chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shaking in left hand; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Dec2021 (Batch/Lot number: unknown) as dose number unknown, (booster) single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious) with onset 05Dec2021, outcome "unknown", described as "Booster"; TREMOR (non-serious), outcome "unknown", described as "Shaking in left hand".  Additional Information: The report was not related to a study or programme. She then said she has shaking in left hand and unable to confirm if she had that prior. No further details provided.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Profuse night sweat; Neck muscle ache; Sore arm; muscle ache; Fever 102; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Profuse night sweat), NECK PAIN (Neck muscle ache), PAIN IN EXTREMITY (Sore arm), MYALGIA (muscle ache) and PYREXIA (Fever 102) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (Profuse night sweat), NECK PAIN (Neck muscle ache), PAIN IN EXTREMITY (Sore arm), MYALGIA (muscle ache), PYREXIA (Fever 102) and HEADACHE (Headache). At the time of the report, NIGHT SWEATS (Profuse night sweat), NECK PAIN (Neck muscle ache), PAIN IN EXTREMITY (Sore arm), MYALGIA (muscle ache), PYREXIA (Fever 102) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided Treatment for the events were not provided
3 ADULTS IN HOUSEHOLD GOT THE SHOT...I HAVE LUMP IN THROAT...HEADACHE ETC..SO DOES ANOTHER PERSON...AND THIRD HAS FLU SYMTOMS AND EAR PROBLEMS...LUMP HAS NOT GONE AWAY....TODAY IS THE 16TH..CHECKED FOR STREP...NEGATIVE...NO PROBLEM TIL FLU SHOT....ARE YOU SURE THE MANUFACTUER IS A SAFE ONE...OR IS IT THE MENIGITIS ONE?
Tongue felt numb per client.  No swelling or breathing problem.   EMS evaluated. Stayed an extra 10 minutes. Instructed to go home. Patient plans to take Benadryl.  Instruct to call 911 if gets worse.
Adverse effect of other vaccines and biological substances, initial encounter on 2021-12-29.
The bottom of her feet hurt; Kind of tired; Body aches; Joint cramps; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (The bottom of her feet hurt), FATIGUE (Kind of tired), MYALGIA (Body aches) and ARTHRALGIA (Joint cramps) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient stated she had COVID-19 approximately 60 days ago.) in October 2020.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2020, the patient experienced PAIN IN EXTREMITY (The bottom of her feet hurt), MYALGIA (Body aches) and ARTHRALGIA (Joint cramps). 27-Dec-2020, the patient experienced FATIGUE (Kind of tired). At the time of the report, PAIN IN EXTREMITY (The bottom of her feet hurt), FATIGUE (Kind of tired), MYALGIA (Body aches) and ARTHRALGIA (Joint cramps) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 test: positive Date of test not provided. Approximately 60 days ago..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant products were reported. patient took acetaminophen and ibuprofen every 4 to 6 hours alternating for treatment.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: no new information, its not a follow up received.
On 08/06/2021, I was having a hard time breathing. It felt like a regular asthma attack, but it never let up and it progressively became worse. The doctor put me on several rounds of steroids, once a week for the next 3 weeks. I was using the nebulizer constantly. The ended up putting me on Singular, within a month of using, the asthma cleared up.
Vaccines given at appt 10/21/22, the next morning pt developed vertigo symptoms, headache and brain fog,  other symptoms were mild and have since resolved, vertigo worsened throughout the day and has persisted. Brain fog will happen for 10-15 min at a time intermittently throughout the day
First dose after effect symptoms were mild to moderate chills, body malaise, feverish feeling and pain on injection site that lasted for 3 days. On the third day, took Advil and symptoms disappeared the next day and feeling were fine. The second dose was moderate chills, severe body malaise and feeling feverish, decrease concentration ,minimal headache and moderate pain and redness on injection site. On 2/13/2021 had a routine lab follow-up  on MD clinic and surprisingly my PCP called me up today due to decrease WBC at 2.0. This has never happened to me before. I told my PCP I had just received my second dose 2 days prior and could be related somehow ?  They will run a repeat CBC on me next week and we will see from there. Hope nothing serious will come out from this.
tired; Chills; Achy; little dizzy; little nausea; This is a spontaneous report from a contactable consumer (Patient). A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9809), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 at 14:15 (Age at vaccination: 46 years) as dose 1, single for covid-19 immunisation. Medical history included ongoing migraine. Additional Information for Other Conditions was 20 years. Concomitant medications included botulinum toxin type a (BOTOX) taken for migraine from 04Feb2021 to 04Feb2021; Dexamethasone taken for migraine from 06Feb2021 to Feb2021. she only took it for 3 days and that dosing pack has been completed. She was trying to break the migraine cycle and hence she was having. Prior vaccinations within 4 weeks were None. The patient experienced tired, chills, achy, little dizzy, little nausea on 08Feb2021. she was a teacher who got her first vaccine on Friday, 05Feb2021. She was tired over the weekend and more flu like on Tuesday. She went to take a COVID test that was negative on the rapid test and then it was sent off. Her question, since her neurologist gave the steroid and she took Botox for her migraines, could that effect the efficacy of the vaccine. She didn't think about the fact she was prescribed a steroid and that she had been given Botox by her neurologist after the vaccine. The school nurse wanted her to call and report this since she was still experiencing side effects on the 5th and 6th day after the shot. The shot was given on the 05Feb2021 at 2:15pm. The tiredness started Sunday the 08Feb2021, she was feeling got worse and she was feeling pretty lethargic most of Tuesday evening and Tuesday night into Wednesday. It was better now but still ongoing. Chills- This started Sunday, they were better. Achy- This started Sunday but the worst of it was Tuesday and Wednesday. A little dizzy and nausea- this started Sunday and was less today. Rapid tests were done Wednesday, 10Feb2021 which was negative; the test was sent away for the PCR and she should get results back in 3-5 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 10Feb2021. The outcome of the events was recovering.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Slept in air conditioning beside dog and woke up with welts all over from waist down both legs to feet. Extremely itchy. Not red or open sores. "Looks like mosquito bites."  None above waist.  Typically sleeps with dog without issues; no new clothing/laundry detergents, etc. lotions, or medications.  Guardian given diphenhydramine and had her soak in cool Aveno bath.  Plans to take to PCP if symptoms do not subside by 1600 today.
Information has been received from a registered nurse referring to five patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with an improperly stored GARDASIL, lot # L010596 with expiration date 06-APR-2017 (dose and route of administration were not reported). No adverse effects were reported. On 19-OCT-2015 a phone call was placed to the registered nurse who was unable to provide information. Follow up information has been received on 20-OCT-2015. Patient identifiers was given. This case refers to a 12 year old patient. On 01-SEP-2015, the patient was vaccinated with the improperly stored GARDASIL. This is one of several cases from the same reporter. Additional information has been requested.
The pt developed chicken pox that was confirmed by a physician on 5/15/00. The pt had several small vesicles on the face and trunk. There was no treatment.
Diarrhea, nautious, loss of appetite, throw up to eat. Stomach has not been the same since. No pre existing health Conditions.
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). The administration vaccine underwent temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
On 8/17/16 patient was seen in MD office for bump and bruise on right upper arm at injection site. States it appeared 2 weeks after HPV-9 vaccine and is still there.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2008, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions.  Subsequent to patient's inoculation, patient was treated by a healthcare provide for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   The outcome of shingles was reported as not recovered.   The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Information regarding Flumist was received from a consumer herself, a 40 year old female, who experienced gagging, eyes watered and awful taste. At 40 years of age, she received a dose on 11/7/03. The pt experienced gagging (retching), eyes watered (lacrimation inc) and awful taste on 11/7/03. No additional info was available at the time of this report.
Patient stated that the same day she got her vaccine, she stated that her left leg started to hurt  (around her sciatic nerve) and the pain would get worse, and eventually she couldn't walk around. Patient stated that she was feeling uncomfortable, so she took some tylenol. The next day, she started feeling nauseous. The leg pain comes and goes. Patient also stated that she was feeling confused, and nauseous for the next 3 weeks. Patient stated that her heart was feeling bad, and beating irregularly.
Acute Kidney Injury, formally diagnosed on 8/6/2021 based on lab values obtained 4/20/2021, 5/20/2021 and 6/?/2021
Cellulitis and abscess of upper limb. Shingles outbreak. Redness, soreness.
Hives around site of injection, dry cough for 24 hrs post injection. Rx Beandryl.
Developed diffuse, erythematous bumpy rash on her face with some swelling around eyes.
pt recvd vax approx 8:35am;8:45 c/o h/a & dizziness;assisted to exam table;feet up cold cloth applied;8:50 BP 180/100 P 60;color pale;resp quiet & regular;8:55 BP 170/80;given orange juice;color better; dec dizziness & h/a; Pt better;
Broke out in a rash all over body. Fever. Also has had loss of word skills.
105 fever for 48 hours, vomiting, muscle aches, chills, full-body sweating, hallucinations
infanrix administered below deltoid muscle / administered below the deltoid; Infanrix administered subcutaneouslyy; Havrix administered below deltoid muscle / administered below the deltoid; Havrix  administered subcutaneously; This case was reported by a nurse via call center representative and described the occurrence of vaccine administered at inappropriate site in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st August 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 1st September 2021, the patient received Infanrix (subcutaneous) and Infanrix Pre-Filled Syringe Device. On 31st August 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device and not applicable after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site and intramuscular formulation administered by other route. On 1st September 2021, the patient experienced vaccine administered at inappropriate site and intramuscular formulation administered by other route. The action taken with Havrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the vaccine administered at inappropriate site, intramuscular formulation administered by other route, vaccine administered at inappropriate site and intramuscular formulation administered by other route were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Registered nurse reported that Havrix was administered below deltoid muscle to a pediatric patient and also administered subcutaneously which led to vaccine administered at inappropriate site and intramuscular formulation administered by other route. The reporter declined for providing demographic details from patient.  Reporter provided limited information. Health care professional noted the product Infanrix was also administered below the deltoid also stated it was likely subcutaneously administered which led to vaccine administered at inappropriate site and intramuscular formulation administered by other route. Health care professional did not provide lot number or expiration date of product.  The reporter did not consent to follow-up.
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        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.  Treatment information was not provided.   This case was linked to MOD-2021-392458 (Patient Link).
Muscular Weakness Right side of Face (Bells Palsy), External Massage/Therapy
Local cellulitis (resolving), palpations, malaise, loss of appetite, fatigue.
recurrent dizziness, motion sickness,lasting for hours, no nausea or vomiting.
Within minutes of receiving my Moderna Covid-19 vaccine around 5pm, my left eye felt irritated. I didn't think much of it but it stayed slightly irritated. About 1am, as I prepared for bed, it had become red and was quite irritated. I went to sleep and woke up in the middle of the night and my eye was quite irritated and it was filled with tears. The next two days it remained irritated in this way, red and painful. As of now (over 48 hours later), it is still red and irritated.
Had a little fever & was irritable; 22JUL was given APAP; 23JUL91 woke up from nap w/high pitched cry, t103.8, refuse to eat; APAP given, sponge bath & cool compress to leg, t102 began drinking; 24JUL TC to mom pt is fine;
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Facility had a temperature excursion for Moderna COVID-19 Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion for Moderna COVID-19 Vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 5:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 5:00 PM, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion for Moderna COVID-19 Vaccine). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion for Moderna COVID-19 Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  It was reported that patient received vaccine which was stored in an ultra cold freezer at minus 82 degrees Fahrenheit  Vial was stored in frozen storage which was in super cold freezer. On 19-Nov-2021 vial was went from super cold freezer to the refrigerator. 70 vials were still in the ultra cold freezer, 8 vials were in the refrigerator, so a total of 78 vials were affected. Vaccine vial state changes were noticed and vial was never refrozen. None of the vials were punctured before the event. Temperature excursion remained for 1 month.   This case was linked to MOD-2021-402935 (Patient Link).
Right arm swelled from shoulder to elbow area and redness extended from shoulder to distal area of humerus to just above elbow. Motrin was given, which helped reduce swelling somewhat. Benadryl treatment was suggested on 7/4/07 at the visit.
Vaccine given morning of 2/21/17. Pt called morning of 2/23/17, stated this morning she noted a "knot" (hard mass) at injection site, "about the size of a 50 cent piece", red, swollen, warm to the touch. Onset just this morning 2/23/17. (VARIVAX vaccine).
Low-grade fever (100.2 F), brain fog, fatigue the morning after the injection
nine hours after injections: fever, muscle pain, nausea, chills, joint pain, headache, injection site pain, vomiting, muscle spasms, lymph node appearance in neck, sleepiness, malaise, vivid dreams, unable to sleep well, or function.
Soreness at injection site, warmth at injection site, swelling and tenderness of lymph node under left arm, headache, (headache gone within 24 hours). All other events are still active.
Sensitivity on left side of face and eyeball; herpes simplex breakout between lip and nose; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Sensitivity on left side of face and eyeball) and HERPES SIMPLEX (herpes simplex breakout between lip and nose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included Herpes simplex since an unknown date.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HYPOAESTHESIA (Sensitivity on left side of face and eyeball) and HERPES SIMPLEX (herpes simplex breakout between lip and nose). At the time of the report, HYPOAESTHESIA (Sensitivity on left side of face and eyeball) and HERPES SIMPLEX (herpes simplex breakout between lip and nose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  No treatment information was provided.
Severe nose bleed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EPISTAXIS (Severe nose bleed) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039k2014 and 029k2074) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy, Seasonal allergy and Bronchiectasis (More coughing, increased inflammation). Concomitant products included CELECOXIB for Arthritis, LOSARTAN POTASSIUM for Blood pressure high, RISEDRONATE SODIUM (ACTONEL) from 24-Feb-2021 to an unknown date for Bone density abnormal, ATORVASTATIN for Cholesterol, CITALOPRAM for Depression and Hot flashes.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced EPISTAXIS (Severe nose bleed). At the time of the report, EPISTAXIS (Severe nose bleed) had resolved.            Treatment for the events included packing her nose with gauze for the first two episodes and cauterization for the final episode.    This case was linked to MOD-2021-018593, MOD-2021-018593 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2021: The patient's demographics and medical history was updated. The Batch/Lot numbers for mRNA-1273 were updated.  Concomitant products used were reported. Two additional events of nose bleed and treatment for all events was reported. Medically confirmed has been updated.