chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a consumer, concerning a 55-year-old, female patient, who received the Moderna COVID-19 vaccine (mRNA-1273) and experienced hives in front of her chest with red and raised bumps. The patient's medical history and concomitant medications not provided. On Jan 16, 2021 (prior to the onset of the events), patient received their first of two planned doses of mRNA-1273 (Lot number: 039K202A) for prophylaxis of COVID-19 infection. Prior to receiving mRNA-1273, on Jan 18, 2021, patient felt hives in front of her chest with red and raised bumps. Treatment for the events included Benadryl. Action taken with mRNA-1273 in response to the events not reported. The outcome of the hives in front of chest with red and raised bumps: not recovered.
Fever up to 102 on day 2 (48 hrs) after immunizations.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 24-Sep-2021 at 2:52 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Expiration date of vaccine was 22 Sep 2021. The patient did not have any adverse events and did not require any medical attention. No problems were reported from the patient.
Confusing:   Only slight pain at site of injection , but noticed some pain in back of head on right side the evening of shot (Fri.Jan.22). Pain at skull continued for two more days in back of head but took Tylenol and OK.    Colonoscopy on Mon. Feb 1st;  while lying on cot just prior to having the procedure, I felt a pain near right ear.   The next day following colonoscopy, (I was given Versed).   I had difficulty removing a dental tooth cover (which I usually don't wear at night---an Essex ?) and noticed weakness of mouth.   Symptoms got worse during day and  right eyebrow lower than left.   I was cooking and shopping---obviously not a stroke. But next day (Wed.) face drooping.
Narrative:  74 y/o male patient died at community hospital due to transient cerebral ischemic attack complicated by traumatic intubation, ENT consulted for blood in airway after intubation. Patient had received covid vaccines on 11/29/2021; 3/12/2021; 2/9/2021. Death not related to covid vaccines.
Patient had syncope/seizure episode and fell face forward. Patient then had an episode of seizure like activity. She was transported to the emergency room.
Sore arm; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), HEADACHE (Headache) and FATIGUE (Fatigue) in a 51-year-old male patient 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (Sore arm), HEADACHE (Headache) and FATIGUE (Fatigue) 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. Lab details were not provided.
8 days p/immunizations, woke up w/sz; fever 105; went to ER; child then taken to another ER by car; another sz @ that ER & child quit breathing; child was hospitalized 3 days;
This case was reported by a nurse via sales rep and described the occurrence of therapy non-responder in a 57-year-old male patient who received ENGERIX B adult (batch number 995J5, expiry date 6th February 2017). This case was associated with  a product complaint. Co-suspect products included ENGERIX B adult (batch number F3BB3, expiry date 18th April 2017 and ENGERIX B adult (batch number 9937B, expiry date 2nd October 2017). On 5th January 2015, the patient received the 1st dose of ENGERIX B adult. On 11th February 2015, the patient received the 2nd dose of ENGERIX B adult. On 17th July 2015, the patient received the 3rd dose of ENGERIX B adult. On 9th September 2015, 247 days after receiving ENGERIX B adult, 210 days after receiving ENGERIX B adult and 54 days after receiving ENGERIX B adult, the patient experienced therapy non-responder. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the therapy non-responder and pharmaceutical product complaint were unknown. The reporter considered the therapy non-responder to be possibly related to ENGERIX B adult, ENGERIX B adult and ENGERIX B adult. Additional details provided were as follows: This case was one of the seven reports reported by an occupational nurse for patients tested negative for Hepatitis B titers following vaccination with ENGERIX B (see cases US2015GSK136757, US2015GSK136758, US2015135763, US2015GSK136760, US2015GSK136761 and US2015GSK136762). The caller reported that, they had their laboratory equipment recalibrated and the tests were rerun and results were same or even lower titers. All the seven patients were new hires at the company and that so the reporter was following them. This case concerned to the patient number 4. On 9th September 2015, 247 days after receiving 1st dose of ENGERIX B adult, 210 days after receiving 2nd dose of ENGERIX B adult and 54 days after receiving 3rd dose of ENGERIX B adult, the patient underwent test for Hepatitis B antibodies and it was found to be negative (quantity 0.1), causing the patient to be non-responder to the therapy.
Gave pt COVID vaccine yesterday morning. Was using a different syringe than normal and accidentally gave pt 1 mL instead of 0.5. Called pt 2/16/21 at 3 pm said she was doing fine just had a sore arm.  Pt later called back and spoke to another pharmacist with her concerns. I called the patient this morning 2/17 at 9 am she said she had a sore arm yesterday but after she iced it it no longer hurts no other symptoms and she talked to a nurse about her concerns. Told her to call me back if he is having any issues.
Per patient starting just over 24 hours ago patient developed redness, warmth, itching, and welt (now size of golf ball) around the injection site. Reaction just started about 1 week after dose administration and no reported reaction prior. has taken a couple doses of benadryl which patient stated helped reduce symptoms
2 TO 3 MINUTES AFTER RECEIVING KINDERGARTEN VACCINES CHILD C/O L ARM BURNING.ARM BECAME RED AND BEGAN TO WHELP AROUND AREA OF DTaP INJECTION. AREA APPROX. 5x3". NO OTHER SYMPTOMS. RECOMMENDED BENADRYL IM BUT MT REFUSED. HAD CHILD WAIT 30 MIN BEFORE LEAVING AND AREA WAS DECREASING. MT PLANNED TO GIVE PO BENADRYL AT HOME.
When she woke up that morning after, she came to me crying of chest discomfort and difficulty breathing. I took her to the Emergency Room, they did a chest x-ray and EKG. They came back normal, they said it was a vaccine reaction. They gave her Tylenol and Ibuprofen, she took it alternating, but the pain did not go away. It came back a couple of days later. I called her pediatrician, they said to take her to the emergency room. I took her to the  Emergency Room. They did bloodwork EKG to check the functioning of her heart to check for damages. They said the vaccine has caused some issues to the muscles around and behind and behind her heart also the center of her chest behind her ribs. They said to keep using the previous medications but the pain she has was not relieved. She was Still having difficulty breathing. The doctor just gave her Naproxen because the other medications were not helping. She went to school today but is still having discomfort in her chest. Second doctor seen.
Headache, fatigue, body aches, slightly elevated temperature of 99.7. Side effects lasted less than 24 hours after onset. No medical attention was required.
10 days post vax pt devel scattered, red spots;(no blisters) now they cover stomach, back, neck, legs, arms & few on face;had 24hr fever up to 101;2 days ago loss of appetite but otherwise no s/s;
Extreme pain, swelling and redness of the entire arm for more than 2 weeks. I used the walk-in clinic at my doctors office on 2 or 3 occasions. I took only Ibuprofen for pain and tried using ice but the swelling remained. I was told it was ?COVID Arm? and nothing they could do but run it?s course
sweating; dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 27Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERHIDROSIS (non-serious) with onset 27Apr2021, outcome "unknown", described as "sweating"; DIZZINESS (non-serious) with onset 27Apr2021, outcome "unknown", described as "dizzy".  Additional information: Reporter and husband received first dose this morning, husband sweating and dizzy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
still a little sick from Pfizer shot; This is a spontaneous report from a contactable consumer. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history included COVID-19. The patient's concomitant medications were not reported. The patient experienced still a little sick from Pfizer shot on an unspecified date with outcome of unknown. No treatment received for the event.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
NUMBNESS LEFT ARM, ANXIOUS, FEELS HEAVY, SHAKY, PARAMEDIC CAME, HR 120, SYMPTOMS RESOLVED, NO TRANSPORT
Patient complained of soreness, itching to left deltoid injection site 3-4 hours after immunization.  Pain, swelling, induration to size of a quarter by the next morning.  MD drew circle around area, assessed patient for other symptoms of anaphylaxis, found none.  Pt seen on 7/19 for erythema/induration well beyond margins drawn on day 2.  At that point, on 7/19, pt was treated with subcutaneous epinephrine and a Medrol dose pack.
Patient complained of itchy ear, head, neck 15 minutes post vaccine observed for additional 15 minutes and the itchiness had resolved.
Lightheadedness, body tired, stomach upset. Same symptoms for days, missed school progressed to head cold on 2/6 then sore throat 2/7,  stomach upset, lightheadedness, sore throat, reflux and cough began 2/8. Continued cough and chest discomfort ( chest cold symptoms) to date.
This spontaneous report was received from a physician concerning a currently 18 year old male patient. The patient did not have historical drugs. The patient's concurrent conditions included ulcerative colitis. On 15-SEP-2000, the patient was vaccinated with M-M-R II (dose, route, lot number and expiration date were not reported) for prophylaxis. The concomitant medication included REMICADE. On an unknown date, antibody testing was performed, showing that the patient had negative titers for measles and mumps. At the time of reporting, the outcome of the events was not reported. The causal relationship between the events and M-M-R II was not reported. Additional information has been requested.
One full day of symptoms.  Body aches, occasional queasy stomach,  head felt bad but not a headache.  Sensitive pain at injection site. Symptoms lasted only one full day, the day after the injection.
Patient began to "feel sleepy" and leaned forward as if to fall for about 10 seconds after adminstr. of MCV-4 and HPV #1 dose. Heart rate fell to 67 and returned to baseline (100-107) in approx. 20 min.
Subcutaneous lump on right thigh. No erythemas edema.No treatment. 9/30/12 Recheck lump gone.
Severe pain (8 out of scale to 10) at time of injection for approximately 10 minutes, at injection site and radiating down to my fingers and up to my left jaw.  Shortness of breath.  Medical professional administering the injection was initially unable to inject fluid, then after pressing extremely hard, the fluid burst into my arm.  Excruciating pain at night, especially on night 3 after injection. Moderate pain continued for 3 weeks; was unable to use arm for work or other functions for one week, unable to sleep on my left side and work moderate restricted for another two weeks. Still occasionally experience pain.  Gastrointestinal issues have continued to today.  pain or discomfort after eating every meal.  Constant bloating, even when I wake in the morning. Constipation and occasional diarrhea.
Bell's Palsy - Onset of symptoms 1/21/13. Treatment with prednisone and acyclovir. FLUMIST given 1/16/13.
11/30/21 presents to  ED for "sudden onset left sided chest pain". PMHx of "LVH, type 2 diabetes, atrial fibrillation, and previous coronary artery stent placement".
Missed second dose. 4 months since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose. 4 months since first dose) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. U11A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose. 4 months since first dose). On 29-Jun-2021, PRODUCT DOSE OMISSION ISSUE (Missed second dose. 4 months since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned.  No treatment was mentioned.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Contained Update information- No AE after first dose; no new information (Possible NNI)
Inadvertently administered the monovalent Moderna vaccine as a booster after the authorization ended.
Day of immunization developed fever of 102.8 taken rectally, a cough, was lethargic, vomiting couple of times. Parents took child to urgent care who thought it might be a bad reaction to vaccine. Symptoms lasted 2 days and then fever broke, slight cough for 1 wk after, did have x-ray of lung - slight inflammation but no treatment, no major irritation at site of infection.
Pt noted pain on inhalation, starting approximately midnight on 4/5/00. Became severe in the AM of 4/5/00, upon arising. Pain described by physician as (integratal retr) generalized, according to pt. Advised Motrin with food which has produced relief reportedly. Seen at ER and pt's report only noticed discomfort on 4/5/00 and 4/6/00, OK today, lessened discomfort, no SOB or pain or coughing. Only physician examination and blood pressure taken.
Didn't know it should have a 2nd dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received few years ago from the date of reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingrix vaccine few years ago. The patient did not know it should have a second dose. The patient asked did he/she need to repeat dose or just a second dose. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up would not possible, as no contact, details were available
vaccines were given after a temperature excursion > 77F with no reported adverse event; refrigerator containing vaccines reached a low temp of 32.2F before thermometer was adjusted upward for 1 hour 15 minutes and reached a high temp of 91.2F for about 2 hours after thermometer was adjusted upward with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from a physician via Agency (Reference number- 00636513) and transmitted to Sanofi on 10-Jun-2021 from.  This case involves a 02-months old male patient for whom it was reported that refrigerator containing vaccines reached a low temp of 32.2f before thermometer was adjusted upward for 1 hour 15 minutes and reached a high temp of 91.2f (Fahrenheit) for about 2 hours after thermometer was adjusted upward (product temperature excursion issue) and vaccines were given after a temperature excursion > 77f (off label use), while she received DIPHTHERIA/TETANUS/2 AC PERT/IPV/HIB/HEP B (HANSENULA) VACCINE [HEXYON], ROTAVIRUS VACCINE LIVE ORAL 1V [ROTARIX] and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) [PREVENAR 13].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6874AB and expiration date: unknown) via intramuscular route in unknown administration site for prophylactic vaccination.  On 31-Mar-2021, the patient developed a non-serious. refrigerator containing vaccines reached a low temp of 32.2f before thermometer was adjusted upward for 1 hour 15 minutes and reached a high temp of 91.2f for about 2 hours after thermometer was adjusted upward (product temperature excursion issue), (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  On an unknown date, the patient developed a non-serious, vaccines were given after a temperature excursion > 77f (off label use), (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.
Not sure if the vaccine stirred up the neuropathy in arms; Still getting outbreaks of itching various sites on her body; Redness on the arm and redness proceeded to go down arm; Intense itching at the injection site and it moved down to her forearm; A spontaneous report was received from a consumer concerning a 86-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events patient reported intense itching at the injection site and it moved down to her forearm .  The patient's medical included diabetes. Concomitant medications reported were dulaglutide for diabetes.  On 9 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031LZOA) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.   on unknown date, Patient reported intense itching at the injection site and it moved down to her forearm and now 2.  Treatment details included steroid cream  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, patient reported intense itching at the injection site and it moved down to her forearm  was not reported.  Follow-up was obtained on 23 Mar 2021.  Patient had history of neuropathy in feet because of diabetes.  The patient experienced redness on the arm and redness proceeded to go down arm/erythema and not sure if the vaccine stirred up the neuropathy in arms/neuropathy peripheral. It was medically significant event.  Treatment included cortisone 10 over the counter (OTC) medication.   The events still getting outbreaks of itching various sites on her body, intense itching at the injection site and it moved down to her forearm, redness on the arm and redness proceeded to go down arm were recovered with the medication on unknown date.  The outcome of the event not sure if the vaccine stirred up the neuropathy in arms was unknown.  Practitioner said to not get 2nd dose because could be much worse, so she was afraid to get the second dose.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events pruritus, erythema, and vaccination site pruritus, a causal relationship cannot be excluded.The peripheral neuropathy aggravated event is related to the patient's comorbidities.
My pcr test today was positive; infected; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (My pcr test today was positive) and INFECTION (infected) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (My pcr test today was positive) and INFECTION (infected). At the time of the report, COVID-19 (My pcr test today was positive) and INFECTION (infected) outcome was unknown.            No relevant Concomitant Medications were reported. No Treatment Information Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient noted with the following symptoms: Fever, decrease in Oxygen saturation (documented in 70's), chills and poor intake.  Resident was taken to hospital.  Patient indicated on VAR that he had not had any vaccinations in the last 14 days.  When pharmacist entered moderna vaccine information into the vaccine reporting system, it was discovered that the patient received a pfizer COVID-19 vaccination on 4/16/2021.
Chills, profuse sweating, body aches, nausea, excessive urination, difficulty sleeping.
pt recvd vax;started screaming around 4pm & lasted until 1am;mom unable to console or feed pt;talked to FMD 3 x during;MD decided pt not to get any more pertussis;
symptomsTongue and throat swelling with dizziness,  treatment benadryl,  outcome back to baseline
Large red area around injection site, hard nodule underneath injection site, pus coming out of injection site. Multiple lesions that burst and heal over all over baby's buttocks, genital area and thighs. As of 7pm on 11/19/2014, baby has a fever of 100.9 degrees. Reported to the physician that the baby saw for the actual vaccine and was told that the baby's lesions were coincidental and was folliculitis and given the antibiotic cream Bactroban. I told the Dr. that I was skeptical of that diagnosis, as my daughter had not had any issues with folliculitis at all and had completely clear skin prior to the shot.