chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A few days after the J & J shot I got a terrible bloody nose.  Clots of blood came out.  ( I normally never get bloody noses even in dry climate)In order to  travel to see my Mom I got a booster shot. I decided it would be a good idea to switch brands since I had a negative side effect.     After taking the Moderna shot the same thing happened a few days and a week later. This time it was worst than the first time. It was a "waterfall" bloody nose.    Both times the bloody nose stopped with tissue in my nasal area for about 10  minutes.
3 days after Vaccination I got a whole body rash, went to ER, was given prescription for Bactrim from local pharmacy. After 1 month and rash still present, went back to ER and this time was given Amoxicillin, it took about another month before rash went away completely.
Breakthrough case admission after 2 vaccines Moderna 3/10/21 lot# 029A21A;  Moderna 4/7/21 lot# 016B21A
weakness, clammy, low blood kpressure,           treated with rest and hydration  sudden wide spread red rash with severe itching on day 3         treated with steroid injection, Benadryl and steoid cream
Complaint of headache upon waking next day after receiving vaccine. Heachache accompanied by loss of appetite, chills, generalized discomfort, chest pain, difficulty breathing, and difficulty sleeping.  All symptoms resolved with the exception of headache and difficulty sleeping until day 2 after receiving vaccination. Day 2 without symptoms
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) in a 6-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 216K22A and AS7647B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 08-Jul-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 25 microgram. On 30-May-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated).    No concomitant medications were reported.   No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:
PERIPHERAL NEUROPATHY 4/1/2022 ADHD, PREDOMINANTLY INATTENTIVE PRESENTATION PERIPHERAL NEUROPATHY 4/1/2022 ADHD, PREDOMINANTLY INATTENTIVE PRESENTATION PERIPHERAL NEUROPATHY 4/1/2022 ADHD, PREDOMINANTLY INATTENTIVE PRESENTATION
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 2 years old female patient who experienced redness at injection site and swelling at injection site, while she received vaccine FLUZONE QUADRIVALENT. Patient had been ill with a cold and sinus infection prior to flu vaccine for 5 weeks. On 05-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via intramuscular route in the left deltoid. The patient developed a non-serious redness at injection site same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient developed a non-serious swelling at injection site same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Patient also had cough, low grade fever and vomiting on an unknown date following vaccination. (Other relevant tests included no lab test). Final diagnosis was swelling at injection site and redness at injection site. The doctor told to give her BENADRYL. The patient outcome is reported as recovered for redness at injection site and as recovered for swelling at injection site. Outcome of other events were not recovered.
RED, HOT SWOLLEN AREA OF INJECTION FOR A FEW DAYS.  AFTER 6 DAYS SHE TOOK BENADRYL AND FELT BETTER. NEXT DAY WOKE UP AREA SWOLLEN HOT AND PURPLE. WENT TO DOCTOR AND THEY SAID IT WAS CELLUTIS AND THEY PUT HER ON AN ORAL ANTIBIOTIC, CEPHALEXIN.
My symptoms began with headache and cough with low grade fever.  I was also fatigued.  This began on Monday April 18, 2022.  I tested positive on April 20, 2022.  I got a prescription for Paxlovid and began taking this on Saturday the 23rd.  After the five-day dosing of Paxlovid I felt better.
Compression fracture in her back.; This is a spontaneous report from a contactable consumer(patient). A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/batch number: not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medication was not reported.  Patient stated that she had recently taken Flexeril, a muscle relaxant, for a compression fracture in her back. She did not specify if it was prescribed to her before vaccination or in between vaccine doses. Patient received Pfizer Covid19 vaccine and asked if there was a contraindication with taking Flexeril because she was due for second dose tomorrow. The outcome of the event was unknown.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Patient initially experienced tingling in left hand right after injection. This resolved but then she began to have tingling in her lips. Then she had tingling at the tip of her tongue and then her neck began to feel stiff. Her blood pressure also rose to 145/72. Her baseline BP is usually 96/69. She was administered 02.ml epinephrine subcutaneously, Then when her lip tingling did not resolve, Benadryl 50mg IM injection was given. After 2 hours of observation, her symptoms resolved and she was released to go home. No ER visit was necessary.
The caller got the first dose and tested positive after 6 days; This is a spontaneous report from the Pfizer Sponsored Program. A contactable consumer (patient herself) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the first dose and tested positive after 6 days on an unspecified date and she is asking if she can still get the second dose. The patient underwent lab tests and procedures which included COVID-19 test on an unspecified date: positive. The outcome of the event was unknown.  Information about Batch/Lot number has been requested.
Got my 2nd dose on a Friday. Tuesday, I went to see my OB for a regular check up, my BP was 130s/90. Protein in urine and headaches. Wednesday, BP high 140s/90s. Friday, developed swelling in legs and hands. BP high 145/93. Dizziness. I had to be induced at 38 weeks due to  preeclampsia. Due date 10/01/2021. Born 9/20/2021. Healthy pregnancy up until vaccine was given. Blood pressure spiked, swelling.
This case was reported by a other health professional via call center representative and described the occurrence of walking difficulty in a 16-month-old male patient who received INFANRIX (batch number 5A425, expiry date 27th February 2017). Concomitant products included PEDVAXHIB and PREVNAR-13. On January 2015, the patient received the 4th dose of INFANRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On 23rd January 2015, 1 days after receiving INFANRIX, the patient experienced walking difficulty and fever. On 25th January 2015, the outcome of the walking difficulty was recovered/resolved. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the walking difficulty to be related to INFANRIX. The reporter considered the fever to be possibly related to INFANRIX.
This was my booster and I developed a fever of 104 the evening of the day I had the booster. I took 1300 MG of Arthritis strength Tylenol but still had the fever after an hour so then I took 600 MG of Ibuprofen and the fever finally broke late evening. The next day 17Nov21 I had a massive headache and was achy but my fever was gone.
This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age. On 02-MAY-2014, the patient was vaccinated with both the VARIVAX (lot#J009992; exp: 12-AUG-2015) (dose and route of administration not provided) and MMR II (lot#J008533; exp: 12-JUL-2015) (dose and route of administration not provided) that were improperly stored. The reporter stated that VARIVAX was exposed to 10F for 9 hours and MMR II was exposed to 71F for 9 hours. No adverse symptoms reported. This is one of several reports from the same source. Additional information has been requested.
78 yo male presented to the ER with the complaint of weakness and diarrhea.  He has ill family members at home as well.  The diarrhea started approximately 1 week ago.  Two days prior to presentation he also developed pain and swelling along his left upper gums into his cheek.  He was started on amoxicillin by his PCP for presumed dental abscess.  He states that has improved.  In the ER he was noted to have acute kidney injury and he tested positive for Covid.  He was admitted for management of his acute kidney injury.  His home lisinopril was held and he was given IVF.  Overnight the patient notes improvement in his symptoms.  He has been able to eat without resulting in acute stooling.  His renal function has normalized.  He is anxious to return home as his wife also was diagnosed with Covid and he wants to be there to help her.  He was screened for OT/PT but was moving independently without concern.  He will discharge home today in improved and stable condition.
I was dizzy and had a fever of 101.7 - it went up and down but that was the highest. Body aches and fatigue. A week or so later - bump on my lower left calf and it felt like my foot was falling asleep. Dr visit on the 16th and then an ultrasound later that day. It's still there but they said it should dissipate in a couple of months and if it doesn't to get it checked it out.
Intense back pain mainly in left side Numbness and tingling in left arm.  Extreme hair loss
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Additional Details: pt became light headed then fainted.  pt quickly regained conciousness but remained lightheaded for approximately an hour.  follow up with pt and he is no longer having any symptoms
This case was reported by a pharmacist via call center representative and described the occurrence of feeling bad in a female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 9th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling bad, fever and sickness. On an unknown date, the outcome of the feeling bad, fever and sickness were unknown.  It was unknown if the reporter considered the feeling bad, fever and sickness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX in the left deltoid. The pharmacist reported that, the patient told him that, she wanted to delay her 2nd dose of SHINGRIX vaccination because the first vaccination made her feel bad. The patient stated, it knocked her down a little bit. The pharmacist tried to schedule her second SHINGRIX vaccination several times. The patient had a fever and was feeling a little bit sick when the pharmacist spoke to her the last time. The pharmacist stated, he did not note a doctor for the patient.
Reporting system indicates adult received a pediatric dose for Pfizer booster.   Contacted patient and advised to repeat booster dose as soon as convenient at adult dose.
has Rheumatoid Arthritis, and her severe pain has disappeared since receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Feb2021 (Lot number: EN6202) as dose 1, single and administration date 19Mar2021 (Lot number: EP7534) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing), notes: Verbatim: Rheumatoid arthritis, Diagnosed 5-6 years ago. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 19Feb2021, outcome "not recovered", described as "has Rheumatoid Arthritis, and her severe pain has disappeared since receiving the vaccine".  Additional Information: The reporter stated she wanted to report a positive reaction to the Covid 19 vaccine. She has had 2 doses already for 6 weeks. She has Rheumatoid Arthritis, and her severe pain has disappeared since receiving the vaccine. Stated it seems to have a positive effect on her immune system. Clarifies she has no more severe pain. Events neither required Emergency Room nor Physician Office visit. The patient age at vaccination was 66 years. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Vaccination Facility Type: Pharmacy. Prior Vaccinations (within 4 weeks): Received both first and second doses of the Pfizer Covid Vaccine. There were no adverse event following prior vaccinations. There was no relevant family medical history.   No follow-up attempts are possible. No further information is expected.
Rash, Fever, weakness, sweating at site.  Erratic vitals.  Treating with tylenol and bringing to ER for evaluation.
Information has been received from a physician concerning a 4-year-old female who on 11-OCT-2006 was vaccinated with a second 0.5 ml, dose of Varivax. Subsequently, the patient experienced shingles on three of her dermatomes. Unspecified medical attention was sought. No additional information provided. There was no product quality complaint. The outcome was not reported. Additional information has been requested.
Allergic reaction occuring 4 hours after #2 dose of Moderna: symptoms were sudden onset of flushing, tachycardia, swelling of lower lip and feeling of need to clear throat due to sensation in throat. Took Benadryl at home due to edema of lip and feeling the need to clear throat.
Had headache; fever; backache; aches in both upper and lower legs; fatigue; dose received:3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 84 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 (Lot number: FH 8030) at the age of 84 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LISINOPRIL; LEVOTHYROXINE. Past drug history included: Codine, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN 6201, Location of injection: Arm Left), administration date: 19Feb2021, when the patient was 84 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL 9261, Location of injection: Arm Left), administration date: 29Jan2021, when the patient was 84 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Nov2021, outcome "unknown", described as "dose received:3"; HEADACHE (non-serious) with onset 10Nov2021 20:00, outcome "recovering", described as "Had headache"; PYREXIA (non-serious) with onset 10Nov2021 20:00, outcome "recovering", described as "fever"; BACK PAIN (non-serious) with onset 10Nov2021 20:00, outcome "recovering", described as "backache"; PAIN IN EXTREMITY (non-serious) with onset 10Nov2021 20:00, outcome "recovering", described as "aches in both upper and lower legs"; FATIGUE (non-serious) with onset 10Nov2021 20:00, outcome "recovering", described as "fatigue". The events "dose received:3", "had headache", "fever", "backache", "aches in both upper and lower legs" and "fatigue" were evaluated at the physician office visit. Therapeutic measures were taken as a result of headache, pyrexia, back pain, pain in extremity, fatigue.  Additional Information: Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the flonase, prednisone as a treatment for the events.  Follow-up attempts are completed. No further information is expected.
Patient has a rash to his abdomen and back ? not sure if it was from the vaccine or from his excess edema.
Red Bumps raised almost looked like small hives or rash of some kind.  Her face looked puffy but she did cry for an hour.
Headache, dull pain in frontal and occipital area. refused EMS, symptoms resolved after being observed for 30 minutes.
Immediate left upper arm pain.  As arm pain worsened she began having left neck and left upper back pain. Seen in ER on 10/25/14. Given Solu Medrol, pain meds, anti inflammatory meds and muscle relaxers.  Has since been treated with Depo Medrol. Physical therapy has been ordered.
When I woke up my left leg was swollen more than usual since I have had a history of a blood clot in that leg I called my Dr. and he made an appointment to have an ultrasound on that leg. The Ultrasound department called the Dr. with the results and the doctor in turn called me and told me to go tot the emergency room. The ER department called my doctor and I was taken off of ELIQUIS and prescribed LOVENOX. I was told to follow up with my Dr.
I got up in the middle of the night to go to the bathroom as usual, and after washing my hands, apparently passed out. My husband heard and attended to me ( I have a large bump on the back of my head, and a cut on my forehead). This morning, I'm okay except for a slight blurriness when reading. My physician recommended going to urgent care, which I am doing.  I cannot remmber ever having fainted in my entire life.
Patient does not meet minimum age to receive pfizer vaccine, but received it anyway.   No adverse events noted during 15 minute waiting period.   Registrar acknowledged patient was 11 and EMR did not let registrar check patient in due to age requirement, but registrar sent through anyway.  Vaccinator did not notice patient was underage when vaccinated.
2/5  vaccination 2/6 arm a little sore when moved, very fatigued- 2/7-2/8-2/9 very fatigued 2/9 nausea, vomited once, diarrhea several times, aches, fever of 101.5, sleeping 2/10 totally recovered
Tingling & numbness in left leg, right foot, left forearm 10 minutes after vaccine that persisted for 12-14 hours.  Prednisone was taken when symptoms did not subside after 2 hours.  Some mild aches still persist 4 days later.
I first started to feel overall sick symptoms along with upper arm pain. After 2 weeks, I visited the same location for a follow up and the doctor advised me that in rare occasions I would still feel pain at that time. She also mentioned that it was possible that a nerve was hit which could cause extended pain.
Fever on 2-5-08 of 101 and right arm in deltoid area was red and indurated 3cm x 2 1/2cm area, warm to touch.  Returned to office on 2-6-08 and arm was worse, increased redness, edema, tenderness, warmth and blistering.  Culture was done and was negative.  Treated with Keflex for cellulitis vs allergic reaction.
A report has been received from a Health Professional concerning a 2 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMSIT quadrivalent (intranasal) started on 04-Dec-2013. It was reported that four patients were inadvertently administered expired FLUMIST quadrivalent which started on 04-Dec-2013. The outcome of the event of inadvertently administered expired FLUMIST quadrivalent to four patients is unknown. The report was considered to be non-serious.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Concurrent conditions and medical history were not provided. On 30-JUL-2015, the patient was vaccinated with an unspecified improperly stored dose of GARDASIL, injection, lot # K006124 and expiration date 02-FEB-2017 (route of administration and anatomical location were not reported). There was not concomitant medication reported. No adverse effect reported. This is one of three cases from the same reporter. Additional information has been requested.
Patient experienced mild pain in arm pit of vaccinated arm. lymphedema like swelling in arm pit. Loss of concave nature to arm. Treated with ice pack X2 days. Continuing to monitor.
Vaccine was administered to a 15 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine was administered to a 15 year old) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00621CA) for COVID-19 vaccination.     No medication history was provided.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine was administered to a 15 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine was administered to a 15 year old) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was unknown   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up accepted on 27-May-2021
PATIENT WAS SITTING IN THE WAITING AREA AND HE STARTED TO FAINT WHEN HE WAS SITTING IN THE CHAIR WITHIN 5 MINUTES OF RECEIVING THE VACCINE. 911 WAS CALLED AND WHEN I GOT OUT TO HIM, HE CAME TO AND WAS ALERT BUT DIZZY, SWEAT CAME DOWN FROM HIS FOREHEAD, HAD CHILLS AND FELT NAUSEAOUS. THE PATIENT WAS GIVEN WATER AND I GAVE HIM REESES CUPS BECAUSE HE LOOKED LIKE HE NEEDED SOMETHING TO EAT.  THE PARAMEDICS ARRIVED AND TOOK CARE OF HIM FROM THERE.