chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient with history of atrial fibrillation, dementia, CKD, and stroke. He was brought to the ED by EMS on 2/20/23 for lethargy and weakness as noted by his nursing home staff. Per EMS, the patient had a fall the day prior but was evaluated by EMS and was determined he could stay home. He was found to have a fever with a temp of 104.2. A COVID PCR test performed in the ED resulted positive. He was admitted 2/20-2/28. He was diagnosed with COVID-pneumonia and superimposed bacterial pneumonia. Initially he was treated with broad spectrum antibiotics and steroids with improvement in symptoms, however the patient's condition worsened on 2/25. He had increased oxygen needs during his admission, and ultimately was transitioned to comfort cares on 2/27. He passed away on 2/28/23. The patient received the primary COVID vaccine series and one booster dose.
rash and itchy, dry skin around mouth, eyelids, and neck. Rash around mouth started 2 days after injection and eye and neck rash started 10 days after injection
Rash on the soles of the feet. Not sure when the rash developed, but parents noticed it when child woke up in the morning around 6 am the day after being vaccinated. Rash involved raised, bumpy lesions, some containing fluid. Rash started on the soles of the feet and slowly spread over the course of the day. At 6:30 pm there were a couple small lesions on the palms of the hands, and a few isolated lesions on the arms, legs, and trunk of the body, with the highest concentration still on the soles of the feet. Child did not seem bothered by the lesions. He scratched one on his belly, but it was unclear if this was the rash or a pre-existing bug bite.
Flulaval on October 25, 2022 and October 13, 2022; This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 17-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 437BK, expiry date 30th June 2023) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT).   On 25th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season. On 25th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 25-Oct-2022 and 26-Oct-2022 Reporter's comment: Medicine of doctor reported that they administered a Flulaval on the day of reporting to a patient, who already received a Flulaval vaccine. The reporter had reported this to vaers already. The reporter asked that they want to know what kind of effect this may had on him and the impact of next year's flu vaccine or there was anything that they need to be on the lookout for. No additional adverse event details were available outside of what was reported in the adverse report. The reporter consented to follow-up. Additional supportive information: The patient received an extra dose of Flulaval, which led to extra dose administered.
Swollen lymph node in groin area; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6208), via an unspecified route of administration, administered in gluteus medius right on 25Mar2021 at 09:00 as single dose for COVID-19 immunization. Medical history included ER+/HR+HER2- IDC and DCIS, left breast. The patient did not had allergies to medications, food, or other products. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), via an unspecified route of administration, administered in right buttocks on 04Mar2021 09:00 as single dose for COVID-19 immunization. Concomitant medication(s) included acetylsalicylic acid (BABY ASPIRIN), fish oil (OMEGA 3 FISH OIL [FISH OIL]) and curcumin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced swollen lymph node in groin area on 27Mar2021 at 06:00. The patient did not received treatment for the adverse event. The outcome of event was not recovered. The reporter classified the event as non-serious.  No follow-up attempts are needed. No further information is expected.
Cellulitis at injection site. Redness, swelling and puss at site of both injections rt thigh became progressively worse over 2 weeks period. Dx as cellulitis
First shot: soreness around shot Second shot: soreness around shot. However, after a few days, my left arm became very weak and pain traveled up from my hand to my shoulder. It continues to this day.  The first few days, I could not lift a water bottle, remote control, or make a fist. The pain was intense.  As of today, If I try to lift something with my left hand, the pain is not as intense as it was a few months ago, but it is still painful.  If I bend my left arm for a few minutes, it is painful to straighten my arm.  As an older woman, it's important for me to lift weights, and I cannot to this day lift a 5 lb weight at the gym to do bicep curls.   It's very painful to perform upper body exercises at the gym.
Information has been received from a physician concerning a 15 month old female with no pre-existing allergies, birth defects, or medical conditions who on 21-DEC-2006 was vaccinated SC in the left thigh with her first 0.5 ml dose of measles virus vaccine (+) mumps virus vaccine (+) rubella virus vaccine (RA 27/3) (+) varicella virus vaccine (Oka/Merck upgrade process) (lot# 655842/1330F). There was no illness at th etime of vaccination. Concomitant therapy that day included a fourth dose of PREVNAR (Batch # B08545A) administered IM in the right thigh. Subsequently, the patient experienced pink and "ray" spots on lower thigh and was irritable for 72 hours after injection, form which she was recovering at the time of this report. Unspecified medical attention was sought. No additional information to report. There was no product quality complaint involved. Additional information has been requested.  Follow up information receivved from a registered nurse indicated that on 22-DEC-2006 the patient developed a fever of 102 degrees that lasted 72 hours. She also developed a rash on her lower libs, torso, and face. Some rash was raised and some was flat. The child was also irritable and not sleeping. The patient recovered 4 days after immunization. There were no relevant diagnostic test or laboratory data.  No additional information is expected.
She stated she felt more SOB than usual for the last 3-4 days; though in retrospect she admitted she may have slowly been getting more SOB, with more LE edema, for longer than that. She has a known elevated left hemidiaphragm. She has a home O2 of 2L and chronically admits to some right-sided chest pain that is worse with inspiration. Mild nonproductive cough, no fever/chills. Denied palpitations. She has chronic orthopnea, sleeps in a chair; feels chronic LE edema is worse. Upon admission, patient found to have a-fib with RVR.
PT REPORTED NUMBNESS IN THROAT AT 1337 WHILE DRINKING WATER, VISTAL SIGNS AT 1357: BP 120/53, OXYGEN SATURATION 100% ON ROOM AIR, HR 74, TEMP 99.0 F, RESPRATORY RATE 18, PT DENIES PAIN. MD ASSESSED PT, NORMAL EXAM. PER MD PT GIVEN ZYRTEC ODT 10MG AT 1357 FOLLOWED BY JUICE AND CRACKERS. PT EXPRESSED SHE WAS FEELING BETTER AND MD DISCHARGED HOME AT 1422, AMBULATORY INDEPENDENT WITH STEADY GAIT, NO ACUTE DISTRESS.
This spontaneous report as received from a medical student refers to a patient of unknown age and gender. Patient's pertinent medical history, drug reactions and allergies were not reported. On an unknown date in 2011, the patient was vaccinated with the first dose of GARDASIL (lot number and expiry date unspecified). No concomitant medications were reported. On an unknown date in 2012 (reported as a year later), the patient was vaccinated with the second dose of GARDASIL (inappropriate schedule of drug administration). The reporter confirmed that the patient did not receive the third dose of the three dose vaccine series (drug dose omission). No adverse effects were reported. The action taken with the suspect therapy and outcome of the events was unknown. There was not product quality complaint (PQC) reported. Additional information has been requested.
burning, icy hot feeling in my arms, chest, stomach, back, neck, and head; burning like a sunburn; icy hot; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning like a sunburn), FEELING OF BODY TEMPERATURE CHANGE (icy hot) and FEELING OF BODY TEMPERATURE CHANGE (burning, icy hot feeling in my arms, chest, stomach, back, neck, and head) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.".  Concomitant products included PROPYLTHIOURACIL and Prenatal Vitamin/Multivitamin for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced BURNING SENSATION (burning like a sunburn) and FEELING OF BODY TEMPERATURE CHANGE (icy hot). On an unknown date, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (burning, icy hot feeling in my arms, chest, stomach, back, neck, and head). The patient was treated with HYDROXYZINE HYDROCHLORIDE for Adverse event, at a dose of 1.25 mg. At the time of the report, BURNING SENSATION (burning like a sunburn), FEELING OF BODY TEMPERATURE CHANGE (icy hot) and FEELING OF BODY TEMPERATURE CHANGE (burning, icy hot feeling in my arms, chest, stomach, back, neck, and head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt presented from a nursing home with increasing falls and altered mental status.  He was found to be COVID positive.
Swelling, redness, and pain (L) upper arm coming on within 30 mins of injections and persisting for 3 days.
Starting around 10:30 pm the night of the vaccination, experienced a sudden optical migraine in both eyes that lasted about 45 mins, which turned I to a severe headache. At around 5:15 am the following morning, woke up to severe cramping in the legs, swelling in the knees, pain in the lower back and legs, shaking, chills, arm pain at injection sight, and fever which lasted the majority of the day. These symptoms finally subsided around 6 pm, but started again around 12:30 am July 13th, until I finally fell asleep around 4 am. At 9 am, I awoke with a severe headache and pain in the lower back/hip area, pain in the left arm and occasional light headed while moving. I am trying to contact my family physician to find out what I need to do.
30 minutes after taking the vaccine my left toes started burning and then went numb for 24 hours.
Information has been received from a registered nurse concerning a 4 year old boy who on 06-JAN-2005 was vaccinated subcutaneously into left arm with first dose of VARIVAX 0.5ml (Merck), and in 17-JUL-2007 was vaccinated subcutaneously into left arm with the second dose of VARIVAX 0.5ml (Merck). There was no concomitant medication. On 13-MAY-2008 the patient developed chicken pox. On 14-MAY-2008 the patient was seen by the physician where the diagnosis was made. The patient's chicken pox was recovering. The nurse also mentioned that the patient's grandmother recently had a case of shingles. The patient sought medical attention with a physician office visit. Additional information has been requested.
This spontaneous report as received from a pharmacist via company representative refers to a 10 year old child patient of unknown gender. No medical history and concurrent conditions reported. On an unknown date the patient was vaccinated with VARIVAX (Merck) (dose, route, frequency, lot#, expire date not reported). No concomitant medications reported. On an unknown date the patient experienced herpes zoster after receiving VARIVAX (Merck). The outcome of herpes zoster was unknown. This is one of two report from the same reporter. (MARRS# 1507USA013566). Additional information has been requested.
Patient experienced loss of appetite, fuzziness in head, severe fatigue, headache, severe joint pain, muscle aches, chills, flu-like symptoms. Fever - woke up to pool of sweat. Feeling much better but still experiencing fatigue.
Initially the only response I had from the shot was a headache for 3-4 days. On 05/14/2021 I went to the ER with a racing heartbeat. My husband and I were just watching tv and my heart started to beat really fast. It was scary. They did blood work and other tests. They monitored me for about 5 hours and then they diagnosed me with Hashimoto's disease. I have never had high blood pressure before. It has always been normal. I was a runner for 25 years. I regularly see an internist and have a physical every year and everything always comes normal. Suddenly I have this onset of Hashimoto's disease. I have it to the extent that I have uncontrollable high blood pressure. It goes 101/60 to 170/90. My hair started falling out. I was very tired. Everything all at once. My endocrinologist is convinced that it was triggered by the Pfizer vaccine. I am convinced too since I have never had these issues before. I am a very active person and I always maintain a good diet and take care of myself, so we were quite shocked about this. Now I am on Metoprolol, which has helped bring those levels down but it still goes up and down. I am concerned this caused some damage to my heart. I am going to have a CT scan of my heart to see if this is going to be damaging my heart.
2 days p/vax pt devel severe itching, along w/redness & warmth @ rt upper arm;area size of fist;also devel gen achey feeling, chest congestion w/o fever;saw MD 28OCT96 tx w/med;
Arm was a little sore after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was a little sore after the first dose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Asthma.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm was a little sore after the first dose) (seriousness criterion hospitalization). At the time of the report, PAIN IN EXTREMITY (Arm was a little sore after the first dose) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.  Company comment: This case concerns a 41 year-old, female subject, who experienced the unexpected event of pain in extremity. The event occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.  Company Comment: This case concerns a 41 year-old, female subject, who experienced the unexpected event of pain in extremity. The event occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-313196 (Patient Link).; Sender's Comments: This case concerns a 41 year-old, female subject, who experienced the unexpected event of pain in extremity. The event occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.
18 hours after the shot, I started feeling very tired and sore in my muscles.  After both shots, I had some pain at the injection site.  by the next day, I had recovered from the symptoms.
CLIENT WAS ADMINISTERED MMRV (PROQUAD) INSTEAD OF MMR TODAY. CLIENT INFORMED OF ERROR VIA PHONE.
Information was received from an investigator for a study concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. On an unspecified date on week 8 the patient experienced injection site pain and edema/swelling/induration (tox grade 3). The reporting investigator felt that injection site pain and edema/swelling/induration were definitely related to study therapy. Injection site pain and edema/swelling/induration, were considered to be an other important medical event. No further information is available.
Ten minutes after receiving the shot, I felt a burning sensation all over my body and passed out. They used smelling salts on me and laid me down and put a cool rag on my head. My heart rate was elevated. My legs below my knees and my arms below my elbows felt like the were asleep and all of the muscles in those areas were completely rigid and I could not move my hands or wrists at all from the rigidity. As time passed, I was slowly able to move everything around, but was shaky. I was able to walk and leave the facility I'd say about 30-40 minutes after passing out.
Patient stated that she had vaginal bleeding. Tenderness and painfulness in her breast. Her breast was heavy. Patient had normal side effects with back pain. Patient stated that she was in menopause.  With the second vaccine bleeding was heavier and patient had blood clots. Bleeding lasted 10 days as well. Patient said her nipples are still swollen. Patient stated that she had pain in her arm from the first vaccine and pain in her neck from the second vaccine. Also after the first vaccine the patient complained of heart complications.
This literature marketed report was received from the authors of the published article entitled as stated above regarding a 13-month old girl with inoculation pigmenti (IP). As a neonate, her initial IP lesions involved the left thigh, extending to the groin, and her left flank. After the vesiculobullous stage, she maintained stable whorled hyperpigmented patches for months, with slightly atropic area interspersed with prominent vasculature. Mild ocular findings were noted, which were checked regularly by the patient's ophthalmologist. The patient's mother had a personal history of IP and currently presented with both hyper- and hypo pigmented patches on her torso and left thigh. On 11-DEC-2012, the patient had her 12-month immunization with MMR II (manufacturer unknown); HIB (manufacturer unknown); and pneumococcal conjugate vaccine (manufacturer unknown) (doses, routes of administration, lot # were not provided). On an unknown date in December 2012, in the 2 weeks after immunization, the patient presented to the Dermatology Clinic with erythematous, vesicular plaques consistent with IP which developed on the patient's left hand and right foot. The first vesiculobullous lesions to appear had, according to the mother's report, subsequently transformed into verrucous papules. According to the patient's mother, her previous immunizations had not resulted in similar lesions. The mother also denied that the patient had recent infections or fevers. Examination of the left thigh and flank found slightly hyperpigmented, whorled patches, with prominent vasculature. No diagnostic tests were ordered because she already carried a biopsy-supported diagnosis of IP completed at birth, and the classic appearance of the reactivation lesions was sufficient to make the diagnosis. Reactivation of IP after 12-month immunizations was diagnosed. The outcome of IP reactivation was not reported. The reporter considered that there might have been a link between the event and administration of MMR II (manufacturer unknown), HIB (manufacturer unknown); and pneumococcal conjugate vaccine (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
45 min after vaccine administration - high pitched cry extending off and on through night and next morning. Baby stopped trying to sit up and stopped verbalizing consonants. Also stopped eating solids. Identical twin sat up 9/21- pt sat up 11-27.
This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (nasal congestion), COUGH (slight cough), INFLUENZA LIKE ILLNESS (flu-like symptoms lasting 2 days), RASH (rash over stomach) and VACCINATION SITE PAIN (soreness in upper arm,) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. No Medical History information was reported. On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced NASAL CONGESTION (nasal congestion), COUGH (slight cough), INFLUENZA LIKE ILLNESS (flu-like symptoms lasting 2 days), RASH (rash over stomach) and VACCINATION SITE PAIN (soreness in upper arm,). The patient was treated with VITAMIN C [ASCORBIC ACID] at a dose of UNK dosage form. On 24-May-2021, NASAL CONGESTION (nasal congestion), COUGH (slight cough), INFLUENZA LIKE ILLNESS (flu-like symptoms lasting 2 days), RASH (rash over stomach) and VACCINATION SITE PAIN (soreness in upper arm,) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication information includes blood pressure medication,cholesterol medication and muscle spasms; for which details were not provided. Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Non significant Followup - Caller hang up the call
This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 17-Nov-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23, lot # L022795, expiration date 05-NOV-2016, (dose number, route and anatomical location of administration were unknown). No adverse effects were reported. Additional information has been requested.
Narrative:  59 year-old female reported dizziness following her second  COVID-19 Pfizer vaccine on 02/19/2021. No adverse reactions were reported following her first COVID-19 Pfizer vaccine on 01/29/2021.
pt recv vax;had been sleeping 3-4 hrs;mom thought baby looked pale and floppy;lips purple,lethargic;lasted about 3 hrs,needed lots stimulation
PATIENT CALLED STATING HER HEART RATE HAS BEEN ELEVATED. NORMALLY AROUND 80 AND TODAY RUNNING AROUND 120.
Around 1:35pm I noticed my nose starting to itch. I didn?t think anything of it and continued to drive. Around 1:38 I started feeling very hot and numb in my face, ears, and toes. I felt that my heart was beating very rapidly and I felt a sinking feeling in my stomach, and felt I might pass out.  I pulled over and contacted 911 for fear of my reaction progressing. Around 1:45pm I started to feel better. By the time the ambulance arrived, I felt a little fuzzy but better. They checked breathing and vitals, all of which were normal. By the end of the day my symptoms had self resolved.
Pt is claiming she still has arm/shoulder pain after receiving the vaccine 49 days ago.