chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Poor quality product administered, Product quality issue
Clinical narrative: states she is hot; had been a mishandling of vaccine she received; had been a mishandling of vaccine she received; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) f The reporter is the patient. A 51-year-old female patient received BNT162b2 (BNT162B2), on 19Jul2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Disabled" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but unknown manufacturer), for Covid-19 Immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 19Jul2022, outcome "unknown", PRODUCT QUALITY ISSUE (non-serious), outcome "unknown" and all described as "had been a mishandling of vaccine she received"; FEELING HOT (non-serious), outcome "unknown", described as "states she is hot".  Additional information: The patient was calling about the Pfizer COVID 19 vaccine. The patient stated she received her booster dose on19Jul2022. She then received a call on Sunday 31Jul2022 where she got her dose asking her how she was feeling and that there had been a mishandling of the vaccine at the pharmacy, but no other details were given. She wanted to make a report about that she has called the pharmacy back and they won't give her any details about what the mishandling was, if it was a temperature excursion or whatever. The patient was told that the pharmacy did call into Pfizer and today was Tuesday already and the patient just called in a little while ago saying that they did not hear back from Pfizer and so the patient was kind of freaking out because she did not know what the mishandling was. She did not know if the vaccine was good or proper because if they mishandled it, that told her that there might be something wrong,  she might be protected, but she might not be protected, and she lived with her father. Her father is 80 years old and the last thing she needed was for him to get him sick and get her family sick. She has called back and the pharmacy told her they were waiting to hear from Pfizer to tell her more details about her dose mishandling. She was asking if there was anything that can be done or any information about this. The patient stated she was disabled and had been stuck in her house because she didn't know what to do. The patient states she was hot, she lives in (withheld) and didn't know if that was why she was hot or if she was just nervous and that was why she was hot. She was very frustrated, not at Pfizer but just with this whole situation. She stated  they referred her to a web site and to Pfizer. The patient was appreciative for any help that can be given her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54-year-old male patient received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 53 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 had no relevant medical history. Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]; MUCINEX D; ZINC; VITAMIN C [ASCORBIC ACID]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient had a rebound case of covid within 5 days of finishing Paxlovid. Anti-viral details: product: COVID 19 Treatment, Treatment start date: 21Jun2022,Treatment stop date: 26Jul2022, Indication: Treatment of COVID-19, Administrator route: Oral  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54-year-old male patient received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 53 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 had no relevant medical history. Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]; MUCINEX D; ZINC; VITAMIN C [ASCORBIC ACID]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient had a rebound case of covid within 5 days of finishing Paxlovid. Anti-viral details: product: COVID 19 Treatment, Treatment start date: 21Jun2022,Treatment stop date: 26Jul2022, Indication: Treatment of COVID-19, Administrator route: Oral  No follow-up attempts are possible. No further information is expected.
Age: 4.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: Pt had a syncopal event w/ associated dizziness.   Vitals: 95/69, 84, 18, 99.0F, 100% O2 Pt given 2L O2 Pt stable and released from the vaccination site.  Recommended pt F/U w/ PCP.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Diarrhoea, Fatigue, Headache
Clinical narrative: 7/24/2022 - headache, nausea, diarrhea, weakness, fatigue, severe left knee pain, and flu-like symptoms.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea
Clinical narrative: 7/24/2022 - headache, nausea, diarrhea, weakness, fatigue, severe left knee pain, and flu-like symptoms.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Gait disturbance, Laboratory test, Muscle spasms
Clinical narrative: I have been in excruating pain since receiving the 2nd boost shot. I am unable to walk without using a walker,  which I not had to use since 2007. I was experiencing pain in my whole body, until the June, then the pain began moving down to my hips, thighs and legs. There is burning sensation, muscle cramps and sharp pain.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Radicular pain, Walking aid user
Clinical narrative: I have been in excruating pain since receiving the 2nd boost shot. I am unable to walk without using a walker,  which I not had to use since 2007. I was experiencing pain in my whole body, until the June, then the pain began moving down to my hips, thighs and legs. There is burning sensation, muscle cramps and sharp pain.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: I have been in excruating pain since receiving the 2nd boost shot. I am unable to walk without using a walker,  which I not had to use since 2007. I was experiencing pain in my whole body, until the June, then the pain began moving down to my hips, thighs and legs. There is burning sensation, muscle cramps and sharp pain.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Injection site erythema
Clinical narrative: Patient received 1st dose of Moderna vaccine on June 28, 2022. After three days, patient had symptoms of irritation, redness and itching at site of injection. The next 4 days, patient symptoms intensified and he experienced  chills, fatigue and headache. On the 5th day after receiving the Moderna vaccine, patient had noticeable erythema at site of injection. He went to an urgent care clinic June 28, 2022. He had an outpatient appointment for worsening symptoms July  6, 2022. Patient instructed to discontinue COVID-19 Moderna vaccine and receive Pfizer vaccine to complete initial COVID-19 vaccination series.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: Patient received 1st dose of Moderna vaccine on June 28, 2022. After three days, patient had symptoms of irritation, redness and itching at site of injection. The next 4 days, patient symptoms intensified and he experienced  chills, fatigue and headache. On the 5th day after receiving the Moderna vaccine, patient had noticeable erythema at site of injection. He went to an urgent care clinic June 28, 2022. He had an outpatient appointment for worsening symptoms July  6, 2022. Patient instructed to discontinue COVID-19 Moderna vaccine and receive Pfizer vaccine to complete initial COVID-19 vaccination series.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Bladder pain, Chills, Constipation, Dysuria, Pain
Clinical narrative: Difficulty urinating - feeling of a full bladder, but unable to urinate freely. Pain as if bladder is overly full. Constipation - unable to defecate at all from 8/2-8/5. Slowly recovering Fever and chills - 8/2-8/4 Body aches - 8/2 - 8/4 - managed with 600mg ibuprofen every 6 hours (4 x per day)
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Difficulty urinating - feeling of a full bladder, but unable to urinate freely. Pain as if bladder is overly full. Constipation - unable to defecate at all from 8/2-8/5. Slowly recovering Fever and chills - 8/2-8/4 Body aches - 8/2 - 8/4 - managed with 600mg ibuprofen every 6 hours (4 x per day)
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EK4176), in left arm, on 27Jan2021 as dose 2, single (Lot number: EN5318), in left arm and on 03Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient was treated with Antiviral (Paxlovid, Lot: 6D5282) from 30Jul2022. The patient did not received any other medication in 2 weeks before receiving Paxlovid. No known allergies were reported.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure and covid-19 and BNT162B2.
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Tumour vaccine therapy
Clinical narrative: A 30-year-old patient with recurrent respiratory papillomatosis (RRP) treated with Gardasil; Literature Report:   This literature marketed information has been received from the authors of a published article, title as above, regarding to a 30-year-old healthy female non-smoker with known recurrent respiratory papillomatosis (RRP)experienced rapid recurrence three months after initial surgical intervention, and repeated recurrence two months after additional surgical intervention. She declined further surgery and opted for quadrivalent human papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination(strength, dose, route of administration, lot# and expiration date were not provided)( Off label use), which led to spontaneous regression of most visible disease after a single injection. The remaining disease resolved completely after her second dose of the three-injection series.  At the initial presentation (October 2017) Videolaryngostroboscopic Exam Findings (Vocal fold mobility intact bilaterally during all exams): Papilloma presence was medial edges including superior surface of true vocal folds covered with sessile papilloma bilaterally, the medial edge appearance was irregular bilaterally, the glottic closure incomplete, and the mucosal wave and amplitude was absent on right, moderately decreased on left. The Derkay score was 10, 1 surgery was required, and the voice handicap index at the time was 29.  On an unspecified date in August 2018, (2 Months postop, prevaccination) the papilloma was present at left posterior and anterior commissure with a medial edge appearance of irregular bilaterally, the glottic closure was complete and the mucosal wave and amplitude was mild to moderately decreased bilaterally. The derkay score was 6, no surgery was required, and the voice handicap index at the time was 2.  On an unspecified date in October 2018, the patient received the first dose of quadrivalent human papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) and two months post first vaccination dose, it was clear for papilloma, except one small site at right zones 8-9. The medial edge appearance was Straight, fullness on right posterior fold, the Glottic Closure was complete, the Mucosal Wave and Amplitude was Normal bilaterally. The Derkay score was 2, no surgery was required, and the voice handicap index at the time was 0.  On an unknown date in December 2018, the patient received the second dose of quadrivalent human papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), and six months post second vaccination dose (June 2019), no papilloma was visualized, the medial edge appearance was straight, the glottic closure was complete and regular and the mucosal wave and amplitude was normal bilaterally. The Derkay score was 0, no surgery was required, and the voice handicap index at the time was 0.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Magnetic resonance imaging abnormal, Pulmonary thrombosis
Clinical narrative: Patient having a hard time breathing. MRI showed blood clots in both lungs.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: Central neurological cluster of symptoms  (dysosmia, fatigue, brain-fog, headache) , cardiorespiratory cluster of symptoms (difficulty breathing/shortness of breath, elevated heart rate).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Parosmia
Clinical narrative: Central neurological cluster of symptoms  (dysosmia, fatigue, brain-fog, headache) , cardiorespiratory cluster of symptoms (difficulty breathing/shortness of breath, elevated heart rate).
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Injection site pain, Vaccination site erythema, Vaccination site mass, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Vaccination site lump; Vaccination site redness; Vaccination site warmth; Vaccination site swelling; mild soreness at the injection site; mild soreness at the injection site; mild soreness at the injection site; This spontaneous report was received from a registered nurse, concerning a 36-year-old female patient. The patient's pertinent medical history included skin cancer diagnosed in 2012. The patient did not have any concomitant medications and drug reactions or allergies.  On 10-DEC-2021, 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) pre-filled syringe, in the left deltoid, at a dose of 0.5 milliliter (ml) by intramuscular route (lot number U008315, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 15-AUG-2023), indication reported as "human papillomavirus (HPV) vaccine". Subsequently, she experienced mild soreness at the injection site that lasted a few days and then went away (vaccination site pain).   On 25-FEB-2022 and 16-JUN-2022, she was vaccinated with the second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, in the left deltoid, at a dose of 0.5 milliliter (ml) by intramuscular route (lot numbers U032636 and U029623, which were verified to be valid lot numbers, expiration dates not reported but upon internal validation established as 26-OCT-2023). The reporter further stated, the patient developed new onset of mild soreness at the injection site that lasted a few days and then went away (vaccination site pain) on unspecified dates in 2022 reported as "after the second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)".  On 03-JUL-2022 reported as "approximately 2 weeks after the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)", the patient experienced redness, warmth and swelling with a lump at the injection site (vaccination site erythema, vaccination site warmth, vaccination site swelling and vaccination site mass). The patient was advised to use cold compress. However, she contacted physician on 05-JUL-2022, as there was no improvement, she was still experiencing redness and swelling.  At the time of the report, the outcome of the events vaccination site erythema, vaccination site warmth, vaccination site swelling and vaccination site mass was reported as not resolved.  Causality assessment was not provided by the reporter.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative, Vaccination failure
Clinical narrative: titer test for varicella and MMR and the results were low; titer test for varicella and MMR and the results were low; titer test for varicella and MMR and the results were low; titer test for varicella and MMR and the results were low; This spontaneous report was received from an office manager concerning to a 21-year-old male patient.   The patient medical history, current condition, previous drug reactions or allergies, and concomitant therapies was not reported.  On an unspecified date,in the past when he was younger,the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, both administered as prophylaxis (dose, strength, vaccination scheme frequency, route of administration, anatomical site of application, lot # and expiration date were not provided).  On unknown date in 2022 (also reported as "sometime in the past 6 weeks"), the patient did the titer test for varicella and measles, mumps, and rubella (MMR) and the results were low(antibody test negative, measles antibody negative, mumps antibody test negative, rubella antibody negative).  The outcome of the events antibody test negative, measles antibody negative, mumps antibody test negative and rubella antibody negative; and the causal relationship between the above-mentioned events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) were not provided
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Hyperhidrosis, Syncope
Clinical narrative: syncope; shortness of breath; diaphoresis; LIGHTHEADEDNESS; This spontaneous report was received from a physician and refers to a female patient of unknown age. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  In January 2009, the patient was vaccinated with the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) lot number reported as "0524u" (dose, route, anatomical location, and expiration date were not reported) for prophylaxis.  On the same date, the patient experienced lightheadedness (dizziness), diaphoresis (hyperhidrosis), shortness of breath (dyspnoea), and syncope.  The patient had recovered in the office and was sent home on the same date.  The relatedness between the events of syncope, dizziness, hyperhidrosis and dyspnoea with therapy of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) was not reported.  Upon internal review, syncope was determined to be medically significant event.  Lot number "0524u" is an invalid lot number for quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional Adverse event; ROTATEQ was 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 06-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°C (product storage error). No additional adverse event was reported (no adverse event)
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: developed breakthrough Varicella after being vaccinated with VARIVAX; This spontaneous report was received from a physician assistant and refers to a 4 or 5 years old child female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date in July 2022, the patient developed breakthrough Varicella after being vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX). The physician assistant reported that the patient was diagnosed at an urgent care and the case was uncomplicated. It was unknown what symptoms the patient experienced.  At the time of reporting, the outcome of breakthrough varicella was not known.   The causal relationship between breakthrough varicella and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event; a 4th dose of GARDASIL 9 was inadvertently administered to the patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 27-JUL-2022, the patient  was inadvertently vaccinated with the 4th dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) 0.5 milliliter, lot#U028826, expiration date 04-NOV-2023 (route of administration was not reported) as prophylaxis (extra dose administered). No adverse event was reported.
Sex: M
Vaccine: COVID19, COVID19, VARZOS
Symptoms: Atrial fibrillation, Diarrhoea, Injection site pain, Nausea
Clinical narrative: atrial fibrillation; BOTH WERE PAINFUL; diarrhea; nausea; This case was reported by a consumer via other manufacturer and described the occurrence of atrial fibrillation in a elderly male patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   Co-suspect products included ELASOMERAN (COVID-19 MRNA VACCINE MODERNA) for prophylaxis, COVID-19 MRNA VACCINE PFIZER for prophylaxis and ibrutinib (Imbruvica) for chronic lymphoid leukemia.   On an unknown date, the patient received Hz/su + AS01B, COVID-19 MRNA VACCINE MODERNA (intramuscular), COVID-19 MRNA VACCINE PFIZER (intramuscular) and Imbruvica (oral) at an unknown dose and frequency. On an unknown date, unknown after receiving Hz/su + AS01B, the patient experienced atrial fibrillation (serious criteria GSK medically significant), injection site pain, diarrhea and nausea. The action taken with Imbruvica was unknown. On an unknown date, the outcome of the atrial fibrillation, diarrhea and nausea were unknown and the outcome of the injection site pain was recovered/resolved.   The reporter considered the atrial fibrillation, injection site pain, diarrhea and nausea to be possibly related to Hz/su + AS01B.   Additional Information: GSK Receipt Date: 29-JUL-2022 Reporter's Comments: This was a solicited report by a consumer of an elderly male. The patient had moderna covid-19 vaccination and the shingles shot, one in each arm. The patient's both arms were painful, atrial fibrillation, diarrhea and nausea with imbruvica (ibrutinib).  There was no reported medical history. Concomitant drugs were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Primary reporter did not have the lot number information, because the packaging was discarded.  On an unknown date, unknown after receiving COVID-19 MRNA VACCINE MODERNA and COVID-19 MRNA VACCINE PFIZER, the patient experienced atrial fibrillation, vaccination site pain, diarrhea and nausea. The reporter considered the atrial fibrillation, vaccination site pain, diarrhea and nausea to be possibly related to COVID-19 MRNA VACCINE MODERNA and COVID-19 MRNA VACCINE PFIZER. Causality for IMBRUVICA (IBRUTINIB) was not reported with respect to atrial fibrillation, vaccination site pain, diarrhea and nausea. Follow-up would not be possible as no contact details available.
Age: 48.0
Sex: F
Vaccine: HEP, MEN
Symptoms: Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: for the second half (10 mcg) dose inadvertently administered an unknown Men B. on 5/15/22 instead of the other half of the Engerix B (10 mcg).; administered half dose of Engerix (10mcg) to adult patient on 4/12/22; administered half dose of Engerix (10mcg) to adult patient on 4/12/22; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 48-year-old female patient who received HBV (Engerix B 10 mcg) for prophylaxis.   Co-suspect products included Men B NVS (Meningococcal B vaccine) (batch number 2573G, expiry date 28th May 2022) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Meningococcal B Vaccine Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th April 2022, the patient received Engerix B 10 mcg. On 15th May 2022, the patient received Meningococcal B vaccine and Meningococcal B Vaccine Pre-Filled Syringe Device. On 12th April 2022, unknown after receiving Engerix B 10 mcg, the patient experienced underdose and adult use of a child product. On 15th May 2022, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the underdose, adult use of a child product and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 8-Jul-2022 Reporter's comment: Medical Assistant called in to inquired that how to proceed. The reporter reported they administered half dose of Engerix (10 mcg) to adult patient on 12th April 2022 and for the second half (10 mcg) dose inadvertently administered an unknown Meningococcal B on 15th May 2022, instead of the other half of the Engerix B (10 mcg).  The reporter stated they intended to split the Engerix (20 mcg) dose due to the patient's past with medication reactions.  The reporter did not consent to follow-up. Additional supportive information: The patient was administered half dose of Engerix 10 mcg to adult patient and for the second half (10 mcg) dose inadvertently administered an unknown Meningococcal B instead of the other half of the Engerix B (10 mcg), which led to underdose, adult use of a child product and wrong vaccine administered. The vaccine start date for unknown Meningococcal B vaccine was captured as per narrative information. As unknown Meningococcal B was reported therefore suspect was coded with generic name and device with the market.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Loss of personal independence in daily activities, Neuralgia, Rash
Clinical narrative: Blisters between fingers, palm hand; Mild rash up to the arm; Nerve pain; one finger is pretty much crippled; This case was reported by a consumer via interactive digital media and described the occurrence of blister in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced blister, rash, nerve pain and activities of daily living impaired. On an unknown date, the outcome of the blister, rash, nerve pain and activities of daily living impaired were unknown.   It was unknown if the reporter considered the blister, rash, nerve pain and activities of daily living impaired to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient did not end up with blisters until after the booster shot.  The patient only had couple of blisters between the fingers a few small ones and palm of the hand and then a rash, mild rash that went up the arm.  But, his/ her all started in the nerves and with nerve pain.  The patient now had one finger that was pretty much crippled.  That's on his/ her right hand. The patient was right-handed and had no idea if he / she would ever get the use of that finger back again.  The patient advised people to get the shot if they coukd, because if they did not know what nerve pain was trust him/ her they don't want to find out. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Nausea, Night sweats, Peripheral swelling
Clinical narrative: Arm is still swollen; Arm is still red; Night sweats; Nausea; Chills; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2022, the patient received the 1st dose of Shingrix. In July 2022, less than a day after receiving Shingrix, the patient experienced swelling arm, erythema of extremities, night sweat, nausea and chills. On an unknown date, the outcome of the swelling arm, erythema of extremities, night sweat, nausea and chills were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, erythema of extremities, night sweat, nausea and chills to be related to Shingrix.     Additional Information: GSK receipt date: 29-Jul-2022 Reporter comment: This case was reported by a patient via interactive digital media. The patient received the first dose of Shingrix. After 3 days the patient still had issues with arm swollen, red, night sweats, nausea and chills. The patient want to know that was this normal and how long does it go on. Additional Supportive Information: Follow-up would not possible, as no contact, details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st Shingrix on 25May2018 2nd will be today (01Aug2022); This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in an unknown arm intramuscularly on 25th May 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 01-Aug-2022 Reporter's comment: The reporter reported that he and his wife both had received the 1st dose of Shingrix vaccine. The reporter reported that they were not told that they need a 2nd dose of Shingrix vaccine to complete the series. The reporter stated that they would go on the day of reporting for their 2nd dose. The reporter did not gave consent to contact health care professional, but welcome to contact him and his wife. This case was linked to the case US2022113789, reported by the same reporter for himself. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2022113789:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Product administered at inappropriate site, Pyrexia, Rash macular, Urticaria
Clinical narrative: hives; 2 red blotches under my right arm; patient received 1st dose of Shingrix vaccine in late june, in my right shoulder; body aches; slight fever; This case was reported by a consumer and described the occurrence of general body pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hives.   In June 2022, the patient received the 1st dose of Shingrix. In June 2022, 1 day after receiving Shingrix, the patient experienced general body pain, fever and vaccine administered at inappropriate site. On an unknown date, the patient experienced hives and red blotches. On an unknown date, the outcome of the general body pain, fever, hives, red blotches and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the general body pain, fever, hives and red blotches to be related to Shingrix.     Additional Information: GSK Receipt Date: 1-Aug-2022 Reporter's Comments: On an unknown date, less than 2 months after receiving Shingrix, the patient experienced hives and red blotches. The patient received the 1st dose of the Shingrix vaccine in late June, in right shoulder. The patient had body aches and a slight fever the following day. The patient believed that he/she had hives which appeared as just 2 red blotches under right arm. The patient absolutely not sure they were hives but patient had hives in the past and they appeared to be hives. The patient wanted to know he/she should receive the 2nd dose or not. Additional Supportive Information: As patient received Shingrix vaccine in shoulder, which led to vaccine administered at inappropriate site.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix administered; This case was reported by a other health professional via other manufacturer and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number BG92Z, expiry date 7th April 2022) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 01-Aug-2022 Reporter's comment: The medical assistant called to asked a question about Recobivax Hib. During that call, she mentioned that Engerix-B was administered past its expiration date. No additional information was reported. No product quality complaint was reported. The reporter consented to follow-up. The case was linked with case US2022113782, reported by same reporter. Additional supportive information: The patient received an expired dose of Engerix-B, which led to expired vaccine used.; Sender's Comments:  US-GSK-US2022113782:Same reporter
Sex: U
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody, Therapeutic response decreased
Clinical narrative: Low titers, received a hep B vaccine series when babies; This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in an unspecified number of patients who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.   Additional Information: GSK receipt date: 2-Aug-2022 Reporter's comment: The health care professional also mentioned the most of the nurse staff had low titers of Hepatitis-B, so they decided to restart the series.  They received a Hepatitis-B vaccine series when they were babies. The reporter did not consent to follow-up. The case was linked with case US2022114307, reported by same reporter. Additional supportive information: The patients received Hepatitis-B vaccine series and had low titers of Hepatitis-B, which led to therapeutic response decreased.; Sender's Comments:  US-GSK-US2022114307:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2-3 years ago, forgot 2nd dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a 82-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had 1st dose of Shingrix about 2-3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 2-Aug-2022 Reporter's comment: The case was received from the patient via (Shingrix GSK Chatbot) interactive digital media. The patient had 1st dose of Shingrix about 2 to 3 years ago and forgot to follow up on 2nd dose.  The patient was concerned about getting 2nd dose now and wonder if better to start over and requesting for advise.  Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose August 2019, didn't get second yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received 1st dose in August 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 2-Aug-2022 Reporter's comment: The patient did not get his/her second shot yet. The patient asked that what should he/she do. Additional supportive information: Till the time of reporting the patient did not receive the second shot of Shingrix, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Age: 19.0
Sex: U
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration, Overdose, Product administered to patient of inappropriate age
Clinical narrative: first dose 1/6/22, second dose on 2/17/22; 19 year old received adult dose of 20 mcg; 19 year old received adult dose of 20 mcg; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 19-year-old patient who received HBV (Engerix B adult) (batch number 2793Z, expiry date 5th December 2022) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 333M4, expiry date 7th April 2024) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th January 2022, the patient received the 1st dose of Engerix B adult 20 ug. On 17th February 2022, the patient received the 2nd dose of Engerix B 10 ug and Engerix B Pre-Filled Syringe Device. On 6th January 2022, unknown after receiving Engerix B adult and not applicable after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and inappropriate age at vaccine administration. On 17th February 2022, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the overdose, inappropriate age at vaccine administration and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-JUL-2022 Reporter's Comments: The reporter reported that the 19 years old patient received the first Engerix as an adult dose of 20 mcg. The pharmacy technician inquired what was the guidelines to giving 20 mcg and, how to proceed with Engerix series. The reporter did not consent to follow-up Additional Supportive Information: The patient received the first Engerix as an adult dose of 20 mcg which led to overdose and inappropriate age at vaccine administration. The patient received 2nd dose of Engerix B late than recommended time frame, which led to which led to lengthening of interval between vaccine doses.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: he continues to experience the outbreak of shingles/ Suspected Vaccination failure; rash across their chest, down both of their arms, hands, and legs; Shingles outbreak in upper, left quadrant; severe ache, which was lessened; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2021, the patient received the 2nd dose of Shingrix. On 22nd October 2020, the patient received the 1st dose of Shingrix. On 20th January 2021, less than a day after receiving Shingrix and 90 days after receiving Shingrix, the patient experienced shingles and ache. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and rash. The patient was treated with benadryl (nos) (Benadryl), valaciclovir (Valacyclovir), ibuprofen and benadryl (nos) (Benadryl). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, ache and rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, ache and rash to be related to Shingrix and Shingrix.     Linked case(s) involving the same patient:  US2022AMR114253   Additional Information: GSK Receipt Date: 29-Jul-2022, 1-Aug-2022 Reporter's comment: The patient reported the case. The pateitn received a dose of Shingrix on 22nd October 2020 and other dose on 20th January 2021. Within a day of receiving second dose, the patient experienced a Shingles outbreak. The episodes began as little outbreaks, primarily in his upper, left quadrant.  early episodes were accompanied by a severe ache, which was lessened with more recent outbreaks.  The patient currently had a rash across his chest, down both of his arms, hands, and legs.   The patient was using oral Benadryly every 4 hours, as well as valacyclovir, when the Benadryl isn't effective in relief of symptoms.  He continued to experience the outbreak of shingles over his entire body.  He also states that he uses valacyclovir three times every 8 hours, Benadryl every 4 hours, topical Benadryl as needed and Ibuprofen as needed. The patient had never experienced an outbreak of Shingles prior to receiving the second dose of Shingrix.  He had experienced numerous and ongoing outbreaks since the date of the second dose of Shingrix.  The reporter consented to follow up. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments:  US-GSK-US2022AMR114253:same patient
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Crying, Dysuria, Emotional distress, Fatigue
Clinical narrative: Suicidal thoughts, felt like hurting myself; swallen all over body; I have trouble peeing; fever; fatigue; vomiting; Anxiety; really scared; crying and very upset, many bad reactions; upset; This case was reported by a consumer via call center representative and described the occurrence of suicidal ideation in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetic.   On 21st July 2022, the patient received the 1st dose of Shingrix. In July 2022, less than 2 weeks after receiving Shingrix, the patient experienced generalized swelling, urination difficulty, pyrexia, fatigue, vomiting, anxiety, fear, crying and emotional distress. On 28th July 2022, the patient experienced suicidal ideation (serious criteria GSK medically significant). The patient was treated with diclofenac. On an unknown date, the outcome of the suicidal ideation, generalized swelling, urination difficulty, fatigue and anxiety were not recovered/not resolved and the outcome of the pyrexia, vomiting, fear, crying and emotional distress were unknown.   It was unknown if the reporter considered the suicidal ideation, generalized swelling, urination difficulty, pyrexia, fatigue, vomiting, anxiety, fear, crying and emotional distress to be related to Shingrix.     Additional Information: GSK receipt date: 29-Jul-2022 Reporters comment:  The reporter was a Spanish-speaking patient. Her call was transferred to me by a non Spanish speaking agent. She was crying and very upset. The patient stated she received Shingrix dose 1 ( on left arm) on 21st July,22. Had many bad reactions to it. swollen all over her body and hands, troubled peeing, fever, fatigue, vomiting, anxiety. She went to the physician on 28 July 2022 and he given to her shot and a pill diclofenac. she did not know what else to do. she was really scared because had suicidal thoughts, she stated she was alone and has nobody that could help her.  The reporter did not consent to follow-up.