chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Polyarthritis
Clinical narrative: Excruciating new onset arthritis in multiple areas of body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Aug2023 as dose 6 (booster), single (Lot number: GK0928) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "No adverse effects"; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "No adverse effects"; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "No adverse effects"; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "No adverse effects"; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "No adverse effects". The following information was reported: POLYARTHRITIS (medically significant), outcome "not recovered", described as "Excruciating new onset arthritis in multiple areas of body". Therapeutic measures were taken as a result of polyarthritis. Clinical Course: Patient reported that since the onset of covid 19, as soon as it became available patient was vaccinated 6 times. The first 5 presented No adverse effects, however the 6 administered on 02Aug2023 had basically destroyed the quality of life. With excruciating new onset arthritis in multiple areas of body for over 3 months now with no pain relief in spite of hard narcotics. Patient was asking how to escape from hell. It kept getting worse.
Sex: M
Vaccine: COVID19
Symptoms: General physical health deterioration
Clinical narrative: ruined my health; This is a spontaneous report received from a non-contactable reporter (Consumer or other non0HCP), Program ID: (201253).  A 64-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as DOSE 1, SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown" described as "ruined my health."  No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: but ended up getting the covid-19; but ended up getting the covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 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. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "but ended up getting the covid-19". Clinical course: Caller mentioned that she already got the COVID-19 vaccine, but ended up getting the covid-19. She would like to know how long she had to wait before getting the booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: He said he had both shots and every booster except the most recent booster, in Oct he caught Covid; He said he had both shots and every booster except the most recent booster, in Oct he caught Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID. The reporter is the patient.  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (2023) and all described as "He said he had both shots and every booster except the most recent booster, in Oct he caught Covid".  Clinical course details: The caller said he has been looking all over the place and his doctor hasn't returned his call. He said he had both shots and every booster except the most recent booster, about the time he was going too early and in Oct2023 he caught Covid and he was over covid now. He said he was just trying to get somebody a straight answer if how long he should wait after he had covid recently to get the most recent booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: right hand/arm shaking; right hand/arm shaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), on 27Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (first dose, lot FD8448), administration date: 30Aug2021, for Covid-19 immunisation, reaction(s): "no adverse effect". The following information was reported: TREMOR (non-serious), TREMOR (non-serious) all with onset 2021, outcome "unknown" and all described as "right hand/arm shaking". Additional information: Shaking started 2/3 months (Nov-Dec) 20212 later. Physical checkup determined "Not  Parkinson's."   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Aneurysm
Clinical narrative: I had someone in my family suffer an aneurysm after receiving the pfizer covid 19 vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANEURYSM (non-serious), outcome "unknown", described as "I had someone in my family suffer an aneurysm after receiving the pfizer covid 19 vaccine". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: each time, only had sore spot to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (unknown if pregnant) received bnt162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6200) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "each time, only had sore spot to touch". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Each time, only had sore spot to touch and negative COVID-19 test (PCR) after the vaccinations.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Illness, Pelvic pain
Clinical narrative: become serverly ill; chronic pelvic pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, lot number unknown), for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "become serverly ill"; PELVIC PAIN (non-serious), outcome "unknown", described as "chronic pelvic pain".  Additional information: the patient specified that he/she was forced to receive two of Pfizer covid 19 vaccines for work when the covid virus came into existence and the patient has become severely ill since then. The patient has chronic pelvic pain as a result and no doctors can help.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Autoimmune disorder, Condition aggravated, Haemorrhage, Immunisation reaction
Clinical narrative: become serverly ill; chronic pelvic pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, lot number unknown), for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "become serverly ill"; PELVIC PAIN (non-serious), outcome "unknown", described as "chronic pelvic pain".  Additional information: the patient specified that he/she was forced to receive two of Pfizer covid 19 vaccines for work when the covid virus came into existence and the patient has become severely ill since then. The patient has chronic pelvic pain as a result and no doctors can help.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pain, Pelvic pain
Clinical narrative: become serverly ill; chronic pelvic pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, lot number unknown), for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "become serverly ill"; PELVIC PAIN (non-serious), outcome "unknown", described as "chronic pelvic pain".  Additional information: the patient specified that he/she was forced to receive two of Pfizer covid 19 vaccines for work when the covid virus came into existence and the patient has become severely ill since then. The patient has chronic pelvic pain as a result and no doctors can help.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 16 year old patient was given an extra dose of ADACEL with no reported adverse event; Initial information received on 13-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old female patient was given an extra dose of Diphtheria-2/Tetanus/5 AC Pertussis vaccine [Adacel] 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 Meningococcal vaccine A/C/Y/W CONJ (TET TOX) (Menquadfi) for Prophylactic vaccination.  On 10-Nov-2023, the patient received an unknown extra dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis vaccine Suspension for injection of lot U7648AA and expiry: 15-Feb-2025 via unknown route in unknown administration site for immunization; with no reported adverse event (extra dose administered) (latency: same day).  No lab data was reported.  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 and Regulatory Authority 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: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: she received Fluzone Quadrivalent and is currently pregnant with no reported adverse event; Initial information was received on 13-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 30 years old female patient who was currently pregnant and exposed to influenza quadrival A-B vaccine [Fluzone quadrivalent]with no reported advesre event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 29-Oct-2023, the patient received a 0.5 ml, total (once) dose of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot UT8144NA, expiry date: 30-Jun-2024, strength: standard) via unknown route in unknown administration site for Immunization and she received fluzone quadrivalent and is currently pregnant with no reported advesre event (exposure during pregnancy) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Pharmacy technician reports PNEUMOVAX23 that expired on 10/20/2023 was administered on 11/1/2023. No symptoms or side effects reported. Operator of device is an HCP. Confirmed no p; This spontaneous report was received from a technician referring to a 67-year-old patient with unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 01-NOV-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #W007035, expiration date: 20-OCT-2023, administered for prophylaxis (strength, dose, anatomical site of administration and route of administration were not provided) (Expired product administered). No symptoms or side effects reported (no adverse event). It was confirmed no previous temperature excursions.
Sex: U
Vaccine: RSV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: arm is in a lot of pain; Swollen 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 (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: arm is in a lot of pain) and swelling arm (Verbatim: Swollen arm). The outcome of the pain in arm and swelling arm were not reported.   It was unknown if the reporter considered the pain in arm and swelling arm to be related to Arexvy.     It was unknown if the company considered the pain in arm and swelling arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 15-NOV-2023 The case was received from the patient via (Open field AE monitoring) interactive digital media. The reporter stated his/her arm was in lot of pain and was swollen. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Liver transplant, Malaise
Clinical narrative: ill; liver transplant; This serious case was reported by a consumer via call center representative and described the occurrence of liver transplant in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received the 1st dose of Shingrix. In JAN-2023, an unknown time after receiving Shingrix, the patient experienced liver transplant (Verbatim: liver transplant) (serious criteria clinically significant/intervention required). On an unknown date, the patient experienced unwell (Verbatim: ill). The outcome of the liver transplant was unknown and the outcome of the unwell was not reported.   It was unknown if the reporter considered the liver transplant and unwell to be related to Shingrix.     It was unknown if the company considered the liver transplant and unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-NOV-2023 The patients wife reported more than one year ago patient received a first dose of Shingrix. The patient never received second dose because he got ill. The doctor recommended him not to receive the second dose. The patient was immunocompromised. In January 2023 patient had liver transplant. The reporter did not consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Breast cancer
Clinical narrative: breast cancer; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (breast cancer) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAST CANCER (breast cancer) (seriousness criterion medically significant). At the time of the report, BREAST CANCER (breast cancer) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. The patient states she has two friends with breast cancer after shots 5 and 6. No treatment medication reported.  This case was for the first of two patients reported. Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (due to medically significant ) unexpected, event of breast cancer, which occurred on an unknown date after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine. The outcome of the event was reported as not recovered. The event was considered unrelated to the vaccine due to lack of biological plausibility. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-748863, US-MODERNATX, INC.-MOD-2023-750551 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Nov-2023: Live follow-up received with no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748863:Different patient US-MODERNATX, INC.-MOD-2023-750551:Different patient
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Oropharyngeal pain
Clinical narrative: Within approximately 14 hours of the administration of the vaccine, I started to feel a mild sore throat which has lasted for a couple of days. It is very mild and does not cause coughing. There is no associated nasal congestion. No fever, no fatigue.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The vaccine given had passed the beyond use date. Vaccine beyond use date of 11/16/23, vaccine administered 11/17/23
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Computerised tomogram abdomen, Computerised tomogram head, Epstein-Barr virus infection, Menstrual disorder
Clinical narrative: Gushing blood clots with an erratic menstrual cycle . Hurting so badly went to er with migraine , body aches - joint and muscle pain . Have spent thousands for answers
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstruation irregular, Migraine, Myalgia, Pain, Thrombosis
Clinical narrative: Gushing blood clots with an erratic menstrual cycle . Hurting so badly went to er with migraine , body aches - joint and muscle pain . Have spent thousands for answers
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan vagina
Clinical narrative: Gushing blood clots with an erratic menstrual cycle . Hurting so badly went to er with migraine , body aches - joint and muscle pain . Have spent thousands for answers
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Atrioventricular block first degree, Blood test, Cardiac ventricular disorder, Chest X-ray, Dysgeusia
Clinical narrative: She got her vaccine, the next day she was tired like she always is.  She noticed things were not tasting right, "nickle mouth", peaked about day #5, and resolved by day #7 or 8.  On day #13, she noticed in the evening palpitations as her heart was beating hard, different from anything she experienced before.  She immediately worried about myocarditis as she had read about it.  The next day she called to get an appointment with her doctor to check her heart, and they did not have any openings, and she wanted her to go to the ER.  She went to one and they did a chest x-ray, EKG and blood work.  They found that she had a first AV block.  Then another doctor looked at it the next day and he noticed somethi   noticed ventricular complexities.  Then they got sent to her PCP and she sent her the next day to a cardiologist.  He put a Holter monitor on her and then did another EKG and he saw the first AV block, which he was not too concerned about it.  He said that one of the chambers of the ventricular was a little enlarged, and he did see the ventricular complexities and he did schedule her for an echo after she wears the holter for 2 weeks, and she is scheduled for that on 12/1/23.    She is still having palpitations, and she is keeping a record.  Most of her symptoms happen in the evening, especially in the night.  It could be anxiety or something else, but it did not happen until she received the vaccine.  She did not have any issues with her heart prior to the vaccine.    Previously about 20 years had an EKG and was told that she had a left bundle branch block, but was told that was gone.    The ER she went to was hospital.  None of the doctors were concerned that it was 13 days after she had received the vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal, Fatigue, Palpitations, Ventricular enlargement
Clinical narrative: She got her vaccine, the next day she was tired like she always is.  She noticed things were not tasting right, "nickle mouth", peaked about day #5, and resolved by day #7 or 8.  On day #13, she noticed in the evening palpitations as her heart was beating hard, different from anything she experienced before.  She immediately worried about myocarditis as she had read about it.  The next day she called to get an appointment with her doctor to check her heart, and they did not have any openings, and she wanted her to go to the ER.  She went to one and they did a chest x-ray, EKG and blood work.  They found that she had a first AV block.  Then another doctor looked at it the next day and he noticed somethi   noticed ventricular complexities.  Then they got sent to her PCP and she sent her the next day to a cardiologist.  He put a Holter monitor on her and then did another EKG and he saw the first AV block, which he was not too concerned about it.  He said that one of the chambers of the ventricular was a little enlarged, and he did see the ventricular complexities and he did schedule her for an echo after she wears the holter for 2 weeks, and she is scheduled for that on 12/1/23.    She is still having palpitations, and she is keeping a record.  Most of her symptoms happen in the evening, especially in the night.  It could be anxiety or something else, but it did not happen until she received the vaccine.  She did not have any issues with her heart prior to the vaccine.    Previously about 20 years had an EKG and was told that she had a left bundle branch block, but was told that was gone.    The ER she went to was hospital.  None of the doctors were concerned that it was 13 days after she had received the vaccine.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Pain
Clinical narrative: Patient states having left shoulder pain continuing 1 week after vaccination. She is experiencing pain when lifting her left arm.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, pain at the site of injection. Seen 11/24/2023, no fever. Prescribed Keflex and Prednisone.
Age: 6.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product administration error, Wrong product administered
Clinical narrative: The patient received adult TDap instead of DTap. The patient was monitored for 15 minutes while in the clinic?no signs/symptoms of allergic reaction. The patient's mother was notified at the time of the error and encouraged to monitor the patient closely and to follow up with PCP.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood test, Chills, Computerised tomogram, Fall
Clinical narrative: She got her vaccine, that night I fell asleep in her chair and then could not get out of the chair over night.  The next day she tried to get up to go to the bathroom, and fell to the floor.  All the feelings in her legs were gone, she called 911.  They took her to the hospital and was in the hospital for 5 days.  She was then transferred to a rehabilitation center as she still could not walk, and was there for a week, and was released on Tuesday 11/21/23.  They want her to do more out patient therapy.  Her diagnosis is Rhabdomyolysis.  At the hospital they felt that she may have had sepsis, which she did not have.  They pumped her with all kinds of stuff, and then transferred to rehab.  She is able to walk with a walker or a cane and if she tries to do without those she is extremely slowly.  But she is able to get up with the walker and go to the bathroom on her own.   She had also experienced extreme chills where her teeth were chattering, but had no fever, no cough or any other symptoms.    They believed her that she felt that it was related to the vaccine.  That is the only thing that she would have done differently.  She was ready to go on a cruise due to this.    She went to Hospital.  She was then transferred to Rehab Center.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Gait inability, Hypoaesthesia, Mobility decreased, Rhabdomyolysis
Clinical narrative: She got her vaccine, that night I fell asleep in her chair and then could not get out of the chair over night.  The next day she tried to get up to go to the bathroom, and fell to the floor.  All the feelings in her legs were gone, she called 911.  They took her to the hospital and was in the hospital for 5 days.  She was then transferred to a rehabilitation center as she still could not walk, and was there for a week, and was released on Tuesday 11/21/23.  They want her to do more out patient therapy.  Her diagnosis is Rhabdomyolysis.  At the hospital they felt that she may have had sepsis, which she did not have.  They pumped her with all kinds of stuff, and then transferred to rehab.  She is able to walk with a walker or a cane and if she tries to do without those she is extremely slowly.  But she is able to get up with the walker and go to the bathroom on her own.   She had also experienced extreme chills where her teeth were chattering, but had no fever, no cough or any other symptoms.    They believed her that she felt that it was related to the vaccine.  That is the only thing that she would have done differently.  She was ready to go on a cruise due to this.    She went to Hospital.  She was then transferred to Rehab Center.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Walking aid user, X-ray
Clinical narrative: She got her vaccine, that night I fell asleep in her chair and then could not get out of the chair over night.  The next day she tried to get up to go to the bathroom, and fell to the floor.  All the feelings in her legs were gone, she called 911.  They took her to the hospital and was in the hospital for 5 days.  She was then transferred to a rehabilitation center as she still could not walk, and was there for a week, and was released on Tuesday 11/21/23.  They want her to do more out patient therapy.  Her diagnosis is Rhabdomyolysis.  At the hospital they felt that she may have had sepsis, which she did not have.  They pumped her with all kinds of stuff, and then transferred to rehab.  She is able to walk with a walker or a cane and if she tries to do without those she is extremely slowly.  But she is able to get up with the walker and go to the bathroom on her own.   She had also experienced extreme chills where her teeth were chattering, but had no fever, no cough or any other symptoms.    They believed her that she felt that it was related to the vaccine.  That is the only thing that she would have done differently.  She was ready to go on a cruise due to this.    She went to Hospital.  She was then transferred to Rehab Center.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal pain upper, Diarrhoea, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: INJECTION SITE SORENESS, ARM PAIN, MUSCLE ACHE INJECTION SITE ITCHINESS, WELT/ERYTHEMA 2X3 INCH STOMACH ACHE AND DIARRHEA
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Injection site reaction, Myalgia, Pain in extremity, Urticaria
Clinical narrative: INJECTION SITE SORENESS, ARM PAIN, MUSCLE ACHE INJECTION SITE ITCHINESS, WELT/ERYTHEMA 2X3 INCH STOMACH ACHE AND DIARRHEA
Age: 12.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product administration error
Clinical narrative: The patient received MenB (Trumenba) The patient was monitored for 15 minutes while in the clinic?no signs/symptoms of allergic reaction. The patient's mother was notified at the time of the error and encouraged to monitor the patient closely and to follow up with PCP.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Chills, Erythema, Lymphoedema, Peripheral swelling
Clinical narrative: Joint pain, fever, lymphedema, redness, swelling and erythema of injection arm, chills
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: Joint pain, fever, lymphedema, redness, swelling and erythema of injection arm, chills
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Face and arms red and swollen
Age: 56.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Chills, Fatigue, Injection site hypersensitivity
Clinical narrative: Patient complained of chills and fatigue the night after the vaccination. He also stated the site of injection flared up for the flu vaccine. Patient was advised before and after vaccine to ice the area of injection and to increase fluids for a min of 24 hours. Patient confirmed he did neither. Patient has since recovered from the reactions.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Rash, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: She got her vaccine, about 5 days later her armpit started itching when she put her deodorant on, and used the same deodorant for a long time.  They got a rash underneath them, and started not using it and has not shaved as the rash is so bad.  It is red, bumpy and blotchy.  It started that way for about a month and then it started spreading.  it spread to her trunk area, around her stomach area with little bumps that were itchy.  The armpits were the itchiness.  It seemed as long as she did not wear deodorant it was tolerable.  It was painful, itchy.  She has been keeping it dry and clean.  Last week it spread to her groin area on her thighs and when it took a warm shower that is was extremely painful.  It is all bumpy and painful.    She would say it is up a bit in her upper thigh, groin area, around her trunk which has improved in the last day or two.  It has now spread down her arms, on her hands, very light on her arms.  Her armpits are starting to improve, and the rash is now on the upper thighs which is probably the worst now.  It's been 2 1/2 months and it's weird and wonders if she should get her 2nd one at the end of December.    She went to the doctor yesterday and gave her some antifungal medicine which she started yesterday and gave her some steroid cream, and to take an antihistamine as well.  She was also told to use a lot of lotion on her skin, and that possibly she may need to see a dermatologist.    She wonders if she is having shingles, she is a teacher and was told that one of her students may have given you the chicken pox.
Age: 70.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: fever arm swollen starting day of vaccine going for 3 days, still sore 2 weeks later but getting better
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received the COVID adult shot instead of the ped's COVID vaccine
Age: 5.0
Sex: F
Vaccine: COVID19, DTAPIPV, FLU4, MMRV
Symptoms: Encopresis
Clinical narrative: Acute onset encopresis 24 hours after vaccination with possible decreased anal sensation/tone? Continuing for at 1 week at time of report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Dyspnoea, SARS-CoV-2 test
Clinical narrative: Patient, with a history of COPD, HTN, and previous oxygen use history, presented to ED on 11/24/23 for shortness of breath. The symptom started on 11/23/23. Upon admit to ER, patient had a temperature of 99.2 with no cough noted.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: THE PATIENT CAME IN AND ASKED FOR A COVID 19 VACCINE. WE CONFIRMED WITH THE PATIENT PRIOR TO GIVING THE VACCINE THAT THEY WERE GETTING A COVID VACCINE AND SHE SAID YES.  UPON ENTERING THE INFORMATION IN THE IMMUNIZATION REGISTRY I DISCOVERED THAT SHE HAD BEEN GIVEN THE PFIZER COVID VACCINE 2 WEEKS AGO.  SO SHE WAS GIVEN AN UNNECESSARY DOSE OF VACCINE TOO CLOSE TO THE PREVIOUS DOSE
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: vaccine was administered past the beyond use date, beyond use date of 11/16/23, vaccine was administered on 11/17/23
Age: 51.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Lymphadenopathy, Pruritus, Rash
Clinical narrative: Rash, itching, swelling of lymph nodes on left side of body.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Blood pressure decreased, Loss of consciousness, Pallor
Clinical narrative: Patient lost vision and consciousness. The patient's complexion was very pale and their blood pressure dropped. The patient was assisted to the floor and EMS was called. Ice packs were placed on patients necks and their color and blood pressure came back to normal range. EMS stayed until blood pressure was within normal range.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Back pain, Headache, Influenza like illness, Oropharyngeal pain
Clinical narrative: Both my husband and I ages 72 and 74 had the RSV (Glasco) vaccination on 11-16-23.  We both have the same symptoms which were flu like, sore throat, fever, extreme lower back pain (kidney's), weakness, headache.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia, Renal pain
Clinical narrative: Both my husband and I ages 72 and 74 had the RSV (Glasco) vaccination on 11-16-23.  We both have the same symptoms which were flu like, sore throat, fever, extreme lower back pain (kidney's), weakness, headache.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Papule, Rash
Clinical narrative: Pt describes rash and papules occurring day after vaccine.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Blood pressure decreased, Loss of consciousness, Pallor
Clinical narrative: Patient lost vision and consciousness. The patient's complexion was very pale and their blood pressure dropped. The patient was assisted to the floor and EMS was called. Ice packs were placed on patients necks and their color and blood pressure came back to normal range. EMS stayed until blood pressure was within normal range.
Age: 34.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: I am 34 weeks pregnant and was given the Arexvy RSV vaccine instead of Abrysvo. Arexvy has not been approved for pregnant women.
Age: 34.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: I am 34 weeks pregnant and was given the Arexvy RSV vaccine instead of Abrysvo. Arexvy has not been approved for pregnant women.
Age: 34.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: I am 34 weeks pregnant and was given the Arexvy RSV vaccine instead of Abrysvo. Arexvy has not been approved for pregnant women.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient got both covid shot (left deltoid )ant flu shot (right deltoid). On his way out of the store, after waiting for 15-20 minutes in pharmacy area, he fainted for 5 seconds according to his dad who was with the patient. Paramedics were called and check his status. His vitals were ok and he didn't have any injuries while passing out. Patient and his dad returned to the pharmacy areas where he could be monitored . They left in about 30-35 minutes.
Age: 81.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Pain in extremity, Rash
Clinical narrative: Started as a sore arm then a red rash appeared as a circle around the injection site. A rash also appeared down both sides of torso.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immune system disorder, Inflammation, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Covid Comirnaty vaccine has cause a inflammatory immune response. Joint stiffness in hands, shoulder, knee and ankle area. Patient has taken ibuprofen and a muscle relaxant (tizantidine), the pain is just not in the muscle, but Joint/tendon. Patient has not experienced any of the common side effects of Headache or Fever.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tendon pain
Clinical narrative: Covid Comirnaty vaccine has cause a inflammatory immune response. Joint stiffness in hands, shoulder, knee and ankle area. Patient has taken ibuprofen and a muscle relaxant (tizantidine), the pain is just not in the muscle, but Joint/tendon. Patient has not experienced any of the common side effects of Headache or Fever.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Febrile convulsion, Hand-foot-and-mouth disease
Clinical narrative: Febrile seizure, patient went to hospital, treated with tylenol and motrin
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Fall, Feeling abnormal, Head injury
Clinical narrative: He had COVID prior to the vaccine, felt he was forced to get the vaccine.  He got the vaccine, started feeling strange with fever, and after a while it felt normal, and then he started getting dizzy spells "vertigo".  He was riding his scooter, does not recall getting a dizzy spell but before he knew it he was in an ambulance and was unconcious for about an hour.  He was taken to the ER.  In the ER they were trying to figure out how he fell and he did not remember and told them that he did not remember that.  In the ER he had x-rays and was treated for the fall and sent home.  His  When he fell he hit his  head and had stitches on the side/top of the head.  After that he had his stitches removed, and went back home.  He was referred to a neurologist and they are treating him for Vertigo and has been using medication for that.  He has had MRI's done, and sound wave testing done but has an apponitment for FU on 12/5/23 for those results.    The last dizzy spell he had was yesterday, and he fell on his brothers bed.  The dizzy spells are intermittent, unexpected.  He does have a little high BP, and is on medication for that. He is still being treated for the dizziness.  He has had MRI's, and is beging treated with sound waves on 12/5/23.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Loss of consciousness, Magnetic resonance imaging, Pyrexia, Suture insertion
Clinical narrative: He had COVID prior to the vaccine, felt he was forced to get the vaccine.  He got the vaccine, started feeling strange with fever, and after a while it felt normal, and then he started getting dizzy spells "vertigo".  He was riding his scooter, does not recall getting a dizzy spell but before he knew it he was in an ambulance and was unconcious for about an hour.  He was taken to the ER.  In the ER they were trying to figure out how he fell and he did not remember and told them that he did not remember that.  In the ER he had x-rays and was treated for the fall and sent home.  His  When he fell he hit his  head and had stitches on the side/top of the head.  After that he had his stitches removed, and went back home.  He was referred to a neurologist and they are treating him for Vertigo and has been using medication for that.  He has had MRI's done, and sound wave testing done but has an apponitment for FU on 12/5/23 for those results.    The last dizzy spell he had was yesterday, and he fell on his brothers bed.  The dizzy spells are intermittent, unexpected.  He does have a little high BP, and is on medication for that. He is still being treated for the dizziness.  He has had MRI's, and is beging treated with sound waves on 12/5/23.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo, X-ray
Clinical narrative: He had COVID prior to the vaccine, felt he was forced to get the vaccine.  He got the vaccine, started feeling strange with fever, and after a while it felt normal, and then he started getting dizzy spells "vertigo".  He was riding his scooter, does not recall getting a dizzy spell but before he knew it he was in an ambulance and was unconcious for about an hour.  He was taken to the ER.  In the ER they were trying to figure out how he fell and he did not remember and told them that he did not remember that.  In the ER he had x-rays and was treated for the fall and sent home.  His  When he fell he hit his  head and had stitches on the side/top of the head.  After that he had his stitches removed, and went back home.  He was referred to a neurologist and they are treating him for Vertigo and has been using medication for that.  He has had MRI's done, and sound wave testing done but has an apponitment for FU on 12/5/23 for those results.    The last dizzy spell he had was yesterday, and he fell on his brothers bed.  The dizzy spells are intermittent, unexpected.  He does have a little high BP, and is on medication for that. He is still being treated for the dizziness.  He has had MRI's, and is beging treated with sound waves on 12/5/23.
Age: 69.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Arthralgia, Back pain, Blood test, Chest X-ray, Computerised tomogram head
Clinical narrative: Lightheaded, head too heavy to hold up, headache on top of head (ongoing since 11/11/2023), right shoulder pain (ongoing since 11/11/2023) spreading across back. EKG, Ct scan of head, chest x-ray, blood work, urine test, blood pressure tests - lying down, standing, sitting. Treated as if I was having a heart attack. Tests inconclusive. Sent me home saying I was "probably coming down with something".  Took another two days for lightheadedness to go away. Still have shoulder pain.  Did not seek treatment for shoulder pain when it first started. Thought it would go away.
Age: 69.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Dizziness, Electrocardiogram, Head discomfort, Headache, Urine analysis
Clinical narrative: Lightheaded, head too heavy to hold up, headache on top of head (ongoing since 11/11/2023), right shoulder pain (ongoing since 11/11/2023) spreading across back. EKG, Ct scan of head, chest x-ray, blood work, urine test, blood pressure tests - lying down, standing, sitting. Treated as if I was having a heart attack. Tests inconclusive. Sent me home saying I was "probably coming down with something".  Took another two days for lightheadedness to go away. Still have shoulder pain.  Did not seek treatment for shoulder pain when it first started. Thought it would go away.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: patient came to pharmacy on 11-24 stated her arm is sore at site of injection and has not improved for about one week now. soreness started to occur on 11-18 after vaccine.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac murmur, Lymphadenopathy, Malaise, Pain
Clinical narrative: pt had pain and swollen lymph nodes and went to the hospital. a cardiologist told him he had a heart murmur He later went to see his regular pcp and was told he could not find a heart murmur Pt states he still feels ill after nearly a month
Age: 63.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: Arm swelling, pain, warmth starting 1 day after vaccine administration
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin warm
Clinical narrative: red area 5x5inches warm to the touch
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient given the 5-11 yr old Covid vaccine.  Patient will turn 5 on 12/11/2023.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: severe swelling, itching, redness
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No symptoms or side effects; Nurse called to inquire about revaccination for an Adult given a pediatric dose of RECOMBIVAX HB on 10/20/2023. Confirmed no symptoms or side effects. Nurse did not provide name at this time, therefore patient name marked "refused to answer". Operato; This spontaneous report was received from a nurse referring to a 47-year-old male patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.     On 20-OCT-2023, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (route of administration not reported) lot number W022795, expiration date 19-MAY-2025, 0.5 milliliter for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported.