chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hoarse voice and body aches, by next day developed a large local reaction where vaccine was administrated (9cm x 15 cm).  Taking Benadryl and ice for swelling.  Reevaluation tomorrow to determine if she has a cellulitis and needs antibiotics.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. On 09-OCT-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # J007786, expiration date 29-SEP-2014, 0.5 ml, intramuscularly). No adverse effect reported. Additional information has been requested.
severe leg pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe leg pain) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (severe leg pain). At the time of the report, PAIN IN EXTREMITY (severe leg pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Heavy bleeding; Irregular menstrual cycles; This is a spontaneous report received from non-contactable reporter(s) (Pharmacist). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Nov2021 13:00 (Lot number: 023M20A) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 03Dec2021, outcome "unknown", described as "Heavy bleeding"; MENSTRUATION IRREGULAR (non-serious) with onset 03Dec2021, outcome "unknown", described as "Irregular menstrual cycles". The events "heavy bleeding" and "irregular menstrual cycles" were evaluated at the physician office visit. Therapeutic measures were taken as a result of heavy menstrual bleeding, menstruation irregular.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: None. Patient had irregular menstrual cycles after the vaccine. It was heavy bleeding, and this never happened to her before this vaccine. Adverse event result in any other healthcare professional office/clinic visit. OB visit and medications to control bleeding was given as a treatment. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a registered nurse refers to a 4 month old patient of unknown gender. Patient's concurrent conditions and relevant medical history was unknown. On 26-AUG-2014 the patient was vaccinated with ROTATEQ (dose unspecified)(lot number: J015689 with expiry date of 20-NOV-2015), orally and PEDVAXHIB (dose and route unspecified) (lot number: J016186 with expiry date of 24-OCT-2016) in the right leg. Concomitant medications were unknown. The nurse stated that refrigerator temp were out of range from 19-AUG-2014 to 26-AUG-2014. All vaccines were viable. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with ROTATEQ and PEDVAXHIB was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Chest tightness, Body Aches and Pains, Headache, Fatigue, inpaired decision making, swollen lymph nodes, lost of appetite, chills, vision had yellow color, and just feeling unwell.
TC from parent indicating that patient had possible reaction to vaccine given on 2/15/19. Patient received 2nd HPV vaccine. Parent reports that patient had a strong headache soon after receiving the vaccine. The next morning, patient had facial swelling (eyes, lips) and face was yellow per parent. Parent took patient to Urgent Care on 2/16/19, patient given a shot in the shoulder and 2 pills, parent unsure what was given. The doctor did not say what it could have been other than may have been from the vaccine. Parent showed vaccine documentation to doctor of what vaccine patient received. Patient felt better soon after receiving medication and slept. Per parent, patient is doing better. Per parent, patient did not have any issues with receiving HPV or other vaccines given on 8/10/18.
pt recv vax 5OCT98 & that evening pt devel n/v & syncope;also devel severe swelling @ site of vax progressed into cellulitis;pt lt arm turned yellow from elbow to wrist;pt hosp;while in hosp vomited, aspirated the vomitus & devel pneumonia
Pt received PNEUMOVAX and FLUZONE HD on 10-20-12 reported pain, swelling, redness at injection site and on anterior antecubital.
I skipped and did not receive 2nd shot.; Severe allergic reaction within 24 hrs.; started as little bumps and then it started spreading.; broke out in hives on both hands, around her neck; feeling tired; itchy underneath her legs, around the ankles, and on both hands.; Body aches/soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I skipped and did not receive 2nd shot.), ALLERGY TO VACCINE (Severe allergic reaction within 24 hrs.), PAIN (Body aches/soreness), MASS (started as little bumps and then it started spreading.) and PRURITUS (itchy underneath her legs, around the ankles, and on both hands.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN (Body aches/soreness). 22-Mar-2021, the patient experienced PRURITUS (itchy underneath her legs, around the ankles, and on both hands.). On 23-Mar-2021, the patient experienced MASS (started as little bumps and then it started spreading.), URTICARIA (broke out in hives on both hands, around her neck) and FATIGUE (feeling tired). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I skipped and did not receive 2nd shot.) and ALLERGY TO VACCINE (Severe allergic reaction within 24 hrs.). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, PRODUCT DOSE OMISSION ISSUE (I skipped and did not receive 2nd shot.) and ALLERGY TO VACCINE (Severe allergic reaction within 24 hrs.) outcome was unknown, PAIN (Body aches/soreness) and FATIGUE (feeling tired) had not resolved and MASS (started as little bumps and then it started spreading.), PRURITUS (itchy underneath her legs, around the ankles, and on both hands.) and URTICARIA (broke out in hives on both hands, around her neck) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up information received on 7-JUN-2021, updated reporter mail address, initials, added events ( allergy to vaccine, product dose omission) and updated action taken.
On 7/22/21 I developed Sudden Sensorineural Hearing Loss and was diagnosed by an ENT on 7/27/21
pt exp generalized sz like activity lasting 20-30 seconds; uneventful hosp course; neg work up
Suddenly was short of breath; numbness and tingling in L face on the buccal side and her L arm.; L side of the face and eyelids were swelling; L side of the face and eyelids were swelling; Agitated; Worried; general malaise; Delayed ear swelling; A spontaneous report was received from a healthcare professional concerning a 43-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced numbness and tingling in L face on the buccal side and her L arm. She felt like her L side of the face and eyelids were swelling. She was agitated and worried.   The patient's medical history included breast cancer and axillary swelling.  Concomitant product use was not provided by the reporter.     On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 [LOT#301] for prophylaxis of COVID-19 infection.    The reporter was called to see a patient in drive up lane 7 min post vaccination. The patient immediately felt after the vaccination, numbness and tingling in L face on the buccal side and her L arm. She felt like her L side of the face and eyelids were swelling. She was agitated and worried. Past medical history of breast cancer and axillary swelling. Initial examination lungs CTA, regular tachycardia. Pt moved to observation area. Initial vitals: BP: 154/82, HR 129, 97 percent O2. BP 154/82, 136, RR 20, O2 sat 99 percent 10:43 am. BP 162/84, HR 131, RR 22, O2 sat 100 percent at 10:49 am. At 10:49 am, she suddenly was short of breath, general malaise, delayed ear swelling, and was put on a stretcher and 10L nonrebreather. She was brought to Medical Center at 10:54.   Treatment for the event included Benadryl 25 mg po given at 10:25 am and 3 mg Epi pen injection given at 10:41am. A second epinephrine 3mg injection given at 10:44 am  The events of hypoaesthesia, swelling face, swelling of eyelids, agitation, anxiety, dyspnoea, malaise and ear swelling were unknown; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (Diluent Mrk Inj) which was used for the reconstitution of VARIVAX (unknown lot# and expiration date). On an unknown date the patient was vaccinated with improperly stored VARIVAX (dose, units and frequency not reported) (lot # N022981 and expiration date: 23-AUG-2019) subcutaneously at a temperature from -14 degree Celsius (°C) to -10 °C for 10 hours (product storage error). The vaccine VARIVAX also had previous temperature excursion at a temperature from -14 degree Celsius (°C) to -10 °C for 11 hours and 30 minutes. No data logger was involved. No adverse effects and no additional information was provided. No product quality complaint was involved. This is one of 6 reports received from the same reporter. Sender's Comments: US-009507513-1803USA004613; US-009507513-1803USA004760; US-009507513-1803USA004757; US-009507513-1803USA004759; US-009507513-1803USA004758.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received covid-19 treatment as PAXLOVID from 28Sep2022 to 02Oct2022. Patient did not received any other medication in 2weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 27-MAR-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # N020016 and expiry date 17-JUL-2019) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
Felt like crap; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.     Additional Information: GSK Receipt date: 01-Mar-2023 Reporter's Comment: The patient was a friend of the reporter. The reporter stated that the patient felt like crap after the first dose of Shingrix. The reporter provided limited information. The reporter did not consent to follow up. Additional Supportive Information: The case is linked with cases US2023033391 and US2023033387, reported by same reporter.; Sender's Comments:  US-GSK-US2023033391:Same reporter US-GSK-US2023033387:Same reporter
Got much sicker second time around with the flu.  Other than arm pain at vaccine site along with later skin sensitivity all over my body (as before),  I was sick to my stomach with bad headache and overall body pain and weakness.  Couldn't sleep the whole night due to discomfort and pain and nausea.  [Once i learned that there can be bad reactions to this vaccine, I figured I would just need to wait it out.]  I still don't quite feel right, like feel weak with occasional slight nausea, but don't know if that's from any lingering effect of the vaccine.
Mouth sores; Red bumps all over body; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 10:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation.  On 23Apr2021, the patient experienced mouth sores and red bumps all over body. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mouth sores and red bumps all over body were resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient received vaccine on 01/24/18 with no adverse reaction. On 02/06, patient noticed a red, warm bump on injection site along with 2 varicella-like bumps on chest and back. RPH advised patient to avoid coming in contact with anyone susceptible to contracting varicella. RPH counselled on use of calamine to help ease itch, along with cold compresses and bath with baking soda for symptom relief.
Moderna vaccine was administered outside of source - reported by patient ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------- J96.00 ACUTE RESPIRATORY FAILURE 1/24/2023 HOSPICE ADMISSION
Patient stated that on 3rd day after receiving PNEUMOVAX vaccine her arm became swollen and discolored (red/purple) (approx 7" x 4" area). gradually swelling and discoloration resolved but small, hard area (approx size of nickel) remains under skin. Site was palpitated and seems to be hardened area under layer of soft tissue - no discoloration, but slightly higher on deltoid than expected.
unusual high pitched cry w/in 6 hrs of DTP inject lasted 1 hr;
This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates since October 2016, the patients were vaccinated with a dose of PNEUMOVAX23 (dosage, route of administration, lot # and expiry date were not provided) which were improperly-monitored. No adverse experience was reported. The temperatures, when recorded, were always within the recommended storage range. There was a period, when the temperature would not be recorded for 3 or 4 days and there were occasions when the temperature would be recorded only once a day. There was no previous temperature excursion reported. Digital data logger was not involved. No product quality complaint was involved. Follow up information has been received from an unspecified reporter referring to a patient of unknown age and gender on 11-APR-2017. The first dose of PNEUMOVAX23 was vaccinated in October 2016. On 04-FEB-2017, the patient was vaccinated with the second dose of PNEUMOVAX23 (Inappropriate schedule of vaccine administered) (dose and expiration date unknown, lot# M036728, right deltoid) intramuscularly for prophylaxis. There was potential compromise of PNEUMOVAX23 due to multiple in monitoring refrigerator temperature. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA013522:
OBSTRUCTIVE SLEEP APNEA 12/22/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
approx 8hr p/vax pt vomited 3-4times profusely, then stopped;was irritable for several days, but did not have non-stop crying fore greater than or equal to 3hr;no fever noted per mom;
Parent called office on 5/22/07, reported onset of headache and stomach ache on 5/20/07 with increase of head today and c/o spinal pain. Patient was examined on 5/22/07 ---> lab work, afebrile. (H.A. persisted x 1 week)
Vaccine given with sterile water instead of manufacturer's diluent. No reported adverse events by mother of patient in subsequent visits to the Immunizations clinic. Revaccination determined by local medical team with advice from the following medical professional.   *Item 5 was filled due to form requirement but it is unknown if patient has experienced an adverse health event. This VAERS form is being filled out for documentation and education purposes.
Day after(08/01/2018) soreness, red, andswelling at injection site. Tired, a little sick on my stomach and achy. 8/3/2018- light rash on sides and backs of my arms. Doesn't itch and is not red.
Severe headache; fever of 102;  fatigue and muscle aches; injection site pain;  severe pain on right side of neck/shoulder, shooting down right arm and down left leg.  My pulsatile tinnitus also greatly worsened.  The worst of the reactions lasted two days.  Fatigue, muscle aches and injection site pain lasted 7 days.  I did not seek treatment, though I should have based on the information that is currently being put out regarding this vaccine and possible adverse reactions.
Pt seen in clinic on 6/20/18 given pneumonia vaccine. Last 2 days or starting 6/21 has been feeling ill then yesterday noticed L arm injection site red/warm and TTP. States is not itchy but hurts to touch. She was found to have a 8x6cm urticarial lesion on left arm. Initially treated with vancomycin, de-escalated abx therapy to KEFLEX for cellulitis.
5 days post vaccine 3/9/2021 - small (rash-like) bumbs on arms, and minimal on legs, attempted to treat with Benadryl, bumps persisted to todays date 3/11/2021.  Do see a dermatologist for other skin issues (acne), saw dermatologist today (two days after symptoms appeared) said it could be related to the vaccine and did not think it was anything of concern but more of an immune response.
Patient took first dose on Wed 7/13. Two days later, 7/15 patient noted a rash on chest. Took second dose same day 7/15. The following day 7/16, patient noted rash all over chest, arms and back. Non-pruritic. That day patient experienced diarrhea for approx. 4 hours. Also reports nausea.
Patients receiving expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients receiving expired doses) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients receiving expired doses) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. Health care professional (HCP) mentioned that there was incident because of miscommunication as a coworker told that there were some lot number whose expirations dates had been extended.  The patient received the second (2nd) booster dose.   No treatment medication was provided.