chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Additional Details: Pt states site of injection was normal in (L) deltoid &"felt fine and normal, not high in shoulder". Pt states vaccine was given friday & symptoms developed 12 hours after injection HA, Nausea, chills, fatigue, minimal soreness & pain and no swelling at the start. 24-48 hours after injection still fatigue & HA, monday, arm become more sore, still dealing with fatigue and HA, tuesdya pt had soreness & pain, "red and hot, spreading from arm down to elbow" advised to f/u with DR/Urgent care
03/25/23 presents to  ED for "fever and cough". PMHx of "CKD stage 4, breast cancer and sarcoma in remission"
About 30 minutes after the injection my throat became swollen, and I felt pressure in my ears. I had difficulty swallowing,  and some pain in my upper longs with coughing.
Dose administered after 30-day Use By Date or after manufacturer date of expiry; Expired dose administered to 14 patients; 0.25ml/3rd; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (0.25ml/3rd) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (0.25ml/3rd). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (0.25ml/3rd) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator: 14-Mar-2022 The vial does not undergo any temperature excursions.  No concomitant medications was reported. No treatment medications was reported.
She had a reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (She had a reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   No Medical History information was reported.  In March 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 IMMUNISATION REACTION (She had a reaction). At the time of the report, IMMUNISATION REACTION (She had a reaction) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication information was reported. No treatment medication information was reported. Patient did not receive second dose. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
blisters on three of his fingers; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 10-month-old male patient received BNT162b2 (BNT162B2), on 06Feb2023 as dose 2 (maroon cap), single (Lot number: FX5095) at the age of 10 months, in left thigh for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, Date: 28Dec2022, Anatomical Site of injection: In the thigh, unsure which one. , Batch/Lot number: FX5095), administration date: 28Dec2022, when the patient was 9-month-old, for Covid-19 Immunization. The following information was reported: BLISTER (non-serious) with onset 07Feb2023, outcome "not recovered", described as "blisters on three of his fingers". Therapeutic measures were not taken as a result of blister.  Additional information: Vaccine for covid, the second dose, was administered around 9:50am in morning. Indication was Mom is a ball of anxiety when it comes to covid and vaccinated whole family. Onset Time: Around 8am it was noticed, Seriousness criteria was not provided. Reporter later clarified it's on three of his fingers. She knows for sure it's on his index, pinky, but unsure of what the other one is. She just put him down for a nap. AE required visit to: None. AE Outcome: Still ongoing, persisting. Treatment: None, called the doctor this morning to ask if this was a vaccine side effect and they indicated they had not heard of that yet. The doctor of will call back. The event did not require the initiation of new medication/other treatment/ procedure. Vaccine was not administered at Facility. No other conditions. No Investigations.
01/31/15 high fever of 107 and hallucination mom took child to doctor on 02/02/15.
12 1/2 x 10cm Circular, swollen leasion on lt upper thigh. Red, hard, and tender
Itching face, arms, legs, trunk. Tired, joint aching, headache, disturbed sleep. Mild SOB intermittently, sx lasted until 8 am 10/4/09.
On Oct 21st the mobile clinic vaccine team went to provide covid vaccines. The vaccine team gathered their vaccines from the pharmacy fridge kept in the pharmacy under their control. At the clinic the team started to draw and provide vaccines. One of the associates working at the clinic checked the QR code and realized the Janssen vaccine was expired. By the time the vaccine was checked, it was already given
Single large urticaria to the left upper arm - given Medrol dose pack and Kenalog today 6/7/21 in clinic
She received her immunizations earlier today (DTaP-IPV, MMRV and Influenza) at about 11 am this morning. She went home and had lunch. After eating lunch, she complained that her stomach hurt. She had complained of stomach pain after breakfast also. Mom told her to go use the bathroom to see if that would help with her stomach ache. She voided and passed a BM. Mom wiped her afterwards and noticed red "discharge" on the toilet paper. Mom then had her lay down so she could see where the blood was coming from. She wiped her bottom and there was no blood so the pink discoloration was not coming from her anus. The urine in the toilet bowl was clear yellow, not pink tinged. When asked if she had pain with urination, pt. responded yes. She had not stated anything about painful urination prior to being asked. ROS neg fever, back pain, vomiting, enuresis, urinary urgency or urinary frequency. No recent bubble baths
Patient called clinic on 2/12/21 to report systemic reaction of nausea, headache, chills, and dizziness that began yesterday.  States vaccine was given subcutaneously on left arm (instead of IM).  Pt states left arm became red 2/11/21 about 3 x 3 in and now is 6 x 6 in, reddened, and warm.  Took Tylenol for constitutional symptoms.  Pt is upset vaccine was given subq and now has large local reaction.
Initial unsolicited report received from a nurse on 14 Dec 2016. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed Flu caused by strain A (retrieved in culture examination). It was a case of vaccination failure. The patient's other laboratory data and corrective treatment was not reported. The outcome of event was not reported. Upon medical review, the case was considered as serious due to important medical event: Flu caused by strain A. List of documents held by sender: none. Sender's Comments: As with any other vaccine, INFLUENZA QUADRIVAL A-B VACCINE may not protect 100% of susceptible individuals. Aspects such as patient's immune status at the time of vaccination might interfere with the immune response to the vaccine. PCR confirmation test showed Flu caused by strain A. However patient's immune status, medical history, concomitant medication etc. is required to further assess this case.
PHARMACIST BELIEVES SHE MIGHT HAVE GIVEN ADULT COVID SHOT, INTENDED FOR MOTHER, TO 3 YO CHILD. WATCHED CAMERAS AND ATTEMPTED TO CHECK COUNTS BUT UNABLE TO CONFIRM FOR SURE.
Case was vaccinated with 3 Pfizer vaccines, then hospitalized for Covid-19 3 months following the booster shot. Hospitalized at local Hospital. 1, with MD discharging physician.  Patient is a pleasant 78 yo female with pmh CLL, htn, hld, CKD III, OSA on CPAP, osteoporosis, GERD. She presents to ED with shaking chills and cough. She has Covid-19 pneumonia. She was vaccinated with Pfizer x2 and boosted against Covid-19. She had a fever in ED. She was given Decadron and remdesivir. She has had symptoms for two weeks which worsened in the past 3 days prior to admission. She has no antibodies against Covid on testing. Dr. was consulted with ID and has prescribed casirivimab and imdevimab which bind to SARS-CoV-2 spike protein, on 24/Dec.  * Pneumonia due to COVID-19 virus Assessment & Plan Fully vaccinated with 3 mRNA shots but likely had poor response in the setting of immunosuppression. Presents with sepsis, F and unrelenting cough as well as chills today. N/V- Symptom onset about 7 days ago. Will treat with Decadron and remdesivir. Would d/w ID tomorrow to see if any additional changes considering her current treatment for CLL.    CXR with only small changes to RLL. CRP is 1.9. She was 89% on RA - 2L but her oxygen needs did not increase during her stay. (2L) Denies sob, pleuritic pain or cp.    Continue with supportive care. Encouraged use of CPAP at night.  Stable at discharge without ongoing fevers or worsening o2 needs.  Sepsis (HCC) Assessment & Plan 12:34 AM MST 12/24/2021   Source of Infection: Pneumonia SIRS Criteria: Temp >38 C or < 36 C, HR > 90 and WBC > 12,000 or < 4000 Acute Organ Dysfunction: Not present Shock: Not Present Based on the above findings, the patient has evidence of: Sepsis (Infection + 2 SIRS
Shortly after receiving MMR a hive developed close to injection site. Within 30 minutes after injection approx. quarter to 1/2 dollar hive at site. Approx. 1 hour after injection 2 more hives appeared on back and neck. Child complained of itching. Benadryl given as directed. Hives gone after approx. 3-4 hours.
pt recv vax;48 hrs later,swollen soft areas,size of small carrots;very sore;no T;MD feels probably related to vax;used hot compressed&apap;not improving;Pt to call MD if area does not feel better;
Redness-lump- raised 5mm "rock hard" area.  Tender to touch.  Not able to walk, leg swollen from thigh to knee.
Information has been received from a health professional concerning a approximately 18-year-old male who was vaccinated with a dose of MMR II. On an unspecified date the patient experienced a stroke following vaccination. No other information was known about the patient or when the stroke occurred in relation to vaccination, since the vaccine was not administered at the reporter's office. The patient's status at the time of the report was unknown. A product quality complaint was not involved. The adverse event of stroke was considered an other medically important event (OME) by the reporter. No further information is available.
Overnight after receiving 2nd dose of vaccine, patient developed intense body aches, joint pain in larger joints, and chills. Also very vivid dreams, headache and intermittent nausea, but no vomiting. R upper arm at injection site is very tender, but no redness or warmth.  Ibuprofen helped with the aches and chills.   Unsure of exact temp, as thermometer just reads ?low? (think the battery needs to be replaced).   Pt rested, increased fluids, and used anti-pyretics as needed to recover. Symptoms subsided after 24 hours.
fever; chills; fainted; fell on the floor; This case was reported by a consumer via call center representative and described the occurrence of fainting in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fainting (not after vaccines but during medical procedures). The patient had a Family History of fainting (she comes from a family of fainters).   On 30th July 2019 12:45, the patient received the 1st dose of Shingrix. In July 2019, 13 hrs 15 min after receiving Shingrix, the patient experienced fainting (serious criteria GSK medically significant) and fall. On 30th July 2019 22:00, the patient experienced fever and chills. On an unknown date, the outcome of the fainting, fall, fever and chills were recovered/resolved.   It was unknown if the reporter considered the fainting, fall, fever and chills to be related to Shingrix.  Additional details were provided as follows: At night 9 hours and 15 minutes after vaccination, the patient presented with symptoms of fever and chills. Early the next morning at approximately 2 or 3 am, the patient got up to go to the bathroom and fainted and fell on the floor and recovered after some time. The other symptoms resolved the next day. The reporter consented to follow up.
Patient has lost 4 pounds, had fatigue for several days, and just has a general feeling of unwell
Shortly after receiving the vaccine the patient complained of tightness in the chest and throat. Staff administered liquid Benadryl but after the symptoms progressed administered an Epi-Pen and called an ambulance. The patient recovered after administration of the Epi-Pen and went to the hospital with the ambulance.
I got my vaccine, and it was about 3 pm, I felt like I was exhausted and pale. I decided to go home and relaxed. I took my temperature, and it was 102 and I took Tylenol. I laid down and took my temperature again later and it was 104. I called the on-call doctor and they told me it was probably from the vaccine. The fever did come down. I was taking Tylenol every six hours. The fever finally broke on the following Monday. I did not feel well, fatigue, brain fog, weakness. I decided to go to urgent care because I did not feel well. I started to have GI issues, I had diarrhea, cramping and blood in my stool. My work would not let me come back because the diarrhea. I went back to the urgent care on Thursday, and they did IV fluid. They told me to keep resting and intaking fluids. The following week they brought me in for an MRI of my abdomen. I went back to urgent care, and they did labs, and gave me more fluids. I went and saw my GI doctor they did a stool test. I had a Flex Sig done about a month after and she told me that my Crohn's Disease was moderate. She called in prednisone. I have tampered off them, and then back on to them. I had a scope back in August of 2020 and my Crohn's disease was in remission. I had no GI symptoms until after the vaccine.
Severe body aches and pain, fever, chest pain, jaw pain, back pain upon taking a breathe, Pain across shoulder blades and through arms
Swollen arm; Arm turned red pinkish; Arm was tender; Normal soreness; This spontaneous case was reported by a health care professional and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), MYALGIA (Normal soreness), ERYTHEMA (Arm turned red pinkish) and TENDERNESS (Arm was tender) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), FAMOTIDINE, DEXLANSOPRAZOLE (DEXILANT), ESCITALOPRAM OXALATE (LEXAPRO) and ZALEPLON (SONATA ADAMED) for an unknown indication.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced MYALGIA (Normal soreness). On 25-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Arm turned red pinkish) and TENDERNESS (Arm was tender). On 21-Apr-2021, MYALGIA (Normal soreness) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Arm turned red pinkish) and TENDERNESS (Arm was tender) outcome was unknown. Not Provided      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.   Treatment medication reported includes Ibuprofen.
7-11-2006 eruption of small vesicles lesion neck extremities, few spread to back, vesicles opened slightly crusted and dried, pruritic.  Breakthrough Varicella.
Feeling Itchy; Redness; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness), VACCINATION SITE PRURITUS (Feeling Itchy) and VACCINATION SITE ERYTHEMA (Redness) in a female patient of an unknown age 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 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced VACCINATION SITE PAIN (Soreness). On 25-Dec-2020, the patient experienced VACCINATION SITE PRURITUS (Feeling Itchy) and VACCINATION SITE ERYTHEMA (Redness). On 30-Dec-2020, VACCINATION SITE PRURITUS (Feeling Itchy) and VACCINATION SITE ERYTHEMA (Redness) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to an 11-year-old patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W026315, expiration date: 18-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:00 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 58.03 No concomitant medications were reported. The vial was initially moved to the fridge on 23-Mar-2021 and proposed beyond use date was 22-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
tender; other side is inflamed one side of mouth; sound like a "frog"; sick; ulcer on one side on her mouth; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 82 years old female patient who experienced ulcer on one side on her mouth (mouth ulceration), tender (tenderness), inflamed one side of mouth (stomatitis), sound like a "frog" (breath sounds) and was sick (malaise), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot: UJ518AB) via an unknown route at an unknown administration site as prophylactic vaccination.  On an unknown date, the patient developed non-serious ulcer on one side on her mouth (mouth ulceration), tender (tenderness), inflamed one side of mouth (stomatitis), sound like a "frog" (breath sounds) and was sick (malaise) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown at the tie of reporting.
Documentation in death summary noted patient expired 2/11/21. Clinical diagnosis; respiratory failure due to pneumonia, GI bleed due to duodenal bulb ulcer, renal failure, uncontrolled atrial fibrillation, protein calorie malnutrition, community acquired pneumonia. SARS-COVID-19 not detected per documentation found on DNA molecular diagnostics laboratory report collected 2/2/21. Patient had received covid vaccination 1/29/21 prior to arrival at ED on 2/1/21. No documentation found of which brand or dose number patient had received.  No lot number available for documentation.