chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Cardiovascular disorder
Clinical narrative: Died a week later from a cardiovascular cause; This is a spontaneous report received from a Physician.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergy   " (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CARDIOVASCULAR DISORDER (death), outcome "fatal", described as "Died a week later from a cardiovascular cause". It was unknown if therapeutic measures were taken as a result of cardiovascular disorder. The patient date of death was unknown. Reported cause of death: "Died a week later from a cardiovascular cause". It was not reported if an autopsy was performed. Clinical course: Physician stated that a friend/work colleague received his first dose of the COVID vaccine and died a week later from a cardiovascular cause.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based from plausible temporal relationship and safety profile, the causal association of reported cardiovascular disorder resulting to fatal outcome in relation to suspected vaccine Comirnaty formula 2023 to 2024 cannot be totally excluded.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate  ; Reported Cause(s) of Death: Died a week later from a cardiovascular cause
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted COVID. Tested positive 16Jun2024. Symptoms started 12Jun2024.; Contracted COVID. Tested positive 16Jun2024. Symptoms started 12Jun2024.; This is a spontaneous report received from a Consumer or other non HCP.  A 34-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: SERTRALINE. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER) SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER) SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER) SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jun2024, outcome "recovering" and all described as "Contracted COVID. Tested positive 16Jun2024. Symptoms started 12Jun2024.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jun2024) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19; COVID 19; Dose 1/Dose 2/Dose 3/Dose 4/Dose 5/Dose 6: Pfizer /BioNTech; Dose 7/Dose 8: Moderna; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GH9693), in right arm and on 05May2023 as dose 6 (booster), single (Lot number: GJ3268) at the age of 73 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Apr2022 as dose 4 (booster), single (Lot number: FM0698), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL3247), in right arm, on 16Feb2021 as dose 2, single (Lot number: EN6201), in right arm and on 25Sep2021 as dose 3 (booster), single (Lot number: 30155BA), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Sep2023 as dose 7 (booster), single), in right arm and on 04Apr2024 as dose 8 (booster), single (Lot number: AU3920B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: latex" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN, stop date: 10Jun2024. Past drug history included: Gadolinium, reaction(s): "Known allergies: gadolinium". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Sep2023, outcome "unknown", described as "Dose 1/Dose 2/Dose 3/Dose 4/Dose 5/Dose 6: Pfizer /BioNTech; Dose 7/Dose 8: Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that the patient received other vaccination and medication in 2 weeks. Paxlovid was taken as treatment for COVID-19 from 08Jun2024 to 12Jun2024
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Malaise, Rash pruritic
Clinical narrative: heaviness feeling in chest; ill feeling in general; itchy body rash with large and small elevated rashes and bumps; This is a spontaneous report received from a Consumer or other non HCP.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Aug2022 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Amoxycillin, reaction(s): "Allergy:Amoxycillin". The following information was reported: CHEST DISCOMFORT (medically significant) with onset Aug2022, outcome "unknown", described as "heaviness feeling in chest"; MALAISE (medically significant) with onset Aug2022, outcome "unknown", described as "ill feeling in general"; RASH PRURITIC (medically significant) with onset Aug2022, outcome "unknown", described as "itchy body rash with large and small elevated rashes and bumps". The events "heaviness feeling in chest", "ill feeling in general" and "itchy body rash with large and small elevated rashes and bumps" required emergency room visit. Therapeutic measures were taken as a result of chest discomfort, malaise, rash pruritic. Clinical course: No covid prior vaccination. No other vaccine received in four weeks. No other medications in two weeks. Adverse event start time: 03:00 PM. The adverse event result in Emergency room/department or urgent care. No covid tested post vaccination. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: balance issue/unsteady condition; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Primary Immunization series complete), for COVID-19 immunisation; Pneumococcal vaccine, for Immunization; Varicella zoster vaccine, for Immunization; Influenza vaccine, for Immunization. The following information was reported: BALANCE DISORDER (non-serious), outcome "not recovered", described as "balance issue/unsteady condition". The event "balance issue/unsteady condition" required physician office visit. Therapeutic measures were taken as a result of balance disorder.  Additional information: For the past year patient had been experiencing a balance issue that had caused her to fear she was going to fall when she stood up to begin to walk. This was an ongoing problem that seemed to come and go. She once explained it as being on a ship for a few days and hen stepping on land and feeling off balance. Patient had seen numerous doctors, had many x-rays, been to physical therapy, checked for neuropathy and no one had gotten to the root of her problem. She had become a prisioner of her own house as she was afraid she would go out and experience an episode. When these bouts happened, to help her walk, she used a walker or relied on her husband to hold on to her. Something that had not been explored is if there might be a correlation between her unsteady condition and the vaccines and boosters she had. Patient had all the Pfizer vaccines and the recommended boosters. Around the same time she also had the pneumonia, shingle and flu shots. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness to injection site; swelling to injection site; Initial information received on 10-Jun-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 46 years old male patient who experienced redness to injection site and swelling to injection site after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-May-2024, the patient received a unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (strength and expiry date: unknown; lot U7953AA) via intramuscular route in unknown administration site as Prophylactic vaccination (immunization).  On 07-May-2024 the patient developed redness to injection site (vaccination site erythema) and swelling to injection site (vaccination site swelling) (latency: same day).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date in 2024 for the events.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue, Single component of a two-component product administered
Clinical narrative: Only the liquid DTAP-IPV portion was administered with no reported adverse event; Initial information was received on 10-Jun-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 2 months old female patient to whom only the liquid dtap-ipv portion of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was administered 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 hepatitis b vaccine, pneumococcal vaccine conj 20v (crm197) (Prevnar 20) and rotavirus vaccine live reassort oral 5v (Rotateq) for prophylactic vaccination.  On 07-Jun-2024, the patient received an unknown dose (Dose 1) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot UJ985AA, expiry date: 14-Feb-2025, Strength: standard) via intramuscular route in the left vastus lateralis for Immunization and only the liquid dtap-ipv portion was administered with no reported adverse event (single component of a two-component product administered) (Latency: same day).  Reportedly, only partial dose of PENTACEL was administered to a patient. The PENTACEL was not reconstituted with the ACTHIB powder portion.   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: DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PENTACEL adminstered to 3 days old, with no reported adverse event; Initial information received on 14-Jun-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 3 days old female patient who received Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] 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 Rotavirus Vaccine and Pneumococcal Vaccine Conj 20V (CRM197) (Prevnar 20) for Prophylactic vaccination.  On 14-Jun-2024, the patient received a dose 1 of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Powder and suspension for suspension for injection) (lot UK026AA,Expiry date: 30-Jun-2025, strength was unknown) via intramuscular/leg route in unknown administration site for Prophylactic vaccination (Immunization) (product administered to patient of inappropriate age) (latency : same day).  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.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1 (toppac), single (Lot number: HG4629) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE; Manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: home test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: No known allergies. No other medical history. Paxlovid treatment has been taken for COVID from 02Jun2024 to 06Jun2024. On 11Jun2024, patient had Sinus pressure and sore throat. Tested positive for COVID on a home test.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Palpitations
Clinical narrative: Employee reported to me today that when she had her flu shot at the flu clinic several hours later she experienced sweating and heart palpitations.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, Pain, Pyrexia
Clinical narrative: Onset of symptoms within 24 hours. Symptoms included severe nausea, diarrhea , chills and body aches. Also had a low grade fever. Duration of symptoms was 5 days.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was administered the second dose of shingrix  before the eight week period was complete. Patient recieved the first dose on 05/24/24 and the second dose on 06/19/24. Patient stated having no symptoms at the time of vaccination.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site swelling
Clinical narrative: The patient called the pharmacy to report that 2 days before she received the second Shingrix vaccine. She said the site of injection was black and blue and swollen. I asked her to come in the pharmacy to view the reaction. She was told to report the incidence to her doctor for evaluation. She was told that we would be reporting the incident to VAERS.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Feeling abnormal
Clinical narrative: Back pain, severe. Overall feeling like garbage.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Echocardiogram, Electrocardiogram, Tachycardia
Clinical narrative: Unknown arm shot was given in, but think it was left arm.  Two weeks after second vaccine, severe episodes of tachycardia began.  Heart rate while sitting reached 170 bpm.  Tachycardia lasted multiple days.  Child was sent to a cardiologist.  No myocarditis reported.  Child had unspecified tachycardia. Tachycardia is now continuing and Child will be seeing another cardiologist. Three weeks ago, Child had heart rate of 170 bpm and could not get under 125 bpm for almost 24 hours.  Child had another episode two nights ago where her heart rate reached 165 while sitting in the bath.   Heart rate did not go under 125 bpm. I cooled her body off in her sleep with wet towels and her heart rate finally went down to 110 bpm.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram normal, Lymph node pain, Pain in extremity
Clinical narrative: On 10/13/2023, roughly 16 hours after receiving the vaccine, I began feeling pain on the left side of my chest; it felt like my heart itself was hurting.  When the pain had not subsided after a few hours, I went to urgent care where they performed an EKG and determined that my heart and lungs sounded normal.  I was sent home without any further instructions. That evening, the sensation migrated to the center of my chest and became more of a burning sensation rather than strictly pain.It felt slightly hard to breathe but the sensation still felt more superficial, and did not feel as if it was occurring inside my lungs.  I also felt pain and ashiness in my auxiliary lymph nodes and down my arms on both sides of my body.  The burning sensation in my chest, as well as the pain in my arms, continued into the next day, now 36 48 hours after the vaccine. I considered going to the emergency room but decided to wait another 24 hours to see if I would feel any better. The sensation slowly began to fade, and took roughly 7-10 days to fade entirely. After that, I would feel the chest burning and arm pain arise every few weeks or so with decreasing frequency. The sensations reactivated when I had COVID in December 2023 (my second time having COVID, the first being in April 2022). I visited my primary care office and had a myriad of tests run that all came back normal. The provider instructed me to hold off on getting another COVID vaccine, as I was young and relatively healthy. I discussed this incident with my actual primary care doctor in May 2024, and she agreed that I should at the very least wait a few months after a new COVID booster was released to get it, so that I could gauge reactions of the people around me. The last time I felt the chest burning and arm pain was in February 2024; overall, these sensations occurred from October 2023 to February 2024 with decreasing frequency, but with a reactivation period in December 2023 due to actually having COVID. Please note that I had had reactions to previous iterations of the vaccine, but those were limited to expected side effects, including headaches, mild body aches, and fatigue, and these symptoms faded within 48 hours. Also note that all four of my previous COVID vaccine doses were Pfizer, and the vaccine I had this strong adverse reaction to was Moderna.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Injected limb mobility decreased, Injection site erythema, Malaise
Clinical narrative: Right arm where he got the shot was red around, big as a saucer; He could not lift his arm; face and everything was red; weak; 104 degree fever; sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (On an unknown date received first dose 3 months before the second shot. For the tolerance of first dose refer case US2024072088).   On an unknown date, the patient received the 2nd dose of Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Right arm where he got the shot was red around, big as a saucer), injected limb mobility decreased (Verbatim: He could not lift his arm), erythema of extremities (Verbatim: face and everything was red), weakness (Verbatim: weak), fever (Verbatim: 104 degree fever) and sickness (Verbatim: sick). The outcome of the injection site erythema, injected limb mobility decreased, erythema of extremities, weakness, fever and sickness were unknown.   It was unknown if the reporter considered the injection site erythema, injected limb mobility decreased, erythema of extremities, weakness, fever and sickness to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injected limb mobility decreased, erythema of extremities, weakness, fever and sickness to be related to Shingrix.   Linked case(s) involving the same patient:  US2024072088   Additional Information: GSK receipt date: 10-JUN-2024 Reporter was the wife of the patient who stated that the patient received both doses of Shingrix, second dose was received 9 months ago from the reporting day and the first dose 3 months before the second dose. Reporter stated that the patient receive vaccine and got really sick, specially after the second dose, he had fever after the first dose and after the second dose he had 104 degree fever, the right arm where the he got the shot was red around, big as a saucer, he could not lift his right arm, he was really weak, his face and everything was red. Reporter refused to provide patient's date of birth and address. The vaccination start date provided as 2023. The reporter did not consent to follow-up. This case had been linked with the case US2024072088, reported by same reporter.; Sender's Comments:  US-GSK-US2024072088:First dose
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Right arm where he got the shot was red around, big as a saucer; He could not lift his arm; face and everything was red; weak; 104 degree fever; sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (On an unknown date received first dose 3 months before the second shot. For the tolerance of first dose refer case US2024072088).   On an unknown date, the patient received the 2nd dose of Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Right arm where he got the shot was red around, big as a saucer), injected limb mobility decreased (Verbatim: He could not lift his arm), erythema of extremities (Verbatim: face and everything was red), weakness (Verbatim: weak), fever (Verbatim: 104 degree fever) and sickness (Verbatim: sick). The outcome of the injection site erythema, injected limb mobility decreased, erythema of extremities, weakness, fever and sickness were unknown.   It was unknown if the reporter considered the injection site erythema, injected limb mobility decreased, erythema of extremities, weakness, fever and sickness to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injected limb mobility decreased, erythema of extremities, weakness, fever and sickness to be related to Shingrix.   Linked case(s) involving the same patient:  US2024072088   Additional Information: GSK receipt date: 10-JUN-2024 Reporter was the wife of the patient who stated that the patient received both doses of Shingrix, second dose was received 9 months ago from the reporting day and the first dose 3 months before the second dose. Reporter stated that the patient receive vaccine and got really sick, specially after the second dose, he had fever after the first dose and after the second dose he had 104 degree fever, the right arm where the he got the shot was red around, big as a saucer, he could not lift his right arm, he was really weak, his face and everything was red. Reporter refused to provide patient's date of birth and address. The vaccination start date provided as 2023. The reporter did not consent to follow-up. This case had been linked with the case US2024072088, reported by same reporter.; Sender's Comments:  US-GSK-US2024072088:First dose
Age: 74.0
Sex: F
Vaccine: FLU4, PNC20, RSV, FLU4, PNC20, RSV
Symptoms: Musculoskeletal discomfort
Clinical narrative: She got her vaccines, had no initial problems.  Gradually her arm started hurting to the point that she had very good range of motion of her arm, except she could not take the right arm and reach it across her chest to her left shoulder. If she had an itch she could not reach it.  She could lift it, she could do exercises, but she could not sleep.  She had a gnawing feeling when she tried to sleep.  She had to move from the bed to a chair, to another chair.  The pain was so bad she was at the point of crying.  She eventually went to the doctor as she decided it was not a regular reaction to a shot.  As she had gotten 3 vaccines in the same arm at the same time, she felt it was related to the vaccines.  She did not go to her PCP right away as she had an appointment coming up and decided to wait for that appointment.  After she saw them and after she talked about her routine stuff she discussed her shot and having cerva.  She explained her what that was related to the rotator cuff, and she seemed to have dismissed the issue.  She had to do more blood work for her other conditions.  She then decided to find a doctor and went to an Orthopedist.  She told him about her shoulder and told him she suspected cerva and he took the x-ray of her shoulder, told her the bones looked good. She told him that it was not her bones and it is what happened from the shot.  When she told him that when she slept the pain went to her neck, and he took an x-ray of her neck and showed some compression of her cervical spine and she told him she did not think it was from that.  He told her to take Naproxen, and sent her to PT.  She made an appointment with the spine speicalist and took the medicine, and then she couldn't stand the pain anymore and she told them he needed to see the doctor for an MRI.   That showed the rotator cuff tear and knew it was not in her spine.  He pointed the tear on the MRI and suggested cortisone injections, and she declined.  He then suggested her to see the Orthopedic surgeon, saw Dr.  When she saw him he recommended an Orthoscopic surgery.  She decided to do that and she had that done 6/13/24 at the orthopedic institute.  She has a postop appointment tomorrow at 11:15.  She did not have any problems with her shoulder prior to the vaccines, no falls or arthritis in the shoulders either.  The patient is angry that she is going through this, and the pain that she is going through since the vaccine.
Age: 74.0
Sex: F
Vaccine: FLU4, PNC20, RSV, FLU4, PNC20, RSV
Symptoms: Anger, Blood test, Crying, Immunisation reaction, Injected limb mobility decreased
Clinical narrative: She got her vaccines, had no initial problems.  Gradually her arm started hurting to the point that she had very good range of motion of her arm, except she could not take the right arm and reach it across her chest to her left shoulder. If she had an itch she could not reach it.  She could lift it, she could do exercises, but she could not sleep.  She had a gnawing feeling when she tried to sleep.  She had to move from the bed to a chair, to another chair.  The pain was so bad she was at the point of crying.  She eventually went to the doctor as she decided it was not a regular reaction to a shot.  As she had gotten 3 vaccines in the same arm at the same time, she felt it was related to the vaccines.  She did not go to her PCP right away as she had an appointment coming up and decided to wait for that appointment.  After she saw them and after she talked about her routine stuff she discussed her shot and having cerva.  She explained her what that was related to the rotator cuff, and she seemed to have dismissed the issue.  She had to do more blood work for her other conditions.  She then decided to find a doctor and went to an Orthopedist.  She told him about her shoulder and told him she suspected cerva and he took the x-ray of her shoulder, told her the bones looked good. She told him that it was not her bones and it is what happened from the shot.  When she told him that when she slept the pain went to her neck, and he took an x-ray of her neck and showed some compression of her cervical spine and she told him she did not think it was from that.  He told her to take Naproxen, and sent her to PT.  She made an appointment with the spine speicalist and took the medicine, and then she couldn't stand the pain anymore and she told them he needed to see the doctor for an MRI.   That showed the rotator cuff tear and knew it was not in her spine.  He pointed the tear on the MRI and suggested cortisone injections, and she declined.  He then suggested her to see the Orthopedic surgeon, saw Dr.  When she saw him he recommended an Orthoscopic surgery.  She decided to do that and she had that done 6/13/24 at the orthopedic institute.  She has a postop appointment tomorrow at 11:15.  She did not have any problems with her shoulder prior to the vaccines, no falls or arthritis in the shoulders either.  The patient is angry that she is going through this, and the pain that she is going through since the vaccine.
Age: 74.0
Sex: F
Vaccine: FLU4, PNC20, RSV, FLU4, PNC20, RSV
Symptoms: Magnetic resonance imaging abnormal, Neck pain, Orthopaedic procedure, Pain in extremity, Rotator cuff syndrome
Clinical narrative: She got her vaccines, had no initial problems.  Gradually her arm started hurting to the point that she had very good range of motion of her arm, except she could not take the right arm and reach it across her chest to her left shoulder. If she had an itch she could not reach it.  She could lift it, she could do exercises, but she could not sleep.  She had a gnawing feeling when she tried to sleep.  She had to move from the bed to a chair, to another chair.  The pain was so bad she was at the point of crying.  She eventually went to the doctor as she decided it was not a regular reaction to a shot.  As she had gotten 3 vaccines in the same arm at the same time, she felt it was related to the vaccines.  She did not go to her PCP right away as she had an appointment coming up and decided to wait for that appointment.  After she saw them and after she talked about her routine stuff she discussed her shot and having cerva.  She explained her what that was related to the rotator cuff, and she seemed to have dismissed the issue.  She had to do more blood work for her other conditions.  She then decided to find a doctor and went to an Orthopedist.  She told him about her shoulder and told him she suspected cerva and he took the x-ray of her shoulder, told her the bones looked good. She told him that it was not her bones and it is what happened from the shot.  When she told him that when she slept the pain went to her neck, and he took an x-ray of her neck and showed some compression of her cervical spine and she told him she did not think it was from that.  He told her to take Naproxen, and sent her to PT.  She made an appointment with the spine speicalist and took the medicine, and then she couldn't stand the pain anymore and she told them he needed to see the doctor for an MRI.   That showed the rotator cuff tear and knew it was not in her spine.  He pointed the tear on the MRI and suggested cortisone injections, and she declined.  He then suggested her to see the Orthopedic surgeon, saw Dr.  When she saw him he recommended an Orthoscopic surgery.  She decided to do that and she had that done 6/13/24 at the orthopedic institute.  She has a postop appointment tomorrow at 11:15.  She did not have any problems with her shoulder prior to the vaccines, no falls or arthritis in the shoulders either.  The patient is angry that she is going through this, and the pain that she is going through since the vaccine.
Age: 74.0
Sex: F
Vaccine: FLU4, PNC20, RSV, FLU4, PNC20, RSV
Symptoms: Sensory disturbance, Sleep disorder, Spinal X-ray abnormal, X-ray limb normal
Clinical narrative: She got her vaccines, had no initial problems.  Gradually her arm started hurting to the point that she had very good range of motion of her arm, except she could not take the right arm and reach it across her chest to her left shoulder. If she had an itch she could not reach it.  She could lift it, she could do exercises, but she could not sleep.  She had a gnawing feeling when she tried to sleep.  She had to move from the bed to a chair, to another chair.  The pain was so bad she was at the point of crying.  She eventually went to the doctor as she decided it was not a regular reaction to a shot.  As she had gotten 3 vaccines in the same arm at the same time, she felt it was related to the vaccines.  She did not go to her PCP right away as she had an appointment coming up and decided to wait for that appointment.  After she saw them and after she talked about her routine stuff she discussed her shot and having cerva.  She explained her what that was related to the rotator cuff, and she seemed to have dismissed the issue.  She had to do more blood work for her other conditions.  She then decided to find a doctor and went to an Orthopedist.  She told him about her shoulder and told him she suspected cerva and he took the x-ray of her shoulder, told her the bones looked good. She told him that it was not her bones and it is what happened from the shot.  When she told him that when she slept the pain went to her neck, and he took an x-ray of her neck and showed some compression of her cervical spine and she told him she did not think it was from that.  He told her to take Naproxen, and sent her to PT.  She made an appointment with the spine speicalist and took the medicine, and then she couldn't stand the pain anymore and she told them he needed to see the doctor for an MRI.   That showed the rotator cuff tear and knew it was not in her spine.  He pointed the tear on the MRI and suggested cortisone injections, and she declined.  He then suggested her to see the Orthopedic surgeon, saw Dr.  When she saw him he recommended an Orthoscopic surgery.  She decided to do that and she had that done 6/13/24 at the orthopedic institute.  She has a postop appointment tomorrow at 11:15.  She did not have any problems with her shoulder prior to the vaccines, no falls or arthritis in the shoulders either.  The patient is angry that she is going through this, and the pain that she is going through since the vaccine.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Maternal exposure before pregnancy, No adverse event
Clinical narrative: HCP stated 30-year-old female patient received 2nd dose of GARDASIL 9 after her pregnancy on 5/25/2024. HCP stated patient received their first dose 13 months before the 2nd dose; No additional AE; HCP stated patient received their first dose 13 months before the 2nd dose; This spontaneous report was received from a pharmacist and refers to a 30-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 25-APR-2023 (reported as 13 months before the second dose)(also reported as exact date unknown, discrepancy), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). Then, on 25-MAY-2024, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (inappropriate schedule of product administration).  It was mentioned that there was interruption of vaccine schedule between first and second dose due to patient being pregnant (Maternal exposure before pregnancy) on an unspecified day. In addition, the reporter confirmed that patient did not receive hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) during pregnancy. No additional adverse event (AE) reported.  Lot # is being requested and will be submitted if received.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; A HCP called to report that his data logger in his vaccine refrigerator quit working on 03/08/2024, but was not realized and reset until 05/31/2024, which resulted in unknown temperature condition exposure to the vaccines.  A dose of GARDASIL 9 affec; This spontaneous report was received from a nurse and referred to an 11-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  The health care professional reported that his data logger in his vaccine refrigerator quit working on 08-MAR-2024 (but was not realized and reset until 31-MAY-2024, which resulted in unknown temperature condition exposure to the vaccines). On 08-MAR-2024, the patient was inadvertently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, affected by the unknown temperature conditions, lot #W028349, (expiration date: 07-JUN-2025), administered for prophylaxis (strength, dose, and route of administration were not provided) (Product storage error). The patient did not experience any adverse issues or side effects from the administered dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (No adverse event). No other information was able to be provided during the call. No product quality complaint (PQC). No prior excursions were reported. ; Sender's Comments:  US-009507513-2406USA001983: US-009507513-2406USA001859: US-009507513-2406USA001829: US-009507513-2406USA001816: US-009507513-2406USA001684: US-009507513-2406USA001795: US-009507513-2406USA001818: US-009507513-2406USA001844: US-009507513-2406USA001849: US-009507513-2406USA001893: US-009507513-2406USA001987: US-009507513-2406USA002012: US-009507513-2406USA002143:
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; her patient originally missed her second dose of GARDASIL 9 and didn't receive it until 23-APR-2024 (dose was administered late).; This spontaneous report has been received from Other Health Professional (Registered Nurse) referring a female patient of an unknown age.   The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On 08-MAR-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose reported as 0.5mL/series, administered for prophylaxis (strength, route and anatomical location of administration were not provided; lot # reported as u039529, which is a valid lot # for this vaccine, expiration date provided and validated to be on 09-AUG-2024). Then on 23-APR-2024, she was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose reported as 0.5mL/series, administered for prophylaxis (strength, route and anatomical location of administration were not provided; lot # reported as 1998828, which is a valid lot # for this vaccine, expiration date provided and validated to be on 11-NOV-2025).  It was stated that the patient originally missed her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and didn't receive it until 23-APR-204 (dose was administered late) (inappropriate schedule of product administration). The exact date of the missed dose was unknown. No symptomatic adverse events were reported. No additional adverse event (AE) (no adverse event).
Age: 3.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: inadvertent administration of MMR-II and PROQUAD to a patient; No additional AE; This spontaneous report was received from a nurse referring to a 3-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.  On an unknown date (reported as " on the same day a few months ago"), the patient was inadvertently vaccinated a first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection (both strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis by health professional (accidental overdose). No additional adverse events (AE) were reported.  Lot# is being requested and will be submitted if received.
Age: 45.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: 3rd dose had not been administered; Late 2nd dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 49-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received in Mar-2019).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. In JUL-2020, the patient received the 2nd dose of Twinrix. In JUL-2020, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose.). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: 3rd dose had not been administered). The outcome of the incomplete course of vaccination 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: 14-JUN-2024 The patient received 2nd dose at longer interval, which led to lengthening of vaccination schedule. Till the time of reporting the patient had not received the third dose of Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: They got covid in June 2024; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (They got covid in June 2024) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030498) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In June 2024, the patient experienced COVID-19 (They got covid in June 2024) (seriousness criterion medically significant). At the time of the report, COVID-19 (They got covid in June 2024) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Dosage text reported as unknown. It was unknown if the patient was vaccinated with any other vaccinations 4 weeks prior to the COVID-19 vaccine. In Oct 2023, the patient received the vaccines and completed the recommended doses. Unfortunately, in Jun 2024, he got Covid-19 and had pain allover body and was too tired get up from bed. No treatment medication was provided. Company Comments: This is a spontaneous case concerning a male patient of an unknown age with no medical history reported who experienced the unexpected serious (medically significant) event of COVID-19. The event occurred on unknown date after the dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS). As reported, In Oct 2023, the patient received the vaccines and completed the recommended doses. No further information provided. At the time of the report the event was resolving. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) is not affected by this report
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Mar2024 as dose 1, single (Lot number: HN0477) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1;MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2;MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3;MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4;MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 5;MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 6;MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19: (09Jun2024) Positive, notes: Positive Test 09Jun and 11Jun2024; (11Jun2024) Positive, notes: Positive Test 09Jun and 11Jun2024. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient received other vaccination and medication in 2 weeks. Paxlovid was taken as treatment for COVID-19 FROM 02Jun2024 to 06Jun2024