chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEART RATE INCREASED; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug or non-drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1502072, and batch number: 1502072 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021 21:05, the subject experienced heart rate increased. On 11-MAR-2021 21:05, the subject experienced chills. On 11-MAR-2021 21:05, the subject experienced fever. On 11-MAR-2021 21:05, the subject experienced headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 106.7 (units unspecified), and Heart rate (NR: not provided) 120 (units unspecified), 65 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart rate increased, and chills on 12-MAR-2021, was recovering from fever, and had not recovered from headache. This report was non-serious.
an expired Fluzone High Dose Trivalent was given to a patient, no AE; Initial information was received on 02-Sep-2020 regarding an unsolicited valid non-serious case from the pharmacist via web enquiry.  This case is linked to cases 2020SA241782 and 2020SA241783 (same reporter).  This case involves a 81 year old male patient who was vaccinated with a 0.5 ml dose of an expired INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (prefilled syringe, lot UJ299AA and expiration date 30-Jun-2020) via an intramuscular route at an unknown administration site on 01-Sep-2020 for prophylactic vaccination (Expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant therapy were not provided.   It was an actual medication error case due to expired vaccine used (latency was same day).  No adverse event reported at the time of reporting.  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.
(L) shoulder extremely painful several hours after flu shot. Pain increased over several weeks. Unable to move arm without severe pain ROM limited. MD placed on modified duty, NSAIDS stretching exercises.
1ST DOSE TO 2ND DOSE PFIZERS 14 DAYS APART
Starting approximately 2 days after vaccination, pt experienced soreness in left arm that has continued until day of report (7/5/21). Pain is intermittent, located in deltoid muscle only, comes and goes. No redness or swelling at site. Pain has been unrelieved with OTC pain relievers.
Brief loss of consciousness, nausea, Brought to med screening for evaluation, then nausea worsened, emesis x1. Vital signs: B.P =132/98     Pulse = 80       Po2=97% Declined further interventions, left in stable condition at 12:58. Recorded and Evaluated by Providers
lymphoma side effects of itchy feet and odd feeling to her left ear had resolved; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic drug effect in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included lymphoma, pruritus (Itchy feet) and night sweat.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced unexpected therapeutic drug effect. On an unknown date, the outcome of the unexpected therapeutic drug effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic drug effect to be related to Shingrix.  Additional details were provided as follows: The patient stated that shortly after vaccination she noticed that her lymphoma side effects of itchy feet and odd feeling to her left ear had resolved, and her night sweats, also a side effect of her lymphoma, was not as bad. The patient went to her oncologist. The patient was due for her second Shingrix vaccination at the end of September. The patient consented to follow up.
Pt developed a fever and seizure. This child was admitted. It seems that seizure associated with febrile episodes was related to vaccination.
This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M044032 and  expiration date 03-JUL-2019 (route, dose, dose number frequency and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit  for 108 hours and 32 to 42 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA005600: US-009507513-1706USA011006:
On Saturday after the vaccine, I had discharge, I called the doctor, I went to see the doctor, they did a biopsy and sent it to the lab, by the end of the week the result came back and the result was negative, no bad cells. He said it could be the vaccine could affect the uterus. He sent me to a cancer specialist, and he did a DNC and cleaned my uterus. I will do a follow up in December to make sure my uterus is not ticked.
Tonic-clonic seizure for about one minute, post-ictal phase, not entirely back to normal for about 6 hours.
Initial report received on 18 November 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 2-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System electronic database. The subject's vaccine history included 3 doses of DAPTACEL; lot number C2870AA received on 27 February 2009, lot number C3290AA received on 30 April 2009, and lot number C3193AA received on 30 June 2009, and a dose of TRIPEDIA, lot number U3282BA received on 30 June 2010 (route and site of vaccine administration not reported). The subject developed cold-like symptoms on 11 August 2011, approximately 13 months after the last dose. On 16 August 2011, the subject developed a paroxysmal cough without a whoop and posttussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 18 August 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 19 August 2011 for 5 days. The subject was not hospitalized. At the time of final contact on 16 September 2011, the subject's cough had resolved. The duration of the cough was reported at that time as 30 days. Documents held by sender: None.
Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 dosage form. At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information not provided. Patient Consent Denied to save the caller's information within our database and Denied for safety to follow up.
Expired Menactra vaccine was administered to the patient/ No AE; Initial information was received on 21-Jul-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 19 year old male patient who received 0.5 mL once dose of expired vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6208AD and expiry date 08-Jul-2020) (Pharmaceutical form- Injectable) via intramuscular route in the left deltoid for prophylactic vaccination on 21-Jul-2020 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was an actual medication error case due to expired vaccine used. It was reported that on 21-Jul-2020 the patient received vaccine which was expired 08-Jul-2020.  No adverse event symptoms at the time of reporting.  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
Hotness to touch at the injection site; Tenderness on the lymph nodes; Hardness at the injection site; Redness at the injection site; Swelling on the lymph nodes; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Hotness to touch at the injection site), LYMPH NODE PAIN (Tenderness on the lymph nodes), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and LYMPHADENOPATHY (Swelling on the lymph nodes) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hotness to touch at the injection site), LYMPH NODE PAIN (Tenderness on the lymph nodes), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and LYMPHADENOPATHY (Swelling on the lymph nodes). At the time of the report, VACCINATION SITE WARMTH (Hotness to touch at the injection site), LYMPH NODE PAIN (Tenderness on the lymph nodes), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and LYMPHADENOPATHY (Swelling on the lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient was planning on getting pregnant.
As soon as I got the vaccine I felt loopy I came home and was exhausted  Woke up from nap with extreme arm pain and severe headache as the day progressed left jaw pain and ear aches chills body and muscle aches Nausea Diarrhea  Chills Extreme fatigue This continued through the second day Today is day 3 very mild jaw pain No earaches Arm only slightly sore Extreme fatigue  Nauseous  Stomach cramping  Chills went away and today around noon became extremely hot had to put shorts on turn the heat down and put fans on me sweating bad  Continue with headache fatigue and muscle cramps and nausea
got my first shot, and it hurt; arm is killing me, very sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain and pain in arm. On an unknown date, the outcome of the pain and pain in arm were unknown.   It was unknown if the reporter considered the pain and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and it hurt like hell his/her arm was killing him/her, very sore. The follow-up would not possible, as no contact details were available.
For three weeks before my hearing became impaired, I had been dealing with a horrible headcold. I began coughing pretty hard and my sinuses were particularly full when I'd wake in the morning.  On 7 Dec I had blocked hearing in my left ear with little pain. I was in a loud elementary school lunchroom at the time. The blockage did not clear and by the end of the day the ear was slightly sore. I saw my NP the following afternoon when the right ear became blocked. She said the left eardrum was perforated and the right ear was clogged with wax. She prescribed Ofloxacin (2 wks) for both ears as well as lavage procedures for the right ear. Claritin and Afrin were also directed to dry up the sinuses.
Hot to the touch right around the injection site; Very large knot right around the injection site; Itchiness right around the injection site; Redness right around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch right around the injection site), VACCINATION SITE NODULE (Very large knot right around the injection site), VACCINATION SITE PRURITUS (Itchiness right around the injection site) and VACCINATION SITE ERYTHEMA (Redness right around the injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included EPINEPHRINE BITARTRATE (ASTHMAHALER) for Asthma, LABETALOL for an unknown indication.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch right around the injection site), VACCINATION SITE NODULE (Very large knot right around the injection site), VACCINATION SITE PRURITUS (Itchiness right around the injection site) and VACCINATION SITE ERYTHEMA (Redness right around the injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot to the touch right around the injection site), VACCINATION SITE PRURITUS (Itchiness right around the injection site) and VACCINATION SITE ERYTHEMA (Redness right around the injection site) was resolving and VACCINATION SITE NODULE (Very large knot right around the injection site) 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.   Treatment information provide as put ice on injection site; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
I had a major headache begin within ten minutes after the vaccination, my blood pressure rose and I could not get it down. Within the next two months I began to get sick and also began to suffer from pericarditis for the three months.
Initial unsolicited report received from a pharmacist on 22 Nov 2016. This case involves a 70 years old female patient who was vaccinated with a dose of FLUZONE HD (batch number- UI700AA, expiry date- 03 May 2017; dose in series and route of administration- unknown) in right arm on 11 Nov 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Any other vaccinations within 4 weeks of vaccination was reported as none. The patient's other concomitant medications were not reported. On 11 Nov 2016, one hour following the vaccination, the patient's both eyes began to burn and within 6 hours after receiving vaccine, clear mucous was present in both eyes, and then the mucous turned to yellow in color. On 12 Nov 2016 in the morning, one day following vaccination,patient's both eyes were reddened. Laboratory investigations was reported as none. The patient corrective treatment were not reported. On 12 Nov 2016 in the evening, patient was recovered from reddened eyes. On an unspecified date, the patient was recovered from other events. List of documents held by sender: none.
This non-serious spontaneous case, initially received from other non-health professional on 18-Jun-2018, concerning an adult female patient of an unspecified age. The patient's current conditions included: hypothyroid and migraine headache. The patient had no known allergies (reported as no true allergies). Concomitant medication included FIORICET and EXCEDRIN TENSION. On an unspecified date in 2015, the patient was administered FLUVIRIN Thiomersal (batch number: 1515101, dose, route of administration, anatomical location, expiry date: not reported). Seqirus Quality Assurance have confirmed that the batch number reported (1515101) was 2015 FLUVIRIN Thiomersal. On 12-Jan-2015, the patient experienced excruciating headache. At the time of this report, the outcome of the event was not reported. This case was cross linked to the case: 201802417 (same patient). Update on 17-Jul-2018: Significant case correction was performed 18-Jun-2018: Seqirus Quality Assurance have confirmed that the reported batch number (1515101) was 2015 FLUVIRIN Thiomersal. Hence, the batch number was captured on the screen of product tab. The narrative was amended accordingly.
pt recv vax 1AUG96 & on 1OCT96 pt devel dermatomal varicella rash-herpes simplex type 1;
9/9/03 male employee described achy joints, finer stiff to move, swelling of joints in hands. Difficulty in playing guitar and carrying briefcase. Plan to rest. 9/15/03 pt described being at 90% of normal, 2 fingers remain stiff.
Within 5 min (L) hand on dorsum turned cyanotic & cool. Rest of arm was fine. Nail bed fine. No swelling or paresthesia. Better after 30 min but still not back to normal.
Acute hypoxic respiratory failure due to COVID-19; sepsis; lactic acidosis; AKI; hyponatremia
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Mar2021 as dose 1, single (Lot number: 006B21A), in left arm, on 17Apr2021 as dose 2, single (Lot number: 040B2119), in left arm and on 14Jun2022 as dose 4 (booster), single (Lot number: 058A22-2A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing), notes: Other medical history: Type 2 Diabetes; "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; LISINOPRIL; ATORVASTATIN.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I tested for covid and was prescribed paxlovid; (19Jul2022) Negative, notes: I tested negative on days 4 & 7; (22Jul2022) Negative, notes: I tested negative on days 4 & 7; (26Jul2022) Positive, notes: Then on day 11 my symptoms returned and I tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient tested positive for Covid and was prescribed Paxlovid (patient had T2 diabetes) which patient took for the full five days. Her symptoms had disappeared, and she tested negative on days 4 and 7. Then on day 11 her symptoms returned and she tested positive. She was suffering worse symptoms than the previous event and she was on day 6 of the new event.
I am not sure if this was a result of the vaccine or not and am trying to be helpful! I woke up 1/4/2020, feeling nauseous. I vomited about 6 times that day and had diarrhea. Next morning, my face was flushed. I had a low grade fever of 99.5, and checked my BP. On my home machine, my pulse was 135. I decided to go to the hospital. My Apple Watch measured my heart rate to be 150 at one time. At the ER, I was diagnosed with sinus tachycardia and dehydration. I was placed on oxygen as my levels were between 90-93, and I was given IV fluids. I have felt fatigued since then, some nausea, and mild diarrhea still.