chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ACHES; RASH; CHILLS; DEHYDRATION; This spontaneous report received from a consumer concerned a 62 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2-2A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021 (about 4 days later), patient experienced chills (was cold and could not warm up), aches (head to toe) and a rash (sides, stomach, arms and fingers). Patient used unscented lotion to help manage, but it continued to spread. It looked like the rash had spread into an infection. The rash looked similar to the rash which was listed as a side effects with all vaccines. Patient had been admitted in the hospital on 03-OCT-2021, for the past three days and was discharged on 06-OCT-2021. The hospital could not find anything wrong with patient. They gave patient IV (intravenous) saline. On an unspecified date in 2021, the patient also experienced dehydration. All symptoms were still present. Reporter stated that had only spoken with the doctors in the hospital about the patient's symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, aches, rash, and dehydration. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20211011470-covid-19 vaccine ad26.cov2.s  Aches and dehydration. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20211011470--covid-19 vaccine ad26.cov2. s chills and rash .This evens are labeled per RSI and is therefore considered potentially related.
Flu shots and pneumonia shots were given to patients in our facility on 10/12/2005 By employees. Approximately 50 injections were given, Four of my employees had the typical reaction to a flu shot, soreness, swelling, redness, and heat at the injection site. On employees reaction was worse than the others. Two other patients reported a bad reaction, with one seeking medical attention at the physicians office next door. She had received the pneumonia shot in the affected arm, and she had severe inflammation and redness. the physician states that the injections were not given in the deltoid muscle of any of the patients that he saw. The shots were given much lower in the fatty tissue of the arm, and the physician was concerned that one patient may develop cellulitis because of the error. Representatives were contacted on 10/14/2005, and they told the physician that the administration technique problem had been addressed with the nurse, and that they had not received any other complaints concerning this particular lot number of the drug.
18AUg93 approx 4 hrs p/immun had unconsolable crying x 3 hrs; 3Pm-6PM; mom lay pt down 6PM & had vomiting followed by shallow breathing & poor color & tone; called 911 recvd 02, looked Ok @ that time;
35 patients exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.  A vial was punctured 30 times at the clinic. 10 patients who were administered the vaccine were affected.
First dose JUL-2020, second SEP-2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number PG35Z, expiry date 11th March 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17th July 2020).   On 24th September 2021, the patient received the 2nd dose of Shingrix. On 24th September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The patient was now presenting to the reporter saying he was told to come back for another dose. At the time of reporting, a third dose had not been administered.  The reporter did not have the lot number and expiration date of dose one. The reporter consented to follow up.
Headache, Myalgia, SkinRash,  chills, 2 days post vaccine, headache and myalgia Narrative:
My left eye started twitching within two days of getting the first dose. This persisted and accelerated after the second dose. While it has mostly subsided, the twitching does occasionally return.
Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Nov-2021. The vial did not undergo any temperature excursions. It was reported that the patient had no adverse event (AE) as a result of this misadministration and was monitored. Some of the vaccines were administered on 05-Nov-2021 and some on 12-Nov-2021. No treatment information was reported
Very cold, tired, drinking a lot of water, fever slept over 22 hrs. Hurt all over. Never felt this bad from a flu shot before and will never take it again. Still have rash.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 28-NOV-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 27-JUN-2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as shingles. The patient was prescribed tramadol and VALTREX for management of his painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient fainted post vaccination, in the recovery area. Vaccination given at 3:03 pm. BP was 93/62. Patient has breakfast. but not lunch. After fainting, Pt got up immediately, and sat back on his chair. After about 30 minutes, Pt left for home.
pt recv vax 1APR97 & 18APR97 pt devel papular chickenpox-like rash on body & extremities;
accidentally received two doses of the fluzone high-dose quadrivalent vaccine two weeks apart with no reported adverse event; Initial information received on 16-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to case 2023SA361826.  This case involves a 70 years old female patient who accidentally received two doses of the Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent] two weeks apart with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Immunisation.  On 01-Nov-2023, the patient received unknown dose (dose 1) of suspect influenza quadrival A-B high dose HV vaccine (lot number, strength, formulation and expiry date not reported) via unknown route in unknown administration site and on 15-Nov-2023 patient somehow accidentally received another dose 0.7 ml  (Dose 2) of the same vaccine  (lot UT8111DA; Expiration Date : 30-JUN-2024; strength and formulation not reported) via intramuscular route in the left deltoid for Immunization two weeks apart with no adverse event (inappropriate schedule of product administration) (latency: on same day) following the last dose.  Action taken: Not applicable  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 the Directive and Regulatory Authority 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.
Localized reaction (redness, warmth, rash) at site and up arm, shortness of breath and respiratory distress. Treated in ER and admitted to hospital.
Right sided hyperesthesia, numbness, tightness, tingling in right  shoulder, arm hip, and leg with concomitant disequilibrium. lasting seconds to minutes at a time.  Maximum duration , intensity, and frequency occurred 4 weeks after the Moderna booster and has slowly been decreasing in the above mentioned parameters.
sore arm (after the second dose); diarrhea (after the second dose); Feeling with no energy (after the second dose); Fever (after the second dose); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm (after the second dose)), DIARRHOEA (diarrhea (after the second dose)), ASTHENIA (Feeling with no energy (after the second dose)) and PYREXIA (Fever (after the second dose)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Redness on 24-Feb-2021.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm (after the second dose)), DIARRHOEA (diarrhea (after the second dose)), ASTHENIA (Feeling with no energy (after the second dose)) and PYREXIA (Fever (after the second dose)). At the time of the report, VACCINATION SITE PAIN (sore arm (after the second dose)), DIARRHOEA (diarrhea (after the second dose)), ASTHENIA (Feeling with no energy (after the second dose)) and PYREXIA (Fever (after the second dose)) outcome was unknown. Not Provided          Concomitant medication was not provided Treatment information was not provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable    This case was linked to INC.-MOD-2021-059947 (E2B Linked Report).; Sender's Comments: INC.-MOD-2021-059947:Case for first dose
Information has been received from a licensed practical nurse, concerning an 11 year old female student with no known drug allergies or illness at the time of vaccination, who on 11-JUL-2007 was vaccinated with the first dose of Gardasil (lot #658100/0525U).  Concomitant vaccine administered at the visit included ADACEL.  The following day, the patient's mother reported that on 11-JUL-2007, the patient had experienced dizziness, and on 12-JUL-2007 she experienced confusion and nausea.  There was no fever and no redness at the site of injection, and no treatment was required.  The nurse noted the duration of each symptom as "2 hours," however, the date of recovery was indicated as 13-JUL-2007.  No further information is expected.
sore arm; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6207) at the age of 62 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "arrhythmia" (ongoing); "arthritis" (not ongoing). Concomitant medication(s) included: METOPROLOL oral taken for arrhythmia (ongoing); MELOXICAM oral taken for arthritis. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown".  Additional information: The patient had no adverse events associated with any of vaccine. On an unknown date, the patient experienced sore arm plus fatigue for one day.
Severe pain all over. No fever. Felt like I had the flu but with no fever. Very weak. All joints hurt, no swelling or heat in joints. Unable to sleep because of pain. From 4/23 till 4/25 am.
PT WAS GIVEN ANTHRAX INSTEAD OF PPD IN THE LEFT FOREARM.  PT HAS NOT EXPERIENCED ANY SYMPTOMS AT THIS TIME.  HE HAS A LOCAL RED AREA AT INJECTION SITE WITH NO OTHER SYMPTOMS.
Employee described itching @ site within few minutes of injection, redness @ site, extending to arm and L ear. She took her own prescriptions for Benadryl, Prednisone and advil. Went to bed. Woke up with rash/hives in patches on her body; back, tummy, chest, legs, arms. She took benadryl, prednisone & Zyrtec. Next day she had no rash, but still had itching. Took benadryl. She went to work and at the end of her shift, her hands were itching and beginning to swell. Took Benadryl again. Today 9.25, she reports no itching, no rash, no symptoms.
Twitching of arms and legs, increased heart rate, irregular breathing, limp arm 9:45 PM on 11/23/2015. Loss of motor skills, weak arms, reduced ability to grasp, reduced consciousness, hours of inconsolable  crying 9:00 AM 11/24/2015.  Still has reduced ability to hold head upright and steady, turn head to the left, move arm, and grasp 12/2/2015.
Rash around the injection site in circle spreading up and down in the arm; Injection site is hard; Rash around the injection site in circle; Injection site is swelling; Itchy spot in the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021 and was forwarded to Moderna on 18-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash around the injection site in circle spreading up and down in the arm), VACCINATION SITE PRURITUS (Itchy spot in the injection site), VACCINATION SITE INDURATION (Injection site is hard), VACCINATION SITE RASH (Rash around the injection site in circle) and VACCINATION SITE SWELLING (Injection site is swelling) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048X21AH) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Latex allergy, Diabetic and Hearing impaired.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy spot in the injection site). On 17-Mar-2021, the patient experienced RASH (Rash around the injection site in circle spreading up and down in the arm), VACCINATION SITE INDURATION (Injection site is hard), VACCINATION SITE RASH (Rash around the injection site in circle) and VACCINATION SITE SWELLING (Injection site is swelling). At the time of the report, RASH (Rash around the injection site in circle spreading up and down in the arm), VACCINATION SITE PRURITUS (Itchy spot in the injection site), VACCINATION SITE INDURATION (Injection site is hard), VACCINATION SITE RASH (Rash around the injection site in circle) and VACCINATION SITE SWELLING (Injection site is swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified low pressure and depression medications. Treatment medication included unspecified cream.
The doctor ordered Dtap to be given to the patient, but the patient was given Tdap in error. There was no adverse reaction. The patient will continue with the recommended immunization schedule.
Headache, Myalgia, Arthralgia, Fever, Whole body weakness Narrative:
In February, I dealt with Hives. I thought it was because of the insulation due to a remodeling I was doing. It was on and off. It lasted about 2 to 3 weeks. I don't remember very well, due to not really paying much attention to them. It was all over my body in different spots.
Breakthrough case admission after 3 vaccines Moderna 2/3/21 Lot# 007M20A;  Moderna 3/3/21 Lot# 023M20A;  Moderna 11/3/21 Lot# 071F21A
Hospitalized;  COVID-19 positive (9.1.21);  (fully vaccinated)  Admission Date: 9/1/2021 Discharge Date: 9/5/21  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Failure to thrive in adult At high risk for falls COVID-19 virus detected   HOSPITAL COURSE: Patient is a 83 yo male with history of Parkinson's disease and mild dementia, CAD s/p CABG, HTN, and mild intermittent asthma. Patient presented from home on 9/1 due to inability to care for himself. He was recently admitted from 8/12-8/17 for rib fractures after a fall at home. He discharged and returned home, but was having trouble caring for himself so returned to the ED 8/31. At that time, he was discharged directly to a Long term care facility, but did not stay after he discovered he would be living in a room with five other residents. Upon returning home with his son, he again was unstable and had a near fall, leading to his return to the ED. He notes ongoing right sided rib pain as well as an unproductive cough for two weeks. In the ED, he had a low grade temp of 100.3 with VS otherwise stable. COVID PCR was tested and positive. CXR unremarkable. He was unable to be discharged from ED due to COVID, so he was placed under observation.   PT/OT evaluated patient and initially recommended subacute rehab versus home with assistance.  However, the following day patient had improved and PT OT recommended return to home with assist. As family had concerns with patient returning to live on his own, set up multiple resources for home care.  Patient appears to have decision making capacity and ultimately preferred to go home, reporting that he would not have been agreeable to a long-term care facility including assisted living.  Patient did not develop any symptoms from COVID.  He is without any complaints at time of discharge and denies any rib pain.  Family updated prior to discharge and in agreement with plan
Erythema with slight swelling right anterior thigh. Treated in ER in 5-5-13 with KEFLEX for localized allergic reaction to imm vas celluliitis. Seen in office 5-6-13 symptoms improving.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Tachycardia-Mild, Systemic: Weakness-Medium, Additional Details: Patient and his father sat down in the observation area post vaccination. Within less than 5 min, the father called for help and pharmacy clerk notified the pharmacist that the patient needed attention. Patient had turned white and started to twitch lost consiousness for less than 30 seconds. Epipen was administered by pharmacist (pt was conscious, alert, and oriented nearly immediately after Epipen) and patient was reclined on his back on the floor. BP/ HR monitored while waiting for 911
Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Systemic: Weakness-Medium, Additional Details: Headache every day since vacination needs to take APAP every 4-6 hours to function.  BP increased averaging around 160/80 (normally under 140/80). Bad fatigue, weakness in legs, chest tightness, shortness of breath.  Had to stop a dose of Ozempic it caused greater weakness than normal
The patient reported on 1/29/2020 that the area was itching, red and swollen from shoulder to elbow on left extremity
About 4 weeks after having the COVID shot, patient noted 2 firm cylindrical subcutaneous anomalies. She presented for evaluation of these to my clinic 2/4/22, and I determined that she had superficial venous thromboses by physical exam, also known at Mondor's disease.
Weakness in upper legs, pain in knees and thighs, typically will occur after sitting or laying down,  During nighttime pain will wake me and become severe while attempting to roll over on my side.   Sometimes it is difficult to stand from a sitting position and once I do obtain a vertical position, baby steps are required until my legs are loosened up. This pain seams to come and go, one day the pain level will be a 2 and the next a 5 with no reason, I have been minimizing  activities to provide rest for it, but it does not seam to be doing any better.
Information has been received from a physician, via a company representative, concerning a 65 year old female patient, who on approximately 17-NOV-2006 ("six months ago") was vaccinated "incorrectly on the shoulder joints" with the first dose, 0.5ml of Pneumovax23. The physician reported that the patient had consequently been experiencing soreness and pain since the vaccination, and at the time of this report had not yet recovered. The patient sought unspecified medical attention. Additional information has been requested.
Routine physical post retirement in June. New onset heart murmur. Valve structural problem - MR (moderate to severe) Ongoing monitoring - appt in 6 mo to repeat the test