chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experienced fatigue afternoon of shot, then chills, mild fever and severe migraine.  Fatigue, migraine, fever and chills resolved the following day.  Rash appeared on back of body, extreme itching and pain every 1-3 hours were unbearable.  Severe pain and itching reduced one week after shot.  Treated with Steroid cream, Dr confirmed rash reaction was unexplained other than vaccine.
Initial misuse report received from a healthcare professional on 21 February 2013. A dose of ActHIB was reconstituted with Merck diluent and administered to a patient. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
NAUSEA; VOMITING; weak; tired, fatigue; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from a company (manufacturer control number: EC-2020-085712), for BNT162B2.   A non-pregnant female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunization. Co-suspect drug included oral Lenvima 8mg daily from 21Jan2021 for liver cell carcinoma. The patient's medical history and concomitant medications were not reported. On an unspecified date, 2 weeks after COVID-19 vaccination, the patient experienced nausea, vomiting and fatigue. On 21Jan2021, she was feeling weak and tired and did not want to get up from bed. Patient missed 2 doses of Lenvima due to side effects and planned to see primary care physician. The clinical outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
After vaccination, client stated that she felt faint . Syncopal episode ensued  for 10 seconds with muscle tension in arms  per mother's report . MD on site  assessed client and ALS / EMS activated at 11:05. Chief informed and patient transferred to hospital at 11:18.
1st dose Pfizer 6/3/21; 2nd dose Pfizer 6/24/21; 9/24/21 telogen effluvium with diffuse shedding - duration of telogen effluvium 3mo; scalp radiating heat/hot & on-fire feeling/tingling/inflammation, RX Closbetasol Prop 0.05% Sol 50ML - ; duration of scalp inflammation 5mo. RX Spironolactone for alopecia post 1st & 2nd dose Pfizer.    Pfizer Booster 1/27/22; 4/2022 telogen effluvium with diffuse shedding - duration of telogen effluvium 3mo; Scalp radiating heat/hot & on-fire feeling/tingling/inflammation, RX Closbetasol Prop 0.05% Sol 50ML; duration of scalp inflammation 5mo
Woke up the following morning after receiving the shot with a headache that increased during the day.  Taking Tylenol 500mg but barely relieves the pain.  Took 100mg and headache still increased.
After 15 min of sitting was walking back to work and heart started to race and become short of breathe and dizzy. 10/15/2021 urine became tea like. 10/16/2021 went to ED because heart rate became very high, began to become sweaty, numbness in legs and hand and face with a tingling sensation. 10/26/2021 episode happened again went to ED.  Slight chest pain and sharpness continue even occurs in the back directly behind heart.
Resident was on Macrobid for UTI, received 2nd dose of Pfizer, presents with blotchy red rash on body, no respiratory symptoms noted, no pain, no itching or irritation. Patient is stable
IMMUNODEFICIENCY; INJECTION SITE BRUISING; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient via AbbVie concerned an elderly female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (dose 1) (dose number in series: 1) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total administered on 15-MAR-2021 for prophylactic vaccination. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (dose 2) (dose number in series: 1) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination which was an off label use for inappropriate schedule of vaccine administered (dose number in series: 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported, expiry: unknown) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On an unspecified date, the patient experienced immunodeficiency, and injection site bruising (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from injection site bruising, and the outcome of immunodeficiency, off label use and inappropriate schedule of vaccine administered was not reported. The reporter causality between covid-19 vaccine ad26.cov2.s and injection site bruising was not related.  On 15-DEC-2021, the patient received booster dose of covid-19 vaccine ad26.cov2.s (dose 3) (dose number in series: 2) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination. No adverse events were reported following covid-19 vaccine ad26.cov2.s (dose number in series: 2). This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220401843-Covid-19 vaccine ad26.CoV-2.s- -Immunodeficiency. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS(adalimumab). Therefore, this event(s) is considered not related.
LOSS OF SMELL; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported.  The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced loss of smell. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive diagnosis of Covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of loss of smell was not reported. This report was non-serious.
Information was received from a pharmacist concerning a patient of unknown age and gender. On 28-NOV-2014, the patient was vaccinated with ZOSTAVAX, subcutaneously. On 28-NOV-2014, while administering the vaccine, the pharmacist noticed that the syringe leaked, resulting in an unknown dosage amount. No adverse experience reported. No further information provided. Additional information has been requested.
the patient jumped, the needle came out of her arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 59K92, expiry date 26-MAR-2025) for prophylaxis.   On 13-NOV-2023, the patient received Arexvy. On 13-NOV-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: the patient jumped, the needle came out of her arm). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date:13-NOV-2023 The pharmacist reported Arexvy vaccine was given and during administration, the patient jumped and the needle came out of her arm. Some of the vaccine squirted out of the needle and into the pharmacist's right eye, which led to incomplete dose administered. The reporter consented to follow up. The pharmacist could not provide the patients initials or date of birth. Adverse event filed separately for the pharmacist. This case had been linked with US2023157050, reported by the same reporter.; Sender's Comments:  US-GSK-US2023157050:Pharmacist case, same reporter
Pt was admitted on 2/6 for chest pain and was a direct admit from an outlying facility.  She was tested for COVID on admission and was negative.  She was re-tested on 2/10 pre-operatively and found to be positive.
Information has been received from a registered nurse concerning a 22 week old male pt with asthma, gastroesophageal reflux disease and no known drug allergies and a history of prematurity at 15 weeks who was exposed to his vaccinated sister (WAES0201USA00366) who developed chicken pox on 01/04/2002. This pt had not been vaccinated with varicella vaccine virus live. The pt was taking Zantac and Xopenex. On 01/19/2002, the pt developed a secondary transmission when he broke out in chickenpox lesions and a low-grade fever. On 01/21/2002, the pt was seen in the office with lesions on his face and torso and was afebrile at the time. He was treated with Tylenol and Aveeno baths prn. It was reportedthat the pt was breast-feeding and his mother had a positive history for varicella. On 01/23/2002 it was reported that the pt was covered with varicella lesions, he has them in his eyes and on his head. A swab specimen was obtained from a vesicular lesion and sent for PCR analysis. On 02/01/2002, the PCR results were received and it was reported that the specimen was positive for wild type VZV. On 02/06/2002, the registered nurse reported that the pt was treated with Benadryl and Aveeno baths and was recovering (he just had dried lesions). Additional info has been requested.
Runny nose Body aches Unable to get out of bed Trouble breathing Swollen mouth I broke out in hives
When I woke on top of my right hand I had little bumps that felt like fire and continued to creep up my arm. It became hot and itchy and by noon it had crossed my chest and neck. Was advised by my PCP to put on some Benadryl cream for the issue and called it Urticaria which is another name for hives. After about 24hrs it was gone and has never returned.
3/5/04 was given outdated Hep B expired 1/11/04.
Information has been received from a registered nurse (R.N.) and a mother of a student concerning another child in elementary school who was vaccinated with a dose of Varivax. It was reported that the patient now has breakthrough chickenpox after an outbreak occurred in the elementary school. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information from a health professional indicated that the index case was an unimmunized individual. This is a consolidation of two reports concerning the same patient. Additional information is not expected.
symptoms started during the night while sleeping after the day of the immunization: extreme achiness, lethargy, headache, cough. treatment started at 0900 the morning after immunization: tylenol and ibuprofen
got J&J vaccine yesterday around 0800. c/o nausea, chills, headache and bodyache per pt. Denies blurry vision or dizziness. Eating and drinking normally per pt. Last dose of Tylenol was 0800.
pt had vax 18FEB on 20FEB was fussy, wasn't sleeping lt leg had redness & hardness size of dime; no warmth; seen PA on 22FEB still fussy some bruising of area; Augmentin ordered x 5 days;
fever/fever 102 Extreme exhaustion; hand, arm, leg pain; fever/fever 102 Extreme exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Mar2021 11:00 (Lot number: EP7534) at the age of 72 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SIMVASTATIN; LISINOPRIL. Vaccination history included: Bnt162b2 (Dose Number: 1 , Batch/Lot No: EN6203 , Location of injection: Arm Left , Vaccine Administration Time: 11:00 AM, Route of administration: Intramuscular), administration date: 28Feb2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), FATIGUE (non-serious) all with onset 08Oct2021, outcome "recovered" (Oct2021) and all described as "fever/fever 102 Extreme exhaustion"; PAIN IN EXTREMITY (non-serious) with onset 08Oct2021, outcome "recovered" (Oct2021), described as "hand, arm, leg pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19. No specific relevant test for thromboembolic events with thrombocytopenia. The case assessed as non-serious by the reporter.  No follow-up attempts are possible. No further information is expected.
Pounding, very rapid heart beat; On 10-10-11, while hiking, experienced slight weakness in right arm, and slurred speech to left side of mouth and slight drooling, mouth was pulled to the left side. At hospital, heart showed Atrial Fibrillation which righted itself while in the emergency room. Patient previously healthy, tests showed nothing significant. Symptoms went away within 1/2 hour after onset previous to emergency room visit.
Information has been received from a registered nurse concerning a 14 year old male who on 30-Jan-1996, was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (lot# unspecified). A booster dose of varicella virus vaccine live (Oka/Merck) was administered on 22-May-2007 (lot# 656692/04572U). There was no concomitant medication. The nurse reported that the patient experienced bump on the upper right arm which was diagnosed as cellulitis after booster dose. Injection site warm, red, tender, no pus and inflamed. After having used cold compresses and Motrin to relieve the symptoms, the patient was ordered on Keflex. The patient's status was reported as unspecified. No product quality complaint was involved.
Breakthrough case admission after 3 vaccines Moderna 2/11/21 lot# 015M20A;  Moderna 3/11/21 lot# 044A21A;  Moderna 11/3/21 lot# 033F21A
it was observed in rigid physical state;pupils were dilated & fixed;it was unresponsive to verbal stimuli approx 60 sec;pt was positioned is a supine position, called & physical stimuli introduced;
ON 12/24/20 AT 2PM, DEVELOPED SORE ARM, LASTING UNTIL 12/25/20 AND A HEADACHE THAT LASTED UNTIL 12/26/20.
Broke out with a terrible case of chickenpox. All children in family was given the Varivax on the same day and all ended up with chicken pox.
lost my sense of smell and taste for about 11 months; lost my sense of smell and taste for about 11 months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANOSMIA (non-serious), AGEUSIA (non-serious), outcome "unknown" and all described as "lost my sense of smell and taste for about 11 months". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received 2 Pfizer vaccines for Covid 19 + 2 Booster shots. I have lost my sense of smell and taste for about 11 months. Was this a side effect of the vaccine? I have never tested positive for Covid 19. I have been tested 8 times in the past 2 years.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
pt had several sz w/in 18hr of vax;had multiple sz p/first larger one;
Pt recvd vax 1NOV92 & on 8NOV92 exp arthritic sx; No further details were provided;
Information has been received from a physician concerning a 71 year old female patient with seizures, hypothyroidism, allergies, arthritis and no drug reactions/allergies and a history of shingles in the past with severe post herpetic neuralgia (PNH) who in approximately July 2010 (reported as "about 7 days ago"), was vaccinated with a dose of ZOSTAVAX (Merck) at a local senior center. Concomitant therapy included SYNTHROID, NASONEX, montelukast sodium, KEPPRA and ALLEGRA. On 06-JUL-2010, the patient presented to the office with a "shingle like" rash at the 11-2 region of the left trunk. The patient also stated that she had "erthymea" at the injection site of the left arm for about 48 hours following the vaccination. No laboratory diagnostic study was performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Pt. presented to the ER with a temperature of 102.5 (rectal).
Moderna booster vaccine administered 11/5/2021 with an expiration date of 10/11/2021. Inquiry submitted to Moderna requesting validation of vaccine potency. A response from Moderna is expected between 8-10 business days. Expiration date currently not printed on the vaccine vial or carton. Vaccine expiration date listed in the database lookup tool is 12/31/2069. Patient contacted on 12/4/2021. No adverse effects reported.
Incomplete protection from varicella, with varivax min. symptoms. No fever. Approx. 30 pox. ((+) outbreak at school).
Clinician reconstituted with 0.8 instead of 1.8 cc saline
Went home felt fine, took a nap, woke up with significant hearing loss in one ear, about 18 hours after injection loss is near total, loud metallic sounding echo when people talk.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On 16-JAN-2017, the patient was vaccinated with an improperly stored dose of (incorrect product storage) M-M-R II (lot # M008588 with an expiration date in 16-FEB-2018) for prophylaxis (dose, dose number and frequency were not provided). The dose was stored at a temperature > 46 degrees Fahrenheit but < 77 degrees Fahrenheit with a time frame of 7 hours. No adverse effects were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
very red and swollen arm; itchy in her body; Red arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced swelling arm (Verbatim: very red and swollen arm), generalized pruritus (Verbatim: itchy in her body) and erythema of extremities (Verbatim: Red arm). The outcome of the swelling arm, generalized pruritus and erythema of extremities were unknown.   It was unknown if the reporter considered the swelling arm, generalized pruritus and erythema of extremities to be related to Shingrix.  It was unknown if the company considered the swelling arm, generalized pruritus and erythema of extremities to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-NOV-2023 The reporter stated that a person she did not know well, told her she received Shingrix dose a couple of months ago and had a horrible reaction, itchy in her body and a very red and swollen arm.  No other information was provided. The reporter consented to follow up.
Recived vaccine on Saturday, February 27, 2021, at 4:15 PM.  No adverse events at that time.  On Thursday, March 4, 2021, at 9:00 PM, I noticed on both inner arms a red, raised rash.  It was burning, painful and itching.  Can not touch or wear long sleeves. Notified PCP but office has not responded yet.
Pt at vaccine clinic for 2nd dose covid vaccine with a history of anaphylactic reaction to immunotherapy. Pt presented with rash/itching on chest, tingling around ears and runny nose 20 minutes after vaccine administered.(0828) Doctor notified and Benadryl 25mg PO given VS at time 169/98, 60, 100%. 0847 pt c/o slight chest tightness, slight labored breathing, feeling of periorbital swelling,VS at time 173/91, 51, 99% Doctor again notified and an RN stat called, pt taken to the ER and report given to ER RN, pt appeared to be comfortable and feeling somewhat better
Upon administration I noted "I don't remember ever receiving a vaccine that high or that far back" and "that almost felt like it was given directly into my shoulder joint"  Within the first three days, I couldn't lift my arm or engage my shoulder in any capacity, and it was in excruciating pain-- although my deltoid mule (where the shot should have been administered) was fine.  I was seen on April 15 by my PCP and an injury was confirmed.  I was sent for an ultrasound to rule out clotting (J&J had been halted nationally days before).  I was then referred to orthopedics.  I have been under the care of a care taker since April. In her care I have been given prednisone, cortisone injection, multiple ultrasound guided steroid injections.  I have had XRAY, ultrasound, MRI, EMG.   I have also been in physical therapy for the duration of my treatment with care taker and Orthopedics.
Syncope occurred in parking lot of health clinic approximately 5-10  minutes post vaccination with Tdap. She had previously received 5 total doses of DTAP between 2007 and 2011.
Headache, nausea, fatigue, difficulty with balance, difficulty with concentration, loss of appetite. Time - whole week.
Blisters on top and bottom lip, spread in the right side if the fave to the eye. Also clustered blisters near the eye causing the eye to swell in a puffy way
The patient reported pain extending from her elbow to her shoulder that presented a few hours following the injection. She stated she had some difficulty lifting her arm. She stated it hurt more than previous IM injections, including the first shot in the SHINGRIX series. She tried an OTC pain reliever with little success. I counseled her to also use a hot pack. This is currently the same day as the vaccination so outcomes are yet to be determined.
Swelling around injection site. Seen at after hour treatment center and diagnosed with cellulitis. Seen in office 11-5-12, appears to be local reaction to vaccine and is resolved today.
Developed a generalized rash on arms and back initially felt to be urticarial but then developed a vesicles on trunk and arms. Looked just like chicken pox as 5/3/12.
Initially mildly itchy on left arm and neck. Noticed red blotchy rash end of the following day. Worst bright red and itchy end of the second day after the vaccine. Took antihistamine. Nearly resolved by the end of the third day
Infant developed an acute respiratory life threatening event within 1 hour of vaccine administration. Infant taken to ER and transferred here for further work up at parent's request.
Got MMR-Varicella & Hep A, for first time,. Woke up Wed. AM with the rash all over. Mom gave him Benadryl 3 ml, it helped a little. No facial swelling or prob. breathing