chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PROQUAD was administered to one consumer following a temperature excursion; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age. No information regarding the patient's pertinent medical history, concomitant therapy and drug reactions or allergies were provided.  On 14-MAR-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # X023401 has been verified to be valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported as: 30-MAR-2025, but upon internal validation established as: 20-MAR-2025, Albumin status rHA (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis.  No additional adverse event reported.   The temperature excursión was: -9.2°C and the time frame was 25 minutes. There was no previous temperature excursión.
Age: 0.67
Sex: U
Vaccine: RV5
Symptoms: Condition aggravated, Product administered to patient of inappropriate age, Rotavirus infection, Rotavirus test positive, Seizure
Clinical narrative: It is unknown if patient had autism or seizure diagnosis at time of ROTATEQ administration; rotavirus test positive; FBE reporting AE on behalf of HCP.  HCP reported in 2/2024 a 5 year old patient with a history of Autism and Seizures was seen at an emergency department due to uncontrolled seizure activity.  Patient was found to have rotavirus from a viral panel.; Inappropriate age at vaccine administration; This spontaneous report was received from physician via a company representative, concerning a currently 6-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 10-DEC-2018, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, (lot #R015437, has been verified to be valid, expiration date not reported but upon internal validation established as 18-APR-2020) taken orally for prophylaxis (strength was not provided). The patient was 8 months when the patient received the first dose of the vaccine (inappropriate age at vaccine administration). The operator of device was health professional.   On 11-FEB-2019, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, (lot #R027159, has been verified to be valid, expiration date not reported but upon internal validation established as 30-APR-2020) taken orally for prophylaxis (strength was not provided). On 10-APR-2019, the patient was vaccinated with the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, (lot #R027155, has been verified to be valid, expiration date not reported but upon internal validation established as 25-JUN-2020) taken orally for prophylaxis (strength was not provided).  On unknown date, the patient was found to have rotavirus from a virus panel (rotavirus test positive).   It was reported that patient had history of autism and seizure diagnosis, however it was unknown if the patient had those diagnosis at the time of the vaccination.  Then, on unspecified date in February 2024, the patient was seen at the emergency department due to uncontrolled seizure activity. At the reporting time, the outcome for all the events was unknown.   rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was discontinued.   The causal relationship between all the events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.   Upon internal review, autism and uncontrolled seizures activity were considered to be medically significant events.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE, no PQC; HCP reported VARIVAX was administered after a temperature excursion to two patients. This AE is for patient one of two. Product was administered on 15-MAR-2024. No further information provided. Cross reference case: 02570945. No additional AE reporte; This spontaneous report was received from nurse concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 15-MAR-2024, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, once, (lot #X021930, has been verified to be valid, expiration date: 29-AUG-2025) administered for prophylaxis (strength, and route of administration were not provided), after a temperature excursion (product storage error). No adverse event reported. The operator of device was health professional.   It was also reported that the temperature was -13.2 degrees Celsius, with 18 minutes of time frame with no previous temperature excursion.   This is one of the two cases created from the same source.; Sender's Comments:  US-009507513-2403USA007089:
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Injection site erythema, Limb discomfort, Pain in extremity
Clinical narrative: large redness around vaccinated area; through days redness crept down through the elbow; a rather large arm reaction with discomfort; a rather large arm reaction with itching; pain value 3 described in a scale 1-10; bruise; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: large redness around vaccinated area), erythema of extremities (Verbatim: through days redness crept down through the elbow), arm discomfort (Verbatim: a rather large arm reaction with discomfort), itchy upper limbs (Verbatim: a rather large arm reaction with itching), pain in arm (Verbatim: pain value 3 described in a scale 1-10) and bruising of arm (Verbatim: bruise). The outcome of the injection site erythema, erythema of extremities, arm discomfort, itchy upper limbs, pain in arm and bruising of arm were unknown.   It was unknown if the reporter considered the injection site erythema, erythema of extremities, arm discomfort, itchy upper limbs, pain in arm and bruising of arm to be related to Shingrix.     It was unknown if the company considered the injection site erythema, erythema of extremities, arm discomfort, itchy upper limbs, pain in arm and bruising of arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-MAR-2024 The health care professional (pharmacist) reported Shingrix adverse reaction after a first dose applied to her friend (patient) and she experienced a rather large arm reaction with discomfort, itching, pain value described as 3 on the scale of 1 to 10, bruise and large redness around the vaccinated area (left arm) probably 4-6 inches diameter size, through days it crept down through the elbow. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: large redness around vaccinated area; through days redness crept down through the elbow; a rather large arm reaction with discomfort; a rather large arm reaction with itching; pain value 3 described in a scale 1-10; bruise; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: large redness around vaccinated area), erythema of extremities (Verbatim: through days redness crept down through the elbow), arm discomfort (Verbatim: a rather large arm reaction with discomfort), itchy upper limbs (Verbatim: a rather large arm reaction with itching), pain in arm (Verbatim: pain value 3 described in a scale 1-10) and bruising of arm (Verbatim: bruise). The outcome of the injection site erythema, erythema of extremities, arm discomfort, itchy upper limbs, pain in arm and bruising of arm were unknown.   It was unknown if the reporter considered the injection site erythema, erythema of extremities, arm discomfort, itchy upper limbs, pain in arm and bruising of arm to be related to Shingrix.     It was unknown if the company considered the injection site erythema, erythema of extremities, arm discomfort, itchy upper limbs, pain in arm and bruising of arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-MAR-2024 The health care professional (pharmacist) reported Shingrix adverse reaction after a first dose applied to her friend (patient) and she experienced a rather large arm reaction with discomfort, itching, pain value described as 3 on the scale of 1 to 10, bruise and large redness around the vaccinated area (left arm) probably 4-6 inches diameter size, through days it crept down through the elbow. The reporter consented to follow up.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pain in extremity, Somnolence
Clinical narrative: Patient was accidentally given the entire volume of the single-dose Moderna vial (more than the 0.25mL indicated dose).  My best guess is that it was approximately double the amount she should have received.  No immediate adverse reactions noted - I am in contact with parent and they say she is still doing ok today.  No side effects beyond expected arm pain and a little drowsy (also was dosed with benadryl by her mother just to be safe).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Fatigue, Muscle spasms, Muscle twitching, Myalgia
Clinical narrative: Shaking, muscle twitching, muscle spasms, muscle pain, Exercise intolerance, fatigue
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Shaking, muscle twitching, muscle spasms, muscle pain, Exercise intolerance, fatigue
Age: 0.5
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Pt experienced urticaria on her trunk; Zyrtec administered
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: Vaccine was administered correctly by pharmacist.  Patient called two days after vaccine administration to say that she has a sore knot on her arm where vaccine was administered
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram ambulatory, Headache, Neck pain
Clinical narrative: Severe headache and neck pain x 5 days.  Shortness of breath,  lightheaded,  feeling faint ever since.  Now diagnosed with V tach.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular tachycardia
Clinical narrative: Severe headache and neck pain x 5 days.  Shortness of breath,  lightheaded,  feeling faint ever since.  Now diagnosed with V tach.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: duplicate vaccine one in September 2023 and one in October 2023
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever body aches
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain
Clinical narrative: Morning after the vaccine was administered, patient complained of a sore throat. She stated that she normally does not have a sore throat after receiving the vaccine.
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Hypotension, Malaise, Pallor, Syncope, Vomiting
Clinical narrative: Within minutes of receiving vaccine, patient reported 'not feeling well'. She looked pale in color. She then vomited, and said she was feeling a little better. She wanted to go to the bathroom. I asked if she felt she could stand and walk and she said yes. I escorted her to the restroom, and on the way she proceeded to faint. I caught her on the way down so she did not hit her head. We called EMS and shortly after paramedics showed up and took her blood pressure. She was hypotensive, and the paramedics gave her an IV bolus of fluids. After about 10 minutes, her blood pressure had not yet returned to normal so the paramedics took her to the hospital where she received further treatment.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Hypoaesthesia, Insomnia, Neck pain, Paraesthesia
Clinical narrative: Headache, numbness and tingling in thighs and biceps and checks, neck pain, difficulty sleeping for 9 days post vaccine and still ongoing
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Myalgia
Clinical narrative: headache (lasted for 2 days), shivers (continue after 2 days), diarrhea (continues after 2 days) muscle/joint aches (continues after 2 days)
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Gastrointestinal pain, Myalgia, Proctalgia, Rectal prolapse
Clinical narrative: Day 2 and 3 had GI distress, with fiery rectal pain, including prolapse of rectum. Muscles in back both arms and legs were aching. Soreness in the gut.
Age: 1.17
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 21.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Injection site rash
Clinical narrative: Started getting a rash at area of injection site for both vaccines, the rash at the site of the boostrix was larger. Has taken tylenol so far with no result
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Skin reaction, Skin swelling
Clinical narrative: Local skin reaction/swelling. Seen in urgent care, supportive care instructions given.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: Fever, body aches and joint pain, headache, fatigue, pain at injection site
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Fever, body aches and joint pain, headache, fatigue, pain at injection site
Age: 42.0
Sex: F
Vaccine: DTAP
Symptoms: Exercise tolerance decreased, Gait disturbance, Mobility decreased, Musculoskeletal disorder, Myalgia
Clinical narrative: Myalgia in Left thigh :  Onset began 3 days after vaccination, there was a "knot" in the muscle that inhibits free movement.  This has lead to limping and inability to run (previously running 40+ miles per week pain free).  Neurological deficit/component where legs are no longer working together.  Currently working with physical therapy to attempt to restore fluid leg movements, however this has not resolved.
Age: 42.0
Sex: F
Vaccine: DTAP
Symptoms: Nervous system disorder, Nodule, X-ray limb normal
Clinical narrative: Myalgia in Left thigh :  Onset began 3 days after vaccination, there was a "knot" in the muscle that inhibits free movement.  This has lead to limping and inability to run (previously running 40+ miles per week pain free).  Neurological deficit/component where legs are no longer working together.  Currently working with physical therapy to attempt to restore fluid leg movements, however this has not resolved.
Age: 54.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Sensation of foreign body
Clinical narrative: patient has swelling redness and burning, skin hot to touch and has a lump at injection site
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: Outdated
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Erythema, Nausea, Skin warm, Swelling
Clinical narrative: Donor contacted center complaining of swelling, redness, nausea, warm to the touch.. Symptoms developed the day after injection. Donor stated she applied an ice pack and took Benadryl. Donor advised to contact PCP if symptoms persist.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: PATIENT GOT HER VACCINE ON 3/20/2024. CAME BACK TO PHARMACY ON 03/24/2024 - WITH INJECTION SITE REACTION. PATIENT HAS REDNESS/PINKNESS AROUND SITE. PATIENT STATES SHE IS ITCHY AND SORE WITH MILD PAIN AROUND THE AREA. SHE STATED SHE DID NOT HAVE ANY SYSTEMIC REACTIONS ASIDE FORM INJECTION SITE REACTION.
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Injection site pain, Loss of personal independence in daily activities, Musculoskeletal disorder, Pain
Clinical narrative: patient called on 3rd day of reaction. says it is painful in left upper arm, feels like no energy and can't do any function with it, i.e tie shoes, hold stuff. if she tries bend her arm backwards, she feels very painful. She did not take any analgesics, I recommended her to take tylenol and see the doctor if not responding or if she can't tolerate the pain.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis, Scan myocardial perfusion
Clinical narrative: Pericarditis
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Dysphagia, Dyspnoea, Muscle spasms
Clinical narrative: Beginning at 1:00 AM on 2/24/24 I had difficulty breathing, difficulty swallowing, and weak and dizzy walking to the bathroom. I felt like I passed out intermittently throughout the night. I went to urgent care the following day and presented with muscle spasms and twitching, and continued difficulty breathing. My blood pressure was taken and was
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle twitching
Clinical narrative: Beginning at 1:00 AM on 2/24/24 I had difficulty breathing, difficulty swallowing, and weak and dizzy walking to the bathroom. I felt like I passed out intermittently throughout the night. I went to urgent care the following day and presented with muscle spasms and twitching, and continued difficulty breathing. My blood pressure was taken and was
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Generalized itching and urticaria started on day 11 and has persisted (today is 7th day with no improvement).  Itching is improved with antihistamine (fexofenadine) but recurrent.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Epistaxis, Haemorrhage, Platelet count normal
Clinical narrative: Nose Bleed three days after Covid vaccination.  My nose spontaneously started bleeding.  I was able after some time to get it stopped.  I also had a bleeding event one week after the Moderna Covid  vaccination in September 2023.  I had nicked a blood vessel on top of my left hand.  It would not stop bleeding.  I finally went to a hospital emergency room where they applied a pressure bandage which eventually stopped the bleeding.  I followed up with my doctor at the time who checked my platelets which were in the normal range.  I am certain this bleeding event and the one today were related to the Covid vaccination because this has never happened to me before.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cardiovascular symptom, Catheterisation cardiac abnormal, Chest pain, Echocardiogram abnormal
Clinical narrative: On 6/2/21, almost 8 weeks after second vaccine, woke in early morning with chest pain which was worse when bending over.  Thought I had pulled a muscle and ignored for 2 days, then went to ER on 6/4/21 with tests showing elevated troponin and abnormal EKG.  I immediately asked if it could be myocarditis due to the vaccine, but the possibility was dismissed since I most (but not all!) cases are among young men, not older women.  Was admitted and cardiac catheterization done the next day showed what appeared to be "reverse takotsubo cardiomyopathy" with a left wall motion weakness that could be attributable to that or myocarditis, but later in the day an echocardiogram was consistent with myocarditis. [continued] No inflammatory marker tests were ever run and no cardiac MRI was done.  It was a complete failure of conventional medicine.    I believed the misdiagnosis of "reverse takotsubo cardiomyopathy" until 11/19/22 when, one week after recovering from a Covid infection, I had a recurrence of the same chest pain, even more severe, and went to the ER at Hospital.  I still tested positive on a PCR for Covid in the ER.  This time, I had also developed a painful occipital headache that persisted 2 weeks before this episode of severe chest pain, along with frontal neck/carotid artery soreness, especially painful when lying down.  In the ER, troponin was not elevated 4.5 hours after onset of pain.  No BNP or inflammatory marker tests, no echocardiogram was done.  Was sent home with no diagnosis and in severe pain.  The worst symptoms resolved after a few days, but I was left with the severe occipital headaches and carotid artery neck tenderness.  I had another episode of severe chest pain in June 2023, October 2023, February 2024, and March 2024 (now, actually), but did not go to the hospital this time.  I did see my cardiologist after all of those episodes except the most recent one in March 2024.  He is mystified as to the cause and is of little help.  I know that all of this was triggered by the Covid vaccine.  I have never had any issues before that.  I also noted that my second vaccine was given to me only 3 weeks after my first vaccine, which is closer than is recommended.  I'm sure that the vaccine caused some sort of injury to my immune system which has now resulted in this recurrent viral myocarditis which happens every time I get a virus, with Covid being the worst.  Now I see a series of doctors including my regular cardiologist, who is of no help. I have also seen 2 other cardiologists with the system for second opinions, also no help.  I began seeing a doctor at Hspital's Post-Covid Clinic, who was at least able to offer me a prescription I requested, that was the only thing to help with my ongoing cardiovascular symptoms.  Ultimately, I had to turn to other doctors who do not accept insurance to get a prescription for low-dose rapamycin, in the hope it will improve my immune system and stop these recurring myocarditis attacks.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Headache, Immune system disorder, Inappropriate schedule of product administration, Myocarditis
Clinical narrative: On 6/2/21, almost 8 weeks after second vaccine, woke in early morning with chest pain which was worse when bending over.  Thought I had pulled a muscle and ignored for 2 days, then went to ER on 6/4/21 with tests showing elevated troponin and abnormal EKG.  I immediately asked if it could be myocarditis due to the vaccine, but the possibility was dismissed since I most (but not all!) cases are among young men, not older women.  Was admitted and cardiac catheterization done the next day showed what appeared to be "reverse takotsubo cardiomyopathy" with a left wall motion weakness that could be attributable to that or myocarditis, but later in the day an echocardiogram was consistent with myocarditis. [continued] No inflammatory marker tests were ever run and no cardiac MRI was done.  It was a complete failure of conventional medicine.    I believed the misdiagnosis of "reverse takotsubo cardiomyopathy" until 11/19/22 when, one week after recovering from a Covid infection, I had a recurrence of the same chest pain, even more severe, and went to the ER at Hospital.  I still tested positive on a PCR for Covid in the ER.  This time, I had also developed a painful occipital headache that persisted 2 weeks before this episode of severe chest pain, along with frontal neck/carotid artery soreness, especially painful when lying down.  In the ER, troponin was not elevated 4.5 hours after onset of pain.  No BNP or inflammatory marker tests, no echocardiogram was done.  Was sent home with no diagnosis and in severe pain.  The worst symptoms resolved after a few days, but I was left with the severe occipital headaches and carotid artery neck tenderness.  I had another episode of severe chest pain in June 2023, October 2023, February 2024, and March 2024 (now, actually), but did not go to the hospital this time.  I did see my cardiologist after all of those episodes except the most recent one in March 2024.  He is mystified as to the cause and is of little help.  I know that all of this was triggered by the Covid vaccine.  I have never had any issues before that.  I also noted that my second vaccine was given to me only 3 weeks after my first vaccine, which is closer than is recommended.  I'm sure that the vaccine caused some sort of injury to my immune system which has now resulted in this recurrent viral myocarditis which happens every time I get a virus, with Covid being the worst.  Now I see a series of doctors including my regular cardiologist, who is of no help. I have also seen 2 other cardiologists with the system for second opinions, also no help.  I began seeing a doctor at Hspital's Post-Covid Clinic, who was at least able to offer me a prescription I requested, that was the only thing to help with my ongoing cardiovascular symptoms.  Ultimately, I had to turn to other doctors who do not accept insurance to get a prescription for low-dose rapamycin, in the hope it will improve my immune system and stop these recurring myocarditis attacks.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, SARS-CoV-2 test positive, Stress cardiomyopathy, Tenderness, Troponin increased
Clinical narrative: On 6/2/21, almost 8 weeks after second vaccine, woke in early morning with chest pain which was worse when bending over.  Thought I had pulled a muscle and ignored for 2 days, then went to ER on 6/4/21 with tests showing elevated troponin and abnormal EKG.  I immediately asked if it could be myocarditis due to the vaccine, but the possibility was dismissed since I most (but not all!) cases are among young men, not older women.  Was admitted and cardiac catheterization done the next day showed what appeared to be "reverse takotsubo cardiomyopathy" with a left wall motion weakness that could be attributable to that or myocarditis, but later in the day an echocardiogram was consistent with myocarditis. [continued] No inflammatory marker tests were ever run and no cardiac MRI was done.  It was a complete failure of conventional medicine.    I believed the misdiagnosis of "reverse takotsubo cardiomyopathy" until 11/19/22 when, one week after recovering from a Covid infection, I had a recurrence of the same chest pain, even more severe, and went to the ER at Hospital.  I still tested positive on a PCR for Covid in the ER.  This time, I had also developed a painful occipital headache that persisted 2 weeks before this episode of severe chest pain, along with frontal neck/carotid artery soreness, especially painful when lying down.  In the ER, troponin was not elevated 4.5 hours after onset of pain.  No BNP or inflammatory marker tests, no echocardiogram was done.  Was sent home with no diagnosis and in severe pain.  The worst symptoms resolved after a few days, but I was left with the severe occipital headaches and carotid artery neck tenderness.  I had another episode of severe chest pain in June 2023, October 2023, February 2024, and March 2024 (now, actually), but did not go to the hospital this time.  I did see my cardiologist after all of those episodes except the most recent one in March 2024.  He is mystified as to the cause and is of little help.  I know that all of this was triggered by the Covid vaccine.  I have never had any issues before that.  I also noted that my second vaccine was given to me only 3 weeks after my first vaccine, which is closer than is recommended.  I'm sure that the vaccine caused some sort of injury to my immune system which has now resulted in this recurrent viral myocarditis which happens every time I get a virus, with Covid being the worst.  Now I see a series of doctors including my regular cardiologist, who is of no help. I have also seen 2 other cardiologists with the system for second opinions, also no help.  I began seeing a doctor at Hspital's Post-Covid Clinic, who was at least able to offer me a prescription I requested, that was the only thing to help with my ongoing cardiovascular symptoms.  Ultimately, I had to turn to other doctors who do not accept insurance to get a prescription for low-dose rapamycin, in the hope it will improve my immune system and stop these recurring myocarditis attacks.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vascular pain, Viral myocarditis, Wall motion score index abnormal
Clinical narrative: On 6/2/21, almost 8 weeks after second vaccine, woke in early morning with chest pain which was worse when bending over.  Thought I had pulled a muscle and ignored for 2 days, then went to ER on 6/4/21 with tests showing elevated troponin and abnormal EKG.  I immediately asked if it could be myocarditis due to the vaccine, but the possibility was dismissed since I most (but not all!) cases are among young men, not older women.  Was admitted and cardiac catheterization done the next day showed what appeared to be "reverse takotsubo cardiomyopathy" with a left wall motion weakness that could be attributable to that or myocarditis, but later in the day an echocardiogram was consistent with myocarditis. [continued] No inflammatory marker tests were ever run and no cardiac MRI was done.  It was a complete failure of conventional medicine.    I believed the misdiagnosis of "reverse takotsubo cardiomyopathy" until 11/19/22 when, one week after recovering from a Covid infection, I had a recurrence of the same chest pain, even more severe, and went to the ER at Hospital.  I still tested positive on a PCR for Covid in the ER.  This time, I had also developed a painful occipital headache that persisted 2 weeks before this episode of severe chest pain, along with frontal neck/carotid artery soreness, especially painful when lying down.  In the ER, troponin was not elevated 4.5 hours after onset of pain.  No BNP or inflammatory marker tests, no echocardiogram was done.  Was sent home with no diagnosis and in severe pain.  The worst symptoms resolved after a few days, but I was left with the severe occipital headaches and carotid artery neck tenderness.  I had another episode of severe chest pain in June 2023, October 2023, February 2024, and March 2024 (now, actually), but did not go to the hospital this time.  I did see my cardiologist after all of those episodes except the most recent one in March 2024.  He is mystified as to the cause and is of little help.  I know that all of this was triggered by the Covid vaccine.  I have never had any issues before that.  I also noted that my second vaccine was given to me only 3 weeks after my first vaccine, which is closer than is recommended.  I'm sure that the vaccine caused some sort of injury to my immune system which has now resulted in this recurrent viral myocarditis which happens every time I get a virus, with Covid being the worst.  Now I see a series of doctors including my regular cardiologist, who is of no help. I have also seen 2 other cardiologists with the system for second opinions, also no help.  I began seeing a doctor at Hspital's Post-Covid Clinic, who was at least able to offer me a prescription I requested, that was the only thing to help with my ongoing cardiovascular symptoms.  Ultimately, I had to turn to other doctors who do not accept insurance to get a prescription for low-dose rapamycin, in the hope it will improve my immune system and stop these recurring myocarditis attacks.
Age: 24.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Syncope
Clinical narrative: PTE fainted after administering vaccines, recovered soon
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction, Injection site rash, Injection site urticaria, Rash
Clinical narrative: Patient reported getting a rash and hives at injection site 2-3 days after receiving Comirnaty. The rash continued to other parts of the body and patient wasn't sure if it was poison ivy or reaction to vaccine (however he was not outdoors, but reported that is what it seemed like). He went to MD on 3/11 for treatment, MD told him it would be a reaction to the vaccine and he was given Prednisone, came in 3/24 for refill because was still experiencing rash. Pt previously had Moderna and had no reaction, however, this was first time with Pfizer and experienced reaction.
Age: 6.0
Sex: F
Vaccine: PNC15
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: She developed pain, itching, and swelling at injection site. This was treated with cold packs and benadryl.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Affect lability, Arthralgia, Back pain, Balance disorder, Blood pressure increased
Clinical narrative: Starting a few hours after receiving vaccine, arm turned red.  Later that day she began to have severe burning pain and sensitivity to touch in her whole body.  She had an episode of urinary incontinence and reported muscle weakness and impaired balance.  She felt dizzy and more sleepy than normal.  She reported unable to lift arms and legs  (lack of control) while standing and required assistance for walking, but was able to lift them better when seating.  Over the next several weeks, symptoms persisted, continued to have impaired balance and shuffling gait and she also developed memory impairment, stuttering, inability to speak normally, emotional lability, severe R hip pain, and pain in multiple joints.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Dysphemia, Electrocardiogram normal, Erythema, Full blood count normal
Clinical narrative: Starting a few hours after receiving vaccine, arm turned red.  Later that day she began to have severe burning pain and sensitivity to touch in her whole body.  She had an episode of urinary incontinence and reported muscle weakness and impaired balance.  She felt dizzy and more sleepy than normal.  She reported unable to lift arms and legs  (lack of control) while standing and required assistance for walking, but was able to lift them better when seating.  Over the next several weeks, symptoms persisted, continued to have impaired balance and shuffling gait and she also developed memory impairment, stuttering, inability to speak normally, emotional lability, severe R hip pain, and pain in multiple joints.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Gait disturbance, Magnetic resonance imaging, Memory impairment, Metabolic function test normal, Mobility decreased
Clinical narrative: Starting a few hours after receiving vaccine, arm turned red.  Later that day she began to have severe burning pain and sensitivity to touch in her whole body.  She had an episode of urinary incontinence and reported muscle weakness and impaired balance.  She felt dizzy and more sleepy than normal.  She reported unable to lift arms and legs  (lack of control) while standing and required assistance for walking, but was able to lift them better when seating.  Over the next several weeks, symptoms persisted, continued to have impaired balance and shuffling gait and she also developed memory impairment, stuttering, inability to speak normally, emotional lability, severe R hip pain, and pain in multiple joints.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Muscular weakness, Pain, Red blood cell sedimentation rate normal, Sensitive skin, Somnolence
Clinical narrative: Starting a few hours after receiving vaccine, arm turned red.  Later that day she began to have severe burning pain and sensitivity to touch in her whole body.  She had an episode of urinary incontinence and reported muscle weakness and impaired balance.  She felt dizzy and more sleepy than normal.  She reported unable to lift arms and legs  (lack of control) while standing and required assistance for walking, but was able to lift them better when seating.  Over the next several weeks, symptoms persisted, continued to have impaired balance and shuffling gait and she also developed memory impairment, stuttering, inability to speak normally, emotional lability, severe R hip pain, and pain in multiple joints.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Speech disorder, Thyroid function test normal, Urinary incontinence, Walking aid user
Clinical narrative: Starting a few hours after receiving vaccine, arm turned red.  Later that day she began to have severe burning pain and sensitivity to touch in her whole body.  She had an episode of urinary incontinence and reported muscle weakness and impaired balance.  She felt dizzy and more sleepy than normal.  She reported unable to lift arms and legs  (lack of control) while standing and required assistance for walking, but was able to lift them better when seating.  Over the next several weeks, symptoms persisted, continued to have impaired balance and shuffling gait and she also developed memory impairment, stuttering, inability to speak normally, emotional lability, severe R hip pain, and pain in multiple joints.
Age: 35.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Fatigue, Headache, Pruritus, Urticaria
Clinical narrative: Patient states experiencing Headache, Fatigue, Hives and Itching.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy bone marrow, Cytology, Laboratory test, Lymphocyte count decreased, Platelet count decreased
Clinical narrative: Moderna 040A21A on 03/04/21, Moderna 025B21A om 04/01/21, Pfizer 33030BD on 12/14/21. Subsequent routine blood tests (for quarterly hormone management, routine physicals, doctors visit) began to show decreasing lymphocyte count, decreasing platelet count, decreasing white blood count.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count decreased
Clinical narrative: Moderna 040A21A on 03/04/21, Moderna 025B21A om 04/01/21, Pfizer 33030BD on 12/14/21. Subsequent routine blood tests (for quarterly hormone management, routine physicals, doctors visit) began to show decreasing lymphocyte count, decreasing platelet count, decreasing white blood count.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Injection site reaction, Pain, Pain in extremity, Rash macular
Clinical narrative: Blotchy bruise at injection site still visible after 5 months and pain in arm, especially when raising arm above shoulder height.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Brain fog, Dizziness, Fatigue, Gastrointestinal disorder
Clinical narrative: Dizziness within 1 hour following injection.  Later additional new health symptoms are noted, including brain fog, new polyarthritis, immune dysfunction, gastrointestinal dysfunction, severe fatigue, ?brain fog?, headaches, Reynaud?s phenomenon.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immune system disorder, Polyarthritis, Raynaud's phenomenon, X-ray limb abnormal
Clinical narrative: Dizziness within 1 hour following injection.  Later additional new health symptoms are noted, including brain fog, new polyarthritis, immune dysfunction, gastrointestinal dysfunction, severe fatigue, ?brain fog?, headaches, Reynaud?s phenomenon.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cardiovascular disorder, Dizziness, Hypertension, Magnetic resonance imaging head, Magnetic resonance imaging neck
Clinical narrative: Ever since receiving this vaccine I have had adverse neurological and cardiovascular issues. Started 2 days after getting the vaccine. High blood pressure and dizziness ongoing for many months now. Seeing neurologists, cardiologists, rehab, MRIs, ER visit, urgent care. Etc etc.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nervous system disorder, Venipuncture
Clinical narrative: Ever since receiving this vaccine I have had adverse neurological and cardiovascular issues. Started 2 days after getting the vaccine. High blood pressure and dizziness ongoing for many months now. Seeing neurologists, cardiologists, rehab, MRIs, ER visit, urgent care. Etc etc.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: Death
Clinical narrative: Patient expired 3/21/2024.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5, UNK
Symptoms: Respiratory rate increased, Wheezing
Clinical narrative: Wheezing and fast breathing - noticed about 2-4 hours after shots.   Wheezing was intermittent.  Breathing was back to normal around 12-14 hours after vaccine administration.  Referred to allergist.  Pt did not have any breathing issues/congestion prior to her appointment.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Electronystagmogram, VIIIth nerve injury
Clinical narrative: ISSUES; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series:1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of issues was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Adverse event
Clinical narrative: ISSUES; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series:1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of issues was not reported. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Nasopharyngitis
Clinical narrative: Cold symptoms
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Unknown
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antinuclear antibody, Dizziness, Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: Generalized debilitating body pain, difficulty breathing, shortness of breath, dizziness, fast heart beat, and fatigue.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain
Clinical narrative: Generalized debilitating body pain, difficulty breathing, shortness of breath, dizziness, fast heart beat, and fatigue.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Unevaluable event
Clinical narrative: Unknown
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; patient received MMR II and VARIVAX during temp excursion; This spontaneous report was received from an Other Health Professional and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 05-MAR-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) injection, 0.5 milliliter, lot #W028734, expiration date: 08-SEP-2024; and  varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #X021281, expiration date: 20-AUG-2025, both administered for prophylaxis (both: strength, and route of administration were not provided). The administered vaccines were during temperature excursion (Product storage error). The reporter was unable to provide time or highest temperatures reached as excursion occurred during power outage/transport and was not monitored. No additional AE.
Sex: F
Vaccine: HEP, HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE; received HEPLISAV (by Dynavax) for her 3rd Hep B vaccination series on 3/11/2024 instead of RECOMBIVAX- unknown why; This spontaneous report was received from a Pharmacist via a Company Representative and referred to a 41-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 11-MAR-2024, the patient was vaccinated with hepatitis b vaccine rhbsag (yeast) (HEPLISAV B), (strength, formulation, dose, lot #, expiry date, route of administration were not provided) for her 3rd Hep B vaccination series instead of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, unknown why (Interchange of vaccine products). No additional AE.
Age: 0.33
Sex: U
Vaccine: PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; products were administered after experiencing temperature excursion; route/site: intramuscular (ROTATEQ); This spontaneous report was received from a Nurse Practitioner and refers to a 4-month-old patient of unknown gender. The patient's medical history, concurrent conditions, previous drug allergies and reactions and concomitant therapies were not reported.  On 13-NOV-2023, the patient was vaccinated with previously exposed to temperature excursion (Product storage error) rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, (lot #1933912, expiration date: 21-APR-2024, valid lot number per internal review), administered intramuscularly (Incorrect route of product administration) for prophylaxis (strength was not provided) and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, (lot #X019438, expiration date: 07-NOV-2025, valid per internal review), administered intramuscularly for prophylaxis (strength was not provided). No adverse events were reported.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2403USA005001: US-009507513-2403USA005001: US-009507513-2403USA005312: US-009507513-2401USA016206:
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administerd after multiple temperature excursion; This spontaneous report was received from a nurse practitioner referring to a 9-year-old patient (gender unknown).  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 19-OCT-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion of 49.5 degrees Fahrenheit for 2 minutes (refrigerated vaccines); and total time in the range from -14 to -10 degrees Celsius for 27 minutes. On 04-DEC-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to the temperature excursion at a total time in the range from -14 to -10 degrees Celsius for 28 minutes. On 06-DEC-2023, administered doses of vaccines were exposed to the temperature excursion at total time in the range from -14 to -10 degrees Celsius for 15 minutes. On 20-DEC-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #X012267, expiration date: 30-APR-2025, administered subcutaneously for prophylaxis (strength was not provided) that underwent in a temperature excursion. The temperature excursion occurred because of a reading from the Digital Data Logger in the vaccines' storage in clinical practice. There was no adverse event. It was noted that the vaccines were reported as right to use.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2401USA016206: US-009507513-2403USA005243: US-009507513-2403USA005252: US-009507513-2403USA005253: US-009507513-2403USA005254: US-009507513-2403USA005255: US-009507513-2403USA005256: US-009507513-2403USA005257: US-009507513-2403USA005258: US-009507513-2403USA005259: US-009507513-2403USA005260: US-009507513-2403USA005261: US-009507513-2403USA005262: US-009507513-2403USA005263: US-009507513-2403USA005264: US-009507513-2403USA005265: US-009507513-2403USA005267: US-009507513-2403USA005268: US-009507513-2403USA005269: US-009507513-2403USA005270: