chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX
Symptoms: Death, Fall, Illness, Lung disorder, Pneumonia
Clinical narrative: took your flu shot last fall and died about a month later from pneumonia\both illnesses that attack the lungs; both illnesses that attack the lungs; both illnesses that attack the lungs; Initial information received on 15-Sep-2023 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves an unknown age male patient who took the flu shot last fall and died about a month later from pneumonia\both illnesses that attack the lungs.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer via unknown route in unknown administration site for prophylactic vaccination (strength, formulation, dose, batch number and expiry date: unknown). Information on the batch number was requested  On an unknown date the patient took flu shot last fall and died about a month later from pneumonia\both illnesses that attack the lungs (pneumonia) (illness) (lung disorder) (unknown latency).  It is unknown if there were lab data/results available  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (pneumonia) (illness) (lung disorder).  Outcome was Fatal for the event pneumonia and was Unknown for the event illness and lung disorder No autopsy was done. The cause of death was reported as Pneumonia.  Seriousness criteria: Medically significant and Fatal for event pneumonia; Sender's Comments: Sanofi Company Comment dated 19-Sep-2023: This case involves an unknown age male patient who took the last flu shot on an unknown date and said to had fall on an unknown date and died about a month later from pneumonia\both illnesses that attack the lungs. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, with no time to onset, the role of the individual suspect vaccine cannot be assessed. Case will be re-evaluated post further update on the missing information; Reported Cause(s) of Death: took your flu shot last fall and died about a month later from pneumonia
Age: 59.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 59 years old received Fluzone HD with no reported adverse event; Initial information received on 14-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 59 years old and unknown gender patient who received fluzone hd with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect influenza quadrival A-B high dose HV vaccine, expiry: 30-Jun-2024 via unknown route in unknown administration site for Prophylactic vaccination (strength, formulation, dose, batch number: unknown), 59 years old received fluzone hd with no reported adverse event (product administered to patient of inappropriate age) (latency same day). Information on the batch number was requested  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event 59product administered to patient of inappropriate age   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: U
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: fluzone high-dose qiv. administration of 2 doses instead of 1 with no reported adverse event; Initial information received on 14-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who experienced Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent] administration of 2 doses instead of 1 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Sep-2023, the patient received 2 doses instead of 1 at dose 0.7 ml (Frequency = Twice) suspect Influenza Quadrival A-B High Dose HV Vaccine (lot: UC8072AA, Expiry date: 30-Jun-2024) with unknown formulation, strength via unknown route in unknown administration site for Immunization with no reported adverse event (overdose).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.
Age: 48.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: FLUBLOK have been administered since the excursion with no reported adverse event; Initial information received  on 14-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 48 years old female patient whom influenza quadrivalent recombinant vaccine [Flublok QIV] have been administered since the excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Quadrivalent Recombinant Vaccine strength, dose: not reported lot U8058AA expiry date: 31-May-2024 via unknown route in unknown administration site for immunization.  On an unknown date flublok have been administered since the excursion with no reported adverse event (poor quality product administered) on the same day following the administration of Influenza Quadrivalent Recombinant Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event flublok have been administered since the excursion with no reported adverse event.   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: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: nurse gave a fluzone high dose quadrivalent dose of a patient, after the vaccine had a temperature excursion of below 0 C with no reported adverse event; Initial information received on 15-Sep-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves male patient of an unknown age and nurse gave a Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] of a patient, after the vaccine had a temperature excursion of below 0 c.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Sep-2023, the patient received a dose of 0.7 ml of suspect Influenza Quadrival A-B High Dose Hv Vaccine (expiry date: not reported, lot UT8072EA, Frequency: once, Strength: high dose) unknown route in unknown administration site as Immunization and after the vaccine had a temperature excursion of below 0 c with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Syncope
Clinical narrative: 09/15/23 48 yr old woman known to service for ESRD on HD MWF, respiratory failure on chronic tracheostomy on collar, severe obesity but remains fairly functional and ambulatory presented to ER yesterday with syncopal episode, found to have COVID positive. Recently treated for PNA with Levaquin with no improvement.  Last HD 09/13 Wed with 5.2L fluid removal, left at 129 Kg(1 Kg below target weight). She was dialyzed on 2K bath.    Chart reviewed.
Age: 70.0
Sex: M
Vaccine: UNK
Symptoms: Mobility decreased, Neck pain, Sleep disorder
Clinical narrative: I have had fusion in my next and by 8 pm I had emense pain in my next, I put on some voltaren and it did help to help me sleep. It was very painful and could not move my neck. It is getting better today. It lasted over 10 hours but getting better.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Confusional state, Infection
Clinical narrative: SUMMARY OF PATIENT PROGRESS:   STATUS: Progressing as expected towards goals - continuing present plan   Primary Problem: COVID-19 DISEASE    Key findings related to primary problem: Pt AxO x3. VSS. On 2L NC. No complaints of pain. Pt repositioned. Right hip dressing CDI. Male purewick in place. IV abx.   Other key findings: Bed alarm on. Call light within reach. BP 130/54  | Pulse 61  | Temp 98.2 °F (36.8 °C)  | Resp 20  | Ht 1.854 m (6' 1")  | Wt 93.7 kg (206 lb 9.1 oz)  | SpO2 97%  | BMI 27.25 kg/m²        Problem: Confusion Acute Goal: Optimal Cognitive Function Outcome: Progressing   Problem: Adult Inpatient Plan of Care Goal: Plan of Care Review Outcome: Progressing Goal: Patient-Specific Goal (Individualized) Outcome: Progressing Goal: Absence of Hospital-Acquired Illness or Injury Outcome: Progressing Goal: Optimal Comfort and Wellbeing Outcome: Progressing   Problem: Fall Injury Risk Goal: Absence of Fall and Fall-Related Injury Outcome: Progressing   Problem: Skin Injury Risk Increased Goal: Skin Health and Integrity Outcome: Progressing   Problem: Infection Goal: Absence of Infection Signs and Symptoms Outcome: Progressing           Note Details  Author (R.N.) File Time 9/18/2023  1:59 PM Author Type REGISTERED NURSE Status Signed Last Editor (R.N.) Specialty GENERAL, OTHER Hospital Acct #  Admit Date 9/14/2023  ED to Hosp-Admission (Discharged) on 9/14/2023  ED to Hosp-Admission (Discharged) on 9/14/2023   Detailed Report  Note shared with patient Care Timeline  09/14   Admitted from ED (Observation) 1918 09/16   Admitted 0746 09/18   Discharged 1645
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: LOCAL REDNESS, SWELLING, ITCHING, HOT TO THE TOUCH
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine stored in unapproved storage unit
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: 60 hours of intense muscle aches and pains, headache and joint pain. Extreme fatigue.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine stored in unapproved storage unit
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 75.0
Sex: F
Vaccine: FLUA4
Symptoms: Back pain, Head discomfort
Clinical narrative: Pt complained of pain immediately upon receiving vaccine. Stated she had never had any adverse reactions to vaccines previously. Pain mostly in the back. Head felt full she said. Did not want us to call EMS. Had her sit  and although pt did not feel dizzy/faint we put an ice pack on her neck, gave her water and juice. Stayed with her til she felt better and then called and checked on her later. She stated she still felt weak about 3 hrs later but was improving with time. Told her to call us if any further issues
Age: 97.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine stored in unapproved storage unit
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine stored in unapproved storage unit
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine stored in unapproved storage unit
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Fall
Clinical narrative: After the vaccination pt said that she might faint because it happened before with another vaccine. She indicated that she would be alright. About two minutes after sitting down she fell on the ground. after helping her by laying her down on the ground and later sitting up she was okay. She mentioned that she had this vaccine when she was 11 years old and she didn't faint from it. She said in the past she fainted with the Gardisil vaccine. After sitting down to rest she was okay after.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Pruritus, Rash
Clinical narrative: Patient has experienced body rashes and severe itching for weeks after vaccination
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: PATIENT REPORTED BACK PAIN AFTER RECIEVING VACCINE
Age: 85.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Gait inability, Pain
Clinical narrative: Patient called/talked with me in the morning around 10AM. She stated that she got the vaccine the previous day and around 4:30 in the evening she has aching all over body and she couldn't walk. However, She's feeling better at the time we're talking. I advice her that since she's feeling better, she can take some Tylenol to help with the aching, rest and drink plenty of fluid.  I advice her to get medical help if she's feeling worse.
Age: 63.0
Sex: F
Vaccine: FLUC4, RSV
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Patient reported rash along the length of her arm, from shoulder to wrist.  Slightly raised pink bumps.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Injection site bruising, Muscular weakness, Pain
Clinical narrative: PATIENT IS HAVING FULL BODY PAIN AND WEAKNESS, PARTICULARLY IN HER LEGS, SO MUCH SO THAT SHE CANNOT STAND UP. SHE HAS BRUISING AT THE INJECTION SITE, NOTHING ABNORMAL THERE. PT IS TRYING TO GET SOME SLEEP AND SEE HOW SHE FEELS IN THE MORNING, ADVISED TO CALL HER MD IF NO BETTER IN THE MORNING.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Condition aggravated, Night sweats, Pain
Clinical narrative: Onset of mild body aches and fever (3 on a scale of 1-10) eight hours after injection. These symptoms had worsed to 9 (same scale) by midnight. Could only "cat nap" for sleep until 3am when vomiting began and continued until 6am until there was nothing remaining. Body aches and weakness continued throughout the next day (01/05/22). Performed a self COVID-19 (BinaxNOW) test early afternoon on 01/05. The test was negative. Was limited to bed rest, only tolerating sips of water or watered-down gatoraid and low salt crackers. At 1am on 01/06/22 woke from sleep covered in sweat. After returning from the bathroom, noted considerable high-frequency ringing in both ears, but no apparent loss of hearing. [Continued on P.2]  A bout of abdominal cramps occured the evening of 1/5. Fever and body aches abated by mid-morning of 1/06. Contacted primary care medical provider (see Item #14) the afternoon of 1/5 of the symptoms experienced after third Moderna injection (first booster). High frequency ringing in the ears rediced in intensity over the following weeks and months, but has not abated. (Determined frequency at 1750 Hz - A6 on an 88-key piano).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rest regimen, SARS-CoV-2 test negative, Sleep disorder, Tinnitus
Clinical narrative: Onset of mild body aches and fever (3 on a scale of 1-10) eight hours after injection. These symptoms had worsed to 9 (same scale) by midnight. Could only "cat nap" for sleep until 3am when vomiting began and continued until 6am until there was nothing remaining. Body aches and weakness continued throughout the next day (01/05/22). Performed a self COVID-19 (BinaxNOW) test early afternoon on 01/05. The test was negative. Was limited to bed rest, only tolerating sips of water or watered-down gatoraid and low salt crackers. At 1am on 01/06/22 woke from sleep covered in sweat. After returning from the bathroom, noted considerable high-frequency ringing in both ears, but no apparent loss of hearing. [Continued on P.2]  A bout of abdominal cramps occured the evening of 1/5. Fever and body aches abated by mid-morning of 1/06. Contacted primary care medical provider (see Item #14) the afternoon of 1/5 of the symptoms experienced after third Moderna injection (first booster). High frequency ringing in the ears rediced in intensity over the following weeks and months, but has not abated. (Determined frequency at 1750 Hz - A6 on an 88-key piano).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Onset of mild body aches and fever (3 on a scale of 1-10) eight hours after injection. These symptoms had worsed to 9 (same scale) by midnight. Could only "cat nap" for sleep until 3am when vomiting began and continued until 6am until there was nothing remaining. Body aches and weakness continued throughout the next day (01/05/22). Performed a self COVID-19 (BinaxNOW) test early afternoon on 01/05. The test was negative. Was limited to bed rest, only tolerating sips of water or watered-down gatoraid and low salt crackers. At 1am on 01/06/22 woke from sleep covered in sweat. After returning from the bathroom, noted considerable high-frequency ringing in both ears, but no apparent loss of hearing. [Continued on P.2]  A bout of abdominal cramps occured the evening of 1/5. Fever and body aches abated by mid-morning of 1/06. Contacted primary care medical provider (see Item #14) the afternoon of 1/5 of the symptoms experienced after third Moderna injection (first booster). High frequency ringing in the ears rediced in intensity over the following weeks and months, but has not abated. (Determined frequency at 1750 Hz - A6 on an 88-key piano).
Age: 34.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Fatigue, Headache, Injection site pain, Lymph node pain, Lymphadenopathy
Clinical narrative: Fatigue, body aches, soreness at injection site in both arms though worse in covid arm, and swollen and sore lymph nodes in left armpit (same side as covid vax), and slight headache.
Age: 34.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Pain
Clinical narrative: Fatigue, body aches, soreness at injection site in both arms though worse in covid arm, and swollen and sore lymph nodes in left armpit (same side as covid vax), and slight headache.
Age: 69.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Injection site nodule, Injection site warmth
Clinical narrative: PATIENT HAS A KNOT IN HER LEFT ARM WHERE THE SHOTS WERE GIVEN. PER PATIENT DESCRIPTION IT IS WARM TO THE TOUCH AND HAS BEEN PUTTING ICE ON IT. WILL SEEK MEDICAL ATTENTION IF SYMPTOMS GET WORSE.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Swelling of eyelid
Clinical narrative: Patient stated left eye lid swelling for about 12 hours. Stated swelling and warmth of the upper arm of injection site for a little over 2 weeks .
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: Pt came in to receive 3rd dose and pharmacist was unaware that the bivalent covid boosters could no longer be given. Pt wanted to receive 3rd dose because they were receiving a bonus if they received another dose in a certain time frame.
Age: 5.0
Sex: F
Vaccine: MMRV, MMRV, VARCEL
Symptoms: Erythema, Pruritus, Skin lesion, Varicella virus test
Clinical narrative: 9/17/23  Developed lesions on upper extremities 9/18/23  Seen in office - right arm x1, left arm x 5 (small intact vesicles on an 50 cent flat erythematous base, very pruritic) 9/19/23  No new lesions, erythema decreasing in size
Age: 5.0
Sex: F
Vaccine: MMRV, MMRV, VARCEL
Symptoms: Blister, Erythema, Papule, Polymerase chain reaction, Rash vesicular
Clinical narrative: 9/17/23  Developed lesions on upper extremities 9/18/23  Seen in office - right arm x1, left arm x 5 (small intact vesicles on an 50 cent flat erythematous base, very pruritic) 9/19/23  No new lesions, erythema decreasing in size
Age: 5.0
Sex: F
Vaccine: MMRV, MMRV, VARCEL
Symptoms: Skin lesion, Varicella virus test negative
Clinical narrative: 9/17/23  Developed lesions on upper extremities 9/18/23  Seen in office - right arm x1, left arm x 5 (small intact vesicles on an 50 cent flat erythematous base, very pruritic) 9/19/23  No new lesions, erythema decreasing in size
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Cough, Headache, Rash
Clinical narrative: Symptoms started on 9/20/23, headache, cough, rash to RLE, joint pain
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Symptoms started on 9/20/23, headache, cough, rash to RLE, joint pain
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Pruritus
Clinical narrative: Went to medical facility on Friday, was diagnosed with Shingles; This non-serious case was reported by a consumer and described the occurrence of shingles in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure. Concomitant products included losartan.   On 01-SEP-2023, the patient received Shingrix. On 03-SEP-2023, 2 days after receiving Shingrix, the patient experienced shingles (Verbatim: Went to medical facility on Friday, was diagnosed with Shingles). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 10-SEP-2023 The patient self-reported this case. The patient was on concomitant products pro air, amplodine, and losartan. The patient went on Friday and was diagnosed with Shingles. The symptoms were treated. The reporter gave permission to contact.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Went to medical facility on Friday, was diagnosed with Shingles; This non-serious case was reported by a consumer and described the occurrence of shingles in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure. Concomitant products included losartan.   On 01-SEP-2023, the patient received Shingrix. On 03-SEP-2023, 2 days after receiving Shingrix, the patient experienced shingles (Verbatim: Went to medical facility on Friday, was diagnosed with Shingles). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 10-SEP-2023 The patient self-reported this case. The patient was on concomitant products pro air, amplodine, and losartan. The patient went on Friday and was diagnosed with Shingles. The symptoms were treated. The reporter gave permission to contact.
Age: 64.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Balance disorder, Dizziness, Electronystagmogram, Labyrinthitis, Vestibular neuronitis
Clinical narrative: Vestibular Neuritis; Labyrinthitis; Is bivalent: False; administration date: 20Dec2022; dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 20Dec2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation. The patient didn't receive bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing). No COVID prior vaccination. No known allergies. The patient's concomitant medications were not reported. No other vaccine in four weeks. Vaccination history included: bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 15Jun2022, when the patient was 64-year-old, for COVID-19 immunization; bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 18Dec2021, when the patient was 63-year-old, for COVID-19 Immunization. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 20Dec2022, outcome "unknown", described as "Is bivalent: False; administration date: 20Dec2022; dose number: 3"; LABYRINTHITIS (disability) with onset 23Feb2023, outcome "recovered with sequelae" (2023); VESTIBULAR NEURONITIS (disability, medically significant) with onset 23Feb2023, outcome "recovered with sequelae" (2023), described as "Vestibular Neuritis". The events "vestibular neuritis" and "labyrinthitis" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of vestibular neuronitis, labyrinthitis. AE Treatment: 9 weeks of vestibular rehabilitation therapy. The information on the batch/lot number for bnt162b2, bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300303713 same reporter/patient, different dose number/ AE;
Age: 64.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Labyrinthitis, SARS-CoV-2 test, Vestibular neuronitis, Wrong product administered
Clinical narrative: Vestibular Neuritis; Labyrinthitis; Is bivalent: False; administration date: 20Dec2022; dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 20Dec2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation. The patient didn't receive bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing). No COVID prior vaccination. No known allergies. The patient's concomitant medications were not reported. No other vaccine in four weeks. Vaccination history included: bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 15Jun2022, when the patient was 64-year-old, for COVID-19 immunization; bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 18Dec2021, when the patient was 63-year-old, for COVID-19 Immunization. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 20Dec2022, outcome "unknown", described as "Is bivalent: False; administration date: 20Dec2022; dose number: 3"; LABYRINTHITIS (disability) with onset 23Feb2023, outcome "recovered with sequelae" (2023); VESTIBULAR NEURONITIS (disability, medically significant) with onset 23Feb2023, outcome "recovered with sequelae" (2023), described as "Vestibular Neuritis". The events "vestibular neuritis" and "labyrinthitis" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of vestibular neuronitis, labyrinthitis. AE Treatment: 9 weeks of vestibular rehabilitation therapy. The information on the batch/lot number for bnt162b2, bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300303713 same reporter/patient, different dose number/ AE;
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Anxiety, Dizziness, Dyspnoea, Emotional distress, Expired product administered
Clinical narrative: On the same day of administration that she was starting to experience heart palpitations, blurred vision, difficulty breathing, dizziness, and headaches; On the same day of administration that she was starting to experience heart palpitations, blurred vision, difficulty breathing, dizziness, and headaches; On the same day of administration that she was starting to experience heart palpitations, blurred vision, difficulty breathing, dizziness, and headaches; On the same day of administration that she was starting to experience heart palpitations, blurred vision, difficulty breathing, dizziness, and headaches; On the same day of administration that she was starting to experience heart palpitations, blurred vision, difficulty breathing, dizziness, and headaches; HCP states that expired PNEUMOVAX-23 was administered on 14-SEP-2023; HCP also reports that patient was anxious and upset on the phone and was also upset about the physician who treated her; This spontaneous report has been received from a nurse, regarding a 66-years-old female patient. The patient's pertinent medical history included depression and anxiety, previous drug reactions or allergies were not reported. Concomitant medications included clonazepam (KLONOPIN) and salbutamol (ALBUTEROL).  On 14-SEP-2023, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection, at a dose of 0.5 milliliters as prophylaxis (lot number: W007356, which was determined to be valid as vial formulation, with an expiration date on 10-AUG-2023) (strength, scheme, route and anatomical location of administration were not reported) (Expired dose administered).  In addition to administration of expired vaccine, patient also reports symptomatic adverse events after receiving Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). HCP states that patient reported that on the same day of administration that she was starting to experience heart palpitations, blurred vision, difficulty breathing (dyspnea), dizziness, and headaches. HCP also reports that patient was anxious (anxiety) and upset on the phone and was also upset about the physician who treated her. Patient was advised to go back to the clinic, an urgent care, or an emergency room for further treatment, but patient declined all options.   Nurse reporter states that patient has not called them back yet and they are unable to collect any additional information, they would receive a notice if patient went to the hospital or emergency room and states patient has not received any kind of treatment yet.  It was confirmed that vaccine did not experience any temperature excursions in its lifetime.  The outcome of the events was not provided.   The causal relationship between Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) and the aforementioned events was not provided.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Palpitations, Vision blurred
Clinical narrative: On the same day of administration that she was starting to experience heart palpitations, blurred vision, difficulty breathing, dizziness, and headaches; On the same day of administration that she was starting to experience heart palpitations, blurred vision, difficulty breathing, dizziness, and headaches; On the same day of administration that she was starting to experience heart palpitations, blurred vision, difficulty breathing, dizziness, and headaches; On the same day of administration that she was starting to experience heart palpitations, blurred vision, difficulty breathing, dizziness, and headaches; On the same day of administration that she was starting to experience heart palpitations, blurred vision, difficulty breathing, dizziness, and headaches; HCP states that expired PNEUMOVAX-23 was administered on 14-SEP-2023; HCP also reports that patient was anxious and upset on the phone and was also upset about the physician who treated her; This spontaneous report has been received from a nurse, regarding a 66-years-old female patient. The patient's pertinent medical history included depression and anxiety, previous drug reactions or allergies were not reported. Concomitant medications included clonazepam (KLONOPIN) and salbutamol (ALBUTEROL).  On 14-SEP-2023, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection, at a dose of 0.5 milliliters as prophylaxis (lot number: W007356, which was determined to be valid as vial formulation, with an expiration date on 10-AUG-2023) (strength, scheme, route and anatomical location of administration were not reported) (Expired dose administered).  In addition to administration of expired vaccine, patient also reports symptomatic adverse events after receiving Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). HCP states that patient reported that on the same day of administration that she was starting to experience heart palpitations, blurred vision, difficulty breathing (dyspnea), dizziness, and headaches. HCP also reports that patient was anxious (anxiety) and upset on the phone and was also upset about the physician who treated her. Patient was advised to go back to the clinic, an urgent care, or an emergency room for further treatment, but patient declined all options.   Nurse reporter states that patient has not called them back yet and they are unable to collect any additional information, they would receive a notice if patient went to the hospital or emergency room and states patient has not received any kind of treatment yet.  It was confirmed that vaccine did not experience any temperature excursions in its lifetime.  The outcome of the events was not provided.   The causal relationship between Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) and the aforementioned events was not provided.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Fever (101.3), overall joint and muscle pain, headache, feeling unwell, pain/swelling/redness at injection site.  All resolved by approx. 3:00 p.m. 9/18/2023.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: Fever (101.3), overall joint and muscle pain, headache, feeling unwell, pain/swelling/redness at injection site.  All resolved by approx. 3:00 p.m. 9/18/2023.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Injection site pain, Myalgia
Clinical narrative: Intense pain at site for over 24 hrs. Fever, chills, sweats,headache,sore muscles, aches
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Intense pain at site for over 24 hrs. Fever, chills, sweats,headache,sore muscles, aches
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Muscular weakness, Tremor
Clinical narrative: 9/19/23, 9:30am - woke shaking violently/uncontrollably, severely cold (unable to get warm), headache. Took 0.5 mg clonazepam to calm shaking, Tylenol for headache, piled multiple blankets and hunkered down in bed. Affects subsided after three hours, however, legs shaky and weak the remainder of the day
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Rash, Rash pruritic, Skin swelling, Skin warm
Clinical narrative: Bumpy itchy skin on raised red area that is very hot
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Conjunctivitis, Eye inflammation
Clinical narrative: Developed severe inflammation and conjunctivitis in left eye within 24 hours of getting updated booster
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: she was only able to receive two doses of GARDASIL 9; No additional AEs or PQC reported; This spontaneous report has been received from a 45 years old female patient referring to herself. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not provided.  In February 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) for prophylaxis (strength, dose, route, lot# and expiration date were not provided). In April 2023, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, route, lot# and expiration date were not provided). The operator was unknown. The patient reported she was only able to receive two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) due to turning 46 (years old) before 3rd dose was due (inappropriate schedule of product administration). No additional adverse events (AEs) or product quality complaint (PQC) reported.
Sex: U
Vaccine: UNK
Symptoms: Fatigue, Feeling hot, Peripheral swelling
Clinical narrative: I was wiped out the day; my arm was swollen and hot for almost a week; arm hot for almost a week; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tired out in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced tired out (Verbatim: I was wiped out the day), swelling arm (Verbatim: my arm was swollen and hot for almost a week) and extremities hot feeling of (Verbatim: arm hot for almost a week).  The outcome of the tired out was not reported and the outcome of the swelling arm and extremities hot feeling of were resolved (duration 1 week).   It was unknown if the reporter considered the tired out, swelling arm and extremities hot feeling of to be related to RSV vaccine.     It was unknown if the company considered the tired out, swelling arm and extremities hot feeling of to be related to RSV vaccine.   Additional Information: GSK receipt date: 10-SEP-2023 The case was received from the patient interactive digital media. The patient got the RSV vaccine a little over a week ago.  The patient was wiped out the day after and my arm was swollen and hot for almost a week. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   In SEP-2023, the patient received RSV vaccine. In SEP-2023, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK receipt date: 10-SEP-2023 The case was received from the patient interactive digital media. The patient got his/her shot on Thursday and had sore arm but was protected. The follow-up could not be possible as no contact details were available.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Fatigue, Headache, Lethargy, Migraine
Clinical narrative: Onset of s/s approx 1800: Migraine, fever 100.5, fatigue, weakness, lethargic. Symptoms persisted throughout the night into next morning. Continues to have daily HA/Migraines without prior hx of HA/migraines.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Onset of s/s approx 1800: Migraine, fever 100.5, fatigue, weakness, lethargic. Symptoms persisted throughout the night into next morning. Continues to have daily HA/Migraines without prior hx of HA/migraines.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Injection site discomfort, Nausea
Clinical narrative: Extreme fatigue, Chills, injection site discomfort, dizziness, nausea
Age: 46.0
Sex: M
Vaccine: TD
Symptoms: Fatigue, Influenza like illness, Pain in extremity
Clinical narrative: Donor received a tetanus immunization on 09/12/23. Upon donors return to the center on 09/16/23, the donor stated that he had a reaction to the shot. He stated he felt very fatigued and had flu-like symptoms. He also stated that he felt that his arm had significantly more pain than he expected from getting a vaccine. Donor states that he feels better and no longer has pain.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Complex regional pain syndrome, Dizziness, Drug hypersensitivity, Ehlers-Danlos syndrome
Clinical narrative: -Episode of syncope + Dizziness immediately after vaccine -Onset of new chronic health conditions (hEDS,CRPS,MCAS,POTS,and gastroparesis) -Pain, nausea, vomiting, weakness, numbness, dizziness
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Food allergy, Hypermobility syndrome, Hypoaesthesia, Immediate post-injection reaction, Impaired gastric emptying
Clinical narrative: -Episode of syncope + Dizziness immediately after vaccine -Onset of new chronic health conditions (hEDS,CRPS,MCAS,POTS,and gastroparesis) -Pain, nausea, vomiting, weakness, numbness, dizziness
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mast cell activation syndrome, Nausea, Pain, Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: -Episode of syncope + Dizziness immediately after vaccine -Onset of new chronic health conditions (hEDS,CRPS,MCAS,POTS,and gastroparesis) -Pain, nausea, vomiting, weakness, numbness, dizziness
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: -Episode of syncope + Dizziness immediately after vaccine -Onset of new chronic health conditions (hEDS,CRPS,MCAS,POTS,and gastroparesis) -Pain, nausea, vomiting, weakness, numbness, dizziness
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Pain
Clinical narrative: I felt a little tired after taking the shot. At about 10pm, I developed severe shivering, teeth chattering, aches and pains,  The chills broke around 1am. My spouse had no symptoms; My cousin felt sore at the site of injection; My mother developed a hard red spot at the injection site.  The symptoms are similar, but worse than the the second shot I received for COVID.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Malaise, Nausea
Clinical narrative: nausea, chills, general malaise, headache
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Fatigue, Headache, Insomnia
Clinical narrative: Heavy fatigue, difficulty sleeping, mild headache. The vaccine seemed to amplify the fatigue I was already feeling because I was not getting my Levothyroxine. The latter issue is fixed, but I'm guessing it will be a couple more days before my body gets back to normal.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fear, Pain in extremity, Pyrexia
Clinical narrative: Patient reported that approximately 5 hours after receiving vaccine that her arm was sore and she developed a fever up to 100.9 with chills and shivering.  She reported that the next day she was okay and the fever broke but she was very scared of her reaction.
Age: 71.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Headache, Pyrexia
Clinical narrative: Fever reaching 101 F for about 15 hours. Weakness. Headache.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria
Clinical narrative: chronic spontaneous urticaria occurs every every day. currently treating with zyrtec daily.
Age: 69.0
Sex: M
Vaccine: PNC20
Symptoms: Cerebrovascular accident, Transient ischaemic attack
Clinical narrative: Possible Stroke   TIA
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Biopsy skin abnormal, Blood test, Cardiac disorder
Clinical narrative: Persistent diffuse joint pain, Reynauds, skin lupus, dysphagia, cardiac issues, decreased stamina, diagnosis pending from Rheumatology.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Cutaneous lupus erythematosus, Dysphagia, Raynaud's phenomenon
Clinical narrative: Persistent diffuse joint pain, Reynauds, skin lupus, dysphagia, cardiac issues, decreased stamina, diagnosis pending from Rheumatology.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given High Dose Influenza and not the normal for his age.   No adverse reaction noted.  Patient and Provider were notified and no concerns reported.
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 4 boosters
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Influenza like illness, Myalgia, Tremor
Clinical narrative: Flu-like symptoms (soreness in muscles/joints, shaking/shivering). Shivering resolved within 2 hours after taking an Advil; continued minor muscle/joint soreness the following day (unmedicated).
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Patient administered the diluent only. Vaccine powder was not mixed in prior to administration.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Abdominal pain upper, Abdominal tenderness, Cough, Dyspnoea, Dyspnoea exertional
Clinical narrative: Mild swelling, tenderness at injection site;  day 2 post-injection - mild dyspnea on exertion, cough, rhinorrhea, no fever;  day 3 post-injection - fatigue, muscle aches, dyspnea on exertion worsened affecting activities of daily living, cough + rhinorrhea worse but no meds taken, left upper quadrant abdominal pain with mild tenderness, difficulty sleeping due to cough, pulse ox SPO2 85 - 90 during dyspneic episodes but 90 - 95 remainder of time, no fever day 4 post-injection - mild dyspnea on exertion at beginning of day, cough improved - mild and non-productive, rhinorrhea improved
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Fatigue, Injection site pain, Injection site swelling, Insomnia, Loss of personal independence in daily activities
Clinical narrative: Mild swelling, tenderness at injection site;  day 2 post-injection - mild dyspnea on exertion, cough, rhinorrhea, no fever;  day 3 post-injection - fatigue, muscle aches, dyspnea on exertion worsened affecting activities of daily living, cough + rhinorrhea worse but no meds taken, left upper quadrant abdominal pain with mild tenderness, difficulty sleeping due to cough, pulse ox SPO2 85 - 90 during dyspneic episodes but 90 - 95 remainder of time, no fever day 4 post-injection - mild dyspnea on exertion at beginning of day, cough improved - mild and non-productive, rhinorrhea improved