chrisvoncsefalvay/vaers-outcomes huggingface dataset:
While patient was standing at checkout counter, he experienced a new syncopal episode. Pt reports feeling nauseated, dizzy, and weak. Pt placed in reclining position, vital signs obtained, level consciousness assessed. Given water to drink and crackers to eat.
NO AE REPORTED, HOWEVER, VACCINE WAS ADMINISTERED IM INSTEAD OF SQ. PER BAVARIAN NORDIC, NO REPEAT DOSE IS REQUIRED
Had cutaneous flareup after vaccine.   Rash on face.   Tingling and burning sensation on my back, scalp and ears,    It felt like shingles.    Dr. prescribed Mometasone Furoate Cream, USP for the rash.   Rash was reduced significantly by my May 12 appointment.     No longer had the tingling and burning sensations in my skin.  Got a rash after the second vaccine.  Presently, I have a rash on my face due to the Bermuda sun.    I now experience tingling and burning sensations on my back, scalp, arms and ears when I have the rash.
Flu shot was administered, pain at injection site deep in the arm was immediate as soon as entire needle was inserted. Pain increased over the following weeks inside arm at injection site. No redness or swelling visible, not sore to the touch (outside). Pain prevented movement, cannot put weight on arm, difficulty sleeping due to pain and discomfort in arm, frequent numbness and tingling in right pinkie and ring finger. Seen by PCP at 24 days, PCP believes rotator cuff muscle was damaged during the injection, prescribed Meloxicam for two weeks to reduce inflammation, and patient was given exercises to start one week after start of medication.
walking difficulty; Knee pain; This spontaneous case was reported by a non-health professional and describes the occurrence of GAIT DISTURBANCE (walking difficulty) and ARTHRALGIA (Knee pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 008B21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (walking difficulty) and ARTHRALGIA (Knee pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 UNK. At the time of the report, GAIT DISTURBANCE (walking difficulty) and ARTHRALGIA (Knee pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 in response to the event was not applicable.
Complained of numbness in left arm from injection site to finger tips.  Subsided within 30 minutes.  Applied ice to area with improvement.  Subsequently patient followed up with her PCP for recurring, transient numbness.  Diagnosis:  brachial plexus neuropathy of left upper extremity
This 16-year-old patient inadvertently received a pediatric dose of Pfizer (10 mcg/0.2 mL) which is approved for ages 5-11.  Patient was observed for the recommended 15 minutes with no adverse reactions.  This was the third dose for the patient; the first 2 doses were the Pfizer (purple cap) for 12+.
Employee received flu vaccine on 10/01/2009 at 4 pm in Employee Hospital around 7pm she began to experience chills, body aches and malaise. Patient was seen and treated in the E.D. ED doctor stated that employee was level and at a "post vaccine reaction". Employee was discharge home.
patient is off schedule from her first dose of GARDASIL 9 due to becoming pregnant after her first dose; patient is off schedule from her first dose of GARDASIL 9 due to becoming pregnant after her first dose; No additional AE/PQC reported; This spontaneous report was received from a nurse, concerning a female patient of unknown age. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On an unknown date the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, frequency, strength, route of administration, anatomical injection site, lot number and expiration date were not provided). It was reported that the patient was off schedule from her first dose of  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) due to she become pregnant after her first dose (inappropriate schedule of product administration and maternal exposure before pregnancy). The last menstrual period (LMP) and estimate day of delivery (EDD) were not provided. The pregnancy outcome was pending. It was reported that the adverse event was not a cancer event. Additionally, it was stated that the patient did not received the vaccine from the provider's office that reported it. The reporter did not want to provide any patient demographic information or any other information pertaining to case. No additional adverse event (AE)/ product quality complaint (PQC) reported. No further details provided.  The outcome of maternal exposure before pregnancy, no adverse event and inappropriate schedule of product administration was unknown.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had antiviral COVID 19 Treatment with Paxlovid treatment start date was 13Sep2022. Dose 4 vaccine administration date was reported as Mar2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from an 80 year old female patient referring herself. The patient had no pertinent medical history and concomitant medication. The patient's drug reactions/allergies were not reported. On 29-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, lot/batch# and expiration date were not reported) (parenteral) for prevention of pneumococcal disease. On an unknown date in January 2018 (reported as "soon after the vaccination with PNEUMOVAX 23) the patient experienced chills, fever, body aches, tiredness, and cough. The patient contacted her physician and was prescribed with MOTRIN and another unspecified medication, which to date 09-FEB-2018, she hadn't retrieved from the pharmacy. Patient decided to treat herself with unspecified home remedies. No lab diagnostics were performed. The patient sought medical attention and contacted office by phone. At the time of the report, the patient was recovering and only still had the coughing. There was no product quality complaint (PQC) involved. There was no hospitalization involved. The causality assessment was not provided by the reporter.
I got the modera shot 3/17/21 in the early afternoon.All seemed to be going fine until 3/18/21 my body was very itchy.On 3/19 I called my dr. who suggested an antihystamine.That night I had a low grade fever.3/20 my skin was less itchy,so far no fever ,but tired.
It was discovered after administration that the vial had been in the refrigerator 23 hours post puncture instead of 12 hours. A cast was opened with moderna to determine if vaccine was still efficacious. No adverse reactions yet reported by patient.
COVID-19; COVID-19; Vaccine brand other=Moderna/ vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Oct2022 as dose 4 (booster), single (Lot number: GJ3275) at the age of 37 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6208) and on 02Apr2021 as dose 2, single (Lot number: EW0151) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Dec2021 as dose 3 (booster), single (Lot number: 024C21A) 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) with onset 04Dec2021, outcome "unknown", described as "Vaccine brand other=Moderna/ vaccine brand=Pfizer / BioNTech"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included COVID-19 Treatment form 24Feb2023 to 01Mar2023.  No follow-up attempts are possible. No further information is expected.
A week later, my left arm (a couple inches below the injection site) started itching and I developed a small red patch. It grew to a 3x3 inch path by Friday, the 15th. I increased my Zyrtec - taking an extra one each day. It was gone by Sunday, the 17th. It came back on the Wednesday the 20th - at the same spot. I don't think it went away. And then a week later, 1/28/2021 - I had breakthrough hives again - which can be anywhere on my body. Once my hives started - that spot just stayed - it's just there. (I have chronic hives). (My chronic hives  - stays in remission with meds). Other than that one Zyrtec, I had been off my hives medication and in remission from hives for an entire year. On the 29th of January, I had the IUD taken out. When my hives started on 28th, I added medications:  I increased to 40 mg Zyrtec; Pepsid - 40 in morning and 40 in night - in addition to all my other meds. I was prescribed Singulair - 10 mg in the morning. This did not resolve my hives. Hives actually got worse during the course of that week up until the second vaccine which was on February 4th. Telehealth visit - and I happened to have an annaul allergy doctor visit on January 25th  - who looked at it at that time.
This spontaneous report was received from a registered nurse referring to a female patient of unknown age. The patient's medical history and concurrent conditions were reported as none, and concomitant therapy was not provided. On 05-JAN-2017, the patient who is also a medical assistant, was administering ROTATEQ oral liquid (lot # M016919, expiration date 17-FEB-2018) for prophylaxis to a patient. During administration, the patient spit some of the vaccine into the medical assistant's eye. The nurse reported that medical assistant's eye was "burning" (eye irritation) and she "flushed her eye out with water". The "burning" resolved 5-10 minutes. Labs were not performed. The causal relationship between ROTATEQ and eye irritation was unknown. This is one of two reports from the same source MARRS: 1701USA010121. Additional information has been requested.; Sender's Comments: US-009507513-1701USA010121:
Death; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Death) in a  patient of an unknown age and 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Reporter stated that he lost 22 family members in the past 2 years due to covid vaccine. Of this, 2 received the Moderna vaccine and 2 received the Pfizer. No treatment medication reported.  This case was for the second of 2 patients reported who died. Company comment This spontaneous case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the unexpected, serious (medically significant and fatal), event of death. The patient received a dose of mRNA-1273.222 (BA.4/BA.5). The event onset date and vaccination date were not provided, thus, exact latency between vaccination and onset of the events could not be assessed. Reporter stated that he lost 22 family members in the past 2 years due to covid vaccine. Of this, 2 received the Moderna vaccine and 2 received the Pfizer. No treatment medication reported. This case was for the second of 2 patients reported who died. No further clinical information was provided for review. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-734472, US-MODERNATX, INC.-MOD-2023-734538, US-MODERNATX, INC.-MOD-2023-734863 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734472:Invalid case (MOD-2023-734472 - Patient 1) US-MODERNATX, INC.-MOD-2023-734538:Grandmother case (MOD-2023-734538 - Patient 2) US-MODERNATX, INC.-MOD-2023-734863:Patient 4 (Fatal - MOD-2023-734864); Reported Cause(s) of Death: Unknwon cause of death
Swollen glands in neck, left side (fairly significant swelling) Extremely sore throat, difficult to swallow Fever around 100 - typical issues that with fever (tired, achy, etc.) Rash on chest
A rash appeared two days after the 1st injection, mainly on stomach; This is a spontaneous report from a contactable nurse reporting for herself. A 28-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0140), via an unspecified route of administration on 30Dec2020 07:00 AM at single dose in left arm for COVID-19 immunisation.  Patient age at time of vaccination was 28 years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included allergies to eggs, shellfish, peanuts. Concomitant medication included desogestrel, ethinylestradiol (APRI). On 01Jan2021 the patient experienced a rash appeared two days after the 1st injection, mainly on stomach. The event was reported as non serious and resulted in Doctor or other healthcare professional office/clinic visit. Treatment for the event included steroid cream. The event had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
After receiving vaccine, patient fainted as needle was being removed.  Patient responded within seconds of fainting.  B/P 90/60
Information has been received from a registered nurse concerning a 23 months old female patient with no drug reactions/allergies, who was preemie baby born at 36 weeks. On 01-FEB-2012 the patient was vaccinated with a dose of VARIVAX (Merck) 0.5 ml subcutaneously (lot # reported as 1206AA - in validation process). Other secondary suspect therapies included: M-M-R II (lot #, route and dose not reported) given on the same date. Concomitant therapy included FLUZONE administered on the same day. The nurse reported that the patient developed chickenpox which presented with rash and itchiness on 23-SEP-2012. The patient received treatment for the events: BENADRYL, calamine lotion and AVEENO bath. The outcome of chickenpox was reported as recovering/resolving. No laboratory diagnostic studies were performed. The patient sought medical attention - contacted physician. The relatedness for chickenpox was unknown for VARIVAX (Merck) and M-M-R II. Additional information has been requested.
flu like symptoms; pain in arm; pain; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (pain in arm) and PAIN (pain) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and first dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (pain in arm) and PAIN (pain). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (pain in arm) and PAIN (pain) outcome was unknown.        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.   Treatment information was not provided.   Reporter did not allow further contact
This individual tested positive for Covid 19 seven days post first dose of Moderna Covid vaccine.  The patient experienced mild cold symptoms such as nasal congestion.
Information has been received from a certified nurse midwife who reported that a patient of his mentioned that her 16 year old female cousin was vaccinated with her third dose of Gardasil. Her cousin subsequently experienced grand mal seizures and was hospitalized. Her cousin did not have any prior history of seizures, and her cousin's twin and older sister received the Gardasil vaccine series and had no adverse effects post vaccination. The nurse stated he did not have any additional information regarding his patient's cousin's experience. At the time of reporting, the patient was still hospitalized. Additional information is not expected.
vaccin given a beyond use date of 3:30pm and vaccine administered approximately 30 minutes pas the BUD of 3:30pm
Headache, fatigue, fever for 24-40 hours.   Knot and arm pain  at injection site for  two weeks.  Itching and rash at injection site second half of those two weeks.
pt recvd vax & 24 hrs p/vax exp h/a, nausea, vomiting, diarrhea & achiness; pt was not seen by MD;
Patient reported via consent form that she was due for the 2nd COVID vaccine.  She stated on the consent form that she had received Pfizer as the 1st dose.  Pharmacist doubled checked that she had received 1st dose Pfizer at intake window and she confirmed.  Pharmacist also checked again prior to vaccination that she needed a 2nd dose Pfizer and patient confirmed.  Patient did not come in with vaccine card for 1st dose.  Several hours later patient returned stating that she had checked with the 1st pharmacy where she had received the 1st dose and they stated that she had been given a Moderna vaccine, not a Pfizer vaccine.  Patient also stated at time of return that she had not been given a vaccine card showing proof of vaccination from first pharmacy where she received the first dose.   Patient did not report any adverse events other than that stated above.
pt recv vax 10DEC96 & 23JUN97 pt exp a red, blister-like, fluid-filled area on rt thigh which hurt;presented to MD who was dx w/shingles on rt upper thigh on 25JUN97;pt recovered;
REVACCINATION WITH DIFFERENT COVID-19 VACCINE; OFF LABEL USE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative via social media concerned an elderly female. The patient's weight, height, and medical history were not reported. The patient received first and second dose of Pfizer (tozinameran) (dose number in series 1) (form of admin, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether the adverse event reported following to first dose of vaccination (dose number in series 1). The patient received third dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis (revaccination with different covid-19 vaccine) (dose number in series 2). It was unknown whether the adverse event reported following to first dose of vaccination (dose number in series 2). The patient received fourth dose of covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. The drug was associated with off label use (dose number in series 3). No concomitant medications were reported.  On an unspecified date of OCT-2022 the patient tested positive for COVID-19. The patient was extra tired for about 3 days, and experienced confirmed covid-19 infection (dose number in series 3). But the patient was just as active as before, working in the house and working in the yard. On an unspecified date of 2022, after about 7 days the patient tested negative for COVID-19 (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection on 2022, and the outcome of revaccination with different covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20221234943, 20221235149, 20221234743 and 20221234779. This report was associated with product quality complaint: 90000263487. Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Information was received from a certificated medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 23-AUG-2016, the patient was inadvertently administered expired M-M-R II injection (dose unknown, lot# K011317, expired on 13-AUG-2016, recombinant human albumin (rHA)) subcutaneously. No adverse effect was reported. Additional information is not expected as there is no consent for follow up.