chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Chest pain, Electrocardiogram normal
Clinical narrative: 25 year old male here. A couple days after the first dose of Pfizer, I experienced this discomfort in my left side of my chest (not near the center of my chest, more right in front of my left armpit). Thought nothing of it. Couple days later it started to feel painful. So, 5 days after the first shot, I finally went to the ER and they did all the tests (blood work, EKG, chest x-ray, etc) and it came back normal. The doctor said I might have a pulled muscle or something and to treat it like a sprained ankle (couple weeks recovery). It's now been over a year since the first shot and I have developed severe side effects from the vaccine including chest pain, testicular pain, muscle spasms, headaches, nerve pain, tingling, and muscles shaking. All symptoms have developed over a year long span since vaccination. It began with left side chest pain then I developed all symptoms as weeks went forward since vaccination. I wake up everyday in pain now and this event has changed my entire life. I previously was healthy before the vaccine. I have been to many doctors who are unsure of what?s causing my symptoms but some think that due to me having Covid right before the injection might be why my body isn?t responding well and the reason for my lingering symptoms.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Laboratory test normal, Muscle spasms, Neuralgia, Pain
Clinical narrative: 25 year old male here. A couple days after the first dose of Pfizer, I experienced this discomfort in my left side of my chest (not near the center of my chest, more right in front of my left armpit). Thought nothing of it. Couple days later it started to feel painful. So, 5 days after the first shot, I finally went to the ER and they did all the tests (blood work, EKG, chest x-ray, etc) and it came back normal. The doctor said I might have a pulled muscle or something and to treat it like a sprained ankle (couple weeks recovery). It's now been over a year since the first shot and I have developed severe side effects from the vaccine including chest pain, testicular pain, muscle spasms, headaches, nerve pain, tingling, and muscles shaking. All symptoms have developed over a year long span since vaccination. It began with left side chest pain then I developed all symptoms as weeks went forward since vaccination. I wake up everyday in pain now and this event has changed my entire life. I previously was healthy before the vaccine. I have been to many doctors who are unsure of what?s causing my symptoms but some think that due to me having Covid right before the injection might be why my body isn?t responding well and the reason for my lingering symptoms.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Testicular pain, Tremor
Clinical narrative: 25 year old male here. A couple days after the first dose of Pfizer, I experienced this discomfort in my left side of my chest (not near the center of my chest, more right in front of my left armpit). Thought nothing of it. Couple days later it started to feel painful. So, 5 days after the first shot, I finally went to the ER and they did all the tests (blood work, EKG, chest x-ray, etc) and it came back normal. The doctor said I might have a pulled muscle or something and to treat it like a sprained ankle (couple weeks recovery). It's now been over a year since the first shot and I have developed severe side effects from the vaccine including chest pain, testicular pain, muscle spasms, headaches, nerve pain, tingling, and muscles shaking. All symptoms have developed over a year long span since vaccination. It began with left side chest pain then I developed all symptoms as weeks went forward since vaccination. I wake up everyday in pain now and this event has changed my entire life. I previously was healthy before the vaccine. I have been to many doctors who are unsure of what?s causing my symptoms but some think that due to me having Covid right before the injection might be why my body isn?t responding well and the reason for my lingering symptoms.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: 18yo patient was given Moderna vaccine 0.25mL indicated for 6mo-5yo on 2/9/23. Pt came back on 3/9/23 to receive the correct Moderna vaccine 0.5mL indicated for 12+ yo. This is reported as an administration error. No adverse event occurred.
Age: 21.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient came in to be vaccinated for second shot in primary series.  Had here a vaccine card showing she had received first dose. protocol changed between doses.   administered 2nd dose .  was not aware at the time that a 2 month separation and not a one month separation should be between monovalent and bi-valent.  found out two days later and pulled up the database to check what I thought    states in the database that the administer of first dose submitted a bi-valent dose as her primary.   this was before protocol change.    patient did not have an actual adverse event
Age: 19.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Headache, Nausea, Palpitations
Clinical narrative: Racing heart,  dizziness, nausea, headache
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Breast enlargement, Feeling hot, Hair growth abnormal, Hyperhidrosis
Clinical narrative: Profuse perspiration and always hot. Menstruating 20 years after menopause, with breasts getting extremely larger & denser. Skin easily sunburned - never before.  Balding on scalp. Facial hair.  Much more. I regret ever getting this poison.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mammogram abnormal, Photosensitivity reaction, Postmenopausal haemorrhage
Clinical narrative: Profuse perspiration and always hot. Menstruating 20 years after menopause, with breasts getting extremely larger & denser. Skin easily sunburned - never before.  Balding on scalp. Facial hair.  Much more. I regret ever getting this poison.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Dizziness
Clinical narrative: Patient stated that about 1 hour after receiving vaccine, he experienced lightheadedness and dizziness. His BP went down to 77/53 which lasted for about 6 hours.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysphonia, Headache, Laboratory test, Musculoskeletal pain
Clinical narrative: In the early morning of the day after I received the Vfizer vaccination,  I developed a severe  pounding headache that lasted  two days  following this if have had many severe headaches and several dull headaches.  I I also developed severe joint pain, knees, elbows, hips, hands, pain between shoulder blades. and a sore throat. Since this time I develop hoarseness  off and on without a sore throat This has continued to the present date.  I also spike fevers out of the blue,
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: In the early morning of the day after I received the Vfizer vaccination,  I developed a severe  pounding headache that lasted  two days  following this if have had many severe headaches and several dull headaches.  I I also developed severe joint pain, knees, elbows, hips, hands, pain between shoulder blades. and a sore throat. Since this time I develop hoarseness  off and on without a sore throat This has continued to the present date.  I also spike fevers out of the blue,
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: leFt arm Itchy really bad. and rash going up my hand
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Capillary nail refill test abnormal, Diarrhoea, Pallor
Clinical narrative: Diarrhea started the day after rotateq vaccination and had multiple episodes of very watery diarrhea; was pale looking with concerns of dehydration; eval in office 4/24/23 and advised pedialyte and close monitoring; did have reduced capillary refill that day in office; phone FU on 4/26/23 and reported that diarrhea improved 4/25/23.
Age: 66.0
Sex: F
Vaccine: COVID19, HEP, TD
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given five does of the Pfizer Sars-Cov-2 vaccine do to incorrect measurement during medication prep. Patient had no obvious symptoms of adverse reactions up to 48rs after administration and was scheduled to follow up in one week.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: NUMBING SENSATION IS LOCATED IN BOTH FEET AND IN THE TOES; This spontaneous report received from a patient concerned a 68 year old male. The patient's weight was 195 pounds, and height was 69 inches. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient was very healthy beside that numbing issue. The patient had No known allergies. The patient had no history of drug abuse or illicit drug usage. The patient was very healthy and does lot of exercise and go to the gym. The patient had shrunk a little bit. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 68 years old. No concomitant medications were reported. On APR-2021, the patient experienced numbing sensation is located in both feet and in the toes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of numbing sensation is located in both feet and in the toes was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Eye pain, Headache, Vomiting
Clinical narrative: issues with mental clarity; very very sick and started vomiting; very very sick and started vomiting; "felt very strange, didn't feel as if she had the strength to walk, and had issues; mild headaches, almost as if you move your head to fast there is a; "felt very strange, didn't feel as if she had the strength to walk,; This spontaneous report has been received from a consumer, regarding to a 66-year-old female patient. The patient's concomitant medications included Pravastatin, Methylphenidate hydrochloride (CONCERTA), and Vitamins nos (MULTIVITAMINS). Her pertinent medical history, current conditions, and previous drug reactions or allergies were not reported.  On 08-FEB-2023, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX) syringe injection, at a dose of 0.5 milliliters (ml), (lot number W007035 which has been verified as valid, and expiration date not reported but stablished as 20-OCT-2023) as prophylaxis (route of administration, strength and vaccination scheme were not provided).  On the same date, the patient felt very sick (Illness) and started vomiting, she felt very strange (Feeling abnormal), she did not have the strength to walk (Muscular weakness), additionally, it was reported that the patient developed mild headaches and had issues with mental clarity (Mental disorder). On 09-FEB-2023, the patient has recovered from aforementioned events.   The causality assessment between the events and the suspect vaccine was not provided.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Asthenia, Feeling abnormal, Gait inability, Headache, Malaise
Clinical narrative: issues with mental clarity; very very sick and started vomiting; very very sick and started vomiting; "felt very strange, didn't feel as if she had the strength to walk, and had issues; mild headaches, almost as if you move your head to fast there is a; "felt very strange, didn't feel as if she had the strength to walk,; This spontaneous report has been received from a consumer, regarding to a 66-year-old female patient. The patient's concomitant medications included Pravastatin, Methylphenidate hydrochloride (CONCERTA), and Vitamins nos (MULTIVITAMINS). Her pertinent medical history, current conditions, and previous drug reactions or allergies were not reported.  On 08-FEB-2023, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX) syringe injection, at a dose of 0.5 milliliters (ml), (lot number W007035 which has been verified as valid, and expiration date not reported but stablished as 20-OCT-2023) as prophylaxis (route of administration, strength and vaccination scheme were not provided).  On the same date, the patient felt very sick (Illness) and started vomiting, she felt very strange (Feeling abnormal), she did not have the strength to walk (Muscular weakness), additionally, it was reported that the patient developed mild headaches and had issues with mental clarity (Mental disorder). On 09-FEB-2023, the patient has recovered from aforementioned events.   The causality assessment between the events and the suspect vaccine was not provided.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Mental disorder, Muscular weakness, Vomiting
Clinical narrative: issues with mental clarity; very very sick and started vomiting; very very sick and started vomiting; "felt very strange, didn't feel as if she had the strength to walk, and had issues; mild headaches, almost as if you move your head to fast there is a; "felt very strange, didn't feel as if she had the strength to walk,; This spontaneous report has been received from a consumer, regarding to a 66-year-old female patient. The patient's concomitant medications included Pravastatin, Methylphenidate hydrochloride (CONCERTA), and Vitamins nos (MULTIVITAMINS). Her pertinent medical history, current conditions, and previous drug reactions or allergies were not reported.  On 08-FEB-2023, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX) syringe injection, at a dose of 0.5 milliliters (ml), (lot number W007035 which has been verified as valid, and expiration date not reported but stablished as 20-OCT-2023) as prophylaxis (route of administration, strength and vaccination scheme were not provided).  On the same date, the patient felt very sick (Illness) and started vomiting, she felt very strange (Feeling abnormal), she did not have the strength to walk (Muscular weakness), additionally, it was reported that the patient developed mild headaches and had issues with mental clarity (Mental disorder). On 09-FEB-2023, the patient has recovered from aforementioned events.   The causality assessment between the events and the suspect vaccine was not provided.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness bilateral, Ear discomfort, Magnetic resonance imaging, Tinnitus
Clinical narrative: lost approx 80% hearing in my left ear and approx 30% hearing in my right ear; developed a feeling of "fullness" in both ears; I developed a constant ringing / buzzing in my left ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Sep2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: EN6198), administration date: 02Mar2021, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/lot number: EN6207), administration date: 23Mar2021, for COVID-19 immunization. The following information was reported: EAR DISCOMFORT (disability) with onset 14Sep2021, outcome "not recovered", described as "developed a feeling of "fullness" in both ears"; DEAFNESS BILATERAL (disability) with onset 14Sep2021, outcome "not recovered", described as "lost approx 80% hearing in my left ear and approx 30% hearing in my right ear"; TINNITUS (disability) with onset Sep2021, outcome "not recovered", described as "I developed a constant ringing / buzzing in my left ear". The events "lost approx 80% hearing in my left ear and approx 30% hearing in my right ear", "developed a feeling of "fullness" in both ears" and "i developed a constant ringing / buzzing in my left ear" required physician office visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: (14Sep2021) I have lost approx 80% hearing in my left ear and, notes: I have lost approx 80% hearing in my left ear and approx 30% hearing in My right ear; Smear test: (23Feb2023) Negative. Therapeutic measures were not taken as a result of deafness bilateral, ear discomfort, tinnitus. Clinical course: Approximately 3 days after receiving third covid vaccine, patient developed a feeling of "fullness" in both ears with significant hearing loss, especially in left ear. Approx 7 days later, developed a constant ringing / buzzing in my left ear. The patient had no known allergies. Patient's medical history was reported as yes (not further specified).
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests, Deafness bilateral, Ear discomfort, Smear test, Tinnitus
Clinical narrative: lost approx 80% hearing in my left ear and approx 30% hearing in my right ear; developed a feeling of "fullness" in both ears; I developed a constant ringing / buzzing in my left ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Sep2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: EN6198), administration date: 02Mar2021, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/lot number: EN6207), administration date: 23Mar2021, for COVID-19 immunization. The following information was reported: EAR DISCOMFORT (disability) with onset 14Sep2021, outcome "not recovered", described as "developed a feeling of "fullness" in both ears"; DEAFNESS BILATERAL (disability) with onset 14Sep2021, outcome "not recovered", described as "lost approx 80% hearing in my left ear and approx 30% hearing in my right ear"; TINNITUS (disability) with onset Sep2021, outcome "not recovered", described as "I developed a constant ringing / buzzing in my left ear". The events "lost approx 80% hearing in my left ear and approx 30% hearing in my right ear", "developed a feeling of "fullness" in both ears" and "i developed a constant ringing / buzzing in my left ear" required physician office visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: (14Sep2021) I have lost approx 80% hearing in my left ear and, notes: I have lost approx 80% hearing in my left ear and approx 30% hearing in My right ear; Smear test: (23Feb2023) Negative. Therapeutic measures were not taken as a result of deafness bilateral, ear discomfort, tinnitus. Clinical course: Approximately 3 days after receiving third covid vaccine, patient developed a feeling of "fullness" in both ears with significant hearing loss, especially in left ear. Approx 7 days later, developed a constant ringing / buzzing in my left ear. The patient had no known allergies. Patient's medical history was reported as yes (not further specified).
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Carpal tunnel syndrome, Headache, Pain in extremity, Urticaria
Clinical narrative: Terrible hives all over the body head to toe that need medical attention in ER at the third day; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). In MAR-2023, between 2 and 3 weeks after receiving Shingrix, the patient experienced hives (Verbatim: Terrible hives all over the body head to toe that need medical attention in ER at the third day). The patient was treated with prednisone. The outcome of the hives was resolved (duration 1 week).   It was unknown if the reporter considered the hives to be related to Shingrix.     It was unknown if the company considered the hives to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-APR-2023 The reporter reported that two and a half weeks later patient had terrible hives all over the body head to toe that need medical attention in ER at the third day.  The hives lasted for a week.  The patient was put on prednisone during that time. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Terrible hives all over the body head to toe that need medical attention in ER at the third day; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). In MAR-2023, between 2 and 3 weeks after receiving Shingrix, the patient experienced hives (Verbatim: Terrible hives all over the body head to toe that need medical attention in ER at the third day). The patient was treated with prednisone. The outcome of the hives was resolved (duration 1 week).   It was unknown if the reporter considered the hives to be related to Shingrix.     It was unknown if the company considered the hives to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-APR-2023 The reporter reported that two and a half weeks later patient had terrible hives all over the body head to toe that need medical attention in ER at the third day.  The hives lasted for a week.  The patient was put on prednisone during that time. The reporter consented to follow up.
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received the Moderna Covid-19 vaccine after the 6-Apr-2023 use by Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after the 6-Apr-2023 use by Date) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. as7180b) for COVID-19 prophylaxis.     No Medical History information was reported.  In April 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In April 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after the 6-Apr-2023 use by Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after the 6-Apr-2023 use by Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after the 6-Apr-2023 use by Date).    No concomitant medications were reported.  No other adverse events had been reported. Date(s) of administration of vaccine on 22-Apr-2023 (3 patients) 21-Apr-2023 (5 patients), 20-Apr-2023 (2 patients), 16-Apr-2023 (1 patient) and 12-Apr-2023 (1 patient).  The patients involved were all over the age of 65.   No treatment medications were reported.  This case contains information for the 1st of 12th elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721066, US-MODERNATX, INC.-MOD-2023-721068, US-MODERNATX, INC.-MOD-2023-721070, US-MODERNATX, INC.-MOD-2023-721071, US-MODERNATX, INC.-MOD-2023-721072, US-MODERNATX, INC.-MOD-2023-721074, US-MODERNATX, INC.-MOD-2023-721077, US-MODERNATX, INC.-MOD-2023-721078, US-MODERNATX, INC.-MOD-2023-721079, US-MODERNATX, INC.-MOD-2023-721080, US-MODERNATX, INC.-MOD-2023-721081 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721081:patient 12 US-MODERNATX, INC.-MOD-2023-721066:Patient 2 US-MODERNATX, INC.-MOD-2023-721079:patient 10 US-MODERNATX, INC.-MOD-2023-721078:Patient - 9 US-MODERNATX, INC.-MOD-2023-721070:Patient 4 US-MODERNATX, INC.-MOD-2023-721071:Patient 5 US-MODERNATX, INC.-MOD-2023-721072:Patient 6 US-MODERNATX, INC.-MOD-2023-721080:patient 11 US-MODERNATX, INC.-MOD-2023-721074:patient 7 US-MODERNATX, INC.-MOD-2023-721077:Patient - 8 US-MODERNATX, INC.-MOD-2023-721068:Patient 3
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Palpitations
Clinical narrative: heart palpitations; palpitations are significantly impacting my life; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), 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, Expiration date: Unknown , Route of administration: Unknown), for COVID-19 immunization, reaction(s): "heart palpitations"; Bnt162b2 (DOSE 2, SINGLE , Lot number: Unknown, Expiration date: Unknown , Route of administration: Unknown), for COVID-19 immunization, reaction(s): "palpitations are significantly impacting my life", "heart palpitations". The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "heart palpitations"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "palpitations are significantly impacting my life".  Additional information: The patient was administered with three COVID-19 vaccines which had caused the heart palpitations in the last year and a half. The patient had hoped that the palpitations would pass, however, they still came and went. The mRNA marker had been affecting patients heart. Pfizer was running research on the long-term impacts of the vaccine, and the patient had expressed interest in being part of that research. The patient had requested a response to message, as the palpitations were significantly impacting life and patient wanted to know how to resolve them. The patient believed that Pfizer should be (and likely is) the best source to find a resolution.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300073947 same reporter/patient/product/event, different dose;US-PFIZER INC-202300168646 same reporter/patient/product/event, different dose;
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate increased, Palpitations
Clinical narrative: heart palpitations; palpitations are significantly impacting my life; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), 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, Expiration date: Unknown , Route of administration: Unknown), for COVID-19 immunization, reaction(s): "heart palpitations"; Bnt162b2 (DOSE 2, SINGLE , Lot number: Unknown, Expiration date: Unknown , Route of administration: Unknown), for COVID-19 immunization, reaction(s): "palpitations are significantly impacting my life", "heart palpitations". The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "heart palpitations"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "palpitations are significantly impacting my life".  Additional information: The patient was administered with three COVID-19 vaccines which had caused the heart palpitations in the last year and a half. The patient had hoped that the palpitations would pass, however, they still came and went. The mRNA marker had been affecting patients heart. Pfizer was running research on the long-term impacts of the vaccine, and the patient had expressed interest in being part of that research. The patient had requested a response to message, as the palpitations were significantly impacting life and patient wanted to know how to resolve them. The patient believed that Pfizer should be (and likely is) the best source to find a resolution.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300073947 same reporter/patient/product/event, different dose;US-PFIZER INC-202300168646 same reporter/patient/product/event, different dose;
Sex: U
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE reported; Customer called and reported that VARIVAX was inadvertently administered concomitantly with PROQUAD to a 4 year old patient. No additional AE reported. No PQC reported. No additional information provided.; This spontaneous report was received from Medical assistant and refers to a 4-year-old of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 25-APR-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered for prophylaxis (dose, units, strength, lot #, expiry date, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (dose, units, strength, lot #, expiry date, and route of administration were not provided).  Customer called and reported, that on 25-APR-2023, varicella virus vaccine live (oka/merck) (VARIVAX) was inadvertently administered concomitantly with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) to a 4-year-old patient (Accidental ovedose). No additional AE reported. No PQC reported. No additional information provided.
Sex: U
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No additional AE reported; Customer called and reported that VARIVAX was inadvertently administered concomitantly with PROQUAD to a 4 year old patient. No additional AE reported. No PQC reported. No additional information provided.; This spontaneous report was received from Medical assistant and refers to a 4-year-old of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 25-APR-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered for prophylaxis (dose, units, strength, lot #, expiry date, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (dose, units, strength, lot #, expiry date, and route of administration were not provided).  Customer called and reported, that on 25-APR-2023, varicella virus vaccine live (oka/merck) (VARIVAX) was inadvertently administered concomitantly with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) to a 4-year-old patient (Accidental ovedose). No additional AE reported. No PQC reported. No additional information provided.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Customer called for a temperature excursion and reported PROQUAD that had undergone temperature excursion was administered to patients before calling MNSC. No additional AE reported. No PQC reported. No patient demographics was provided. No further i; No additional AE reported; This spontaneous report was received from an other health care professional referring to 12-month-old female patient. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 27-FEB-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) injection (VARIVAX) intramuscularly in right thigh, lot #W006412, expiration date 23-FEB-2024, (exact dose and dose number were not provided) for prophylaxis.  On 20-JAN-2023, the suspect vaccine experienced a temperature excursion from -14 to -10 degrees Celsius for 1 hour (product storage error). There were no reported previous temperature excursions. No additional adverse events (AEs) or product quality complaints (PQC) were reported (no adverse event). It was indicated that medication error could occur during storage in clinical practice. Adverse event had been reported previously to manufacturer. The patient was vaccinated at private doctor's office/hospital. Temperature excursion occurred as a result of a reading from a Digital Data Logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2304USA007931:
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Adverse event, Product storage error
Clinical narrative: No additional AE reported; temperature excursion and administered to patient; This spontaneous report was received from an other health care professional referring to 15-month-old female patient. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 27-FEB-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) injection (VARIVAX) intramuscularly in right thigh, lot #W018828, expiration date 14-JUN-2024, (exact dose and dose number were not provided) for prophylaxis.  On 05-DEC-2022, the suspect vaccine experienced a temperature excursion from -14 to -10 degrees Celsius for 1 hour (product storage error). There were no reported previous temperature excursions. No additional adverse events (AEs) or product quality complaints (PQC) were reported (no adverse event). It was indicated that medication error could occur during storage in clinical practice. Adverse event had been reported previously to manufacturer. The patient was vaccinated at private doctor's office/hospital. Temperature excursion occurred as a result of a reading from a Digital Data Logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2304USA007931:
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Gastrooesophageal reflux disease
Clinical narrative: The customer said the patient's mother reported that the patient had GERD; Projectile vomited everything after the dose of ROTATEQ; This spontaneous report was received from a registered nurse (also reported as a costumer, conflicting information) and refers to a 9-week-old female patient. The patient did not have any medical history, nor drug reactions/allergies. Concomitant medications included pneumococcal vaccine, polio vaccine, HIB vaccine, and diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) vaccine.  On 03-APR-2023, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose, taken orally as rotavirus vaccination. Lot #1917915 has been verified to be a valid lot# for rotavirus vaccine, live, oral, pentavalent, expiry date was not reported but upon internal review it was established was 22-MAR-2024.  On the same date, the patient's mother reported that she developed gastroesophageal reflux disease (GERD), and projectile vomited everything after the dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). The patient sought medical attention; however, no treatment was given for the events. At the time of reporting, the outcome of the events was unknown.  The causal relationship between both events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal, Vaccination failure
Clinical narrative: abnormal pap smear; HPV strains 6 and 7; HCP reported an adverse event for GARDASIL. Caller explained a patient who was vaccinated with GARDASIL had three abnormal pap smears. Caller said the first abnormal pap smear was on 21FEB2021; she did not provide any additional dates for the other a; This spontaneous report was received from nurse and refers to a 24-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-DEC-2010, the patient started therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 10-MAR-2011, the patient started therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 18-JUL-2011, the patient started therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On unknown date, HCP reported an adverse event for GARDASIL. Caller explained a patient who was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)  had three abnormal pap smears. On 21-FEB-2021, the patient experienced first abnormal pap smear. Caller did not provide any additional dates for the other abnormal pap smears. On unknown date, the patient experienced abnormal pap smear, the patient experienced abnormal pap smear and the patient had HPV typing which detected HPV strains 6 and 7. No treatment was given for HCP reported an adverse event for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). On 22-APR-2023, the patient had a Colposcopy, but the results were still pending. Caller was unable to provide any further clarifying details. No additional AE or PQC reported. No additional information provided. The action taken with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) regarding events was reported as Not Applicable.  The causal relationship between events  and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown.
Age: 0.08
Sex: U
Vaccine: HEP, HEPA, MMRV, PPV, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age, Vaccination error
Clinical narrative: No other adverse events reported; vaccines were given in error; there was nothing pertaining to the products that resulted in confusion; 1 month 17 day old; This spontaneous report was received from a nurse and referred to a 1 month 17 day years old patient with unknown gender. The patient's concurrent condition, concomitant therapy and medical history were not reported.  On 24-APR-2023 (reported as today), the patient was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (1 dosage form, lot # W039842 has been verified to be a valid lot number, expiration date was reported as 12-JUN-2024, route and anatomical location were not provided) and hepatitis a vaccine, inactivated (VAQTA) (1 dosage form, lot # W036268 has been verified to be a valid lot number, expiration date was reported as 20-MAY-2024, route and anatomical location were not provided) for prophylaxis in error (vaccination error and product administered to patient of inappropriate age). The reporter inquired about side effects and next steps. The reporter reported that the vaccines were given in error and there was nothing pertaining to the products that resulted in confusion (product confusion). On 24-APR-2023 (reported as today), the patient was also given phenoxymethylpenicillin (PENTACILLIN) (dose, lot number, expiration date, route and anatomical location were not reported), hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (dose, lot number, expiration date, route and anatomical location were not reported), pneumococcal conjugate vaccine (PCV 13) (dose, lot number, expiration date, route and anatomical location were not reported) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, lot number, expiration date and anatomical location were not reported) orally for prophylaxis as intended as well. The patient had not experienced any side effects as a result of the error. No other adverse events reported (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; a patient received improperly stored vaccine on 4/20/2023; This spontaneous report was received from a pharmacist and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-APR-2023, the patient was vaccinated with the first dose of improperly stored vaccine (temperature: 35.1F; time frame: 16 hours 45 minutes) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid orally for prophylaxis (lot #W014173, expiration date: 15-NOV-2023, strength and dose were not provided) (product storage error). No additional AEs were reported (no adverse event). There was no previous temperature excursion.
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Ear infection, Rash, Rash vesicular
Clinical narrative: developed an ear infection a cuple days after; developed a generalized varicella type rash; This spontaneous report was received from a consumer and refers to a 12-month-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-APR-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, lot #, expiry date, route of administration,exact dose and indication were not provided); measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (strength, lot #, expiry date, exact dose and route of administration were not provided); and  hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (strength, lot #, expiry date, exact dose and route of administration were not provided). All of those vaccines were administered for prophylaxis.  On 23-APR-2023, the patient developed a generalized varicella type rash. Caller stated her son has no other symptoms. Caller said she has applied benadryl (BENADRYL) cream to the sites. Caller mentioned her son developed an ear infection a couple of days after the varicella virus vaccine live (oka/merck) (VARIVAX). The patient started cefdinir (CEDSINIR) to treat the ear infection, but did not provide specifics about the dosage or course therapy. Caller was unable to provide any further clarifying details. At the time of reporting, the patient had not recovered from the event of generalized varicella type rash and an ear infection. No additional advere event was reported.  The reporter considered an ear infection to be not related to varicella virus vaccine live (oka/merck) (VARIVAX). The causal relationship between generalized varicella type rash and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported. The causal relationship between generalized varicella type rash and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported. The causal relationship between an ear infection and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported. The causal relationship between generalized varicella type rash and hepatitis a vaccine, inactivated (VAQTA) was not reported. The causal relationship between an ear infection and hepatitis a vaccine, inactivated (VAQTA) was not reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE's were reported; patient received a dose of GARDASIL 9 after it expired; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender (initials were reported). The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 21-APR-2023, the patient received a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml, 1 dose, lot # U007477, expiration date: 14-APR-2023, administered intramuscularly for prophylaxis after it expired (strength, and route of administration were not provided) (Expired product administered). No other adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additonal AE; An HCP is reporting an AE on behalf of a patient. The HCP reports that the patient was adminstered an expired dose of GARDASIL 9. No additional clarifying statements or AE details were provided and no additional AE's were reported. No PQC.; This spontaneous report was received from medical assistant, concerning to patient of unknown gender and age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-APR-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter intramuscularly (lot #U007652, has been verified to be a valid lot, expiration date: 14-APR-2023) for prophylaxis (strength was not provided). No additional adverse event were reported (expired product administered) (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; GARDASIL 9 administered to patient following excursion; This spontaneous report was received from a Physician and refers to a patient of unspecified gender and age.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  The reporter informed about a temperature excursion for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # W006559 has been verified to be a valid lot number, expiration date: 04-DEC-2024), as follows: Temperature 32.7F; time frame 48 hours; previous temperature excursion 33.8F for 5 hours 30 minutes.   On 24-APR-2023, the patient was administered a dose of this hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot # and expiration date as reported, administered for prophylaxis (dose and route of administration were not provided), following the excursion (Product storage error). There were no additional adverse events (AEs) reported (No adverse event); no product quality complaints (PQCs) were reported.