chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Possible incorrect administration of the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Possible incorrect administration of the second dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A, and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Possible incorrect administration of the second dose). At the time of the report, PRODUCT ADMINISTRATION ERROR (Possible incorrect administration of the second dose) outcome was unknown. Not Provided          Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-070271 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-070271:crosslink for DOSE 1
After receiving shot my tongue had a weird sensation and my mouth has a metallic taste. The next day my left lower lip had a weird sensation and the left cheek was tight.  Symptoms has disappeared within 4 days
Varicella - Information has been received from a nurse practitioner concerning a 29 month old female who on 05 Nov 1998 was vaccinated with one dose of varicella virus vaccine live (lot 627875/1245B.  Concomitant therapy included one dose of measles-mumps-rubella vaccine (MSD).  on 18 Apr 2000 the patient experieced varicella disease.  Subsequently the patient recovered from varicella disease
Patient received Pfizer COVID vaccine on 3/3/21, 3/25/21, 8/23/21, and 3/30/22. On 10/2/22, patient was admitted to our inpatient facility (med/surg unit) with COVID-19 infection, acute metabolic encephalopathy, and ketoacidosis. As of today (10/6/22), patient is still admitted in the med/surg unit.
painful shoulder/vaccine worsened her shoulder pain and caused fatigue/pain is 9 out of 10; painful shoulder/vaccine worsened her shoulder pain and caused fatigue/pain is 9 out of 10; Painful shoulder/vaccine worsened her shoulder pain and caused fatigue/pain is 9 out of 10; This is a spontaneous report from a contactable consumer, the patient. A 67 age (unit- not specified) female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 11Feb2021 (as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a painful shoulder condition and was due to surgery one week after the second dose. Caller states she thinks the vaccine worsened her shoulder pain and caused fatigue. Caller states pain was 9 out of 10. Caller wants to know what is Pfizer saying about taking pain medications. Caller does not want to reduce the efficacy of the vaccine. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Painful during injection and pain continued weeks after. Still painful when raising arms overhead/move arms laterally.
Since being vaccinated, I have begun experiencing very painful, long menstrual cycles. Some of these cycles are lasting longer than 60 days.
Soreness in her left armpit; Hurts to raise her left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 10:50 (Lot number: EN6198) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Lot no.: EL9261, Left Arm.), administration date: 09Apr2021, for Covid-19 Immunisation. The following information was reported: AXILLARY PAIN (non-serious) with onset 01May2021, outcome "not recovered", described as "Soreness in her left armpit"; PAIN IN EXTREMITY (non-serious) with onset 01May2021, outcome "not recovered", described as "Hurts to raise her left arm".  Additional information: The patient received her second dose on Friday, 30Apr2021. She has soreness in her left armpit, it hurts to raise her left arm. She received her second dose in her left arm. The soreness in her armpit started the day after she received her second Covid 19 vaccine, on 01May2021. She woke up that Saturday and her armpit was sore. The soreness is staying about the same. She hasn't seen her primary care doctor in 3 to 4 years. Reporter seriousness for soreness in her left armpit, hurts to raise her left arm was Unspecified. Vaccine was not administered at Facility. AE(s) did not required to visit Emergency Room/Physician Office. The patient had not received any vaccine within 4 weeks prior Vaccinations. The patient had no AE(s) prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Dec2022 as dose 5 (booster), single (Lot number: GG044U) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EM9810), in right arm, on 27Jul2021 as dose 2, single (Lot number: EN6205), in right arm, on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 22Jul2022 as dose 4 (booster), single (Lot number: FM7553), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing); "Known allergies: Polio vaccine allergy" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: Sep2011. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 20Apr2023 to 24Apr2023 for COVID-19 treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300178172 same patient, different drug/event;US-PFIZER INC-202300178192 same patient/vaccine, different dose/event (Dose 2);
OPEN IPOL was exposed to 82.62 F for 15 minutes believes the door was left open with no reported adverse event; Open IPOL was administered to patient after excursion with no reported adverse event; Initial information received on 15-Jun-2022 regarding an unsolicited valid non-serious case received from health professional. number: 01148676  This case involves a 5-year-old female patient to whom open IPV (VERO) [IPOL] was administered to patient after excursion with no reported adverse event and open ipol was exposed to 82.62 f for 15 minutes believes the door was left open with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2022SA234797, 2022SA235652, 2022SA235540 and 2022SA235642.  On an unknown date, It was reported that open ipol was exposed to 82.62 f for 15 minutes believes the door was left open with no reported adverse event (product storage error).  On 21-Feb-2022, the patient received suspect Ipol vaccine (lot T1871M, expiry date: 10-Oct-2022) at dose 0.5 ml via unknown route in unknown administration site for immunization after excursion with no reported adverse event (poor quality product administered, latency same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for both events.  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 guidelines. 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.
Pt. at 10 minutes past vaccine began to itch ears. Redness to ears and neck noted. Pt given benadryl 50 mg. Pt then began to cough. Reported feeling tightness to chest. Epi administered. Pt sent to ER.
The pt. received an Influenza vaccination (IIV) on 9/13/13. About 10 days later he experienced "moderate to severe" generalized muscle aches which lasted about 2-3 weeks and resolved without intervention. The pt. denied experiencing, fever, chills, N, V, headache or arthralgias. The pt. states that when he had his Influenza vaccination (TIV) 5/24/13 (a condition of employment) he noted about 2 weeks of fatigue which started about 10 days after vaccination receipt. Prior to this time the pt. does not recall getting an Influenza vaccination. The pt's daughter and barber noted a "bald spot" at the back of his head in the Dec/Jan timeframe. The pt. visited dermatology 2/24/14. His exam revealed a 3x3 cm well demarcated alopecia patch at the occiput (left side) and was diagnosed with Alopecia Areata. The pt. declined treatment. As of 7/14/14, the pt. has not experienced any additional autoimmune illness. According to the pt, the area of hair loss has expanded slightly.
During her lifetime, she has received 5 doses of M-M-R II; No known adverse effects; This spontaneous report was received from a registered nurse who was also a female patient of unknown age referring to herself.      The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On 13-DEC-1979, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not provided) as prophylaxis.   The patient stated that during her lifetime, she had received 5 doses of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). A second dose was administered on 02-AUG-2002, a third one on 24-MAY-2019 and she could not remember the other 2 dates. No known adverse effects were reported.
patient was treated for shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 10-DEC-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route were unknown) as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and zoster-related conditions (prophylaxis).   On an unspecified date, the patient experienced shingles, which led to hospitalization. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX), the patient had and would 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.  Additional information has been requested.
From information received on 11/19/02, it was reported by a nurse that a 46 year old female employee was vaccinated with a 0.5ml dosage of Fluzone, lot # U0929AA, given IM, on 11/19/2002. Recipient reported that on the same day she experienced dizziness, fatigue, nausea, and soreness at injection site with pain down to her forearm, injection site was also warm to touch. Patient was not evaluated by a physician.
Rash in his right thigh; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021 and was forwarded to Moderna on 11-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash in his right thigh) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rash in his right thigh). At the time of the report, RASH (Rash in his right thigh) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.
The patient had no reaction until the next evening after the administration. There is a tennis ball sized bruising and swelling around the injection site. It is hot to the touch and painful and the swelling and pain has been progressively getting bigger and worse. Patient tried icing with ice bag, taken TYLENOL and MOTRIN. Patient was at the hospital but not for this reaction, asked the doctor about the arm but the doctor said that it's an adverse reaction to the vaccination but did not do any further check-up. Urged patient to seek urgent care or call PCP if no relief in few more days and to continue icing the area and taking OTC for pain relief and swelling.
A nurse described the occurrence of injection site pain in a 53 year old female who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. The subject's medical history and concurrent medications were not reported. The subject experienced no adverse events following previous immunizations. The subject received the "entire series" of Engerix B injections in 1988. On 2/10/03, her "hep B titer" was "less than 2.0.: On 2/25/03, the subject received her fourth injection of Engerix B (5371A4) injected into the right arm. At that time, she was experiencing right shoulder pain. She also received an injection of tetanus toxoid injected into the left deltoid. On 2/27/03, the subject experienced injection site pain. She telephoned the vaccine provider to report the event. The reporting nurse considered the event to be possibly related to Engerix B administration, or to the right shoulder pain that was present at the time of immunization. As of 3/25/03, the outcome of the event was unknown.
fever of 102; Slight soreness at injection site (right arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Slight soreness at injection site (right arm)) and PYREXIA (fever of 102) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (Slight soreness at injection site (right arm)). On 02-Feb-2021, the patient experienced PYREXIA (fever of 102). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Slight soreness at injection site (right arm)) and PYREXIA (fever of 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: 102 (High) Fever of 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
After leaving the location I got tingling at the base of my neck, soon after it moved to the left side of left side of my the back of my head around my ear, then I started to get ringing in my ear which is progressively getting louder. I am rather concerned.
Pt. vaccinated on 10/6/04 with Pneumovax23. Came to my office on 10/8/04 showing a med pink, sl. warm to touch sl. raised area on left deltoid and downward. Encouraged pt. to call primary physician for antibiotic ?cellulitis. Spoke with primary MD who called in prescription to pharmacy.
Stroke; This is a spontaneous report from a contactable consumer or other non-health care professional (reporting for son-in-law). A 32-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on 28Aug2021 as dose number unknown, single for COVID-19 immunization (Age at Vaccination was 32years). The patient's medical history and concomitant medications were not reported. It was stated that, the patient was diagnosed with COVID-19 prior to vaccination and Unknown whether been tested for COVID-19 since the vaccination. The information about patient received any other vaccines within 4 weeks prior to the COVID vaccine and received any other medications within 2 weeks of vaccination was unknown. On 28Aug2021, it was reported that, the patient experienced stroke after getting vaccinated. The seriousness of the event was serious and was hospitalized. The hospitalization was not prolonged for the event and treatment received was unknown. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. On an unspecified date the multiple unspecified patients were administered a dose of LIQUID PEDVAXHIB (lot # unspecified) (dose, route, frequency and location unspecified) that went through an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
1hr p/vax c/o feeling heavy, dizzy, face flushed, pupils dilated, equal, reactive;BP 114/74, 72, 16, t98, hearing echoes, seeing blurred images, felt diff to move arms & legs;no paresthesias of gingers or feet;grips - 02 by EMT
12 hrs after the shot: onset of chills, body ache, fever, pain in left armpit and swollen. headache Still happening 60 hrs later: painful and very swollen left armpit lymph node, painful and swollen upper shoulders by shoulder blades on both sides, painful headache with any type of head movement.
Immediately after (in the car in the parking lot) I began to sweat and get light headed. My wife who was in the car told me to pull over because she could see I didn?t look right. I pulled over, passed out and had a seizure. My wife called 911 and the paramedics came to check me out. BP was very low but everything else checked out ok. On the way home I threw up violently filling up the entire bag that the EMT had given me where my wife had to pull over and dump it out. I felt very weak, excruciating headache, and my head just didn?t feel right. Arm is very sore and still very fatigued with headache.
Patient became dizzy and light headed and diaphoretic. Symptoms occurred at 1:00PM Patient was placed on mats, vials taken, BP 105/60,  Pulse 50.Patient was offered advanced medical care, but refused.  Patient was observed for 30 mins. Vital signs at 1:30PM, BP 110/60, Pulse 50. Patient was asked about his heart rate, he stated it runs between 50 and 60. Patient was asked how he was feeling stated he felt okay.  He was asked if he was okay to drive home, stated he could drive. Patient was asked if we could do anything else for  him and refused.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 17-DEC-2013 the patient was vaccinated with 2 ml (overdose) PNEUMOVAX23, via an unknown route. No adverse symptoms were reported. Additional information has been requested.
SYSTEMIC ITCHINESS (LEGS, FACE AND ARM); STUFFY NOSE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included uterine cancer, and concurrent conditions included seasonal allergy, non smoker, and abstains from alcohol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042821A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 10:30 in left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced systemic itchiness (legs, face and arm). On 06-APR-2021, the subject experienced stuffy nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stuffy nose, and systemic itchiness (legs, face and arm). This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not was required as per standard procedure as the case assessed as non-serious.
For the 3 months after the vaccine, I have been extremely fatigued, had difficulty concentrating and ringing in my ears.
muscle weakness in her left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received bnt162b2 (BNT162B2), on 02Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: bnt162b2 (Batch/lot number: EL9269), administration date: 06Feb2021, when the patient was 74-year-old, for COVID-19 Immunization, reaction(s): "unable to walk". The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 07Apr2021, outcome "not recovered", described as "muscle weakness in her left leg". The event "muscle weakness in her left leg" required physician office visit. Therapeutic measures were not taken as a result of muscular weakness. Additional information:  Patient got the first Pfizer Covid vaccine 06Feb2021, second one on 02Mar2021 and got the booster on 05Nov2021. About four weeks after the first vaccine she was unable to walk; has muscle weakness in left leg since 07Apr2021. Patient had been like that for 2.5 years (as of ). Patient was wondering if it was going to get any better. She had been to so many doctors, they did not know anything and were not talking as much. No investigations were performed.    The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300348112 Same patient/vaccine, different vaccine dose (dose 1)/event;US-PFIZER INC-202300337515 Same patient/vaccine, different vaccine dose (Comirnaty (2023-2024 Formula))/event;