chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Therapeutic response decreased
Clinical narrative: inadequate titer response; This literature marketed report was received from the authors of a published literature article, titled as stated below, and refers to a child patient of unknown age and gender (mean age of group of the patients in the article was 12 years old +/- 2.9). The patient's concurrent conditions included sickle cell disease (SCD) and immunodeficiency. The patient's medical history included chronic transfusion therapy. The patient was vaccinated with 7-valent pneumococcal conjugate vaccine (reported as PCV7) or 13-valent pneumococcal conjugate vaccine (reported as PCV13), or both.  On an unknown date, the patients was vaccinated with 2 doses of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as PPSV23), for prophylaxis (dose, route of administration, lot # and expiration date were not provided). The vaccinations were given at 2 and 5 years of age, or in 3 to 5 years interval if vaccination was initiated at a later age.  Five (+/- 1) years after completion of a 2-dose pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) vaccination series (also reported as 5.42 +/- 1.19 years) , the patient had inadequate titers (also reported as inadequate response) which was defined as immunoglobin (Ig) G levels less than 1.3 mcg/mL. The patient did not have any serious pneumococcal infections. The outcome of the event was not provided. The data analysis did not demonstrate associations between disease characteristics with an inadequate immune response. It was considered that the event was related to the suspect vaccine, as the authors stated that the patient had inadequate titers despite vaccination.  A copy of the published article is attached as further documentation of the patient's experience.   This is one of two reports derived from the same literature article (cross-referenced with US-009507513-2106USA002866).; Sender's Comments:  US-009507513-2106USA002866:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: no other AEs reported; Caller is a medical assistant reporting that a 35 year old patient received a dose ofPROQUAD today, 25Jun2021. Per caller, the patient was supposed to receive MMR II and V ARlV AX separately.; Caller is a medical assistant reporting that a 35 year old patient received a dose ofPROQUAD today, 25Jun2021. Per caller, the patient was supposed to receive MMR II and V ARlV AX separately.; This spontaneous report was received from a medical assistant and refers to a 35-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 25-JUN-2021, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin) (PROQUAD) lot # T027112 was confirmed to be valid, expiration date 07-FEB-2022, 1 injection for prophylaxis (exact dose, route and site of administration were not reported) (inappropriate age at vaccine administration ). The patient was supposed to receive Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) separately (wrong vaccine administered). No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: NO additional AE's; M-M-R II that underwent a temperature excursion and was administered.; This spontaneous report was received from an office manager and refers a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 15-JUN-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # S020162 was confirmed to be valid, expiration date 30-JUN-2021, for prophylaxis (dose, route and site of administration were not reported). The administered dose was exposed to the temperature of 57 degrees Fahrenheit (F) for 1 hour and 53 minutes, 56.3 F for 48 minutes, 47.8 F for 11 minutes and 47.8 F for 5 minutes. The previous temperature excursion was reported as temperature out of range on 03-JUN-2020 for 1 hour and 53 minutes and reached 57 F, 04-JUN-2020 for 48 minutes and reached 56.3 F, 10-SEP-2020 for 11 minutes and reached 47.8 F. The call was because of a digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's.; temperature excursion that occurred on ROTATEQ; This spontaneous report was received from a physician referring to patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.   On 24-JUN-2021, the patient was vaccinated with oral rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose,  frequency, were not provided) for prophylaxis. Lot No. T028130 has been verified to be a valid lot number for [rotavirus vaccine, live, oral, pentavalent], expiration date reported as 28-JAN-2022, and upon internal validation established as the same.  The physician reported that the vaccine dose was administered on 24-JUN-2021 to the patient and the vaccine was improperly stored (incorrect product storage). The vaccine presented a temperature excursion with digital data logger, at a temperature of 36 Fahrenheit (F) to 46F (47.8F) for 0 hours 5 minutes and 0 seconds and a second temperature excursion with a temperature of 36F to 46F (47.8F) for 0 hours 5 minutes and 0 seconds. No previous temperature excursion had occurred. And no adverse events were reported.
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Underdose
Clinical narrative: unspecified number of patients have potentially been given a smaller than recommended dose; prescribing information is confusing and contradictory; no additional information; This spontaneous report as received from a nurse, referring to multiple unspecified patients of unknown age and unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.     On an unknown date,  the patients was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (0.5 ml, strength, route and lot# were not provided), measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (0.5 ml, strength, route and lot# were not provided) and varicella virus vaccine live (oka/merck)(VARIVAX) (0.5 ml, strength, route and lot# were not provided) for prophylaxis (an unspecified number of patients have potentially been given a smaller than recommended dose) (underdose). The prescribing information was confusing and contradictory (product label confusion). In section 2.2 of the prescribing information it states to withdraw the entire amount of the reconstituted vaccine, inject the total volume and discard the vial. She states that most of the time the reconstituted amount is greater than 0.5 ml. She has always administered 0.5 ml which the prescribing information also states as the appropriate dose (section 2.1). She was concerned because "for 10 years" that she has worked in pediatrics she had given and taught other nurses and MA's to give 0.5 ML dose of the vaccine. She is worried that the children have not been adequately vaccinated based on this information in the prescribing information (Section 2.2). No additional information.  This is a non-valid case due to no patients' identifiers.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; an expired dose of ROTATEQ was administered today; This spontaneous report was received from a medical assistance regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not provided.  On 28-JUN-2021 (reported as "today"), the patient was vaccinated with 1 expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot number 1660992 has been verified to be valid, expiration date reported and validated as 30-APR-2021; vaccination scheme frequency was not reported) via oral route for prophylaxis (expired product administered). It was also reported that Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was properly stored up through the time of administration.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Facial paralysis; This case was received via FDA VAERS (Reference number: 1389251) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of FACIAL PARALYSIS (Facial paralysis) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (diflucan) and Allergy (poppy seeds).    On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FACIAL PARALYSIS (Facial paralysis) (seriousness criteria hospitalization and medically significant). At the time of the report, FACIAL PARALYSIS (Facial paralysis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided. Treatment medication information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Incomplete course of vaccination
Clinical narrative: first shot last Oct 2020; experienced the allergic reactions; This case was reported by a consumer and described the occurrence of allergic reaction in a unspecified number patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 19th April 2021, between 5 and 7 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the allergic reaction and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.   Additional details were reported as follows: The age at vaccination was not reported for 1st dose. The patient received 1st dose and experienced allergic reaction. Till the time of reporting, patient didn't received second dose of Shingrix, which led to incomplete course of vaccination. This case was linked with US2021AMR137024, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR137024:Same reporter
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Impaired work ability
Clinical narrative: Mild anaphylaxis; This case was reported by a nurse via sales rep and described the occurrence of anaphylaxis in a 25-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number 7923K, expiry date unknown) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2020, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 7th October 2020, 1 days after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the patient experienced . On an unknown date, the outcome of the anaphylaxis and  were unknown.   The reporter considered the anaphylaxis to be related to Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient had received Fluarix and experienced mild anaphylaxis on the next day after vaccination.  The patient went to Emergency Room and was out of work for the day.  Reporter and Emergency Room's doctor believed that the event was related to the vaccine. The reporter consented to follow-up.
Age: 0.42
Sex: M
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: Rotarix dose via IM instead of oral; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate route of vaccination in a 5-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 7S55T, expiry date 7th September 2021) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator (batch number 7S55T, expiry date 7th September 2021) for prophylaxis.   On 21st June 2021, the patient received the 1st dose of Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 21st June 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination 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 details were reported as follows: On 21st June 2021, the patient received a Rotarix dose via IM instead of oral, wrong route of administration occurred which led to inappropriate route of vaccination. The reporter consented to follow up.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: patient received a dose of expired Pediarix.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 7-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number YS4Z5, expiry date 21st June 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th June 2021, the patient received Pediarix (intramuscular) .5 ml and Pediarix Pre-Filled Syringe Device. On 29th June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were reported as follows : This case was reported by a nurse. The nurse reported that the patient received a dose of Pediarix, which was expired on 21st June 2021. The Health care professional reported the dose was 0.5 ml. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Contusion, Peripheral swelling, Pruritus
Clinical narrative: SWELLING OCCURRING FROM TIME TO TIME IN LEFT FOOT/SWELLING OF LEFT FOOT AND RIGHT HAND/FINGER; BRUISE; TENDERNESS; BURNING SENSATION; VEINS ARE MORE PUFFED UP DISTENDED AND SWOLLEN; DISCOLORATION OF FOOT AND HAND/ FINGER; LESION/BLISTER ON FOOT; ITCHING ON LEFT FOOT; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight was 200 pounds, and height was 65 inches. The patient's concurrent conditions included deep vein thrombosis, hypothyroidism, hypertension, penicillin allergy, nickel allergy, wasp sting, peanut allergy, alcohol user, and non smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: 20-MAY-2021) dose was not reported, administered on 11-MAR-2021 15:11 for prophylactic vaccination. Concomitant medications included epinephrine for anaphylaxis, cannabidiol for burning sensation on back of hand/are of foot or hand, acetylsalicylic acid for prevention of deep vein thrombosis, amlodipine for treatment of hypertension, and levothyroxine sodium for treatment of hypothyroidism.  On APR-2021, the subject experienced lesion/blister on foot. On APR-2021, the subject experienced itching on left foot. On 17-APR-2021, the subject experienced discoloration of foot and hand/ finger. On an unspecified date, the subject experienced swelling occurring from time to time in left foot/swelling of left foot and right hand/finger, bruise, tenderness, burning sensation, and veins are more puffed up distended and swollen. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, and X-ray (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lesion/blister on foot, had not recovered from itching on left foot, discoloration of foot and hand/ finger, swelling occurring from time to time in left foot/swelling of left foot and right hand/finger, and bruise, and the outcome of tenderness, burning sensation and veins are more puffed up distended and swollen was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Skin lesion, Tenderness, Vasodilatation, X-ray
Clinical narrative: SWELLING OCCURRING FROM TIME TO TIME IN LEFT FOOT/SWELLING OF LEFT FOOT AND RIGHT HAND/FINGER; BRUISE; TENDERNESS; BURNING SENSATION; VEINS ARE MORE PUFFED UP DISTENDED AND SWOLLEN; DISCOLORATION OF FOOT AND HAND/ FINGER; LESION/BLISTER ON FOOT; ITCHING ON LEFT FOOT; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight was 200 pounds, and height was 65 inches. The patient's concurrent conditions included deep vein thrombosis, hypothyroidism, hypertension, penicillin allergy, nickel allergy, wasp sting, peanut allergy, alcohol user, and non smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: 20-MAY-2021) dose was not reported, administered on 11-MAR-2021 15:11 for prophylactic vaccination. Concomitant medications included epinephrine for anaphylaxis, cannabidiol for burning sensation on back of hand/are of foot or hand, acetylsalicylic acid for prevention of deep vein thrombosis, amlodipine for treatment of hypertension, and levothyroxine sodium for treatment of hypothyroidism.  On APR-2021, the subject experienced lesion/blister on foot. On APR-2021, the subject experienced itching on left foot. On 17-APR-2021, the subject experienced discoloration of foot and hand/ finger. On an unspecified date, the subject experienced swelling occurring from time to time in left foot/swelling of left foot and right hand/finger, bruise, tenderness, burning sensation, and veins are more puffed up distended and swollen. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, and X-ray (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lesion/blister on foot, had not recovered from itching on left foot, discoloration of foot and hand/ finger, swelling occurring from time to time in left foot/swelling of left foot and right hand/finger, and bruise, and the outcome of tenderness, burning sensation and veins are more puffed up distended and swollen was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Chills, Cognitive disorder, Feeling cold
Clinical narrative: WEIRD DREAMS; COGNITIVE CHANGES; FEELING LIKE FREEZING; CHILLS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-JUN-2021, the subject experienced feeling like freezing. On 21-JUN-2021, the subject experienced weird dreams. On 21-JUN-2021, the subject experienced cognitive changes. On 21-JUN-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, weird dreams, cognitive changes, and feeling like freezing. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site nodule, Injection site warmth, Musculoskeletal stiffness, Pain in extremity, SARS-CoV-2 test
Clinical narrative: KNOT AT INJECTION SITE (2 INCHES IN DIAMETER); INJECTION SITE WARMTH; ACHINESS IN THE LEFT ARM; STIFFNESS IN LEFT ARM; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and pneumonia, and concurrent conditions included haskimoto thyroiditis, fibromyalgia, asthma, and allergies. The patient experienced ibuprofen allergy when treated with ibuprofen.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-JUN-2021, the subject experienced stiffness in left arm. On 19-JUN-2021, the subject experienced achiness in the left arm. On 21-JUN-2021, the subject experienced knot at injection site (2 inches in diameter). On 21-JUN-2021, the subject experienced injection site warmth. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive, Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stiffness in left arm, and achiness in the left arm on 21-JUN-2021, and was recovering from knot at injection site (2 inches in diameter), and injection site warmth. This report was non-serious.; Sender's Comments: V0-Medical Assessment comment is not required as per standard procedures, as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypophagia, Therapeutic response unexpected
Clinical narrative: A STRONG HEADACHE; DID NOT EAT MUCH; UNEXPECTED THERAPEUTIC BENEFIT/ ROSACEA SYMPTOMS IMPROVED/DISAPPEARED; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included bruising on thumb, and concurrent conditions included rosacea, iodine allergy, dust allergy, pollen allergy, pustules mostly present on her face and nose, and ocular rosacea. The patient was previously treated with acetylsalicylic acid for bruising on thumb; and experienced drug allergy when treated with dextropropoxyphene hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. Concomitant medications included doxycycline for ocular rosacea, rosacea, and pustules mostly present on her face and nose, and clindamycin. On 14-MAR-2021, the subject experienced unexpected therapeutic benefit/ rosacea symptoms improved/disappeared. On 15-MAR-2021, the subject experienced a strong headache. On 15-MAR-2021, the subject experienced did not eat much. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a strong headache on 16-MAR-2021, and the outcome of unexpected therapeutic benefit/ rosacea symptoms improved/disappeared and did not eat much was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS AFTER BEING VACCINATED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: paliperidone palmitate ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On an unspecified date, the subject experienced flu like symptoms after being vaccinated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with paliperidone palmitate was not reported. The outcome of flu like symptoms after being vaccinated was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Loss of personal independence in daily activities, Pain, Psoriatic arthropathy
Clinical narrative: FLARE LOWER BACK/ SCALP/EARS AND ON FACE; A LOT OF PAIN; MAKING DAILY ACTIVITIES DIFFICULT; This solicited report received from a patient via PPSIMM001960: Pharmacy concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included morphine allergy. The patient was treated with guselkumab (solution for injection, subcutaneous, batch number was not reported) 100 mg, 1 time every 8 weeks, from 25-SEP-2020 for psoriatic arthritis. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, Expiry : unknown) dose was not reported, 1 total, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included naproxen for drug used for unknown indication, hydrochlorothiazide/triamterene, losartan potassium, metformin, and metoprolol.  On MAY-2021, the patient experienced flare of Psoriatic arthritis in the lower back/ scalp/ears and on face. The patient was also experiencing a lot of pain, making daily activities difficult. The action taken with covid-19 vaccine ad26.cov2.s, and guselkumab was not applicable. The patient had not recovered from flare lower back/ scalp/ears and on face, a lot of pain, and making daily activities difficult. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and flare lower back/ scalp/ears and on face, a lot of pain, and making daily activities difficult was not related; and between guselkumab, and flare lower back/ scalp/ears and on face was related, and between guselkumab, and a lot of pain, and making daily activities difficult was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210652721-covid-19 vaccine ad26.cov2. s- flare lower back/ scalp/ears and on face. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE. V0: 20210652721- Guselkumab- flare lower back/ scalp/ears and on face was related. This event(s) is labeled per regulatory authority and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: 2ML OF VACCINE ADMINISTERED TO A PATIENT; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) 2 ml, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-JUN-2021, the subject experienced 2ml of vaccine administered to a subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 2ml of vaccine administered to a patient was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Illness, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SICK FOR 1 DAY AFTER EVERY COUPLE  OF WEEKS; SAD REACTION; SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a 45 year old male patient. The patient's weight was 170 pounds, and height was 68 inches. The patient's concurrent conditions included cancer and non smoker and other pre-existing medical conditions included no known allergies. The patient suffers from cancer and had gone through chemotherapy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: 1805018 expiry: unknown) dose was not reported, with frequency 1 total dose administered on APR-2021 (exact date asked but unknown) for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced sad reaction to the vaccine which lasted for 5 days (no hospitalization) and after every couple of weeks, patient felt sick for 1 day. On 20-JUN-2021, the patient started feeling fatigue and loss of appetite. On 23-JUN-2021, the patient tested for Covid-19, and the results came back positive on 24-JUN-2021. On 24-JUN-2021, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection. However, consumer could not provide details on the type of Covid-19 testing.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick, and sad reaction, and the outcome of suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000184005. The suspected product quality complaint has been confirmed to be not voided, the reported allegation could not be confirmed. a manufacturing related root cause could not be identified. based on the PQC evaluation/investigation performed.  Additional information received from product quality department on 28-JUN-2021. The following information was updated and incorporated into case narrative: PQC result updated.; Sender's Comments: V0: 20210654471-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, SPECIAL SITUATIONS.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: VACCINE ADMINISTERED TO A 14 YEAR OLD PATIENT; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 14 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-JUN-2021, the subject experienced vaccine administered to a 14 year old subject. On 23-JUN-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to a 14 year old patient and off label use was not reported. This report was non-serious.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: EXPIRED VACCINE USED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no illness at the time of vaccination, past history of similar event, patient had no adverse event after any previous vaccination, patient had no history of allergy to vaccine, drug, or food, patient had no family history of any disease (relevant to vaccination) or allergy. it was not confirmed by test, if event is covid-19 infection. patient have no allergies and history of history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, expiry: 11-JUN-2021) .5 ml, administered on 12-JUN-2021 09:15 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced expired vaccine used. On 12-JUN-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine used and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210629340.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Frequent bowel movements, Musculoskeletal stiffness, Ultrasound scan, Urinary tract infection
Clinical narrative: URINARY TRACT INFECTION SYMPTOMS (URGENCY TO URINATE AND BURNING)/ ELEVATED WBC AND NITRATES; UPSET STOMACH; INCREASED FREQUENCY OF BOWEL MOVEMENTS/NUMBER 2 MORE OFTEN; STIFF NECK; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 235 pounds, and height was 64 inches. The patient's past medical history included hysterectomy, gall bladder removal, lost voice, urinary tract infections, factor v leiden, and biceps tenodesis, and concurrent conditions included high blood pressure, seasonal allergies, and environmental allergies ( cannot use cleaners wheeze and headache with bleach, perfume).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included salbutamol for allergies, amlodipine for high blood pressure, lisinopril for high blood pressure, and epinephrine for stings. On 09-APR-2021, the subject experienced stiff neck. On JUN-2021, the subject experienced upset stomach. On JUN-2021, the subject experienced increased frequency of bowel movements/number 2 more often. On 16-JUN-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Enlarged liver, but her bladder was emptying properly, and Urine analysis (NR: not provided) Not reported. On an unspecified date, the subject experienced urinary tract infection symptoms (urgency to urinate and burning) / elevated wbc and nitrates. Laboratory data (dates unspecified) included: Urinalysis (NR: not provided) positive for increased WBC, nitrates and negative for infection, positive urinary tract infections. Treatment medications (dates unspecified) included: ibuprofen, nitrofurantoin, azithromycin, phenazopyridine, and phenazopyridine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from urinary tract infection symptoms (urgency to urinate and burning)/ elevated wbc and nitrates, and increased frequency of bowel movements/number 2 more often, and had not recovered from stiff neck, and upset stomach. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: URINARY TRACT INFECTION SYMPTOMS (URGENCY TO URINATE AND BURNING)/ ELEVATED WBC AND NITRATES; UPSET STOMACH; INCREASED FREQUENCY OF BOWEL MOVEMENTS/NUMBER 2 MORE OFTEN; STIFF NECK; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 235 pounds, and height was 64 inches. The patient's past medical history included hysterectomy, gall bladder removal, lost voice, urinary tract infections, factor v leiden, and biceps tenodesis, and concurrent conditions included high blood pressure, seasonal allergies, and environmental allergies ( cannot use cleaners wheeze and headache with bleach, perfume).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included salbutamol for allergies, amlodipine for high blood pressure, lisinopril for high blood pressure, and epinephrine for stings. On 09-APR-2021, the subject experienced stiff neck. On JUN-2021, the subject experienced upset stomach. On JUN-2021, the subject experienced increased frequency of bowel movements/number 2 more often. On 16-JUN-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Enlarged liver, but her bladder was emptying properly, and Urine analysis (NR: not provided) Not reported. On an unspecified date, the subject experienced urinary tract infection symptoms (urgency to urinate and burning) / elevated wbc and nitrates. Laboratory data (dates unspecified) included: Urinalysis (NR: not provided) positive for increased WBC, nitrates and negative for infection, positive urinary tract infections. Treatment medications (dates unspecified) included: ibuprofen, nitrofurantoin, azithromycin, phenazopyridine, and phenazopyridine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from urinary tract infection symptoms (urgency to urinate and burning)/ elevated wbc and nitrates, and increased frequency of bowel movements/number 2 more often, and had not recovered from stiff neck, and upset stomach. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Bone densitometry, Bursitis, Fatigue
Clinical narrative: BLOODY STOOL; INFLAMED BURSA OF LEFT HIP, RADIATING TOWARDS SPINE; ARTHRALGIA; MYALGIA; SLIGHTLY LOW KIDNEY FUNCTION; FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism. The patient had no known allergies. The patient was previously treated with cortisone in shoulder joint.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-MAR-2021 on right arm for prophylactic vaccination. Concomitant medications included ascorbic acid, calcium, chondroitin sulfate/glucosamine hydrochloride, colecalciferol, levothyroxine sodium, and magnesium.  In the morning of 17-MAR-2021, the patient felt some fatigue, stayed in bed until noon and fatigue disappeared in the afternoon. On 07-APR-2021, the patient started experiencing pain and soreness in hamstring, behind knees and in hips. The pain and soreness gradually progressed upwards towards spine. The symptoms were worse in the morning and evening, with the period between noon and 8 PM saw some improvement. Since pain and soreness started, the patient had been taking painkillers like candy, Tylenol (paracetamol), Advil (ibuprofen) and Aleve (naproxen sodium) and had no effect on symptoms. On 21-APR-2021, the patient had some bloody stool and saw primary care physician that week. The blood tests, bone density and thyroid function were done. Only finding of note was slightly low kidney function and diagnosis of myalgia and arthralgia. The patient was told to discontinue painkiller use. On 12-JUN-2021, the patient saw orthopedist, was diagnosed with inflamed bursa on the left hip, radiating towards spine and was prescribed a 5 days tapering course of prednisone. The symptoms disappeared starting on the second day of prednisone. The symptoms reappeared with same severity 2 days after stopping prednisone (19-JUN-2021).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bloody stool on 21-APR-2021, and fatigue on 17-MAR-2021, had not recovered from inflamed bursa of left hip, radiating towards spine, myalgia, and arthralgia, and the outcome of slightly low kidney function was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210660357-covid-19 vaccine ad26.cov2.s- bloody stool, slightly low kidney function. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Haematochezia, Myalgia, Renal impairment, Thyroid function test
Clinical narrative: BLOODY STOOL; INFLAMED BURSA OF LEFT HIP, RADIATING TOWARDS SPINE; ARTHRALGIA; MYALGIA; SLIGHTLY LOW KIDNEY FUNCTION; FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism. The patient had no known allergies. The patient was previously treated with cortisone in shoulder joint.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-MAR-2021 on right arm for prophylactic vaccination. Concomitant medications included ascorbic acid, calcium, chondroitin sulfate/glucosamine hydrochloride, colecalciferol, levothyroxine sodium, and magnesium.  In the morning of 17-MAR-2021, the patient felt some fatigue, stayed in bed until noon and fatigue disappeared in the afternoon. On 07-APR-2021, the patient started experiencing pain and soreness in hamstring, behind knees and in hips. The pain and soreness gradually progressed upwards towards spine. The symptoms were worse in the morning and evening, with the period between noon and 8 PM saw some improvement. Since pain and soreness started, the patient had been taking painkillers like candy, Tylenol (paracetamol), Advil (ibuprofen) and Aleve (naproxen sodium) and had no effect on symptoms. On 21-APR-2021, the patient had some bloody stool and saw primary care physician that week. The blood tests, bone density and thyroid function were done. Only finding of note was slightly low kidney function and diagnosis of myalgia and arthralgia. The patient was told to discontinue painkiller use. On 12-JUN-2021, the patient saw orthopedist, was diagnosed with inflamed bursa on the left hip, radiating towards spine and was prescribed a 5 days tapering course of prednisone. The symptoms disappeared starting on the second day of prednisone. The symptoms reappeared with same severity 2 days after stopping prednisone (19-JUN-2021).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bloody stool on 21-APR-2021, and fatigue on 17-MAR-2021, had not recovered from inflamed bursa of left hip, radiating towards spine, myalgia, and arthralgia, and the outcome of slightly low kidney function was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210660357-covid-19 vaccine ad26.cov2.s- bloody stool, slightly low kidney function. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Dyspnoea, Feeling abnormal, Fibrin D dimer
Clinical narrative: POSSIBLE BLOOD CLOT ISSUE; ELEVATED HEART RATE (OVER 100 AT REST); KIDNEY PAIN; NO APPETITE; FLU LIKE SYMPTOMS; SWOLLEN GLANDS IN NECK; SERIOUS BRAIN FOG; DIARRHEA; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to contrast dye.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: unknown) dose was not reported, 1 total, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021 after getting vaccination, the patient experienced elevated heart rate of over 100 at rest for four days. On an unspecified date in JUN-2021 after vaccination, the patient also experienced shortness of breath, headache, kidney pain, diarrhea, no appetite, flu-like symptoms, swollen glands in neck, aches and pains and had severe fatigue. On 14-JUN-2021, after four days of vaccination, the patient heart rate decreased to a healthier range but shortness of breath, headache, swollen glands, extreme fatigue and diarrhea continued. The patient also had serious brain fog. On 21-JUN-2021, after 11 days of vaccination, the patient had a severe shortness of breath and the patient's PCP (primary care physician) directed patient to visit an emergency room in a hospital. The patient took blood test and showed an elevated d-dimer indicating possible blood clot issue. The patient could not perform lung CT (computed tomography) or angiography due to a severe allergy to contrast dye. The patient also had an MRI (magnetic resonance imaging) of brain and ultra sound of the legs and the results were normal. The patient was on day 16 post vaccination at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated heart rate (over 100 at rest) on 14-JUN-2021, had not recovered from flu like symptoms, swollen glands in neck, possible blood clot issue, serious brain fog, and diarrhea, and the outcome of shortness of breath, kidney pain and no appetite was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210660381-Covid 19 Vaccine ad26.cov2.s-Possible blood Clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).