chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable nurse (reported for herself). A 49-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported) intramuscular on 10Jan2021 10:15 at a single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. The patient had no COVID prior to vaccination. The patient was not pregnant at the time of the vaccination. There were no concomitant medications. The patient had no other vaccine in four weeks and no other medications in two weeks. The first dose of BNT162B2 (Pfizer brand) for COVID-19 immunization was administered on 23Dec2020 08:00 AM intramuscularly in the left arm (at the age of 49 years old). On 15Jan2021, patient was unable to smell or taste at 6 day post injection. No treatments received in response to the events reported. Patient had Covid test post vaccination as Nasal Swab, Pcr on 15Jan2021 with negative result. The outcome of the events unable to smell or taste at 6 day post injection was not recovered.   Information about lot/batch number has been requested.
Child received the correct vaccine (Children's Pfizer shot) in correct amount.  Dad and patient stayed close to the pharmacy for 15 minutes then returned to the pharmacy stating child was having itching on the arm the shot was injected into as well as some itching on the shin area of the legs.  Pharmacist and dad checked patient for swelling/angioedema, hives, trouble breathing, worsening of condition, and then patient stated legs were no longer itching.  Had patient wait in waiting area for an additional 45 minutes to make sure nothing worsened.  Patient would change his statement claiming that his legs would itch as well to only the vaccinated arm was itching, perhaps out of fear of having an epi-pen administered.  With permission of father, I gave child 10 ml of Benadryl just in case when they initially presented back after the shot.  Father called the mother to make sure she didn't see anything on him in terms of hives or swelling as she had previously seen his allergic reaction to ibuprofen.  Father also called his brother who is a pharmacist to get his opinion on whether to hold off on an epi-pen administration or not.  I counseled father to make sure to take son to a doctor next time to get his second shot/consult with his physician in case it was an anaphylactic type reaction, that way help would be ready if anything happened.  Also, to make sure he was seen immediately if child claimed of additional or worsening symptoms.  When dad and son left, son had no more complaints.
immediate feeling running down left arm to my wrist after injection later that evening fatigue, fever overall not feeling well  .. 1st day , 2nd day fatigue , sore arm , nauseous, sore muscles , fever by evening wiped out , 3rd day fever, fatigue ,sore arm , sore muscles , and now swollen left arm pit Lymph node pretty large I realized this when shaving ,  I can feel pain  down my left side  side above my hip  , and lymph node in my   neck on left side ..4 day same symptoms now a cough sore throat scratchy feel but no fever now ..
Itchy eyes, chills, cold hands and feet, uncontrolled shaking, vomiting, coughing.
104 fever  Shakes  Chills  Ovary pain  Join pain Body aches  Sweating  Headache  Anxiety  Dizziness  Confusion Light headed
No adverse events or side effects. Expired vaccine administered (beyond use date/time of 19.75 hours outside the refrigerator temperature)
This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age and gender. Initially reported as PNEUMOVAX23 (sealed vials) (lot # K007824, expiration: 05-NOV-2015) and GARDASIL via wet SD 120 Y (lot # K005083; expiration: 04-NOV-2016) were improperly exposed to 31 Fahrenheit (F) for 48 hours on an unspecified date, and to several other unspecified dates. Further it was reported that PNEUMOVAX23 (sealed vials) (lot # K007824, expiration: 05-NOV-2015) were exposed to 31F for 600 hours and GARDASIL (lot # K005083, expiration : 04-NOV-2016) were exposed to 31F for 15 days (360 hours). However later it was confirmed that GARDASIL was not administered to anyone. On 12-SEP-2014, intramuscularly, (lot # K007824, expiration: 05-NOV-2015), for unknown indication. Later it was confirmed with the reporter that the PNEUMOVAX23 were improperly exposed to 33F for 96 hours from 04-SEP-2014 to 08-SEP-2014, and to 34F for 48  hours from 09-SEP-2014 to 11-SEP-2014, and to 34F for 72 hours from 12-SEP-2014 to 15-SEP-2014. No adverse effects reported. Outcome of events was unknown. No product quality complaint (PQC) was involved. No further information reported. This is one of several reports received from the same reporter. Additional information has been requested.
Tiredness, soreness in the arm.  After being asleep last night for about 4 hours, woke up with joint aches, right armpit pain, arm pain, tingling in my right hand and shooting pains down my arm into my hand, severe chills, headache.   Took Tylenol.  Chills and pain continued for about 3 hours.   Had the shot on the 25th.  Typing this on the 26th.  Chills are gone, severe pain in right armpit and bad soreness in right arm.  Some water retention in hands.  Light joint pain.
New on-set tonic-clonic seizures upon waking, two occurring within 24 hours of each other.
Injection site tenderness: Started at 2 hours post vaccine, lasted approximately 48 hours Malaise: started at 4 hours post vaccine, lasted approximately 20hours Low-grade fever: started at 12 hours post vaccination, lasted approximately 12 hours  Treated successfully with acetaminophen
Patient came in for second dose of Covid vaccine. Patient was asked if second dose was Moderna. Patient exclaimed yes. He was screened. Patient was given Moderna dose. But later, nurse found out his first dose of Covid vaccine was actually Pfizer.
Around 6 o clock I became very ill. I felt like I was hit by a truck, we were at my grandson's soccer game and then we were all going to go out for pizza and I told my husband I don't feel good, I started getting achey all over and chilled. He stopped at the drug store to get me some medicine. When we got home I threw up. then I started shaking, very violently, it scared me. I took a shower and couldn't even hold the soap I was shaking so bad, I got in bed and started crying, moaning (something I've never done). I cried all night long. I stayed in bed for 2 days. It was the worst experience I've ever had. Nobody in my family has gotten sick so it was not the flu, it was a terrible reaction to the shot. I thought about going to the emergency room, but was honestly to weak. It took me a good 2 weeks to recover from the shot
6 out of 10 got COVID; 6 out of 10 got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm (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. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "6 out of 10 got COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2022) positive.  Comments/Narrative: After receiving booster sat Christmas dinner and 6 out of 10 and 5 children got covid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient reported arm pain, itchy rash and swelling after receiving the vaccine. It has been 3 days and she doesn't have any resolution of symptoms.
pt recv vax & was fine & later became weak & felt ill around noon;pt changed MD recently & had recv 1st shot in MAY96;
Flu-like symptoms, headaches, sore at injection site, pain in lower abdomen, fatigue, UTI symptoms, faint feeling.
Report # 2000026339-1 describes eye swelling in a pt who rec'd Engerix-B. Allergies, medical history, and concomitant medications are not specified. On an unspecified date, the pt received his first dose of Engerix-B. On 8/29/00, he experienced eyelid swilling in one eye, and the eyelid closed shut. As of 8/29/00, the outcome of the event is ongoing.
Rash all over body; appeared suddenly; unsightly and somewhat itchy; topical steroids were prescribed but did not solve the problem; dermatologist said the rash was a vaccine reaction that she had seen in several other patients approximately 10 days after the 2nd COVID shot
Information has been received from a registered nurse referring to two patients of unknown age and gender. On 21-MAY-2015 the 2 patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot #, expiry date, dose and route not reported). No symptoms were reported. No other details were reported. No PQC (Production Quality Complaint) was involved. Additional information has been requested.
pt recvd vax; devel fever,t unk; approx 31jul94 fever lasted 2 days;approx 24 hrs later,devel "small spots,pinkish rash" on face,chest & stomach lasting approx 7 days;seen by FMD; apap given for fever; no oth tx;
Some who got the shot for Shingles they still got it (shingles)/Suspected vaccination failure; They still got it (shingles) but not bad; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patients received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's Comment: This case was reported via interactive digital media. The reporter knows some who got the shot for shingles and they still got the shingles but not bad. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available. This case was one of 3 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR134920:Same reporter/ husband US-GSK-US2022AMR134931:Same reporter/ inavlid case
This spontaneous report as received from a 50 year old female patient who is a physician refers to the patient herself with Ehlers Danlos Syndrome type 3, interstitial lung disease, allergy to sulfa and subcutaneous tissue does not have normal barriers. The patient's medical history included welts developed every time she received a subcutaneous injection. On 17-JUN-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously (lot # not reported). Concomitant therapies included prednisone (manufacturer unknown) 5 mg daily. The patient reported that "within a couple hours" of receiving ZOSTAVAX, on approximately 17-JUN-2013, the developed a red welt. She stated that the red welt "within two days" spread from her shoulder to her elbow. She reported that the reason she developed this welt was not because of the ZOSTAVAX but due to her having Ehlers Danlos Syndrome. She stated that a welt developed "every time" she received a subcutaneous injection because her subcutaneous tissue does not have "normal barriers". The patient emailed her physician for medical attention. She applied ice and took ibuprofen on unspecified days for the event. No lab diagnostics were performed. The outcome of red welt was reported as recovering. Additional information has been requested.
p/DTP/MMR/OPV recvd in AM 15APR92 pt devel urticaria & elevated temp to 103;
1 day post injection of DTaP & MMR (both in right deltoid) redness 10cm, warmth, mild pain with movement all at injection site.
*Tingling left side of face, and lips and tongue 2 pm on 4/12 to present Extreme fatigue, dizziness, buzzing of head, tinnitus,  increase in head ache, stomach pain,  4/13/21 starting at 11 am and worsening throughout the day
Pt complained of extreme pain at the time of the injection and her arm was very sore for a couple of days. She is still experiencing pain in her arm when moving up and down. Pain is relieved by myoflex rub.
Fever accompanied by extreme pain in the left inner ear the day after the vaccine. Fever and pain responded to Tylenol. Tinnitus and mild dizziness developed on the date listed (1/20/23) and has not abated (1.5 months). No treatments offered.
4 hours after receiving it I got dry mouth and mild headache. Next day severe headache, body ache, and severe Short of breathe. Third day was worse same symptoms as the next day had to go to Urgent care because I couldn?t even bend down, walk from my room to the restroom without getting Short of breathe. Got a steroid injection. Missed a whole of work bet it was getting worse. Called my doctor to get seen because on the fifth day both ear pain and my voice was going out. Started Pro-Air Inhaler, Amoxicillin, methyl prednisone pack, and Prednisone. Started getting better by Sunday.  I have never been Short of breathe before
History of Herpes and had a re-occurrence; Redness; Chills; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes virus infection.   On 26th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a day after receiving Shingrix, the patient experienced erythema, chills and herpes virus infection. On an unknown date, the outcome of the erythema and chills were recovered/resolved and the outcome of the herpes virus infection was unknown.   It was unknown if the reporter considered the erythema, chills and herpes virus infection to be related to Shingrix.  Additional details were provided as follows: The patient called with an inquiry but mentioned that that when she received dose of Shingrix, she had redness and chills within the first 24 hours of receiving it.  The patient also stated that she has a history of Herpes and had a re-occurrence within 24 hours as well, noting that she has not had an outbreak in years.  The redness and chills lasted about 24 hours. The reporter consented to follow up.
Couldn't walk or even go to the pool.Mostly rested; Terrible fatigue; Shoulder blader pain; Shortness of breath; Soreness in the arm; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm), GAIT INABILITY (Couldn't walk or even go to the pool.Mostly rested), DYSPNOEA (Shortness of breath), FATIGUE (Terrible fatigue) and ARTHRALGIA (Shoulder blader pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm). On 16-Apr-2021, the patient experienced DYSPNOEA (Shortness of breath) and ARTHRALGIA (Shoulder blader pain). On 18-Apr-2021, the patient experienced GAIT INABILITY (Couldn't walk or even go to the pool.Mostly rested) and FATIGUE (Terrible fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Apr-2021, PAIN IN EXTREMITY (Soreness in the arm) had resolved. On 24-Apr-2021, DYSPNOEA (Shortness of breath) and ARTHRALGIA (Shoulder blader pain) had resolved. On 25-Apr-2021, GAIT INABILITY (Couldn't walk or even go to the pool.Mostly rested) and FATIGUE (Terrible fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication were not reported  Treatment medication were also include cold care medication
shingles; Information has been received regarding a case in litigation concerning the patient of unknown age and gender. In 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported), as prescribed and/or administered by a healthcare provider at Outpatient Clinic located for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by a physician for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has 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 reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Information has been received from a Medical Assistant concerning a female patient who was vaccinated with her 3rd dose of Gardasil and developed redness at the injection site.  Her outcome was unknown.  Additional information has been requested.
patient got COVID-19 during a week or so; pain in the arm; mild headache; low fever of 99 degree F; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), HEADACHE (mild headache), PYREXIA (low fever of 99 degree F) and COVID-19 (patient got COVID-19 during a week or so) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 prophylaxis.     Concurrent medical conditions included Seasonal allergy (season allergies) and Glaucoma. Concomitant products included CALCIUM and PRAVASTATIN for an unknown indication.    On 25-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm), HEADACHE (mild headache) and PYREXIA (low fever of 99 degree F). In August 2022, the patient experienced COVID-19 (patient got COVID-19 during a week or so). The patient was treated with IBUPROFEN for COVID-19, at an unspecified dose and frequency. On 27-Nov-2021, PAIN IN EXTREMITY (pain in the arm), HEADACHE (mild headache) and PYREXIA (low fever of 99 degree F) had resolved. In September 2022, COVID-19 (patient got COVID-19 during a week or so) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: low fever of 99 degree F. In August 2022, SARS-CoV-2 test: (Positive) Positive.         Patient did not have any medical history relating to mentioned AE and both Acute and had no chronic illnesses at the time of vaccination. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. Concomitant medication included Medications for allergies, eye drops for glaucoma.  Patient called doctor. Patient did not experienced a similar event in the past.   This case was linked to MOD-2022-654642 (Patient Link).
This is a spontaneous report from a contactable Physician. This Physician reported for a 80-year-old female patient that: A 80-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: EN0203), via intramuscular route, administered right arm as dose 2, single on 02Mar2021 11:00 (at the age of 80-year-old) for covid-19 immunisation at hospital. Medical history included hypertension from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medication included amlodipine besilate (NORVASC) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: E18982), via intramuscular route, administered right arm as dose 1, single on 09Feb2021 11:00 (at the age of 80-year-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medications within 2 weeks of vaccination was Norvasc. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination. ON 16Mar2021, the patient has had a persistent diffuse body rash that was very pruritic. It began as urticarial rash then those resolved but she had small nodules under her skin and then a popular diffuse rash appeared and was persisted. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 15Jun2021. Therapeutic measures were taken as a result of adverse events with steroids after 4 weeks of persistent rash and now antihistamines. Adverse event resulted in doctor or other healthcare professional office/clinic visit. At the time of this report, the outcome of event urticarial rash was recovered on unspecified date in 2021; the outcome of all other events was not recovered.   Follow-up attempts are completed. No further information is expected.
Information has been received from a health professional concerning a 4 year old female who on 19 FEB 1997 was vaccinated with varicella virus vaccine live. On 23 NOV 2000 the patient experienced breakthrough varicella that lasted 3 days. Subsequently, the patient recovered. Additional information has been requested.
Rash/hives over most of body, particularly torso after dose 1.  Treatment with methyl prednisone; hydroxyzine;  Increased rash/hives following dose 2 plus swelling of cheeks/face.  Rx written today (Feb 18) for additional steroids and hydroxyzine following telemedicine visit with primary care provider
Itchy rash to elbow and under arm. Red spots, warm, took BENADRYL on night of 1/20 and it helped itch. Rash getting worse every day since administration.
Insidious onset of redness and swelling of the middle and distal phalanges of the 3rd, 4th and 5th fingers of the right hand with progression to swollen fingers with painful finger tips during week 2 of ADR.  Initial erythema began about one week after the first dose of Pfizer COVID-19 vaccine. Also redness and swelling of the distal phalanges of the 1st, 2nd and 3rd toes of the left foot with similar onset. Also headache and sore left arm for 2 days after vaccination.  Association of "COVID Fingers and Toes" with vaccination was noted about 3 weeks after the 1st dose. Fingers were treated with topical corticosteroid and intense erythema coalesced around the nail beds of 3rd & 4th fingers of the right hand. Also..noted "brain fog" with poor attention and loss of context during weeks 2 and 3 of reaction. Cutaneous manifestations are ongoing.
Patient called to report chills, feeling cold with 100.2 temperature, and numbness/tingling in her hands. Advised patient to contact her primary care provider due to numbness/tingling. Patient does not yet have an established provider, she stated she will visit urgent care if symptoms worsen.