chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he has a rash on his back and a little bit towards the front where his rib cage is; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (Pfizer BioNTech Covid-19 vaccine, Formulation: Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on 30Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical Vaccine include BNT162B2 (Pfizer BioNTech covid-19 vaccine, Formulation: Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced he has a rash on his back and a little bit towards the front where his rib cage is. The outcome of the event was unknown.  PSCC Communication: Informed caller that medical information is unable to provide treatment advice and it would be recommended for him to contact his primary care doctor for treatment advice. Caller purposefully disconnected from the line, unable to obtain further details.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
8x9 cm large, indurated warm red raised swelling on thigh where shot given.
Patient with vomiting the day after receiving vaccines. Parents state that she vomited 4 times within 30 minutes the evening after receiving vaccines. Her appetite was poor for the next 2 days. They also described runny nose and watery eyes as well as bruising at one of the vaccine sites.  No other rash
A 91-year-old female patient developed lower back pain on the right side, radiating to the left side over a course of 2-3 days following the intramuscular injection of FLUZONE, lot # U18811AA in the left deltoid on 04-OCT-2005. The symptoms resolved on their own. No medical treatment was sought, and no diagnostic tests performed. The patient receives the flu vaccination yearly and is on sleeping pills. As per reporter the patient recovered. Follow-up information received on 24-MAR-2006 from a health care provider. The patient had no history of back problems, and the lower back pain she experienced lasted for 7-10 days. The patient indicated the pain was quite severe for three days after vaccination and got less severe day by day after that. She had not aggravated her lower back in any way prior to vaccination. The event did not require examination by a physician. Same reporter and reporting facility in cases 2005-02155 and 2005-02156.
01/29/22 presents to ED for "tachycardia and increased confusion". PMHx of "leiomyosarcoma, pulmonary embolism, and intra-abdominal abscess"
chills, fever, dry heaves, muscle and back aches, weakness, digestive system stopped for 10 days, could not eat, 18 days to recover, no medical doctor seen
Fever, Decreased PO intake which started on 1/11/16. Finally diagnosed with Acute Disseminated Encephalomyelitis.
Patient got dizzy and fainted and fall down the chair.  She did come back alert within a minute.  Patient said that she fainted once time before when she got her blood draw.  She admitted that she did not eat anything in the morning before the vaccine appointment.  We did call 911 and the firemen responded within 5-10 minutes and verified that all her vitals signs are normal . Patient declined to go to the hospital.  We have patient sit on the floor, drink some water and eat some Skittles and she did reported she was feeling better.   We had patient call her family to pick her up.
Left arm at injection site was swollen with 2 patches of warm, red, welps down my arm.  Doctor looked at it and gave me a script for antibotics and Claritin.
use to get chronic bronchitis and sinus infections every year too. No more....not even a cold since stopping the flu vaccine; use to get chronic bronchitis and sinus infections every year too. No more....not even a cold since stopping the flu vaccine; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 13-Dec-2020.  This case involves a patient of unknown demographics who used to get chronic bronchitis (bronchitis  chronic) and sinus infections (sinusitis) every year too, while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient stated that he/she used to get chronic bronchitis (bronchitis  chronic) and sinus infections (sinusitis) unspecified days after the patient got the shot.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.  The reporter assessed the causal relationship with suspect vaccine as related.
No other AE; patient who inadvertently received an extra dose of VAQTA; extra dose of VAQTA on 10/21/2022 / The caller said the patient received 1 dose of a hepatitis A (brand name and manufacturer unknown by reporter) vaccine in 2001, and the patient received a second dose in 2022; This spontaneous report was received from a Registered Nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  Patient was previously vaccinated with 4 doses of a polio vaccine (manufacturer unknown), 2 doses on an unknown date in 1984, 1 dose on an unknown date in 1985 and 1 dose on an unknown date in 1989.   On an unknown date in 2001, the patient received a dose of Hepatitis A Vaccine, Inactivated (VAQTA) administered as prophylaxis (dosage regimen, route of administration, lot number and expiration date were not provided) (also reported as Hepatitis A vaccine, manufacturer unknown). On 21-OCT-2022, the patient was vaccinated with an extra dose of Hepatitis A Vaccine, Inactivated (VAQTA) administered as prophylaxis (dosage regimen, route of administration, lot number and expiration date were not provided) (Extra dose administered). On the same date, the patient also received an extra dose of a polio vaccine (manufacturer unknown) (Inappropriate schedule of product administration). The reporter did not know the patient had received both of these vaccines in the past. No other adverse events occurred (No adverse event).
Stiffness in my arm where I got the shot; Brief small amount of diarrhea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness in my arm where I got the shot), DIARRHOEA (Brief small amount of diarrhea) and CHILLS (Chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in my arm where I got the shot), DIARRHOEA (Brief small amount of diarrhea) and CHILLS (Chills). On 11-Mar-2021, MUSCULOSKELETAL STIFFNESS (Stiffness in my arm where I got the shot) and DIARRHOEA (Brief small amount of diarrhea) had resolved. On 12-Mar-2021, CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: At 10.30 pm body temperature was 95.7 At 11.30 pm body temperature was 96.1. On 12-Mar-2021, Body temperature: At 12.20 am body temperature was 97.1.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25 Mar 2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25 Mar 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25 Mar 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25 Mar 2022) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2022 at 4:58 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-Mar-2022 at 4:58 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25 Mar 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25 Mar 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25 Mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient ethnicity was reported as Asian. The patient received Moderna vaccine on 25-Mar-2022 16:58:30, past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. The patient received the booster dose of vaccine. No treatment medications were provided.   This case was linked to MOD-2022-542869 (Patient Link).
Engerix-B instead of 2nd dose of Twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 28-year-old female patient who received HBV (Engerix B) (batch number 337TC, expiry date 29th March 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 19th September 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 19th September 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-Sept-2022 Reporter's comment: The pharmacist reported that Engerix-B was administered to a patient instead of 2nd dose of Twinrix. The 2nd dose of Twinrix was not administered. The adverse event contains all reported information. The reporter consented to safety team follow-up. Additional supportive information: The patient was administered Engerix-B instead of Twinrix (2nd dose), which led to wrong vaccine administered.
pt had 3 brief fainting spells 24hrs p/vax; no fever, PE nl; crying
Experienced sharp pains in ribs area & up into shoulder (beginning Tues., Dec. 7, 2021) and started having difficulty / limited breathing. Thought I might have a rib "out." Saw chiropractor on Wed. (Dec. 8,), who made an adjustment. Felt a little better after appt. and that day. Next day (after night's sleep - (Didn't sleep well, due to discomfort a/breathing & pain - Could Not sleep on either side - Could only lay on back) - pain was much worse (next morning/day - Thurs., Dec. 9). Went to ER that afternoon. Had EKG (told it was fine), chest x-rays (showed liquid in left lung), bloodwork (told all were good), then chest CT scan (showed multiple blood clots/pulmonary embolisms in left lung). ER Dr. ordered Eliquis , to be taken as directed for at least 3-4 mos. , and told to follow up w/PCP.   Dec. 14, '21 - Spoke w/PCP by phone - Dr. ordered add'l bloodwork (to check for Factor V, etc.)                                & ultrasound on both legs (ankles to pelvic) - He noted, there is no apparent cause for blood clots - No "smoking gun," per se. Dec. 15, '21 - Bloodwoork done - Results were all good - No problems (causes for clots) detected Dec. 17, '21 - Ultrasound(s) done on both legs - Showed (slightly?) slower blood flow on left leg (knee area?)
It hurts to raise my left arm and I cannot cross my arms to take off a shirt over my head.  It aches during most of the day and I really notice it at night when I try to roll over.
Information has been received from a nurse referring to a 4-month-old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 14-MAR-2019, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 (1 dosage form, lot# R024025, expiration date of 02-SEP-2020, strength and frequency were unknown) intramuscularly for prophylaxis (Wrong product administered). No adverse event was reported. No product quality compliant (PQC) was involved.
15 days after shot developed substernal chest pain and was seen emergently in the ED and was found to have acute st elevation myocardial infarction (STEMI) requiring emergency cardiac catheterization and had RCA stent placed due to 95% thrombotic lesion and was also found to have 50% LAD lesion.   He also had 3rd degree heart block as well as 2nd degree heart block. We was found to have acute systolic congestive heart failure with left ventricular ejection fraction of 32% and mildly reduced right ventricular ejection fraction and moderate pulmonary hypertension was noted.
Patient came today reporting the evening after her first COVID vaccine, she started to experience racing heart rate and left sided chest pain.  The pain is constant, burning feeling and worsens with activity.  Patient also experiences fatigue during activity.  Pain when pressure applied to left chest.
Patient had a breathe holding episode for about 15 seconds. This was around 9:20 on 06/26/2018. Patient held her breath and then lost consciousness. No further action was needed. Patient was transported by EMS for observations for a few hours.
Eyes turned very red, swollen, dry and itchy.  My eyes were also weeping.  This was the worst eye infection/reaction I have ever had. Nothing seemed to help.  I had avoided going out throughout the pandemic, especially avoiding the doctor's office or hospital I made a Video appointment and the dr recommended I come.
left arm soreness has continued since first immunization received on 2/14/2021, as well as since 2nd immunization on 3/7/2021. Although mild in most positions, it is painful when I attempt to extend my arm laterally in an upward direction. The discomfort is mild under most circumstances, but is quite painful when, and only when, my arm is extended in the aforementioned manner. It has not required medication, and has not required me to seek medical attention. It has been persistent, and the severity has neither increased nor decreased. I've simply adjusted my range of motion to avoid those positions that elicit the pain. I would have expected the pain to gradually lessen, but it is not doing so. I suspect that there may be others experiencing the same side effect, so I want to report it.
Pt recvd vax & exp a rash, size of a quarter, @ both vax inject sites rashes were papular; no other sx present; treatment included Hydrocortisone cream; pt recovered;
A large, painful, raised red mark developed the day after the injection site.  It measured about 2? diameter. By this morning at 8am, 2 days later, it measured 2.25? and the painful area extended much further. By this evening at 8:30, the red blotch has increased in size to 3.5? across. I have been taking ibuprofen, but it is still painful.
Sore; Puffy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore) and SKIN SWELLING (Puffy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN (Sore) and SKIN SWELLING (Puffy). At the time of the report, PAIN (Sore) and SKIN SWELLING (Puffy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Hypertension-Mild, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Severe, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Severe, Systemic: Unable to Sleep-Medium, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Medium, Additional Details: Started experiencing symptoms about 6 hours after receiving vaccines. Experienced swelling immediately. Symptoms lasted for 2 weeks afterwords. Some symptoms resolved over time earlier than 12 weeks. Swelling and bruising lasted the longest.
Information has been received from an individual concerning a 1 year old non-Hispanic male pt who did not attend daycare who on 8/9/98, 10/14/98 and 7/13/99 was vaccinated with a 1st dose (lot #623436/1176E), 2nd dose (lot #623436/1176E) and 3rd dose (lot #629768/1797H), respectively of Haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast). The pt was subsequently, dx'd with pneumonia and bacteremia (through a blood specimen). The first culture was on 11/15/99. Upon internal review, pneumonia and bacteremia were considered to be 'Other Medical Events'. This was reported as a case of vaccine failure. Additional information has been requested.
cracked tooth; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH FRACTURE (cracked tooth) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TOOTH FRACTURE (cracked tooth). At the time of the report, TOOTH FRACTURE (cracked tooth) outcome was unknown.            Patient wanted to know whether it was ok to take steroid pack for the event or was it true that she should wait for 14 days.The action taken was assessed as not applicable since the patient had already taken the second dose of the vaccine. No concomitant drugs were provided.
Fluid in lungs; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY OEDEMA (Fluid in lungs) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced PULMONARY OEDEMA (Fluid in lungs) (seriousness criterion medically significant). At the time of the report, PULMONARY OEDEMA (Fluid in lungs) outcome was unknown.            Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter.  Very limited information regarding this event has been provided at this time. 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. Further information can't be requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. 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. Further information can't be requested.
About 4 hours after receiving vaccine, multiple sneezes followed by running, watery right eye and very runny nose on right side.  Feeling flushed (especially on the right side of face) without fever.
Crying, red swelling, slight fever, loss of muscle control & strength. Lethargic, unable to speak or walk w/out assistance. Severe diarrhea, weight loss & toe walking.
No adverse event; lot that had been expired was administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patients) and NO ADVERSE EVENT (No adverse event) in an 88-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patients).    Patient age was reported as 88 Year 11 Months.  No concomitant medication was provided.  ID number was reported as 80777027398.   It was reported that also another lot of vaccines lot number 065F21A was also expired and administered to patient and lot number O70H21A was administered to patient between 08-Apr-2022 and 15-Dec-2022.  Treatment medication was not provided by the reporter.