chrisvoncsefalvay/vaers-outcomes huggingface dataset:
only half of the volume  administered; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number kk3jm, expiry date 25th September 2023) for prophylaxis.   On 20th October 2022, the patient received the 1st dose of Shingrix. On 20th October 2022, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment: This case was reported by pharmacist. Pharmacist reported that when administering the first dose of Shingrix to a patient, the needle leaked and only half of the volume was administered. Pharmacist does not think it was a product quality issue. The Vaccine Administration Facility is the same as Primary Reporter. Reporter consented to follow up. Additional supportive information: As patient received only partial dose of vaccine due to syringe leaked which led to accidental under dose.
Patient was being given the following vaccines hep a hep b typhoid when giving the vaccines hep a and typhoid the patient was given bandages then the hn was going to give the hep b in the other arm and he fell to the floor hn got help and then returned to the patient and he was awake hn help him to a chair and he went to lay in the back were he was deemed ok by the doc.
Lightheaded, dizziness, jittery, nausea within 5 minutes of vaccination lasting several hours.
Had a really bad night terror; Night terror was a bad night terror that lasted for about 20 minutes to half hour; It was really bad episode of night terror, severe night terror; Fever; Arm was sore; Armpit was sore; Tired; This is a spontaneous report from a contactable consumer (patient mother) reported for a 13-year-old male patient (reporter son). A 13-years-old male patient received BNT162B2 (PFIZER COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0182) via an unspecified route of administration, administered in arm left on an unspecified date at an unknown, single dose for COVID-19 immunization. The patient medical history was not reported. It was reported that NDC number, UPC number and Expiry Date (Reporter stated, They did not write the expiration date) of COVID-19 Vaccine were unknown. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), multivitamins (VITAMINS NOS). Reporter stated, She was just calling because his 13-year-old son got the Pfizer vaccination on Friday at 2:00 pm and she spoke to his pediatrician about it like about 10-20 minutes ago and he told me to contact to you guys because patient experienced had a really bad night terror from it with a fever obviously, his armpit was sore; arm was sore but the night terror was a bad night terror that lasted for about 20 minutes to half hour severe night terror and he was tired, those were the reactions to it on an unspecified date. The patient received tylenol as a treatment medication to the events. The outcome of the events was unknown.  Follow-up attempts needed. Further information is expected.
Hives, chills, headache. OTC Benadryl and ibuprofen.
SWELLING OF THE LEFT ELBOW; SOFT KNOT IN LEFT ELBOW; This spontaneous report received from a patient concerned an 81 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced swelling of the left elbow. On MAY-2021, the subject experienced soft knot in left elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling of the left elbow and soft knot in left elbow was not reported. This report was non-serious.
Woke up morning after vaccination went to use bathroom and start usual routine.  Suddenly felt very hot, flush, and sweaty (while sitting bathroom). Decided to go lay down in bed again. Passed out walking back to bed. Recovered within a few minutes, but with headache persisting throughout day. Day 2 post, woke up with fullness in left ear (same side as shot) and mild tinnitus.  Headache was still present but alleviated with analgesic.
after vaccine about 10 min into waiting period patient began to C/O  L chest pain. Patient rating pain @ 1-2. " intermittent stabbing". Vitals  11:10  120/ 70, A-72, 18, 99% lungs clear, HR regular                11:15  120/70,  A. - 70, 18, 98%  No change in condition                11:20   110/70,  A- 70  HR regular. Pain has subsided. Patient states he eat breakfast that consist of 2- BBQ chicken wings and cold cereal.                11:30  120/70,  A-70, 18, 99% Patient resting quietly.                11:40 Patient ambulating hallway wo chest pains. Patient reports feeling normal. patient left with work friend.  patient has been instructed to seek medical attention if chest pains return. patient states understanding.
Around four hours after getting the shot I became very lightheaded and had to sit for a long period of time. My left arm (where i go the injection) became stiff and my elbow, wrist, and finger joints were all on fire. I then got the chills and stated vomiting non stop until about 3 am.  At 12 pm I noticed red circles about 2 inches in diameter beginning to appear around my injection site.  I then called the pharmacy that gave me the injection to ask questions. I ended up going back to the clinic at 4 pm the next day. I had one of the staff look at my arm and talked  him through my symptoms. He said it was more than likely my body reacted very strongly to the vaccine.
On the late morning of Monday December 5th I began to have some facial dropping, lip twitching and check felt numb like it had Novocain. The next day, Dec 6th, since the paralysis was getting worse in my face I went to the hospital out patient office to get it checked and they sent me to the hospital emergency room. After speaking with the ER Doctor he said it was very likely  Bell's palsy and prescribed some steroids to help with the condition.
Pt. complains of soreness and pain in her shoulder and elbow joints. Contacted PCP.
head ache 3-4 hours day of vaccination, lips tingly 3-4 hours day of vaccination, shortness of breath 2-3 hours (2 different times) next day after vaccination, increased vertigo symptoms since vaccination & still remains, but other symptoms are improved.  Note:  just wondering if interaction of the steroid injections every two weeks with the covid vaccination????  (in answer to be if recovered...all except the increase of vertigo)
urinary tract infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 84 year-old female patient received bnt162b2 (COMIRNATY), administration date 02Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "urinary tract infection".  Additional information: The patient stated that on 02Dec2021 she received her first Pfizer Covid Vaccine and she has been trying to get her second one but just keeps getting the run around. She says at her first appointment she scheduled the second appointment but then she was diagnosed with a urinary tract infection so she had to cancel. The patient says she was able to reschedule that appointment but then her son-in-law came home and had Covid. She stated she lives with her daughter and son-in-law so she had to quarantine for 20 days and therefore had to cancel that appointment as well.   The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were not reported. On 06-JUL-2017, the patient was vaccinated with first dose of VAQTA (lot# N005274 and expiration date 03-APR-2018) (anatomical location, route and dosage details were not reported). On 04-OCT-2017, the patient was vaccinated with another dose of VAQTA (lot# N017094 and expiration date 31-AUG-2018). No adverse effects were reported. No product quality complaint was reported. Follow-up information was received from registered nurse on 08-MAY-2018. The registered nurse was unsure what patient was being reported on in this report. It was reported that the registered nurse was hopeful that the original reporter the physician may know which patient was reported on. The registered nurse has no further information to share. Follow-up information was received from physician on 08-OCT-2018. It was confirmed that the age of the patient was currently 2 and half year old and gender was female. On 06-JUL-2017, the patient was vaccinated with first dose of VAQTA (lot# N005274 and expiration date 03-APR-2018) for prophylaxis (anatomical location, route and dosage details were not reported). The nurse in error ordered the second dose too early and at the age of 18 months, on 04-OCT-2017, the patient was vaccinated with the second dose of VAQTA. On the same day, the patient was vaccinated with third dose of influenza vaccine, lot # UT595TNA intramuscularly in left thigh. The patient had no illness at time of vaccination. The patient had no pre-existing physician-diagnosed allergies, birth defects and medical conditions. The patient did not experience any side effects. There was no temperature excursion occurred as a result of a reading from a Digital Data Logger. This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid, as the patient identifiers were provided.
Started with shot site pain on first day, then second day had fever (100.5), extremely painful headache, body aches, nausea. Couldn't eat or drink liquids. Third day fever and most body aches gone, but headache and nausea persisted, which prevented me from eating and drinking liquids.
Wheezing, rapid irregular HR, 911 called, paramedics arrived, mom present. Child evaluated by paramedics; observed for > 1 hour.; became stable; sent home in care of mother.
I believe there were doses given after being in the refrigerator for the 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I believe there were doses given after being in the refrigerator for the 30 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (I believe there were doses given after being in the refrigerator for the 30 days). On 24-Jun-2021, EXPIRED PRODUCT ADMINISTERED (I believe there were doses given after being in the refrigerator for the 30 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   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.
Patient received a dose of Pfizer COVID-19Vaccine formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial  was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL ,  0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.
Vaccine was injected on the back/at the back of the arm (near crease of the armpit & back). A large rash formed near the injection site (back of right arm) within 12 hours. Rash is red in color, itchy, and warm to the touch. I has been 8 days and remains. Throat irritation occurred within 24 hours and subsided.
Narrative: 08/17/2021 ADDENDUM STATUS: COMPLETED Adverse reaction report per RN: Mild reaction, submitted-Sudden migraine , (Patient reports h/o migraines) - sharp smell *reports h/o affinity to smell, can smell others getting sick, smells from far away -bitter taste in mouth-facial flush/warmth declined PO Rx
Within 24 hours of vax on 12/8/00, the pt became fussy. Two days post vax on 12/9/00 she developed moderate redness and swelling at the Infanrix site. She was treated with ibuprofen (Motrin) and recovered. The reporter considered the fussiness, injection site redness, and injection site swelling to be related to Infanrix administration.
Per patient she has a very red and painful arm.  Like a band around the arm several inches wide.
Left side of my face is numb/hot, neck sore, hot flashes, shortness of breath when walking
Shortness of breath; Petechiae on top of both hands, more prominently on Left hand; Tiredness; This is a spontaneous report from a contactable nurse. A 35-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6200) via an unspecified route of administration in the right arm on 11Mar2021 at 12:15 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension (HTN) since an unknown date. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included finasteride (MANUFACTURER UNKNOWN) and isotretinoin (MANUFACTURER UNKNOWN), both for unknown indications received on unknown dates. On 11Mar2021 at 13:30, the patient experienced petechiae on top of both hands, more prominently on left hand, tiredness and shortness of breath. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of petechiae, tiredness and shortness of breath were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Father called and stated he took pt to ER because left arm was swollen, red and a big bruise on it. When pt was in ER, doctor told him to use ice packs and Benadryl and call Health Dept to report allergic reaction.
Elevated Heart Rate; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Elevated Heart Rate) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Elevated Heart Rate). At the time of the report, HEART RATE INCREASED (Elevated Heart Rate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
second dose was improperly stored and administered; second dose was improperly stored and administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (second dose was improperly stored and administered) and EXPIRED PRODUCT ADMINISTERED (second dose was improperly stored and administered) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A Í¾ 20Sep2021) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PRODUCT STORAGE ERROR (second dose was improperly stored and administered) and EXPIRED PRODUCT ADMINISTERED (second dose was improperly stored and administered). On 12-Mar-2021, PRODUCT STORAGE ERROR (second dose was improperly stored and administered) and EXPIRED PRODUCT ADMINISTERED (second dose was improperly stored and administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided.
Extreme swelling and pain from elbow to upper arm within 4 hours.  Acute for 3 days, then arthritic symptoms all joints, muscles 3 months.  Diagnosis in emergency room as bacterial then revised as allergic reaction, viral.  Extreme fatigue, then constant low fever, ear and throat infections.* NB: below not until October 2006.
devel body rash, itching-rash was raised, sl pink in places resembled hives-got worse as morning progressed;sent to MD w/dad;came into school 27OCt office 930AM c/o itchy rash;
Child was given the CYW liquid vial of vaccine which had not been mixed with the A part of the vaccine. No reactions from child. GSK and CDC notified. Advised child does not need to be vaccinated with A unless traveling abroad. Family notified.
Drowsiness; Joint pain in left thigh; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the right arm on 18May2021 at 16:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any medication within two weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 27Apr2021 at 16:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19May2021 at 05:00, the patient experienced joint pain in left thigh, drowsiness. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events joint pain in left thigh, drowsiness was not recovered.  No follow-up attempts are needed. No further information is expected.
Patient didn't report any pain during vaccination. The next day, the patient had to have Gabapentin, Valacyclovir and a MEDROL DOSEPAK filled. The wife reported that the patient said he didn't feel very good yesterday evening. They didn't go to the doctor until the next day, when they said they saw a rash developing. The only thing different he said he did was get the SHINGRIX shot. The wife, having received the same vaccination on the same day didn't report any side effects.
Pt had single episode of syncope resulting in falling on rear of head. Pt denied SOB, pt exhibited redness (minor) to upper chest collar/long board/O2/25mg BENADRYL.
PREVNAR 13, Hepatitis A, PROQUAD, and ACTHIB were ordered by provider. No PROQUAD was given. ACTHIB was given twice accidently. Dr. informed. Patient's mother informed. No known adverse reactions. Error occurred at Medical Clinic. Age of patient at time of event: 1 years.
Local reaction, redness of ~6 cm in diameter with firm center. Slightly raised. Itching present. The symptoms improved after 5 days.
Flush and dizziness ,Increased heart rate and elevated BP 8 mins after the shot. Evening of the shot 12/18/20,patient c/o blurry vision and joint pains.
Left arm erythema and mild induration 9cm by 5cm. No secretion in side of injection. Varivax
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 15Oct2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that patient received treatment of Paxlovid for COVID-19 from 21Jul2022 to 25JUL2022.   The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Red welt developed. 4.5 cm by 6 cm, No treatment administered.
1st dose 17Dec2020, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 17th December 2020 on an unknown arm).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comments: The patient stated that she got her first Shingrix vaccine 17th December 2020.  She had not gotten her second vaccine yet but plans on it. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 18-MAR-2014, the patient was vaccinated with expired dose of ZOSTAVAX (lot # reported as H0199996, dose not reported). No adverse events were reported. Patient's outcome was not reported. No PQC (Product Quality Complaint) was involved. Additional information has been requested.