chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of consciousness, Muscle spasms, Muscular weakness, Nausea, Pain in extremity
Clinical narrative: Red injection site then bad arm pain,vomiting ,sick to stomach then slowly my right leg started giving out when I?d stand or try to walk and my right hand lost grip , noticed intense jerking movements and double vision. Barely could stand , then I lost consciousness ,Turned blue / medics came and ran some test and had to bring me in because my oxygen was only 71% and even on high flow air it would not pass 80%, couldn?t walk, weakness, muscle spasms , went into ICU
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Red injection site then bad arm pain,vomiting ,sick to stomach then slowly my right leg started giving out when I?d stand or try to walk and my right hand lost grip , noticed intense jerking movements and double vision. Barely could stand , then I lost consciousness ,Turned blue / medics came and ran some test and had to bring me in because my oxygen was only 71% and even on high flow air it would not pass 80%, couldn?t walk, weakness, muscle spasms , went into ICU
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC20, RV5
Symptoms: Wrong patient received product
Clinical narrative: Patient was incorrectly administered vaccines intended for other patient due to misidentification of patient by nursing staff.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Neck pain, Pain in extremity, Swelling face, Swollen tongue
Clinical narrative: Arm and neck pain with facial and tongue swelling, shortly after injection. He now has persistent neck pain.
Age: 49.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No additional AE; pediatric dose of VAQTA was inadvertently administered to a 49 year old adult patient; This spontaneous report was received from a medical assistant referring to a 49-year-old patient of unknow agender. The patient's medical history was not reported. Concomitant therapies were not reported.  On 01-FEB-2024, the patient was inadvertently vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) injection (incorrect dose administered), administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  No additional adverse event.   Lot number is being requested and will be submitted if received.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; inadvertently administered PROQUAD after it arrived two days past the acceptable " must be received by date"; This spontaneous report was received from registered nurse referring to a patient of unknown age and gender. The patient's medical history was not reported. Concomitant therapies were not reported.  The nurse reported that on 04-DEC-2023, the patient was inadvertently administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD rHA) after it arrived two days past the acceptable date of 02-DEC-2023 (Incorrect product storage) (0.5ml, lot #X021127, expiration date: 10-FEB-2025, administered for prophylaxis; strength, and route of administration were not provided).    No symptomatic adverse events reported.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Bacterial test positive, Bacterial vaginosis, Cystitis, Dizziness, Full blood count abnormal
Clinical narrative: UTI; sinus tachycardia; decreased WBC; another bladder infection; bacterial vaginosis; This spontaneous report was received from a nurse refers to a 55-year-old female patient. The patient's concurrent conditions included drug hypersensitivity (to Ceclor). The patient's medical history included hypertension, depression, gestational diabetes and covid-19. The patient's concomitant therapies included tramadol, gabapentin, escitalopram oxalate (LEXAPRO), hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ) and alprazolam.  On 20-DEC-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II), formulation: injection, lot # X000177, expiration date: 02-JAN-2025, 0.5 milliliter/once (route of administration and anatomical location were not provided) for Titer negative for Rubeola - vaccine.  On 02-JAN-2024, the patient experienced sinus tachycardia, bacterial vaginosis, urinary tract infection (UTI) and white blood cell count decreased. On the same day, the patient went to the emergency room (ER) with a 103.7 degrees Fahrenheit fever, lightheadedness, and dizziness. In the ER the patient received laboratory examination reported as: Lab work (unspecified) exact results were not provided, urinalysis showed moderate bacteria in her urine, flu swab exact results were not provided, covid test exact results were not provided, checked for strep (unspecified) exact results were not provided, complete blood count (CBC) showed white blood cells (WBC) decreased, comprehensive metabolic panel (CMP) exact results were not provided. The patient received medications, antibiotics for UTI, and fluids. The patient was diagnosed with sinus tachycardia, urinary tract infection (UTI) and white blood cell count decreased, and then was admitted to the hospital to rule out sepsis. The hospital visit provided noted that the patient's symptoms may have potentially been a mild reaction to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine, or a UTI, or bacterial vaginosis. The subject was also hospitalized for bacterial vaginosis. On 16-JAN-2024, the patient continues to have a low WBC. On 12-FEB-2024, the patient experienced cystitis (another bladder infection). The patient stated that she believes it was still related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine. The outcome of urinary tract infection, cystitis, bacterial vaginosis, white blood cell count decreased and sinus tachycardia was reported as not recovered/not resolved.   The causality assessment was not provided.  Lot number X000177 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), with rherapy type - rHA.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Influenza virus test, Laboratory test, Metabolic function test, Pyrexia, SARS-CoV-2 test
Clinical narrative: UTI; sinus tachycardia; decreased WBC; another bladder infection; bacterial vaginosis; This spontaneous report was received from a nurse refers to a 55-year-old female patient. The patient's concurrent conditions included drug hypersensitivity (to Ceclor). The patient's medical history included hypertension, depression, gestational diabetes and covid-19. The patient's concomitant therapies included tramadol, gabapentin, escitalopram oxalate (LEXAPRO), hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ) and alprazolam.  On 20-DEC-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II), formulation: injection, lot # X000177, expiration date: 02-JAN-2025, 0.5 milliliter/once (route of administration and anatomical location were not provided) for Titer negative for Rubeola - vaccine.  On 02-JAN-2024, the patient experienced sinus tachycardia, bacterial vaginosis, urinary tract infection (UTI) and white blood cell count decreased. On the same day, the patient went to the emergency room (ER) with a 103.7 degrees Fahrenheit fever, lightheadedness, and dizziness. In the ER the patient received laboratory examination reported as: Lab work (unspecified) exact results were not provided, urinalysis showed moderate bacteria in her urine, flu swab exact results were not provided, covid test exact results were not provided, checked for strep (unspecified) exact results were not provided, complete blood count (CBC) showed white blood cells (WBC) decreased, comprehensive metabolic panel (CMP) exact results were not provided. The patient received medications, antibiotics for UTI, and fluids. The patient was diagnosed with sinus tachycardia, urinary tract infection (UTI) and white blood cell count decreased, and then was admitted to the hospital to rule out sepsis. The hospital visit provided noted that the patient's symptoms may have potentially been a mild reaction to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine, or a UTI, or bacterial vaginosis. The subject was also hospitalized for bacterial vaginosis. On 16-JAN-2024, the patient continues to have a low WBC. On 12-FEB-2024, the patient experienced cystitis (another bladder infection). The patient stated that she believes it was still related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine. The outcome of urinary tract infection, cystitis, bacterial vaginosis, white blood cell count decreased and sinus tachycardia was reported as not recovered/not resolved.   The causality assessment was not provided.  Lot number X000177 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), with rherapy type - rHA.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Sinus tachycardia, Streptococcus test, Urinary tract infection, White blood cell count decreased
Clinical narrative: UTI; sinus tachycardia; decreased WBC; another bladder infection; bacterial vaginosis; This spontaneous report was received from a nurse refers to a 55-year-old female patient. The patient's concurrent conditions included drug hypersensitivity (to Ceclor). The patient's medical history included hypertension, depression, gestational diabetes and covid-19. The patient's concomitant therapies included tramadol, gabapentin, escitalopram oxalate (LEXAPRO), hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ) and alprazolam.  On 20-DEC-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II), formulation: injection, lot # X000177, expiration date: 02-JAN-2025, 0.5 milliliter/once (route of administration and anatomical location were not provided) for Titer negative for Rubeola - vaccine.  On 02-JAN-2024, the patient experienced sinus tachycardia, bacterial vaginosis, urinary tract infection (UTI) and white blood cell count decreased. On the same day, the patient went to the emergency room (ER) with a 103.7 degrees Fahrenheit fever, lightheadedness, and dizziness. In the ER the patient received laboratory examination reported as: Lab work (unspecified) exact results were not provided, urinalysis showed moderate bacteria in her urine, flu swab exact results were not provided, covid test exact results were not provided, checked for strep (unspecified) exact results were not provided, complete blood count (CBC) showed white blood cells (WBC) decreased, comprehensive metabolic panel (CMP) exact results were not provided. The patient received medications, antibiotics for UTI, and fluids. The patient was diagnosed with sinus tachycardia, urinary tract infection (UTI) and white blood cell count decreased, and then was admitted to the hospital to rule out sepsis. The hospital visit provided noted that the patient's symptoms may have potentially been a mild reaction to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine, or a UTI, or bacterial vaginosis. The subject was also hospitalized for bacterial vaginosis. On 16-JAN-2024, the patient continues to have a low WBC. On 12-FEB-2024, the patient experienced cystitis (another bladder infection). The patient stated that she believes it was still related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine. The outcome of urinary tract infection, cystitis, bacterial vaginosis, white blood cell count decreased and sinus tachycardia was reported as not recovered/not resolved.   The causality assessment was not provided.  Lot number X000177 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), with rherapy type - rHA.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC.; HCP called to report TE where products have been administered to patients. TE case number: 02551934. Operator of device = HCP. No additional AE/PQC.      PROQUAD: x022923    exp; 03/12/2025   5.8F for 0 hours 15 minutes 0 seconds   no previous excurs; This spontaneous report was received from certified medical assistant and refers to a 5-year-old patient of unknown gender.  There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 05-FEB-2024, the patient was vaccinated improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA)injection, 0.5 milliliter, lot #x022923, expiration date: 12-MAR-2025, administered for prophylaxis (route of administration were not provided). On an unknown date, the vaccine was stored in 5.8 F for 15 minutes. There was no previous excursion. No additional adverse event was reported.  This is one of few reports from the same reporter.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product packaging issue, Product preparation issue
Clinical narrative: box was missing one vial, package only came with 9 vials instead of 10, plus there was no diluent inside; box was missing one vial, package only came with 9 vials instead of 10, plus there was no diluent inside; box was missing one vial, package only came with 9 vials instead of 10, plus there was no diluent inside; This non-serious case was reported by a consumer and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA902A, expiry date JAN-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: box was missing one vial, package only came with 9 vials instead of 10, plus there was no diluent inside), inappropriate dose of vaccine administered (Verbatim: box was missing one vial, package only came with 9 vials instead of 10, plus there was no diluent inside) and product packaging issue (Verbatim: box was missing one vial, package only came with 9 vials instead of 10, plus there was no diluent inside). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and product packaging issue were unknown.   Additional Information: GSK Receipt Date: 31-MAY-2023 The reporter reported that the box was missing one vial, package only came with 9 vials instead of 10, plus there was no diluent inside, which led to product packaging issue. The reporter had been notified in writing that their complaint was forwarded to GlaxoSmithKline for investigation.  The patient received Menveo without diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 65.0
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 65-year-old patient received a dose of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 65-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA975A, expiry date 31-JUL-2024) for prophylaxis.   On 02-JAN-2024, the patient received Menveo. On 02-JAN-2024, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: 65-year-old patient received a dose of Menveo). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 14-FEB-2024 The pharmacy intern called to inform that a 65-year-old patient received a dose of Menveo, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 11 year old was due for a Tdap but instead an MA gave a Dtap; a 11 year old was due for a Tdap but instead an MA gave a Dtap; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) (batch number 7hm5J, expiry date 13-SEP-2024) for prophylaxis.   On 09-FEB-2024, the patient received Infanrix. On 09-FEB-2024, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: 11 year old was due for a Tdap but instead an MA gave a Dtap) and inappropriate age at vaccine administration (Verbatim: a 11 year old was due for a Tdap but instead an MA gave a Dtap). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-FEB-2024 The health care professional (HCP) chat received that a patient was due for a Tdap but instead an MA gave a Dtap, and needing to knew when the child can be given a Tdap since Dtap was given. A 11 year old patient was inadvertently administered the Infanrix vaccine instead of the Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administered. The reporter consented to follow up.
Age: 31.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administration of Havrix before the recommended interval; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 31-year-old female patient who received HAV (Havrix) (batch number 55M72, expiry date 13-DEC-2024) for prophylaxis.   Previously administered products included Havrix (Received first dose of Havrix vaccine on an unknown date).   On 15-FEB-2024, the patient received the 2nd dose of Havrix. On 15-FEB-2024, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: Administration of Havrix before the recommended interval). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-FEB-2024 A nurse practitioner inquired about Havrix and what information was available about the administration of Havrix before the recommended interval, which led to shortening of the vaccination schedule. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: never got the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on July 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never got the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 15-FEB-2024 The pharmacist reported that an immunocompetent female patient received Shingrix first dose on a doctor's office back on July 2021 and never got the second dose, which led to incomplete course vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-FEB-2024 The reporter was the pharmacist who stated that patient received her first dose of Shingrix over a year ago and had not gotten her second dose yet. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Pediatric dose in adult patient; Adult use of a child product; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 34-year-old female patient who received HBV (Engerix B pediatric) (batch number N73FA, expiry date 31-MAY-2024) for prophylaxis.   On 13-FEB-2024, the patient received the 1st dose of Engerix B pediatric. On 13-FEB-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Pediatric dose in adult patient) and adult use of a child product (Verbatim: Adult use of a child product). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-FEB-2024 A Pharmacist contacted GSK via phone on inquiring about Engerix-B and what information was available about the administration of less than the recommended dose in an adult patient.  They provided partial information about event, vaccine and patient. The Vaccine Administration Facility was the same as Primary Reporter. The adult patient received a pediatric dose of Engerix b, which led to underdose and adult use of child product. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: patient was inadvertently administered a Shingrix diluent only dose without the lyophilized component; patient was inadvertently administered a Shingrix diluent only dose without the lyophilized component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number H379C, expiry date 30-SEP-2025) for prophylaxis.   On 15-FEB-2024, the patient received Shingrix. On 15-FEB-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient was inadvertently administered a Shingrix diluent only dose without the lyophilized component) and inappropriate dose of vaccine administered (Verbatim: patient was inadvertently administered a Shingrix diluent only dose without the lyophilized component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 16-FEB-2024 The reporter was certified pharmacy technician called to inquire that how to proceed. The reporter asked if the patient could get another shot of Shingrix. The reporter reported that a patient was inadvertently administered a Shingrix diluent only dose without the lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter was unable to provide patient details at this moment. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: adverse event NOS; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT (adverse event NOS) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Demerol.), Anxiety, Arthritis, Chronic pain, COPD, Depression and Hypothyroidism. Concomitant products included ESTRADIOL, LEVOTHYROXINE, MORPHINE, PREGABALIN, ROPINIROLE HYDROCHLORIDE (REQUIP), SERTRALINE, TRAMADOL, BUPROPION HYDROCHLORIDE (WELLBUTRIN) and IBUPROFEN for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (adverse event NOS) (seriousness criteria hospitalization, disability and life threatening). The patient was hospitalized for 4 days due to ADVERSE EVENT. At the time of the report, ADVERSE EVENT (adverse event NOS) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  This case was identified during the EMA inspection 2023 as part of the no patient identifier clean-up finding. All corrections and updates to the case have been made and the case is locked.  Company comment:  This is a spontaneous case concerning a 63-year-old patient with current conditions of anxiety, arthritis, chronic pain, COPD, depression, and hypothyroidism, who experienced an unexpected serious event (seriousness criteria: hospitalization, disability, and life-threatening) of adverse event reported as 'adverse event not otherwise specified (NOS)' which occurred at an unknown latency after the administration of an unknown dose of the mRNA-1273 vaccine. The patient was hospitalized for 4 days, and the outcome was reported as not resolved. No further information on the clinical course, investigations, or treatment received was available in the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Case unlocked on 15-Feb-2024 as a part of inspection 2023 to perform significant correction. Classification of no patient identifier was removed, and case was made valid, hospitalization, life-threatening and disability seriousness added.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: It was reported that that there was a temperature excursion; No reported adverse effects from administered vaccines; This spontaneous report was received from a registered nurse, concerning a 1-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 20-DEC-2023, she was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) (lot number W007040 has been verified to be valid, expiration date reported as 24-FEB-2024, but upon internal validation established as 29-FEB-2024) (albumin status: recombinant human albumin (rHa) and with varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number W008712 has been verified to be valid, expiration date not reported, but upon internal validation established as 14-MAR-2024) (exact dose, route of administration and anatomical location were not reported as prophylaxis. The vaccines experienced temperature excursion. Additional information was not expected.   This is one of the several cases reported from the same source.; Sender's Comments:  US-009507513-2402USA005567: US-009507513-2401USA005218:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Dyspnoea, Inflammation, Product administered at inappropriate site
Clinical narrative: chest pain; breathing issue; left arm swelling; severe pain in her arms/pain; high inflammation; injected her lower down in the arm part; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 55-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Feb2024 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for covid-19 immunisation. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 04Feb2024, outcome "unknown", described as "injected her lower down in the arm part"; CHEST PAIN (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "breathing issue"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "left arm swelling"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "severe pain in her arms/pain"; INFLAMMATION (non-serious), outcome "unknown", described as "high inflammation". The event "left arm swelling" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site swelling, inflammation.  Additional information: After taking the booster, the patient was having chest pain, some breathing issue, left arm swelling. She was in a lot of pain, she said the pharmacist injected in the wrong place, she got the shot on the 4th and its been 10 days. She ended up in the ER twice because of the swelling, she said she was in a lot of pain and she have all other Covid shot and nothing happened like this and she wanted to get something for pain. the ER doctor said that it might have been the needle or he injected way down low in the arm. They did blood work and it showed had high inflammation in her blood from that shot and the doctor said that it was from the shot. The ER doctor gave her 3 days supply of Doxycycline (antibiotic) and hydrocodone with Tylenol and she took last one Sunday 8-9 pills. she said she can't lay on her left arm and said she would never get another shot from that pharmacist he injected her way down in the arm. The pharmacist apparently injected her not in the top part of her shoulder. He injected her lower down in the arm part. She cannot even sleep on her arm. She was in severe pain, 11 days out and she was still in severe pain in her arms and she could not even lay on it.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: chest pain; breathing issue; left arm swelling; severe pain in her arms/pain; high inflammation; injected her lower down in the arm part; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 55-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Feb2024 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for covid-19 immunisation. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 04Feb2024, outcome "unknown", described as "injected her lower down in the arm part"; CHEST PAIN (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "breathing issue"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "left arm swelling"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "severe pain in her arms/pain"; INFLAMMATION (non-serious), outcome "unknown", described as "high inflammation". The event "left arm swelling" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site swelling, inflammation.  Additional information: After taking the booster, the patient was having chest pain, some breathing issue, left arm swelling. She was in a lot of pain, she said the pharmacist injected in the wrong place, she got the shot on the 4th and its been 10 days. She ended up in the ER twice because of the swelling, she said she was in a lot of pain and she have all other Covid shot and nothing happened like this and she wanted to get something for pain. the ER doctor said that it might have been the needle or he injected way down low in the arm. They did blood work and it showed had high inflammation in her blood from that shot and the doctor said that it was from the shot. The ER doctor gave her 3 days supply of Doxycycline (antibiotic) and hydrocodone with Tylenol and she took last one Sunday 8-9 pills. she said she can't lay on her left arm and said she would never get another shot from that pharmacist he injected her way down in the arm. The pharmacist apparently injected her not in the top part of her shoulder. He injected her lower down in the arm part. She cannot even sleep on her arm. She was in severe pain, 11 days out and she was still in severe pain in her arms and she could not even lay on it.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP from product quality group.  A 29-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Nov2022 as dose 4 (booster), single (Lot number: GH9703) for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Jan2021 as dose 1, single (Lot number: EL3246), on 30Jan2021 as dose 2, single (Lot number: EN5318) and on 04Nov2021 as dose 3 (booster), single (Lot number: 3203080) for covid-19 immunisation. The patient's relevant medical history included: "Mild generalized anxiety" (unspecified if ongoing); "migraines" (unspecified if ongoing); "vertigo" (unspecified if ongoing); "Codeine allergy" (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 2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 03Feb2024 to 08Feb2024.  No follow-up attempts are possible.; Sender's Comments: Based on available information a contributory role of BNT162b2, BNT162b2 omi ba.4-5, BNT162b2  to the reported event, drug ineffective, covid-19 cannot be totally excluded as efficacy of a drug varies from individual to individual. The case will be reassessed once further information is available
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Vision blurred, Weight
Clinical narrative: started having blurred vision, feels like she is loosing her vision she cannot see; started having blurred vision, feels like she is loosing her vision she cannot see; This is a spontaneous report received from a Nurse.  A 60-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Feb2024 as dose 1, single (Lot number: HN0477, Expiration Date: 04May2024) at the age of 60 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. The following information was reported: BLINDNESS (medically significant), VISION BLURRED (medically significant) all with onset 10Feb2024, outcome "unknown" and all described as "started having blurred vision, feels like she is loosing her vision she cannot see". The patient underwent the following laboratory tests and procedures: Weight: 210 lbs, notes: She weighs about 210 pounds.  Additional information: NDC number of COVID-19 Vaccine: 00692377-10.; Sender's Comments: As per temporal association , causal association of the events BLINDNESS , VISION BLURRED with suspect drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Drug ineffective, Dysphonia, Hypoacusis
Clinical narrative: It gave me a Covid of first time within a couple of weeks after I got the shot; It gave me a Covid of first time within a couple of weeks after I got the shot; rash on my skin; throat problems; altered my voice and my vocal cords; irritation in my throat; can't hear on call so good; mucus spitting up; thirsty; nauseous; diarrhea; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer / biontech (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "It gave me a Covid of first time within a couple of weeks after I got the shot"; RASH (non-serious), outcome "unknown", described as "rash on my skin"; PHARYNGEAL DISORDER (non-serious), outcome "unknown", described as "throat problems"; DYSPHONIA (non-serious), outcome "unknown", described as "altered my voice and my vocal cords"; THROAT IRRITATION (non-serious), outcome "unknown", described as "irritation in my throat"; HYPOACUSIS (non-serious), outcome "unknown", described as "can't hear on call so good"; SECRETION DISCHARGE (non-serious), outcome "unknown", described as "mucus spitting up"; THIRST (non-serious), outcome "unknown", described as "thirsty"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". Clinical course: Consumer stated, "Well, I have been 'checking' couple of times, actually it gave me a Covid of first time within a couple of weeks after I got the shot (COVID-19 Vaccine) back in Dec or Nov and it also, that's what my throat and my voice and it gave me a rash on my skin. I have throat problems that's why I can't hear on call so good because lately I have been having voice vocal problems like clearly speaking with my voice." "The vaccine also has altered my voice and my vocal cords. It's causing irritation in my throat, and I have some mucus spitting up, some side effects. But it makes me very thirsty and nauseous, and it gives me a lot of diarrhea."  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pharyngeal disorder, Rash, Secretion discharge, Thirst
Clinical narrative: It gave me a Covid of first time within a couple of weeks after I got the shot; It gave me a Covid of first time within a couple of weeks after I got the shot; rash on my skin; throat problems; altered my voice and my vocal cords; irritation in my throat; can't hear on call so good; mucus spitting up; thirsty; nauseous; diarrhea; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer / biontech (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "It gave me a Covid of first time within a couple of weeks after I got the shot"; RASH (non-serious), outcome "unknown", described as "rash on my skin"; PHARYNGEAL DISORDER (non-serious), outcome "unknown", described as "throat problems"; DYSPHONIA (non-serious), outcome "unknown", described as "altered my voice and my vocal cords"; THROAT IRRITATION (non-serious), outcome "unknown", described as "irritation in my throat"; HYPOACUSIS (non-serious), outcome "unknown", described as "can't hear on call so good"; SECRETION DISCHARGE (non-serious), outcome "unknown", described as "mucus spitting up"; THIRST (non-serious), outcome "unknown", described as "thirsty"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". Clinical course: Consumer stated, "Well, I have been 'checking' couple of times, actually it gave me a Covid of first time within a couple of weeks after I got the shot (COVID-19 Vaccine) back in Dec or Nov and it also, that's what my throat and my voice and it gave me a rash on my skin. I have throat problems that's why I can't hear on call so good because lately I have been having voice vocal problems like clearly speaking with my voice." "The vaccine also has altered my voice and my vocal cords. It's causing irritation in my throat, and I have some mucus spitting up, some side effects. But it makes me very thirsty and nauseous, and it gives me a lot of diarrhea."  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: It gave me a Covid of first time within a couple of weeks after I got the shot; It gave me a Covid of first time within a couple of weeks after I got the shot; rash on my skin; throat problems; altered my voice and my vocal cords; irritation in my throat; can't hear on call so good; mucus spitting up; thirsty; nauseous; diarrhea; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer / biontech (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "It gave me a Covid of first time within a couple of weeks after I got the shot"; RASH (non-serious), outcome "unknown", described as "rash on my skin"; PHARYNGEAL DISORDER (non-serious), outcome "unknown", described as "throat problems"; DYSPHONIA (non-serious), outcome "unknown", described as "altered my voice and my vocal cords"; THROAT IRRITATION (non-serious), outcome "unknown", described as "irritation in my throat"; HYPOACUSIS (non-serious), outcome "unknown", described as "can't hear on call so good"; SECRETION DISCHARGE (non-serious), outcome "unknown", described as "mucus spitting up"; THIRST (non-serious), outcome "unknown", described as "thirsty"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". Clinical course: Consumer stated, "Well, I have been 'checking' couple of times, actually it gave me a Covid of first time within a couple of weeks after I got the shot (COVID-19 Vaccine) back in Dec or Nov and it also, that's what my throat and my voice and it gave me a rash on my skin. I have throat problems that's why I can't hear on call so good because lately I have been having voice vocal problems like clearly speaking with my voice." "The vaccine also has altered my voice and my vocal cords. It's causing irritation in my throat, and I have some mucus spitting up, some side effects. But it makes me very thirsty and nauseous, and it gives me a lot of diarrhea."  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; Vaccine brand=Other, vaccine brand other=Moderna/vaccine brand=Pfizer/BioNTech; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 45 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Nov2021 as dose 3 (booster), single (Lot number: FE3590) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), on 01Oct2023 as dose 5 (booster), single) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Feb2021 as dose 1, single (Lot number: 012M20A) and on 07Mar2021 as dose 2, single (Lot number: 013A21A) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Iron Deficiency" (unspecified if ongoing); "IBS" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: FLUOXETINE HCL, start date: Aug2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Nov2021, outcome "recovered", described as "Vaccine brand=Other, vaccine brand other=Moderna/vaccine brand=Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "recovered" (2024) and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2024) Positive, notes: I took the full course of Paxlovid after a positive test indicated I had COVID; (2024) Negative, notes: My symptoms improved and I tested negative after taking the full course of medication. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (start date: 02Feb2024, stop date: 06Feb2024).