chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to the pharmacy informing of his recent diagnosis by Dr of a shingles rash following the C5 and C6 dermatomes unilaterally on his right side (same side as the Shingrix vaccination).  Rash is concentrated on the spine, is spotty along the trapezius muscle from spine to top of shoulder, and another small concentration on the top of the shoulder.  Patient reports rash symptom onset around 9/30/2019 to 10/3/2019.  Patient used topical lidocaine and ibuprofen as over the counter treatments.  No other treatments reported.
During the same day as my vaccination of my second dose, about two hours after my vaccine, my bladder emptied itself completely, and I thought that I had a bladder infection and went to the the emergency room and was told by a specialist that there was nothing that they could do for me and offered a type of bladder surgery. My GI system was in a lot of disarray as well during this time. I was greatly fatigued and did not know what was going on. After being sick for around 6 months, symptoms began to improve and I then received my booster shot and For the booster shot, I had burning sensation in my bladder and had to use the bathroom right after the vaccine. I then met with a doctor after and was prescribed Gemtesa. This prescription began to help, and before I had to use the bathroom every 15 minutes, but now my bladder is starting to improve.  1ST DOSE: FG3527 : 02/11/2021 2ND DOSE:  WAG6599 3/04/2021 BOOSTER: EM6206 : 12/01/2021
Too much tiredness; lymphatic nodes were swollen (bean size, one was hard and the other one was bigger and softer) at the right lower side of the neck. They are still swelled today; This is a spontaneous report from a non-contactable Health care professional. A 46-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date: was not reported) via intramuscular, administered in right arm on 26Jan2021 at 12:15 as 2ND single dose for COVID-19 immunization. The patient medical history included penicillin drug allergies. The patient concomitant medications were not reported. Historical vaccine includes patient received, BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 intramuscular, administered in right arm on 05Jan2021 at 02.30 as 1st dose, single dose for COVID-19 immunization. Patient did not received any other vaccine in four weeks and no other medication in two weeks. Patient had no COVID-19 prior vaccination. Patient had not tested for COVID-19 post vaccination. The patient experienced the night of vaccination too much tiredness. on thursday (2 days after), 2 lymphatic nodes were swollen (bean size, one was hard and the other one was bigger and softer) at the right lower side of the neck. they are still swelled today at 06.00AM on 28Jan2021. The event was not treated. The outcome of events was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt. admitted to the Medical Center 6/8/2021 with atrial fibrillation. COVID test positive but pt. asymptomatic. Discharged to skilled nursing facility on 6/18/2021
Pain in the left hip joint, left knee, and chest. No treatment, just rest and hydration. The symptoms lessened in two days.
This spontaneous report was received from a physician via a company representative, concerning unspecified patients of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patients were subcutaneously vaccinated with different lots of PNEUMOVAX 23 injection (dose, frequency, lot # and expiration date were not provided), for prophylaxis. On unspecified dates, after vaccinations, the patients had unspecified "site reactions". At the time of the report, the outcome of the events was unknown. The causality between the event and PNEUMOVAX 23 was unknown. Additional information is not expected, as no consent to contact the reporter was granted.
for 48 hr high fever; for 48 hr chills.; very red hives (2 by 3 inches) it burns; very red hives (2 by 3 inches) it burns; A spontaneous report was received from a healthcare professional concerning a Drug Start Date-1947-1-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events for 48 hr high fever and chills, very red hives (2 by 3 inches) and it burns.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 0X8L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events for 48 hr high fever and chills, very red hives (2 by 3 inches) and it burns.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events for 48 hr high fever and chills, very red hives (2 by 3 inches) and it burns were unknown.
Patient was observed in vehicle crying.  Clinical staff evaluated patient who stated she had untreated anxiety and depression, as well as a fear of needles. She was experiencing an anxiety attack and complaints' of lightheadedness, and right sided head pain. Symptoms resolved at 1212
No adverse event; 5 patients received expired Moderna Bivalent Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 patients received expired Moderna Bivalent Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 044H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jun-2023, 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. On 15-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 patients received expired Moderna Bivalent Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 patients received expired Moderna Bivalent Covid-19 vaccine) 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 EXPIRED PRODUCT ADMINISTERED (5 patients received expired Moderna Bivalent Covid-19 vaccine).    This case belongs to the 2nd patient out of 4 patients.  No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732810 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732810:Master case
about 20hr post vax pt rose earlier than usual in the morning requesting to eat;sat @ table to eat & suddenly fell over backwards & was unconscious x1min;
I have been sick for 7 days from booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (I have been sick for 7 days from booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (I have been sick for 7 days from booster). At the time of the report, ILLNESS (I have been sick for 7 days from booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   Reporter did not allow further contact
I had hives on site.  They administered 50mg of Benadryl and I was able to go home.   Once at home, I did experience syncope, nausea, and headache.  I still have hives and feel unwell but am otherwise okay.  I haven't gone back to see anyone.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 07-Feb-2021, VACCINATION SITE PAIN (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was reported.   This case was linked to MOD-2021-035330 (Patient Link).   Reporter did not allow further contact
Rash; On 10AUG2021 a spontaneous report was received from the immunoglobulin program:  On 07AUG2021 an adult male of (age unknown) received a booster dose of ACAM2000 (smallpox vaccine, live) as part of the immunoglobulin program.  He reported that he had experienced two unspecified reactions since the administration of smallpox vaccine. He reported that the event had placed him "in the hospital last night".  His face and head were noted to not be affected by the rash. It was noted that the male had since been discharged and a diagnosis was unknown.  The donor reported he has had two reactions since administration. No further medical history or concomitant medications are known.  Company comment:  The picture shows generalized rash consistent with an allergic reaction. The information received Is limited and there is no indication that the patient was admitted to the hospital or what the second event was. The rash doesn't seem to be enough reason for admission to the hospital, therefore, the company considers that the rash was an allergic reaction, not serious and possible related to ACAM2000. More information will be sought.
could not walk; Lethargic; A spontaneous report was received a consumer (patient's husband) for a 72-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced she was lethargic and could not walk.  The patient had secondary progressive stage MS.  On 25-Feb-2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 011A21A) intramuscularly for prophylaxis of COVID-19 infection. 20 hours after the injection on 26-Feb-2021 she was lethargic and could not walk. Patient's husband called an ambulance and she was transported to the hospital. The patient was hospitalized at the time of reporting. She was currently needing physical therapy.  The patient had a similar event 1 year ago.   Seriousness criteria for all events was hospitalization.  Treatment information was unknown.  Action taken with mRNA-1273 was unknown.  The outcome of the events was unknown.; Reporter's Comments: 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.
Inconsolable crying, onset: 15 minutes after vaccines, duration: 3 hours, description: no fever, no/mild injection site reaction. Shrill-high-pitched loud screaming cry non-stop despite rocking, walking, feeding, verbal comforting, etc.
Generalized erythema multiforme exanthem dev. x 8 days after vaccination (was on amoxicillin).
Patient reported having chest pain and tightness along with pain in LEFT arm (opposite from vaccine site). Started "later" that night and unrelieved with standard angina medications and at home protocol.  Hospital admission to rule out heart attack (previous heart attack 7 years ago, with no other cardiac episodes since per patient).
Severe Headache starting about 6 hours after injection lasting until 36 hours post injection.  Extreme fatigue starting about 8 hours post injection lasting 36 hours post injection.  Redness and a lot swelling  (about 2 1/2 by 2 inches swelling out to about the size of a clementine) at the injection site started about 40 hours after injection. Itching over the rash/redness started about 72 hours after the injection.
Severe local swelling, redness and systemic signs of illness, fever 103, chills, body aches.
pt came to clinic the day p/vax fluid filled skin below & inside of the area when inject was given; The following day swelling nearly all gone;
I developed hives with uncontrollable itch all over the body.  My lip tingled as well.  The symptoms lasted all day with no specific time fram.
This spontaneous report as received from a consumer refers to her daughter, a 17 year old female patient. The patient was not pregnant. There was no history of drug allergies or reactions. Pertinent medical history and concurrent conditions were none. On 06-AUG-2015, the patient was vaccinated with one single shot of ZOSTAVAX instead of VARIVAX (Merck). Concomitant therapies included LEXAPRO. On 06-AUG-2015, since administration, the patient had not felt well. There were no lab diagnostics performed. The patient did not seek medical attention and no treatment was received in response to the event. The outcome of the event was reported as recovering. Causality assessment was no provided. There was no product quality complaint involved. Additional information is not expected as no reporter contact information was available.
Pt had redness and swelling at the site of her Tdap vaccine. Pt reported vomiting for 2 days.
fever; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2022 at 10:00 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid issues" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Vascular issues with stents" (unspecified if ongoing); "Seafood" (unspecified if ongoing), notes: Known allergies : Seafood. Concomitant medication(s) included: TOPROL XL; LISINOPRIL; BABY ASPIRIN; SYNTHROID; Z-PAK. Past drug history included: Mycins, reaction(s): "Drug allergy", notes: Known allergies : Yes many meds (most mycins). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9263, Anatomical location: Arm Left), administration date: 27Jan2021, when the patient was 78-year-old, for COVID-19 immunisation, reaction(s): "sore arm"; BNT162b2 (DOSE 2, SINGLE; Lot number: EL9267, Anatomical location: Arm Left), administration date: 17Feb2021, when the patient was 78-year-old, for COVID-19 immunisation, reaction(s): "sore arm"; BNT162b2 (DOSE 3 (BOOSTER) SINGLE; Lot number: FC3184, Anatomical location: Arm Left), administration date: 25Aug2021, when the patient was 79-year-old, for COVID-19 immunisation, reaction(s): "Chills", "Fever". The following information was reported: CHILLS (non-serious) with onset 2022, outcome "recovered" (2022); PYREXIA (non-serious) with onset 2022, outcome "recovered" (2022), described as "fever". Therapeutic measures were taken as a result of pyrexia, chills that included Tylenol.  Additional information: The patient did not receive any other vaccine within the four weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID -19. Around 10 hours after vaccination dose 5, the patient awoke with fever and chills which lasted around 10 to 12 hours and which responded to Tylenol. Exact same response for vaccination dose 4. With dose 3, was more intense and same symptoms lasted for 3 days. Oddly no after effect other than sore arm for dose 1 or dose 2. Since the vaccination, the patient had not been tested for COVID-19.
Patient's response to vaccine was VERY similar to her response to the illness.  Lack of body strength, stability,(unable to stand by herself, to walk, to follow commands requiring body movement) incontinence, inbility to think clearly, unable to recognize her loved ones,   No fever, no vomiting or diarreah, no cough.    These symptoms lasted for 24 hours, then went away almost fully and completely. Left arm soreness exists two days after injection.
Patient had a brief syncopal episode after receiving immunizations. Patient became pale diaphoretic, and hypotensive. Patient was transferred per EMS to hospital. Patient was alert and oriented at transportation. Blood pressure and heart rate remained low. Unable to reach parent.
Swollen, itchy inflamed feet an d hands. Severe blisters on right foot, less  so on left foot and hands
no adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jan-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    Patient ID was reported as Unknown. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant drug was reported. Reportedly, the patient was eligible for COVID-19 vaccine. No treatment drug was reported.
Around noon on 1/29/21 (less than 24 hours after the shot) i felt a weird nerve sensation throughout my entire body.  The only way to describe it is the nerve pain you feel when you hit your funny bone. That was the sensation I was feeling throughout the body.   There was also intense bone pain and lower back pain.  These were also the same symptoms I had when I had a mild case of covid 3/2020 and didn?t know I had it.   In June 2020 I tested positive for antibodies.
25 minutes after injection, pt felt flushed, developed sinus/eye pain, difficulty breathing  7 hours later, at midnight, pt woke up with above sx again.   Next morning, pt had a fever, continued sinus pressure, in the forehead, and more difficulty breathing
headache started 4/15/21 at 5 p.m. EST, ongoing nausea started 4/15/21 at 8 p.m. EST, ongoing fever under 100 degrees F started 4/15/21 at 12 p.m. EST, ongoing chills started 4/15/21 at 10 a.m. EST, ongoing tremors/shaking started 4/16/21 at 9 a.m., ongoing fatigue started 4/14/21 at 8 p.m. EST, ongoing
complete exhaustion; tailbone headache/migraine; body aches; This is a spontaneous report from a non-contactable consumer, the patient. An adult non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Unknown) via an unspecified route of administration in the left arm on 14Mar2021 at 09:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported and concomitant medications taken within 2 weeks of vaccination were numerous (Unspecified). Patient was allergic to penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 as well. The patient experienced complete exhaustion, body aches, tailbone headache/ migraine. The patient did not receive any treatment for adverse events. The clinical outcome of the events of complete exhaustion, body aches, tailbone headache/migraine was not recovered at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
I was sick for 1 1/2 days with a fever, chills, fatigue and a sore arm. I had a little dizziness after the first shot as well. I thought the dizziness may have been due to the fever at first.
Per facility, patient received Moderna COVID vaccine on 2/4/21 and 3/16/21. On 1/5/22, patient tested positive for COVID ( exposure at adult family home). On 1/7/22, patient admitted to our hospital for acute metabolic encephalopathy (likely due to complex UTI in the setting of chronic indwelling suprapubic catheter, urine grew E. Coli, morganella, and enterococcus) and COVID infection (not hypoxic). As of today (1/11/22), patient is still admitted in our med/surg unit.
Began to make myself breakfast before 6:30 AM. Suddenly everything went gray and I felt like I was going to pass out. I sat down and placed my head between my knees. It did not help. My forehead was wet with perspiration. I stood up. Everything was still gray. I needed to lie down. I took a few steps toward the bedroom. Had to stop and hold onto a table to steady myself. Did not know where I was for a few moments; came to. Took a few more steps and reached the bed. As soon as I lay in the bed, the fainting spell ended. I felt fine. The entire episode lasted a few minutes.
My arm hurt so badly that I couldn't lift it or sleep tiredness headache chills joint pain feeling unwell difficulty breathing a fast heartbeat weakness
Day after shots dizzy-vision issues due to dizzy symptoms. Overall sick feeling. Weakness. No joint pain but shaky feeling. 24 hrs for most symptoms-72 hrs overall.
Hives at the site of injection-small covering a quarter size area around injection site. Pt took BENADRYL-2 hrs later- Rash is not bigger-also seen by PMD by then.