chrisvoncsefalvay/vaers-outcomes huggingface dataset:
IMMOBILIZED LEFT ARM; SLEEPING; COUGHING; ACHES AND PAINS; LIKE DEAD FOR A WHOLE WEEK; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced immobilized left arm, sleeping, coughing, aches and pains, like dead for a whole week, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sleeping, coughing, fever, aches and pains, immobilized left arm and like dead for a whole week was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
arm swollen; redness in arm; arm was hot to the touch; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 92M54, expiry date 2nd June 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, erythema of extremities and skin warm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema of extremities and skin warm were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema of extremities and skin warm to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient's whole arm from front to back was red and swollen(extensive swelling of vaccinated limb). The caller also reported that it was hot to the touch and the red spot was size of a soft ball where the vaccine was given.
It was arthritis pain. I am going to a pain management doctor now. After about a week I noticed that I was stiffer, but I did not think much of it. It progressively got more noticeable where before it was an annoyance. The last couple of months the right side has been extremely painful. The pain in more in my right hip. I am doing physical therapy, but I am unable to determine whether I am improving. I use a TENS unit at home, and I was hoping that what I was taking for the left hip, which is hydrocodone, but it is not helping with the issue of my right leg. I take physical therapy 3 times a week for a month, and I do have the option of extending it. I suffered a fall on a Friday December 02, 2022, so they completed an x-ray and an MRI on December 07, 2022. I returned to the doctor on December 15, 2022.
Headache; Lots off Allergic reaction; Heart beat high; Dry cough; Dose Number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Nov2021 20:15 (Lot number: FH8030) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Prior to vaccination, the patient was diagnosed with COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Prev dose brand=Pfizer, Dose Number: 2, Batch/Lot No: Lot er 8730. Location of injection: Arm Left, Vaccine Administration Time: 06:15 PM.), administration date: 25Mar2021, when the patient was 30 years old, for COVID-19 Immunization; Bnt162b2 (Prev dose brand=Pfizer, Dose Number: 1, Batch/Lot No: Lot Ewo 161. Location of injection: Arm Left. Vaccine Administration Time: 06:15 PM.), administration date: 14Apr2021, when the patient was 30 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 25Nov2021, outcome "unknown", described as "Dose Number 3"; HEADACHE (hospitalization) with onset 26Nov2021 15:15, outcome "not recovered", described as "Headache"; HYPERSENSITIVITY (hospitalization) with onset 26Nov2021 15:15, outcome "not recovered", described as "Lots off Allergic reaction"; HEART RATE INCREASED (hospitalization) with onset 26Nov2021 15:15, outcome "not recovered", described as "Heart beat high"; COUGH (hospitalization) with onset 26Nov2021 15:15, outcome "not recovered", described as "Dry cough". The patient was hospitalized for immunisation, headache, hypersensitivity, heart rate increased, cough (hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: heart rate: (26Nov2021) high; sars-cov-2 test: (29Nov2021) negative, notes: Nasal Swab. Since the vaccination, the patient had been tested for COVID-19. Covid test type post vaccination was Nasal Swab, Covid test name post vaccination was Rapid Taste. Therapeutic measures were not taken as a result of headache, hypersensitivity, heart rate increased, cough.  Follow-up (02Dec2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected.
approx 2 weeks p/2nd dose of MMR, pt was hospitalized due to febrile illness, abdominal pain, & thrombocytopenia; warfarin sodium crystalline was discontinued; pt developed DIC & adult respiratory distress syndrome; died from DIC & ARDS;
Within 5 minutes of receiving the vaccine I began to experience shortness of breath and chest tightness.  Within 20 minutes I was experiencing further shortness of breath, shakiness, and lip numbness and swelling. I received the vaccine through my workplace.  I called the employee health line who recommended that I stay with someone else until the symptoms resolved and for not less than an hour.  It took 2 hours for symptoms to resolve.  I also followed up with my primary care regarding my reaction.
Pt complained fo itching and hives 20 minutes after receiving influenza vaccine.  Pt was given Diphenhydramine 50mg po, 40min later pt had wheeezing, tingling in throat with some SOB and mild edema of tongue noted.  Pt was given 125mg IV methylprednisolone and trasported to E.D.  Pt kept over night and given a prednisone taper.
Patient received vaccination and experienced adverse effect within 24 hours. Patient developed a large painful blister in periumbilical area. Patient visited emergency room for treatment. Bloodwork was drawn and patient was given diagnosis of "Sweet's Syndrome". Patient was treated with steroids. Patient followed up with primary care provider. Patient also experiencing left arm pain and limited range of motion since vaccination which persists a year later. Patient has been seeing orthopedist for treatment. Blister has resolved but  patient still experiences pain in left arm and limited range of motion.
About 5 minutes after receiving the vaccine, the patient appeared to suddenly become dizzy and loss balance, causing them to fall and hit their head on a wall. We immediately sought assistance from providers at the urgent care located in the building who were able to assess him right away. While the patient was naturally upset and seemed slightly disoriented, the providers on hand were able to determine that he did not have any symptoms of a concussion, no cuts or bruises where he fell, no signs of seizure, or alterations to cardiovascular function. Per Urgent Care policy, we called 911, and paramedics reached the same conclusions when they came and assessed the patient independently.
Two days  after receiving vaccination patient woke with significant pain in bilateral knees, pain and swelling along bilateral Achilles tendons as well as purpuric rash on bilateral lower extremities
bad headaches; Her whole body was jumping like she was getting shocked; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Feb2021 (Lot number: EN6200) at the age of 66 years as 1st dose, single for covid-19 immunisation. Relevant medical history included: "diagnosed allergies" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic / chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "illness" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: HEADACHE (non-serious) with onset Feb2021, outcome "recovered", described as "bad headaches"; NERVOUSNESS (non-serious) with onset Feb2021, outcome "recovered", described as "Her whole body was jumping like she was getting shocked". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Did any AE(s) require a visit to: Emergency Room/ Physician Office.  No follow-up attempts are possible. No further information is expected.
He had hives and was very warm to the touch; He had hives and was very warm to the touch; This spontaneous safety report, with reference number 2023SA216537 was received by the partner on 14-JUL-2023 and forwarded on 17-JUL-2023, from a health professional.  A four-month-old neonate had an immediate reaction to Vaxelis. He experienced hives and was very warm to the touch.  Due to the short latency period between time of vaccination and occurrence of the event, the causality between the event "He had hives and was very warm to the touch" and Vaxelis was assessed as related.  Further information is expected.  Follow-up information was received on 01-AUG-2023, from an HCP. This case is maintained as non-serious.  The patient was given Benadryl as treatment for the reported event.  The reporter assessed the causal relationship between Vaxelis and the reported event "He had hives and was very warm to the touch" as related.  No further information is expected, given that reporter replied to all our queries.
Breakthrough COVID-19 case with symptom onset 8/3/2021: Diarrhea (>/=3 loose/looser stools in 24 hr period). died on 8/11/2021
Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Headache; distorted facial sensory; slight torso rash; tremor; spasticity; cognitive fog; fatigue; joint/tendon stiffness/inflammation; joint/tendon stiffness/inflammation; slightly increased temp; sensory distortion; cutaneous vasculitis on feet (aka "COVID toes"); slow digestion; This is a spontaneous report from a contactable consumer. A non-pregnant 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on right arm on 10Mar2021 13:00 (Batch/Lot Number: EN6200) at single dose (at the age of 64 years old) for COVID-19 immunisation.  Medical history included known allergies: oats, also saturated fats (trigger multiple sclerosis symptoms), intolerant of many drugs but not allergic, Multiple sclerosis/fibromyalgia, systemic rheumatoid disease, Raynaud's, underweight and very low bone density . Concomitant medications included naltrexone taken for an unspecified indication, start and stop date were not reported.  On 11Mar2021, the patient experienced headache and distorted facial sensory, slight torso rash, flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing. Includes tremor, spasticity, cognitive fog, fatigue, joint/tendon stiffness/inflammation, sensory distortion, cutaneous vasculitis on feet (aka "COVID toes"), slow digestion, slightly increased temp. No new symptoms yet. Postponed 2nd dose due to flare. The patient received no treatment. The outcome of the events was recovering.
4/29/15 (10:00pm)- Pt mom called on-call triage nurse, reported leg edema, leg twice the size of the other leg, redness, warm to touch, rash on leg reported to be bigger than the size of a softball. Per patient's father, Sx's occurred 4/29/15 after a bath.
pt recv vax & devel anaphylaxis;pt was taken to ER by emergency medical personnel, treated & sent home;
Patient reported a fever of 102.8 around 3 am after receiving the vaccine yesterday.  Feeling overall badly.
Pt states 04/11/2021 groggy, fatigued. May 5th high grade fever for 3 days continuing, ER visit with Negative Covid-19 test. Antibiotic prescribed and sent home. 04/17/2021 HBP, high pulse rate, A-fib, 06/11/2021 admitted into ICU for a week with palpations. Discharged 06/16/2021. Sent home with recommendation for follow up with Cardiologist. Currently in A-fib, July 7th appt. set to decide how to correct heart A-fibrillation.
Chills, aches, and bruising/pain at injection site. These symptoms lasted for 2 days.
general feeling unwell; chills; tiredness; she was trying to do a walk but could not; pain at injection site; pain at injection site; That side was hot; headache got worse after getting the COVID 19 vaccine; joint pain; muscle pain continued to get worse; preventing her from sleeping/ she could not sleep; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at the left arm on 18Jan2021 13:33 at a single dose for COVID-19 immunization. Medical history included back pain (a lot of time due to physical work). She had COVID in Aug2020 and she had muscle pain and was sick. The patient also had headache started initially the day before got the vaccine on 17Jan2021. The patient also has ongoing grass allergy. Concomitant medication included acetylsalicylic acid (ASPIRIN), ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) and unspecified pain medicine for back pain. She had the flu shot and Tetanus shot 2 months ago (2020) both for immunization. The patient started to notice the muscle pain on 18Jan2021 while diving back from the place she received the vaccination. She normally has muscle pain, but she thought this was something normally occurring. However, the muscle pain continued to get worse. She went to sleep, and the muscle pain continued to occur when she was trying to sleep. The muscle pain was occurring in the middle of the night and she was in so much pain it was preventing her from sleeping. She took a muscle relaxant for the pain and felt better. She noticed the pain at injection site initially around 6PM on 18Jan2021 but noticed it more when she was going to bed like 11PM. She tried to sleep on that side and it hurt. That side was hot, so she placed some ice on it. The headache started initially the day before got the vaccine 17Jan2021, but it got worse after getting the COVID 19 vaccine. It was worse on 18Jan2021, on 19Jan2021 it was better. She noticed the joint pain on 18Jan2021 but does not know really what time. She thinks it was around time noticed muscle pain. She woke up at 3AM something from the pain because she could not sleep. The chills started 4AM or 5AM on 19Jan2021. She noticed she felt tired, so tired when she woke up on 19Jan2021. She mentioned she was trying to do a walk but could not on 19Jan2021. She also mentioned she works at 1PM and would have to call out 2 hours before. She commented she needed her glasses to read the lot written on the patient card. Also was feeling unwell on an unspecified date. The events did not require Emergency Room nor Physician Office visit.  The outcome of the events was recovering.
This spontaneous report was received from a physician assistant student regarding an adult patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies, or concomitant therapies were not reported. On 21-MAR-2017, the patient was inadvertently vaccinated with a second dose of RECOMBIVAX HB injection 5/0.5 microgram/ml, pediatric formulation (dose and route were not reported) (lot number: M044032; expiration date: 03-JUL-2019) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Patient reports right upper quadrant abdominal pain at end of 15 minute observation.  vitals obtained @ 2:25 134/65, HR 72, Spo2 98%, RR 16.  No acute signs of distress. Patient denies any adverse symptoms. (2:34) Vitals 122/84, HR 79, SpO2 98%, RR 16.  Patient states RUQ abdominal pain is "better."
Information has been received from a physician concerning a female with an allergy to neomycin who, on an unspecified date was vaccinated with a "single dose" of Zostavax. On an unspecified date the patient developed a very large red "indurated" area at the injection site. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
INJECTION SITE PAIN Narrative:  MILD INJECTION SITE PAIN, RESOLVED IN 1-2 DAYS
Mother states the redness and swelling happened "all at once" about 9:00 PM the next night after the vaccine.  Pt was seen at ER.  Pt's shoulder and L arm down to the elbow is red, warm to touch and is swollen tight.  No fever noted at this time.  MD ordered cold and warm packs, Tylenol and Benadryl and followup.
Starting day of vaccine I had extreme soreness in the arm abdomen pain, nausea, extreme diarrhea. I developed an elevated heart rate of over 100 and I saw a dr on June 4th, I  visited a facility on July 8th.
This spontaneous report as received from a nurse via a field employee refers to two patients of unknown ages and genders. On unknown dates the patients were vaccinated with the second or third dose of GARDASIL (lot#, dose and route not reported). The nurse reported that 2 patients experienced arm pain at the injection site for 2 weeks duration, after receiving the second or third dose of GARDASIL. These patients received the same lot number of GARDASIL, but the actual lot number was unspecified. The outcome of arm pain at the injection site was unknown. Additional information has been requested.
The patient stated that she was dizzy and passed out when the  first Pfizer vaccine was administered.  She received the second dose of the Pfizer vaccine on 8/24/21. I told her to take a seat after I administered the vaccine. She turned red and fell down on her knees while still seated in the chair. I asked her if she can still breath and she said yes. I gave her a pillow to lay on. Five minutes later, the EMT workers arrived and took her blood pressure and vital signs. They asked her more questions and the EMT workers left. She thanked me for calling 911 and  walked out the store..
Pt developed rash the evening after receiving vax. The next morning rash was all over the body and face. Treated with diphenhydramine
Atrial Fibrillation; Heart beating fast; A Spontaneous report was received from a consumer(patient) concerning herself a 72 year old female patient, who received dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart beating fast/heart rate increased, atrial fibrillation.  The patient's medical history was not provided. Concomitant medications included metformin, gabapentin, metoprolol, thyroid medication, folic pills, frusemide.   On 27 Feb 2021 prior to the onset of events the patients received first dose of the two planned doses of mRNA-1273 (Batch N0:039K20A) intramuscularly in the left arm for prophylaxis of covid 19 infection.  On 28 Feb 2021, patient experienced heart beating fast, She ended up going to hospital where she was diagnosed for Atrial Fibrillation. She stayed in hospital for four days. She was discharged on 03 Mar 2021. The event caused hospitalization and was serious. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, increased heart rate and atrial fibrillation resolved on 03 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
fever to 103 ax < 4 hrs then 101-5 to 102.5 for 24 hrs post vax; vomiting began 19 hrs post vax x 2; startle rxn during sleep approx 19 to 24 hrs post vax;
Excessive bleeding,  Patient's spouse called 2 hours post vaccination and said the site was still bleeding.  RPh instructed patient's spouse to get several layers of gauze pad apply direct and firm pressure and raise arm above heart level and go to ER if it did not subside shortly.  RPh called 40-45 minutes after the initial call to check on the patient.  He said it was still bleeding.  The patient's spouse called 30 minutes later and said it had
Admission Date: 6/21/2022 Discharge Date: 6/25/2022  ADMISSION DIAGNOSES: 1. Incisional hematoma   DISCHARGE DIAGNOSES 1. Status post incision and drainage 2. Incisional hematoma 3. Positive bacterial cultures 4. COVID 19 positive   CONDITION ON DISCHARGE: Good     PROCEDURES PERFORMED:  Evacuation of incisional hematoma   Hospital course Patient presented 6/21 as a 36 yo G3P1114 postoperative from primary cesarean secondary to triplet gestation with NRFHT with a chief complain of incisional bleeding. Patient medical history complicated by Factor V homozoygous. She was anticoagulated on  Lovenox 120 mg BID. She has history of DVT/PE and plan was for 6 weeks of anticoagulation. Incision began same evening, and she soaked through multiple pads at home. Evaluated in ED, admitted to L and D for monitoring of bleeding. Lovenox held. CT abdomen and pelvis demonstrated large subcutaneous hematoma. Liver hemangiomas were also noted. She was taken for I and D. Hematoma removed, necrotic tissue fused with hematoma was noted. Rectus/fascia intact. Wound vac placed. Started on zosyn, monitored on postpartum. Did well post operatively. Was mild symptomatic with respiratory symptoms, found COVID positive during stay. Discussed paxlovid for improvement of COVID symptoms and shortening duration of illness but unknown long term outcomes with breastfeeding, patient desired to start. Wound cultures grew out serratia and klebsiella. She was deescalated from zosyn to cipro. Discharged home in stable condition with instructions to start paxlovid and start PO cipro. Will continue on lovenox postpartum. Cultures resulted as sensitive to cipro, patient to continue. Stable at time of discharge. At time of discharge patient was ambulating, pain controlled, voiding, tolerating po intake, passing gas/flatus.
Client called 7/16/15. States that after administration of flu vaccine had loss of olfactory sense. Went to ENT. After a month has some sense of smell but not complete.
COVID-19 Break Through Case after 2nd booster shot. I received my second booster shot on 04/21/2022. Adverse event started on 05/04/2022. In the morning woke up with a cough. I took a home test on the same day it was negative. Then I  took PCR test it was positive in the clinic. I wrote to my doctor she prescribed me Paxlovid. I started on the 05/06/2022. Today is the last day. My husband had it 3 days after I  got it from him.