chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 2, single (Lot number: EN6205) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EL9269, Anatomical Location: Arm Left), administration date: 14Feb2021, when the patient was 34-year-old, for COVID-19 Immunization. The following information was reported: LYMPH NODE PAIN (non-serious) with onset 09Mar2021, outcome "not recovered", described as "It has now been 17 months that it has been swollen and tender"; LYMPHADENOPATHY (non-serious) with onset 09Mar2021, outcome "not recovered", described as "The lymph node in my left arm pit has been swollen since I received the second dose on 3/8/21". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain. Additional information: The patient did not have COVID prior to vaccination and COVID was not tested post vaccination. The patient did not receive any other vaccine in four weeks.; Sender's Comments: Linked Report(s) : PFIZER INC-202201049780 Same reporter/patient/product/event; different dose;
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Imaging procedure abnormal, Thrombosis
Clinical narrative: BLOOD CLOT; SWOLLEN ANKLE; SWOLLEN LEG; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned an 81 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was active tennis player. Didn't play for 3 weeks, but can resume with less intensity per doctor. No relevant medical history contributing to blood clot. The patient was previously treated with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: T306683, expiry: unknown) dose was not reported, 1 total, administered on 04-MAR-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 4382881 expiry: unknown) dose was not reported, 1 total, administered on 06-JUL-2021 for covid-19 prophylaxis which was off label dosing frequency. The drug was associated with Off label use. Age at time of vaccination 81 years old. No concomitant medications were reported.  In late MAY/early JUN-2022, the patient experienced swollen ankle, and swollen leg (dose number in series 2). On 20-JUN-2022, the patient experienced blood clot confirmed by Radiologist (dose number in series 2). Recommended to go to ER (emergency room), but did not go. On JUN-2022, Laboratory data included: Blood test from hospital: did not indicate relationship with Janssen Covid 19 vaccine. Treatment medications included: Saw physician who put patient on Xarelto (rivaroxaban). 6 weeks on Xarelto so far out of 6 month planned course.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot, swollen ankle, swollen leg and off label dosing frequency was not reported. The reporter provided causality between covid-19 vaccine ad26.cov2.s and blood clot, swollen ankle, swollen leg as not related. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220818962-covid-19 vaccine ad26.cov2.s-blood clot. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Joint swelling, Off label use, Peripheral swelling, Thrombosis
Clinical narrative: BLOOD CLOT; SWOLLEN ANKLE; SWOLLEN LEG; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned an 81 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was active tennis player. Didn't play for 3 weeks, but can resume with less intensity per doctor. No relevant medical history contributing to blood clot. The patient was previously treated with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: T306683, expiry: unknown) dose was not reported, 1 total, administered on 04-MAR-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 4382881 expiry: unknown) dose was not reported, 1 total, administered on 06-JUL-2021 for covid-19 prophylaxis which was off label dosing frequency. The drug was associated with Off label use. Age at time of vaccination 81 years old. No concomitant medications were reported.  In late MAY/early JUN-2022, the patient experienced swollen ankle, and swollen leg (dose number in series 2). On 20-JUN-2022, the patient experienced blood clot confirmed by Radiologist (dose number in series 2). Recommended to go to ER (emergency room), but did not go. On JUN-2022, Laboratory data included: Blood test from hospital: did not indicate relationship with Janssen Covid 19 vaccine. Treatment medications included: Saw physician who put patient on Xarelto (rivaroxaban). 6 weeks on Xarelto so far out of 6 month planned course.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot, swollen ankle, swollen leg and off label dosing frequency was not reported. The reporter provided causality between covid-19 vaccine ad26.cov2.s and blood clot, swollen ankle, swollen leg as not related. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220818962-covid-19 vaccine ad26.cov2.s-blood clot. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy test, Biopsy, Blood test, Computerised tomogram, Disturbance in attention
Clinical narrative: Chronic daily headache
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Endoscopy, Headache, Magnetic resonance imaging, Migraine, Pyrexia
Clinical narrative: Chronic daily headache
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Vision blurred, X-ray dental
Clinical narrative: Chronic daily headache
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, New daily persistent headache
Clinical narrative: Chronic daily headache
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A minute or so after receiving the shot, I felt dizzy and my vision started to blacken. I informed the nurse who had me lay down and gave me a cup of water. After drinking the water the dizziness and blackness faded and I was fine 5-10ish minutes later. The next morning, my arm was swollen and red around where the shot was and it is painful to touch.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Visual impairment
Clinical narrative: A minute or so after receiving the shot, I felt dizzy and my vision started to blacken. I informed the nurse who had me lay down and gave me a cup of water. After drinking the water the dizziness and blackness faded and I was fine 5-10ish minutes later. The next morning, my arm was swollen and red around where the shot was and it is painful to touch.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Bell's palsy, Eyelid function disorder, Facial paralysis, Neurological symptom
Clinical narrative: On August 9th, 2022 woke up to drooping left side of my face unable to smile fully. Also, unable to close my left eye or raise my left eyebrow. Went to the Emergency Room because I thought I was having a stroke. It was the Emergency room. I was seen by Dr. and was diagnosed with facial paralysis/Bells palsy with no known cause on 08/09/2022 around 1 pm. I have no previous medical history. I have been  prescribed glycerin-hypromellose-PEG 400 0.2-0.2-1% solution for my left eye since it cannot close fully. prediSONE 60 MG once a day for 7 days. valACYclovir 1 g tablet 3 times a day for 7 days. I am still unable to close my eye fully, raise my eyebrow, nor smile like I used to.  Will be going to an acupuncture clinic on 08/12/2022 after researching ways to get my facial nerves back.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Blood pressure decreased, Disturbance in attention, Dizziness, Headache
Clinical narrative: I am experiencing ringing in my ears or head which started mid year 2021.   I was a perfectly healthy adult.   Never drank liquor,  never smoked, or did any drugs.   Now I am not only experiencing ringing, I am getting slight headaches and dizziness which cause my blood pressure to spike extremely high and then drop to almost normal (strange).   I have lost my job due to this conditions. I am lucky to have found another job and if I can't perform, I will lose this job too.   The sound in my ear makes it so difficult to concentrate and the dizziness unbearable to function.  I started to experience these issues after I took the second covid vaccine. I am hoping that this annoyance will someday go away. I have see an ENT and my hearing is ok.   I am now seeing a neurologist and getting an MRI follow by a cardiologist.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypertension, Impaired work ability, Loss of personal independence in daily activities, Tinnitus
Clinical narrative: I am experiencing ringing in my ears or head which started mid year 2021.   I was a perfectly healthy adult.   Never drank liquor,  never smoked, or did any drugs.   Now I am not only experiencing ringing, I am getting slight headaches and dizziness which cause my blood pressure to spike extremely high and then drop to almost normal (strange).   I have lost my job due to this conditions. I am lucky to have found another job and if I can't perform, I will lose this job too.   The sound in my ear makes it so difficult to concentrate and the dizziness unbearable to function.  I started to experience these issues after I took the second covid vaccine. I am hoping that this annoyance will someday go away. I have see an ENT and my hearing is ok.   I am now seeing a neurologist and getting an MRI follow by a cardiologist.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient arrived for an Evusheld appointment, upon approaching the check in area. he said he was there for his booster. The check - in nurse checked him in without verifying the appointment type. Vaccinator did read the label correctly.   Patient was given a Moderna booster instead of Evusheld injection
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No Adverse Event) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 012H21B, 004C21A and 018B21A) for COVID-19 prophylaxis. Concurrent medical conditions included Drug allergy (Ultran) and Drug allergy (Flagyl). On 15-Apr-2021 at 11:11 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 13-May-2021 at 3:17 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 18-Nov-2021 at 9:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 9:15 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 9:15 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) and PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022). It was reported that, the error in the documentation, and administered an expired vaccine to more than 40 patients. They thought that Moderna had an extension like Pfizer, and though it would expire on 13-Jul-2022 but it was expired on the 13-May-2022, they realize this on the 8-Jun-2022. The event did not cause the patient to seek medical care. The used vial was placed in the refrigerator on the same day of administration (26 May 2022). The vial did not undergo any temperature excursions. No treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 036A21A, 018B21A and 070H21A) for COVID-19 prophylaxis. The patient had not diagnosed or tested positive for COVID-19. On 05-Mar-2021 at 12:06 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Apr-2021 at 3:21 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 20-Dec-2021 at 4:34 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Jun-2022 at 2:34 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Jun-2022 at 2:34 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022). No concomitant medications was reported. The event did not cause the patient to seek medical care. It was unknown if there was any other potential causes. It was unknown if the patient experienced a similar event in the past. The used vials were placed in the refrigerator on the same day of administration 07-Jun-2022. The vial did not undergo any temperature excursions. No treatment medications was reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Hypersensitivity, Immunisation reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Reaction to COVID-19 Vaccine) and HYPERSENSITIVITY (General body allergy) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 21-Apr-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg,1 in 2 wk, Solution for injection in pre-filled pen. On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2022, the patient experienced IMMUNISATION REACTION (Reaction to COVID-19 Vaccine) and HYPERSENSITIVITY (General body allergy). In 2022, IMMUNISATION REACTION (Reaction to COVID-19 Vaccine) and HYPERSENSITIVITY (General body allergy) had resolved.            No concomitant medications were reported.  The reporter's causality for the events of reaction to COVID-19 vaccine and general body allergy with HUMIRA 40MG/0.4ML(ADALIMUMAB) was reported as no reasonable possibility. Reporter did not have the lot number information, because the packaging was discarded. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment medications were reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Oct2021 at 16:00 as dose 3 (booster), single (Lot number: FF2588) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Peanuts" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Aug2022) Positive, notes: Tested positive again after 3 days of finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient did not take any other medication in 2 weeks. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; Rebound 3days after complete therapy/COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arterial hypertension" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "gout" (unspecified if ongoing); "Known allergies: Quinolones" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN; AMLODIPINE; METOPROLOL SUCCINATE; ROBITUSSIN DM; SYNTHROID. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 07Aug2022, outcome "unknown", described as "Rebound 3days after complete therapy/COVID 19"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. (Paxlovid). Therapeutic measures were not taken as a result of disease recurrence.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, a causal association between BNT162b2 and the reported events cannot be excluded as drug efficacy varies form one patient to another and is affected by different factors.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE's; a dose of PROQUAD was administered to a patient via the intramuscular route instead of the subcutaneous route; This spontaneous report has been received from a nurse regarding a patient of unknown age and gender. The pertinent medical history, concomitant medications and drug reactions/ allergies were not provided.   On 13-JUL-2022, the patient was vaccinated with measles (+) mumps (+) rubella (+) varicella (Oka/Merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) administered via intramuscular route instead of subcutaneous route (incorrect route of product administration) (strength, anatomical location, dose number and dose were not provided; lot #: W007746; expiration date: 04-SEP-2023) for prophylaxis (also reported as use as directed to prevent measles, mumps, rubella and varicella infection). No additional adverse events (AEs) and no product quality complaints (PQCs) were reported.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; received PROQUAD/that experienced a temperature excursion; This spontaneous report was received from a registered nurse referring to unknown patients of unknown age and gender. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 11-JUL-2022, following vaccines were administered after temperature excursion to 10.8 degree Celsius for 2 hours 27 minutes (product storage error). Names of vaccines involved: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) (lot # U011995, expiration date: 15-APR-2023, lot # U009511 expiration date: 25-MAR-2023, lot# U014656 expiration date: 07-MAY-2023, lot # U022318, expiration date: 15-JUL-2023, lot # T025930, expiration date: 30-JUL-2022, lot # U029619, expiration date: 22-SEP-2023) for prophylaxis (strength, dose and route of administration were not provided), measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot #U029319, expiration date: 19-MAR-2023, lot# U024296 expiration date 21-SEP-2023, lot# U039723 expiration date: 15-DEC-2023, lot# U015679 expiration 18-AMY-2023), varicella virus vaccine live (oka/merck) (VARIVAX) (lot #U010396, expiration date: 01-APR-2023, lot# U039723 expiration date: 15-DEC-2023, lot# U015679 expiration date: 18-MAY-2023, U024296 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX) expiration date reported as 21-SEP-2023) for prophylaxis (all vaccines strength, dose, anatomical location and route of administration were not provided). The reported was unsure how many administrations occurred and did not have individual patient information. No additional adverse event was reported (no adverse event).  This case is non-valid due to the number of patients was unspecified and lack of patients' identifiers.  Follow-up information was received from a registered nurse on 09-AUG-2022. This case was previously considered non-valid but per follow-up it was determined to be valid (there were only 3 patients who receive the vaccines). This spontaneous report refers to a 5 year old male patient. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On 02-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # W004027, expiration date 02-AUG-2023, for prophylaxis (dose and route of administration was not provided) that experienced a temperature excursion. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA004874: US-009507513-2208USA004875:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown gender, who was currently 70 years-old. The patient's past medical history, concurrent conditions, or concomitant medication were not reported.   On 13-SEP-2013, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dosage and route of administration were not provided) at a pharmacy, for the long-term prevention of shingles and zoster-related conditions.   On an unknown date, the patient was treated by a physician for shingles. The outcome of the shingles was unknown and the casuality assessment between the singles and the vaccination with zoster vaccine live (ZOSTAVAX) was reported as related.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE/PQC reported.; administered the GARDASIL 9 vaccine at 0, 2, and 4 months.; This spontaneous report was received from the consumer and referred to a female patient of unknown age. The medical history, current conditions and concomitant medications were not provided.  Approximately in March 2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route, lot# and expiration date were unknown) for prophylaxis. Approximately in May 2022, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route, lot# and expiration date were unknown) for prophylaxis.  On 21-JUL-2022, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route, lot# and expiration date were unknown) for prophylaxis (Inappropriate schedule of product administration). The patient was administered the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at 0, 2, and 4 months. The patient wanted to know if receiving the third dose early would create a need to get another dose at a later time? No further information provided. No additional adverse event (AE) or product quality compliant (PQC) reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported.; PEDVAX HIB and ROTATQ administered after temperature excursion. Temperature 23.8C . Time frame 9 Hours 45 minutes.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 25-JUL-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number: W004502 has been verified to be a valid lot number with expiration date on 09-OCT-2023); and a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot number U039951 has been verified to be a valid lot number with expiration date on 22-JUN-2024 (doses, strengths, routes of administration, anatomical injection sites and frequencies were not reported), both administered for prophylaxis. Both vaccines were  stored at a temperature of 23.8 degree Celsius (C) for the time frame of 9 hours and 45 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; an expired dose of MMR II was administered; This spontaneous report was received from a pharmacist referring to a 4 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-JUL-2022, an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (therapy type: rHA (recombinant Human albumin) (lot # T020656, expiration date: 16-JUN-2022) was administered to the patient for prophylaxis (strength and route of administration were not provided) (expired product administered). The vaccine was stored in the recommended storage range until administration. No additional adverse event reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: No additional AE details; HCP transferred from MVCC agent who stated a patient was believed to have received less than the recommended dosage of GARDASIL 9 due to needle leakage. No additional AE details or PQC.; needle leakage; Poor quality product administered; Product quality issue; This spontaneous report has been received from a nurse and refers to a patient, of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot  number: 1780876, expiration date reported as 09-NOV-2023, administered for prophylaxis (strength, and route of administration were not provided). The patient was believed to have received less than the recommended dosage of he suspect vaccine due to needle leakage (underdose, needle issue, poor quality product administered, and product quality issue). No additional adverse event reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; administered after a temperature excursion; This spontaneous report was received from a Licensed Practical Nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 19-JUL-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) by oral route, lot # 1837116, expiration date: 24-MAR-2023, administered for prophylaxis (formulation, and strength were not provided), after the vaccine was exposed to a temperature excursion of 4 hours 12 minutes and at a temperature of 10.8 Celsius degree (product storage error). No additional adverse event was reported (no adverse event).
Sex: F
Vaccine: PPV
Symptoms: Autoantibody positive, B-lymphocyte count, Blood immunoglobulin A decreased, Blood immunoglobulin G, Blood immunoglobulin G decreased
Clinical narrative: decreased specific antibody response after immunization with Pneumovax; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 62-year-old female patient with chronic obstructive pulmonary disease (COPD). She developed four acute exacerbations of COPD (AECOPD) over the past year, manifested as acute worsening of cough, dyspnea, and sputum production. She required hospitalization three times and was treated with systemic glucocorticoids, antibiotics, and short-acting bronchodilators. Sputum culture on one occasion grew Streptococcus pneumoniae. She had two AECOPD treated the previous year with outpatient oral antibiotics. Chest CT during hospitalizations showed emphysematous changes without bronchiectasis. She had a remote history of pneumonia and three to four sinus infections, but no other history of recurrent or unusual infections. She smoked two packs per day (/d) for 25 years and stopped 5 years ago. Concomitant medications included high-dose inhaled corticosteroid (ICS), long-acting b-agonist (LABA), long-acting muscarinic antagonist (LAMA), roflumilast and azithromycin.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (dose, strength, lot #, expiry date, site and route of administration were not provided) for prophylaxis. After immunization with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), she had a decreased specific antibody response, with two of 23 pneumococcal antibody levels above 1.3 microg/mL. On an unknown date, the immune workup demonstrated consistently decreased immunoglobulin G (IgG) of 340 (610-1500 mg/dL), immunoglobulin A (IgA) of 24 (80-450 mg/dL), and immunoglobulin M (IgM) of 42 (40-230 mg/dL), without systemic glucocorticoids. Lymphocyte immunophenotyping showed normal B-, T-, and natural killer cell subsets and normal switched memory B cells. The IgG levels to tetanus and diphtheria were in the protective range. She was given the diagnosis of common variable immune deficiency (CVID) and began 150 mg/kg weekly subcutaneous immunoglobulin therapy. Outcome of the event decreased specific antibody response was not reported.  The reporter considered decreased specific antibody response to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  Literature Report  A copy of the published article is attached as further documentation of the patient's experience. This is one of 2 reports derived from the same literature article (cross referenced with MARRS #2207USA008796).; Sender's Comments:  US-009507513-2207USA008796:
Sex: F
Vaccine: PPV
Symptoms: Blood immunoglobulin M decreased, Immunisation reaction, Immunodeficiency common variable, Immunoglobulin therapy, Immunology test
Clinical narrative: decreased specific antibody response after immunization with Pneumovax; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 62-year-old female patient with chronic obstructive pulmonary disease (COPD). She developed four acute exacerbations of COPD (AECOPD) over the past year, manifested as acute worsening of cough, dyspnea, and sputum production. She required hospitalization three times and was treated with systemic glucocorticoids, antibiotics, and short-acting bronchodilators. Sputum culture on one occasion grew Streptococcus pneumoniae. She had two AECOPD treated the previous year with outpatient oral antibiotics. Chest CT during hospitalizations showed emphysematous changes without bronchiectasis. She had a remote history of pneumonia and three to four sinus infections, but no other history of recurrent or unusual infections. She smoked two packs per day (/d) for 25 years and stopped 5 years ago. Concomitant medications included high-dose inhaled corticosteroid (ICS), long-acting b-agonist (LABA), long-acting muscarinic antagonist (LAMA), roflumilast and azithromycin.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (dose, strength, lot #, expiry date, site and route of administration were not provided) for prophylaxis. After immunization with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), she had a decreased specific antibody response, with two of 23 pneumococcal antibody levels above 1.3 microg/mL. On an unknown date, the immune workup demonstrated consistently decreased immunoglobulin G (IgG) of 340 (610-1500 mg/dL), immunoglobulin A (IgA) of 24 (80-450 mg/dL), and immunoglobulin M (IgM) of 42 (40-230 mg/dL), without systemic glucocorticoids. Lymphocyte immunophenotyping showed normal B-, T-, and natural killer cell subsets and normal switched memory B cells. The IgG levels to tetanus and diphtheria were in the protective range. She was given the diagnosis of common variable immune deficiency (CVID) and began 150 mg/kg weekly subcutaneous immunoglobulin therapy. Outcome of the event decreased specific antibody response was not reported.  The reporter considered decreased specific antibody response to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  Literature Report  A copy of the published article is attached as further documentation of the patient's experience. This is one of 2 reports derived from the same literature article (cross referenced with MARRS #2207USA008796).; Sender's Comments:  US-009507513-2207USA008796:
Sex: F
Vaccine: PPV
Symptoms: Immunophenotyping, Natural killer cell activity normal, T-lymphocyte count normal
Clinical narrative: decreased specific antibody response after immunization with Pneumovax; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 62-year-old female patient with chronic obstructive pulmonary disease (COPD). She developed four acute exacerbations of COPD (AECOPD) over the past year, manifested as acute worsening of cough, dyspnea, and sputum production. She required hospitalization three times and was treated with systemic glucocorticoids, antibiotics, and short-acting bronchodilators. Sputum culture on one occasion grew Streptococcus pneumoniae. She had two AECOPD treated the previous year with outpatient oral antibiotics. Chest CT during hospitalizations showed emphysematous changes without bronchiectasis. She had a remote history of pneumonia and three to four sinus infections, but no other history of recurrent or unusual infections. She smoked two packs per day (/d) for 25 years and stopped 5 years ago. Concomitant medications included high-dose inhaled corticosteroid (ICS), long-acting b-agonist (LABA), long-acting muscarinic antagonist (LAMA), roflumilast and azithromycin.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (dose, strength, lot #, expiry date, site and route of administration were not provided) for prophylaxis. After immunization with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), she had a decreased specific antibody response, with two of 23 pneumococcal antibody levels above 1.3 microg/mL. On an unknown date, the immune workup demonstrated consistently decreased immunoglobulin G (IgG) of 340 (610-1500 mg/dL), immunoglobulin A (IgA) of 24 (80-450 mg/dL), and immunoglobulin M (IgM) of 42 (40-230 mg/dL), without systemic glucocorticoids. Lymphocyte immunophenotyping showed normal B-, T-, and natural killer cell subsets and normal switched memory B cells. The IgG levels to tetanus and diphtheria were in the protective range. She was given the diagnosis of common variable immune deficiency (CVID) and began 150 mg/kg weekly subcutaneous immunoglobulin therapy. Outcome of the event decreased specific antibody response was not reported.  The reporter considered decreased specific antibody response to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  Literature Report  A copy of the published article is attached as further documentation of the patient's experience. This is one of 2 reports derived from the same literature article (cross referenced with MARRS #2207USA008796).; Sender's Comments:  US-009507513-2207USA008796:
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dyspnoea, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: She felt shortness of breath; feeling sore and weak; pain in her L arm (from where se received the injection of PNEUMOVAX 23 the day before); feeling sore and weak; the swelling was not only around the injection site, but also in her L armpit; PNEUMOVAX 23 was inadvertently administered to a patient on 26-JUL-2022 after it was improperly stored; This spontaneous report was received from a licensed practical nurse and refers to a 73-year-old female patient. The patient's medical history included right cataract. The patient's concurrent conditions included asthma, depression, iron deficiency anaemia, heart murmur, tobacco use and shortness of breath (dyspnea on exertion). Concomitant medications included dextran (reported also as artificial tears), famotidine (PEPCID), iron supplement, salbutamol (ALBUTEROL) inhaler, formoterol fumarate (+) mometasone furoate (DULERA) inhaler and loratadine (CLARITINE).   On 26-JUL-2022, the patient was inadvertently vaccinated with improperly stored (product storage error) dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe, 0.5 milliliter, administered in her left arm, lot #: W004863 upon internal validation was confirmed as valid, expiration date: 21-AUG-2023 (strength and route of administration were not provided) for prevention of pneumococcal disease. Temperature excursion information: 8.7 degree Celsius for 15 minutes. No previous temperature excursion.   On 27-JUL-2022, the patient felt shortness of breath, swelling and pain in her left arm from where she received the injection of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) the day before. The swelling was not only around the injection site but also in her left armpit. On the same day, the patient was feeling sore and weak. The reporter recommended the patient to go to emergency room but the patient declined and the reporter was unaware of the patient receiving or seeking any medical treatment. On 28-JUL-2022, the reporter followed up again with the patient and she reported that the swelling had improved. Outcome of the rest of events was not provided.   The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: She felt shortness of breath; feeling sore and weak; pain in her L arm (from where se received the injection of PNEUMOVAX 23 the day before); feeling sore and weak; the swelling was not only around the injection site, but also in her L armpit; PNEUMOVAX 23 was inadvertently administered to a patient on 26-JUL-2022 after it was improperly stored; This spontaneous report was received from a licensed practical nurse and refers to a 73-year-old female patient. The patient's medical history included right cataract. The patient's concurrent conditions included asthma, depression, iron deficiency anaemia, heart murmur, tobacco use and shortness of breath (dyspnea on exertion). Concomitant medications included dextran (reported also as artificial tears), famotidine (PEPCID), iron supplement, salbutamol (ALBUTEROL) inhaler, formoterol fumarate (+) mometasone furoate (DULERA) inhaler and loratadine (CLARITINE).   On 26-JUL-2022, the patient was inadvertently vaccinated with improperly stored (product storage error) dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe, 0.5 milliliter, administered in her left arm, lot #: W004863 upon internal validation was confirmed as valid, expiration date: 21-AUG-2023 (strength and route of administration were not provided) for prevention of pneumococcal disease. Temperature excursion information: 8.7 degree Celsius for 15 minutes. No previous temperature excursion.   On 27-JUL-2022, the patient felt shortness of breath, swelling and pain in her left arm from where she received the injection of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) the day before. The swelling was not only around the injection site but also in her left armpit. On the same day, the patient was feeling sore and weak. The reporter recommended the patient to go to emergency room but the patient declined and the reporter was unaware of the patient receiving or seeking any medical treatment. On 28-JUL-2022, the reporter followed up again with the patient and she reported that the swelling had improved. Outcome of the rest of events was not provided.   The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Age: 11.0
Sex: M
Vaccine: MMR, MNQ
Symptoms: No adverse event, Product preparation error, Wrong product administered
Clinical narrative: no adverse event; HCP called to report administration of MMR II reconstituted with MENACTRA vaccine instead of MRK STERILE DILUENT; HCP called to report administration of MMR II reconstituted with MENACTRA vaccine instead of MRK STERILE DILUENT; This spontaneous report was received from a pharmacist and refers to an 11-year-old male patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 04-AUG-2022, the patient was vaccinated with measles, mumps, and rubella virus vaccine, live (M-M-R II)0.5 ml, frequency reported as once (strength, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis. The measles, mumps, and rubella virus vaccine, live (M-M-R II) vaccine was reconstituted with meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) vaccine (strength, dosage regimen, lot #, expiry date,  and route of administration were not provided) as prophylaxis, instead of sterile diluent (Vaccine incorrect diluent used, wrong drug administered). No adverse event was reported.
Age: 27.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional adverse event; Caller reports VARIVAX administered IM to a 27yo.; This spontaneous report was received from a nurse and refers to a 27-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 04-AUG-2022, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot # U015688, expiration date: 18-MAY-2023, that was administered intramuscularly for prophylaxis (anatomical location was not provided) (Incorrect route of product administration). No additional adverse events were reported.