chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Info has been received from a health professional concerning a year old (also reported as 3 year old) white female with a history of grade II reflux of kidneys that began in August, 2001 and resolved in August, 2003 and allergies that began in August, 2001 and resolved in August, 2003 and allergies to amoxicillin and cephalosporins, who on 1/31/02 was vaccinated with a 1st 0.5ml, SC dose in the left thigh of varicella virus vaccine live. There  was no concomitant medication. There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that on 5/21/05, the pt experienced 20-30 scattered varicella-like lesions over her face, trunk and extremities. She was given symptomatic relief with diphenhydramine hydrochloride (Benadryl) and calamine (+) camphor (+) pramoxine hydrochloride (Aveeno) lotion as needed. The pt's status was reported as not recovered. There were no lab or diagnostic tests performed. Unspecified medical attention was sought. No product quality complain was involved. Follow-up info from a health professional indicated that the pt was seen in the office on 5/25/05 for 20-30 scattered varicella lesions over her face, trunk and extremities that began on 5/20/05. There was no fever. It was reported that the pt recovered. Additional info is not expected.
I would get winded very easily and felt my heart rate go up dramatically. When taking my blood pressure and heart rate the heart rate would be in the upper 90s. My blood pressure would be around 121/85. This typically happened in the afternoon although I would get winded at any time.
BILATERAL BUZZING SOUND IN EARS CAME ON SUDDENLY THE DAY AFTER THE VACCINE. NO PREVIOUS ISSUES WITH HEARING PRIOR TO THIS. HAS NOT CHANGED AND IT'S 3 DAYS POST VACCINE.
I am having an adverse reaction to the COVID vaccine. It has been 10 days and I still have a welt that?s roughly 2 inches x 2.5 inches at the injection site. The welt is raised, itches, tender, and is warm to touch.
Patient received the vaccine. She subsequently broke out in hives. She went to see her primary care physician and was given an antihistamine and steroids to combat the reaction.
pt states arm turned red, swelling up, itching, burn; reporter states 5/8" needle provided by Wyeth for IM flu vax;
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 34-year-old female patient (gravida 4, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage in June 2016. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and 4-STEARYLAMINO-PHENYL-TRIMETHYLAM. METILSULF. for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 22-Dec-2020 and the estimated date of delivery was 28-Sep-2021. On 12-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventh week of the pregnancy.  On 12-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter. It was reported that she found out she was pregnant on 8 Feb 2021. She was having the dating ultrasound on 15 Feb 2021. On 08 Feb 2021 she had positive pregnancy test. She had 3 previous pregnancies. On  Jun 2016 had spontaneous abortion and gave live and full-term birth. The bedside ultrasound was performed on 08 Feb 2021.
PATIENT BEGAN TO PASS OUT AND WAS SWEATING. PUT ICE PAK ON HIS NECK. HE RESPONDED WELL. SPOKE TO HIM TODAY AND HE SAID HE WAS FINE
2nd day after vaccine my left collarbone area had a small painful lump. I?m assuming it?s a supraclavical lymph node swollen due to vaccine.
Within an hour: sore throat, headache, stiff neck, fatigue  Within 12 hours: same symptoms and body aches, joint pain, chills, severe vomiting and diarrhea
I FEEL HEART PALPITATIONS, SKIPS A BEAT AND FLUTTERS. wILL SEEK MEDICAL ADVICE
Received KINRIX (DTaP/IPV) on (L) thigh 2nd day had large local rxn, red, hot, swollen, soreness, no painful.
Received FLULAVAL on 10/29. Next morning injection site red, itchy and bruised. All symptoms subsided without medical treatment with 3-4 days. Reaction reported to me - when employee.
It is itchy and warm  to the touch; It is itchy and warm  to the touch; Injection site is raised with approximately 3-4cm diameter; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PRURITUS (It is itchy and warm  to the touch), VACCINATION SITE WARMTH (It is itchy and warm  to the touch) and VACCINATION SITE SWELLING (Injection site is raised with approximately 3-4cm diameter) in a  patient of an unknown age and 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 17-Oct-2022 at 8:15 AM, 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 18-Oct-2022, the patient experienced VACCINATION SITE PRURITUS (It is itchy and warm  to the touch), VACCINATION SITE WARMTH (It is itchy and warm  to the touch) and VACCINATION SITE SWELLING (Injection site is raised with approximately 3-4cm diameter). At the time of the report, VACCINATION SITE PRURITUS (It is itchy and warm  to the touch), VACCINATION SITE WARMTH (It is itchy and warm  to the touch) and VACCINATION SITE SWELLING (Injection site is raised with approximately 3-4cm diameter) 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 relevant concomitant medications were reported.  Events were reported as similar to that of an allergy shot. No treatment information was provided.
Hard marble mass in leg, raised red warm spot measuring 3 cm by 6 cm.
no adverse effects; patients received improperly stored doses, exposed to a temperature of 34.5 Fahrenheit for 100 minutes; This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 09-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012732 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
fever and chills again; Chills; Fatigue; nausea; ache all over the body; fever; chills; feels "very very tired"; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), MYALGIA (ache all over the body), PYREXIA (fever), CHILLS (chills) and FATIGUE (feels "very very tired") in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced NAUSEA (nausea), MYALGIA (ache all over the body), PYREXIA (fever), CHILLS (chills) and FATIGUE (feels "very very tired"). On 01-Mar-2021, the patient experienced PYREXIA (fever and chills again), CHILLS (Chills) and FATIGUE (Fatigue). On 28-Feb-2021, NAUSEA (nausea), MYALGIA (ache all over the body), PYREXIA (fever), CHILLS (chills) and FATIGUE (feels "very very tired") had resolved. At the time of the report, PYREXIA (fever and chills again), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Slight pain on the shoulder after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Slight pain on the shoulder after the first dose) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included CALCIUM CARBONATE (ANTACID [CALCIUM CARBONATE]), ALLOPURINOL, GABAPENTIN, TESTOSTERONE, VITAMIN C [ASCORBIC ACID] and CALCIUM for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced ARTHRALGIA (Slight pain on the shoulder after the first dose). At the time of the report, ARTHRALGIA (Slight pain on the shoulder after the first dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant products included prostate medication for an unknown indication. No treatment medications were reported.  Patient he did not feel anything after the second dose.    This case was linked to MOD-2021-322736 (Patient Link).
This spontaneous report was received from a medical assistant refers to a unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unspecified dates in 2016, starting on or after 14-JAN-2016, the patients were vaccinated with improperly stored doses of ROTATEQ, oral, lot # reported as L023866 and lot# L023866 and expiration date 24-MAR-2017, (dose was not reported). There were no concomitant medications provided. No adverse effect was reported. Excursion details were reported as follows: Temperature: 34F; Time frame: 25 hours. There was no previous temperature excursion and it was not because of data logger. There was no product quality issue involved. Lot number L023866 has been verified to be a valid lot number for ROTATEQ. Lot number L028366 is an invalid lot number for ROTATEQ. Additional information has been requested. It was determined that the Aware Date for the initial version should have been 08-FEB-2016 instead of 09-FEB-2016; therefore, MARRS # 1602USA005194 will be deleted from our database and replaced with MARRS #1602USA005200.
Systemic: Fainting / Unresponsive-Severe, Additional Details: according to daughter patient crashed about 1 hour after receiving vaccine, taken to hospital in diabetic coma with glucosse level of 20..hospital trying to rule out TIA
Cold like symptoms: Runny nose, head cold, Scratchy throat. Lethargy, muscle aches, congestion,
Shaking, fever of 102.9, body aches, pain in right shoulder later the day of receiving the vaccine, no improvement in symptoms the day after, 2 days after symptoms improved, 3 days after patient was feeling back to normal.
Strange taste in mouth, heart felt like it was pounding out of chest, blood pressure 195/100 (elevated), dry/burning mouth Was brought to ED and given Benadryl and Lorazepam
Needle wouldn't work and allow me to administer the vaccine.  I put on a new needle and readministered the shot without issue.  It was a double stick.  The vaccine was Spikevax.  It is not a choice on the drop down won't let me pick other vaccine.
Pt experienced mild pink colored maculopapular rash on mildly erythematous base over abdomen, left thigh and face approximately one week post vax.
Information has been received from a licensed practical nurse concerning an approximately 7 year old patient who on 29-MAY-2002 was vaccinated with a dose of VARIVAX (Merck) (lot#, route and site of administration not reported). On approximately 14-APR-2008 the patient developed 5 small chickenpox. At the time of the reporting, the patient's outcome was unknown. This is one of several reports from the same source. No further information is available.
pt recvd vax & 1/2-1 hr started screaming for 1-1 1/2 hrs; screaming episode stopped in clinic; vax site 1/2 cm x 1/2 cm induration;
Menstrual cycle delayed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 10:15 (Lot number: EW0151) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "migraine headache" (unspecified if ongoing); "allergen induced asthma" (unspecified if ongoing), notes: allergen induced. Concomitant medication(s) included: IBUPROFEN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset Apr2021, outcome "recovering", described as "Menstrual cycle delayed". Therapeutic measures were taken as a result of menstruation delayed.  Additional information: Reported menstrual cycle delayed by 12 days after first shot. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received ibuprofen, zyrtec within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not have relevant past drug history. Patient received treatment as ibuprofen and vitamins. The event was assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
COVID vaccine breakthrough case. Moderna 3/2/21 025A21A, 03/30/2021 028A21A and 12/12/21 031H21A
I have been sick all week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Lot number: FE3592) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I have been sick all week".  Additional information: The patient took the Pfizer vaccine. The patient was given a pamphlet when she got it and because she have been sick all week.    Follow-up: Follow-up attempts completed. No further information expected.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and GERD. Concomitant products included OMEPRAZOLE and FLUOXETINE for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 21-May-2022 to 26-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2022, SARS-CoV-2 test: positive positive. In June 2022, SARS-CoV-2 test: negative Negative.         It was reported that rebound in symptoms after finishing Paxlovid treatment and testing negative on 3 different antigen self tests. Device date was reported as 05-Jun-2022.  Company Comment: This is a spontaneous case concerning  a  35-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred on June 1, 2022. Patient received the third dose of mRNA-1273 COVID 19 Vaccine on December 1, 2021. Patient was treated with nirmatrelvir and ritonavir from 21-May-2022 to 26-May-2022 at an unspecified dose and frequency. Patient tested positive SARS-CoV-2 test on June 1, 2022. It was reported that patient had rebound symptoms after completion of course of nirmatrelvir and ritonavir (Paxlovid). The event was reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.  Sender's Comments: This is a spontaneous case concerning  a  35-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred on June 1, 2022. Patient received the third dose of mRNA-1273 COVID 19 Vaccine on December 1, 2021. Patient was treated with nirmatrelvir and ritonavir from 21-May-2022 to 26-May-2022 at an unspecified dose and frequency. Patient tested positive SARS-CoV-2 test on June 1, 2022. It was reported that patient had rebound symptoms after completion of course of nirmatrelvir and ritonavir (Paxlovid). The event was reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
ON 10/29, FLU, VARICELLA ADMINISTERED, PT LEFT IN GOOD CONDITION; ON 11/01, PT RTC WITH CELLULITIS AT IMMUNIZATION SITE. PT TREATED EMPIRICALLY WITH COURSE OF KEFLEX. PT MEDICALLY EXCUSED FROM SCHOOL FOR 2 DAYS.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 27-MAR-2019 the patient was vaccinated with a 0.5 ml dose of M-M-R II albumin status rHA, diluted in sterile diluent, lot # N009798, expiry date 24-MAR-2019, subcutaneously, in the left arm, for prophylaxis. The vaccine was expired for three days when it was given and the pharmacist was concerned about this being an invalid dose.
Patient was in the office yesterday afternoon, 10/11/22, for his COVID booster and Influenza Vaccine. He has tolerated all vaccines well in the past. Nurse noted that he was a little nervous prior to getting the vaccines but the administration of the vaccines was unremarkable. The patient, sister, and dad were sent to the waiting room to wait 15 minutes. I was in my office and heard commotion and hollering for help in the waiting room. When I arrived, the patient was sitting on the floor with some other helpers around him, and he was crying. He apparently had been sitting near dad when he slumped over to the left and hit the side of his head on the chair next to him. He quickly came to, dad reports that he was out for less than a second, and then started crying and hyperventilating. Patient reported that he felt "really weird" and that it was like he "was in a dream." Several nurses, MAs, and staff members were present and helping with getting him laying down, applying a cool cloth and fan, and taking vitals. BP initially was 120/90 shortly after the syncopal/near-syncopal episode. Heart rate 88, regular. After resting for 15 minutes and calming down, BP was 98/42. Patient remained in the waiting room with family and was able to leave without further incident after staying for another 15 minutes. He reported feeling fine at that time. Chart note was placed in the Immunization Record from 10/11/22.
Ice cold legs; Circular itchy rash on top of chest; Throat felt swollen; burning sensation on both legs and underside of the arms; tingling sensation on both legs and underside of the arms; stinging sensation on both legs and underside of the arms; Injection site red and hot; Felt fatigued; body aches and pains; Extreme headache; Ached all over; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ached all over), PERIPHERAL COLDNESS (Ice cold legs), RASH PRURITIC (Circular itchy rash on top of chest), PHARYNGEAL SWELLING (Throat felt swollen) and BURNING SENSATION (burning sensation on both legs and underside of the arms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN (Ached all over), MYALGIA (body aches and pains) and HEADACHE (Extreme headache). On an unknown date, the patient experienced PERIPHERAL COLDNESS (Ice cold legs), RASH PRURITIC (Circular itchy rash on top of chest), PHARYNGEAL SWELLING (Throat felt swollen), BURNING SENSATION (burning sensation on both legs and underside of the arms), PARAESTHESIA (tingling sensation on both legs and underside of the arms), PAIN (stinging sensation on both legs and underside of the arms), INJECTION SITE ERYTHEMA (Injection site red and hot) and FATIGUE (Felt fatigued). The patient was treated with PREDNISONE at a dose of 120 mg. On 26-Jan-2021, PAIN (Ached all over) and HEADACHE (Extreme headache) had resolved, MYALGIA (body aches and pains) outcome was unknown. At the time of the report, PERIPHERAL COLDNESS (Ice cold legs), RASH PRURITIC (Circular itchy rash on top of chest), PHARYNGEAL SWELLING (Throat felt swollen), BURNING SENSATION (burning sensation on both legs and underside of the arms), PARAESTHESIA (tingling sensation on both legs and underside of the arms), PAIN (stinging sensation on both legs and underside of the arms), INJECTION SITE ERYTHEMA (Injection site red and hot) and FATIGUE (Felt fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter.
MODERNA COVID-19 Vaccine chills, nausea, headache, muscle pain at injection site and into left shoulder blade, diarrhea, fatigue, loss of appetite, cough, low temperature
Patient returned 2 days after MCV4 vaccine with c/o redness, swelling and pain to injection site. Also had aching into entire left shoulder and upper left body. Felt hot, had headache & lightheaded. Tx-Tylenol, Motrin, cool packs- report to ER if worse.
Nausea, Fever/chills, body aches, lingering headache starting at 3:30AM 01/05/2021. Symptoms continued all day 01/05/2021. Fever spiked to 102 around 10PM on 01/05/2021.