chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna vaccine given to patient who had J&J; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Moderna vaccine given to patient who had J&J) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Moderna vaccine given to patient who had J&J). On 14-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (Moderna vaccine given to patient who had J&J) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Patient received Johnson and Johnson vaccine on 27-May-2021. Then returned on 14-Sep-2021 and was asked if patient was vaccinated, patient said no and was given a dose of the Moderna vaccine.  No treatment information was provided by the reporter.
Redness about 12.5 x 1 cm, swelling and induration (about 9 x 9 cm) left upper arm and shoulders.
Body ache; Left arm was super sore; A spontaneous report was received from a consumer, concerning herself, a 51-year-old female patient, who received Moderna's COVID-19 vaccine and developed left arm was super sore and body ache.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 31-Dec-2020, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly in her left arm for COVID-19 infection prophylaxis.  On 01-Jan-2021, the patient reported that she felt her left arm was super sore. Additionally, on 05-Jan-2021, she developed body ache.   Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the events left arm was super sore and body ache was considered to be unknown.; Reporter's Comments: This case concerns a 51 year-old, female patient, who experienced events of left arm was super sore and body ache.  The event of left arm was super sore occurred the next day after the first and last dose of mRNA-1273 vaccine administration. The event of body ache occurred 5 days after the first and last dose of mRNA-1273 vaccine administration.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
23x22mm wound with blister surrounding wound. Feeling of general malaise, achiness, nausea,dizziness,loss of appetite.
The reporter who just lost his 16 years old son with a Pfizer shot; This is a spontaneous report from a non-contactable consumer (parent of patient). A 16-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated the COVID vaccine was not a vaccine, it was a big experimental medication and it was also killing people. The reporter who just lost his 16 years old son with a Pfizer shot because he taught him government told him it was safe. The outcome of the event was fatal. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: The reporter who just lost his 16 years old son with a Pfizer shot
Patient was in observation area after having the 1st dose of the Pfizer COVID Vaccine. He became short of breath, complained of chest tightness, and nearly passed out.911 called at 0945AM and responded to the Center. Patient moved to wheelchair without incident due to fall concerns. Patient transported to ER via ambulance to follow up due to reaction.   Treatment Rendered: Patient was assessed by EMS and placed onto stretcher. He was then transported via ambulance to local ER.
Headache, Myalgia, Fever, chills, fatigue, arm tingling Narrative:  Fever, myalgia, headache, chills, fatigue, tingling  in arm, TDAP administered 1/13/21 which was reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 27 years, in left arm 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's relevant medical history included: "Latex" (unspecified if ongoing); "food dye" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment".
allergic reaction to the product/ throat was swelling and started to close up/ hives and itching/ blood pressure dropped and heart rate increased/ chest tightness; This is a spontaneous report from a contactable consumer (patient). A 33-year-old-female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL3248), via an unspecified route of administration into left deltoid on 21Jan2021 10:20 at a single dose for covid-19 immunization. The patient was allergies to sulfa medications and latex and she had the flu vaccine in Nov2020. The patient concomitant medications were none. The patient called to report on the COVID 19 vaccine and she had an allergic reaction to the product. The patient explained that she got the vaccine yesterday at around 10:20 am and was in the emergency room at 10:48 am. Her throat was swelling and started to close up and this has resolved after medication. She had hives and itching which are now ongoing and about the same, her blood pressure dropped and there was an increased in her heart rate which have both gotten better, and she had chest tightness which is about the same. She received IV Benadryl, Solumedrol, and Pepcid. The patient was treated and released from the emergency room. No investigation assessment. The outcome of the event was not recovered.
Patient assessed via virtual visit on 2/21  Got 2nd dose of Moderna vaccine on 2/20. On way home was having tongue swelling.  Sharp CP radiating to diaphragm and throat swelling since last night. +wheezing. Walking from bed to bathroom gets SOB SOB gradually worsened as time passed Dizziness since difficulty breathing paresthesia in hands diaphoresis - pt attributes to fever/chills she has been getting since having the vaccine  Denies n/v, abdominal pain, syncope  Dyspnea, oral swelling, CP began s/p Moderna vaccine 2 of 2 and gradually worsening Advised ER via ambulance. Pt prefers to wait for her dad to take her to the ER Counseled pt on risk of death due to airway cut off due to worsening sx: bronchial inflammation/throat swelling or decreased oxygen to heart/brain with dizziness (MI/stroke). Advised tools EMS would be able to administer life saving medications to support her in these emergent situations and quickly get pt to ER vs having her die in car with dad bearing guilt of losing daughter. Pt expresses understanding, will wait for her dad. Suggested pt have a code word to say so if things getting worse her dad pulls over to call 911. Pt agreeable.
Warm feeling in left arm at injection site and face; Warm feeling in left arm at injection site and face; Increased heart rate; Salty taste in mouth; Head felt out of touch; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN9581, Expiration date were not reported), intramuscularly, administered in the left arm on 30Jan2021 13:15 (at the age of 62-years-old), as dose 1, single for COVID-19 immunisation. Medical history included high blood pressure and palpitations. Concomitant medications included metoprolol succinate (TOPROL, 50 mg Tablet) taken for high blood pressure and palpitations, patient has been on it for 20 years; loratadine (CLARITIN) taken as premedication for vaccination from 30Jan2021; and levothyroxine sodium (SYNTHROID). Patient had no additional vaccines administered on same day of BNT162B2. Patient also has no history of previous immunization with Pfizer vaccine considered as suspect. On 30Jan2021, the patient experienced warm feeling in left arm at injection site and face (1-2 minutes after vaccine), increased heart rate (3-4 minutes after vaccine), salty taste in mouth (3-4 minutes after vaccine), and head felt out of touch (3-4 minutes after vaccine). It was reported that patient knew it was a personal choice of whether or not to get second dose, but she had a brief reaction from the first one. It felt like when you get IV contrast. In a matter of minutes, it was a warm feeling in her injection site arm and face and then her heart rate increased, but not dangerously high. She then had a salty taste in her mouth and her head felt out of touch for a few minutes. She can't really tell if it was related. It only lasted a few minutes and completely resolved. She was fine after that and went food shopping with no ill effects. She thought it was probably some additive in the vaccine because it happened so quickly. Some people said she had a Vaso-Vagal response and she said no. She is due for 2nd vaccine on Saturday. She wanted to know if anyone has any insight about any of the additives that may have caused this. Patient stated that the increased heart rate followed flushed face. She then stated it was not flushed but warm. She took a loratadine (CLARITIN) that morning because she heard horror stories and she did not know what vaccine she was getting. She wondered if her reaction would have been worse if she did not have that. She then said, if she wasn't on a beta blocker, maybe the heart rate would have been higher and maybe that prevented her from having a worse reaction. The events were reported as non-serious.  The patient underwent lab tests and procedures which included heart rate: increased on 30Jan2021. Events did not result to emergency room and physician office visit. The outcome of events was recovered on 30Jan2021.  No follow-up attempts are possible. No further information is expected.
DTaP was to be given but Tdap was given accidentally. Patient acting fine. Called immunization branch to report. This was to be his 4th dose of this series.
Patient called today and said that she had her moderna bivalent booster and that last night she started to get redness, swelling and a rash on the injection site and it is increasing in size and very itchy.  She said she  did not have any previous reactions to previous covid vaccinations.   I recommended taking  Benadryl and putting an ice pack on it.  I recommended if it gets worse or doesn't get better with treatment to contact her primary care physician or be seen.
Patient had flu vaccine in right deltoid and felt like arm was numb approximately 5 minutes after injection.  Dr. examined the patient immediately.  On exam site was normal; no bruising, no mass, no hematoma.  Senasation was normal with eyes closed.  Normal pulse and capillary refill time.  Observed for 10 minutes at which time patient stated he felt normal and wanted to go.  Full upper extremity strength 5/5 and 2+ reflexes entire time.  Normal color and sensation.  Advised to return to clinic or go to ED for any concerns.
Received 2nd dose and had extreme muscle weakness that caused collapse twice. Unable to stand for over 6 hours. Did  not lose consciousness.  As a result of the collapses, injured knee and arm.
Burning/stinging sensation in body and head, headaches, rapid heartbeat, diarrhea, cramps, joint and muscle pain, rash itching, nausea, dry itchy eyes, and outer ear pain.
passed out; blood clots; broke their collar bone; black eyes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) and THROMBOSIS (blood clots) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart disease, unspecified.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), THROMBOSIS (blood clots) (seriousness criterion medically significant), CLAVICLE FRACTURE (broke their collar bone) and EYE CONTUSION (black eyes). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), THROMBOSIS (blood clots), CLAVICLE FRACTURE (broke their collar bone) and EYE CONTUSION (black eyes) outcome was unknown.      No concomitant and treatment medication was reported by patient.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable.  Patient reported that 3 friends of her who received Moderna vaccine had serious events after second dose.  This case concerns a patient of unknown age and gender with no relevant medical history, who experienced the unexpected serious events of Loss of consciousness and Thrombosis. The events occurred approximately on an unknown day after the unknown dose of Moderna Covid-19 Vaccine. The rechallenge was not applicable, as the event happened after the unknown dose. The benefit-risk relationship of Moderna Covid-19 Vaccine in not affected by this report.   This case was linked to MOD-2021-376600, MOD-2021-376153 (Patient Link).; Sender's Comments: This case concerns a patient of unknown age and gender with no relevant medical history, who experienced the unexpected serious events of Loss of consciousness and Thrombosis. The events occurred approximately on an unknown day after the unknown dose of Moderna Covid-19 Vaccine. The rechallenge was not applicable, as the event happened after the unknown dose. The benefit-risk relationship of Moderna Covid-19 Vaccine in not affected by this report.
She had vomiting; muscle aches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "heart problem" (unspecified if ongoing); "she is on oxygen" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (First dose), administration date: 04Mar2021, when the patient was 69 years old, for COVID-19 immunisation, reaction(s): "First vaccine she got made her left arm like the area got really big and swelled up". The following information was reported: VOMITING (non-serious) with onset 25Mar2021, outcome "not recovered", described as "She had vomiting"; MYALGIA (non-serious) with onset 25Mar2021, outcome "not recovered", described as "muscle aches". Therapeutic measures were not taken as a result of vomiting, myalgia. Additional information: The patient was on lot of medicine because she has heart problems and other issues.  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 other reporter, who posted an information on independent site in social media and refers to a female (also reported as gender unknown) patient of unknown age. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, lot#, expiry date, route and site of administration were not reported) for prophylaxis. Other suspect therapies included VIOXX tablets (dose, frequency, lot#, expiry date and indication were not reported). On an unknown dates, the patient experienced difficulty to get out of bed, fatigue (sometimes enormous fatigue), problems with balance and an unspecified other symptoms. She also, on an unknown date, lost her period. On an unknown date, the patient died (also reported as "killed"). Cause of death and information about autopsy were not reported. Action taken with suspected therapies was not reported. The outcome of non-fatal events was unknown. The relatedness between the event and suspected drugs was not reported.
At the doctors office patient was given Flu Mist, Then a TB test, he was scared and moved, then the nurse had to do a second one.  We stood up to leave and he fell to the floor and could not stand.  Said " I can't stand" I picked him up laid him on the table and his face was pale, his eyes unfocused and he was incoherent, I told the nurse to get the doctor.  Patient then said he was going to be sick.  He vomited for about 15 minutes then laid down, the doctor had his blood preassure checked and the nurse check his oxygen and about 20 minutes later he felt better.  But he was lethargic for another 2 hours ate little to no food the rest of the day but was better by bed time.
Morning after administration, husband called pharmacy and reported patient had been up all night vomiting and had severe stomach pain. Vomiting had subsided (stomach was empty) but still nausea and not able to keep anything down. Patient was recommended to treat hydration with pedialyte and try to eat non-irritating foods such as saltines. She was considering self treating pain with medical marijuana. Next encounter with patient ws 2 days later, husband called pharmacy staff to inform patient had a heart attack and passed away. It is unknown if related to vaccine administration.
I had a breakthrough case of Covid-19 started with a head and fatigue and massive diarrhea for about 12 hour  I was prescribed Paxlovid it went away after a few days but then I had a rebound case and had full symptoms congestion, fever chills muscle aches. I also tested positive for the flu as well.
No additional adverse events; patient received VAQTA pediatric dose instead of adult dose; This spontaneous report was received from a licensed practical nurse, concerning a patient of unknown gender and age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 14-OCT-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) pediatric dose instead of adult dose (incorrect dose administered) (lot number S021092, expiration date: 18-MAY-2020) (dose, route of administration and anatomical location were not provided) for prophylaxis. No additional adverse events were reported (No adverse event).
Approximately 30 minutes after vaccination she had swelling and redness in her hands and small hive and redness on her chest. Symptoms lasted for about 2 hours and she took benedryl.
The pt received his 1st Lymerix injection on 1/24/01. Immediately, post vax, he became light-headed and dizzy and experienced blurred vision. He recovered "within moments", without treatment. The reporter stated that "it sounded like" the pt "had a problem with needles."
Patient is fully vaccinated.  COVID + on 11/22/2021.  Hospitalized from 11/22-11/28, 2021.  85 year old female who presents with increased confusion starting yesterday.Lungs: clear to auscultation bilaterally. CT stroke protocol IMPRESSION: 1. No acute intracranial hemorrhage or shift of midline structures. 2. Senescent and postoperative changes as described. 3. If there is sufficient clinical concern for acute ischemia, further evaluation with brain MRI is recommended. SpO2 98%. Respiratory: Positive for cough. Negative for chest tightness and shortness of breath.  Treatment:  remdesivir, decadron, lovenox. neuro consult. 11/23 ID consult: she is hypoxic requiring 3L of supplemental oxygen.  Her CRP is only 11.8, but her D-dimer is 1737. patient discharged to a HCF.
Severe back ache, severe shoulder pain, bad headache. Felt like had temperature (did no have thermometer). Three to four days later had diarrhea. Made Dr. appt. Had increase blood pressure.
Was sitting in chair, fell over. Hit head on cement floor. Seized for 35 seconds. Eyes rolled in to back of head and foaming at the mouth. Awakened suddenly to confusion. Escorted off floor to wheelchair. Reoriented.
Patient  received 1st dose of Pfizer Covid-19 dose at age 11 instead of 12 or older. Patient's mother states that patient did just fine with the dose and had no adverse reaction.
Pt developed redness, swelling at injection site on (L) ant thigh after immunizations given on 5/7/13. Had low grade fever on day 1.
Within approximately 36 hours the left deltoid area became red, swollen and mildly painful. By 48 hours the redness spread to a length of 6-8 inches surrounded by a red rash. The redness and swelling continued for almost two weeks. The left arm rash slowly resolved in 3 weeks. Within 6-7 days, I experienced the same sort of hot and prickly sensation I had with active shingles 10 years ago on the right axilla and back. The symptoms of axillary and back discomfort have continued intermittently with some mild overall lessening in the past two days. My concern is why was the post-herpetic neuralgia stimulated by the vaccine?
Muscle aches, fatigue. Treatment rest. Resolved by 12/27/2020
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 54 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: EW0150), on 01May2021 as dose 2, single (Lot number: EW0171), on 14Nov2021 as dose 3 (booster), single (Lot number: FH9027) and on 03Mar2022 as dose 4 (booster), single (Lot number: FK9896) for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" 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; Positive, notes: tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Primary cancer of ampulla of Vater. ED visit and hospitalization. This visit was within 6 weeks of receiving the COVID vaccine.