chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states that arm was very sore the evening of receiving the vaccine. The next afternoon (7/19) the patient noticed it was warm to the touch, very tender, and red, she took an antihistamine and ibuprofen. The site of swelling was near the elbow on the same arm where the vaccination was given. She came by the pharmacy on Friday (7/20) to show the pharmacist the rash. The pharmacist recommended she seek medical treatment. The patient was seen on the evening 7/20 at an urgent care. The doctor at the urgent care was unsure if the reaction was caused by a vaccine or by a but bite that was near the patients elbow. She was treated with oral steroids and antibiotics. She will be reevaluated 7/23.
3 days of arm pain, swelling, fever, chills, fatigue, head ache on the 4thd day I developed a rash. I was so sick I was going to call the ambulance but I was scared.
22 year old was given a pediatric dose; 22 year old was given a pediatric dose; given an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 22-year-old female patient who received HBV (Engerix B pediatric) (batch number LM992, expiry date 13th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th February 2023, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 20th February 2023, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced adult use of a child product, underdose and expired vaccine used. On an unknown date, the outcome of the adult use of a child product, underdose and expired vaccine used were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2023031106   Additional Information: GSK Receipt Date: 24-FEB-2023 Reporter's Comments: The information for the adverse event was collected and reporter accepted to be escalated. The vaccine administration facility was the same as primary reporter reported. The reporter consented to follow up. Additional Supportive Information: The pharmacist reported that the patient inadvertently received a pediatric dose of Engerix-B that had also expired, which lead to underdose, adult use of a child product and expired vaccine used. This case was found as duplicate of case US2023031106. All the information from the case US2023031106 was merged into this case. The case US2023031106 was deleted and this case stand as case of record for this patient; Sender's Comments:  US-GSK-US2023031106:same reporter - FU1 - deleted
patient was administered Pentacel from two different lot, pentacel vials were placed in dispensing machine incorrectly and lots were not put together with no reported adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient where patient was administered diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] from two different lot, pentacel vials were placed in dispensing machine incorrectly and lots were not put together with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (wrong technique in product usage process). Information on the batch number was requested.  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
5-10 minutes after injection, patient was not feeling well. Her head dropped and fist clenched and she started shaking for 2-3 minutes. 911 was called and patient taken to local ER for treatment. She was also referred to Neuro.
Vaccine administered 9.29.22 approximately 9:45am Experienced tiredness and chills @ 6:30pm Side effects worsen and begin to lose mobility @ 9:00pm Side effects continue to worsen: vomiting, fever, complete loss of mobility @ 11:30pm Call to 911 - ambulance and EMT -transported to Emergency room
Chills, low grade fever, body ache, entire body, shooting pains in toes and fingers. Lethargic, over decline in health.
Had lymph adenopathy; This case was reported by a other health professional and described the occurrence of lymphadenopathy 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, unknown after receiving Shingrix, the patient experienced lymphadenopathy. On an unknown date, the outcome of the lymphadenopathy was unknown.   It was unknown if the reporter considered the lymphadenopathy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced lymphadenopathy after 1st injection. The patient requested full ingredient list, as she was planning on getting Pfizer COVID 19 vaccine and wanted to avoid a similar experience. No further details was provided. The reporter consented to follow-up.
Headache, vomiting, felt to be "migraine" but developed meningitis 370 mononuclear WBCs in CSF, pressure > 55 cm H2O, all viral, fungal and bacterial studies are normal.
No additional AE reported; patient was administered improper stored dose of varivax and MMRII; This spontaneous report has been received from a registered nurse concerning 5-years-old male patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions and allergies were not provided.   On 15-SEP-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R-II), albumin status of rHA (recombinant human albumin), for prophylaxis, subcutaneously, in the right thigh, lot number T012419 is an invalid (lot number for measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R-II)) (dosage and frequency were not provided). Additionally, on 15-SEP-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX), for prophylaxis, subcutaneously, in the left arm, (lot number T003706 had been verified to be a valid number; expiration date 30-JAN-2022), and upon internal validation established as the same date (dosage and frequency were not provided).  However the administered doses of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II), and varicella virus vaccine live (Oka/Merck) (VARIVAX) were stored at an unspecified temperature, during an unspecified time frame (product storage error). There was a previous temperature excursion on 25-OCT-2020. No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA002212:
I received the second Pfizer covid 19 vaccination on Feb 23.  A week later I came down with tinnitus
was given their first dose / subcutaneously; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 57ex2, expiry date 26th March 2022) for prophylaxis.   On 24th January 2022, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On 24th January 2022, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The reporter was the patient's health care professional. The medical assistant stated that the patient was given a dose of Shingrix in left arm subcutaneously, which led to intramuscular formulation administered by other route. The reporter's call was transferred to medical informer for information on how to proceed. The reporter considered the wrong route of administration to be related to Shingrix The reporter did not consent to follow-up.
Intense and severe arm, elbow, shoulder and neck pain; Intense and severe arm, elbow, shoulder and neck pain; Intense and severe arm, elbow, shoulder and neck pain; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: not reported), dose 1 via an unspecified route of administration, administered in right arm on 19Feb2021 15:30 (at age of 38-year-old) as dose 1, single for covid-19 immunization at clinic. Medical history included tooth infection (treated with antibiotics), rash (treated with antibiotics). Concomitant medications (within 2 weeks of vaccination) included amoxicillin trihydrate, clavulanate potassium (AMOXICILLIN & CLAV. POTASSIUM). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 22Feb2021 12:00, the patient experienced intense and severe arm, elbow, shoulder and neck pain. Treatment received as Flexiril muscle relaxers for the adverse events. The outcome of events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Pt requested his first dose of Pfizer. We had Janssen and Pfizer available to walk-in patients. The pharmacist accidently grabbed the Janssen vial and pulled out 0.3ml of the vaccine and administered 0.3ml of the Janssen vaccine instead of the Pfizer.   Pt was contacted and made aware of the error. Per CDC, the patient received more than 50% of the dose so he is considered fully vaccinated.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 05-JUL-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 144 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 144 hours with the lowest recorded temperature of 24 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Patient experienced itching following administration of vaccine. 50mg Capsules of Benadryl was administered & we monitored her for 45 minutes. Itching was only slightly relieved so employee, had a contact at Hospital & called Dr. Dr said to bring patient over to office & he would examine her. She was actually a patient at office currently. Dr said she was having an allergic reaction & conitnue to take Benadryl around the clock.
Patient stated being ok after 15 min observation time. She came back a few minutes later to the clinic stating she felt a burning, numbing and swelling sensation near on her right neck/throat area. Her vitals were taken at 10:25am and read BP-140/84, HR-75, RR-18, O2 sat-98% at room air. She was given water and observed. she was talking and had no difficulty in drinking water, she had no complaint of having difficulty drinking. she stated it was feeling a bit better than when she first felt it. vitals were taken again in 10:45 and read BP-128/82, HR-70, RR-20, and O2 sat-97% at room air. Provider came in to exam patient and informed patient to monitor symptoms and if they got worse to return to clinic or go to hospital.  Patient stated feeling better after being observed by the provider and was released home. Pt was contacted by phone at 4:17pm she stated the sensation and numbness had gone away and felt better.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "High Blood Pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Keflex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Apr2023 at 01:00, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took Paxlovid from 26Mar2023 to 30Mar2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300144428 same reporter/patient, different product/event;
had the vaccine, Suffered with breakouts / suspected vaccination failure; Breakouts mostly on legs feet and arms, in hot months; Feel doomed; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (suffered over 20 years with breakouts, mostly happened in hot months).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and impending doom. On an unknown date, the outcome of the vaccination failure and impending doom were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and impending doom to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient stated that, he/she had vaccine and it did not work on him/her. The patient felt doomed and he/she had shingles mostly on legs feet and arms, which drive him/her crazy. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination 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. Note: From narrative it seems that, patient had shingles breakouts over 20 years, hence it was captured as historical condition and outcome of shingles captured as not recovered, because it seems that, patient was suffered from the shingles breakouts at the time of reporting as well.
hand discomfort/It snows at the moment with my 3 fingers of the hand; Intense pain; depression; Sores; Fear; This serious case was reported by a consumer and described the occurrence of limb discomfort in a patient who received Herpes zoster (Shingrix) (batch number GR375, expiry date 28-MAY-2024) for prophylaxis.   On 30-OCT-2019, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced limb discomfort (Verbatim: hand discomfort/It snows at the moment with my 3 fingers of the hand) (serious criteria hospitalization), pain (Verbatim: Intense pain) (serious criteria hospitalization), depression (Verbatim: depression) (serious criteria hospitalization), skin ulcer (Verbatim: Sores) (serious criteria hospitalization) and fear (Verbatim: Fear) (serious criteria hospitalization). The patient was treated with analgesic, nos (Pain Medication) and ambiguous medication nos (Cortisone (Nos)). The outcome of the limb discomfort, pain, depression and skin ulcer were not resolved and the outcome of the fear was not reported.   It was unknown if the reporter considered the limb discomfort, pain, depression, skin ulcer and fear to be related to Shingrix.  It was unknown if the company considered the limb discomfort, pain, depression, skin ulcer and fear to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-AUG-2023 It showed at the moment with his/her 3 fingers of beeping hand.  The patient affected and one on the left hand and felt like a bicero when his/her fingers and the internal dox flowed through his/her whole body and toes, frightening Ansages, Without savir what farges, intense pains.  The reporter stated that left the hospital and doctor said two days of 1 Side effects and everything would be fine but unfortunately it was not. The patient experienced sores and depression. They had Satin commission, the patient was clear and already knew.  The varis berection / exchanges of remedies and it had been 2 months and still. In the morning as the patient lunch, the patient began to feel uncomfortable in his leg, hand (who fears Vaccine), hand (passed at night he/she feared a medication because his/her deco was a lot of docx (middle finger), at he/she hours of the morning, he/she called his/her husband because the dose she was unbearable, intense.  The patient had felt nothing and we were in the hospital where he/she was medicated. The reporter stated that he/she need cortisone the almost until gone. The reporter stated that he/she felt like animal in his/her finger.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Covid-19 vaccine that were given beyond the 30 day use by date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022 at 4:57 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jan-2022 at 4:57 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  Patient's Census Ethnicity was reported.  Patient received booster dose of Moderna. It was reported that, vaccine was administered on 28-Jan-2022 at 16:57:41. Its 30 days expiry date vaccine went into 2 to 8 degree Celsius thaw state on or about to 20-Dec-2021, this vaccine administered until its Mfg date of 04-Apr-2022.  No treatment information provided.   This case was linked to MOD-2022-542869 (Patient Link).
Within 5 minutes developed hives rash on face, neck and chest. Upon advise of personal physician, took 50 mg of Benadryl. Medical staff on site recommended being checked out by an ambulance EMT crew, due to ongoing hives and very high blood pressure reading by them. Ambulance called by site medical personnel, ambulance crew strongly recommend transport to ER. Went in ambulance to Hospital ER. In ER for roughly 3.5 hours for observation and vital signs monitored until rash subsided and blood pressure went down.
This is a spontaneous report from a contactable Consumer. A male patient of an unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unknown route of administration on 05Feb2021 at dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer vaccine last Friday no symptoms until Thursday. He read he should not have symptoms that far out, so he wants to know if that's true. He is experiencing chills, body aches, muscle aches, not feeling well; all on an unknown date in Feb2021. Outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
After receiving Janssen vaccine in April 2021, received a Moderna booster and within 24 hours, fever of 102.1 and aches all over.  Fever reduced to 99 following day, aches remain, specifically in the armpit of the arm that received the vaccine.  Vaccine site swollen.
Information has been received from a registered nurse concerning a female child who on an unspecified date was vaccinated with RECOMBIVAX HB. Subsequently, the patient had an anaphylactic reaction. It was reported that the patient was taken to the hospital, but it was unknown if the patient was admitted. It was noted that the patient "almost died," but did recover. There was no product quality complaint involved. "Almost died" was considered life threatening. Additional information has been requested.
Pt developed rash on injection arm 24 hours after vaccination. Rash was faint in color and very itchy. It started below injection site and travelled down forearm.
Initially, I had a sore arm and was tired.  About 4 or 5 days after the vaccine, I felt some swelling  & tightness in my knees.  On Saturday, February 13th, I wore my hiking boots and was running some errands.  After a few hours, I felt extreme pain in both ankles so much that I had difficulty walking.  By Monday, I was able to go to school and taught all day.  On Wednesday, February 17th I noticed my right ankle was noticeably swollen that evening.  Thursday and Friday were inclement weather so we had virtual instruction.  When my ankle remained swollen, I contacted my doctor.  She thought it may be a serum reaction to the vaccine and suggested I try to contact the center where I got the vaccine and ask to speak to the epidemiologist.  Unfortunately, the COVID call center was not available and did not leave a way to leave a message.  I am concerned because my ankle is still swollen and my second dose is March 4th.