chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Did you/the patient previously receive a COVID-19 Vaccine?: Yes; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Lot number: ff2589) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Rash; "Rosacea" (unspecified if ongoing); "rash" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks: Yes. Anti-viral details: product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 16Jun2022, Indication: Treatment of COVID-19, Administrator route: Oral.
A lot of pain in the side of her neck and it kind of goes towards the head and down the collar bones; Vaccination site pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (A lot of pain in the side of her neck and it kind of goes towards the head and down the collar bones) and VACCINATION SITE PAIN (Vaccination site pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included COLECALCIFEROL (VITAMIN D 3), CALCIUM and GLUCOSAMINE, METHYLSULFONYLMETHANE (MSM & GLUCOSAMINE) for an unknown indication, Blood pressure and reflux medication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (A lot of pain in the side of her neck and it kind of goes towards the head and down the collar bones) and VACCINATION SITE PAIN (Vaccination site pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Neck pain, at an unspecified dose and frequency. At the time of the report, NECK PAIN (A lot of pain in the side of her neck and it kind of goes towards the head and down the collar bones) had not resolved and VACCINATION SITE PAIN (Vaccination site pain) had resolved.        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.
So I my roommate tested positive this past Saturday and I started having a sore throat on Sunday and I tested positive after my roommate tested positive and a friend staying with me tested positive and everyone has been quarantining together in our apartment. The first day was pretty bad flu with mild body aches no fever, coughing and extremely fatigued and weirdly enough I was not congested on the first day but I did have a soar throat and the second it felt like a really bad cold and the congestion was hitting really hard and it started as a dry cough but turned into a wet cough and I had extreme fatigue as well. So on Wednesday it felt like bad allergies, still congestion and sneezing a lot and had brain fog and was sneezing a lot which I don't understand but I still did not have fever through any of this.
This occurred at a private pay clinic at place of employement.  First time flu shot-denied any allergies. Ten min. after injection, patient said she felt funny and she had hives covering her upper torso.  No resp. diificulties.  Gave Benedryl 50 mg po and water. B/P 120/80, pulse 80's.  After 30 min. hives resolved b/p 100/66 ate an apple, felt fine, went back to work.
Fever, chills, exhaustion that lasted for 18 hours. Pain and tenderness on the area of the injection
Patient came in for booster and was given her dose. Later when processing in our system it was discovered that she was given her second dose 2 weeks early. She received her 1st dose on 1/19/21 and her second today on 2/2/21
This case was reported by a consumer and described the occurrence of fever in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, muscle fatigue, pain in arm and feeling unwell. On an unknown date, the outcome of the fever, muscle fatigue, pain in arm and feeling unwell were unknown. It was unknown if the reporter considered the fever, muscle fatigue, pain in arm and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: From the time of vaccination the patient was feeling very sick. The patient wanted to speak to someone. The patient felt worse. The patient experienced muscles tiredness, fever for 1 week. The chiropractor did massage and the patient experienced more pain in the left arm. The patient was not feeling better. No consent given for drug safety to follow up with the patient's health care professional.
vomit x 1;fever 3 days 100 to 104;full body rash, fine red dots mainly trunk & arms;some on face & legs 7 days;
Headache "Extreme fatigue, loss of energy" Narrative:  Other Relevant History:
Case previously recorded as MA2009-3829. Initial case report received from a consumer via Novartis Medical Communications on 06 NOV 2009. A 52 year-old female patient was vaccinated with 0.5 ml of S-OIV FLUVIRIN (batch no. unknown) i.m., on 02 NOV 2009. On 03 NOV 2009, the patient experienced a left leg weakness, feeling it "pulverized". The outcome of the events was reported as not recovered. MedCom reference no.: NA09-007773.
without it being reconstituted with the powder component; received only the liquid adjuvant portion of Shingrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient might had received only the liquid adjuvant portion of the Shingrix vaccine without it being reconstituted with the powder component. The reporter stated that this could had been 1 or 2 doses of adjuvant only for these patients, the reporter was unsure at this time, the review of the medical records to confirm was pending. The reporter did not had the dates of administration, lot number, expiration date and any patient information at the time of the reporting. The vaccine administration facility was the same as the primary reporter. The reporter did consent to follow up. Additional supportive information:  The reporter gave by error Shingrix adjuvant diluent portion only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered This case was 1 of 3 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR159619:same report, other patient US-GSK-US2022AMR159620:same report, other patient
t105 since 330PM-taken w tabs of advil & has not dec since having chills;advised to call pvt MD & go to ER immed;
This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 28-NOV-2016, the patient was inadvertently vaccinated with an improperly stored dose of ZOSTAVAX injection, subcutaneously, lot # M035146, expiration date 26-JUL-2017 (dose and site of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. The administered dose of ZOSTAVAX was stored in the temperature of 55 degrees Fahrenheit for 4 hours. Data logger was not involved. There were no previous temperature excursions reported. Additional information is not expected as no consent for contact was given.
Thirty minutes to forty five minutes after receiving vaccine she began to have "facial tingling" from her forehead to the top of her lips. It lasted 5 1/2 hours before resolving. She declined any care. Later, questioned if it was a silent migraine.
TELEPHONE CALL FROM MOTHER STATING CHILD HAD RASH ON BODY WHICH APPEAR 45 MINS POST IMMUNIZATION. CLIENT RETURNED TO CLINIC A FINE PIN POINTED RASH NOTED ON BOTH FEET UP TO ANKLES AND AROUND NECK. BABY REPONSIVE, PLAYFUL AND EXHIBITED NO OTHER SYMTOMS. BABY WAS EXAMINED BY MD. WILL RETURN TO CLINIC IN ONE WEEK FOR FOLLOW UP
Patient with PMH significant for asthma, allergies to shellfish and peanuts, presents to ED for evaluation of difficulty breathing.  Mother reports the patient had been wheezing for the past week, and  gradually worsened.   Per mother, prior to arrival patient could not breath and having increased respiratory distress.  Just prior to arrival the patient became unresponsive.  The patient was tachycardic, tachypneic, hypertensive and hypoxic.  The patient was emergently intubated and placed on mechanical ventilation.  Per the patient's mother.  The patient received her first dose of COVID vaccine the day before arrival to the ED.    Diagnosis: Acute Respiratory Failure; Acute Asthma Exacerbation verses Allergic Reaction.
Tingling, throat tightness, allergy-like symptoms starting about 1 days after vaccine administration. Very similar to beginnings of anaphylactic reaction. Relieved by diphenhydramine.
Pt. given PNEUMOVAX vaccine on 7-24-12. She returned a few days later to complain of redness and soreness in arm. I looked at her arm - no redness or swelling. I told her that was common for vaccines to experienced soreness/redness for a few days. She returned on 8-16-12 and told another RPh of her "extremely swollen arm and red all over". That RPh filled out VAERS. I don't think it is a true AE.
hot at injection site; hard at injection site; arm was like a golf ball at site of injection; tender at injection site; red at injection site; had a real bad headache; she reported she was so sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she reported she was so sick), VACCINATION SITE WARMTH (hot at injection site), VACCINATION SITE INDURATION (hard at injection site), VACCINATION SITE SWELLING (arm was like a golf ball at site of injection) and VACCINATION SITE PAIN (tender at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced ILLNESS (she reported she was so sick) and HEADACHE (had a real bad headache). On 13-Apr-2021, the patient experienced VACCINATION SITE WARMTH (hot at injection site), VACCINATION SITE INDURATION (hard at injection site), VACCINATION SITE SWELLING (arm was like a golf ball at site of injection), VACCINATION SITE PAIN (tender at injection site) and VACCINATION SITE ERYTHEMA (red at injection site). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency. On 13-Apr-2021, ILLNESS (she reported she was so sick) and HEADACHE (had a real bad headache) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot at injection site), VACCINATION SITE INDURATION (hard at injection site), VACCINATION SITE SWELLING (arm was like a golf ball at site of injection), VACCINATION SITE PAIN (tender at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.
Abdominal distress/ Abdominal distress due to school related stress; Broken foot/ Broke left foot; Injection site itching/ itchy injections; Injection site inflammation/ Inflamed injections; Fever; Injection site pain/ painful injections; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Abdominal distress/ Abdominal distress due to school related stress), FOOT FRACTURE (Broken foot/ Broke left foot), INJECTION SITE PRURITUS (Injection site itching/ itchy injections), INJECTION SITE INFLAMMATION (Injection site inflammation/ Inflamed injections) and PYREXIA (Fever) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced INJECTION SITE PRURITUS (Injection site itching/ itchy injections), INJECTION SITE INFLAMMATION (Injection site inflammation/ Inflamed injections), PYREXIA (Fever) and INJECTION SITE PAIN (Injection site pain/ painful injections). In December 2021, the patient experienced ABDOMINAL DISCOMFORT (Abdominal distress/ Abdominal distress due to school related stress) and FOOT FRACTURE (Broken foot/ Broke left foot). At the time of the report, ABDOMINAL DISCOMFORT (Abdominal distress/ Abdominal distress due to school related stress), FOOT FRACTURE (Broken foot/ Broke left foot), INJECTION SITE PRURITUS (Injection site itching/ itchy injections), INJECTION SITE INFLAMMATION (Injection site inflammation/ Inflamed injections), PYREXIA (Fever) and INJECTION SITE PAIN (Injection site pain/ painful injections) outcome was unknown.     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.  Concomitant medication was not provided.  No information regarding treatment medication was provided.
I had occasional leg cramps during the night be fore the vaccine.  The night of taking the vaccine, I had severe leg cramps.  I have had legs cramps every morning when I wake up and often have to take Leg Cramps meds or 2 Extra Strength 650 mg.  It takes at least 2 hours or more before they let up.  I never got leg cramps in the morning before the vaccine.
no adverse effects; the patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from an office manager refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 26-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot # s003868 with expiration date on 08-AUG-2020 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent. The vaccine underwent a temperature excursion of 6 (7.2) to 14 degrees Fahrenheit for 10 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.
Pt developed left thigh swelling with erythema, warmth and tenderness within 12-24 hours, post vax. Pt was dx'd with cellulitis and given Motrin, warm pads and Keflex.
Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient states vaccinated arm went numb shortly within minutes of receiving vaccine then began to tingle. Sensation continued during 15 minutes of observation and did not subside until patient woke up the following morning.
Mom reported blister at injection site on left leg. States slightly red. states fever 99.9 on 7/7/09. No fever or other symptoms this am. Giving TYLENOL every 4 hours.
experienced an allergic reaction after receiving the bivalent COVID-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of IMMUNISATION REACTION (experienced an allergic reaction after receiving the bivalent COVID-19 vaccine) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 IMMUNISATION REACTION (experienced an allergic reaction after receiving the bivalent COVID-19 vaccine). At the time of the report, IMMUNISATION REACTION (experienced an allergic reaction after receiving the bivalent COVID-19 vaccine) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient was over 18 years old.  Reporter wanted to find out about Covid-19 vaccine as the patient experienced Allergic reaction to after receiving the bivalent COVID-19 vaccine.  Patient received an infusion 9 day prior.  No treatment information was reported.   Reporter did not allow further contact
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients received booster doses of Moderna COVID-19 vaccine from a vial that had been punctured for more than 12 hours) and PRODUCT STORAGE ERROR (3 patients received booster doses from a vial that had been punctured for more than 12 hours/the vial was exposed to room temperature range for 24 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients received booster doses of Moderna COVID-19 vaccine from a vial that had been punctured for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (3 patients received booster doses from a vial that had been punctured for more than 12 hours/the vial was exposed to room temperature range for 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 patients received booster doses of Moderna COVID-19 vaccine from a vial that had been punctured for more than 12 hours) and PRODUCT STORAGE ERROR (3 patients received booster doses from a vial that had been punctured for more than 12 hours/the vial was exposed to room temperature range for 24 hours) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that patient was administered with first booster dose of the vaccine around 11:51 A.M or after that time. It was reported that the number of doses/vials that were affected and administered were 3 doses. The vial was initially stored in the refrigerator on 15-Apr-2022. The vial was first punctured at 11:50 A.M. on 19-Apr-2022. The vial was stored at room temperature post puncture. It was reported that the vial was left on counter top overnight. The total amount of time during which the vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius/46 degree Fahrenheit to 77 degree Fahrenheit) was 24 hours. No concomitant medications were reported. No treatment information was reported. This case was linked to MOD-2022-546072, MOD-2022-545341 (Patient Link).
Symptoms: Fever, chills, chronic migraine( last -2 days), cough,  fatigue, sore arm at injection site, ring around the injection site, and sore throat.
both of my legs hurt; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (both of my legs hurt) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pulmonary embolism (Patient had a PE in left lower lobe just a year ago).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (both of my legs hurt). At the time of the report, PAIN IN EXTREMITY (both of my legs hurt) 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 was provided. No treatment information was provided.
This case was reported by a physician via call center representative and described the occurrence of diarrhea in a 83-year-old female patient who received SHINGRIX for prophylaxis. On 5th March 2019, the patient received the 1st dose of SHINGRIX. On 7th March 2019, 2 days after receiving SHINGRIX, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was not reported. It was unknown if the reporter considered the diarrhea to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient's husband. The physician reported that his wife received the vaccine on the left arm, and 48 hours later experienced severe diarrhea. The reporter gave consent to follow up. This case has been linked to the case US2019042995 (husband's case) reported by the same reporter.
severe rash and hive everywhere but the face, come on around 1 to 2 pm daily, location does not matter in car walking sitting etc. Horrible !!!
Information has been received from a health professional concerning a 9 week old female, who was a twin, born at 32 weeks, with severe reflux, who on 02-JAN-2007 was vaccinated with a first oral dose of Rotateq. Concomitant vaccines administered on the same day included a dose of Pediarix, a dose of PedvaxHIB (manufacturer unknown) and a dose of Prevnar. It was reported that, on 02-JAN-2007, the patient had trouble swallowing the vaccine and her lips turned slightly blue. That night her apnea alarm went off and she was admitted to the hospital. The length of hospitalization was unknown. Subsequently the patient recovered. The reporter noted that the patient's twin did not have any trouble. No product quality complaint was involved. The patient's experiences were considered to be immediately life-threatening by the reporter. Additional information has been requested.