chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 16 year old patient who on 17-MAY-2004 was vaccinated with the first dose of VARIVAX (Merck) (lot# unspecified). On 28-SEP-2007 the patient was vaccinated with a second dose of VARIVAX (Merck) (lot# 654807/1066F). The nurse mentioned that on 01-FEB-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Follow-up information was received from a registered nurse who stated that the 16 year old male patient with anemia and no illness at time of vaccination who on 17-MAY-2004, was vaccinated with the first dose of VARIVAX (Merck) (lot# not reported). On 28-SEP-2007 at 18:30, the patient was vaccinated IM in the left arm with the second dose of VARIVAX (Merck) (lot# 654807/1066F). The nurse reported that the patient went to the clinic on 01-FEB-2012, with a rash described as "vesicular, with very few pustules, erythematic, non confluent, asymmetrical, irregular with no swelling", diagnosed with varicella. At the time of the report, the patient's outcome was unknown. The patient did not have testing done. A lot check has been initiated. Additional information has been requested.
Mother called at about 8:30 am stating child has 7" long by 4" wide swollen area with about 1/2" depth to back of (L) arm where varicella administered. Area warm, hard, welpy appearing with pinkish red color. Child noticed this on morning of 4-6-10, but did not inform parent until 9:30 pm last night at which time mother gave BENADRYL. BENADRYL administered this am will see MD if no improvement by this afternoon. Instructed to ER or MD if worsens.
No additional AE reported; MMR II involved in temperature excursion on 01/01/2021; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not provided.     On 01-JAN-2021, the administered dose experienced a temperature excursion at 47.01 Fahrenheit for 1 minute 30 seconds. There was no previous temperature excursion. The temperature excursion was detected by a data logger. On 15-JAN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status recombinant Human albumin (rHA) (strength, dose and route were not provided; lot# was S037500 and expiration date was 20-NOV-2021) involved in a temperature excursion for prophylaxis (product storage error). No additional adverse event reported.   This is one of the 16 cases received from the same reporter.; Sender's Comments:  US-009507513-2102USA007556: US-009507513-2102USA007557: US-009507513-2102USA007558: US-009507513-2102USA007559: US-009507513-2102USA007568: US-009507513-2102USA007561: US-009507513-2102USA007562: US-009507513-2102USA007563: US-009507513-2102USA007564: US-009507513-2102USA005227: US-009507513-2102USA005228: US-009507513-2102USA005229: US-009507513-2102USA005230: US-009507513-2102USA005231: US-009507513-2102USA005232:
information on high and low temperature excursions. Products were exposed to a high of 47.4 and a low of 31.4 with no reported adverse event; an ACTHB vaccine was administered to a 5 month-old female, this was after cold excursion of 31.4F with no reported adverse event; Initial information received on 01-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 month old female patient who had taken HIB (PRP/T) VACCINE [ACT-HIB], this was after cold excursion of 31.4f with no reported adverse event and information on high and low temperature excursions. products were exposed to a high of 47.4 and a low of 31.4 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Jan-2023, the patient received a 0.5 mL (milliliter) dose of suspect HIB (PRP/T) VACCINE (Frequency: once, lot: UJ653AAA, expiry date: 30-Mar-2023) (Strength: not reported) via intramuscular route in unknown administration site for immunization.  On 31-Jan-2023, (Latency: same day) the patient developed a non-serious an acthb vaccine was administered to a 5 month old female, this was after cold excursion of 31.4f with no reported adverse event (poor quality product administered) following the administration of HIB (PRP/T) VACCINE. On an unknown date, the HIB (PRP/T) VACCINE information on high and low temperature excursions. products were exposed to a high of 47.4 and a low of 31.4 with no reported adverse event (product storage error) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
fever and nausea first few days, now hands with erythema, diffuse tenderness and increased crepitece left shoulder
Developed serious tics out of the blue about 3 or 4 days later and never has a history before.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 28Dec2021 16:45 (Lot number: 33036BD) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient had no covid prior vaccination. There were no concomitant medications. There were no other vaccine in four weeks, no other medications in two weeks. The following information was reported: TIC (disability) with onset 31Dec2021, outcome "not recovered", described as "developed serious tics out of the blue about 3 or 4 days later and never has a history before.". The event "developed serious tics out of the blue about 3 or 4 days later and never has a history before." was resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) negative, notes: Rapid at pediatrician; Nasal Swab. Therapeutic measures were taken as a result of tic included so far, treatment with magnesium and B6.  Follow-up attempts are completed. No further information is expected.
pentacel was given inappropriately, states only the diluent was administered and not the powder with no reported adverse event; pentacel was given inappropriately, states only the diluent was administered and not the powder with no reported adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was given inappropriately, stated only the diluent was administered and not the powder with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE lot U7013AA.  On an unknown date,  Pentacel was given inappropriately, stated only the diluent was administered and not the powder with no reported adverse event (product preparation error) (single component of a two-component product administered)  (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  The reporter stated that all the diluents they had were either sterile water or 0.9% normal saline , so they wanted to know how they would obtain the proper diluent (0.4% NaCl saline solution) .  Action taken : not applicable.  Outcome: unknown  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 guidelines. 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.
On February 24, 2023, I had a little bit of a runny nose and headache, slight sensation of a fever. The next day I noticed the fever more and had a sore throat. My ears felt like I had an ear infection and had a little bit of coughing. Sunday morning the 26th I tested positive for COVID-19 on my home test. I contacted my doctor at the urgent care clinic on the same day. I also spoke with my doctor that day. Since I was in a risk category, I was prescribed an antiviral, not PAXLOVID. As of today, I have a lingering deep lung cough. I haven't taken a second test to see if I have a rebound case.
March 11, at about an early 9 pm bedtime, heaviness in left shoulder,  soon into both shoulders, and mild, intermittent ache in other limbs. Thereafter, through the night,  a  feeling of fever, back & forth: skin hot, then normal feeling.  Some chills.  Took my temperature several times and would only get a normal reading.  Puzzled, because  I thought I must have a fever.....the STRANGENESS  of this  was that my skin felt like it was BURNING UNDERNEATH my skin....not like any fever I might have ever had. Still normal temp readings.   The next day...mostly in bed, tired, no appetite, continued fever feeling, but no fever temp reading.  The second day, up and around, eating.
HIGH BLOOD PRESSURE, RIGHT SIDE FROM HEAD TO TOE NUMB, CAN'T SPEAK PROPERLY.
patient has been diagnosed with a medical problem; chills; mild fever, fever for a month after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (patient has been diagnosed with a medical problem), PYREXIA (mild fever, fever for a month after 1st dose) and CHILLS (chills) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     The patient's past medical history included Colonoscopy. Concurrent medical conditions included Blood pressure. Concomitant products included LISINOPRIL for Blood pressure, ALENDRONATE SODIUM, CALCIUM, COLECALCIFEROL (ALOXIN) for an unknown indication.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced PYREXIA (mild fever, fever for a month after 1st dose). On an unknown date, the patient experienced VACCINATION COMPLICATION (patient has been diagnosed with a medical problem) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (patient has been diagnosed with a medical problem), PYREXIA (mild fever, fever for a month after 1st dose) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had been diagnosed with a medical problem (denied sharing more information on this) that might had been causing the fever they reported before, so patient believes their reactions in not related to the vaccine and sees no point in filling the questioners, although they mention that if Safety still wants those filled, they will do it.   This case was linked to MOD-2021-253098 (Dose 2) (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Additional event
On March 15th, I had a complete dizziness, I was laying down, resting, the room started spinning, it lasted 1 minute, after that I was stable to walk, but if I turn over, I get a vertigo feeling, next day I went to UC and suggested for me to ER because my heart rate was elevated. I think it was anxiety, because when I got there to the ER, my hear was fine, they diagnosed me with vertigo, I felt better two weeks after. I have an appointment this Thursday with ear, throat doctor.
Aches and pains; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches and pains) and FATIGUE (extreme fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (Aches and pains) and FATIGUE (extreme fatigue). At the time of the report, PAIN (Aches and pains) and FATIGUE (extreme fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Asthma medications and low-dose budesonide for an unknown indication. Treatment medication included Tylenol.   This case was linked to MOD-2021-089533 (Patient Link).
Pt to ED 5/13 c/o shortness of breath with history of lung cancer and end-stage renal disease on dialysis, pt was 80% RM air. COVID+ 5/13, pt weaned off of O2 NC, SpO2 94-96% on room air with RR 14 br/min. Pt tolerating well. 5/14 completed Pleur x drain care on patient. 375ml removed, pt medicated with pain meds after. No complications during sterile procedure. Pt stated relief afterwards. 5/14 discharge paperwork given to pt, pt understanding verified. Pt o2 98% on room air, no c/o pain, chest pain or sob. Discharged 5/15.
red bump at injection site, started 1 week post vaccine. lasted for 3-4 days and then went back down.
This spontaneous report as received from a healthcare worker and refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with VAQTA for prophylaxis. On an unknown date, the patient experienced hepatitis A virus test positive. The outcome of hepatitis a virus test positive was unknown. Causality assessment was not provided. Additional information is not expected, since there was no consent to contact reporter.
Roughly 12-14 hours after receiving second vaccine, intense pain and pressure in and around the left ear.; Roughly 12-14 hours after receiving second vaccine, intense pain and pressure in and around the left ear.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO173) via an unspecified route of administration in the left arm on 13May2021, at 11:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any other concomitant medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 21Apr2021 at 11:45 as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 14May2021 at 01:00, roughly 12-14 hours after receiving second vaccine, the patient experienced intense pain and pressure in and around the left ear in the middle of that night. Apart from these, the patient had felt no other side effects. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events roughly 12-14 hours after receiving second vaccine, intense pain and pressure in and around the left ear were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Thought it could be shingles; Vesicular rash on the arm and forehead; This case was reported by a nurse and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number NZ4ZJ, expiry date 22nd May 2022) for prophylaxis.   On 15th October 2020, the patient received the 1st dose of Shingrix. On 16th October 2020, 1 days after receiving Shingrix, the patient experienced shingles and vesicular rash. On an unknown date, the outcome of the shingles and vesicular rash were recovering/resolving.   It was unknown if the reporter considered the shingles and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The next day after vaccination, the patient had a vesicular rash on the arm and forehead, they thought it could be shingles. The reporter gave consent to follow up.
Frequent urination; Sore arms; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Frequent urination) and INJECTION SITE PAIN (Sore arms) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced POLLAKIURIA (Frequent urination) and INJECTION SITE PAIN (Sore arms). At the time of the report, POLLAKIURIA (Frequent urination) and INJECTION SITE PAIN (Sore arms) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported. Action taken with mRNA-1273 in response to the events was not Applicable
Day 1 starting approx 6 hours after injection: low grade fever, approx 100.4, lasted for approx 4 hours,  Day 6: low grade fever and headache Day 7: low grade fever and headache, sweating Day 11: difficultly breathing--shortness of breath, difficult to breathe while laying on back and side Day 14: dry cough, exacerbated after extended talking
Patient admitted as inpatient on 10/05/2021 due to Cerebrovascular accident (CVA) due to thrombosis. Patient was tested for COVID-19 and was positive on 10/05/2021, asymptomatic.
low white blood cell count; Itching whenever his skin gets wet; Dermatologist told he has dry skin; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis and COVID-19 VACCINE for prophylaxis.   Concurrent medical conditions included hypertension and atrial fibrillation.   On 8th March 2021, the patient received the 1st dose of Shingrix and the 1st dose of Tdap Vaccine (intramuscular). On an unknown date, the patient received COVID-19 VACCINE. In March 2021, less than 2 weeks after receiving Shingrix and Tdap Vaccine, the patient experienced pruritus and dry skin. On an unknown date, the patient experienced white blood cell count low. The patient was treated with fexofenadine hydrochloride (Allegra), miconazole nitrate (Monistat), hydrocortisone (Hydrocortisone Cream) and antipruritics nos. On an unknown date, the outcome of the pruritus was not recovered/not resolved and the outcome of the dry skin and white blood cell count low were unknown.   It was unknown if the reporter considered the pruritus, dry skin and white blood cell count low to be related to Shingrix and Tdap Vaccine.     Additional Information: GSK Receipt Date: 2-May-2022 Reporter's comments: This case was reported by the patient. He received his first Shingrix dose and he also had a Tdap vaccination of unknown manufacturer that day. Within one to two weeks he developed itching to his arms, chest and back. The itching occurred only whenever his skin gets wet like when showering, sweating, washing and lasts 45 to 90 minutes.  He received his second Shingrix dose two months after the first, in May 2021. The patient seen a dermatologist and was told that he had dry skin. He saw another dermatologist and was told he did not have dry skin but this dermatologist was unable to determine the cause of the itching. He has treated the itch with hydrocortisone cream, another anti-itching cream, Monistat spray, an unknown anti-itch pill and Allegra. The Allegra helped a little. The patient consulted his pharmacist and was told that he received the Shingrix dose too soon after the COVID-19 vaccination. The Shingrix vaccine was given about 6 weeks after the COVID vaccine. Less than 2 years after vaccination, the patient had low white blood cells. He had nothing else to report. The consent to follow up was given. The patient might follow up with cardiologist. It was unknown if the reporter considered the pruritus, dry skin and white blood cell count low to be related to COVID-19 VACCINE.
Fever 100.5 temp; sore arm; red mark at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100.5 temp), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (red mark at injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PYREXIA (Fever 100.5 temp), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (red mark at injection site). On 31-Mar-2021, PYREXIA (Fever 100.5 temp) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (red mark at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: 100.5 mmHg (High) Fever 100.5 temp.         The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported   This case was linked to MOD-2021-049557 (Patient Link).
On 7-8-2022, I started having a cough. The following day, 7-9-2022, I had fatigue so I tested using a home COVID19 test with negative results. On 7-10, I went to an urgent care clinic and they tested me for COVID19 with positive results. They advised me to go to my primary care physician. On 7-12, I started having a runny nose and felt run down. I had a telehealth visit with my primary care doctor on 7-13. He did not order any medications or tests and he told me to go home and rest. I was taking tylenol and OTC cough med to treat symptoms. I am still feeling some fatigue, slight shortness of breath, and an occasional cough. I am reporting a breakthru case of COVID19.
Chicken pox exanthem over trunk, buttocks, micocutaneous junction of lip different stages of eruption started on 5/22/03.