chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sweats; in my left arm a warm itchy rash was noted; Cough / dry hacking cough; Arm pain; Night sweats; Arm rash; Light fever 2nd time around; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), NIGHT SWEATS (Night sweats), COUGH (Cough / dry hacking cough), PAIN IN EXTREMITY (Arm pain) and RASH PRURITIC (in my left arm a warm itchy rash was noted) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma since October 1979, Allergic reaction to drug (Vicodin), Drug allergy (Percocet), Allergic reaction to drug (Naprosyn), Allergic reaction to drug (Sulfur) and Tetracycline (Tetracycline). Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), DUPILUMAB (DUPIXENT) and MAGNESIUM for Asthma, ROSUVASTATIN for Cholesterol, DENOSUMAB (PROLIA) for Osteopenia, VITAMIN D NOS, CALCIUM and UBIDECARENONE (COQ-10) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced NIGHT SWEATS (Night sweats), PAIN IN EXTREMITY (Arm pain), RASH (Arm rash) and PYREXIA (Light fever 2nd time around). On 28-Mar-2021, the patient experienced COUGH (Cough / dry hacking cough). On an unknown date, the patient experienced HYPERHIDROSIS (Sweats) and RASH PRURITIC (in my left arm a warm itchy rash was noted). On 28-Mar-2021, NIGHT SWEATS (Night sweats) and PYREXIA (Light fever 2nd time around) had resolved. On 30-Mar-2021, PAIN IN EXTREMITY (Arm pain) and RASH (Arm rash) had resolved. At the time of the report, HYPERHIDROSIS (Sweats) and RASH PRURITIC (in my left arm a warm itchy rash was noted) outcome was unknown and COUGH (Cough / dry hacking cough) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HYPERHIDROSIS (Sweats), NIGHT SWEATS (Night sweats), COUGH (Cough / dry hacking cough), PAIN IN EXTREMITY (Arm pain), RASH PRURITIC (in my left arm a warm itchy rash was noted), RASH (Arm rash) and PYREXIA (Light fever 2nd time around) to be possibly related.    Vitamin-D and Calcium indicated for Bones. Treatment information not provided for Dose 2 events.    This case was linked to MOD-2021-037257 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14 Jul 2021- Vaccine adverse event  reporting form added.Patient demographics and medical history was updated.Batch no. of the suspect drug added and concomitant drug details was added.Events added.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Within 45min of receiving H1N1 vaccination in (R) deltoid, she experienced tingling and numbness right hand and forearm and erythema hands and feet. Resolved in 24 hrs. Rx antihistamines and Advair/Atenolol.
Most side effect on vaccine card; Fever with temperature of 100.5; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Most side effect on vaccine card) and PYREXIA (Fever with temperature of 100.5) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-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 VACCINATION COMPLICATION (Most side effect on vaccine card) and PYREXIA (Fever with temperature of 100.5). At the time of the report, VACCINATION COMPLICATION (Most side effect on vaccine card) and PYREXIA (Fever with temperature of 100.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5 (Inconclusive) 100.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported
dose of expired Havrix was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 17th July 2022, the patient received Havrix. On 17th July 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 19-Jul-2022 Reporter's comment: Personal assistant reported that a dose of expired Havrix was administered to the patient. The patient did not ask about follow up but email was above. The consent to follow up was given. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
diagnosed with Covid-19; diagnosed with Covid-19; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 52-year-old female patient received first dose at age of 52 years old of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer Covid-19 vaccine and she has been diagnosed with Covid-19. She would like to know how long should she wait to take her second dose. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Case number PHHY2012US051682 is an initial literature report received on 12 Jun 2012. Authors searched VAERS for reports of adverse events (AEs) in pregnant women who received trivalent inactivated influenza vaccine from 01 Jul 1999 through 30 Jun 2009. This case refers to a baby born (sex not specified) to mother (age not specified). The mother was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) at an unknown gestational age, on an unspecified date between 01 Jul 1999 through 30 Jun 2009 (see linked mother file: PHHY2012US051675). The fetus was exposed to this vaccine via transplacental route. On an unknown date at an unspecified gestational period, the baby was born. The baby had developmental disability. The causality was not reported. Authors stated that the VAERS system does not allow for active follow-up of adverse events among pregnant women; thus, pregnancy outcome data are not available for women who had an adverse pregnancy event. Authors concluded that no unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after the administration of trivalent inactivated influenza vaccine.
Fever of 100, chills, headache, nausea. Achy all over
Mother called and stated that the nurse called her and told her the R arm where injection was given was red and swollen and seemed to be gettng worse. Mother referred to PCP or ER.
High heart rate, chills, excruciating headache eyes hurting muscle aches, TMJ joints hurting, dizzy and nauseous
Information has been received from a physician concerning a female patient who on unspecified dates was vaccinated with all three doses of GARDASIL (lot #s not reported). Subsequently, the patient had an abnormal pap test. The physician mentioned that the patient completed her GARDASIL series before she became sexually active. The patient went to the physician's office. It was reported that the patient either did or was going to do a COPO test. At the time of this report, the patient's outcome was not reported. Additional information has been requested.
On internal audit, we discovered a patient received a vaccination held at refrigeration temperature for 36 days. Appropriate steps were taken to notify the state and are coordinating efforts to notify patients to repeat vaccination.
Pentacel was given without the Hib portion with no AE; Initial information was received on 12-May-2021 regarding an unsolicited valid non-serious case from other health professional (Inquiry number: 00598157).  It was reported that a six-month-old female patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] without the hib portion via an unknown route for prophylactic vaccination (product preparation issue).  It was a case of actual medication error due to inappropriate reconstitution technique.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Patient came in for a COVID-19 Pfizer Dose #1 - did not request influenza (wrong vaccine processed and administered)
sx began 5min p/vax given nausea, vomiting, diaphoresis;
Patient broke out in a rash over most of his body. There was also swelling in the hands, feet and face.  This was treated in Urgent Care with an antihistimine shot followed by a course of Benadryl and the application of Triamcinolone Acetonide Ointment USP (0.1%).
This spontaneous report as received from a physician refers to a 5 years old male patient. The patient was vaccinated with, 1 vial dose ZOSTAVAX (lot # was unknown) (injection) on 19-SEP-2012 for chicken-pox prevention. Other suspect therapies included VARIVAX (Merck) (lot # was unknown). Concomitant medications included: INFLUENZA (manufacturer was unknown, not AFLURIA. On 19-SEP-2012 the patient was "accidentally given the ZOSTAVAX vaccine instead of the VARIVAX (Merck) vaccine". "The patient was scheduled to receive the VARIVAX (Merck) and an unspecified flu vaccine (not AFLURIA) on the same day". There were no adverse reactions involved. This adverse event was also technically an overdose to the patient since ZOSTAVAX was a higher dose that the VARIVAX (Merck) as reported. It was not specified if the patient sought medical attention, no treatment was given for adverse events. Additional information has been requested.
Headache; Felt really tired; Very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Very sore arm), HEADACHE (Headache) and FATIGUE (Felt really tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Skin cancer. Concurrent medical conditions included Crohn's disease and COPD.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced MYALGIA (Very sore arm). On 19-Mar-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Felt really tired). The patient was treated with PARACETAMOL (TYLENOL) for Headache, Tiredness and Myalgia, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Tiredness, Headache and Myalgia, at an unspecified dose and frequency. On 21-Mar-2021, HEADACHE (Headache) and FATIGUE (Felt really tired) had resolved. At the time of the report, MYALGIA (Very sore arm) had resolved.            No concomitant medications were reported. Patient reports a recent antibody test on an unknown date that was inconclusive.   This case was linked to MOD-2021-295029 (Patient Link).
Vaccination exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccination exposure during pregnancy) in an adult female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Chronic migraine in 2007. Previously administered products included for an unreported indication: ALCOHOL (1 glass of wine per week). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 28-Jan-2021 at 12:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in May 2020 and the estimated date of delivery was 13-Feb-2021. On 28-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccination exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 28-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccination exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jun-2020, Pregnancy test: positive (Positive) Positive. In October 2020, SARS-CoV-2 test positive: positive (Positive) Patient tested positive Covid-19. In December 2020, Glucose tolerance test: normal (normal) Normal. In 2021, Ultrasound foetal: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Estimated date of conception was reported as 23 May 2020.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received with no new information and patient not interested in follow up.
Event occurred at the school district event on 12/3/21. This RN is entering in system on 12/6/2021. RN is inputting event and realizes that patient received her 2nd dose of Moderna vaccine 7 days too early. Patient received 1st dose on 11/12/21 and second dose on 12/3/21. RN confers with team and they remember that patient was told she was not eligible for vaccine at registration table. She was there with son and proceeded to go through the process with her son. This RN is unsure of how she proceed to receive vaccination but VAR was completed with time stamp and sticker signifying that she did receive the dose.  This RN will complete VAERs report, submit to incident portal, and forward to PCP?s team for further recommendations.  CDC says to ?Repeat dose after invalid dose by the minimum interval.
Bad rash, swelling of limbs.  Fever 5-6 hours after shot: MMR.
Possibly have an "infection"; Experienced some symptoms after; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experienced some symptoms after) 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 No adverse event (No reported medical history).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Experienced some symptoms after). At the time of the report, VACCINATION COMPLICATION (Experienced some symptoms after) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment: Very limited information regarding these events has been provided at this time.  Further information has been requested.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
No additional AE information available; a patient was given both PROQUAD and VARIVAX concomitantly.; This spontaneous report was received from a medical assistant and referred to a patient of unspecified age or gender. The patient's medical history and concurrent condition were not reported. Concomitant medication included sterile diluent.   On 07-DEC-2022, the patient was given both measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, lot #W019631, expiration date: 19-DEC-2023 for prophylaxis (strength, dose, route of administration were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W021743, expiration date: 10-JUL-2024 for prophylaxis (strength, dose, route of administration were not provided) concomitantly (overdose). The sterile diluent used to reconstitute both products was from the same lot #W007177, expiration date: 10-OCT-2024. No additional adverse events information available.
Rash all over the body; Itchy area under the knees; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 47D2Z, expiry date 24th April 2022) for prophylaxis.   On 23rd June 2020, the patient received the 1st dose of Shingrix. On 24th June 2020, 1 days after receiving Shingrix, the patient experienced generalized rash and itchy legs. On an unknown date, the outcome of the generalized rash and itchy legs were unknown.   It was unknown if the reporter considered the generalized rash and itchy legs to be related to Shingrix.  Additional details were provided as follows: After vaccination with Shingrix, the patient experienced rash over body from head to toes and had an itchy area under the knees. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019156556:same reporter US-GLAXOSMITHKLINE-US2019156561:same reporter US-GLAXOSMITHKLINE-US2019188923:same reporter
Ventricular tachycardia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VENTRICULAR TACHYCARDIA (Ventricular tachycardia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VENTRICULAR TACHYCARDIA (Ventricular tachycardia) (seriousness criterion medically significant). At the time of the report, VENTRICULAR TACHYCARDIA (Ventricular tachycardia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment information were not provided.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sore to touch, limited mobility when moved above the head (using ibuprofen). Pain the same as it was on the first day, worse at night. The site is not red or warm to touch.
Information has been received via medical record from a registered nurse concerning a 16 year old female with heavy menstrual periods (last menstrual period approximately on 01-MAR-2009) and a history of osteomyelitis who on 20-MAR-2009 was vaccinated with GARDASIL (lot no. dose and route not reported). On 22-MAR-2009 the patient went to emergency room complaining of fever, itching, back pain and neck pain. Pain was level 5 (scale 1-10). A physical exam was performed which revealed tenderness in back and warm skin. Vital signs: blood pressure 120/72, temperature 99, oxygen saturation 97%, pulse 108. The patient was treated with MOTRIN 800mg, via oral. Laboratory work included an influenza swab and a rapid strep swab, both of which were negative. Vital signs when discharged: blood pressure 110/60, temperature 99, oxygen saturation 99%, heart rate 72, respiratory rate 18 and level of pain 2-3. The patient was diagnosed with GARDASIL side reaction. On 17-APR-2009 a physician reported that no drug reaction was observed on the patient. Additional information has been requested.
Information has been received from a registered nurse (R.N.) referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with ROTATEQ (lot # K001450, expiration date 18-OCT-2015; lot# K006805, expiration date 24-MAR-2016; lot# K010221, 12-MAY-2016; lot# K0103323, 10-MAY-2016; lot# K023535, 22-MAY-2016; dose was not reported) which had been improperly stored. No adverse effects were reported. This one of several reports received from the same reporter. Additional information has been requested.
Approximately 24 hours after receiving the flu shot, the child developed hives in a dispersed pattern all over his body.  Within 5-6 hours, the hives became more prevalent and pronounced, covered more surface area - particularly the face, arms, legs, and trunk, became extremely itchy and uncomfortable.  At that time I, his mother, gave him Children's Benedryl 7.5ml orally.  After the medication took effect, the hives slowly diminished, the itching ceased and he felt better. There were no signs of respiratory distress or indications of life-threatening signs/symptoms, no rapid heartbeat, dizziness, weakness, or generalized swelling of the face / throat. The pediatrician has been notified via the patient portal system.  The pharmacy where the vaccine was given has also been informed via phone call.
hives; itching; starting elbows, shoulder-hands, thighs, feet, face, chest; SOB (DPH taken first); MD gave steroids;
J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/3/2023 INTERSTITIAL LUNG DISEASE