chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhoea; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea), FATIGUE (Fatigue) and PYREXIA (Fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, 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 experienced DIARRHOEA (Diarrhoea), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, DIARRHOEA (Diarrhoea) and PYREXIA (Fever) outcome was unknown and FATIGUE (Fatigue) had not resolved.            No concomitant medication reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up information received reporter mailing address added
Arm pain; This case was reported by a consumer interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis and COVID-19 VACCINE (COVID 19 VACCINE) for prophylaxis.   On 8th September 2021, the patient received Shingles vaccine, Influenza vaccine Quadrivalent 2020-2021 season and the 3rd dose of COVID 19 VACCINE. On 8th September 2021, less than a day after receiving Shingles vaccine and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. On the date of reporting, the patient got the Covid shot, flu shot and shingles shot and mentioned that arm hurts. The contacts details were not reported hence follow up not possible. It was unknown if the reporter considered the pain in arm to be related to Covid shot.
Fatigue, Non-stop Headache, Chills, Muscle pain, injection site pain - in bed incapacitated for 3 days
Inflammatory myositis, severe with high CK 19,000 and weakness lasting several weeks
Pt experienced acute redness of face, itchy rash on arms and legs and one episode of vomiting. On exam, positive urticarial rash on arms and legs mildly on thorax.
Patient called 10/4/14 and reported muscle weakness, body aches, joint pain, headache, nausea, and malaise. Cond lasted several days and pt. still wasn't able to resume normal daily activities as of 10/4/14 afternoon.
Anaphylaxis reaction; fast heartbeats; stomach ache; shortness of breath; orthostatic hypotension; sore shoulder; headache; minor nausea which increased the third day; dizziness; body ache; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis reaction) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN (body ache). On 16-Apr-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (minor nausea which increased the third day). On 21-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis reaction) (seriousness criterion medically significant), HEART RATE IRREGULAR (fast heartbeats), ABDOMINAL PAIN UPPER (stomach ache), DYSPNOEA (shortness of breath), ORTHOSTATIC HYPOTENSION (orthostatic hypotension), ARTHRALGIA (sore shoulder) and HEADACHE (headache). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis reaction), HEART RATE IRREGULAR (fast heartbeats), ABDOMINAL PAIN UPPER (stomach ache), DYSPNOEA (shortness of breath), DIZZINESS (dizziness), ORTHOSTATIC HYPOTENSION (orthostatic hypotension), PAIN (body ache), ARTHRALGIA (sore shoulder), NAUSEA (minor nausea which increased the third day) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant meds were reported. No treatment information was provided. Company comment:Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, and excluding other etiologies, a causal relationship with the product use cannot be excluded. Arthralgia, myalgia, nausea and headache are consistent with the product known safety profile.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, and excluding other etiologies, a causal relationship with the product use cannot be excluded. Arthralgia, myalgia, nausea and headache are consistent with the product known safety profile.
Chicken pox virus (fever, rash head to toe). Friday 6/5/2020 fever 102 started. Saturday 6/6/2020 telehealth appointment for fever and spreading rash on knees, dx. idiopathic. Urgent care appt. 6/8/2020 after spreading of rash head to toe and fever persistent (dx of chicken pox).
I tested positive for COVID today; I tested positive for COVID today; This is a spontaneous report from a nurse (patient). A 46-years-old female patient received first dose of BNT162B2( PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, via intramuscular route of administration, administered in Arm Left on 19Dec2020 07:45, Lot Number: EJ1685 as single dose and second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, via intramuscular route of administration, administered in Arm Left on 05Jan2021 13:45, Lot Number: EJ1685 for COVID-19 immunization. Medical history included Autoimmune disease, psoriatic arthropathy, endometriosis, migraine, seasonal allergy, herpes ophthalmic, ocular herpes from an unknown date and unknown if ongoing. Concomitant medication(s) included estradiol, pantoprazole and acyclovir taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 for COVID-19 immunization, azithromycin and experienced drug hypersensitivity. The patient underwent lab tests and procedures which included body temperature: 100 on 17Feb2021, SARS-COV-2 test: positive on 19Feb2021 and on 17Feb2021. The patient experienced i tested positive for covid today and cannot smell on 19Feb2021 and on 17Feb2021 05:00 the patient experienced nasal congestion, headache, low grade temp (100), chills. The outcome of events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.
Patient woke early the next morning (approx 2-3 am) with a severe headache with nausea. Went to Urgent Care facility the next morning because HA wouldn't go away & was continuing to have nausea. Prescribed zofran prn nausea-last dose on 1/11/2022. Last HA 1/12/2022.
Initial information received on 22-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves an 18 months old female patient who received fourth dose of KINRIX via intramuscular route in the right thigh as well as a separate dose of vaccine IPOL (batch number: P1A171M, expiry date: APR-2020) via Subcutaneous route in the left thigh on 22-Jan-2018 and had crying during the injections. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Jan-2019 during injection patient was crying. Concomitant medication was not reported. It was a case of actual medication error due to Extra dose administered. The outcome of event crying during the injections was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
Within a week after vaccine, severve leg pains all day and enought ot keep me up at night.  Upper and lower leg muscles  and now, In November, is also effecting buttocks and lower back.  Treating with Aleve every 12 hours.  I previously had jouint pain issues in shoulder and one knee, but this is notin joints, but muscles.  The pain is significant enough to be changing my behavior.   I did get my second vaccine before I realized the possible connection to the shot.  Second shot was Moderna on 05-28-2021.
COVID infection Narrative: Pt seen in ER 3/17/21-treated with Bamlanivimab; clinical status then deteriorated as an outpatient, admitted to inpt 3/22/21 and rec'd remdisivir, steroids, oxygen, etc. discharged home on 3/25/21 improved.
Chest tightness; Shortness of breath; Fever; Fatigue; Muscle and joint pain; Muscle and joint pain; Brain fog; nausea; headache; costochondritis; random pain in both upper extremities; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 35-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Ew0153), via an unspecified route of administration, administered in Arm Right on 23Mar2021 13:30 as dose 1, single and a second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: En6207), via an unspecified route of administration, administered in Arm Right on 13Apr2021 13:30 (both doses at the age of 35-years-old) as dose 2, single for COVID-19 immunisation. Medical history included attention deficit hyperactivity (ADD), asthma, intervertebral disc degeneration from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (IBUPROFEN), beclometasone dipropionate (QVAR) Inhaler, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. Patient had no Known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient experienced, on 13Apr2021 16:30, chest tightness, shortness of breath, fever, fatigue, muscle and joint pain, brain fog, nausea, headache that persisted until 17Apr2021 and costochondritis pain began 16Apr2021 and diagnosed on 20Apr2021, and is still persisting along with intermittent brain fog, fatigue, and random pain in both upper extremities. Treatment was received for the events as Albuterol, ibuprofen, declined oral prednisone. Patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was reported as not recovered.  No follow-up attempt are possible. No further information is expected.
pt recvd vax & devel cellulitis described as a small pebble-like swelling @ the inject site;
Pt presented the day after immunization complaining of itching and redness at the injection site that has spread partway down her upper arm. She said it was painful and causing stiffness and soreness in her shoulder. She said she had tried an ice pack to help with the swelling and redness but provided little relief. She also stated that she had taken some APAP to help with the stiff shoulder. She stated she had not allergies to eggs and has never had an adverse reaction to a vaccine in the past. It was recommended to take some Benadryl for the itching and some ibuprofen for the swelling. Pt was also instructed that if symptoms did not improve to follow-up with her primary care physician. The pharmacy tried to follow-up with the pt later in the day as well as the next day but pt would not answer their phone or respond to our voice messages.
A report has been received from a Health Professional concerning a 4 year old, male subject, who had been receiving Nasal FLUMIST (intranasal). FLUMIST (intranasal) started on an unknown date. The child turned his head so only half the dose was administered. The outcome of the event of ONLY RECEIVED HALF THE DOSE is unknown. The reporter's description of the event (s) was as follows: Unknown. The report was considered to be non-serious.
Injection site reaction- raised; Painful at injection site apparent 24H post dose.; Red area surrounding at injection site apparent 24H post dose.; Full body aches; This is a spontaneous report from a contactable pharmacist, the patient. A 31-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 23Feb2021 at 18:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if patient was pregnant at the time of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 24Feb2021, the patient experienced injection site reaction which was raised, painful and red area surrounding injection site was apparent 24 hours post dose and also experienced full body aches. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site reaction which was raised, painful, red area surrounding injection site and full body aches were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Less than 24 hours after receiving vaccine pt. developed fever, chills and unable to get of bed for 3 days and hives and mother stated that pt. stated that "it felt like her throat was closing." Did not seek any medical treatment. Pt's mother stated that the feeling went away and mother was watching pt. the whole time. Allergic reaction was not reported within the week of administration. Mother stated that the symtoms went away and was wondering if pt should receive the other dose of the vaccine. This RN stated that pt should not receive the other dose if experiencing the previous symtoms as described.
Patient received vaccine in left deltoid and immediately responded which looked like a short seizure, losing consciousness shortly, then upon shaking responded by waking back up. Within the next few minutes the patient did the exact same thing and again responded after shaking by waking back up. Patient felt hot, weak and nauseous for quite a long time, he eventually vomited and thought he felt a little better. We called EMS and they responded by checking him over (B.S. 79 and Blood Pressure initially 87/60 but a repeat reading was 105/74 and patient felt well enough to decline a trip to the hospital. Patient was still feeling weak, so we observed him for over 2 hours and he took some water and drank some gatorade. After a bit we had him call his mother to drive him home. Patient was standing when we had one of our interns take him to his mother's car.
I injected a HPV bivalent vaccine....But I forgot to shake it before administration... Is this a problem? . After administration a liquid of vaccine came out of her arm...I am not sure whether she needs re dose of that vaccine....please acknowledge me with help
This spontaneous report was received from a pharmacist via company representative and refers to an unspecified number of patients of unknown age and gender. On an unknown date, more than 1 patient was vaccinated with ZOSTAVAX (dose, route, site of administration and lot# were not reported). On an unknown date, more than 1 patient developed red bump at the injection site after administration of ZOSTAVAX. The patient sought unspecified medical attention. The outcome of events was not reported. The relatedness between adverse events and ZOSTAVAX was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Itching of skin or arms, torso, legs.  No hives or rash.  Lasted 36 hours
Pt. says her symptoms began 8/6 and worsened from there, and as of 8/11, her symptoms have not resolved. Pt. was hospitalized at Regional Hospital. While there, pt. says she received breathing treatments including oxygen through a nasal cannula and the medication Remdesivir
Injection site is bruised and the arm is warm to the touch.  Patient also complains of headaches.
Erythema/edema of left thigh.  Red raised rash anterior aspect left thigh with small central "bump at area of injection of DTAP vaccine.
On 09/24/2005 per child's father child was on his skates playing when all of a sudden child began to shake, he fell to the floor bumping his head. It looked like he had died. Paramedics were called however per father child was not taken to the hospital because it was going to cost a lot of money. Father was told to give child medication (Tylenol). He has not been the same since the incident on 9/24/2005. Son is quite. Prior incident father not sure if child had fever. Referred to dept of health services for evaluation.
Systemic: Other- dizzy, patient reported feeling dizzy 2 hours after administration, bp 126-92 followed by 133/89, pulse 89, patient observed for 30 minutes and released.
Four days after I received the vaccine, I woke up and my vision was blurry. My right eye lost focus and it was foggy. I couldn't focus clearly at all. My family recommended that I go to the ER. I decided to see my optometrist because they know my eyes very well. They checked the pressure of my optic nerve. They didn't see anything there that would need to be treated by an ophthalmologist. There was nothing wrong with my eye pressure. They gave me some eyedrops and told me to take it easy for a couple of days. I would have issues on and off and it would normally clear up after I used Visine. As of today, everything is good. I am going for a follow up with my optometrist in a week or two.
Projectile vomiting, diarrhea, fever, burning nerve pain on left side of body,.
Client called reports on 1/26/10 experienced throbbing from axilla/shoulder to wrist of L arm, muscle contracts, feels pain. 1/28/10 went to Med Ctr-ED. Dx pinched nerve. Advised to Rx with ADVIL 600 mg. Has some relief from meds, generally better now but still has occasional pain.
Complex febrile seizure, onset 7/30.  Two brief episodes on 7/30, prompting hospitalization 7/30-7/31.
Giant red splotch 1 inch below injection site approximately the size of an orange, slightly inflamed and warm. Hard to the touch. Slight pain in underarm lymph node. Nothing that impeded daily activities.
Dizziness; When she is lying in bed it feels everything is spinning/when she is sitting upright she feels fine; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and VERTIGO (When she is lying in bed it feels everything is spinning/when she is sitting upright she feels fine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced DIZZINESS (Dizziness) and VERTIGO (When she is lying in bed it feels everything is spinning/when she is sitting upright she feels fine). At the time of the report, DIZZINESS (Dizziness) and VERTIGO (When she is lying in bed it feels everything is spinning/when she is sitting upright she feels fine) had not resolved.            No concomitant medications provided. No treatment information reported.
pt recv vax & 9 days later pt had a rash on auricle of the ears & several other areas; No further details were provided;
Local immunization clinic held monthly to meet the needs of those who do not have insurance to cover vaccines had the following scenario occur. 7 year old came to immunization clinic with no previous vaccine history. Mom did not want vaccines but dad brought child and with his permission child's first set of vaccines were given. Amongst the multiple immunizations required a KINRIX vaccine was administered. Child returned to clinic 2 months later and received another KINRIX. No adverse reaction occurred. This is off label use not approved for 7 year old, only 4-6 years of age not noted until after administration occurred.
On 1/28/00, Friday evening, pt had edema "size of softball" with c/o pain at site, enough that he could not sleep. Took Tylenol over weekend, 1/31/00, edema is gone. He also had a headache & his tongue was sore & red 2x4cm midline.
"Felt numbness and tingling down left arm into 4th and 5th fingers shortly after flu shot given in left deltoid yesterday afternoon. Still feeling tingling in left fingers this morning. Some tingling felt in left foot for a couple of hours. This resolved yesterday."
Acute perforated appendicitis that went to the OR urgently.  Patient still in hospital
Mastitis in left breast. Symptoms appeared within 15 minutes of the vaccine dose. Symptoms included pain in breast, fever, muscle / body aches, chills. Treated with 10 day course of Clindamycin.
pt recv vax & exp fever (unspecified), joint pain (hips), total body muscles aches;sx reportedly last 3 to 4 days;tx consists of APAP & pt was seen by MD for these sx;