chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Haemoglobin normal, Headache, Hepatic enzyme, Laboratory test normal, Lumbar puncture
Clinical narrative: Previously healthy 16-year-old male admitted on December 19 for altered mental status.  Patient was in his normal state of health until the day of admission when he woke up with a headache for which she took a Tylenol.  He went to school where initially headaches seem to improve but then reappeared followed by tingling sensation that is started on the right leg and neck spread upwards and then moved to the left leg.  He also had a slurred speech.  EMS was called, on arrival patient had blood pressure of 160/80.  He was brought to the ER for evaluation, on arrival patient very slurred and altered, had emesis, complained of myalgia and abdominal pain.  Had episodes of bradycardia and bradypnea.  Patient had to be electively intubated.  The patient denies any fever, or any symptoms before presentation.  He denies using of alcohol, smoking or vaping, any street drugs or other medications except Tylenol.  The patient had MenQuadfi main ACW Y second shot the day before and his pediatrician's office. He was a started on Depakote due to abnormal EEG and vancomycin and ceftriaxone and acyclovir after a spinal tap collected.
Age: 16.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Lymphocyte count decreased, Magnetic resonance imaging, Mental status changes, Metabolic function test normal, Monocyte count increased
Clinical narrative: Previously healthy 16-year-old male admitted on December 19 for altered mental status.  Patient was in his normal state of health until the day of admission when he woke up with a headache for which she took a Tylenol.  He went to school where initially headaches seem to improve but then reappeared followed by tingling sensation that is started on the right leg and neck spread upwards and then moved to the left leg.  He also had a slurred speech.  EMS was called, on arrival patient had blood pressure of 160/80.  He was brought to the ER for evaluation, on arrival patient very slurred and altered, had emesis, complained of myalgia and abdominal pain.  Had episodes of bradycardia and bradypnea.  Patient had to be electively intubated.  The patient denies any fever, or any symptoms before presentation.  He denies using of alcohol, smoking or vaping, any street drugs or other medications except Tylenol.  The patient had MenQuadfi main ACW Y second shot the day before and his pediatrician's office. He was a started on Depakote due to abnormal EEG and vancomycin and ceftriaxone and acyclovir after a spinal tap collected.
Age: 16.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Mononuclear cell count, Myalgia, Neutrophil count normal, Paraesthesia, Platelet count normal
Clinical narrative: Previously healthy 16-year-old male admitted on December 19 for altered mental status.  Patient was in his normal state of health until the day of admission when he woke up with a headache for which she took a Tylenol.  He went to school where initially headaches seem to improve but then reappeared followed by tingling sensation that is started on the right leg and neck spread upwards and then moved to the left leg.  He also had a slurred speech.  EMS was called, on arrival patient had blood pressure of 160/80.  He was brought to the ER for evaluation, on arrival patient very slurred and altered, had emesis, complained of myalgia and abdominal pain.  Had episodes of bradycardia and bradypnea.  Patient had to be electively intubated.  The patient denies any fever, or any symptoms before presentation.  He denies using of alcohol, smoking or vaping, any street drugs or other medications except Tylenol.  The patient had MenQuadfi main ACW Y second shot the day before and his pediatrician's office. He was a started on Depakote due to abnormal EEG and vancomycin and ceftriaxone and acyclovir after a spinal tap collected.
Age: 16.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Respiratory viral panel, Vomiting, White blood cell count increased
Clinical narrative: Previously healthy 16-year-old male admitted on December 19 for altered mental status.  Patient was in his normal state of health until the day of admission when he woke up with a headache for which she took a Tylenol.  He went to school where initially headaches seem to improve but then reappeared followed by tingling sensation that is started on the right leg and neck spread upwards and then moved to the left leg.  He also had a slurred speech.  EMS was called, on arrival patient had blood pressure of 160/80.  He was brought to the ER for evaluation, on arrival patient very slurred and altered, had emesis, complained of myalgia and abdominal pain.  Had episodes of bradycardia and bradypnea.  Patient had to be electively intubated.  The patient denies any fever, or any symptoms before presentation.  He denies using of alcohol, smoking or vaping, any street drugs or other medications except Tylenol.  The patient had MenQuadfi main ACW Y second shot the day before and his pediatrician's office. He was a started on Depakote due to abnormal EEG and vancomycin and ceftriaxone and acyclovir after a spinal tap collected.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Caller reported AE on behalf of an adult patient that received a pediatric dose of RECOMBIVAX HB. Date of administration is unknown, however, Caller reported that dose was administered between 12/15/2023 and 12/18/2023. No symptoms reported. Obtained; Caller reported AE on behalf of an adult patient that received a pediatric dose of RECOMBIVAX HB. Date of administration is unknown, however, Caller reported that dose was administered between 12/15/2023 and 12/18/2023. No symptoms reported. Obtained; Information has been received from a pharmacist, referring to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date in December 2023 (reported between 15-DEC-2023 to 18-DEC-2023), the adult patient received a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). No symptoms were reported or additional adverse events.
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Back pain, Myalgia
Clinical narrative: joint back pain; joint back pain; muscle pain for 2 days following vaccination; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a 82-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced joint pain (Verbatim: joint back pain), back pain (Verbatim: joint back pain) and muscle pain (Verbatim: muscle pain for 2 days following vaccination). The outcome of the joint pain, back pain and muscle pain were resolved (duration 2 days).   The reporter considered the joint pain, back pain and muscle pain to be possibly related to Arexvy.  The company considered the joint pain, back pain and muscle pain to be possibly related to Arexvy.   Additional Information: GSK Receipt Date: 8-JAN-2024 This case was reported by a consumer via interactive digital media. The patient had terrible joint back pain and muscle pain with the vaccine. The patient ever had a reaction for 2 days of pain from last vaccine. The follow up would not possible, as no contact, details were available.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Aug2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 21 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prolonged PR interval" (unspecified if ongoing); "Hyperhidrosis" (unspecified if ongoing); "GAD" (unspecified if ongoing); "MDD" (unspecified if ongoing); "Narcotics" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 26Dec2023 till 31Dec2023for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: 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 Nurse.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Dm2" (unspecified if ongoing); "htn" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Rectal cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Dec2023) Positive, notes: Tested positive for Covid on 20Dec. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment, brand: Paxlovid. Teatment start date: 20Dec2023, treatment stop date: 24Dec2023. No allergies.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 31 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Known allergies: vancomycin, reaction(s): "Known allergies: Vancomycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid received from 23Dec2023 to 27Dec2023 for the treatment of COVID-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injury, Laboratory test
Clinical narrative: Vaccine injury; This is a spontaneous report received from an Other HCP.  A 55-year-old female patient received BNT162b2 (BNT162B2), in Jun2021 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Mmr vaccine, administration date: 2006, when the patient was 37 years old. The following information was reported: INJURY (non-serious) with onset 2021, outcome "unknown", described as "Vaccine injury". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: In 2021, she had the Pfizer COVID-19 Vaccine. She was going to report that also. She had a vaccine injury form that. In 2021 after had receiving the vaccine, she had lab work done in Jun2021 prior to receiving the vaccine in Jul2021 to make sure she was healthy and everything was good.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400002729 Same patient, different drug/event;US-PFIZER INC-202400004740 Same patient, Same product (DOSE 2), different events;
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Interchange of vaccine products, Off label use
Clinical narrative: When she got them in her left arm it effected the arthritis in her left hand.It intensified it more in the thumb area; off-label use; interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 25Oct2021 as dose 2 (initial pfizer dose), single (Lot number: FF2593) at the age of 69 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine janssen (DOSE 1), administration date: 11Mar2021, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 25Oct2021, outcome "unknown"; OFF LABEL USE (non-serious) with onset 25Oct2021, outcome "unknown", described as "off-label use"; ARTHRITIS (non-serious), outcome "unknown", described as "When she got them in her left arm it effected the arthritis in her left hand.It intensified it more in the thumb area". Additional information: Patient reported that sometimes she got the covid shots in her left arm. When she got them in her left arm it effected the arthritis in her left hand. It intensified it more in the thumb area. Now, she does not get it in the left arm anymore. Now, she gets the shots in her right arm.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400005398 Same patient and product, different dose and event;US-PFIZER INC-202400005419 Same patient and product, different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: There was lump on the injection site; almost as big as a marble; it did not go away; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: EN6199) and on 29Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu shot, for Immunisation, reaction(s): "Eosinophils levels last year were high". The following information was reported: VACCINATION SITE MASS (non-serious), outcome "unknown", described as "There was lump on the injection site; almost as big as a marble; it did not go away".  Additional information: The Covid shot, it was early on that I got the lump. Here I have my records and it was like my first or second vaccine. My first vaccine was in March of 2021 and then I had another Pfizer one a month later, on March 29th, 2021 (Clarified as Pfizer COVID-19 Vaccine) And that's when I got the lump, I think. It was there right at the very beginning and then, every time, I went for another one. I have had five injections for Pfizer COVID shot and I want to get another one. But every time I went, they would notice that lump. I said, yes that was from the Covid shot but subsequent Covid shot did not seem to do that. Just the first and the second one from right at the beginning. It was like marble, and it did not go away. Now it is starting to go away. So it was in the beginning, this is like very beginning when I got this like the second shot, I think. I did not make a record, but I think it was not recent, it was there and lasted and I would show it to the others, people that gave me the subsequent shot. They said, oh that must be some fatty 'tissue', something that some lipoma there developed or something. I said, it happened right away afterwards.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: sick; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 70-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "sick"; VOMITING (non-serious), outcome "unknown", described as "throwing up". Batch/lot number is not provided, and it cannot be obtained.  Additional information: The last COVID shot I got was two years ago with a Flu shot. I was so sick for two days that I thought "Never Again?".
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: psoriasis; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 (COMIRNATY NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cuts" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: PSORIASIS (non-serious), outcome "unknown". Therapeutic measures were taken as a result of psoriasis. Additional information: Patient has had 4 Pfizer COVID-19 vaccines. Between her 3rd and 4th boosters, she developed new onset of psoriasis. Never in her life has she had any skin issues. Patient used to heal practically overnight from minor cuts, etc. Never had acne, nothing ever with her skin. Treatments have not been successful. She's at a loss as to how this condition came about and how to return her skin to its former state. Patient asking for any insights.
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen increased
Clinical narrative: PSA rose rapidly after receiving the vaccine; This is a spontaneous report received from a Nurse. Other Case identifier(s): NUS2024US000721_NC (RA).  A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PROSTATIC SPECIFIC ANTIGEN INCREASED (non-serious), outcome "unknown", described as "PSA rose rapidly after receiving the vaccine". Batch/lot number is not provided, and it cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol increased
Clinical narrative: After rebound and high cholesterol, patient went back on medications; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient received BNT162b2 (COMIRNATY), on 27Sep2021 as dose 3 (booster), single (Lot number: 301458A) at the age of 79 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension", start date: 1998 (ongoing); "acid reflux", start date: 2003 (ongoing); "asthma", start date: 1990 (ongoing); "coronary artery disease", start date: 18Sep2023 (ongoing), notes: had glockage +stent. Concomitant medication(s) included: AMLODIPINE oral taken for hypertension, hyperlipidaemia, start date: 2020 (ongoing); LIVALO oral taken for hypertension, hyperlipidaemia, start date: 2020 (ongoing); PLAVIX taken for stent placement, start date: Sep2023 (ongoing); ADVAIR taken for asthma. Vaccination history included: BNT162b2 (DOSE 1, Lot number maybe Eng202, Upper left arm, intramuscular), administration date: 26Feb2021, when the patient was 78-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, Lot number: ER8730, Upper left arm, intramuscular), administration date: 26Mar2021, when the patient was 78-year-old, for COVID-19 immunisation. The following information was reported: BLOOD CHOLESTEROL INCREASED (non-serious) with onset Mar2022, outcome "unknown", described as "After rebound and high cholesterol, patient went back on medications". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood cholesterol increased.  Additional information: Patient had been on and off stains for years. After rebound and high cholesterol, patient went back on medications. Patient have taken Livalo 2mg every daily since Mar2022.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: gave a 4-month old Pediarix, which contains IPV and IPOL today with no reported adverse event; Initial information received on 05-Jan-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 4 months old female patient and reporter reported gave a 4-month old Pediarix, which contains IPV and Poliomyelitis Vaccine (Inactivated) (Ipol)  today/ She also received diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (pediarix)  and IPOL with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hib vaccine conj (ompc) (pedvaxhib) for prophylactic vaccination; pneumococcal vaccine (pneumococcal vaccine) for prophylactic vaccination; and rotavirus vaccine (rotavirus vaccine) for Prophylactic vaccination.  On 05-Jan-2024, the patient received Dose 2 of suspect IPV (VERO) Suspension for injection (lot number: W1B511M) (Expiry date: 08-SEP-2025) via unknown route in the left thigh for immunization.  On 05-Jan-2024, the patient received an unknown dose of suspect PEDIARIX not produced by Sanofi Pasteur (with an unknown strength, expiry date, formulation, lot number) via unknown route in unknown administration site for immunization.  On 05-Jan-2024, reporter reported gave a 4-month old Pediarix, which contains IPV and Poliomyelitis Vaccine (Inactivated) (Ipol)  today/ She also received diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (pediarix)  and IPOL with no reported adverse event (extra dose administered) (latency: same day).  It was reported, Do you have information about an extra dose of polio vaccine. We made an error and gave a 4-month old Pediarix, which contains IPV and IPOL today. Today a 4-month old female patient was given vaccines against rotavirus, pneumococcal, and hib (PedvaxHIB). She also received Pediarix and IPOL (lot and expiry in template). The injection site for IPOL was the left thigh. It was the second dose in the IPOL series. A nurse administered the vaccines. The ordering practitioner is at the same address and phone as the caller.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: Arexvy given to pregnant patient; 31 year old patient received the Arexvy vaccine; This non-serious prospective pregnancy case was reported by a pharmacist via sales rep and described the occurrence of vaccine exposure during pregnancy in a 31-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 37D4F, expiry date 31-MAR-2025) for prophylaxis.   On 29-DEC-2023, the patient received the 1st dose of Arexvy (left arm). On 29-DEC-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 31 year old patient received the Arexvy vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy given to pregnant patient). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 03-JAN-2024 This report was submitted via the online direct entry reporting system. The pregnant patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. No other products receive by the patient. No HCP (health care professional) consent to contact provided. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: COVID-19, SARS-CoV-2 test negative
Clinical narrative: had Covid for the past week and just testing negative; This non-serious case was reported by a consumer via call center representative and described the occurrence of covid-19 in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced covid-19 (Verbatim: had Covid for the past week and just testing negative). The outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     It was unknown if the company considered the covid-19 to be related to Shingrix.   Additional Information: GSK Receipt date: 08-JAN-2024 The reporter was a patient. The reporter reported that he received the Shingrix vaccine and had a covid for the past week from reporting day. Reporter testing negative for covid. The reporter did not consent to follow-up. The case had been linked to the case US2024003279 reported by same reporter.; Sender's Comments:  US-GSK-US2024003279:1 of 2
Age: 0.42
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration, Wrong product administered
Clinical narrative: Priorix administered orally to 2 patients instead of Rotarix; Wrong Route of Administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 5-month-old male patient who received MMR (Priorix) (batch number 3247X, expiry date 11-MAY-2024) for prophylaxis.   On 21-DEC-2023, the patient received Priorix. On 21-DEC-2023, an unknown time after receiving Priorix, the patient experienced wrong vaccine administered (Verbatim: Priorix administered orally to 2 patients instead of Rotarix) and inappropriate route of vaccination (Verbatim: Wrong Route of Administration). The outcome of the wrong vaccine administered and inappropriate route of vaccination 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-JAN-2024 A medical assistant requested data on potential side effects of Priorix administered orally to 2 patients instead of Rotarix, which led to wrong vaccine administered and incorrect route of vaccination. The reporter consented to follow up. This was 1 of the 2 link cases, reported by same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received second dose of Shingrix late; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number LC757, expiry date 21-AUG-2024) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 22nd October 2020).   On 06-NOV-2023, the patient received the 2nd dose of Shingrix. On 06-NOV-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received second dose of Shingrix late). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 09-JAN-2024 The pharmacists reported that a patient received her second dose of Shingrix late and her physician was telling her to ignore the first dose and get another dose.  Her first dose was administered on 22 October 2020 and she did not get her second dose until 6 November 2023. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. (Drug dose administration interval too long) plus 7 days. The  consented to follow up via mail.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: The patient was first time diagnosed with COVID-19 on 20-DEC-2023 and on 30-DEC-2023 patient was again tested positive and developed chills, cough and myalgias.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (The patient was first time diagnosed with COVID-19 on 20-DEC-2023 and on 30-DEC-2023 patient was again tested positive and developed chills, cough and myalgias.) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna (Dose number 1 and batch/lot number was 037K20A.) on 05-Jan-2021, Moderna (Dose number 2 and batch/lot number was 013M20A.) on 02-Feb-2021, Moderna (Dose number 3 and batch/lot number was 014FZ1A.) on 29-Oct-2021, Moderna (Dose number 4 and batch/lot number was 002M21A.) on 21-Apr-2022, Moderna (Dose number 5 and batch/lot number was AS7144B.) on 22-Sep-2022 and Moderna (Dose number 6 and batch/lot number was AS7170B.) on 11-May-2023. Past adverse reactions to the above products included No adverse event with Moderna, Moderna, Moderna, Moderna, Moderna and Moderna. Concurrent medical conditions included Hypothyroidism, Osteoporosis, Hyperlipidemia and Allergy to antibiotic. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) from 31-Dec-2020 to 20-Dec-2023, HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE) from 31-Dec-2020 to an unknown date and LEVOTHYROXINE from 31-Dec-2020 to an unknown date for an unknown indication.    On 09-Oct-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (The patient was first time diagnosed with COVID-19 on 20-DEC-2023 and on 30-DEC-2023 patient was again tested positive and developed chills, cough and myalgias.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 20-Dec-2023 to 25-Dec-2023 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (The patient was first time diagnosed with COVID-19 on 20-DEC-2023 and on 30-DEC-2023 patient was again tested positive and developed chills, cough and myalgias.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2023, SARS-CoV-2 test: Negative. On 29-Dec-2023, SARS-CoV-2 test: Negative. On 30-Dec-2023, SARS-CoV-2 test: Positive.         Patient was diagnosed for the first time with COVID on 20-DEC-2023 and began treatment with Paxlovid on the same day. Patient was tested negative on December 28 and 29 and symptoms had improved, but on December 30 again developed chills, cough and myalgias and tested positive.   This case was linked to US-MODERNATX, INC.-MOD-2024-755815, US-MODERNATX, INC.-MOD-2024-755821 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-755815:Patient 2 of 3 US-MODERNATX, INC.-MOD-2024-755821:Patient 2 of 3
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Mild injection site tenderness (tender to touch); Mild injection site swelling; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of INJECTION SITE PAIN (Mild injection site tenderness (tender to touch)) and INJECTION SITE SWELLING (Mild injection site swelling) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced INJECTION SITE PAIN (Mild injection site tenderness (tender to touch)) and INJECTION SITE SWELLING (Mild injection site swelling). At the time of the report, INJECTION SITE PAIN (Mild injection site tenderness (tender to touch)) and INJECTION SITE SWELLING (Mild injection site swelling) outcome was unknown.            Concomitant medication and treatment information was not reported.  Patient had events during the 2 days after COVID19 vaccination, which occurred on Sunday, 24 Dec 2023 and Monday, 25 Dec 2023   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Mild injection site redness; Moderate injection site swelling; Moderate fatigue with some interference with activity; Moderate muscle pain with some interference with activity; Joint pain with some interference with activity; Headache and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Moderate injection site swelling) and FATIGUE (Moderate fatigue with some interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Moderate injection site swelling), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), ARTHRALGIA (Joint pain with some interference with activity) and HEADACHE (Headache and no interference with activity). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Moderate injection site swelling), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), ARTHRALGIA (Joint pain with some interference with activity) and HEADACHE (Headache and no interference with activity) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication and treatment information was not reported.  Patient had experienced events anytime during the 2 days after COVID-19 vaccination, which occurred on Saturday, Dec 23, 2023 and Sunday, Dec 24, 2023.   This case was linked to US-MODERNATX, INC.-MOD-2024-755971 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-755971:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Mild injection site redness; Moderate injection site swelling; Moderate fatigue with some interference with activity; Moderate muscle pain with some interference with activity; Joint pain with some interference with activity; Headache and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Moderate injection site swelling) and FATIGUE (Moderate fatigue with some interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Moderate injection site swelling), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), ARTHRALGIA (Joint pain with some interference with activity) and HEADACHE (Headache and no interference with activity). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Moderate injection site swelling), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), ARTHRALGIA (Joint pain with some interference with activity) and HEADACHE (Headache and no interference with activity) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication and treatment information was not reported.  Patient had experienced events anytime during the 2 days after COVID-19 vaccination, which occurred on Saturday, Dec 23, 2023 and Sunday, Dec 24, 2023.   This case was linked to US-MODERNATX, INC.-MOD-2024-755971 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-755971:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site pain, Myalgia
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of INJECTION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and ARTHRALGIA (Joint pain and no interference with activity) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced INJECTION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and ARTHRALGIA (Joint pain and no interference with activity). At the time of the report, INJECTION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and ARTHRALGIA (Joint pain and no interference with activity) outcome was unknown.            Concomitant medication was not reported.  Treatment medication was not reported.  On 23-Dec-2023, the patient had mild injection site pain and injection site tenderness, mild fatigue, mild muscle pain and mild joint pain and no interference with activity.  The events of injection site pain, injection site tenderness, fatigue, muscle pain and joint pain were experienced anytime during the 2 days after vaccination.   This case was linked to US-MODERNATX, INC.-MOD-2024-755971 (E2B Linked Report).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Mild fatigue and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of FATIGUE (Mild fatigue and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced FATIGUE (Mild fatigue and no interference with activity). At the time of the report, FATIGUE (Mild fatigue and no interference with activity) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication was not reported.  The fatigue was experienced anytime during the 2 days after vaccination.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-755971 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-755971:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Malaise, Myalgia
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch); Mild injection site redness; Mild muscle pain and no interference with activity; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), INJECTION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)), INJECTION SITE ERYTHEMA (Mild injection site redness) and MYALGIA (Mild muscle pain and no interference with activity) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), INJECTION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)), INJECTION SITE ERYTHEMA (Mild injection site redness) and MYALGIA (Mild muscle pain and no interference with activity). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), INJECTION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)), INJECTION SITE ERYTHEMA (Mild injection site redness) and MYALGIA (Mild muscle pain and no interference with activity) outcome was unknown.            Concomitant medication was not reported.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Master case
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Vaccination site erythema
Clinical narrative: Mild injection site pain and no interference with activity/ Moderate injection site tenderness (tenderness with movement); Mild injection site redness; Mild injection site swelling; Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; Headache and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Mild muscle pain and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity) and HEADACHE (Headache and no interference with activity). At the time of the report, VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity) and HEADACHE (Headache and no interference with activity) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  It was reported that the patient experienced the events anytime during the 2 days after the COVID-19 vaccination, which occurred Saturday, Dec 23, 2023 and Sunday, Dec 24, 2023.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-756004 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756004:Same reporter