chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BODY ACHES; FATIGUE; LOW-GRADE FEVER; RAPID HEART RACING; CHILLS; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient was previously treated with ergocalciferol; and experienced hives when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced rapid heart racing. On 31-MAR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 100.1 F, and Heart rate (NR: not provided) 120 bpm. Treatment medications included: ibuprofen. On 31-MAR-2021 16:00, the subject experienced low-grade fever. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced fatigue. Laboratory data included: Heart rate (NR: not provided) 90 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, rapid heart racing, and fatigue on 01-APR-2021, and chills, and low-grade fever on 31-MAR-2021. This report was non-serious.
Left shoulder hurts, pinching nerve feeling, can't elevate arm past 45 degrees. I did an MRI and it shows muscle atrophy and hole present, needs immediate surgery.
Muscle fatigue, myalagia, arthralgia beginning about 10 hours post vaccine to 36 hours Cold intolerance 12 hours post vaccine to 36 hours Fever 24 hours post vaccine to 36 hours All treated with combination of scheduled acetaminophen and ibuprofen, rest, and water hydration.
vaccine exposed at 30-32 degrees F for one hour due to opening and closing of refrigerator door/no AE; Initial information received on 19-Jun-2020 regarding an unsolicited valid non-serious case received from a physician  This case is linked to cases 2020SA161181, 2020SA161064, 2020SA161183, 2020SA161184 and 2020SA161203(same reporter).  This case involves a 2 months old female patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was exposed at below 30-32 Fahrenheit for one hour due to opening and closing of refrigerator door(product storage error).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 10-Jun-2020, the patient received first dose 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ015AAA and expiry date 26-Oct-2020) via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to product storage error temperature too low.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
heart attacks; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced heart attacks on an unspecified date. The outcome of the event was fatal. The patient died on an unspecified date. Autopsy was done.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Reported Cause(s) of Death: heart attacks
p/vax pt acute non-ketotic ketoacidosis; blood sugar-800 in pt w/NIDDM controlled w/diet
Moderna only approved for 18+.  Patient 15 at time of vaccination therefore reporting.   No adverse reactions observed at time of vaccination or 15 minutes following.
lethargy, low fever. swollen neck(both sides), painful arm and breast on same side of injection. sore throat
About an hour after the vaccine, my legs went numb and my heart rate spiked. My husband and I went to the emergency room and sat in the waiting room for about 2 hours as things calmed down. We never were admitted. We were afraid to incur a large hospital bill, but we wanted to make sure we were close in case emergency care was needed. Within a week, I was profusely vomiting and heart rate high. I couldn't stand without getting dizzy and heart rate spiking. I have been in bed since Sept 2, 2021.
I feel it important to report that a few weeks following my jab, 2 very unusual and odd (never seen on myself before) blisters, sort of like chicken pox, rose on my right upper arm (not the vaccine arm).  They eventually broke and oozed, and took a very long time to heal over.  In fact, it is late November and they still are scabbing over a tiny bit, but are mostly raised bumps left on my arm.  The only thing I can think is that the immune response my body mounted my have triggered them.  If you want to call me to discuss further, I'd appreciate that.  I want to get a J&J booster (do not want to get an MRNA jab), but am a bit concerned about this happening again.  It wasn't painful, maybe a bit itchy, but nonetheless disconcerting because of their persistence for quite a long time, and long time healing over.  Because I wasn't really in any distress I didn't report it to my doctor BUT feel it's important to let VAERS know, and again would like to talk with someone!!
48 hours after tetanus injection (R) swollen & hot to the touch deltoid 5 x 5cm area of induration.
Chronic Epididymitis; Autoimmune disorder; Nerve pain; Condition worsened; Testicular pain; This spontaneous case was reported by a consumer and describes the occurrence of EPIDIDYMITIS (Chronic Epididymitis) and AUTOIMMUNE DISORDER (Autoimmune disorder) in a 39-year-old male patient 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 No adverse event (No Historical Condition reported.).   On 23-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 23-Jan-2021, the patient experienced TESTICULAR PAIN (Testicular pain). On an unknown date, the patient experienced EPIDIDYMITIS (Chronic Epididymitis) (seriousness criterion medically significant), AUTOIMMUNE DISORDER (Autoimmune disorder) (seriousness criterion medically significant), NEURALGIA (Nerve pain) and CONDITION AGGRAVATED (Condition worsened ). At the time of the report, EPIDIDYMITIS (Chronic Epididymitis), AUTOIMMUNE DISORDER (Autoimmune disorder), TESTICULAR PAIN (Testicular pain), NEURALGIA (Nerve pain) and CONDITION AGGRAVATED (Condition worsened ) outcome was unknown.            Treatment medication - Antibiotics, pain killers, Gabapentin, Tramadol, Hydrocodone, Celebrex.  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.   This case was linked to US-MODERNATX, INC.-MOD-2021-076172 (E2B Linked Report).; Sender'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. US-MODERNATX, INC.-MOD-2021-076172:CROSSLINKED WITH DOSE 1
I had a 6 month follow up with my cardiologist recently, I waited until I saw him. Since receiving my second vaccine I noticed more frequently a pinching, cramping, squeezing sensation to my heart. It was something I had previously but it was getting stronger in pain and sensation. To this day I continue with the pinching sensation to my heart periodically but not as much regularity when I received the vaccine.
Fine red itchy rash on trunk, arms, thighs; 14JUN92 spreading, neck, behind ear, arms 14JUN92; t100, rash worse 17JUN92; vacular papular rash arms, back, chest, legs 23JUN to see skin specialist on 24JUN92;
Swollen/painful axial lymph nodes in injection site arm, onset approximately 15 days post-inoculation.
After about 15-20 minutes, patient developed left facial twitch and she felt warm on her left side.  VS: BP 154/88, HR 88, O2 sat 98, BS WNL. Symptoms resolved in about 15 minutes without any intervention.
Sores in mouth: (1) Sore  on left lateral side of tongue; (2) Sore on left lower inner gum line below teeth; (3) Sore on left inner cheek. These sores were open and red and painful. It made it painful to eat.
back pain; Pain in neck; flu-like symptoms; pain moves from neck to her arm; Muscle ache; Fatigue; chills; pain on the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), NECK PAIN (Pain in neck), INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (pain moves from neck to her arm) and MYALGIA (Muscle ache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESTRADIOL, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE), PANTOPRAZOLE, HYOSCYAMINE, PROBIOTICS NOS, VITAMIN E NOS and BACLOFEN for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-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 BACK PAIN (back pain), NECK PAIN (Pain in neck), INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (pain moves from neck to her arm), MYALGIA (Muscle ache), FATIGUE (Fatigue), CHILLS (chills) and VACCINATION SITE PAIN (pain on the site of injection). At the time of the report, BACK PAIN (back pain), NECK PAIN (Pain in neck), INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (pain moves from neck to her arm), MYALGIA (Muscle ache), FATIGUE (Fatigue), CHILLS (chills) and VACCINATION SITE PAIN (pain on the site of injection) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drugs were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 74 years old male patient who experienced this reaction severe dermatitis, pain was so bad that he thought he tore his right rotator cuff, swelling started 4 days after the injection in his right shoulder, redness and warmth started at the injection site, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported) via intradermal route in an unknown site. On an unknown date, the patient developed a non-serious severe dermatitis, pain was so bad that he thought he tore his right rotator cuff, swelling started 4 days after the injection in his right shoulder, and redness and warmth started at the injection site (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was also reported that the redness and warmth started at the injection site and spread to different parts of his arm. It then spread to the back of his arm. Pain was so bad that he thought he tore his right rotator cuff. It was a case of actual medication error case due to Wrong injection technique (reporter stated he doesn't think the RPh knew what he was doing because he went in at an angle instead of straight in) and inappropriate route of vaccination. No lab data was reported. Final diagnosis was redness and warmth started at the injection site, swelling started 4 days after the injection in his right shoulder, pain was so bad that he thought he tore his right rotator cuff and this reaction severe dermatitis. As a corrective treatment the patient placed an ice pack on his right arm at first and that seemed to help. The HCP started him on a high dose of prednisone (40 mg x 4 days and 20 mg x 5 days). The event outcome was reported as unknown for all the events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Within 5 minutes of injection, generalized itching and localized swelling and redness described as the size between a quarter and silver dollar. BENADRYL liquid 50mg given, pt. waited 15 minutes before leaving with no further progression of symptoms. Patient contacted later and no problems.
Patient was given vaccine 9 days past the beyond use date. The clinic is currently working on creating guideline and processes to prevent this from happening again.
24 hours after receiving flu shot patient developed an extremely itchy rash on chest, entire back bilateral groin & upper thighs. The rash had some wheals, was beefy red & indurated. Treatment was steroids x 7 days & antihistamines prn.
pt recv vax & w/in 3hr chills, sweats, generalized weakness, by 12hr urticaria on legs for 30min duration w/pruritus, followed by severe arthralgias (mainly shoulders), myalgias, intermittent tingling lt fingers & fever 38.5C;
Patient received the vaccine after 4pm, which was after the expiration time of 3:17pm after dilution.
Patient felt faint; This case was reported by a physician via sales rep and described the occurrence of faint in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included HPV 16-18 (HPV vaccine) for prophylaxis and MENINGOCOCCAL VACCINES (NOS) (MCV VACCINE) for prophylaxis.   On an unknown date, the patient received Bexsero, HPV vaccine and MCV VACCINE. On an unknown date, less than a day after receiving Bexsero and HPV vaccine, the patient experienced faint (serious criteria GSK medically significant). On an unknown date, the outcome of the faint was unknown.   It was unknown if the reporter considered the faint to be related to Bexsero and HPV vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter shared that, when she administered Bexsero at separate injection site on the same day as MCV and HPV, the patient felt faint. The reporter did not agree to follow up from GlaxoSmithKline.
Client arrived at site for first dose Pfizer COVID19 vaccination. She has a documented allergy to shellfish, with questionable anaphylaxis. She was advised to extend her post vaccine monitoring time to 30 minutes. Shortly after arriving in the observation area, she notified EMS of throat tightening. She was moved to a triage area where her vital signs were closely monitored. Her symptoms did not resolve and the decision to transfer to Emergency Department was made with clients consent.
Patient reports case of cerebral palsy, lower lip swelling, flushed face, + cough, nausea and fever, diaphoretic, no SOB, tachycardic, felt sick. Transferred home. Received Zyrtec and Benadryl stat.
pt recv vax NOV95 & devel an inj site w/redness, swelling & itching;the affected area is about the size of a BP cuff (4" x 10");this case was reported by a MD;cross reference w/ DER 0010150960093/97, DER 0010150960099 to DER 0010150960102;
4/3/2021   Patient was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  dizziness.   Assessment : Time of assessment  09am  Alert and oriented. Complains of dizziness,     Actions taken:  VS taken- BP- 117/64, P- 80, O2- 100 %, 0915- BP-127/73, P- 77, 0917 juice and crackers given, 0932- BP- took while standing- 124/68, P- 81, 0949- 117/68, P- 77           Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 60 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.   RN called person  at 1110 , and patient voiced that her lips feel funny and that the patient took benadryl once she arrived home. RN instructed patient to call 911 if symptoms increase.   Immunizations Administered    Name Date Dose VIS Date Route   Moderna COVID-19 Vaccine 4/3/2021  8:37 AM 0.5 mL 12/1/2020 Intramuscular   Manufacturer: Moderna   Lot: 008821-2A   Moderna COVID-19 Vaccine 4/3/2021  8:30 AM 0.5 mL 12/1/2020 Intramuscular   Manufacturer: Moderna   Lot: 008821-2A
My menstrual cycle came 10 days early.  Heavy bleeding.  I have had regular periods for years.  Never early or late.
SEVERE BLADDER SPASM FREQUEST RESTROOM VISITS STARTED SLOWLY AND PROGRESSED AND WORSENED.
patient developed shingles.; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In OCT-2023, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced shingles (Verbatim: patient developed shingles.). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date:09-NOV-2023 The reporter was the husband of the patient. The reporter reported that within 1 week after receiving the vaccine, the patient developed Shingles. Consent to follow up. This case has been linked to the case US2023155539 reported by the same reporter.; Sender's Comments:  US-GSK-US2023155539:2 of 2 report
Feel weird; Kicked my butt/worse reaction than what I had with the flu shot; Temperature of 103; Headache; Blood pressure was high; Dizziness; Left hand was tingly; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure was high), DIZZINESS (Dizziness), PARAESTHESIA (Left hand was tingly), FEELING ABNORMAL (Feel weird) and VACCINATION COMPLICATION (Kicked my butt/worse reaction than what I had with the flu shot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A, 017B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Immunization: Flu. Past adverse reactions to the above products included Weird feeling with Flu. Concurrent medical conditions included Raynaud's disease (immunocompromised with Reynaud's syndrome) and Immunocompromised. Concomitant products included PAROXETINE, BUSPIRONE, FOLIC ACID, METHOTREXATE from an unknown date to 03-Sep-2021 and OMEPRAZOLE for an unknown indication.   On 27-Mar-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 1 dosage form. On 15-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced HYPERTENSION (Blood pressure was high), DIZZINESS (Dizziness), PARAESTHESIA (Left hand was tingly), PYREXIA (Temperature of 103) and HEADACHE (Headache). 16-Sep-2021, the patient experienced VACCINATION COMPLICATION (Kicked my butt/worse reaction than what I had with the flu shot). On an unknown date, the patient experienced FEELING ABNORMAL (Feel weird). On 18-Sep-2021, HYPERTENSION (Blood pressure was high), DIZZINESS (Dizziness), PARAESTHESIA (Left hand was tingly), PYREXIA (Temperature of 103) and HEADACHE (Headache) had resolved. At the time of the report, FEELING ABNORMAL (Feel weird) had not resolved and VACCINATION COMPLICATION (Kicked my butt/worse reaction than what I had with the flu shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Sep-2021, Blood pressure measurement: high (High) High. On 16-Sep-2021, Body temperature: 103 (High) high. On 16-Sep-2021, Heart rate: 99 (High) high.         Other Concomitant medication included ceterone. No treatment medications were reported.
Heart rate is also down from 60 to 49; Her usual blood pressure is 102/60, however it is at 134/64 right now; She has light-headedness/dizziness; This is a spontaneous report received a contactable pharmacist. A female of unspecified age received a dose (unspecified dose number) of BNT162b2 (solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on 26Apr2021 (reported as forty-eight hours ago) for COVID-19 immunisation. There was no medical history, concomitant medications or past drug history reported. The pharmacist reported that her cousin received the Pfizer COVID vaccine forty-eight hours ago. The pharmacist reported that her cousin's blood pressure is usually 102/60, however it is at 134/64 on 28Apr2021 (reported as right now). The pharmacist also mentioned that her heart rate is also down from 60 to 49 and she has light-headedness and dizziness on 28Apr2021 (reported as right now). The outcome of the events blood pressure 134/64 right now, heart rate is also down from 60 to 49, and light-headedness and dizziness, was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of HR decreased, BP increased and dizziness.   There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to agency, as appropriate.
Seen 10/28/09 with symptoms including fever up to 105 degrees, nasal congestion, cough, fatigue and vomiting. Associated symptoms include decreased appetite.
pt recv vax 7MAY97 & no c/o until, stated sore arm, shoulder @ 5AM 8MAY97 then states ran a fever of 103 was nauseated & weak;9MAY97 reported c/o to (school nurse);better today-nl sensation;a little weaker but able to grasp;to see MD;
Patient was given vaccination to the left arm via intramuscular. She states that the area began to feel itchy and warm to touch. The injection site was made visible by a small bump.