizer vaccine patient had about 10 papular, red, mildly pruritic lesions on the arms which resolved.   Within 1-2 weeks after the second vaccine the same lesions on arms, chest, legs appeared in abundance.  More importantly she developed nausea, anorexia, fatigue, weight loss and extensive bruising on the entirety of both legs.  Liver issues were suspected and full set of blood work revealed ELEVATED TRANSAMINASES to the mid 300s.  All other labs including CBC, hepatitis titers, CMV, ANA were all negative as was an ultrasound.  Patient stopped the supplements and slowly resolved over the next month
Pt.given a child dose of HepA vaccine.No adverse effects noted at the time of administration. Pt denies any difficulty.
2 days post vax pt experienced facial swelling, wheezing, fever, cough, running nose and sore throat. Pt mom stated that pt had blueberry pie for the first time the night before. Pt was treated with nebulizer, albuterol, intal medication and Benadryl. Pt was rechecked the next day and had significant improvement.
Flu-like symptoms; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Consumer reported that he had another person who had flu-like symptoms (No age and gender provided). Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Vaccinated while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccinated while pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event (No medical history reported).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccinated while pregnant). On 08-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccinated while pregnant) had resolved.            This is a case of product exposure during pregnancy with no associated AEs for this XX-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this XX-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Moderna COVID-19 Vaccine EUA. Side effects included arm pain at the injection site, chills and low-grade fever to 100.0 starting approximately 10 hours after receiving vaccine. Fever broke a few hours later and symptoms had resolved within 24 hours of vaccination.
Jan 24 - shortness in breathe,  back and lungs hurt with deep breathe and pressure in chest  lasted 2  1/2 days. Jan 28- large red rash on arm itchy , sill red . Also having light headiness and pressure in chest and short of breath at time
24 hours after the second vaccine shot I had fever 99.1.  Chills with muscle soreness between my shoulder blades and lower back at hip level. These symptoms lasted about ten hours. I took Tylenol immediately after the shot and then about six or seven  hours apart  after the first dose.  The injection sight was swollen and itchy for several days. On 6 April the injection site bled and then scabbed over, continuing to itch until 8 April.
Extreme itching on soles of feet and palms of hands, only at night time, lasted for 18 days, interrupted sleep nightly, began taking Claritin at day 3, no topical or other antihistamines helped
After the two dosis of Moderna, the patient didn't experience any symptoms. On September 3, 2021, the patient got a third complete dose of Moderna. After this third dose, the patient started feeling extreme fatigue, headaches, and fever.  A week passed by and he wasn't feeling any better, on the contrary, he developed more symptoms like loss of memory and imbalance.  He went to the doctor and had blood tests including a D-dimer test which came high and an MRI which revealed a High-rate Glioblastoma. He later died due to complications of the tumor removal.
No adverse event; The pharmacist mistakenly gave me the Moderna booster for the 5th shot, instead of the Pfizer; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (The pharmacist mistakenly gave me the Moderna booster for the 5th shot, instead of the Pfizer) and NO ADVERSE EVENT (No adverse event) in a 96-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1, Lot-EL9265) on 27-Feb-2021, Pfizer (Dose 2, Lot-EP7534) on 20-Mar-2021, Pfizer (First booster) on 24-Oct-2021, Pfizer (second booster and Lot-FK9893) on 16-Apr-2022. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer, Pfizer and Pfizer.    On 27-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (The pharmacist mistakenly gave me the Moderna booster for the 5th shot, instead of the Pfizer). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The pharmacist mistakenly gave me the Moderna booster for the 5th shot, instead of the Pfizer) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant products were not reported.  It was reported that pharmacist mistakenly gave the moderna booster for the 5th shot, instead of the Pfizer vaccine.  Treatment medications were not reported.
Extreme pain in L arm injection site immediately after injection, followed by extreme fatigue, constant L arm pain, ache in body, on Tuesday-Friday, Saturday felt weak and extremely nauseous, at 2:00 pm experienced a embolic stroke on the right side of the brain and paralysis on the left side of body, rushed to ER, administered TPA clot buster and had a removal of the clots by Dr.
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Tngling sensation across dermatomes associated with vaccine site.
Heaviness and discomfort left arm. Little bit of pain in the vaccinated area. July 27 2021 he said he was cold and axillary temperature was taken it was 37.66 Panadol was given and cream was applied on vaccinated area for discomfort. Since it is the first reaction and is early morning and is not a complication at the moment he will continue under my observation and then I will call his doctor.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 43 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EP7534), in right arm, on 09Apr2021 as dose 2, single (Lot number: ER8729), in right arm and on 27Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Apr2022 as dose 4 (booster), single (Lot number: 0E4J214), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Epileptic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2015343690) on 09 November 2016. This case involves a patient (gender and age at onset of event was not reported) who received TETANUS TOXOID (dose, dose in series, batch number and expiry date of product, route and site of administration were not reported) on an unspecified date. The patient's medical history included allergy to adhesive and penicillin (with potassium). Concomitant medications were not reported. On an unspecified date and duration following the vaccination, the patient experienced allergy to vaccine. Laboratory data and corrective treatment were not reported. The outcome of the event were unknown. List of documents held by sender: none.
had flu vax 10DEC93; 11DEC93 had nausea, vomiting & severe h/a for 2 days; 13DEC93 sx were gone;
Patient developed symptoms of MISC on 11/7/21; fevers began on 11/9/21 with a Tmax of 41.1 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, AKI, cough, shortness of breath, abdominal pain, vomiting, diarrhea, rash, headache, neck pain, and myalgias. Abnormal labs included elevated creatinine, elevated bilirubin, elevated transaminases, elevated urine WBC, NT-ProBNP, elevated CRP, and elevated D-dimer. ECHO studies showed trivial tricuspid regurgitation and trivial mitral regurgitation. Patient was admitted to the hospital on 11/9/21 and treated with IVIG and steroids. She was discharged on 11/17/2021.
The patient is a ICU physician, completed Pfizer dose on 1/12/21.  He developed COVID symptoms on 3/11 with cough, headache and runny nose. He went for a test on 3/12/21 and came back POSITIVE on 3/13/21.