chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional (office manager) via sales representative and described the occurrence of trance in a 38-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline), FLULAVAL and typhoid (non-gsk). In 2013 the subject received 1st dose of TWINRIX (intramuscular, unknown details), a dose of FLULAVAL (unknown details), unspecified dose of typhoid (non-GSK) (oral). In 2013, within minutes of vaccination with FLULAVAL, oral typhoid vaccine (Non-GSK) and TWINRIX, the subject experienced trance and sweating. Per the reporter, the events occurred "shortly afterwards" when describing the onset of the events. Per the reporter, the subject "went into 2 to 3 minutes of a trance and was a little sweaty." Per the reporter, the subject stated that "he had never had before." The events were not the result of suspected transmission of an infectious agent via a medicinal product. At the time of reporting the events were resolved. Per the reporter, "after resolution he felt fine." The subject "did not come back for the next dose of TWINRIX." It was unclear from the report of the vaccination course with TWINRIX was discontinued. The reporter did not consider this case to be serious.
Lost power the next day in the middle of the day at 12:00 PM.; Had placed all vaccine into a frozen bag, booster vaccines were then transported to another clinic and was adminstered between 02-MAR-2023 to 28-MAR-2023.; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.), POOR QUALITY PRODUCT ADMINISTERED (Had placed all vaccine into a frozen bag, booster vaccines were then transported to another clinic and was adminstered between 02-MAR-2023 to 28-MAR-2023.) 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. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 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 an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.), POOR QUALITY PRODUCT ADMINISTERED (Had placed all vaccine into a frozen bag, booster vaccines were then transported to another clinic and was adminstered between 02-MAR-2023 to 28-MAR-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.), POOR QUALITY PRODUCT ADMINISTERED (Had placed all vaccine into a frozen bag, booster vaccines were then transported to another clinic and was adminstered between 02-MAR-2023 to 28-MAR-2023.) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.) and POOR QUALITY PRODUCT ADMINISTERED (Had placed all vaccine into a frozen bag, booster vaccines were then transported to another clinic and was adminstered between 02-MAR-2023 to 28-MAR-2023.).    No concomitant medications were reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported than, on 02-Mar-2023 to 28-Mar-2023, vaccines were administered to 26 Patients at facility. No treatment details were reported.  This case was reported for Patient 9 out of 26 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:Patient 1 (Master Case)
Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient took dose 2 on 26-MAR-2021(020B21A) on right arm and booster dose on 17-DEC-2021(032H21A) on left arm. No concomitant and treatment medication was reported.   This case was linked to MOD-2021-423448 (Patient Link).
The next day I felt run down, I started having severe diarrhea and vomiting. When I started vomiting, I passed out and I fell backwards, and I was defecating and vomiting and unresponsive. My wife called 911. They were taking my wife through stroke protocol over the phone and when the fire department arrived, they did a full exam, when the fire crew they hooked me up to heart machine and all my vitals were normal. I refused going to the hospital. I stayed in bed, my chest felt tight, and my voice was low. I had hot and cold chills off and on. I had body aches, bone aches, knees aching. I could not walk to kitchen. I was so weak and exhausted. I had loss of appetite. This went on for 6 weeks or more. For a few months I had trouble with my balance.
Unknown if it's related, but my son suffered a neonatal stroke. Otherwise, I had no complications or issues during pregnancy/labor. He was born full term and healthy but had a massive stroke in utero.
Client presented to vaccine site with her mother on 1/22/2022 to receive the COVID Pfizer Booster dose. RN vaccinated client with the COVID Pfizer Booster dose (Lot# FJ6369) in the L arm while sitting upright at 1340. At approximately 1341 the client stated "i'm feeling dizzy" and  RN called for help. RN stabilized the client in the chair as she fainted and Lead RN assisted in stimulating the client. Client had a strong pulse and patent airway. RN assessed client was unresponsive to stimuli for approximately 2 seconds. Client did not fall out of chair and did not sustain any injuries. When client became responsive to stimuli, RN assessed client was A&O x4 and reoriented client to the room. EMT provided client with water and took client's vitals. Vitals at 1342 were BP in R arm sitting upright 138/90, HR 93, and SPO2 99%. Client's mother reported "she starts to shake even talking about the vaccine" and stated that the client has a history of anxiety with needles. RN reported to Lead RN that the client did not disclose history of syncope with needles prior to vaccination.  Client reported her last intake was carne asada fries at approximately 1230. Client denied SOB, pain, nausea, or changes in vision. Client reported mild dizziness. EMT and Lead RN assisted in transferring the client to lay down cot in observation area. EMT took vitals at 1355 with BP 132/94, HR 98, and SPO2 98%. At 1355 the client reported she was "not really dizzy anymore" and "a little lightheaded". Lead RN reviewed ER precautions and when to f/u with PCP with client and her mother. RN observed a steady and symmetrical gait as client walked around in observation. Client left the vaccine site with her mother who drove her at approximately 1410.
The patient received dose from vial beyond 30-day use by date.; The patient received dose from vial beyond 30-day use by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date.) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date.) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date.) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   the date of refrigeration was mentioned as 7-5-2021.  No concomitant medications was reported.  No treatment drug details was reported.
On 11/17 was not feeling well.  On the 25th felt really sick, couldn't breath, coughing.  On the 26th went to the doctor and was prescribed ERYTHROMYCIN and feels much better now. Took MUCINEX for cough.
This spontaneous report was received from a nurse practitioner and refers to an approximately 11 year old male patient (according to the reporter, the patient is currently "20 or 21 years old"). Concurrent conditions, medical history, historical or concomitant drugs were not reported. On an unspecified date approximately in 2008 (also reported "when he was 11 years old"), the patient was vaccinated with the first dose of GARDASIL Injection, for prophylaxis (strength, dose, route, anatomical location, lot # and expiration date were not reported). Subsequently, he was vaccinated with the second dose of GARDASIL Injection, for prophylaxis (strength, dose, route, anatomical location, lot # and expiration date were not reported) also approximately in 2008. The reporter stated that approximately in 2008 (also reported as "sometime after the patient received a second dose of GARDASIL, the patient began experiencing body aches, fatigue and headache which had persisted for 10 years. The nurse informed that the patient was initially tested for Lyme disease on an unknown date, but tests were negative. It was also reported that the patient was currently functional but not feeling well (the onset date of this event was not reported). He sought medical attention, but it was not known if any treatment was given for the events. The outcome of the events of body aches, fatigue, headache and malaise were reported as not recovered. The causal relationship between the events and vaccination with GARDASIL was reported as unknown (also reported as "they weren't sure if his symptoms were associated with GARDASIL; however, the patient's grandmother stated the symptoms began after the patient received the second dose of GARDASIL.
Sudden onset 14 hrs after injection.  Severe nausea (exact presentation as Covid) Fever 103 12 hour duration  2 day recovery
itching on torso, both arms, and on back of legs; marks from scratching/ scratched didn't itch, it just hurt; Arm was a little bit sore; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 20Mar2021 at 13:40 (Batch/Lot Number: EN6208) (at the age of 80 years old) as dose 2, single for COVID-19 immunisation in a hospital. Medical history included allergies to sulfa, penicillin and nitrofurantoin (MACROBID). There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was previously administered the first dose of BNT162B2, via an unspecified route of administration, administered in left arm, on 25Feb2021 at 11:30 (Batch/Lot Number: EM9809) (at the age of 80 years old) as dose 1, single for COVID-19 immunisation. On an unspecified dates in Mar2021, the patient experienced itching on torso, both arms, and on back of legs; marks from scratching/ scratch didn't itch, it just hurt; and arm was a little bit sore. Clinical course of events was as follows: The patient had itching after first dose and came back after receiving the second dose but does not have a rash anywhere. The itching was on torso, sometimes on both arms, and sometimes on back of legs, but no rash. The patient felt like she has been poisoned. There were marks from scratching only. The patient had an itching attack while she was in the doctor's office. The dermatologist switched the patient's medication to Clobetasol propionate 0.5% (previously from triamcinolone acetonide 0.1%). The patient tried taking non-drowsy loratadine (CLARITIN), but this made her drowsy and reported that she has a poor tolerance to antihistamines. No mark where Pfizer Covid vaccine received and she wasn't puffy. Arm was a little bit sore. The patient took two ibuprofen (ADVIL) before she went to bed last night, because where she scratched didn't itch, it just hurt. It was the first the patient was able to sleep through the night and didn't not have to get up scratching in middle of night. The event itching on torso, both arms, and on back of legs resulted to physician office visit. The outcome of events itching on torso, both arms, and on back of legs; marks from scratching/ scratch didn't itch, it just hurt; arm was a little bit sore was unknown.  No follow-up attempts are possible. No further information is expected.
Seasonal flu vaccine to left arm on 10/19/2009. Pain at the site worsening by 10/23. When arm is immoble like during sleep it becomes very weak and very sore. Went to see PCP on 10/31 (Sat.) referred for physical therapy. MOTRIN helps relieve pain to some degree.
This spontaneous report has been received from a pharmacist referring to an adult patient of unknown gender and age. On an unknown date the patient was vaccinated with RECOMBIVAX HB injection, 0.5 ml, intramuscular, unknown frequency. It was reported that the patient was an unspecified adult and therefore, RECOMBIVAX HB was administered outside the prescribing information. It was unspecified as to which dose that was in the RECOMBIVAX HB vaccination series. No adverse effect was reported. No further information was available. Additional information has been requested.
I had a sore throat, a little cough, fever, headache, chills that lasted for 2 days, weakness, brain fog for 2 and a half weeks, low oxygen, loss of smell, and loss some of my taste. I tested positive for COVID-19. I talked to my doctor about my symptoms, and she said I was not qualified for PAXLOVID. A few days after my positive test, I felt so weak, and I felt like I was about to pass out. My hands and feet started feeling numb. I could barely pick up the phone to call my doctor. When the ambulance came they gave me fluids and by the time I got to the hospital, I started to feel better. They did an EKG, lung x-ray, monitoring blood pressure, and oxygen. Everything seemed to be normal. I still have a touch of brain fog.
On December 9, severe pain began in back, worsening over the course of several days until on December 14, 2021 a spinal staph infection was discovered in thoracic vertebrae resulting in emergency laminectomy and debridement.  Infection also spread to left hip, which required second surgical debridement.  Following surgeries, hospitalization and intense rehab, left with limited function of lower body requiring walker and wheel chair.   Infection treated over multi-week course with pic line and IV antibiotics to eliminate any lingering staph. Physical therapy has been ongoing three times per week and can now walk slowly with the assistance of canes, but still suffering with severe neurological symptoms including pins and needles, partial paralysis and lack of balance.
Pt vaccinated with MMR noted palpable node rt groin 2 wks after shot. Saw MD node rt groin non palpable but node palpable lt axilla. On F/U node receded. Afebrile throughout this episode. Experienced some joint pain in wrists & knees.
The day after I had the shot, i started to itch on my left arm , around the area I had the shot,,and then it developed into a rash like situation on both arms...the itching was so intense and then i noticed tiny bumps  and black and blue spots along my right and left arm.  It then spread to my thighs and upper chest area. I also had tightness in my throat and i took some Benadryll over the weekend hoping it would go away but it didn't. It got worse. On Monday, it was swollen on both arms and looked more like hives, red itchy with tiny bumps. On Tuesday, I went to my PCP who indicated it may have been an allergic reaction from the vaccine. She gave me Medrol and that is what I have been taking. Today the itching is a little less intense ..
(L) upper post arm central red papule 0.5 cm x 0.5 cm with 6 cm x 5 cm tender induration. Slightly warm to touch, mild (L) axillary tenderness DTR's intact in (L) arm. NL. ROM. Lungs = clear. Ht = RRR without M R, G.
17 years old received the Moderna COVID 19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old received the Moderna COVID 19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old received the Moderna COVID 19 vaccine). On 24-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old received the Moderna COVID 19 vaccine) had resolved.        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 product use was not provided. Treatment information was not provided.
Vaccine given. About 1/2 hour later noticed itching of right lower arm and noticed rash. Also left arm itching and rash. States also has nausea feeling and feeling really tired.  Did have blood drawn prior to this reaction. Benadryl 25mg po.
Really hot arm; Rash is my neck same side as second Moderna shot/skin rash on neck looked like fungus, and thought it was ring worm from the way it looked and feltskin rash and described "it was spreading and nothing to do with dermatitis, pinpoint and patchy."; Swelling glands; More pain; Dizziness; Really swollen and really hot arm/r right arm is inflamed and solid/; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (More pain), DIZZINESS (Dizziness), PERIPHERAL SWELLING (Really swollen and really hot arm/r right arm is inflamed and solid/), SKIN WARM (Really hot arm) and RASH (Rash is my neck same side as second Moderna shot/skin rash on neck looked like fungus, and thought it was ring worm from the way it looked and feltskin rash and described "it was spreading and nothing to do with dermatitis, pinpoint and patchy.") in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles in 1996.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 28-Apr-2021, the patient experienced PERIPHERAL SWELLING (Really swollen and really hot arm/r right arm is inflamed and solid/). On 15-May-2021, the patient experienced PAIN (More pain), DIZZINESS (Dizziness) and LYMPHADENOPATHY (Swelling glands). On an unknown date, the patient experienced SKIN WARM (Really hot arm) and RASH (Rash is my neck same side as second Moderna shot/skin rash on neck looked like fungus, and thought it was ring worm from the way it looked and feltskin rash and described "it was spreading and nothing to do with dermatitis, pinpoint and patchy."). On 06-May-2021, PERIPHERAL SWELLING (Really swollen and really hot arm/r right arm is inflamed and solid/) outcome was unknown. At the time of the report, PAIN (More pain), DIZZINESS (Dizziness), SKIN WARM (Really hot arm), RASH (Rash is my neck same side as second Moderna shot/skin rash on neck looked like fungus, and thought it was ring worm from the way it looked and feltskin rash and described "it was spreading and nothing to do with dermatitis, pinpoint and patchy.") and LYMPHADENOPATHY (Swelling glands) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included Valtrex, 14MAY2021 onwards.
Macular rash; new onset; POS ANA nucleolar pattern; homogenous; 1:320 titer. Final diagnosis: Systemic lupus; vaccine reaction.
Arm hurt for about 2 weeks after Moderna Covid Vaccine; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Arm hurt for about 2 weeks after Moderna Covid Vaccine) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products INFLUENZA VACCINE (SWINE FLU VACCINE (1976), MONOVALENT) for an unknown indication and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.  No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, INFLUENZA VACCINE (SWINE FLU VACCINE (1976), MONOVALENT) (unknown route) 1 dosage form and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm hurt for about 2 weeks after Moderna Covid Vaccine). At the time of the report, VACCINATION SITE PAIN (Arm hurt for about 2 weeks after Moderna Covid Vaccine) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The patient had arm hurt for about 2 weeks after Moderna Covid Vaccine. The patient stated that, the syringe backfired and 5cc's, 10 doses of the Swine flu vaccine, hit in his eye and a short time later he started to have some hemiparesis. The patient had received both doses of the Pfizer Covid 19 Vaccine and was due for a booster shot. The patient states that, he thinks most people had the same reaction to the Moderna COVID Vaccine with the sore arm. He thinks it was due to the super dose of the vaccine with Moderna.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.